Q3 2025 BiomX Inc Earnings Call

Speaker #2: Good morning and welcome to BiomX Inc. third quarter 2020 Financial results and Update Program conference call . Currently , all participants are in a listen only mode .

Speaker #2: At the end of this call , there will be a question and answer session . As a reminder , this conference call is being recorded .

Speaker #2: I would now like to turn the call over to Marina Wolfson Chief Financial Officer of BiomX Inc. . Please proceed .

Speaker #3: you and Thank welcome to the conference review the call to company's third 2020 quarter financial results and provide an update on our business and programs .

Speaker #3: Later today , we will file the quarterly report on Form 10-q with the Securities and Commission . In addition , the press Exchange became available at 7:30 a.m.

Speaker #3: today Eastern Time and can be found on our website and BiomX Inc. . A replay of this also be available call will on the investors section of our Com website .

Speaker #3: As we begin , I'd like to review the Safe Harbor provision . All statements on this call that are not factual , historic statements may be deemed forward looking statements .

Speaker #3: For instance , we're using forward statements when we discuss in the the sufficiency of call the company's cash . Our pipeline momentum and milestones , design , the recruitment , expected aim timing and interim and final results of our clinical trial .

Speaker #3: The timing of lifting of the FDA clinical if at The all . of the basis clinical hold magnitude resumption of the VCs for clinical trial .

Speaker #3: Expected FDA and additional feedback from the regulatory agencies and results thereof , the benefits potential of our product candidates , including the potential that they would become an off the shelf formulation for broad intended use in diabetic foot infections .

Speaker #3: The potential safety or of our product candidates because for B 11 and Bcl2l11 and the efficacy partnering opportunities and for our product . In addition , passing clinical candidates results current as well as compassionate use are not indicative and do not guarantee future success of our clinical trials .

Speaker #3: Except as required by law , we do not undertake to update forward looking statements . The safe harbor provision , including risks that could cause actual results to differ from these forward looking statements , are outlined in today's press release , which , as noted earlier , is on our website .

Speaker #3: on the call morning is Chief Executive Officer Jonathan Solomon , to whom I will now turn over the call .

Speaker #4: Thank you . Marina , and thank you all for joining BiomX Inc. third quarter 2025 update today . The third quarter of 2025 has been an important period for BiomX Inc. .

Speaker #4: As we continue to advance our clinical programs and engage with regulatory authorities on a pathway forward for our phage clinical therapy , pipeline Starting with .

Speaker #4: program a lead cystic fibrosis patients with Pseudomonas aeruginosa infections . Throughout the quarter , the program made important progress while navigating some regulatory challenges .

Speaker #4: began the quarter We strongly with first patient dosing in our phase two trial , a significant milestone in the development of this innovative phage therapy as a trial progress , we notification in FDA has placed a August clinical hold US on our trial sites .

Speaker #4: This hold relates solely to third party nebulized device used to deliver vxo for not candidate itself . to a drug Importantly , the FDA received raised no concern about their ae4 in notification , see so we this as a that the technical challenge , but not a fundamental concern when it comes to our approach to or trial .

Speaker #4: We promptly submitted the requested nebulizer data and responded promptly to additional clarification and requests FDA imminently feedback . While this temporary pause affects our US optimistic about resuming enrollment soon .

Speaker #4: Since all components of the nebulizer CE marked in European trial Europe , our continues uninterrupted and in full protocol requirements compliance with . Our European enrollment plan .

Speaker #4: As reported just are a few weeks ago , in October , we received written feedback from the continues to FDA detailing the agency's understanding of the substantial unmet need for treatments targeting chronic Pseudomonas according to aeruginosa infection in patients CF .

Speaker #4: with Even existing Cftr , cystic fibrosis , transmembrane conductance regulator modulators . As part of that feedback , the FDA outlined several potential development pathways for vxo for including specific approaches three inclusion for phase criteria to demonstrate benefits .

Speaker #4: This constructive feedback was encouraging for us , as it provided both valuable guidance on how the FDA sees development for a program . While recognizing its relevance to an important medical which need , a vote we of see as confidence therapeutic for phase two B .

Speaker #4: Following our readout , to we plan incorporate the FDA's recommendation into our development look forward to strategy and further discussion at our end of phase two meeting .

Speaker #4: of today , we are still on report track to the data in Notwithstanding the halt , expect to which we hear Q1 2026 .

Speaker #4: the FDA imminently . As I noted . As Let us now turn to an exciting development in our second program in early November , we reported positive FDA feedback on our plan to target Staphylococcus aureus infection in diabetic and foot infections or DFI .

Speaker #4: This feedback supports a strategy to develop Vxo one one . Our next generation fixed phage cocktail , designed specifically for this difficult to treat condition .

Speaker #4: Pxo1 one , represents a extension natural of a phase two clinical success with rb211 in diabetic foot osteomyelitis targeting the same Staphylococcus aureus pathogen , but in an earlier stage of disease where infection remains localized to the ulcer .

Speaker #4: program The advances toward an off the shelf formulation for intended broad use in diabetic foot infections , while also dual use offering potential as a rapidly deployable solution for treating combat related wound infection .

Speaker #4: As an approach well aligned with the priorities of the US Defense Health Agency , for future conflict environments . I want to take a minute to why we're explain targeting DFI .

Speaker #4: Initially , the defy indication addresses a critical unmet medical need . Approximately 160,000 lower limb amputations occur in diabetic patients in DOJ US annually , with 85% stemming from diabetic foot infection or osteomyelitis .

Speaker #4: Despite this urgent need , no new drugs have been approved for DFI in the US in over two decades . DFI represent a large Additionally , patient population with significant commercial opportunity with a regulatory patients clearly supported by pathway that's established FDA factors These make compelling indication for our guidance .

Speaker #4: program to strategically focus on . strong clinical leveraging the data we already have a DFI FDA provided detailed constructive guidance for . Vrc01 one , The outlining potential a clear While a Bla biologics license application .

Speaker #4: Notably, no non-clinical studies were requested, and their CMC comments are aligned with our established manufacturing approach. This feedback confirms our development plan and harmonizes with current FDA guidance for product development DFI.

Speaker #4: 011 will be applied Rd topically and proprietary includes Previously evaluated in our Rb211 successful study . We advance Vrc01 one in coordination with ongoing discussion plan to DOJ and subject to securing financial resources .

Speaker #4: 011 will be applied Rd topically and proprietary includes Previously evaluated in our Rb211 successful study . We advance Vrc01 one in coordination with ongoing discussion plan to DOJ and subject to securing financial necessary Looking more broadly at the landscape , we're seeing strong momentum across the phage therapy field alongside rising global attention to antimicrobial resistance .

Speaker #4: We think this underscores the growing validation of phage approaches such based ours . This broader across the industry progress validates BiomX Inc. precision phage therapy and strengthens our confidence .

Speaker #4: As we look the ahead for upcoming VCs . Oh four phase two B readouts . I'd like to now pass you to review our third quarter 2020 financial results .

Speaker #3: Thank you . As a reminder , the financial information for the company's quarter in the press we earlier release that today , issued as well as in more detail on form our 10-q , Jonathan . which we will file later today .

Speaker #3: Thank you . As a reminder , the financial information for the company's quarter in the press we earlier release that today , issued as well as in more detail on form our 10-q , Jonathan .

Speaker #3: highlights of 2025 is available our third quarter financial . Our cash third results balance restricted cash as of September 30th ,

Speaker #3: For quarter of the decrease was primarily by reduced salary expenses due to workforce lower rent reduction , expenses a right of use following asset impairment in 2024 , and decreased CF Marina to product related to the candidate , primarily significantly higher manufacturing due to the costs that were incurred driven in 2024 , such decrease was partially offset by an increase in depreciation expenses attributable to an accelerated depreciation of expenses improvements resulting from the modification of our office lease agreement in Israel , as well as by decreased grant funding from the Medical Technology Enterprise Consortium under the Da and the Innovation Authority Israeli .

Speaker #3: General and administrative expenses were $2.4 million for the third quarter of 2025 , compared to $3.2 million for the third quarter of 2020 .

Speaker #3: For the decrease was primarily driven by reduced salary and share based compensation expenses and lower legal and other professional fees . The decrease partially was offset by an increase in depreciation expenses accelerated depreciation of leasehold improvements attributable to the the modification of our office lease in agreement Israel .

Speaker #3: Net loss was $9.2 million for the third Five , of 2020 . quarter to net income of $9.6 million for the third quarter of 2020 .

Speaker #3: Four . The decrease was mainly due to the change in the fair of issued as value part of the warrants company's March 2024 financing .

Speaker #3: Net cash operating used in activities for the nine months ended 2025 was $22 million , compared to $30.7 million for the same period in I'll 2024 .

Speaker #3: now return the call September 30th , closing remarks .

Speaker #3: now return the call September 30th , closing remarks to

Speaker #4: To summarize , our focus remains strongly on clinical and execution regulatory both VCs

Speaker #4: milestones . We anticipate feedback imminently on the VCs zero four clinical hold in the US , which could enable the resumption enrollment in of the near term .

Speaker #4: parallel , encouraging FDA guidance has outlined a clear phase Jonathan for three development In pathways for VCs oh four and strengthen regulatory and the commercial opportunity for BCS one , which will focus infection .

Speaker #4: Diabetic foot presents a large and commercially significant population, with increasing validation across the phage therapy space. BiomX Inc. looks forward to the VC's Q4 trial readout in the upcoming months, as well as the continued progress toward bringing phage therapies to patients in need with precision.

Speaker #4: Thank you all for joining today's earnings call . And with that , we'd like to open questions

Speaker #2: to ask a you'd like question at this time , please star one one on your telephone and wait for your name to be announced withdraw your question , please press star .

Speaker #2: one one again . stand by compile the Q&A To press . Our first question comes from Joe Pinkins with H.C. Wainwright .

Speaker #5: Hey , good morning , Jonathan and Thanks for question . So a few right now . You got a lot questions of working parts and it's really nice to see all the regulatory progress .

Speaker #5: So I'll start with DFI maybe . It's good we have the clarity on the potential path forward . So forward . So I have two questions there with regard to the potential .

Speaker #5: Is defense you might something that look to in do this clinical your program . Or is this has the be independent development defense potential to .

Speaker #4: good So Joe , morning . Quite chilly in New York this

Speaker #4: Da . Right . So they understand unlike other agencies that the get a product best way to to is , support it first in a commercial indication .

Speaker #4: they approved look , if the fastest path kind of say , to get the drug approved is infections , diabetic foot we'll actually support that .

Speaker #4: Get the drug approved . And then we can always kind of expand the indication later , right . So I think that's a very refreshing approach and very practical we had this conversation with them said , look , kind of we're debating we had data and diabetic foot osteo .

Speaker #4: . endpoints that we've discussed are all about soft tissue . So the diabetic foot infection really excited we're about diabetic foot infection . Does it make So endpoints , for you guys .

Speaker #4: they're like And actually yes it's combat wounds . But again they kind of reiterate we'll support whatever you think is the fastest path to get to approval .

Speaker #4: So that's Right . their will view . They continue . They supported with $40 million to date . hopefully continue to support it in a meaningful amount in the future .

Speaker #4: And that an approach which is diabetic foot infection . It's you know , not , like combat something that will look to do together .

Speaker #4: Probably later . And it Hopefully they'll also , I think the would be discussion that bodes well for we did have about the product , closer to said the Right . work on personalized 211 was the approach .

Speaker #4: Probably later . And it Hopefully they'll also , I think the would be discussion that bodes well for we did have about the product , closer to said the Right .

Speaker #4: We have a lot of experience with aureus . We do a broad cocktail off the shelf and an product , and that's what we think will move know how to to 011 using the we use phage that in the trial .

Speaker #4: like , yes , because we view it's more likely that an off the makes sense for combat settings . Right ? But still , they want to see us , you know , pursue diabetic They're get the foot first , drug approved and then sort of expand it later .

Speaker #4: So I hope that helps clarify .

Speaker #5: No , it does . Thanks . And then before I my second question switch to my one for oh four . So on DFI , are there any outstanding certainly ?

Speaker #5: It seems like pretty you have clarity right now or very good good clarity , but are there any outstanding questions that still need to be addressed with regard potential to design or inclusion criteria ?

Speaker #4: There's some fine tuning , but generally right as , as as you kind of know . Right . First there was a is guideline which very clear DFI .

Speaker #4: Right . So the guideline kind of states the endpoints . You can always tweak some of the composite endpoints . But there's pretty good understanding .

Speaker #4: The FDA was very . So we do know clear clinical study is going to look like . Of course we want to consult with the DOJ and make sure we're aligned and that .

Speaker #4: So that's kind I think of the next step . But in terms of regulatory feedback , all the we got feedback we want .

Speaker #4: You know with CMC aspects , which we know and feel , consistent very comfortable . And of course , the reassurance that there's no need to do animal safety's or , you know , the skin penetration , pretty it's straightforward .

Speaker #4: So we feel some of that it's I think the feedback consistent . And I think now we look forward to kind of working together with the DOJ was to lay out the next study .

Speaker #5: Great . Thanks for that . And then question on my zero four , it's pretty intriguing to regarding the us FDA feedback right now .

Speaker #5: So I'm hoping you might be able to provide a little color , even more it's a bit early for this . On next steps .

Speaker #5: With regard to how you might enrich the population or optimize it, as you put it.

Speaker #4: do I think we're super feedback that came from the right ? I think it's thoughtful . You could see appreciative of the as the number of participants just in the document that was provided by the FDA .

Speaker #4: And again , they Sure . understand it's a huge unmet need , So right ? We're seeing it in the clinical study . Right .

Speaker #4: Patients want to go on the study . They know that getting one of these nasty pseudomonas is is really bad outcome . Right .

Speaker #4: they're And willing to do can to whatever they get rid of those Pseudomonas and the understands it FDA appreciates it . They understands the difficulties in the age of Cftr And I think that's where they're modulators .

Speaker #4: open , right , to say , hey , you could potentially enrich the patient population with , you know , I mean , we've talked about bronchiectasis being a really interesting indication .

Speaker #4: You could look at patients who are not taking CFTR modulators, patients who are exacerbating more, and try to get the clinical signal there where it's easier, and hopefully get a broader approval.

Speaker #4: So that's kind of the thinking around enrichment . And I that's what we're so think of . The appreciative FDA kind of taking a step forward .

Speaker #4: And understanding , you know , it is an unmet need . Show us the clinical signal and enrich population and potentially right . We could think about a broader a label broader .

Speaker #5: Great . Appreciate the comments , Jonathan .

Speaker #4: You bet . Always a pleasure .

Speaker #2: Our next question comes from Yale . Jen with Laidlaw .

Speaker #6: Good morning and thanks for taking the questions . I'm just going to follow up with Joe has asked us a little bit more details .

uh, of tests that we provided and seem to be very technical. And, and what we've seen and provided is all within scope. Uh, so we view it as very technical again, only about the nebulizer. No questions whatsoever about, uh, Fage or bxo for specifically. Uh, so, I, I think it's technical, right? We don't know for sure, and that's what we expect that imminently, um, you know, hopefully, right, uh, evenly the whole would be lifted.

Okay great and I think that's just a little bit. I assume a nuisance happened along the way and maybe the last question here is that giving that you have a discussion with the FDA?

About the potential phase 3 study. Uh, I know there's probably still a lot of, uh, you know, moving Parts there yet. But nevertheless, was there any so that general idea, in terms of the size of the study duration of the treatment, or any other color you can review and thanks.

Sure, so I think we can't go too much into details, you know, as as we're thinking but you know, we have a rough understanding of how does the phase 3, of course, everything depends on the outcome of the phase 2B. Uh, but you know, it's an orphan indication. We know phase is safe. Uh, we've got all the, um, all the understandings. So hopefully it's a shorter development path, right? It's an orphan indication as I mentioned. So there are all the regulatory

Um um sort of passed to try to get this thing moving. Uh again I think here we're benefiting so much from the from the help of the CF Foundation. It's actively discussing with the agency as well with us and supporting us in many ways. So I I think it's a relatively

Well-defined and straightforward path. Of course, pending good data. And you know what? What we're also seeing, and I'm sure you're feeling it as well, right? There's a lot of increased... um,

That happen in in respiratory. And, and we're seeing that interest, right? So there is robust.

Pharma interest in um, in that indication, right? We talked about CF and ncfb uh with some of the recent success and approvals in that field. Uh, and also I think is, you know, as we're seeing there's increased page, uh, Fage interest, right? There's success by us and others, which is helping. So I think it's kind of converging to a lot of interest. You know, pending positive data and phase 2B, um, that there's a really interesting path forward. It could be in CF. It could be in ncfb and it all depends on on the setup. The financing and potential Partnerships.

Okay, great. That's very helpful again. Congrats on all the progress and, uh, the best lot for you guys.

Thank you. Great really, really appreciate it.

concludes today's question and answer session, I'd like,

To turn the call back to Jonathan Solomon for closing remarks.

So, I wanted to thank you all for joining us. Uh, this morning. Uh, wishing everyone, happy holidays and we look forward to reporting on our next developments. Thank you so much. This concludes today's conference call, thank you for participating you may now disconnect