BiomX (PHGE) 21 May 242024 Q1 Earnings call transcript

Hello, and welcome to the BiomX First Quarter 2024 Financial Results. [Operator Instructions] As a reminder, this conference is being recorded.

It's now my pleasure to turn the call over to CFO, Avi Gabay. Please go ahead, Avi.

Thank you, and welcome to the BiomX First Quarter 2024 Financial Results and Corporate Update Conference Call. available X:XX became release press just a.m. after The be our website Time today www.biomx.com. on can and Eastern at found A replay Investors section of on of available this our call will website. also be the

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

securities process potential conference sufficiency of the design, the and instance, using the statements and FDA, discussion forward-looking benefits drive related of the for For issued our of when we potential with matters company's and potential clinical in call of the potential to financing, BXXXX. our stockholder of opportunities, efficacy commercial matters and the expected we BXXXX are discuss approval regulatory timing and and recruitment, certain and final on or the ability stockholders, product connection the and results Phage Adaptive related combined market safety and candidate APT interim the the preclinical value opportunities to with merger, the Therapeutics aim, trial,

trial. results and not future clinical not clinical preclinical of and indicative as guarantee well addition, past our use In and compassionate current do as success are

our update Except cause press including release, we not as are forward-looking today's in differ as statements harbor website. outlined results do required from safe which statements. earlier, to risks undertake by full actual to The could on is law, provisions, that these noted forward-looking

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

everyone. morning, Good

will APT entity reporting in a this. with following merger time, elaborate first For on BiomX combined is for more the March, and Avi our results

now quarter company was new for BiomX. first transformational has than nothing the less into XXXX era. a The of entered Overall,

industry. mid-clinical which pipeline the stage With we with believe expanded leading the related in March, we in programs, phage constitute APT our have the merger

phage shipments We approaches phage ]. [indiscernible] are personalized natural focused diverse developing and [ now advancing on

our serious Phase cystic date treat or supporting second the believe advanced for stage clinical harmful we've in diabetic [ CF are diversity our promising underlying key patients. of With ] fibrosis or treatment therapy infections, of inherent added of our osteomyelitis the development. the II shortly. in phage The we a foot candidate shown the to review BXXXX most all product bacteria recent what we've are of data and in biotech approaches merger, progress chronic to seen I'll BXXXX, broadening potential candidate, already reducing and risk has pipeline, the our results mid-clinical DFO,

for accredited and the the potential of Therapy life important disease prospective candidates, of further advance provide gross Fund of their These to our Management. investors, new modality Phage of raised the with merger we the placement Management and Fibrosis including proceeds Deerfield Capital OrbiMed with Cystic the APT, and million and with the as area. validation private the the Nantahala each $XX Foundation, strength led investors the sciences additional existing Concurrently participation in AMR potential new affiliates of having care standard in by a of lead and therapeutic

respectively. the BXXXX for net Including data expected sufficient We XXXX, expects stockholders. for capital, our financing potentially Phase data to and candidates, proceeds could funding readouts XXXX now these quarter existing II elite multiple value third through including of clinical the quarter believe and BXXXX drive BiomX from significant readouts milestones the important our to reach and first of have in XXXX,

with our of II of the dive call, programs. had We are the into of to last On both part BXXXX with Phase the APT. thrilled opportunity our deep continuing take merger earnings I progress a as

are area patients with being limb and outcomes literature. potential phage-based wound in DFO, approximately in have outcomes XX the a placebo-controlled that to to multicenter of believe is diabetic according of with double-blinded, Phase avoiding need. scientific Control amputation. shown II and for DFO improve high lower literature personalized Therapy is use evaluated associated in an unmet greatly reminder, with year, of a amputations the subjects number cases by XX the compassionate there in approaches in is staggering in trial a aureus. which therapeutic Disease Centers We healing randomized, DFO, alone, caused As of phage treatment have the XXX,XXX of to U.S. the Phage of resulted BXXXX reports treatment a that Each positive This Staphylococcus XX%

Phase trial in has XX target, of ongoing II Findings role treatment XX% the already in of the on design XX cases XXXX. the the from Week quarter of on important enrollment track and with of remain to surpassed we played BXXXX, the first target of report these an the results patients, this

chronic were We main pulmonary a aeruginosa, BXXXX are candidates. the infections a mobility by Pseudomonas for stage also by for progress we and January BXXXX, granted these other of with is FDA patients caused this excited patients. Orphan Drug contributor the Designation of CF mortality multi-phage by our mid-clinical lead treatment of the year, in BXXXX. to fixed cocktail In the

Society April, positive safety Infectious Disease, and Global Ib/IIa of ESCMID Clinical Congress. we presented efficacy Phase a in results of at trial X BXXXX of recently, or Microbiology the from More Part European and

patients. second in to for Congress. as category selected the data Top In advanced in top the promising Poster, of the accepted published findings the top-rated believe and amongst for BXXXX Therapy We Phage first, submitted of the fact, abstracts of that most at our percentile date pulmonary treatment a presentation for ranking CF was infections the chronic

readouts. a conversion functional lung to now pronounced longer We've to improved contrast days potential treatment demonstrate findings in months, pulmonary shown Under to of of believe a we Phase which of treatment, both both in XX.X% has effect results signals and we much micrological of demonstrated sputum function a IIb plan treat duration trial, both placebo. after patients X aeruginosa for the on in more and and with XX only the Pseudomonas culture negative BXXXX

by alignment and FDA we holding reported plan anticipate all a end the completion a for by study to remaining clinical of protocol with C IIb the the to Type our the previously our the FDA initiate to discuss of regulatory relevant with is mid-XXXX, As CMC submit Phase authorities this BXXXX, work, development plans and meeting study pending year.

As already in we line results in XXXX. third of noted, the estimate releasing the top quarter study

key to with studies Phase have We pipeline believe in and are both in reported broadest II the readouts most XXXX. phage lead thrilled what data is the we promising in already program advanced

first to results. On this final note, our I'll quarter review Avi? financial it over to Avi XXXX now pass

Thank you, Jonathan.

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

cash XX, and which fourth March used to the was deposits estimates in XXXX. and XXXX, The offset are debt and net company cash, quarter in operating the March equivalent of to operations placement, primarily sufficient activities cash short-term the short-term of cash by were to of The million deposits repayment private compared its increase throughout the of XXXX. its $XX.X facility fund $XX.X million due As was balance XX, XXXX. March as partially

to the net totaled In of mainly of XXXX, and development expenses in because first the was offset due Innovation to Israel were million incurred $X.X APT related merger. trial the and quarter $X.X quarter million by the of less from end grant R&D first research payment CF of partially expenses the lower to compared expenses Authority and XXXX, that the after clinical the

to the of for compared same period private administrative first The the to merger $X.X the XXXX. and expenses were placement. million expenses primarily APT quarter and related General the XXXX $X.X increase with was million to for in concurrent due

quarter operating warrants were for the increase the the is to Net placement quarter the compared million XXXX. fair to of mainly cash $XX.X XXXX. for of The loss period in $X.X compared first was million due for XXXX used to Net million this XXXX in of $X in value $XX.X million quarter. private quarter that of first activity in to same was first change issued

like contain stockholders with issued not our regarding investment doubt ability our current This plan after continue and conversion emphasize concern. On going believe of about the the financing, the million. at explanatory closed have concurred financial as our a with statements to March merger XX XX, as risk fund concurrent the least our is substantial although an an that deposits merger that mainly approving of we convertible to was we the and investment. with months, $XX equivalent APT potential paragraph the cash stock cash, XXXX, of We to due to the preferred of sufficient part operating would short-term APT, will we

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

year this looking we're continuing so BiomX in the lot to and at far and a substantial accomplished into We've forward momentum to XXXX. XXXX,

the apart in recent us therapeutics, has and next us our developing million and to merger to now a allowed readouts pipeline top investments investors year. $XX data BiomX leader in With position development, as institutional expand key itself achieve set healthcare phage-based

advancing BXXXX our build stockholders. for By value clinical significant and is poised our our programs, BXXXX company to

has BiomX. reach seek the advance the financing, sufficient ESCMID to team addressing opportunities Indeed, runway our at additional for recent recent will As in company on we new forums. chronic candidates serious is cash to peer-reviewed it believe Congress, infections. clinical as our era we important a milestones important to continue present Based phage our

from [Operator from Instructions] H.C. Pantginis Our first coming question today is Joe Wainright.

Jonathan. questions, X So

I was your call meeting? to I and any your And going the about First, with been just into second to the year-end thinking efforts design varying facility? study, manufacturing Phase your physicians what additional additional for has CF, mean, talking curious, the you, or how cetera, et IIb in since your have there as of is been C the you've regard upcoming then evolution Type integration inclusion even in going the criteria, are question KOLs,

thanks and for great the always. as questions Joe,

on the study. first, So CF

hand-in-hand quite lot the Foundation. spent CF with we analyzing time and the working So a data of

that Phase So conversion microbiology that handle get some have to well the of even design address we've IIb, patients the of both trying the of endpoint. on I clinical questions clear to and think increase percentage a as obviously the experience trying signals and as we discussed good on

then end So Again, the and the waiting we're has year. matured. loaded FDA of to to locked the where I we're feedback initiate plan, for meeting, the If think the see think I I at we'll kind think is of study all and according is. that

there again, think I lot of upfront. far, work a was so So,

we feel think I good it. about So

DC, The these is simple the cases, companies. X of all integrate integration is in goes, those think task the lacked. access frankly, APT manufacturing compassionate have the strength I to into to that the capability, it BiomX think plays do terms access knowledge, way, strength So I so time plays the as think the I quite agencies, definitely kind right? not it's of Sunny But gorgeous. a weather out, the by to now And rationale in of governmental

think So to sort I feel not we're plans, every lot that I it's it's And the situation we But has teams clear effort. and ready well. there's of been traveling simple. a quite have go. been of work budgets approved integration, now proceeding Like very there's The and stabilized extensively. think

kind again, the continue So momentum to crossing of of and value. more fingers generate

Our & coming next is Jen from from Company. Laidlaw Yale question

got I here. Jonathan. X questions

question, treatment? of is study a II one, that And with First get then Joe's follow-up. adding one can Phase potentially terms have a that I which patients done, and a just in the so extension longer trial be proposing, part follow-up was after would that's an of the

Okay.

and we'll like follow already And think if we I X extend we're conversion. about Phase up the think duration, for seeing a quite long II we're So patients months. is the going whether

that I are think discussing. we're items these

experience extending depends there's I I think do think Definitely, think ]. be long would extend [ from we'll think of it. the a bag patients follow-up chance a I very will to how can on right? some we extent There to sure. in for a bay to see the dramatic. lot longer keep at that explore ], PA also [ I conversion feedback So want kind be that

the of one that we're definitely it's items So discussing.

And Yale, another had I you question? believe

here. little this questions is a Yes, I more bit fundamental do. And

that know lytic the has lysogenic we phage phase. virus the -- and sorry, As the the

us that -- most is the all state ensure a will the in be or you for killing your So and that phage of product how state function would a bacteria? retain lytic the of the that

are viruses think and right? question, like the the Conference. I big and So By a way, conferences analogy. valid do Viruses Microbes, good a It's viruses, the Phage yes. phage -- it's Yes,

sequence are your lysogenic, to has very advance the sure been I way is think actually which forward to clear on by that wanting not And making the all it address actually phage, point, study FDA phage the genes. again, right? to cocktail everything, have don't in genes. a as we few the approach, the that any lysogenic deploy, personalized such We the quite whether these or in DFO are

a a mutation. right? introduce There knocked that mutation lysogeny single lysogeny with is not change lysogeny, spontaneous off not It's no will we whatsoever. it's that So single

of genes So lysogenic the or ]. kind developing manageable acquiring probability of a phage is [

So and kind that's the other of the test such that of it's attributes to phage don't of generalized development. want part sequencing, have the phage all clear again, don't they those see characteristics as characteristics been they that product sure approach, in want what [indiscernible] making has and what transaction on undergoing see battery and the to what and very capabilities, a

congrats That's and very look talking And helpful progress on all to forward again, you. the for investors. to

Michael Ladenburg Thalmann. Next question from from today is Higgins coming

Two ] Farhana from This continued is Michael. your progress. us. on questions of [ on behalf Congrats

to EMA the is study? Phase factors The is in first us enrollment BXXXX. in on DFO And with also question BXXXX. second XXXX? with aligning Could gating you one, completing the Any II the confirm that

questions. good And

make of Just question, mean you compliance the the European regarding like sure BXXXX? first the to

Yes.

it. Got

Okay.

going So Part as question. recruitment then of the X not gained Again, as study, global we indication, bit already Orphan trivial. European a of momentum well all the Part talked So the sites. CF, had already good right? years, I is sites sites, a Israeli lot in a struggled But in was Phase think we've X. through BXXXX after and as -- in We right, We the in U.S. the the that Part IIa. Part X

to that's So going continue.

in going at be IIb. the study key. the much think to of Phase is I we're Europe sites Definitely, looking more second

I -- we'll a good and we've the think, I there's recruitment definitely U.S. continue very that. think experienced, in

of lines So and part works that's the that in and plan the the work presented. time we've

BXXXX, so enrollment well. is going

phage the morning, Again, patients enrolled. a We're this XX% these that of been bacteria. the are deploying complex patients to think verify want As have That's I bank. We the have indication. not studies reported trivial.

phage So ship phage we our that the and for that and treatment that a basically best means patient ship sites. gets. we We back, that to that's patient optimize the it

experience by challenges. So in of the now seen have we Again, lot studies. a there's with these system

think lot. I a learned So we've

well recruitment to but will to even it's expectations, We effort if put are can meeting we studies going and But so know far, we always -- rates. yes, try some it's difficult. improve clinical our

So we just the it continues way it hope has.

back or I'd We our like turn reached over the further comments. for the session. any to of floor end question-and-answer closing

this updates again, you. throughout look morning. you thank So and have forward year everyone, to for a with providing joining day. you the us We great Thank

Thank you. That does conclude today's teleconference and webcast.

thank line You We time, wonderful and at may disconnect this participation your have a today. for your you day.