Hello, everyone. Thank you for joining us, and welcome to the Immix Biopharma, Inc clinical data release. After today's prepared remarks, we will host a question-and-answer session. If you would like to ask a question, please press star one to raise your hand. To withdraw your question, please press star one again. I will now hand the conference over to Dr. Ilya Rachman, Chief Executive Officer. Please go ahead.
Thank you, Hillary, and thank you everyone for joining us today. We're happy to share our clinical and commercial updates today. I'll be joined today by my colleague, Gabriel Morris, President and Chief Financial Officer, as well as Michael Grabow, Chief Commercial Officer. Here's the agenda for our call today. Here's the agenda for this morning's call. We will begin with the clinical update, followed by commercial update, and then we'll proceed to question- and- answer session. We will be updating folks today on the progress we've made in a disease of light chain amyloidosis. It's a disease where normally protective plasma cells residing in all of our bone marrows produce protective antibodies to protect from flus, colds, emerging cancers, and other insults. In this disease, instead, they begin to produce toxic antibody fragments called light chains.
These light chains circulate throughout the body, and they gum up and destroy every vital organ, starting with the heart, kidney, liver, nerves, and others. Unfortunately, patients progress to organ failures, subsequently leading to deaths. Here's an example of a heart that was so destroyed by these light chains, a patient had to undergo a heart transplant to cope with it. Because it's the light chains that cause this organ damage in this disease, clinically, we follow and monitor the levels of light chains in patients' blood. If the light chains stay persistently elevated, we know that patients are on the path to organ failure. If we're able to remove these light chains from patients' blood, we know that they will go into remission and live completely different lives.
In the next handful of slides, we will share with you the current standards of care, the progress we're making in this disease, and we'll take it to the commercial outlook as well. If you were to look at the current lay of the land in 2026, here's the recent report from Amyloidosis Center of Excellence in the United States. It's a 12-patient report that shows that out of 12 patients, in 11, the disease was not able to be controlled. Just one patient was able to be put into complete remission. In 2026, not only there are no FDA approvals in the relapsed/refractory space, the complete response frequently is less than 10%. With a single drug approval only in the newly diagnosed setting, this remains a very poorly served patient population.
In addition, given that 50% will not respond to the frontline therapy and over a third of patients will progress, there is a significant unmet need in this setting. Gabriel, perhaps we could provide folks with the update on the recently announced data.
Thank you, Dr. Rachman. I am Gabriel Morris, President of Immix. We have in the same format on the next page, so disease burden on the top and magnitude of response on the bottom. Our data, we are thrilled to report that at this moment, we have our entire 45 patients, of which 44 have today normalized their toxic light chains, and we have 95% downstream organ responses as well, which provides us with an 89% complete response rate, which we believe will increase to 98% after these 4 patients, so that would be 44 out of 45, have converted to complete response. Folks may know from our prior disclosures, we have had patients who have all patients who have been minimal residual disease negative in the past have converted to CR with subsequent follow-up. Company is thrilled with these results.
For the new 25 patients that we are providing data on today, all are either in complete response or minimal residual disease negative. We believe that at this time, this data not only provides hope to folks, but shows consistency among what we have disclosed before. With that, I will hand it off to Dr. Rachman to talk about safety, organ responses, then we will touch on the landscape briefly and where we are as we move toward a planned BLA next year. Dr. Rachman, anything to add on efficacy before we move to safety?
No, absolutely. Given the magnitude and duration of the efficacy and the complete responses, a number of folks have crossed the two-year mark. It remains extremely gratifying to see this. Obviously, as folks would like to know, it is important to focus on the safety results as well, given this is CAR T. What we would like to highlight is the consistency of the dataset across all patients now, more than doubled from our prior data release. It remains that the median duration of CRS across all patients is still one day. There is no high-grade CRS observed, no neurotoxicity of any kind, no enterocolitis observed, and remains mild and well-tolerated therapy across all patients.
Okay.
In addition, taking a deeper look at the organ responses, folks can see that there is a rapid and sustained non-transient deep organ responses, both cardiac and renal, 100% cardiac, 92% renal, and the effects are observed within days. You can see the cardiac responses were observed in 26 days, with the renal following in the next 59 days post-dosing. There is a predictable sequence that we observe the responses in. Post-dosing at the end of month one, patients turn MRD negative, minimal residual disease negative, which means that there is no plasma cell clone that is the producer of these toxic light chains, followed by complete responses and organ responses. That is what we would like to see in the clinic.
Further, to build on the unique tolerability profile of NXC-201, we would like to highlight the unique advantage versus other CAR Ts, for example, the advantage that provides the foundation for the leadership of NXC-201 in AL amyloidosis. The median durations of CRS being one day, that is three to seven times shorter than any other CAR T, both approved or in development. The reason why that is critically important is because patients with AL amyloidosis present a unique management clinical challenge. They frequently have coexisting heart and kidney failure present in the same patient. CRS being a rapid heartbeat, i.e., heart stress, coupled with fever, which is dehydration, and kidney stress, presents sometimes an untenable management challenge, where for heart failure, you have to dehydrate the patient, and for kidney failure, you have to hydrate the patient.
We believe that the unique tolerability of NXC-201 provides the opportunity to serve this patient population uniquely and better likely than any other CAR T. We would like to expand our leadership now and put it in perspective when it comes to bispecifics as well.
Thank you, Dr. Rachman. We believe that the data that we have presented compares favorably. We can see with other classes of therapies that are not NXC-201, we do see in datasets presented at European Hematology Association Congress, toxicity and infection challenges across the entire set, as well as ICANS. Three points. One, we are advanced in our registrational design trial. Point number two, we believe our clinical is great. We have more prior lines of therapy prior to NXC-201 than other trials. We have more stem cell transplants. Notably, we have an independent review committee assessing complete responses. We have fast and deep organ responses, and we are able to have this effect in 24 hours, not 24 months.
Therefore, for patients that are coming off of a four-drug combo in the front line with monthly dosing where there are side effects for two years, which is the recommended dosing for the front-line therapy, DARZALEX four-drug combo with cyclophosphamide, as you all know, steroid and proteasome inhibitor. We believe that a one-time therapy option, 24 hours, with, as Dr. Rachman touched on, extended responses now going beyond two years, will be a compelling option for these patients when other options remain extended dosing and time near the hospital and very careful close management. Dr. Rachman, anything to add here before we move to a timeline and then back to you to wrap up clinical section?
Thank you, Gabriel. I believe the slide truly highlights the unique offering and uniquely suitable opportunity to provide one and done approach that would offer patients a potentially transformatively effective, convenient treatment option.
Okay. Thank you, Dr. Rachman. As we proceed, we are happy to have everyone on the line today. We have completed a 45-patient readout here in September. We believe the current results are 40 CRs as we sit here today. If we incorporate MRD negativity, we are going to 44 out of 45, and that will take us to 98%, we believe, a complete response rate as we move toward a BLA. We plan to lock the database with follow-up from our completion of enrollment in March 2026. Folks can also look forward to trial initiation of our randomized controlled trial against daratumumab CyBorD coming as well with Breakthrough Therapy designation as well as RMAT designation. We could not be more thrilled with the consistency that we are showing here.
We believe that for patients who have had one drug approval in 100 years, and that four-drug combo in the front line contains some medicines that have been around for a while. We believe it is time for a possible second option when folks look at on the shelf for the array of options in this disease, rare disease, progressive disease. Back to Dr. Rachman to wrap the clinical section, and then we will hand off to our Chief Commercial Officer, Mike Grabow.
Look, for the disease that affects currently over 30,000 patients, as Gabriel mentioned, the innovation is long overdue. We are cautiously optimistic that better answers are just around the corner. We further would like to highlight with the next slide on the increased awareness, improved diagnosis, and speedier diagnosis of AL amyloidosis, in part driven by greater awareness of other types of amyloidosis, including ATTR. With recent availability of transformatively more effective therapies for ATTR, there has been increased push to earlier diagnosis and awareness. I want to point out that to diagnose ATTR, folks have to rule out AL amyloidosis. So the diagnosis of AL amyloidosis has actually paralleled the increased awareness and diagnosis rates of ATTR, as ATTR remains the diagnosis of exclusion. We believe that this further highlights the upcoming increase in an ongoing increase in recognition, diagnosis rates, and the improved awareness.
Patients could get into treatment sooner without incurring the further heavier burden of organ dysfunction. Further—
Go ahead.
Please go ahead, Gabriel, if you would like to add.
Awesome. Yeah. To build on what Dr. Rachman mentioned, we will add that we believe that AL remains underdiagnosed. A recent study with Optum Health records reported at ASH showed a tripling of the prevalence of this disease between 2017 and 2021, as well as an increase in incidents since 2019 of 8% per year. As Dr. Rachman mentioned, this driver, as folks present with heart failure symptoms, then ruling out with a simple blood test first, AL is the ATTR diagnosis path. We believe that awareness with additional approved drugs in TTR, as well as general test volume of this simple blood test, will continue to drive awareness and additional instance and prevalence in this disease. Deadly disease. Dr. Rachman, you have one more slide. Anything to add on ATTR and then are we good?
No, thank you for adding these additional details. I think this provides a great perspective. In large part, draws parallels where increased awareness really drives clinical benefits in earlier diagnosis.
Yep.
Next, we would like to share with folks the nationwide footprint of clinical trial sites that participated in our trial. We will obviously continue to build on this as we expand further in anticipation of our frontline trial and subsequent commercial launch that will obviously provide the basis for all these activities. As we mentioned, amyloidosis remains an underdiagnosed indication that we believe that is going to continue to grow. It is a large indication. We estimate that it currently provides a runway of over $2 billion of sales in the frontline alone. Now, I'm thrilled to introduce and hand off to our Chief Commercial Officer, Michael Grabow.
Thank you, Dr. Rachman. As this is my first investor call with Immix, I would like to provide some highlights of my background. I have over 26 years of experience in the biopharma industry, half with large pharma at Amgen, and half in emerging biotech with a focus in rare disease. In this time, I have played a primary role in more than 10 commercial launches, most recently with MODEYSO, a treatment for a rare form of brain cancer, initially leading commercial readiness with Chimerix, and ultimately with Jazz Pharmaceuticals post-acquisition. With that, I am really excited to now be a part of the Immix leadership team. Today represents an important milestone for Immix in the development of NXC-201. We are really encouraged by this data as it demonstrates significant promise for patients with relapsed refractory AL amyloidosis.
As we continue to develop this important program and march towards our anticipated BLA filing and potential FDA approval, I want to share with you a glimpse into our commercial strategy and plans. To start, we've been very diligent in our approach to understanding the degree of unmet medical need and potential receptivity to NXC-201 in the relapsed refractory AL amyloidosis space. Consistent with my past experience, to help us gauge our commercial opportunity with NXC-201, we've completed an opportunity assessment with an industry-leading consulting firm. That assessment included a robust example of hematologist oncologists with experience treating relapsed refractory AL amyloidosis.
As you can see from this slide, our market research is demonstrating that not only does a significant unmet medical need exist, which you can see from the graphic on the left side, but in sharing our product profile using the data released at ASH 2025, the majority of respondents indicated a strong likelihood to prescribe, which you can see on the right. This gives us confidence that a clear commercial opportunity exists with a benefit to patients suffering with relapsed refractory AL amyloidosis today. With regards to our commercial strategy in this rare disease, we're planning to build a commercial organization that is fit for purpose, agile and scalable for future opportunities. To start, we're going to be highly focused on where the concentration of patients are today.
As you can see from this slide, in evaluation of claims data, there are approximately 2,800 hematologist oncologists who represent 90% of all AL amyloidosis claims. Importantly, the majority of these treaters are connected to FACT Accredited Institutions with hands-on experience administering CAR T therapies. Of which we are going to initially look to onboard about 60- 70 treatment centers strategically located across the country to ensure patients have access upon launch. This high concentration suggests to us that we can launch with a lean and efficient team, including 35- 45 CAR T account managers with an appropriate mix of personal and non-personal promotion in line with other rare disease launches. From my experience in launching multiple rare disease brands, I've learned that to be successful in rare disease, it takes a team built around dedication, agility, and discipline.
Today, I've already begun building out the commercial leadership team with the right experience and mindset, who fully embody these principles. Collectively, my team and I fully understand the responsibility that we have to patients suffering with relapsed/refractory AL amyloidosis, and we're ready to bring NXC-201 to as many appropriate patients as possible upon our FDA approval. I look forward to sharing more updates with you as we approach our BLA filing and potential approval. With that, I'd like to turn the call over to our operator.
Thank you. We will now begin the question and answer session. Please limit yourself to one question and one follow-up. If you would like to ask a question, please press star one to raise your hand. To withdraw your question, please press star one again. We ask that you pick up your handset when asking a question to allow for optimum sound quality. If you are muted locally, please remember to unmute your device. Please stand by while we compile the Q&A roster. Your first question comes from the line of Judah Frommer from Morgan Stanley. Your line is open. Please go ahead.
Hey, guys. Congrats on the update. Thanks for taking the questions. Just a couple from us. Maybe first, just remind us, did all MRD negative patients historically convert to CR, and what is the median follow-up for those four current MRD negative patients that are not in CR yet? Then just maybe on the commercial side, remind us, will patients need to be in the hospital overnight? Could this potentially be outpatient at some point? Does the DARZALEX patent expiry in the coming years affect the market in any way, in your view? Thanks.
Happy to take this question. Thank you, Judah, for this question. Yes, historically, every patient who reached MRD negativity status proceeded to become complete response. Median complete response time point is approximately two months after MRD negativity, but it could take up to 320 days to reach CR. With respect to tolerability and the outpatient setting, at present, you are exactly correct. Given the tolerability profile and the short CRS duration, we anticipate not needing more than a day or two of follow-up post-administration. But not unlike CD19 CAR Ts that are currently being administered on an outpatient basis in up to 50% of cases. We believe that an outpatient transition is only a matter of time as clinicians gain familiarity with this therapy. Would anyone on my team like to add any comments?
The MRD negative patients that have not yet flipped to CR have less than six months of follow-up, those four, Judah. We believe, as we have had seven patients in the past that did flip from MRD to CR, we believe that they will flip prior to BLA submission.
Thank you for your question.
I guess, are we moving on to the next question? Judah, do you have a follow-up, or how does it work?
Judah, I believe that I heard you say thank you. If you could please let us know if you have any follow-up question.
Thanks, Hillary. It was just that DARZALEX patent expiry.
Yeah.
I believe he—
So—
—oh, please go ahead.
—the DARZALEX FASPRO patent, and again, we are not representatives of other companies, but has a handful of years to go, is our understanding.
Thanks, guys.
Okay. Thanks.
Thank you.
Great to hear from you. Thanks.
Thank you for your questions. Your next question comes from the line of Tazeen Ahmad from BofA. Your line is open. Please go ahead.
Hi, guys. Good morning. Congratulations on a really strong data. I just want to have a couple of questions clarified. Can you share anything on organ responses that you're seeing so far? Secondly, just on patient backgrounds and baseline characteristics, for the 25 new patients that you've shown today, how does that compare to the previous 20 patients? Lastly, the data that you presented this morning at top line is quite impressive with the 89% CR in all 45 patients and 84% in the new 25 patients. Given the quality of the data that you have so far, is there a way that potentially your timeline for application and approval could be moved forward?
I know that you've talked about waiting for the full data set, but, given that this is an area of unmet need, I'm just curious how you're thinking about it today, if you have any updated thoughts. Those three questions. Thanks.
Thank you, Tazeen. Great to hear from you today. Thank you for joining. To your three questions, number one, with respect to the organ responses seen so far, you're right. We've demonstrated 100% cardiac organ response and 92% kidney organ responses. The 25 latest additional patients dosed share the baseline characteristics with the first 20 patients. Consistency is the theme. To your last question, with respect to BLA timing, obviously, look, everyone understands the urgency for this patient population, and we intend to move as expeditiously forward as possible. We did set out to provide the adequate follow-up period post-dosing, b ut stay tuned and rest assured that we will do everything possible to bring this to patients as quickly as possible.
To build on Dr. Rachman's comment, we have shown in today's presentation, to your first question, sustained and deepening organ responses over time that deepen all the way out to month 12, month 15. We plan on timing of the submission after sufficient follow-up to have complete response rate in its steady state. Myself, Ilya, as investors in the company, we believe it makes sense to get that one-year follow-up before submission. Tazeen, does that answer your question? Any follow-ups?
Nope, I am good, Gabriel. Thanks.
Okay, great to hear from you.
Thank you, Tazeen.
Your next question comes from the line of Reni Benjamin from Citizens. Your line is open. Please go ahead.
Hey, thanks. Thanks for taking the questions, and congratulations on the outstanding data. Maybe two from us. One, can you talk a little bit about when you might have a pre-BLA meeting with the FDA? Does it make sense to have it earlier and get some advice in terms of filing this, to Tazeen's question, filing this early based on what you have? Maybe even start a rolling submission. As a follow-up, you talked about your confirmatory study, which needs to be ongoing, obviously, as you seek accelerated approval. Can you talk a little bit about that confirmatory study? How big is it? How long could it take to complete? What would the design be? You raised some additional capital today. Congratulations on that. Does this kind of set you up, through commercialization for Michael and his team to get this out there? Thanks.
Thanks, Ren. Great to hear from you. Thanks for joining us today. I will start with, as you know, this therapy has been a recipient of both RMAT and Breakthrough Therapy designation. The agency, the team here, are keenly aware of the urgent need, and we are having ongoing communications with the agency to move this process along as expeditiously as possible. These are working, ongoing communications. With respect to the frontline study, kicking off in 2027, it is going to be a randomized prospective study against daratumumab CyBorD, which is the current frontline standard of care. We anticipate a 260-patient study, one-to-one randomization, design that is mirroring that of ANDROMEDA, which was the phase III that led to the approval of DARZALEX as the current frontline therapy.
Great. Thank you, Dr. Rachman. To build on that, the frontline study, there is an opportunity for a complete response-based interim read built in to that, consistent with the precedent approval in this indication 2021. On your third question, this raise extends runway, assuming zero revenue whatsoever from mid-2028 into Q1 2029. I would like to hand it off to Mike Grabow to comment on the focused commercial, maybe just a high level, Mike, on whether or not this launch will be consistent with your prior experience. Yes, it is covered by existing cash, Ren. Mike?
Yes. No, thank you, Gabriel. Thank you, Ren, for the question. We feel very confident that, as I mentioned to you in my prepared remarks, that in my past experience, I have been able to build a very lean and efficient team in rare disease, and we are going to do just that here as well. We definitely believe that we have enough runway now with our capital raise to absolutely get us through launch, and we are excited to do it. As we approach launch, as we approach our filing and so forth, we are going to continue to hone in and refine our strategy and our focus, but it will be as a very targeted way and very much a significant amount of precision in terms of how we execute in efficiency.
Excellent. Thanks very much, guys.
Thanks, Ren.
Thanks, Ren. Thanks, Mike, Gabriel.
Thank you.
Your next question comes to the line of Graig Suvannavejh from Mizuho. Your line is open. Please go ahead.
Good morning, guys. Thanks so much for taking my questions, and thanks for the presentation earlier today. Just a couple of quick ones from me. First, the complete response rate you saw on this next cohort of 25 patients was quite remarkable, comparing to the 70% you saw previously in the first cut and then 75% for the first 20 patients. Anything you can point to as to why you got such a better response this time around in this next 25 patients? I know you had mentioned the baseline characteristics were roughly similar, but just curious as to whether you have a theory as to why you got that up to 100%, or I guess it is 21 out of 25, so maybe it is not 100%, but it was better. So any comments there would be great.
The second question I have is, given the strength of the efficacy you saw, it might be still very early days for you guys to comment, but any updated thoughts on how you are thinking about how NXC-201 might be able to be priced given this profile? Thanks.
Thank you, Graig. Wonderful to hear from you. Thank you for joining us. On the first question, CRs and MRD. At this point, the biology of the disease has manifested clearly, and we're learning that the MRD is a pretty effective predictive marker of what happens with respect to future upcoming CRs. As the range of time when CRs are reached ranged in a number of months, around three months, plus, minus, it is literally the function of follow-up duration. Given that the follow-up duration ranged around 7± months, we were happy to observe the completed responses, but also in conjunction with the MRD status. It allows us to now predict and preview with much greater precision upcoming responses in addition to organ responses as we monitor the patient's clinical progress through their journey.
With respect to the pricing, your second question, I'd like to hand it off to Michael, who has done a great amount of work in that area, and it will be great, Mike, if you could illuminate some of these aspects.
Yeah. Thank you, Dr. Rachman, and thank you, Graig, for the question. Yeah. Ultimately, as you know, we have the opportunity to set price, but not until approval. We'll take our liberty to be able to do that and wait to set price upon approval. With that said, we are absolutely doing our diligence to evaluate price from every stakeholder's perspective today, our HCPs, payers, the authorized treatment centers, and of course, from a patient's perspective, ensuring patient access. The other thing that we are leveraging and working through is there are several instructive analogs out there today for other CAR T therapies that we're learning from and will help inform our decision on price. As we work through our launch readiness plans, it worked through our BLA submission and potential approval.
We'll certainly provide updates as we provide them, but suffice to say, we're taking a very thorough and diligent approach in working towards setting our price. Thank you.
I guess, let me follow up on that, Mike. In your research to date, and I know on your presentation slides there was a quantum of folks that for that purpose we've chatted with, can you indicate relative to other CAR Ts and given the duration of response we have here, is it looking like it's going to be a premium? Can we share a little bit about what your philosophy might be or not? If I may ask a question of the presenter.
Yeah. Thank you, Gabriel. Look, I will expand. NXC-201 is presenting with a very unique efficacy and safety profile. Given that unique efficacy and safety profile, given the clear unmet medical need and the lack of options, we do believe that we will have an opportunity to price at a premium. At what premium? We have to determine that. We're being very sensitive to, as I mentioned, all stakeholder perspectives. We want to ultimately ensure, and our true north in all of this is patients. In ensuring that patients have access to this program and this product in as big a way as possible. We will look to optimize the price in time, but we will keep in mind the current pricing of various existing CAR T therapies today.
We do believe, given, again, the unique efficacy and safety profile, the clear unmet medical need, and really the lack of available options today in the marketplace, that we would have that opportunity to price it some form of a premium.
Thank you, Mike, for that. Graig, thank you for your question.
Great to hear from you.
Your next question comes from the line of Gil Blum from Needham. Your line is open. Please go ahead.
Good morning, everyone, and let me also add my congratulations on a very consistent data set. A quick couple from us. The lack of relapse in some of these longer follow-up patients is notable. Is this something you guys think we should expect more broadly? And I have a follow-up.
Well, thanks for that. Well, first of all, we are very gratified. Clinicians are gratified, and needless to say, we are thrilled for patients doing well over extended period of time. We are clearly still writing this story as we are living it. We would like to hope and believe that this will be generalizable, these extended remissions will be generalizable, and we will keep updating folks as the story unfolds, a nd I know you had a follow-up, Gil.
Thank you, Ilya. As it relates to how patients are feeling, did you guys collect any PROs? It looks like these patients went through therapy pretty easily. I am wondering if you have any of that data.
Two points, Gil. Yes, we collect PROs as part of the clinical trial data set. Very important. We also getting a lot of feedback from clinicians. We have mentioned on this call, we have mentioned complete responses, we have mentioned MRDs, we have mentioned organ responses. These are quantifiable, objective data sets. What we hear from patients and clinicians, that they feel better within days. What we heard from our investigators, that patients telling them, "Oh my God, I know that I am feeling different first time in a very long time." Burning sensations, pains, fatigue, just suddenly lift and disappear at the end of first week post-dosing. These are the stories that we are hearing consistently from our clinicians.
All right. Guess we will see a further update maybe at ASH. Thank you, guys.
Thank you for joining, Gil.
Great to hear from you.
Thanks, Gil. Great to hear from you.
Your final question comes from the line of Patrick Dolezal from LifeSci Capital. Your line is open. Please go ahead.
Hi, team. Thanks for taking the questions, and congrats on the data. A couple from us. On organ response rate, you reported a 95% rate in evaluable patients, or 20 out of 21. Just curious how evaluable is defined and if there's any further accrual expected with greater follow-up, or if there were just 21 patients with substantial organ disease. Then, appreciate the slide on the likelihood to prescribe NXC-201. Just curious if you have a sense of how physicians may choose a CAR T versus a TCE approach, if the sort of experience in the multiple myeloma setting might push them in one direction or another, and does T-cell exhaustion factor into that equation? Thank you.
Patrick, thank you. Thank you for your questions. With respect to organ levels, organ levels defined in our study, consistent with the consensus definition used in the only approved trial of ANDROMEDA. Just to expand on that, you want to assess patients with a certain amount of organ damage based on markers of disease. When it comes to cardiac, you'd be looking at the proBNP markers. When it comes to kidney organ evaluable patients, you'd look at the degree of loss of protein in the urine or proteinuria. With respect to your second question of sequencing of CAR Ts versus T-cell engagers, bispecifics and otherwise, it's an evolving field, but as was very clearly enunciated by a very recent paper in New England Journal of Medicine just this month, the sequencing is now becoming clear that cell therapies perhaps should be the initial option followed by bispecifics.
Partly referring to your point that you mentioned that repetitive bombardment of any antigen expressed on a cell surface with an antibody of bispecific modality leads to a higher likelihood of losing the ability to target that antigen based on a number of molecular processes. In addition, if you think about this, we believe that providing a one-and-done approach as an upfront makes sense, both from the patient standpoint as well as clinicians' standpoint, where you can provide something that could provide an immediate or near immediate relief with long-term benefit and sort of remove the patients from the burden of being attached to the healthcare system and ability to be free, potentially for the first time in a very long time.
Ilya, if I could also comment on Patrick's.
Absolutely, Mike. Feel free.
As you said, how will patients go from one to the other, given this is a different type of administration? It is important to note that the patients for AL amyloidosis today are predominantly already treated in FACT Accredited centers, right? So where several CAR-Ts are currently being administered. We really truly see an opportunity. This is obviously a disease state that there has been a lack of innovation in and something that we absolutely see an opportunity to kind of redefine the standard of care for relapse refractory amyloidosis, given our unique efficacy and safety profile, b ut I think we have a clear opportunity in the sites and the places where we will focus, where physicians are treating today, to allow for patients to have access to this product and be treated appropriately in the right setting.
Thank you, Mike. I agree with that. We believe that the way that the drug is currently administered offers the convenience, predictability, and that rivals many of the options available today.
I agree with, to build on everything Dr. Rachman and Mike touched on, in relapse refractory today, there's obviously nothing approved and no options available. We see in our research of anonymized data that there are over 100 regimens used as doctors are looking to find a response. And for patients who completed that grueling 24-month four-drug combo in the front line to go into another two years of dosing with reported infection rates as high as 80%-plus, small portion ICANS. And we know from myeloma data, which you all have pointed out as analysts, that there can be up to a 30%- 50% rehospitalization rate that comes along with that. We believe that one and done in NXC-201 is a compelling option.
There are no further questions at this time. I will now turn the call back to Dr. Ilya Rachman, Chief Executive Officer, for closing remarks.
Thank you, Hillary. We are extremely happy to be here with all of you today and sharing this data that we believe will be the first installment on our path to bring a better future to this rare but deadly disease of AL amyloidosis, that is long overdue for innovation and definitely at least the second approval in 100 years. This solution is out there today. It exists here and now. It is no longer science fiction, and we're excited to do this work, continue this work, and continue sharing our updates with all of you in the future. Thank you all for joining us today.
This concludes today's call. Thank you for attending. You may now disconnect.