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spk01: Ladies and gentlemen, thank you for standing by. Welcome to the BioLine Rx second quarter 2021 results conference call. All participants are presently in a listen-only mode. Following management's formal presentation, instructions will be given for the question and answer session. For operator assistance during the conference, please press star zero. I would now like to turn over the call to Tim McCarthy of LifeSci Advisors. Please go ahead.
spk05: Thank you, operator. Before turning the call over to management, I would like to make the following remarks concerning forward-looking statements. All statements in this conference call, other than historical facts, are indeed forward-looking statements. The words anticipate, believe, estimate, expect, intend, guidance, confidence, target, project, and other similar expressions are used typically to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance and may involve and are subject to certain risks and uncertainties and other factors that may affect BioLine Rx's business, financial condition, and other operating results. These include, but are not limited to, the risk factors and other qualifications contained in BioLine Rx's annual report on Form 20F, quarterly reports filed in the 6K, and other reports filed by BioLine Rx with the SEC to which your attention is directed. Actual outcomes and results may differ materially from what is expressed or implied by these forward-looking statements. BioLine Rx expressly disclaims any intent or obligation to update these forward-looking statements. At this time, it is now my pleasure to turn the call over to Mr. Phil Serlin, Chief Executive Officer of BioLine Rx.
spk06: Thank you, Tim, and good morning, everyone. And thank you for joining us on our second quarter earnings conference call today. Earlier this morning, we issued our Q2 results press release, a copy of which is available in the investor relations section of our website. It was also filed as a 6K. As is our custom, I will begin with some brief prepared remarks, and then Molly Zebi, our chief financial officer, will provide a short discussion of our financial results. We will then open up the call to your questions. Also joining the call for Q&A are Abby Weinstein, our chief medical officer, and Ella Serrani, our chief development officer. I would like to begin this morning with a brief recap of the overwhelmingly positive results from our phase three Genesis clinical trial, which we announced in May. The Genesis study evaluated metixifortide on top of GCSF, the current standard of care, versus GCSF alone, in stem cell mobilization from multiple myeloma patients undergoing autologous hematopoietic stem cell transplantation. The main objective of this study was to demonstrate that motixifortide on top of GCSF provides superior mobilization relative to GCSF alone, resulting in more cells collected, fewer doses of GCSF administered, and fewer apheresis sessions required, all of which provide meaningful clinical benefit for patients, while saving potentially significant money for payers and the entire healthcare system. We covered the results in detail during our last quarterly update, but we believe a few key highlights are worth repeating. First, the study met all primary and secondary endpoints with an exceptionally high level of statistical significance, a p-value of less than 0.0001. Perhaps most notably, approximately 90% of patients who received motixifortide in GCSF underwent transplantation after only one administration of motixifortide and in only one aphoresis session. This compares to 10.8% for GCSF alone. In addition, while not a head-to-head study, this compares very favorably to results from the registrational study of plurixifor, which demonstrated that approximately 54% of patients who went to transplantation after one administration of Plurixifor on top of GCSF and in one apheresis session. Using the current standard of care with GCSF alone, several apheresis sessions are generally required to collect the optimal number of stem cells. However, somewhere between 30 and 50% of patients are unable to reach this optimal number of stem cells. Due to the ability of Motixifortide in the vast majority of cases to enable the collection of an exceptionally high number of stem cells following one administration, with only one aphoresis session, thereby lowering the number of GCSF administrations, aphoresis sessions, and related adverse events. We believe there is a compelling case to be made regarding the potentially significant clinical benefits, as well as health system cost benefits that can be achieved with metixifortide if approved. We also note that the higher number of cells collected allows for the transplant of an optimal number of cells, as well as enabling the storage of a sufficient amount of remaining cells for future transplantation without the need for additional mobilization and apheresis procedures. In this regard, we are running a pharmacoeconomic cost effectiveness study that we believe will demonstrate our case for the use of metixifortide as the backbone for all new stem cell mobilization procedures. The study is progressing as planned, and we look forward to reporting data by the end of this year. In addition, we continue to perform additional analyses that were predefined in the statistical analysis plan, as well as post hoc analyses of the Genesis data set, and look forward to presenting our additional findings from the study at future medical meetings. As previously mentioned, this program represents our fastest track to registration, and to that end, we are aggressively working on activities in support of the U.S. New Drug Application, or NDA, which we plan to submit in the first half of next year. We are making preparations now for a pre-NDA meeting with the agency that we anticipate will occur prior to the end of this year. If ultimately approved in this indication, we would begin our transition to a company with a commercial stage molecule, the most important and transformational milestone that we will have achieved as a company to this point. We would have a commercial stage molecule in one indication with significant potential utility in other cancer types as well, most notably pancreatic cancer, which we will discuss next. In addition, based on the strength of the GENESIS results, we are also exploring development of lentixoportide in other stem cell mobilization indications as part of its life cycle management program. Turning now to our Pancreatic Cancer Program, or PDAC, recall that in December we announced positive final results from the Phase 2A Combat Keynote 202 study of motixifortide in combination with Merck's anti-PD-1 Keytruda and chemotherapy as a second-line therapy. A total of 43 patients initially diagnosed with unresectable stage 4 metastatic PDAC who had progressed following first-line gemcitabine-based therapy were enrolled in the triple combination arm. Data from this study demonstrated a substantial and consistent improvement across all study endpoints as compared to historical data. including median overall survival, median progression-free survival, confirmed overall response rate, overall response rate, and disease control rate. As we've previously indicated, we continue to prepare the next development steps regarding this program, including continuing to engage in discussions with potential biopharma partners to collaborate on a randomized controlled Phase 2-3 study. In addition, we are actively engaged in productive discussions with potential commercialization partners for stem cell mobilization. The high level of interest we are receiving reflects the versatility of motixifortide as the potential backbone of innovative new cancer treatments, something that we have demonstrated in two high-need indications so far. Regarding our second innovative candidate, AGI134, we continue to advance our Phase I-II clinical study, evaluating the safety, tolerability, and proof of mechanism in multiple solid tumor types. The study is designed to evaluate a wide array of biomarkers and assess both clinical and pharmacodynamic parameters. In September 2019, we announced positive safety data, and later that same month, we moved quickly to initiate part two, the dose expansion phase. As we have previously disclosed, in 2020, the COVID-19 pandemic impacted enrollment for a period of time, but enrollment did resume earlier this year. In order to improve enrollment and make up some of the time lost during the pandemic, we have worked diligently to open new sites across Spain, and these sites are already beginning to recruit patients. At this time, we still hope to report data in the second half of this year in line with our prior guidance, although due to the recent severe worsening of the COVID-19 pandemic throughout most of the world, there may be some delays. From a balance sheet perspective, we are on a very solid financial footing with approximately $66 million of cash, which we believe enables us to achieve multiple potentially value-creating milestones this year and next. I would now like to turn the call over to Molly Zevi, our CFO, who will give a brief overview of our key second quarter financial statement items. Molly, please go ahead.
spk03: Thank you, Phil. As is our practice, In our financial discussion, we will only go over a few significant items on this call. Research and development expenses and cash. Therefore, let me invite you to review the filings we made this morning, which contain our financials, operating and financial review, and press release for additional information. Research and development expenses for the six months ended June 30, 2021, were $9.4 million, a decrease of $0.6 million, or 6.4%, compared to $10.1 million for the comparable period in 2020. The decrease resulted primarily from lower expenses associated with the Motixa-Fortide, Genesis, and COMET clinical trials, and a timing difference related to a tax credit received in respect of AGI-134. offset by higher expenses related to Mutixa Fortide NDA supporting activities and by an increase in payroll and related expenses due to a company-wide salary reduction in connection with the COVID-19 pandemic in the 2020 comparable period. Turning to cash, as Phil indicated, we held $66 million of cash, cash equivalents, and short-term bank deposits as of June 30, 2021. And with that, I'll turn the call back over to Phil.
spk06: Thank you, Molly. In closing, as is our custom, I would like to take a few moments to summarize our key upcoming milestones. First, data from the pharmacoeconomic cost-benefit study of Motyxifortide in stem cell mobilization in the second half of this year. A pre-NDA meeting with the FDA for stem cell mobilization in the second half of this year as well. Initial results from Part 2 of the Phase 1-2A trial of AGI-134 in solid tumors, also in the second half of this year. An NDA submission for stem cell mobilization in the first half of next year, 2022. And in addition, we are planning to present additional data from the Genesis trial at upcoming medical meetings to be determined. In summary, we achieved the most significant milestone in our company's history with the outstanding positive results of the Genesis study in stem cell mobilization. We also continue to work on the advancement of our PDAC program as well as AGI 134 and believe that potentially significant value creating milestones can be achieved this year and in 2022. Our solid financial footing with approximately $66 million of cash also provides us with ample resources to achieve such milestones. We are pleased with our continued progress and we look forward to providing future updates. With that, we have now concluded the formal part of our presentation. Operator, we will now open up the call to questions.
spk01: Thank you. Ladies and gentlemen, at this time, we'll begin the question and answer session. If you would like to ask a question, please press star 1. To withdraw your question, press star 2. If you're using speaker equipment, kindly lift the handset before pressing the numbers. Your questions will be polled in the order they are received. Please stand by while we poll for your questions. The first question is from Jason McCarthy of Maxim. Please go ahead.
spk08: Hey, everyone. It's Dave on the line for Jason. Thanks for taking my question. I was just wondering, do you currently plan on having discussions with any ex-U.S. regulators regarding potential marketing approval for Mituxifortide? And secondly, can you shed some color on steps you've taken to potentially mitigate the impact of the worsening COVID-19 pandemic with respect to other clinical trials that are ongoing? Thanks.
spk06: Sure. So with regard to other regulatory agencies, Of course, right now our key focus is on the U.S. and the FDA. As we mentioned, we're putting forth extensive efforts to get ready for the pre-NDA meeting with the FDA at the end of this year and the NDA submission in the first half of next year. We will start to put together a plan on Europe, et cetera, but as I said, I think that that will have to wait until we've made a significant progress in the NDA submission. Ella, do you want to add anything to that? Okay. The second question was the steps we're taking to mitigate COVID-19. Abby, would you like to go ahead?
spk04: Yes. Actually, what we did when we saw that there might be a problem in the recruitment due to COVID here in Israel as well as in the UK and US, we immediately put a mitigation plan to increase the probability of recruitment by adding another country and opening new sites. You know, it takes time until you can activate them. And during the period of the COVID, the lockdown, we did all the regulatory tasks that need to be done in order to open the sites. We have been able to open this month three sites in Spain. And at the beginning of this month, we are aiming to open another three by the end of this month. Spain has already bring a few patients, and also UK, who was in lockdown for a long period of time, begin to recruit patients again. We hope that we can wrap up and recruit all the patients by the end of the year, and we are doing all the effort in order to meet the timelines.
spk06: I want to mention one other thing about the submissions and other regulatory areas as well. I think one of the things that we believe is important is also we believe that the process with the FDA and what we learn from that process will help inform us quite a lot as to how to approach things in Europe, for example. So that's another reason as well.
spk08: Great. Thanks for the additional color. I appreciate it.
spk06: No problem. Have a good day.
spk01: The next question is from Joe Pantaginnis of H.C. Wainwright. Please go ahead.
spk07: Hey, everyone. Good afternoon. Good morning. Thanks for taking the question. Hello?
spk01: The questioner is not... answering. We'll go to the next one. The next question is from Mark Ridenback of Oppenheimer. Please go ahead.
spk09: Hey, guys. Thanks for taking the questions. Maybe we'll hear more from Joe in a few minutes. But just with respect to your upcoming pre-NDA meeting, can we expect you to communicate regulatory feedback to the street in 2021? Or would that news more likely come in early 2022?
spk06: It's difficult to say. I mean, I think that we would like to communicate, you know, the results of our meeting with the FDA. It depends exactly when that meeting occurs. I think also the minutes of, you know, usually take, you know, a few weeks after the meeting in order to come out. And so I think we would obviously want to wait for the formal minutes just to make sure that, you about everything we heard at the meeting. So it's hard to say. We're hoping that it'll be by the end of this year, but I think that's where we are right now, but I can't guarantee that.
spk09: Okay, fair enough. And two quick kind of data presentation questions. First, can you remind us how many patients to expect from the dose expansion portion of the 134 study? and if these results will include translational data from paired biopsies. And the second question is just on that Columbia-sponsored triple combination of metixivortide and pancreatic cancer. Is that something we could still see data from by mid-2022, I think, as you guys had guided a while ago? Thanks for taking the questions.
spk04: I will take this one. The first one about the AGI, we are aiming to recruit 35 patients. The idea, the main purpose of this study is to further confirm the mechanism of action of AGI-134. And for this purpose, what we are doing is a very wide biomarker assessment in blood tests as well as genetic tests and tumor-based assessment. We are putting a lot of work on this study because we believe that, based on the data, it is critical for the further development to show all these biomarker parameters in order to decide how to move forward and in which direction to move forward. As I said, you asked which kind of assessment. Again, we have biopsies for the patients. before and after a treatment, and we have biopsies of the patients in the area of the injection as well as in distant lesion in order to prove what we call the abscopal effect is the activity of the AGI that show that if you inject in one lesion, you can have effect in other lesion. This is the reason for what AGI have BLA designation because it's related to the potential vaccination activity. And we are hoping to have all this data when we complete the recruitment of the patient.
spk02: Yeah, and just to add to what Abi just said, we are using really all these state-of-the-art methodologies in order to make this assessment, multi-omics, nanostring, PCR sequencing. So we're looking forward to that. And the second question was?
spk09: Okay, great. And with respect to the Columbia-sponsored trial?
spk04: Sure. About the Columbia study, you know, it's an investigator-initiated study. The investigator has a collaboration with Regeneron and with us. We are working together, but it's led by the lead PI, and we don't have a lot of place to help in the increase of recruitment. However, the investigator is doing a great job, and he's including all other sides to the study. Also, the Brown University is also part of this trial, and we hope to have an increase in the recruitment based on this new addition to the study.
spk06: All right. Mark, can I just go back? I also just want to emphasize, because I don't want any misunderstandings. We have every intent. I'm talking about the pre-NDA meeting. We have every intent of having that meeting this year. Again, it's just not clear as to when the minutes, et cetera, will come out and when we'll feel comfortable maybe putting out some guidance on that. We hope to do that as well by the end of this year. We just can't guarantee it.
spk09: Yeah, that makes perfect sense. It really just depends on how late in the year the meeting ends up happening. Thanks for clarifying, and thanks for taking the questions.
spk06: Thanks. Have a great day.
spk01: The next question is from Joe Pentaginous of H.C. Wainwright. Please go ahead.
spk07: Can you hear me now, guys?
spk06: Yeah, we lost you. We were okay. Yeah, go ahead. Fantastic.
spk07: I'm not sure what happened there because I wasn't on mute, so I apologize. I have a data question and two logistical questions. So first, from a data standpoint, when you look at the SCM data, and I guess this goes to some of your prepared comments, Phil, if you could sort of frame maybe the percentage of patients that had enough cells to freeze that could reach the parameters in case a second transplant was needed?
spk04: I will take this instead of Phil. Actually, we don't have the percentage of patients who freeze themselves because it's not an input of the study. But when we saw that there are patients who, for example, mobilize, I don't know, 15 million cells that were transplanted with five or six million, we understand and we know that they keep some cells for the future. Since we didn't tell the sites and investigate how many cells they need to transplant, we need to tell them to tell us how many cells they keep in cryopreservation. But what we understand, based on the number of cells that the investigator received, they decide how many cells to transplant and how many cells to keep. And there is a difference, and they don't throw out the cells, okay? And as I said before, if you have a patient with 15 million mobilized and And seven million transplanted, the other are going for a cryopreservation. The exact percentage is something that we didn't assess as part of the study endpoint. No, that's really helpful. But what we know, you know, that the median number of cells that patients who receive BLAT40 mobilize is 8 million. If the optimal numbers of, more than 8 million, sorry. If you need to, if we think that we need to infuse and transplant more than 6 or more than 5, we can keep more cells for the future.
spk07: Got it. No, that's helpful. Thank you very much. And then with regard to my first logistical question, and this also goes to Mark's question, because obviously there's a lot of anticipation with regard to your upcoming NDA and FDA feedback. So I guess I'll come from where you are today and what you feel are the key discussion points ahead of this meeting.
spk06: Yeah, so, I mean, I'm not sure that we can really, you know, talk about that, you know, right now. I think that we're in the process of putting together our, you know, our questions and our briefing package, et cetera, et cetera. You know, we haven't disclosed that. I think it's – I don't think it's something that we can talk about publicly at this point. I'm sorry, Joe. That's fair.
spk07: You know, I have to ask. And then the second part is when you look at Metixifortide's oncology program, obviously the big focus is on the – the upcoming randomized study and the potential partnership around that. But when you look at the totality of the oncology program and other indications that you can go into and potential partnering around that, how can you sort of describe internal activities to help bolster the oncology program? Like for example, would the company look to run its own oncology study in another indication? while potential partnership discussions are ongoing, you know, and what can you do to sort of help these discussions along?
spk06: Yeah, well, first of all, you know, we have a lot of, you know, we're planning and we have a lot of ideas about the next studies that need to be done, certainly the next randomized controlled study in pancreatic cancer. And so we are putting together, you know, the plans for that study. We're talking in parallel with multiple partners. The question is whether at this stage we intend to invest more funds. We have limited funds. We're putting most of our efforts into the NDA submission, the NDA process, et cetera, et cetera. The question will be whether at this time we intend to invest more funds or more significant funds in another study. And that's something that we're still discussing internally. Of course, we do have the option of collaborating with other companies. For example, we're doing an investigative initiative study, which we're doing right now, as you know, with Columbia University. And so we have a lot of options on the table. And again, I think that one of the questions for us is whether we want to invest in a large study on our own or continue discussions with partners and collaborators and do it under a collaboration.
spk07: Got it. So it just sounds like you certainly have a good level of flexibility. But thanks for the feedback, Phil.
spk06: Thank you. Have a great day.
spk01: If there are any additional questions, simply press star 1. To withdraw your question, press star 2. Please stand by while we poll for more questions. There are no further questions at this time. Before I ask Mr. Phil Serlin to go ahead with his closing statement, I would like to remind participants that a replay of this call is scheduled to begin two hours after the conference. In the U.S., please call 1-888-295-2634. In Israel, please call 03-9255-904. Internationally, please call 972-39255-904. Mr. Serlin. Would you like to make your concluding statement?
spk06: Yes, I would. Thank you. This concludes our call this morning. Having recently achieved the most significant milestone in our company's history, the outstanding positive results of the Genesis study in stem cell mobilization, we continue to work vigorously to make an NDA submission in the first half of next year. We also see significant potential upside in our pipeline as we continue to work on advancing the development of our PDAC programs and our AGI 134 program through potentially significant value-creating milestones in the remainder of this year and in 2022. We are proud of the continual evolution of BioLineRx into a company with a potential commercial stage asset, which encourages us to foster the innovative development activities that we believe represent the significant long-term value drivers for shareholders. Thank you all very much for your continued interest in BioLineRx. We look forward to providing our next comprehensive update in November. Be safe and have a great day.
spk01: Thank you. This concludes the BioLineRx second quarter 2021 conference call. Thank you for your participation. You may go ahead and disconnect.
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