Immix Biopharma, Inc. Common Stock Study result

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 U.S. 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 2-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 1 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.