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spk08: Welcome to the Iowa Vance Biotherapeutics third quarter and year-to-date 2021 financial results. My name is Andrew, and I'll be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we'll conduct a question and answer session. During the question and answer session, if you have a question, please press star then 1 on your touchtone telephone. Please note that today's conference is being recorded. I will now turn the call over to Sarah Pellegrino, Vice President, Investor, and Public Relations at Iovance. Sarah, you may begin.
spk14: Thank you, operator. Good afternoon, and thank you for joining us. Speaking on today's call, we have Fred Vogt, our Interim President and Chief Executive Officer, Igor Balinski, our Chief Operating Officer, Jim Ziegler, our Senior Vice President Commercials, Dr. Frederick Sinkenstein, our Chief Medical Officer, and Jean-Marc Bellemin, our Chief Financial Officer. Dr. Madan Jagazia, our Senior Vice President, Medical Affairs, and Laurel Todd, Vice President of Policy, are also on the call to participate in the Q&A session. This afternoon, we issued a press release that can be found on our website at iovance.com, which includes the financial results for the three and nine months ended on September 30th, 2021, as well as corporate updates. Before we start, I would like to remind everyone that statements made during this conference call will include forward-looking statements regarding Iovance's goals, business focus, business plans, pre-commercial activities, clinical trials and regulatory plans and results, potential future applications of our technologies, manufacturing capabilities, regulatory feedback and guidance, payer interactions, collaborations, cash position and expense guidance, and future updates. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our SEC filing. Our results may differ materially from those projected during today's call. We undertake no obligation to publicly update any forward-looking statements. With that, I will turn the call over to Fred.
spk12: Thank you, Sarah, and good afternoon, everyone. I am pleased to highlight our year-to-date progress that I have answered in today's conference call. We have continued to advance our tumor-infiltrating lymphocyte, or TIL, platform into new indications and earlier treatment settings throughout this year. For our lead TIL product candidate, lifelucel and metastatic melanoma, our top priority remains our ongoing work to address FDA feedback regarding the potency assays for lifelucel to support our planned VLA submission. We have continued ongoing work developing and validating our potency assays and have engaged in discussions with FDA during the second half of 2021. The anticipated BLA submission for lifelucel continues to be planned for the first half of 2022. We remain confident in our current guidance and timelines. Resolution of the potency assays for lifelucel is also an important next regulatory step for our cervical and non-small cell lung clinical programs. Turning to our clinical pipeline, we now have clinical data showing the promise of TIL therapy in four different solid tumor types, from first line to late-stage treatment settings, furthering our confidence in TIL as a broad platform that may shift the treatment paradigm for patients with cancer. We continue to be excited about three key initiatives that have the potential to meaningfully impact patients while creating shareholder value. First, lifeloosal and post-anti-PD-1 melanoma continues to show increasing long-term durability following one-time treatment. as demonstrated in our ASCO 2021 presentation, where we showed median duration of response was not reached at 33 months of median study follow-up. Second, we continue to build on the potential for the combination of TIL with pembrolizumab, which supports our strategy to broaden access to TIL therapy for more patients in earlier treatment settings. We're excited about presenting combination data in several advanced cancers at the upcoming CITC annual meeting. As noted in this afternoon's press release, The FDA granted fast-track designation for lifeloosal in combination with pamerilizumab for the treatment of metastatic melanoma based on the unmet medical need and potential advantages for this combination over available care. This fast-track designation allows for potential accelerated approval and priority review as well as more frequent interactions with FDA. Finally, our initial clinical data in metastatic non-small cell lung cancer demonstrated a 21.4% overall response rate in heavily pretreated patients, all of whom have progressed prior immune checkpoint inhibitor therapy. This population represents a significant unmet need in non-small cell lung cancer. We provided a top-line corporate announcement of the initial data earlier in the second quarter and look forward to presenting these data to a physician audience for the first time during the upcoming CITSE meeting. On the research side, we are bringing the next generation of toll products and supporting therapies into the clinic. We are advancing a TIL product that is genetically modified to inactivate PD-1, which we have designated IOV-4001, as well as our novel IL-2 analog, IOV-3001. Both IOV-4001 and 3001 are progressing through IND-enabling studies and are moving towards the clinic. In summary, we continue to execute all development, manufacturing, and pre-commercial activities in furthering our commitment to address the critical needs of patients with cancer and multiple solid tumor cancers in treatment settings. I'm confident in the quality of our senior leadership as well as our full internal organization to deliver towards this mission. Today, we have more than 300 employees who on average have more than three and a half years of cell therapy experience. Members of our executive leadership team will now provide updates for their respective departments, beginning with our Chief Operating Officer, Igor Belinsky. Igor Belinsky Thank you, Fred.
spk11: I'm pleased to speak today about a new manufacturing facility, the Eye Events Cell Therapy Center, or ICDC. at the Navy Yard Philadelphia. The ICDC is a 136,000 square foot state of the art lead gold certified cell therapy manufacturing facility. In the third quarter at ICDC, we initiated manufacturing of investigational TIL therapies for patients enrolled in Iovans clinical trials, followed by an official opening ceremony at the end of September. To date, more than 500 patients have received Iovans TIL with a continuing manufacturing success rate above 90%. i-VANCE has transformed TIL manufacturing from a lengthy single center academic process to a shorter scalable centralized GMP process. That yields a cryopreserved product for shipment back to clinical sites where the patients are treated. Our current Gen 2 process is 22 days. We're also continuing to advance our TIL leadership position through our ongoing clinical studies to investigate a 16-day third generation, or Gen 3, process. Gen 3 may further improve eye events till manufacturing efficiencies and deliver eye events till to patients even sooner. We also believe that 16 days for till manufacturing is the fastest in the industry at this time. In addition to commencing clinical manufacturing to supply investigational eye events till therapies to patients with cancer enrolled in our clinical trials, We are advancing commercial manufacturing readiness activities for IVAN still at ICDC. Commercial supply remains on track for 2022 pending regulatory approval with ultimate capacity to meet the demand for up to thousands of patients in multiple indications. Support of IVAN still manufacturing capabilities and pipeline, we have been sharply focused on building our robust and growing intellectual property or IP portfolio. Today, we have more than 30 granted and allowed U.S. and international patents, and more than 700 patents and patent applications filed globally across major pharmaceutical markets and other key geographies. In the past quarter, expansion to our patent portfolio includes two new patents covering till compositions, repairs from tumor digests, and methods of creating HPV, treating HPV-positive cancers, including cervical and head and neck cancers. We believe that our internal manufacturing and IT position have firmly established our leadership in developing and delivering TIL therapies for unmet need patient populations with cancer. I would now like to hand the call to Jim Ziegler, our Senior Vice President Commercial, to highlight our commercial launch preparations. Jim? Thanks, Igor.
spk07: Throughout this year, including earlier this quarter at our ribbon cutting event, we have been fortunate to meet several key opinion leaders investigators, patients, and family members who all understand the challenges of metastatic melanoma. The opportunities to hear their stories reinforce our commitment and our sense of urgency to bring Lifolucil to market. At Iovance, we have a mission to be the global leader in innovating, developing, and delivering TIL cell therapy for patients with cancer. This is an obligation we all take personally. Our commercial team remains focused on customer and patient centricity to ensure a positive experience with Lipoleucine in three areas of operational excellence. First, we continue to enhance our partnership with the leading U.S. cancer centers to build their Iovance TIL service line capabilities. We are pleased with the partnership and engagement with these centers around a shared goal to ensure timely and appropriate access to lifeloosal upon approval. Our customer-centric onboarding program includes a training curriculum that ensures cross-disciplinary teams at each authorized treatment center can administer the lifeloosal treatment regimen upon FDA approval. The planned timing and execution of key onboarding and training is also aligned to our BLA submission to ensure just-in-time training and readiness. Second, our market access team continues to engage commercial, Medicare, and Medicaid payers to ensure patients have appropriate and timely access to Lifolucel. We believe payers appreciate the unmet need and the clinical value of Lifolucel. And third, the development of Iovance CARES our own cell ordering and patient support platform is on track for launch. Iovance Cares is designed to be customer-centric in planning and coordinating patient care throughout the life of Lucille journey. We have incorporated customer feedback in the design of Iovance Cares throughout the process. The platform includes our proprietary chain of identity and chain of custody system, our fully integrated patient management approach, and our integrated approach to quality. Iovance Cares is patient-centric with dedicated Iovance case managers to handle the needs of HCPs and patients. The case managers will also provide reimbursement support for sites and patients at every step of the journey. Demonstrating operational excellence across these three areas is expected to ensure patients have timely access to life elusive upon approval. With a gated approach to commercial readiness, the commercial organization is well positioned to scale our efforts based upon internal milestones and timelines. I will now pass the call to Friedrich to highlight our upcoming clinical presentation.
spk17: Thank you, Jim. I am pleased to highlight upcoming clinical data updates, as well as the status of our four ongoing clinical studies. Our drug development strategy focuses on cancer populations with high unmet needs with substantial opportunity for CHIL to make a meaningful impact. Since we have upcoming presentations as well as a conference call and webcast during CITC, I will briefly touch upon the highlights. As Fred mentioned, we are excited about the combination of CHIL with pembrolizumab as an approach for early aligned treatment settings. Primary resistance to immune checkpoint inhibitors is frequently observed in multiple tumor types. There's a need to increase overall response rate and deepen responses with more complete responses in anti-PD-1 naive patients. Previous results presented in head and neck cancer and melanoma patients demonstrated overall response rates that are significantly higher than pembrolizumab alone in patients who are naive to immune checkpoint inhibitors. Moving to our non-small cell lung cancer program, CITCY, will be the first medical meeting for us to share clinical data for our CHIL therapy LN145 in patients with metastatic non-small cell lung cancer who enrolled in cohort 3B of the ongoing basket study IOV COM202. As a reminder, cohort 3B enrolled 28 patients that had progressed on prior immune checkpoint inhibitor therapy. This was a heavily pretreated population for which there is a significant unmet need to increase response rate and prolong survival. As previously reported in our top-line corporate announcement, we were very pleased to see an overall response rate of 21.4%, and we look forward to providing additional details at CIDC. Turning to our ongoing clinical studies, we have four active clinical studies with Iovanskill as follows. In our IOVLUN202 study in second-line lung cancer, which has more than 20 active sites in the US and Canada, In our IOV COM202 basket study of IOVAMs TIL and TIL plus immune checkpoint inhibitor combinations, we have completed enrollment in the relapsed refractory non-small cell lung cancer and head and neck cohort. Recruitment continues in melanoma and with TIL combinations in non-small cell lung cancer. In our C14504 clinical study in advanced cervical cancer, we continue to recruit a cohort of patients not previously treated with systemic therapy or anti-PD-1 to receive iovanstil plus pembrolizumab. We are also actively enrolling in our IOV CLL-01 study in CLL-SLL patients, which is our first hematologic indication. I will now hand the call over to Jean-Marc to discuss our third quarter 2021 financial results.
spk03: Thank you, Fred. My comments will reflect the high-level financial results from our third quarter and year-to-date 2021. Additional details can be found in this afternoon's press release, as well as in our SEC findings. I will begin with our cash position. As of September 30, 2021, Iovance held $660.8 million in cash, cash equivalents, investments, and restricted cash compared to $635 million on December 31, 2020. Our strong cash position is expected to be sufficient well into 2023 to advance our operating plan, including pipeline development, commercial manufacturing readiness, and launch preparation, with no immediate need to raise dilutive capital. Moving on to the income statement, Our net loss for the third quarter ended September 30, 2021, was $86.1 million, or $0.55 per share, compared to a net loss of $58.6 million, or $0.40 per share, for the third quarter ended September 30, 2020. Net loss for the nine months under the September 30, 2021 was $242.9 million, or $1.60 per share, compared to a net loss of $191.2 million, or $1.41 per share, for the same period ended September 30, 2020. Research and development expenses were $65.4 million for the third quarters ended September 30, 2021, an increase of $22.3 million compared to $43.1 million for the third quarter ended September 30, 2020. Research and development expenses were $183.4 million for the nine months ended September 30, 2021, an increase of $34.1 million compared to $149.3 million for the same period ended September 30, 2020. The increase in research and development expenses in the third quarter of 2021 over the prior year period was primarily attributable to an increase in cost associated with growth of the internal research and development team, an increase in clinical trial costs, and ICTC facility-related costs. The increase in research and development expenses in the first nine months of 2021 over the prior year period was primarily attributable to growth of the internal research and development team and an increase in ICTC facility-related costs. Following completion of the ICTC, we have concluded our initial $85 million investment in constructing the facility. General and administrative expenses were $20.9 million for the third quarter ended September 30, 2021, an increase of $5 million compared to $15.9 million for the third quarter ended September 30, 2021. General and administrative expenses were $59.8 million for the nine months ended September 30, 2021, an increase of $15.7 million compared to $44.1 million for the same period ended September 30, 2020. The increase in general and administrative expenses in the third quarter and first nine months of 2021 compared to the prior year periods were primarily attributable to growth of the internal general and administrative team and higher stock-based compensation expenses. As of September 30, 2021, there were approximately 156.7 million common share outstanding. We continue to focus on investment in four key areas as outlined previously to ensure the growth and strength of our value creation. This includes advancement and expansion of our clinical pipeline, launch readiness, a strong cash position, and manufacturing at ICTC, which will provide new cost efficiencies as we are able to shift work currently being done through contract manufacturers to ICTC. I remain confident that by managing our investment across these priorities, we will continue to stay focused and align our spending with our corporate priorities. I will now hand the call back to the operator to kick off the Q&A session.
spk08: Thank you. As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. We ask that you please limit yourself to one question, and then you may re-enter the queue. If time permits, we will take any additional questions. Our first question comes from the line of Mara Goldstein with Mizzouho.
spk01: Thanks very much for taking the question. I just wanted to go back for a second to the question of the discussion with FDA, and I respect that there's very little that you can say about it, but the press release makes reference to still being able to come up with a solution that will satisfy the agency, and so I'm wondering if you can maybe share with us You know, where you are in the process in terms of the discussion level with them, you know, the original plan had been that you had some assays already on hand and that you also were pursuing a development track for new assays and would present those to the agency. So maybe, you know, because we're just about anniversaring this, maybe you can kind of walk us through exactly where things are at.
spk12: Sure, Mara. That was the plan as we discussed back in June, and that's still the plan. Right now we're in the middle of the second half when we're having the FDA and those regulatory discussions.
spk01: Sorry, I didn't mean to interrupt you. I was going to say, is it fair to characterize that you're still on a back-and-forth with the agency?
spk12: Yeah, you could call. I mean, we would describe it as engagement, but, yes, we're in discussions with the agency and having that kind of level with them. And, again, the anticipated BLA filing timeline is still firsthand at this point.
spk01: Okay. And I know I appreciate the discussion around the activities that companies are undertaking in advance of being able to submit. And I'm speaking, you know, from a commercial perspective. But relative to the capital that the company raised ahead of being able to, ahead of launching, and where you are now. I'm just curious about, you know, how much capital is being deployed while you are waiting that you would have otherwise not spent.
spk12: Well, we're continuing to run our research and development program as we would normally have spent it. So we have all the clinical assets still progressing. We're just running this in parallel, so I wouldn't characterize it that way. I would basically say we're continuing the development of the TIL platform as we intended, and at the same time we're working with FDA on moving forward on the potency assay situation, which is something that we think is a gating item across the TIL platform right now.
spk01: Okay. I really appreciate it. I'll hop off and let others ask questions. No problem.
spk12: Thank you, Mara.
spk08: Thank you. And our next question comes from the line of Michael Yee with Jefferies.
spk06: Hey Fred, thanks and appreciate the question. My question is, if you feel that you can reiterate the filing guidance today, what are you specifically waiting for? Is it an official sign off on the assay? Is it meeting minutes? Do you have a good sense of what actually is going to be measured? Can you just give us a sense of the fact that you feel very good about that, and perhaps you're just waiting for meeting minutes? I guess that's question one. And then question two is, would you press release this announcement? Tell us what would happen and what would need to then happen after that to actually file. Thank you.
spk12: Sure. Thanks, Michael. Let me take them in reverse order. On the press release, we would – When material information is available to us, for example, responses from the FDA that are clear that we could put a press release out on the basis of, I think we would try to do that. We would very much like to update the market as soon as we can about the situation with FDA and our vote in CICs, of course. Turning to your first question, it's a very detailed, long engagement. It's a six-month process here, and it could go beyond that, of course, into 2022. We never said We might have continuing stuff spill over in the early 22 as we sort this out. But nevertheless, in sort of the blow-by-blow of things with the FDA, yes, there are things like minutes. Yes, there are responses from the FDA and that sort of thing. We're not particularly waiting on anything right now. We'll update when we can based on the disclosures that we have available to us at the time.
spk08: Thank you. Thank you. And our next question comes from the line of Mark Bradenbach with Oppenheimer.
spk09: Hey, guys. This is Matt. I'm for Mark. Thanks for the question. Apologies if this has been asked before, but I'm just trying to think of worst-case scenarios here on the potency assay and pass. Have we ruled out FDA asking you for a randomized trial in order to support initial Provol? Is that something that's been discussed, or is that completely out of the question in your view? Thanks.
spk12: Yeah, thanks. While we can never say what FDA truly might want at the end, right now FDA is not asking for that. So the way we've been treating this entire interaction with FDA is on the basis that we would be able to use the cohort for pivotal study data that we've already generated.
spk09: Great, thanks.
spk08: Thank you. And our next question comes from the line of Estika Gunwarden with Truist Securities.
spk04: Hi, this is Bill on for Africa. Um, we just had a couple of questions. We heard from some comments from another till company that the FDA has accepted their proposed potency assays. And we were wondering if the FDA is giving you any guidance as to what components of their assays were viewed favorably or any suggestions and how does what you have in development compared to that in case you do have any guidance?
spk12: Yeah, good question. Yes, there's been some comments by a competitor about this regarding a pre-IND meeting, and I believe a pre-IND meeting, and then definitely an IND. At that stage of development, things are much, much more lightweight in terms of what you have with FDA. We've been engaged with FDA for a long time on these things, and we've got a lot of detail from them about this. We don't really think there's crossover between the two. FDA is not really supposed to tell you what other sponsors are doing anyway. But we think our assay technology, the most recent assay technology that we've developed, does answer the question of how to see if pill therapy is consistent with the mechanism of action of that therapy.
spk04: Great. Thanks. And I guess just one more on the LUN202 study. Would you be able to contrast both the enrollment rate and the number of patients you have recruited so far based on PD-L1 expression level, so below 1% and above 1% to 49% to cohorts.
spk12: Frederick, do you want to answer that one?
spk17: Sure. This is Frederick. Yeah, thanks for the question. I don't think that at this time we would be commenting on the number of enrolled patients. Remember, the study is designed to enroll patients who have failed one line of prior chemo immunotherapy combination in two different cohorts, cohort one and cohort two. I would expect, since the available care for these patients is similar, that the distribution across the two cohorts would be reflective of the distribution of the PD-L1 status in the population, which you can assume is about one-third and two-third. But again, I don't think that we're going to comment on the exact enrollment number or distribution at this time.
spk04: Thank you. Appreciate it.
spk08: Thank you. And our next question comes from the line of Madhu Kumar with Goldman Sachs.
spk02: Yeah, thanks for taking our question. So as we think about kind of the potency assay situation, to what extent is this kind of a process of negotiation of kind of like sorting out your views on what are kind of relevant potency assays versus kind of the regulators take as compared to kind of just really testing hypotheses and really kind of sorting out what is a real metric of TIL cell potency?
spk12: I think it includes both of those components, Madhu. It's a discussion about mechanism of action of TILs and how potency assays can reflect that, and then specifically how assays that we've developed work and how they assess, we think, accurately the potency of TIL therapy. FDA has issued guidance in 2011 on this, as you guys know, and a lot of the detail of that guidance is wrapped up in these sort of discussions. We are at a pretty advanced state in the sense that we've got these methods and we've got data and we've got things we can talk about with FDA. So a lot of that's part of the discussion as well.
spk02: Okay. And then how much lead time do you think you would need to actually get resolution of the potency assay before you could feel confident in maintaining this first half 2022 guidance? Like if it's March of next year and you guys haven't reached resolution, would that be kind of like, what's the bound in which you would try to push back the timing potentially of a BLA from first half 2022? Yeah.
spk12: We don't know exactly. We are able, because a lot of the things we're doing right now are enabling us to file a BLA to sort of do two things at once. We can engage with FDA on the potency assay and prepare everything for the BLA. At some point, obviously, you know, that could slip, but it's not something that I would worry about, at least not initially in the half of next year.
spk02: Okay, great. Thank you.
spk08: Thank you. And our next question comes from the line of Colleen Cussey with Baird.
spk15: Great. Thanks so much for taking your question. So is it fair to assume that the third more novel potency assay is really the lead at this point that you're discussing with the FDA? And when might we get more information on what that is?
spk12: Yeah, Colleen, we haven't disclosed the detail yet, although obviously when we talk about the potency assays, we talk often about the most recent assay or set of assay technologies that we've developed. I really can't say what the lead is at this point. The new assay technology is something that we think is the right answer to FDA's questions alone or perhaps in combination with other assessments that we're already making. I don't know when we can disclose it.
spk13: Remember that all these discussions are in confidence with FDA and the technology itself is proprietary. So Immediately, we won't be able to disclose it. I hope that we can disclose it sometime in the near to mid-future, and then certainly we would want to put it out there so that we're more aware of how it works.
spk15: Great. Thanks. And then one more quick one. On the upcoming presentation at FITC, just what tumor types will be included in that frontline PEMBRO combo?
spk12: We haven't disclosed that yet. The abstracts, we're under embargo right now, so That should be available on November 9th in the morning when the abstracts come out. You'll be able to see more about that.
spk15: Great. Thank you.
spk08: Thank you. And our next question comes from the line of Ben Burnett with Stiefel.
spk16: Hi. This is Kaylee Breeza on for Ben Burnett. Thanks for taking our question. I just had one quick one. We were just wondering if you could give us any guidance or any details about when we might see some data for tills using the Gen 3 manufacturing process for any of the indications that it's being explored in. Thank you.
spk12: That's something we're looking at as soon as we can. Right now, I can't say anything about that, but stay tuned on that. We are interested in trying to get that data out when we have something meaningful to report.
spk16: Okay. Thank you so much.
spk08: Thank you. And our next question comes from the line of Nick Abbott with Wells Fargo. Pardon me, Nick, please check your mute button.
spk05: Sorry about that. Yes, thank you. Can you talk about the ongoing patient assessment for melanoma cohort 2 and specifically will patients be called in for a last scan to ensure inclusion of contemporary data with the BLA, and how does the timing for collection of that clinical data relate to resolution of this potency issue, given that we often hear it takes three months to read and clean clinical data under central review?
spk12: Yeah, Nick, I think you're referring to cohort four, right?
spk05: Oh, sorry. The melanoma BLA cohort. Oh, yes. Apologies.
spk12: So, Frederick, could you answer that one, please?
spk17: I completely heard the question. Can you repeat that?
spk05: Yeah, sure. So, you know, it's about the ongoing patient assessment, efficacy assessment in melanoma cohort four, and specifically, you know, will patients be called in for a last scan to ensure inclusion of contemporary data in the DLA, ELA, and how does the timing for collection of clinical data relate to resolution of potency given that we often hear it takes three months to read and clean data through central review.
spk17: Yeah, understood. Thanks. Yeah, so this is going a little bit into the inner workings of preparing a data cut for a single arm response rate endpoint trial. We would not call patients in specifically for an assessment. This is not an overall survival trial where oftentimes you do an overall survival call as you're getting closer to the data cut. We are continuing to assess patients that are ongoing in the predefined assessment schedule for the CT scans. And then we're defining a data cutoff date. And everything up to that data cutoff date would be included in the analysis. And you usually choose a data cutoff date to allow for sufficient time that then would allow you to clean the data prior to what we call the database lock. And that is still about two to three months time frame that you mentioned that can be shorter, can be longer, depending on what you think you need. So that can be done. without calling patients in specifically for an assessment, which would probably not be appropriate because it would be asking for additional scans more frequently than predefined and what they agreed to in their consent. Did that answer your question?
spk05: Yeah, it does. And then I guess the question is, you know, then the timing of that, defining the cutoff date versus where you are in the potency issue, resolution of the potency issue, you know, Something has to be rate limiting. I guess you don't want the clinical data to be rate limiting.
spk12: Yeah, although they can run in parallel to some extent because we could be doing IRC work while we're resolving the potency assay issue and then sort of at the end of that process, as we've discussed on a lot of our calls, then go back and revisit the full analysis set with the potency assay information in hand.
spk05: Okay, great. Thank you.
spk08: Thank you. Before we continue, if you have any additional questions, please press star 1. Our next question comes from the line of Peter Lawson with Barclays.
spk10: Great. Thanks for taking my questions. Just on the potency assets, just I guess, how many potency assets do you think you need and do you have? And then how many of those do you think you could essentially have patent protection around? could create, could preclude other uses?
spk12: Yeah, good question, Peter. We have a lot of them. I don't have an actual final number on them because there's so many variations. It's really a rather complicated environment, but we've shown multiple assays to the FDA. As most of you know, we're on our third assay or set of assays that we're showing them right now. Some of them, like the newer ones, do have IP associated with them that might create some barriers to entry for others, which we think is valuable. Others are more generic assays that have been out there for a while that may not provide as much protection, if you know what I mean.
spk10: Gotcha. And then you talk about three sets of assays. Is this refinement as you go from step one to step two to step three, or is they kind of reject all of them in set one and you've had to kind of come back with a set two and then a set three? How did that work?
spk12: Yeah, I wouldn't treat them as refinements. Some of them are completely new approaches. One of the ones that we're most focused on right now is what we were just talking about earlier with the question are really new technologies or new ways of looking at
spk13: how pills work, how the mechanism of action of a pill can be reflected in the potency assay.
spk12: So that's more of the, you know, I wouldn't treat them as refinements at all, really, when you're doing something like that. There are some of the earlier assays might be viewed as sort of variations of each other, but the new stuff that we're doing is really fundamentally new.
spk10: Gotcha. And you feel that kind of each step is kind of getting you closer with the FDA? Or has it accelerated recently? Or any kind of sense of of speed of progress.
spk12: We feel like we're making progress, and it's good enough that we can continue to guide towards the first half of 2022 BLA filing, which is coming up fairly soon here. So we're comfortable with where we are right now with FDA. There's work to be done, and we're still working. But that's, you know, as things stand today, we're standing by that guidance.
spk10: Great. Thanks so much. Thanks for the detail.
spk08: Thank you. And I'm showing no further questions. So with that, I'll turn the call back over to Fred for any closing remarks.
spk12: Thank you again for joining the I-Advanced Biotherapeutics Third Quarter 2021 Financial Results Conference Call. I'd like to thank our investors, analysts, patients, collaborators, and employees for their support. Please feel free to reach out to our investor relations team if you wish to follow up. Thanks, everyone.
spk08: This concludes today's meeting.
spk12: Thank you for participating, and you may now disconnect.
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