Precigen Q4 2024 Earnings Call Transcript

Quartr
Provided by Quartr
March 19, 2025

There are 6 speakers on the call.

Operator

Good evening, and welcome to the Precigen's Full Year twenty twenty four Financial Results and Business Update Call. At this time, all lines are in listen only mode. Following the prepared remarks, there will be a question and answer session. Please note that this event is being recorded. I would now like to turn the conference over to Steve Harrison from Investor Relations.

Operator

Please go ahead.

Speaker 1

Thank you, Alan, and thank you for everyone joining us this afternoon. With me today are Doctor. Helen Swazazzari, President and CEO of Precigen Harry Tomasian, our CFO Phil Tennant, our Chief Commercial Officer and Ritu Shah, our Chief Operating Officer. Before we begin, let me briefly review our forward looking statements. During today's call, we will make various forward looking statements.

Speaker 1

Investors are cautioned that our forward looking statements are based on current expectations and are subject to risks and uncertainties that could cause actual results or outcomes to differ from those indicated by our forward looking statements. Please read the Safe Harbor statement contained in our most recent SEC filings as well as risk factors contained in precedent filings. With that, I would like to now turn the call over to Doctor. Sabzavari. Helen?

Speaker 2

Thank you, Steve, and thank you to all for taking the time to join us for our year end 2024 update. It is indeed a transformative time for, as a precaution and as we are on the verge of commercializing our lead asset, PRGN 2012 in RRP, potentially bringing a treatment to this patient population with a high unmet need. From discovery in 2020, Phase I initiation in 2021, Phase II with breakthrough designation and accelerated approval pathway in 2023, followed by publication in science translation and presentation of the groundbreaking data at ASCO in 2024. This program has advanced with a remarkable efficiency and agility. We finished 2024 with submission of our BLA and announced FDA's acceptance with priority review with an upcoming PDUFA date of 08/27/2025.

Speaker 2

The FDA has indicated that they are not currently planning to hold an advisory committee meeting to discuss the BLA. I would like to now take some time, a few minutes to recap of our data, which actually recently has come out in Lancet publication. We are extremely excited about TRG in 2012 potential in RRP to not only be the first but the best in the class treatment due to significant effect in terms of efficacy, safety, ease of route of administration. In our pivotal clinical data, PRGEM twenty twelve demonstrated a statistically significant efficacy. I want to emphasize that our clinical study was designed with a robust, clinically meaningful and most importantly, a prospectively defined statistical primary efficacy endpoint of complete responses in RRP patients.

Speaker 2

Our pivotal study met primary efficacy endpoint with fifty one percent complete response rate. That was a statistically significant and handling these pre specified success criteria established in alignment with FDA. Complete responses have been durable with median durability of response at twenty four months, and all of our Phase one complete responders remain surgery free and in complete response three years. This is highly significant, and I'm gonna stress that the data that was presented at ACTFL showing collectively phase one and phase two, it had such a close repeat that in our Phase one, we had fifty percent complete responders and Phase two, fifty two percent for the average of 51% complete response in a prospective manner. Furthermore, eighty six percent of all of our patients had reduction in the number of In multiple publications, we have also shown significant enhancement of HCV6 and or 11 T cell responses, which is directly corresponds to the mechanism of action of PRGM twenty twelve and our clinical responses.

Speaker 2

And the first set of data was published actually in 2023 in science translation in regard to this. Also, we have shown that PRGN twenty twelve is again because of the differentiation that the gorilla adenovirus has shown, it can be repeatedly dosed, not only in our current program of PLGEM twenty twelve, which there has been four doses, but also in our other programs such as PLGEM two thousand and nine, which has been dosed more than 20 times. These platforms is different than other AAVs or other viral platforms that they have limited amount of time that we can dose them, for instance, once and twice. Gorilla adenovirus, it can be repeat dose and continues to lead to the enhancement of the T cells in the absence of neutralizing antibodies, significant neutralizing antibodies. And finally, I would like to say that the PRG in 2012, based on all the data that has been shown and the follow-up, is extremely well tolerated with no dose limiting toxicity, no treatment related adverse events greater than grade two.

Speaker 2

And as we have already shown, the route of the administration is just a simple subcu administration that can be given at any office. Well, we also have continued with our readiness to hit the ground running post of PDUFA day in August of twenty twenty five as we shift from R and D to commercialization and the sales of Chief of Commercial would be speaking to that. Finally, I would say a few words about our confirmatory trial, which already has been initiated and has started enrolling patients. Our confirmatory trial in alignment with the FDA is a single on, no placebo control required with 35 patients to be enrolled, and we are well on our way. Not only we have started and enrolling patients, but to move very rapidly in finishing this class.

Speaker 2

So with that, I will now turn the call to Rutul Shah, our Chief Operation Officer, which will be speaking to our CNC and Manufacturing Readiness. Ritu?

Speaker 3

Thank you, Helen. I would like to take a few moments to discuss our manufacturing strategy and provide an update. As you are aware, Veo made significant commitment and investment to be in control of our GMP manufacturing activities. With that strategic goal in mind, we have built an in house dedicated GMP facility for our adenovirus drug substance manufacturing back in 2019. We then manufactured all TRVN twenty twelve drug substance plots utilized in our clinical trials at this facility.

Speaker 3

Now we have upgraded the facility and with a strong leadership and operations team, we are ready to support the commercial launch of PRG in 2012. In addition, we utilized an established commercial CDMO for sales finished operations for the PRG in 2012 drug product. We have also built significant GMP quality control capabilities in house to support release testing of PRG in 2012. Together, our GMP manufacturing and testing strategy is designed to give us better control over more specialized operations, overall timelines and provide independence from external vendors as much as practical while containing costs. As part of the PRG and 2012 VLA, we had completed the process validation as previously aligned with the FDA.

Speaker 3

We are confident in our ability to supply PRGM twenty twelve products to meet anticipated demand at launch and beyond. With that, I'd like to now hand over to Phil Tannen, our Chief Commercial Officer, to provide update on PRG and 2012 market opportunity and our commercialization strategy. Phil? Great.

Speaker 1

Thank you, Ritoul. Good afternoon, everyone. The past few months have been incredibly dynamic for our commercialization team as we advance preparations for the commercial launch around the August 27 PDUFA. And as Helen said, this is a pivotal milestone for us as an organization, and I'm excited to share the progress that we've made since our last update. So we've made some significant strides in our launch readiness, including several major accomplishments.

Speaker 1

Firstly, we completed the build out of our Precigen commercial leadership team. We have very strong and experienced team now across sales, marketing, medical affairs and market access and distribution, who have the experience and the capabilities to guide the launch with precision and impact. Secondly, we've established a comprehensive commercialization strategy for The U. S. Launch, and this spans all facets of our operations to ensure we hit the ground running at launch.

Speaker 1

And then in terms of our broader commercial infrastructure, we're delighted to announce our partnership with EVISANA to implement The U. S. Launch. As a proven leader in supporting rare disease launches, EVISANA brings a wealth of experience that complements our vision for PRGN twenty twelve. Together, we are executing on critical launch activities across the spectrum, including the training and deployment of dedicated field teams to ensure a seamless and impactful launch.

Speaker 1

Our updated analytics underscore the importance of this work. Our advanced analysis, as shared at JPMorgan, suggests that up to twenty seven thousand adult patients in The U. S. Are living with RRP, which is higher than the previous estimates of up to twenty thousand and indicative of an even greater unmet need. These data strengthen our resolve to launch PRG in 2012 with a patient centric focus, ensuring timely access to this transformative treatment.

Speaker 1

So in summary, we're moving decisively towards launch, driven by an experienced leadership team, a highly capable commercialization partner and a robust strategy. And these elements position us well to realize the full potential of PRG in 2012 with commercial revenues expected to begin in the second half of twenty twenty five. We are primed to hit the ground running given our PDUFA date and that would clearly position us as the first and only medical treatment available for these patients. Back to you, Helen.

Speaker 2

Thank you, Phil. Well, as you can see that the level of excitement among Precigen and our teams as obviously PRG in 2012 has been our highest priority and remains to be our highest priority as we take and transform the organization from R and D to the commercial organization. With that in mind, however, I would like to also give you an update on two other programs that has been very exciting and very important. The first one is our PRGN 2,009, which is our guerilla adenovirus drug product that targets HPV sixteen and eighteen, which is the lead cause of HPV related cancers. A total of five percent of all cancers are HPV related, and that includes cervical cancers, head and neck, and anal cancer as indications.

Speaker 2

Our PRGN 2,009 has been targeting XPD1618 and we presented the data, the Phase one data at ASCO in 2023, we showed not only a very favorable safety and tolerability profile, but more importantly, in a relapsed refractory patient that they had failed even all the checkpoint inhibitors, we were able to show for the first time for any drug product in these settings 30% objective responses. Complete responders as well as partial responders, We had our complete responders standing close to two years of response, and in these same patients, we have shown and some of them have received excess of twenty doses of PRGN two thousand and nine, which has the exact same backbone as PRGN twenty twelve and have shown not only the neutralizing antibodies are at bay and not increasing at all, but also clear enhancement of T cell responses upon redosing of these patients. So this clearly, this clinical data in conjunction with our immunological data points again to the differentiation of our guerilla adenovirus platform than any other platform. And currently, our PRG in 02/2009 is advancing at Phase II, both for cervical cancer and tetam mesh at NCI and we continue to expand on that and we will be looking forward in near future to be giving updates on these two programs.

Speaker 2

At the same time, I'd like to give you an update on our OSHA CAR T platform. As you are aware, our OSHA CAR T platform to our knowledge is genuinely the only CAR T platform that can deliver autologous CAR T of the patient overnight at the setting of the hospital without a centralized manufacturing. It's decentralized manufacturing, it's overnight, and it's autologous. It contains the CAR of the interest plus a safety switch, which becomes very important if anything goes wrong, you can eliminate these cells immediately. At the same token with the mechanism of membrane bound R15, which allows actually the persistent and expansion of these cells in a way the manufacturing of these cells directly in vivo in patients, and you do not need in vitro expansion of these cells.

Speaker 2

Last year, we communicated that we had finished our phase 1b in AML patients, and we also communicated that we are preparing for the presentation for the end of Phase 1b to FDA. Meanwhile, at JP Morgan, we presented further data and quite exciting data that in our belief it's the first time ever that any company has shown this. For the first time, we have developed and discovered a specific biomarker for AML patients in our responders versus non responders after the treatment with the CAR Ts. And we have shown part of that data at JPMorgan, and I highly encourage people to take a look at that presentation if they have not seen that. We are currently very much excited about putting these materials together, and we are preparing for our meetings with the FDA FDA to discuss not only the platform but also our AML data and also to discuss the strategy for a pivotal Phase II and a path for approval and starting with the AML.

Speaker 2

Please stay tuned. We will be giving you updates on that level as well. And finally, I would like to also mention that our UltraCAR T platform has been generating very exciting data in an autoimmune setting, and as you know, the requirements for autoimmune settings are you have to have a safe cost that you can be actually generated with the price tag that can be used in number of dosing. And our CAR T platform needs all of that, including with safety switches and also the next generation adjustments that it does not require any use of checkpoint inhibitors in them. And with that data, we believe that in the field of autoimmunity, not only we have the ability to be first in a class, but also the best in the class.

Speaker 2

And this is ongoing and we are very excited about this. So with that update, I would like now to hand over to our CFO, Hari. Hari?

Speaker 1

Thanks very much, Ellen, and welcome to those participating in the call today. This really is an exciting time at Pressfield as we prepare for the launch of our first commercial drug product. You've already heard from other members of the Pressfield team as to our preparedness toward this goal, and I'd like to spend some time discussing our financial position as we move toward commercialization. I'll begin by highlighting our financial results for 2024. Overall, we finished the 2024 year with a net loss of 126,200,000 or $0.47 per basic and diluted share compared to a net loss of $95,900,000 or $0.39 per basic and diluted share in the year ended 12/31/2023.

Speaker 1

I'd like to point out that our current year net loss included over $55,000,000 of non cash charges net. Our cash burn for 2024, consisting of cash used in operations plus capital expenditures, totaled $76,800,000 Our press release and management's discussion and analysis included in our 10 K, both of which were just filed with the SEC, provides further detail as to fluctuations in our between 2024 and 2023. With that summary of our operating results, I'd like to spend a little time focused on our financial position. As I believe most of you listening in are aware, we raised $79,000,000 at the end of twenty twenty four via a preferred stock issuance, which included the issuance of warrants to purchase common stock. We believe that the terms of this preferred share instrument are friendly to the Company.

Speaker 1

The preferred stock carries an 8% dividend of which the first two years are to be paid in kind. Beginning with the third year, while dividends will be payable in cash, the payment of such are due when and if declared by Precigen's Board of Directors. While the preferred shares are convertible into common stock, the conversion feature resets each quarter, thus reducing the dilutive effect of a potential conversion as our stock price increases. In addition, the Company has the ability to redeem the preferred shares for the stated value plus accumulated and unpaid dividends, while the holders do not have the ability to put the shares for the Company. You can find more detailed summary of the terms of the preferred stock issuance in the financial statements in our four ten ks just filed with the SEC or within our eight K announcing the transaction that was filed with the SEC on December thirtieth of twenty twenty four.

Speaker 1

On top of the funds received from the preferred stock issuance, we also monetized in a non dilutive manner certain intellectual property rights and royalty rights related to non core assets of the company in December 2024, which resulted in proceeds of $8,500,000 The preferred issuance plus the aforementioned sale of intellectual property rights and royalty rights helped shore up our balance sheet and we finished the year with cash, cash equivalents and investments of $97,900,000 We're confident that this balance will support us well beyond our anticipated launch date and well into 2026. This runway is based on current projections, which includes anticipated revenue from the commercialization of PRGM 2012. As Helen mentioned earlier, our PLA was accepted by the FDA in February under a priority review with a PDUFA target action date set for 08/27/2025. This target action date plus the preparedness of our commercial team, as you heard from Phil earlier, provides me with a level of comfort to include revenue in my projections. Although, from an accounting perspective, this anticipated revenue is considered outside of our direct control as that revenue is dependent upon the successful FDA approval of the PRGN twenty twelve CLA.

Speaker 1

In closing, I want to reiterate that Precigen has always shown a strong financial discipline and we will continue to do so in the future. Our focus has and always will be to utilize our resources to garner the highest value for our shareholders. With that, I'd like to open up the call for Q and A and turn it over to Alan, the operator.

Operator

Thank Your first question comes from Jason Butler of Citizens. Your line is already open.

Speaker 4

Hi. Thanks for taking the questions

Speaker 1

and congrats on the progress. Two for me.

Operator

One, just at a

Speaker 1

high level, can you give us an update on the interactions with FDA and how you characterize the ongoing review for 2012? And then from the commercial side, can you speak to what your current thoughts are on the size of the field force and the number of sensors that you'll be targeting during the initial launch? Thank you.

Speaker 2

Hi, Jason. Thank you for the question. So in regards to our BLA submission and actually receiving a priority review, we have been having as we have mentioned throughout our submissions as well as even before that very, very close interaction and alignment with the FDA and we are very thankful to the FDA for a close interaction and the guidance and continue to do so. We are I think in a very good position in our submissions of the DLA and discussions and we continue to do so as you can imagine throughout the review cycle. So currently, of course, we stay very close in alignment with the FDA.

Speaker 2

And in regards to the commercial, I think maybe Phil can address the Yes, sure.

Speaker 4

There were a couple of parts there. So regarding the size

Speaker 1

of the field force, we've been fairly consistent in our thinking that we believe it's somewhere in the range of 15 to 20 representatives

Speaker 4

in

Speaker 1

the field and that hasn't changed in terms of what we're thinking. So, a fairly modest sales team. We believe there are around 500 fellowship trained otolaryngologists out there who will be responsible for treating the bulk of the patients. And those will largely be concentrated in the urban academic centers and the large IDNs and that will be an important part of our targeting.

Operator

Your next question comes from Ben Burnett of Stifel. Your line is already open.

Speaker 2

Hello, good afternoon. This is Carolina Ibanez, Ventoso on for Ben Burnett. Thank you for taking our question, Tonka, and congratulations for all the progress. Do you have any line of sight at this point on the timing of any additional meetings with the FDA pre licensing inspections and labeling discussions during the review process? I have a follow-up as well.

Speaker 2

Of course, as part of the regulatory process, there are inspections and for air facilities. Because of that, we will not be making any comment, but this is typical especially for GMT facilities as I mentioned. We have been always in very close alignment and continue to be with the FDA and we look forward to further communication as obviously we get closer to our PDUFA date. Okay. Thank you.

Speaker 2

And if PRGM twenty twelve gets approved, did you anticipate there will be a bolus of patients? And how do you plan to position yourself to address it?

Speaker 1

Yes, great question. I mean, we absolutely do think there's pent up demand here. These patients have known, have had no other options really on label at all. It's only surgery and some off label treatments, which don't address the underlying infection. So absolutely, we believe that there will be a concentration of patients who are in desperate need of this type of medication when we get to market.

Speaker 1

And so we will be deploying our team and our efforts accordingly to make sure that as many of those patients appropriately get our treatment as soon as possible.

Operator

Possible. Your next question comes from Suyam Pakula Ramakanth of H. C. Wainwright. Your line is already open.

Speaker 4

Thank you. This is Okay from H. C. Wainwright. Good afternoon, Helen, Phil, Ritel and Steven.

Speaker 4

So in terms of the indication itself, Phil, you are saying that based on you're looking at the claims, the number seems to be higher and in the order of twenty seven thousand in The United States and probably around one hundred and twenty five thousand outside U. S. But that is with no therapy, no approved therapy as you said and only patients who are brave enough to go under the knife. So with an approved drug, how easy two things, how easy is it for patients to get diagnosed that they do have RRP? And number two, how are you thinking of trying to get those patients or approach those patients who have not yet been diagnosed or is there a mechanism by which you can actually get these patients diagnosed correctly?

Speaker 1

Great. Let me take the first part, RK. So, the patients are very visible. They're having surgeries. They have many of them have frequent surgeries on an annual basis.

Speaker 1

So, we believe a lot of those patients are going to be readily identifiable at launch. And obviously, that's a key area for us to focus on. Like all good launches, we will have personal and non personal promotion. We will have remote promotion available. And so, where we can't reach everyone with a face to face interaction, we will be able to provide information and direct people to the appropriate information for their patients.

Speaker 1

But the focus is definitely on those who are already visible because we think that will be the bulk of the patients actually that are out there at the moment. The other phenomenon I would say that we have seen in other rare diseases is when you start to get a new treatment in a rare disease area, the amount of diagnosed patients or presenting patients actually increases because of the enhanced awareness, understanding and education out there. We've seen that in a number of other rare diseases and we don't think this will be any different.

Speaker 2

Okay. And maybe, RJ, this is Helen. I can also add to what Phil mentioned. In regard to the patient, obviously, identifications, currently the adult patients that they have and they live with the RRP, this is a patient population that is at the target and these patients are highly themselves are involved in regard to finding a new, innovative treatment because as you know for almost the past fifty years, this disease has been around and unfortunately there has been no treatment for this disease except the continuous surgery which is just a band aid in a sense. And from that perspective, not only the patients themselves, but also we have been obviously through a whole educational system with our patient group that for instance we had last year the RRP day and for patient awareness and RRP awareness.

Speaker 2

And these basically campaigns will continue as we go through our PDUFA and beyond to ensure that not only all the patients are aware of the innovative treatment, but also that our investigators, laryngologists and the KOLs, they are fully familiar with the various aspects of the hopefully the new soon to be a standard of treatment upon obviously FDA approval for RRP, which is we are thrilled to have played a part when this hopefully becomes approved for these patients in these centers.

Speaker 4

Perfect. Thanks for all that color. And let me try another two part question. As far as the confirmatory trial is for the PRG in 2012, what's the current status? And also, do you think you will be close to completion by the time you get to the PDUFA date?

Speaker 4

And the second part or the second question actually is on the PRG on 03/2006. Should we expect any of that data from the Phase one study to be published either in the first half or later in the year?

Speaker 2

Great, great questions. In regards to the confirmatory for PRG in 2012, as mentioned, part of the BLA submission is that you have initiated the trial already and we did that last year actually, well ahead of the submission of the BLA and currently the patients not only they are being enrolled, The finishing date for the confirmatory trial, as you know, are endpoints. The confirmatory trial design, which again, we have in full alignment and very close agreement with the FDA, FDA has given us the exact same design as we have for on pivotal, which was basically a single arm trial, 35 patients, no placebo requirement for the second basically arm and it's complete responses which takes twelve months, minimum of twelve months. As I mentioned, we currently have been following of course our patients in a patients which are the oldest patients that they have been obviously those, they have now all of those complete responders are still in a complete response three years later. So by the definition of the complete response endpoint, we will not be having the data by close to the PDUFA date.

Speaker 2

We anticipate that of course in 2026, '20 '20 '7, we will be reporting on those data. So, but as you can imagine, there is a high level of excitement from the patients for this trial, especially in the view of the safety that we have shown, the efficacy that we have shown, the ease of administration, the route of administration, which is a subcu, like you are getting a flu shot basically and obviously the durability of the response that is being seen by the patients. So I think this further has added to the enthusiasm of the patients and investigators and also really the physicians for this. Right? And in yes, and in regard to my apologies, in regards to the UltaCar and AML, as we will be having the discussions with the FDA, we will be giving the update and also we are looking at the proper venue to show the data and we will be translating those information in the near Thank you.

Speaker 4

Thank you, thanks for all that.

Speaker 2

Thank you.

Operator

Your next question comes from Jennifer Kim of Cantor. Your line is already open. Hi, thanks for taking my questions.

Speaker 2

Maybe to start off to follow-up on one

Operator

of the previous questions. I just want to clarify, will the FDA's manufacturing facility inspection come ahead of the mid cycle review? And I assume that's happening in late May, but do you think you'll have a

Speaker 5

sense by the mid cycle review how that day is thinking? Maybe we can start there.

Speaker 3

Thank you, Jennifer. Rupal here. I think, yes, we do anticipate pre approval inspection of the AI before the approval. But as Helen had mentioned in response to the prior question that it's part of the regulatory process. So we're not able to comment on the timing at this point.

Speaker 3

But as we have mentioned, we look forward to hosting them and we anticipate that inspection before the approval.

Operator

Okay. And maybe a question for Phil. The 500 doctors that they're initially targeting, what percent of market does that capture? And could you give us some color on how the internal sales force is coordinating with the Versana partnership?

Speaker 1

Right. Yes. I mean, those 500 VNTs that I mentioned, I mean, they'll be responsible for the vast majority of the patients that we believe are out there. There was obviously a community presence as well for patients for this, so that's something that we're not ignoring. But again, we feel that the concentration is in the urban centers and that's how we'll be thinking about our field force deployment to a large extent.

Speaker 1

We all the field teams are through Evisana. So, we're not having any Precigen employees that are in the field as such. They will all be through Evusana, but obviously, they will act like Prestigen employees and through that strong partnership with Evusana. And the other important thing, Fred, sorry, Jennifer, the other thing important to stress, I did mention it in my prepared notes was that they're dedicated to CRGN twenty twelve.

Operator

Okay. That's helpful. If I could squeeze one more question, Phil. In your discussions with payers, is the expectation still that, I guess the access to the treatment if approved would depend mostly

Speaker 5

on treat to trial criteria and label versus the medical exception Or how have those discussions evolved?

Speaker 1

Yes. We continue to support great question. We continue to speak to many payers. We've actually now spoken to payers that represent collectively over 300,000,000 lives in The U. S.

Speaker 1

And we're getting a consistent response that the price range that we've been talking with them about, we're likely to see some degree of utilization management, some prior authorizations. We hope that that is PA to label. That's what we are trying to achieve, but there are some payers who would actually include inclusion and exclusion criteria. We feel that we have strong case. We're building strong value propositions to make sure that in either of those scenarios, we're in a great position.

Speaker 1

Medical exception is really the last resort in terms of where we think some of these payers will go based on the discussions that we have. So we're preparing ourselves with a strong value proposition to complement the clinical value proposition that we have.

Speaker 2

And I think, Jennifer, it's from the perspective of obviously that this would be for all RRT patients and the recent data have shown, when these patients even receive, when they have received up to five surgeries, then the damage to the vocal cords and trachea becomes irreversible. So you can imagine that it becomes very important in a setting that treat their patients prior to getting to this level and obviously the payers also recognize that and basically the effect of the surgery on patients that on their life, on the irreversible damage, but also on their losses that it's occurred as a result of all of that. And I think this is one of the very important parts of the recognition by the payers here.

Operator

Your next question comes from Brian Chang of JPMorgan.

Speaker 5

Maybe just first, can you give us an update on the latest on where you are into preparing sites to administer twenty twelve? And, you know, you talk about, you know, there are 500 initial doctors. Can you talk about how the initial 500 doctors overlap with the initial sites that are ready to go to administer twenty twelve? And then we have a follow-up. Thank you.

Speaker 1

Thanks, Brian. I mean, there's nothing overly complex about administering the drug at the site or special preparation that really needed. We know we have cold chain requirement, but we know we're for septic tanks injections. Nothing in the research that we've done

Speaker 4

and the sites that we're

Speaker 1

speaking to suggests that there's anything in terms of special preparation that is required other than that to think about. So, we at the academic institutions, the large IDNs, they're well equipped. We're obviously understanding exactly what that last 100 yards for the drug journey looks like. And we're speaking to them regarding that so that basically we deliver a seamless distribution service as possible from ordering the drug to the patients. And that's been the focus, and there's nothing particularly complex or special that we need to call out in terms of preparation.

Speaker 5

Okay. And then maybe just one on your thoughts on pricing and payer access. Maybe just one

Speaker 3

is what you'll need

Speaker 5

us take on pricing for 2012? And then just on the pricing standpoint, can you talk about how we should think about our plus here when it comes to your agreement with payers? Do you think that a value based agreement will be expected here? Any initial thoughts just based on your ongoing engagement with payers will be very helpful.

Speaker 1

Yes, sure. As I said earlier, I mean, we continue to speak to payers and we continue to get a fairly consistent response in terms of the value proposition, economic and clinical that we're making. So nothing's really changed in that regard. Value based pricing, I mean, I know it's out there. It's something that's being considered.

Speaker 1

The payers tend to have a view that it's attractive in theory, difficult in practice sometimes. So we're exploring that a little bit more. But again, we believe the price point and the way that we'll bring this value to the market is going to be relatively straightforward and something that is within the wheelhouse of these institutions and not something that they haven't seen before.

Speaker 2

And also, Brian, maybe I can add this to Tawain. Obviously, we have communicated before this is a rare disease with no standard of care for the past for the whole century to be honest and payers recognize that and they recognize also the losses to these individuals, not only the financial but the emotional and also from a life perspective. And then on top of that, one of the things that becomes very, very important and the payers appreciate and then discussions that we have had, it's very clear the safety that this drug delivers, the efficacy, which is unseen prior by any treatment, fifty one percent complete responders. And as I mentioned today and updated actually for the first time, we have now the median standing at twenty four months, but also of Phase one, all the complete responders from a Phase one study that we started in 2021, and they are still in a complete response. And this is another important part of the discussions that payers are very much appreciative of in regards to the efficacy, durability of response, the ease of administration and also the effect that it has not only on stopping the disease for majority of these patients as complete responders and reducing the requirement for surgeries in eighty six percent of the patients, but also from the fact that once they get in and the earlier that they get in with our PRG in 2012, it can really affect and reverse the situation not to get to the situation that now there is irreversible damage to the vocal cords or the trachea of these patients.

Speaker 2

And as a result of that, there is a permanent and lifetime damage. And I think that's another extremely important value out there that they do pay attention to.

Speaker 5

Great. Thank you so much for taking my questions.

Speaker 2

Thank you.

Operator

There are no further questions at this time. I would hand over the call to Doctor. Helen Sabzaveri for closing remarks. Please go ahead.

Speaker 2

Thank you. As we want to step closer to commercialization, I want to take this opportunity to thank our team at Questigen for their tireless work and a steadfast dedication to bringing PRGEM twenty twelve to market. Our team understands that patients with RRP are burdened significantly by this disease and that with surgery, there are innumerable risks to their health and for long term irreversible injury. Our team is actually and acutely focused on delivering the first and only FDA approved therapy to the RRP community as quickly as possible. With that, I wish you all a very good evening and thank you for participating in our call.

Operator

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation and you may now disconnect.

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