PHGE - Earnings call transcript Q2 2021

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Operator

Greetings and welcome to BiomX Second Quarter 2021 Financial Results Call. 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. It is now my pleasure to introduce Marina Wolfson, Senior Vice President of Finance and Operations. begin. may you you, Thank

Marina Wolfson

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

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

release, additional the in to provision as as of actual product risks before press by on cause to outlined undertake Except potential noted up statements. instance, the amount equivalents do our if update studies discuss XXXX of and opportunities, met from The fund full earlier, the Safe we trials, until timing, using sufficiency call Harbor and tranches to which the website. results the For not are the our to deposits, operating we're debt the markets today's including expected cash preclinical forward-looking $XX mid aim, in law, differ that XXXX, interim statements at and platform, Company's we least could these short-term potential full for BOLT our candidates. milestones million until cash, design, statements on forward-looking the potential the existing when and current required final or runway, is forward-looking and capabilities beginning results certain the cash our of our are with plan loan conference of clinical of

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

Jonathan Solomon

morning everyone. and Marina, Thank you, good

Company next have me Let the in multiple how the about year. excited by are catalysts will saying start the we

data In work rich of Company's successful, history is hard our our most to dedication programs. expected all of the entering readouts view, transformative represent could period these for team. if the event our one with are the thanks We all stage four and company. This across of any clinical a in our readouts,

We half more these to important of also second enter sufficient the capital with than XXXX milestones. reach

this As previously announced, million sheet this BiomX in registered offering. from up strengthened debt existing with financing Directors, $XX in companies to balance for offering, and the Participation confidence of customized a of last new by Capital, from included both month that a and of whom offering direct the further markets. completed also We investors, our also Board life of science leader in million. and gratified show financing technology-related the each access $XX participated of was in debt of Hercules

us until tranche million provide middle closing. at become $XX achievement tranches $X debt upon the the financing and with after first is two a available of of million supporting will least of full Two available with milestones. These The subsequent certain runway XXXX million the of cash XXXX. us beginning $XX upon

made of in our up in the clinical fourth acne and X meaningful with through XXXX. for mid week to potentially quarters results four four Now, be XX indications Starting and track XXXX, to-date enable briefly clinical the the to have to program. reported progress summarize we third respectively. line are periods let on programs readouts me in Top different us our to treatment

study enrollment was that We May in XXXX, weeks the we previously completed report two XX, on ahead of pleased are time.

all of completed analysis, together made assay even we eight-week this Given conduct to eight-week a blinded the completion, analysis earlier, if only in study can can confirm week study full analysis communicated bundled of guidance good until for have after forego readout this decision report data. the status be will samples. of that interim and timeline X-week previously microbiological we XX now XX available the October, and earlier the prior progress, with end interim the and eight and be XX-week continue Therefore, weeks and week our the Hence, together. for week, analysis, the planned

acne-prone As of or acne a an subjects of the the is Key comprised tolerability which on acne XXX The of phage safety, in gel naturally C-acne, moderate reminder, vulgaris. in Cutibacterium endpoints that appearance cosmetic study BXXXX its with mild clinical the a of of occurring in study X pathophysiology include implicated impact the BXXXX vulgaris. is topical Phase a cocktail skin. targets to is evaluating acne to addition

of be ascending resistant In Pseudomonas as BXXXX parts. background, BXXXX will activity require aeruginosa an way Part morbidity time cystic bacteria and both fibrosis from be that dose program, aeruginosa, to meaningful aeruginosa main associated infection BXXXX XXXX. active C-acne skin the of network, well cosmetically with in to and will X Pseudomonas a multi-drug safety BiomX CF. are causes reporting for various courses as compromise assemblage diminishes look on Phase forward repeated strong results safety, CF efficacy chronic Xb/Xa microbial improvement upcoming is for respect development the for in cystic the patients burden. respiratory single be We Pseudomonas whose will with and cystic are multiple of long a evaluate microbiologic from doses X chronic contributor to leading days with have penetrate a months. to in P. treatment as of chronic to infections to pharmacokinetic, a will biofilm, effectiveness the two our the aeruginosa eight by over resistance. and strains mortality in against CF lung different extracellular enclosed antibiotics, designed Results suffer target of evaluate therapeutic quarter patients strains in a in reduction the fibrosis, fibrosis of conducting We cocktail this has X fashion, these over chronic or clinical confirmed in of evaluate respiratory antibiotic polymeric of acne-prone cohorts resistant By and potential appear. expected With candidate of a typically respiratory one phage to of BXXXX trial patients Pseudomonas and and CF cells surface consultation of substance subjects in drivers the the infections. and to infection. aeruginosa an BXXXX that of XX followed antibiotic XX of first Part trial Part is

of results this X, of Part As are the XXXX. expected X in trial by Part second from quarter

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

of in the first proof-of-concept XXXX. We of results expect BXXXX efficacy Phase evaluating half Xb/Xa the clinical safety the in study and

direct either target Xb/Xa PSC Klebsiella bacteria subjects of safety XXXX. disease advance as trial and a in During XXXX, placebo and the of bowel by include or healthy of gut. or second a pneumoniae confirmed Phase sclerosing or second arms four-week in inflammatory program will quarter dosing the half controlled target designed Xb/Xa of Phase into the cholangitis of study is primary tolerability The of to the Results efficacy IBD the of measured bacteria expected clinical in their reduction stool. amount to BXXXX. the BXXXX are subjects Study plan we the carriers

preclinical a tumor new let cells briefly of the immunotherapy. and CRC Finally, is to small the percentage be of and lack on and antigens colorectal program due cases of respond touch me or to only immuno-oncology Despite colorectal scarcity limited on tumors. to CRC. focused immunotherapy cancer, of This success novel response immune our believed cancer

have is tumors, in target to deliver plan can enriched or to of and of nucleatum the our We F. these and bacterial such and to nucleatum load bacteria. target to with therapy genes species also material colorectal as phage vivo Fusobacterium intravenously a tumors vitro proteins administer is believed while pathogenesis. dose in coatings immune-stimulating that We payload to reducing in FN, strains highly contribute observed that phage

successfully progress. Operations to program on you of in Wolfson, financial to this have and ethnically our results our payload phage I'd We IL-XX of of keeping second to the for gene in review into informed atom an quarter plan our look and over the results We fourth the XXXX. Vice call Senior Marina XXXX. to Finance like engineered President we turn our quarter preclinical announce to forward

Marina Wolfson

Thank you, Jonathan.

The including XX-Q, XXXX, short-term as of Form debt does some issued $XX.X we recent and available we million financings. through also As in the not and highlights. brief This December I of a our is with include equity balance figure detail later XXXX. cash to release was XX walk as that will financial reminder, will in today. June capital deposits, in compared obtained the our $XX.X of our XX information today be filed million more earlier press which you

financing in Capital debt Importantly, for with our corporate million our during purposes. $XX cash R&D Hercules July $XX up extended and million equity a and trials, August, efforts, runway funding balance and support our we have sheet strengthen clinical secured to and to general from

the the period. for million and primarily increase will were compensation to with General that the facility the public cash, upon salaries also of in Israeli the increase equity quarter that debt second of debt closing $X.X financing XXXX, operating by increased the increase into activities Net and and increased $X.X of full plan XXXX, The expenses beginning moving million million clinical completed $XX.X compared access the and to related for of compensation in associated conducting six close expenses at million million period short-term loss the such same were have and his million of as of administrative of June $XX I'll now, of the until period current an achievement officers and existing the the venture XXXX. operating due headcount due the first a amount up due $X.X We be first to grants we in assuming Increase that and cash of employees. The sufficient ended call back the XXXX, million And the certain was new with we of mid based for the during and clinical to additional of tranche $X.X of development in to and estimate is as XXXX expenses period expenses, for and the compared The $X.X fund months research supporting and was and offset tranche and were mainly research company, compared milestones. Net an for second venture deposits debt and of in primarily was $X.X quarter product Net least million related of over same period and Company's of stock Jonathan? directors will XXXX. our cash Jonathan increased equivalents our the achievement to with the available insurance the to salaries personnel, and same to activities $XX second turn agreement, of XXXX. the XXXX same premises. compared is million used staff-based candidates, number milestones. in partially to operating preclinical Authority a quarter to remarks. us to XXXX, XX XXXX. with million development recorded until the closing expenses for Innovation $XX.X

Jonathan Solomon

Thank you, Marina.

by me readouts. entering that data saying period we an for exciting clinical truly Let ahead are BiomX, our of a conclude

efficiently indications. our in-house and ease to enables for in clinical based and inherent all the data a The clinically at parameters in rapid as investors, capable us readouts our platform on phase data large of cell of testing a phage build BOLT as And that screening to upcoming The in-house BiomX's I XX the opportunity candidates BOLT of potency, phage important what of reflect to clinic. of various novel acceptance XX activity project the patients important combination pass generating and spanning field. broad four number capable BacteriOphage remind BiomX therapy Lead a with as along platform our approach drug together discovery these development with Treatment and stability both think unique that enables and develop facility for us safety clinical portfolio is programs diverse to development, manufacturing. platform other within platform. candidates an speed. specific a it's a libraries microbiome target helped months Having safety, to pathogenic from efficiency compelling such such formulate makes unprecedented within initiation. or is all manufacturing manufacturer potential GMP the optimization capabilities of bacteria discovery of are This well phage are of proof-of-concept

developing As effective treating investors on look to restore the forward in updating for approach this our of like safest we X open medicine We'd now bacteria microbiome clinical of related precision disease, natural most and means questions. represents to we the XX over a of and pioneer balance to that based our the programs that months. Operator. lead the field, next to aim healthy believe call

Operator

Thank you.

your session. the Michael conducting [Operator comes line a with Thalmann. of proceed be question. Ladenburg with now Our from will question-and-answer Higgins We is instructions] question first Please

Michael Higgins

progress. questions taking for Thanks continued guys. afternoon, the and congrats on Good the

such, acne your now. making give going XX looks just X and more insight up you us XX separate? little one, specifically the a on timing and late in to the as the Can together into and October First X for coming in data as like releasing decision

Jonathan Solomon

Good and you I on of more let program, Michael. the can progress process. kind Great into Definitely in have excited decision details to you. about the morning, the give Sailaja

Dr. Sailaja Puttagunta

Michael. Great. good you much, so morning, Thank Jonathan, and

X-week enrollment reported So as of the analysis together, if continued make we earlier. with we've for progress acne, study XXX pleased time with reported sooner enrollment that the dataset turns report earlier, on the that, able microbiological been And about the the the schedule we completed conduct to points than it to bundle very were XX-and we patients study. the entire of of we And as ahead good weeks out two thought. with we we in

difference a treatment interim only analysis, reporting, XX-week the completion the few just was the set time after so complete between versus And the using data the X-week of period weeks. point

didn't study status. and to combine analysis interim end continue them done. for the us of make later the it interim would blinded at And separately. a to than week the sense so, XX And the few this have analysis do analyses all the and X we decided therefore, of deport weeks been Do just

Michael Higgins

curious. Just are be of This Are think for data? I heading a any investors able NDA a that, this would follow-up is towards an filing. you see not to

its So just curious, you Thanks. guys the as are building? able to see data

Dr. Sailaja Puttagunta

data, do we can would We we treatment we the blinded any remain No, obviously status see battle. a in data and study. with as by blinded, not or monitor the

Michael Higgins

appreciate And big Okay, then is one this that. follow-up another and one.

So I'll stop here with this one.

can can Given acne, it on news, Thanks. or active the with for That can the applied, being they're -- under and specifically you the series is describe if us peroxide news, have sorry, given the obviously describe not? for which microbiome are off if treatments you benzoyl environment. in allowed start allowed environments pages series I'll impact an your

Jonathan Solomon

Sailaja, want to address.

Dr. Sailaja Puttagunta

I'm I so the sorry. question? repeat please you sorry. am Can

Michael Higgins

interesting in guys your for Is to about, are what phages defer be allowed? just comments Sure. being it's exact here? of how just are news of that Yes, may which from following different no peroxide applied, being hear your environments acne? series problem. the I example, But in the in was about sort Thanks. benzoyl brief, to you

Dr. Sailaja Puttagunta

Sure.

allowed just that in for acne are other It's or not benzoyl no, the treatments other placebo the allowed. counter or peroxide are So the facial study, the no the allowed. is either study. And over topical

did so back. reported the this out exactly first way Jonathan get The, study as for this is data, the should series year. that earlier be And same the we that on

Jonathan Solomon

you jump can Because up right. point, bring in. important think Yes, an I I

And in field. it's disappointed to we the bloated a very series think I data IBD. see were all

approach think, general, phage is I very differentiated, the right. in

a adding bacteria. not we're phage, of use First

aspect target, important rabid exact an the specific that think patients our high if because IBD, I the in of approach, is to case of of actually XX% Klebsiella. of relevant levels look only phage right, have you is the Second, where

IBD So, approach. you And single broad think can't disease, we don't is a a use right.

patients is that which of something high this to of the manifestation bacteria. specific need You level have

the difference, right. So, key that's

material is I right approach think healthy [ceris] to important and volunteers. another aspect source use Secondly, in and fecal

they've And I bank, issues well produce in use phase. host or are it's the same approach necessarily we phage that we product. these think And defined past. bank, our consistent So, not robust had a

So, that's product at we're very it's it. a consistent and looking where

Michael Higgins

allowed treatment that are and Just CF the to dermatitis. the of follow-up the in the What atopic in meds are patients?

Jonathan Solomon

Sure. Sailaja, please ahead. go

Dr. Sailaja Puttagunta

Yes, thank you.

with So I'll study, start who with are cystic aeruginosa pulmonary Pseudomonas infections. have the CF we In chronic programs. enrolling that patients fibrosis

inhaled cycle of are generally on either off patients standard of extend taking on these continuous So a care XX-day as basis part on basis. or antibiotics an

nebulizer either medication remain are phage will whichever they And treatments, those receive and and use medications will group as randomized or the patients the antibiotic modulators those continue those modulators tobramycin cyclical antibiotics, and used of to on will top allow on the allow top CFTR antibiotics. those phage of inhaled basis receive their so of doing. in we on in or continuation of on we others placebo, And to are standard-of-care allow that nebulized will well. as Aztreonam CFTR the to U.S., especially of the CF on patients that other

CF. that's So

For atopic colonized moderate to this be this atopic we who will dermatitis, enroll patients a with formulation. topical these with plan staff, to study, gel are severe and dermatitis in patients

and and requiring that not for are to off, wash a them biologics allowed will allowed during products other we come medications the use topical that be atopic only the other are who their dermatitis, for study, the So of study. allow of those receiving off systemic period study, topical will patients to course washout be that into treatments

Operator

with your proceed is with Our question. Fitzgerald. of the from next line come Kluska Please Cantor question Kristen

Kristen Kluska

these lead went continuing worked about remind Could personalized indications conditions? play first extent what help your to role antibiotics from targets specifically therapies what of the harmful earlier recognizing and/or into us you they that with come targeted validate do that validating across bacteria And and approach limitations? the is these phase. other comments The just these one then your for have while I

Jonathan Solomon

Sure and Kristen. good morning,

So, right. the you I programs, if different look into think

safe in overcome are it's here resistance. more antibiotics with terms the therapies right. what more know for prolonged think treatment. acne, in We biofilms I better we know work patients I effective these they of most of and now when We they we and and and validation the antibiotics, topical In acne responding parameters and mousetrap. component. CF a to going breathing program, just become That's therapy. and improve patients, trying look but to provide major due kind C. there's antibiotic the CF, they right, and basic is take after, If and different do trying topical antibiotics. care every overcome We're issues for is we're a Biofilm timelines, to more to formed antibiotic know for know building basically sensitive, usage in that but of better We're use. just of resistance. that more stopped

that So think of I use lung now we've even antibiotics phage have resistance And effect. these [indiscernible]. capability. here with and [bacteria] -- moreover, new and use coming antibiotic. compassionate of antibiotic being historical system. germ, is microbiome were Staph in an UCSD we're that chronically, cases improving bacteria can been evidenced derm Same have right is just immune of even up up so chronically with reducing there cannot treated you whole patients their messes evidence forte atopic again, in did right. it's with of that an target effect right, in the that improving well There reducing atopic that messes treated not antibiotic bacteria only in again, just reducing thing patients It And resistant is And as overcome likes studies IBD, can cannot having out capacity. shows be option. as antibiotic has This successfully, antibiotic CF the the this not phage aureus

IBD, published very was work it's think all that Honda. approach. a clear I Professor And in a for the Kenya based there's precise on by So, need excellent

Kristen Kluska

Do XX% you so whether K. clinically in the levels elevated see of pneumoniae And on on composition across PSE patients as this hope and see that start here IBD amount at Great, look to be studies, what the with measures healthy some the of longer have study, where considered an And for know and well percent reduction you correlation you wondering some from the or the that. looking these disease? Appreciate internal relates thanks. you reduction that bacteria, this have of with as then the of effects would to then of goal of dosing? it moving meaningful or to might to four-week patients. the then microbiome other you as IBD

Jonathan Solomon

log a point. again, -- I difficult reduced think There to studies this I think still half at that historical it's it's log. have are by a

we've The is even itself be So, signal, weeks to happens greater which think population of some significant if is But seen that. the I can when IBD is longer, a bacteria. patients probably planned question four other get what since we numbers a the we reduction. like see go to study in the

even think this so microbiome the in and want around time reduction a we I range greater want also Hopefully, see in to might the longer see get it reduction. then be greater So going that over to competition, effect. to of is rest we study,

Kristen Kluska

question. taking the for Thanks great. Okay,

forward acne data Looking to in October.

Jonathan Solomon

Okay. you. Likewise, thank

Operator

from [Operator Markets. comes Chardan question Nakae proceed Please questions. Instructions] line with Keay the next Capital with your Our of

Keay Nakae

data, result Jonathan, as a of good be? the us give anticipate would we sense acne efficacy what a

Jonathan Solomon

that. on I'll let comment Sailaja actually

ahead go Sailaja. So

Dr. SailajaPuttagunta

and Jonathan good you, Keay. Thank morning,

duration change to that in burden you, of in C. of see Just a appearance for clinical acne study but was that correlation of reduction, also we So phage the saw a what able to longer the study? bacterial would was good of the we see remind the reduction, some that the terms in in skin. prone with acnes? treatment, study And here be this acne the what of the expect meaning, outcome reduce to first

Keay Nakae

see improvement your the needs trigger? And in they'll to a say of threshold partner before there potential collaboration that pull specific is

Jonathan Solomon

jump can in. I So

pursuing -- and this a relatively cosmetic test obviously think study. I small is we've

signal, significance but -- very see Not a a people are for a treatment and indicating to this looking So placebo. want not necessarily a that need for separation there's do signal since it's we right. statistical a large between study,

Operator

at closing further I are any to There management for no you. to like comments. time. Thank this the back questions turn call would over

Jonathan Solomon

to I [indiscernible] for again which you I this of clinical as patients for well innovative all therapies the as questions. in BiomX, into our thank Thank to our clinic joining out participating us wanted shareholders you. reach So thank morning. to bring is support want Have phage please team their trial. and any to our a you wonderful have and day, if us testing,

Operator

Thank you. you participation. conclude for Thank This does today's your teleconference.

your this a You time. Have may at disconnect day. great lines

BiomX (PHGE) 16 Aug 212021 Q2 Earnings call transcript