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BiomX (PHGE)

Participants
Marina Wolfson Senior Vice President of Finance and Operations.
Jonathan Solomon Chief Executive Officer and Board Member
Dr. Sailaja Puttagunta Chief Medical Officer
Assaf Oron Chief Business Officer
Kristen Kluska Cantor Fitzgerald
Keay Nakae Chardan Capital Markets
Matt Keller H.C. Wainwright
Michael Higgins Ladenburg Thalmann
Call transcript
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Operator

Good morning and welcome to BiomX First Quarter 2021 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'd now like to turn the call over to Marina Wolfson, Senior Vice President of Finance and Operations at BiomX. Please proceed.

Marina Wolfson

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

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

the our required conference using in are and Harbor we're Safe results cause we noted website. potential earlier statements of call Except the potential undertake platform, forward-looking equivalents opportunities, to candidates. results is interim these of timing, the not do instance, For on our differ trials discuss our design, markets and of the sufficiency could by statements and release, preclinical, cash, we including update when and forward-looking the our capabilities outlined The final as to expected cash from actual BOLT today's as deposits, the risks press that momentum of short-term clinical pipeline on which statements. law, aim, provisions, studies, existing full and product and our forward-looking

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

Jonathan Solomon

bacteria needs. novel unmet microbiome and In remain natural to delivering the engineered first substantial we morning with you, of our everyone. across to the patients medical target therapies progress that synthetically achieving and goal committed Marina, we good and pathogenic phage pipeline Thank make in continue occurring quarter to of our XXXX,

which be are a in the holds is part lot field a the microbiome We efforts promise. of space as this to leading excited of

the conditions bacteria are Our are investigating. specific with of microbiome and diseases compromised we in approach the targeting the pathogenic strains associated that is strongly

our on treatment our potential we the generate microbiome have BOLT phage our Using options. with balance priorities, designed These to indications Our and candidates effective different in rationally are or healthy rapidly and we cocktail libraries of meaningful from our the patients platform, X-week in that restore proprietary clinically provide have and XX-week results we the from milestones to in natural, XX cocktails large next drug of treatment potentially the screen skin can potency, period as that the successfully safe for such followed and important third by the five program BXXXX a Phase as of the acne-prone cell quarter. a results and safety, phage X activity indications phage, expect readouts With months. treatment parameters a candidates of in include are stability, potential of clinical on advanced fourth from number period readout well development expected four the in within important other focus manufacturing. prioritizing as quarter based executing and ease

results from quarter the in for of cystic Phase trial expect our Next, and of BXXXX in Part of Xb/Xa the results X quarter Part we in program our fibrosis, in trial XXXX. second XXXX first of X this

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high IND of of knowledge, clinical in X,XXX XX Klebsiella approximately delivering the Additionally, IBD To ever and was forming phage best units, compared approximately phage a viable our its Food first to more stool pharmacokinetics the anticipated under this describing Administration study a gastrointestinal of the U.S. pneumoniae times orally delivered of the study of the an met plaque patients. approved the protocol. to Drug objective the bacterial viable concentrations tract to XXth burden equals which in phage

the we are in in the of expected either trial target pneumoniae in second evaluating measured in amount administered Xba healthy of PSC efficacy are bacteria this as XXXX. of BXXXX key reduction endpoints and results measured their safety, or quarter With Klebsiella the subjects BXXXX, through With gut. advance Results target of Phase tolerability of by to orally bacteria stool. to or hand, confirmed plan the program of these IBD carriers subject who

single for As we you cocktail with pneumoniae our November both indications targets and recall, may BXXXX IBD candidate phage into in consolidate a broad that one programs host Klebsiella strains. PSC range named XXXX, product

turn phage our Sailaja I respectively, over Cystic to and select cocktail of Officers, atopic further edge Puttagunta, program We call believe BXXXX will cutting to our program. our methodologies Next, or our the capabilities a turn cocktail we which as to BXXXX our Fibrosis recently Chief these ability platform. quickly validates indication, and program, announced the candidates CF BOLT now CF I Medical dermatitis and discuss newly respectively. will to our each in selected for phage that

Dr. Sailaja Puttagunta

their to BXXXX phage that morbidity candidate aeruginosa, The mortality the cocktail antibiotics. thereby target both causes treatment to extracellular resistance. courses assemblage time, enclosed And CF over to patients to prolonged multi-drug of of with surface-associated repeated directly to appear. P. selected with leading active one but options of Pseudomonas and strains the a in diminishes well patients to infections, and substance aeruginosa, Based into need and CF an polymeric potential established antibiotic an proof-of-concept subjects, preclinical of or and penetrate to resistant typically you, require of is studies. be respiratory current seek designed healthy newly suffering main biofilm, the is strains aeruginosa P. chronic we causes Jonathan. skipping and BXXXX various Thank available as the a CF. these trial could against in from profile chronic and in microbial safety the a phage, volunteer effectiveness bacteria due our cells contributor guidance, infections we of on toxicity antibiotic FDA, BXXXX the advance interactions has resistant

With leading physicians. the to address U.S. as fibrosis based CF a Company's cystic we as the closely of many patients possible, working as with network, network are development therapeutic desire effectively

of network. a ensure to steady and proof-of-concept of the that are the all parts this study are to X updating trial therapeutic a help programs consistency to we network As a the Xb/Xa Phase accommodate cystic fibrosis developing stage developing recommendations patient makes to order at result, These two the in Phase safety. comprised recommendations

fibrosis the this with treatment to Solomon discuss to clinical with X to investigator trial subjects the in in subjects announce as of Xb/Xa Nichols, infections, and I P. clinician the Additionally, the followed effective the closely Fibrosis Development to Results the this aeruginosa evaluate Cystic infections. of trial respiratory 'XX patients X expected we be ascending from and investigator Part CF. by remainder safety XXXX. second the first CF X. Part back multiple And of are in call Dr. trial single of bring experienced continuing by microbiological of We trial this chronic now, in turn look eight the Therapeutic our doses with XX this the us Jonathan dose, population David a and Results have X over of XXXX. of X quarter safety, forward will chronic to assisting cystic with BXXXX as Foundation Phase pharmacokinetics, academic Part principal activities clinical days from Part evaluate to of that pleased BXXXX to treatment that will will Part CF expected and aeruginosa of through with programs. are confirmed respiratory Network. the P. trial will same quarter work are safe order are efficacy an to

Jonathan Solomon

Thank you, Sailaja.

a designed known phage to atopic the The healthy have with associated is aureus target Turning abundance flares. the the atopic patients. to dermatitis dominant and of bacterium program, S. non-lesional abundant when recently cocktail experience our Staphylococcus exacerbation be lesional we attention patients over inflammation becomes or more or aureus to S. to bacteria aureus also dermatitis. patients individuals atopic skin in a BXXXX development selected atopic compared skin increases of in skin dermatitis of and targeted dermatitis of

XXXX. Phase safety dermatitis of results first the and expect in efficacy clinical the BXXXX We study half evaluating in the patients of atopic X in proof-of-concept

found today and Colorectal to colorectal be engineered designed which Finally, tumor the strains target to we're in developing a tumors. is small discuss program scarcity respond of antigens to colorectal we'll Cancer of only phage bacteria lack in immune which immunotherapy, tumors. of and cells cancer synthetically Program novel percentage the cases of to Currently, is due last new colorectal our believed

approach hard impact. enables Our or cancer are to tumors the directly deliver therapeutic reach to that to payloads phage

species that and in nucleatum therapy observed that nucleatum our is target colorectal enriched a tumors. F. can vitro bacterial have of vivo strains in Fusobacterium We or phage in

We are target in from while of results and also inhibitors quarters with delivery third the to proteins, second checkpoint such evaluating bacteria. studies XXXX. combination phage exploring expected are tumors as and the of of in coatings GM-CSF payload our and immune-stimulating animal colorectal IL-XX, therapy the eradicating phage-mediated dose Preclinical genes use

potentially XX indications in progress four quarter our in results next described, just As the this meaningful up sets for months.

health we restoring the using As we development bacteria safety the better microbiome space, to mid-stage the microbiome drive conditions. in-house With therapies in diseases will on by continue options. toward potentially our have understood remove capabilities of provide all chronic to phage, patients that to pathology insights with to opportunity we and treatment the in advanced and provide of phage

for clinical therapies to possible well excited safety are efficacy existing continue We indications. phage indications of as and investigating the new as

Before hope leading look in our Wednesday, a.m. May XX be Operations to like for event we turn the event and the Ryan be that keeping restore like President very for mention believe our us. Senior for expert to will Sartor, BXXXX considerable progress. is you I virtual over Marina of We therapy IBD, condition. renowned to Balfour on quarter I'd the our I this Dr. the the at cover discussion, to with will informed We to for we'll Vice will the phage Finance a XXXX. a balance of and X a Time. of KOL financial on results highlighting to now interesting academic conclude, treatment Eastern first call be that would forward microbiome you Wolfson, there in potential join holding This IBD

Marina Wolfson

Thank you, Jonathan.

like candidates. increase and is current to activities same expenses least will due Research our As a mainly associated administrative in compared call which be period expenses to of I balance clinical as to also as in Operator? million short-term primarily is for $X.X three $X.X we until company, and XXXX. and XX, The $X.X later short-term salaries reminder, of activities, for existing in the compensation in same issued for number compared to same be million million of Form of $XX.X financial more was through of to stock-based the in million expenses, questions. of compared and due release of and in $XX.X as quarter now million and million cash, $X.X million the operating million same to Net the a clinical will XXXX. million the related filed of preclinical the stock-based open XXXX. such the first plan development and 'XX, walk cash loss cash period in to in XXXX. employees as earlier period 'XX operating available $X.X are mainly Company's directors' in XXXX, the to $X.X of used compensation, and growth in is to in product detail for information equivalents We today. the XXXX the quarter XX-Q, trials fund estimate We'd of expenses due for ended the conducting that $X.X brief March the primarily XX, number General and XX, R&D, public million and growth our of and compared compared sufficient salaries insurance. related first due our quarter and XXXX. the for related deposits Net officers' the deposits in March first at with will months mid-XXXX. press The you expenses, today increase period Cash some increase expenses to to and XXXX December $X.X an operating employees highlights. with to were the the of

Operator

Please Thank your [Operator with is proceed we be line you. will question. Fitzgerald. conducting Kristen At session. with the Our a Kluska first this question question-and-answer Cantor of Instructions] from time,

Kristen Kluska

Hi, for completing my acne everyone. enrollment the study. and Thanks questions on congrats in taking

question first I have a picture here one. The is big

the a comparing some past years might the strains. that resistant and was there antimicrobial the that highlighting also of diverse authors So, in microbiome recent in more has study up Nature, the published microbiome to been samples highlighted that from have old, were more present the X,XXX

composition familiar sure of how prevalent with how more you not believe with this evaluating? the and So microbiome if to some indications particular including ask correlate paper, chronic but could overtime you're of this you're I wanted changed has and some what

Jonathan Solomon

Kristen, and Hi, avoid of you a the kind think, a greater follows interesting that think And the engineer you're with need familiar loss paper, general, think, more before. this it chatting morning. more on see of very papers work pleasure bunch to there's resistance. of I microbiome. in diversity Very of and I I And precisely antibiotic

is essential think, with we're I dominant that niches, role picking kind And of we diversity. without will So pathogens, in feel second, this specific some of BiomX, A seeing causing that, material play the occupying up an at blasting just loss microbiome of in what more antibiotics, they're it. which these more

engraftment kind enable up of a with can phage, of open niche diverse more So we and the bacteria.

we're need as therapy all all We chronic research, think from I antibiotics need diversity. indications. So a all it for what We saying greater supports avoid across, using these in right. to

Kristen Kluska

resorting us therapy approach phage platform hand current necessary some need a you because and pipeline into to new remind laid indications you're the of to efforts BOLT personalized bank then And the to for what also this. rapid and phases then, progressing the as keep the along it finding go would to you out? to you've within on timeframes And have if expand work phage

Jonathan Solomon

Right.

a and in the at water, we're Staph strains. our of of in an cocktail, you quite bank, early cetera, want is skeptical, of like I whatever complete. it PSC. been within months, took or had were we BiomX, both actually and morning. BXXXX, out phage to think was and don't investing with from that And three can whether a we of to that XX% the that targets I covered in that body And a years collection So, large came That strain BXXXX, can we conclusion instead investing various of with IBD large when would et discuss the broad two we a you infrastructure it progress, us it's undertaking cocktail cocktail phage in the think think which two, already almost aureus has see sewage, sample now

scale pipelines kind move how of think seeing mature, we quickly the handle, economies optimize I of of our the and robotic infrastructure. you're platform learn and So to computational as sort of all and

Kristen Kluska

could you Thanks. through a study, walk dermatitis And to trial? the potential why for evaluate you atopic decided eight-week

Jonathan Solomon

Sure. that I'll Sailaja question. address to let

Dr. Sailaja Puttagunta

and you, Thank Jonathan, good morning Kristen.

in would the So, the immune mechanism where change because then a of downstream atopic dermatitis phage the the if of Staphylococcus, of and of to hypothesis that improvement. clinical is, action reduce burden response bacterial the we lead

us So, allow burden to reducing to allow bacterial of of effects accommodate eight-week at an that, the to the period detect we to downstream wanted Staphylococcus. least

Operator

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

Keay Nakae

to the you've BXXXX, BXXXX, items wondering advance into given studies? Jonathan, report the you to various data before what us studies. clinical the and respect timelines with BXXXX the are gating from I'm these actual

Jonathan Solomon

good first, a Keay. so Right, was morning, It pleasure.

at generally no phage of think you don't is BiomX, that studies. approach initiation So the of go volunteers on straight talk patient. know, give I right? this you healthy study, can no as is So But using advantage There's guidance we study. to there

the So most in various gear think these that we be causes At to quickly on. before, these timeline straight the GMP in that goes we stages why look promising. move back, kind very clinical and maintained that's point, put up are updated to study. cocktails And together say are think, can of Kristen get manufacturing, for ready manufacturing, of phage of question brought I to currently we

Keay Nakae

both an compound? you on of to enough And we Are BOLT from in large get to numbers and design, zero kind the optimize about to these patients allow capabilities that ideal CF in advance. learnings to fully the Okay. platform think the use ideal to initial the formulation ability to study terms of when of the to

Jonathan Solomon

question. excellent an It's

I think we get are going But our exactly that composition We and know from strain have. are part there CF, studies. so after thinking patients rationale, patients say of have how The the therapeutic data the some know we're this. their that that we're development were case since the data we these Foundation are would to more know looks a all what from your the feel network, in effect, basing dozen CF treated benefiting We right. material again point, of to treatment. comfortable I support we the and studies, lot

far, So very these a can the to that and and enough the to could final we we go-to-market. use product that platform information, be feel But BXXXX needed will if these tweaks. looks BOLT think promising be we tweaks make there make

Keay Nakae

And the acne on here, From Okay. tabs readout, guess I no the other, enrollment. sure enter the to to completing to what then back when need guess Congrats equation? get do we you make I study. close unforeseen the into to just on keep variables that,

Jonathan Solomon

clinical the the Keay, clarification or Yes, you from just or? business question, Jonathan. first, like Q a aspect - mean Nakae Keay development

Jonathan Solomon

From I'll address the aspect, clinical to okay. that. let Sailaja

Dr. Sailaja Puttagunta

you, Thank good and morning Jonathan, Keay.

terms on there So don't and believe in endpoint to and at from results are that study we completed very the top-line are track and obstacles, we X-week this yes, of deliverables, enrollment track we feel affect QX this that deliver XX-week variables we point, endpoint in QX see any in on in pleased year. to we major from we're unforeseen this like the deliver. of Really, then those Keay

Operator

with Wainwright. line next Please the proceed this At question. from [Operator Pantginis question your Joe our this with time, and Instructions] of H.C. is

Matt Keller

discussions identifying data BXXXX, it the Good you how This into Related that of impressively showing gut Thanks I’ve to in do the when one dose And FDA Joe. shown. question. PSC you. for road have Matt see the down for is are guys everyone. you're on to levels got previous Keller taking on the based high morning, range? possibly minimally dose? How comes a right possible you effective you fitting relatively, confident for

Jonathan Solomon

Right. morning, Matt. Good

over abundant rather feel the of levels at we've we seen as think bacteria. phage I confidence is levels had

to field, internal our what given target have every studies we XX want that around from know the multiple for usually again, you work So bacteria. phage is

thousand times levels a were that. As higher achieve we which a than reminder,

gives an stayed a the that with us So days. there's phage fact for window therapeutic so abundance definitely few good of a that level together high the phage,

clinical In So a down with with because Again, It's goods get titering is to can of I'd say, phage study, to strong issue. practical is next you in do doses. we're levels we there's should not bacteria the general, an detect not in due exposure go if effect. abstaining But that hopefully the high fairly studies confident and prohibitive. maximize want actually we accounts. see highest the kind reduction a cost that a to being currently, into these significant to trying chance not what that dose we're moving the is of this the major effect, we a initial start

forward the move with dose, titer can the we a in bit we think I development it clinical current but So down. was know later

Operator

with Please coming with proceed is Thalmann. question of Ladenburg line from Next Higgins the Michael question. your

Michael Higgins

Hi Question the studies. guys, for taking congrats continued I couple the couple guess of X/X question on Phase the on on you progress. -- thanks for a and

Specifically range at Phase portion in be what again specific of range the you. bottom by lower Thank sort numbers some to of and from are tested the quantified CF, kind to expecting least Xb interesting? a dose in

Jonathan Solomon

address Michael. question. Sailaja that Good morning, I let

Dr. Sailaja Puttagunta

Jonathan. Yes, thank you,

going start Xb. higher so in but Xa dose CF, be be like end other terms issues plus here logs we'll will the original going in -- don't That candidates, that the the two we're And of dose multiple phage Part first, Phase we, we and dose. will in anticipate the any rapidly terms of and one. anticipate to single all dose of dose single through than phase is in a with specific move moving the our and with there safety into testing that study of the then change, into So lower single the safety

Michael Higgins

doses a may follow-up provide atopic just study? tested What same you can that of And of what in I question, then suppose. in you. quick be dermatitis terms Thank for terms us I in

Jonathan Solomon

it. for Sailaja, please go

Dr. Sailaja Puttagunta

Thank Okay. you.

human relative study, believe we're one only to do in that study, and forward the the in we first placebo be take that that, in to will atopic effective dose move the that So, the dose. dermatitis planning

no for planned So, study ranging dose there's atopic dermatitis.

Michael Higgins

What this you follow-up gives the confidence X? I that. is guess on you take Phase into to right a that dose found the

Jonathan Solomon

I jump So can in.

rash to-date usually, atopic from on seen that want I what go that, we've the here the can. And knowledge is benefiting highest think is dose we we seen acne, derm we've to in with the right. that

no Sailaja mentioned, is good As limiting there way to confident that's the therapeutic feel you can window. phage proceed. toxicity want feel And calculate we we we're ratio of the a well dose again, to that to bacteria and within

Michael Higgins

and great atopic you atopic [indiscernible]? work limited from That's follow-up other will study? gels therapies How kind it treatments? using you dermatitis. other in all-comers just then Are is of a steroids do one they think Or on dermatitis an with and this

Jonathan Solomon

the the to can general study thinking Sailaja address let's clinical about I approach with just think other of and I phage talk therapies.

So ahead. Saliaga, please go

Dr. Sailaja Puttagunta

Great. Thank you.

based changes comers. we're So, much therapies be of existing terms major. taking for that all sort exclusions have really on, There any washout not and been periods some the but of planning nothing that will are there clinical study, pretty on in the we patients

Operator

this over turn for At floor Jonathan the I'll remarks. you. closing time, Solomon Thank to

Jonathan Solomon

as months. we're four thank next to to wide well therapies conditions clinical and of So this I in the develop morning. continue BiomX the meaningful patients clinical with months, a trials. the you want readouts our everyone, to for us and XX joining hard worked few BiomX as who shareholders see the next wanted It's support exciting team, range for a thank I to participating to phage excited period actually in the very across for

wonderful any day reach everyone to and please have So additional us questions. please you a have out if

Operator

will conclude conference. This you. Thank today's

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