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spk03: Thanks for everybody to joining Cassie's update call. So we felt, this is Dr. Wei Wuxi, I'm the chairman and CEO of Cassie Pharmaceuticals. We felt it's important to give our investors an update on the new programs we have just licensed in I apologize a little bit ahead of time. I'm talking too much and lost a little bit of my voice. With that said, with all the typical disclaimers, let's go to slide number three. And joining the call will be our CFO Wei Hao and our CMO Alex is on the call. So the, so it's a real quick call. Uh, Cassie highlights, uh, Cassie is really a commercial stage, uh, uh, company. Uh, we really, our first drug launch evil Mallard really did it very well with our, you know, very, uh, well organized commercial team. Uh, our 2024 year project in revenue is around $15 million. The data should be announced. The actual number should be coming out soon. And we are projecting a 50% growth in 2021 for our first product. And what I always say, it's always the most difficult part of building biotech company is to launch the first product. With our first product launch, we now have truly built a fully integrated pharmaceutical company We actually have another molecule for transplant called ThyroTipa. We're initiating regulatory submission and registration studies in China in 2021. But one of our most exciting programs is the Chinese Domestic CD19 Kachi Therapy. We are on track to this therapy not only got the breakthrough therapy designation in China, we are actually on track to find NDA in 2021. And we obviously have a few more molecules that we have updated our investor. The DI-1206 is a molecule we licensed from BioInvent. We have announced the phase one trial We have six responders out of the nine evaluable non-Hodgkin lymphoma patients in the phase one study. Very encouraging data. And our CID103 anti-CD38 antibody is planning to start a phase one trial in Q1 2021. So today, the real purpose of this call is to update our investors with CD5339, which we think is this is a really, you know, broad range hemological malignancy and solid tumor drugs. And it already started two active phase one trials in dose escalation trial. And with that said, I'm going to let Alex speak. to give investors a overview of the CB5339, which we are really quite excited, you know, about this molecule. And we'd like to share the update with our investors. Alex?
spk04: Good morning. My name is Alex. I'm the Chief Medical Officer of CASSI Pharmaceuticals. I'm going to take you over the next couple of minutes to provide you the background and the status for this very interesting and potentially first-in-class program. Can you advance the slide, please? So the valicin-containing protein is the target for 5339. The P97 role in normal cellular physiology is to maintain protein homeostasis. And you can consider the P97 target to be a cytosolic protein chaperone which in conjunction with a large number of cofactors and adapters, separates polypeptides from immobile cellular structures, such as protein assembly complexes, ribosomes, membranes, etc. This is an ATP-dependent enzyme, and when you disrupt the P97 target, it also induces a DNA damage response. So it interferes with the cell's ability to basically fix any DNA damage. Cancer cells, because of their altered metabolism and proliferation properties, et cetera, are differentially sensitive to inhibition of the VCP P97 target. The lead product, 5339, It's a second generation small molecule inhibitor. It has the potential for a broad range of hematologic malignancies and application in solid tumors. And currently, there are two ongoing phase one dose escalation studies. An AML MDS study sponsored by Cleve, our partner. And the NCI is conducting a solid tumor and lymphoma trial, which has recently been initiated. Next slide, please. Now, as the P97, when it removes these polypeptides off of immobile cell structures, it often targets these polypeptides. They're taken away and degraded in the proteosome system. So this effect leads to an interference with endoplasmic reticulum-associated degradation. This process is critical to protein homeostasis, and its inhibition results in an irreversible, irresolvable stress state, which drives the cell tumors and multiple myeloma cells. into a death spiral, there is substantial potential to combine the 5339 with other multiple myeloma therapeutic agents and other targets in the unfolded protein response. Next slide, please. Now, when we consider the other, I think, very important mechanism of action, that is the interference with the DNA damage response. P97 is responsible for releasing polypeptides from chromatin. And many of the P97 chromatin targets or substrates have been identified, including RNA polymerase, L-complex, transcriptional repressor alpha-2, DNA helicase, double-span DNA break repair protein, et cetera. So that this is a very unique target that has the potential to substantially alter the therapeutic effects of other chemotherapeutic agents in patients with AML who are undergoing treatment. So this is what I would describe as a secondary key critical mechanism of action for the 5339 compound. Next slide, please. When we were undertaking the due diligence, one of the very attractive preclinical aspects was the potential broad application. As illustrated here, in 138 different cancer cell lines, the 5339 had a substantial treatment effect. Of course, this is an in vitro sensitivity assay. The AML and multiple myeloma cell lines were probably the most sensitive across multiple different experiments testing the 5339 activity. In solid tumors with high levels of protein turnover, there was also a substantial level of activity giving us encouragement that the 5339 could have application across multiple different solid tumor subtypes. The next slide outlines the ongoing cleave-sponsored Phase I study in AML and MDS. This is a classical design. It's first an accelerated titration and then a 3 plus 3 dose escalation with potential expansion in both the refractory relapsed AML and the intermediate to high-risk MDS. with the ability to expand the study and look at combinations in both the AML and the MDS indications once the recommended phase dose is reached. The design is very straightforward to date. The safety profile has been very consistent with what was observed in the preclinical toxicology studies. The 5339 has been well tolerated. There has been no evidence or clinical findings of the off-target visual toxicity that was associated with the first-generation molecule. The PK data set is coming in in a dose-proportional manner. And the company has not yet announced any of the safety or efficacy data set, but we Suffice it to say that there was adequate data, and in working with the Cleve management team, it was very easy to support the acquisition of this asset. The next slide, please. This provides the rationale to look at 5339 or assess 539 in patients with acute myeloid leukemia. The VCP P97 inhibition clearly results in a D of A damage repair. and that cascades into accumulation of DNA damage and cytotoxic, genotoxic stress, inducing cellular apoptosis. 5339 has demonstrated a strong level of activity across multiple AML cell lines and synergistic additive activity in conjunction with standard of care chemotherapeutic agents and other targeted agents in the preclinical settings. So there is, I think, very good rationale to move this molecule forward in both the AML and MDS indications. Now, that's the end of the scientific introduction. I will now turn the presentation back to Wei Wu.
spk03: Well, thank you, Alex. You know, we are just very excited to share with investors that the TASI progress With our first drug on the market, we are expecting to have another one or two drugs approved sometime in 2022. But we are also building a very, very strong pipeline of innovative compounds, just like the CD5339. And we think with this portfolio of assets, Sooner or later, CASI will become a very meaningful, fully integrated pharmaceutical company. Thank you so much. We would like to open up for questions.
spk01: Excellent. Thank you. Ladies and gentlemen, we will now be conducting the question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. The confirmation tone will indicate that your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Our first question is coming from the line of Leland Gershel with Oppenheimer. Please proceed with your question.
spk05: Hi, good morning, and thank you, Weiwu, for the update. I just wanted to ask two questions. First, as we look forward to CNCT 2019, becoming available in China. If you could maybe just walk us through the steps and the timelines that may be involved in terms of NRDL listing. And also, with regard to Fiotech, I wanted to ask, I know it's used for multiple cancers. I just wanted to ask kind of what the development path you see for that, if that will be for a specific indication or if the label will be you know, will allow for use in multiple mobile agencies.
spk03: Thank you. So, you know, unfortunately, Mike, you know, I'm not hearing you that clearly. So your question is on CAR T19 and Thyatipa, right?
spk05: Right. So the CAR T19 for the NRDL, just kind of the steps to getting listed there and the timelines, and then Thyatipa, what how you look forward to developing that, and will it be able to be used for the spectrum of cancers that it's used for, or will it take time to kind of have label expansions, just as we think about the China regulatory environment? Thank you.
spk03: Yeah. So right now our guideline for the CAR T19 is we are, you know, our partner, Gervantis, is conducting the pivotal trial, and our understanding is very much on target to fire the first indication sometime before end of this year. So we expect, if all things goes well, we expect, you know, this is obviously not that predictable. You know, we expect to launch the drug you know, around mid-2022. That's our current understanding. But, you know, obviously CDE or NNPA can always delay that process. But that's our internal timeline to push this molecule forward. Does that answer your question?
spk05: Well, I was going to ask, once it's approved, is it immediately, you know, the National Reimburse Drug List, is it immediately placed on the NRDO with With a price or is there additional steps?
spk03: Yeah. So we are probably not expecting to have immediate reimbursement, you know, in the first one or two years. Just like our Eva Mala. So our Eva Mala, you know, it's already launched over four years. we're still not getting into the national reimbursement. Right now, it's all self-pay. We expect our CAR T19 will be self-pay for at least a year or two. Because initially, our current GMP manufacturing capacity is only about 2,000 patients. So if we If our demand is way over our $2,000, we can't even meet that demand. So we think we will be able to find 2,000 self-paid patients first year we launch the CAR T19. And we will slowly negotiate with the national reimbursement to get into the national reimbursement. Is that something?
spk05: Yes, understood. That makes sense. Thank you.
spk04: So initially the pricing will... Yeah, go ahead. Go ahead. I was going to address... I'll address the thiotipa question when you're finished. Yeah, go ahead. So Leland, on the thiotipa, as you are aware, thiotipa is used as a preconditioning regime for allogeneic stem cell transplant. The initial indications will follow that exact path. and beta thalassemia, AML, et cetera. And it will be determined at a later point in time how we will proceed with the potential label expansion. But we will focus our resources on two of the primary indications, which will complement our commercial activities in China.
spk05: Okay. Thank you. Thank you, Alex. That's helpful. Thank you, Weiwu. Congratulations on the great progress. Yeah.
spk03: Thank you, Leland.
spk01: Thank you. As a reminder, if you would like to ask a question, please press star 1 on your telephone keypad at this time. The next question comes from the line of Nathaniel Calloway with Edison. Please proceed with your question.
spk02: Hello. Thank you for taking my question. I have two questions just about the new acquisition, CB5339. My first one is just for Alex, I guess. I'm just wondering, since this is a drug involved in protein homeostasis, should we expect its clinical profile to resemble, say, proteasome inhibitors? Is that something that is a reasonable assumption, or should we expect something different? And then my second question about the program is, since you're involved in, you're going to be involved in the development and rerunning trials in China, I was wondering what sort of timeline you envision for starting those clinical trials in China.
spk04: So for the first question regarding the safety profile, will it look similar to proteasome inhibitors? Difficult to say. On the first blush, understanding the ongoing studies, I would say no. However, if we look to the future for combinations, especially if we can use this in conjunction with the proteasome inhibitor in patients with multiple myeloma, obviously we will be dealing with the safety profile of the intrinsic proteasome inhibitor also. I'm very confident that as monotherapy, the safety profile is going to look a little different than what the classic proteasome inhibitor safety profile has been developed over the past few years. In terms of the timelines, the first step is obviously to assemble the package, to get it translated to Chinese, to get that package submitted, and we will be undertaking a pre-IND equivalent meeting with the Chinese health authority. As this is a new molecular entity, we want to make sure that we get the authority's buy-in, just as we would request a pre-IND meeting in the United States. So depending upon that review process and how fast we can get things in, I am hopeful that we can start participating in the global trials and other requirements in China within the next 12 months.
spk02: All right, that answers my questions. Thank you very much.
spk03: Thank you, Ms. O'Neill.
spk01: Thank you. Once again, if you would like to ask a question, please press star 1 on your telephone keypad at this time. Please hold while we poll for any additional questions. Everyone, I'm currently not seeing any questions coming through. Would you like to make any additional concluding remarks before we end today's webcast?
spk03: Well, yeah, thank you so much. And, you know, thank you for listening to this update call. We, you know, Cassie, you know, we have assembled a very wonderful team and we're moving one compound after another onto the market. And you will expect to see, you know, both, you know, commercial and clinical progress as we move forward. And thank you very much for your support.
spk01: Ladies and gentlemen, this does conclude today's teleconference and webcast. We thank you for your participation, and you may disconnect your lines at this time.
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