Biomx Inc (PHGE) 2024 Q3 法說會逐字稿

Greetings and welcome to the Biomx third quarter, 2024 financial results conference call (Operator Instructions)

It is now my pleasure to introduceMarina Wolfson, Chief Financial Officer. Thank you. You may be good.

Thank you and welcome to the Biomx conference call to review the company's third quarter, 2024 financial results and provide an update on our business and programs. Later today, we will file the quarterly report on form 10-Q with the Securities and Exchange Commission.

In addition, the press release became available at 6:30 a.m. Eastern time today and can be found on our website at Bionics dotcom.

A replay of this call will also be available on the investors section of our website.

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. For instance, we're using forward-looking statements when we discuss on the conference call, the sufficiency of the company's cash, our pipeline, the design recruitment aim expected timing and interim and final results of our preclinical and clinical trials.

The potential benefits of our product candidates and the potential safety or efficacy of our product candidates. BX double four and BX 211.

In addition, passing current preclinical and clinical results as well as compassionate use are not indicative and do not guarantee future success of our clinical trials except as required by law, we do not undertake to update forward leaking statements.

The full safe harbor provisions including risks that could cause actual results to differ from the forward leaking statement are outlined in today's press release, which as noted earlier is on our website.

Joining me on the call this morning is Biomx Inc Chief Executive Officer Jonathan Eitan Solomon, to whom I will now turn over the call.

Thank you, Marina. Good morning everyone.

Thank you for joining biomics quarterly update throughout the last quarter, biomics focus on strategic execution and advancing our clinical pipeline. We are excited as we approach the landmark milestones in our diabetic foot Osteomyelitis or DFO phase two trial of B 201 in the past quarter, we completed patient enrollment for the trial and the readout for topline results through week 13 is expected in the first quarter of 2025.

We are grateful for the continued support behind the DFO program from the US Defense Health Agency or D which provided additional funding this past quarter. Bringing total nonal funding received from the DH A towards this trial to $36.8 million to date.

BX 201 has the potential to dramatically transform treatment for patients suffering from DFO associated with Staphylococcus A.

This is an area of high unmet need each year. There is a staggering number of approximately 160,000 lower limb amputation in diabetic patients in the US alone, 85% of which are estimated to be caused by DFO.

According to the current literature and the US centers for disease control EFO is characterized by intractable infections that have penetrated the bone in patients with diabetic foot ulcers. Antibiotic therapy is the current standard of care but fails to treat 30 to 40% of cases due to antibiotic resistance, accumulation of biofilm and poor blood supply, limiting the concentration of IV and oral antibiotics to the site of infection.

We believe that a phage based therapeutic approach has the potential to greatly improve treatment outcomes. In DFO. Page's potential advantage stands in the ability to address challenges that antibiotics face such as break down the biofilm and targeting antibiotic resistant bacteria.

Reports in the scientific literature of compassionate use with page therapy for the treatment of DFO associated with Staph aurs have shown that 11 of 12 cases resulted in positive outcomes of wound healing and avoiding amputations. Finding from these cases played an important role in the design of the ongoing phase two study of BX 201.

As a reminder, the phase two is a randomized double blind placebo controlled Multicenter study investigating the safety tolerability and efficacy of BX 201 and the standard of care antibiotics in subjects with DFO due to staph aureus, enrolled subjects are randomized 2 to 1 ratio to BX 201 or placebo B 201 or placebo are administered weekly by topical IV route in week one and by the topical route only and each of weeks, 2 to 12 over a 12 week treatment period, all subjects are expected to continue to be treated in accordance with the standard of care which will include antibiotic treatment as appropriate.

The first readout of top line results is expected week 13, evaluating the healing of the wound associated with osteomyelitis with respect to B Xella four. The company's Novel Fix cocktail for the treatment of serious chronic lung infection in cystic fibrosis or CF patients caused by pseudo or GSA.

We are continuing preparation to the phase two B study during the last quarter. The company has experienced manufacturing delays for BX four. The team has been working Dillinger to address these manufacturing jobs which have been successful result.

However, as a result of these delays, we now expect to report top line results for BX double four phase two B study in the first half, 2026.

During the third quarter, we presented positive safety and efficacy results in big four phase one B two A trial at the North American Cystic fibrosis Conference and the European Respiratory Society's annual meeting.

Key highlights of the study presented including that three out of 21 patients which reflect 14.3% converted to sputum culture negative for pseudy sergios after 10 days of treatment including two patients after only four days in the BX double O arm compared to 0% of the patients in the placebo arm.

New data presented included that lung function as measured by four exploratory volume in second or fev one increase in subject to receiving a cocktail compared to placebo in the subgroup on continuous inhaled antibiotics, meaning same antibiotic with no cycling or alterating regimen on C modulars and with lower lung functions, meaning one lower than 70%.

The scientific community, positive feedback to the data presented at these conferences has only further strength or confidence about the future of this program and its potential to address the unmet medical need of cystic fibrosis patients.

Overall, we are confident about the promising data already reported and are looking forward to the first quarter of 2025 which will mark the next significant milestone for the company upon reporting top line results for B 201 phase two trial.

And the FFO we believe our pipeline showcases the potential phase therapy to address a wide range of antibiotics and infections. I'll now pass you to Marina to review our third quarter financial results.

Thank you, Jonathan. As a reminder, the financial information for the company's third quarter, 2024 is available in the press release that we issued earlier today as well as in more detail in our form. Thank you, which we will file later today.

I will now walk you through the highlights of our third quarter. Financial results, cash balance, short term deposits and restricted cash as of September 30th 2024 or $24.7 million compared to $30.7 million. As of December 31st 2023 the decrease was primarily due to net cash used in operating activities and the repayment of our Hercules debt facility which was partially offset by the company's private placement financing of $50 million in March of 2024.

We estimate that our cash cash equivalents and short term deposits are sufficient to fund our operations into the fourth quarter of 2025.

Research and development expenses net was $7.3 million for the third quarter of 2024 compared to $5.6 million for the same period in 2023.

The increase was primarily due to the following factors. Preparations for the phase two B trial of our CF product candidate BX 704, an increase in expenses relating to the clinical trial of our DFO product candidate BX 211 and an increase in rent and related expenses.

Following our March acquisition of adaptive stage therapeutics or AP T this increase was partially offset by higher grants, received.

General and administrative expenses were $3.2 million for the third quarter of 2024. Compared to $2.2 million for the same period in 2023 the increase is primarily attributed to a full quarter consolidation of expenses following Apt's March acquisition, incorporating the combined workforce, increased professional services and additional subcontractor expenses.

In the third quarter of 2024 we recognized goodwill impairment expenses of $801,000 resulting from the fair value assessment of goodwill related to the 2024 APT acquisition.

No comparable goodwill impairment expenses were recorded in the same period of 2023.

Net income was $9.6 million for the third quarter of 2024 compared to a net loss of $7.9 million for the same period. In 2023 the increase primarily reflects noncash income from the revaluation of warrants issued during the March 2024.

Financing net cash used in operating activities for the nine months ended September 30th 2024 was $30.7 million compared to $15 million for the same period. In 2023 in August of 24 we implemented a 1 to 10 reverse stock split. This consolidated our outstanding shares without affecting the par value of the common stock nor the authorized number of shares of common stock or preferred stock.

Now, I'll turn the call back over to Jonathan for his closing remarks. Jonathan.

Thanks Marina. In conclusion, the last quarter was comprised of key events including the finalization of patient enrollment for the BX 201 phase two trial of DFO associated with SCOS A with a readout of top line results expected in the first quarter of 2025.

For BX double four, we had the opportunity to present a promising clinical data at key scientific conferences during the third quarter and revise our phase two topline readout timeline for the first half of 2026.

We are confident in our page pipeline's ability to address serious chronic infection and look forward to presenting some potentially life changing data for DFO patients in the near future.

Thank you all for your participation this morning.

(Operator Instructions)

Joseph Pgen with HC Wainwright. Please proceed with your questions.

Hi, this is Sara on for Joe. Thanks for taking the question. I was just wondering regarding the manufacturing delay you mentioned for BX double 04.

If there's any additional details or specifics you're able to provide on the delay and if whether this was just a one off extenuating circumstance or not. And thank you for taking the question.

Morning and great question. So we do think and view it as a potentially one off. One of the challenges that we had in gearing up for the larger face to b study is just larger volume.

So far, we've manufactured 10 L. This is like moving up to 50 L. So there were some challenges in just calibrating all the system and the fate for 50 L once that was set kind of back on track.

So I think that's where we feel very confident with the process that we have and the revised timeline.

Okay. That's helpful.

Thank you.

Thank you. I'm showing no further questions at this time. I'd like to hand the floor back over to Jonathan Solomon for closing remarks.

So thank you all again for participating. I wish you all happy holidays and we look forward to update you on the data and the upcoming do study. Thanks again.

Thank you. This does conclude today's teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day.