InnoCare Pharma Limited (9969) Earnings Call Transcript & Summary

Good morning, ladies and gentlemen. Welcome to the 42nd Annual JPMorgan Healthcare Conference. I am [ Luisa ] from JPM China Healthcare Investment Banking team. And today, it will be my honor to introduce Dr. Jasmine Cui, Founder and President of InnoCare to give a company presentation on the latest development and highlights. InnoCare is a commercial stage biopharma dedicated to developing innovative drugs for cancer and autoimmune diseases. So without further ado, let's please welcome Dr. Cui.

Thank you, Luisa. Good morning, good evening, ladies and gentlemen. Our thanks first, go to JPMorgan for the presentation opportunity here, especially on online presentation. And also thank you all for your support and attention to InnoCare. InnoCare is a drug innovation company. Our vision is to become a global pharmaceutical leader that develops, delivers innovative therapies for patients worldwide. Our therapeutic focus on oncology, autoimmune diseases, the 2 therapeutic fields with a lot of huge medical needs. This slide summarize our exciting 8 years journey of innovation and development. At the bottom, the corporate milestone, the company was founded in the second half of 2015 by myself and the professor Yigong Shi. By '18, we established R&D Center in Beijing and Nanjing and '18, we started to build manufacturing facilities. By 2020 in March, the company got listed IPO in Hong Kong. That's during Covid pandemic. We were the first health care company IPOed by roadshow virtual ceremony, and we reached $311 million. In 2021, we reached another $393 million. In 2022, we successfully listed in [indiscernible] in Mainland China reached another $400 million. So from the consumption of the company to now, including the pre-IPO runs, we total raised USD 1.34 billion. And the good there is we still have 2 billion enhance demonstrating our effective and efficient operations. At the top is the progression of Orelabrutinib a BTK inhibitor, our first drug, and the project started at 2015 and by 2017 and R&D cleared in China, Australia and the U.S. And the first patient was eroded in April of 2018, and we got 2 indications approved in China by end of 2020. So it means from first patient to the NDA approval commercial launch took us 2.5 years. It's quite a record for the clinical development of a drug. Orelabrutinib also proved in [indiscernible] for MCL in 2022 and also MCL in Mainland China in 2023. And all the indications approved in China being covered by MCL. In the middle, it's our progression of other assets; including autoimmune disease and solid tumor other projects started 2015. By 2020, all those products more than 10 products get on to the clinic and being developed for different indications. 2021, our first biologic IND approved in China in collaboration with KMET, and we licensed in tafasitamab from Incyte as anti-CD19 antibody for DLBCL treatment. And tafasitamab launched in Hainan in Hong Kong, in Singapore by 2022 and 2023. Here are the highlights of InnoCare strength and advantage. First of all, we have established fully integrated and efficient drug innovation platform from basic research, discovery, clinical development, manufacturing and commercialization. Majority of assets are coming from our internal discovery. By far, we have 13 assets in the clinical trials, 12 from our internal effort, and we have 2 marketed products and have over 30 clinical trials ongoing. By far, we have filed more than 350 patents and established 2 GMP-compliant manufacturing facilities. And the second advantage, we are positioned to build leading hemato-Oncology franchise. In there, we have a comprehensive coverage of indications and MOAs. Just to mention we have 2 marketed products in liquid cancer and 6 differentiated asset in the pipeline, and we have best-in-class BTK inhibitor being marketed and the first-in-class asset like bevacizumab and anti-CC8antibody and et cetera. Our pipeline can be effectively used alone and also in combo with ourselves and with others. The third one is we have a well-positioned portfolio in autoimmune diseases. In there, our assets cover both B and T cell pathogenic pathways. And currently, we have 6 large indications ongoing in Phase II and Phase III. And we have 3 clinical assets together with a few preclinical assets in autoimmune space will come from more than 15 in patients in the next couple of years. And we have 2 innovative TYK2 inhibitor offer us a good opportunity to win. And we have a global leading BTK inhibitor in autoimmune disease develop indications in SLE, ITP, NMOSD, MS and others. And finally, but not least, we have a fully-fledged commercial and healthy financial position. As mentioned, we still have USD 1.2 billion among $1.3 billion we relisted mostly are still here. And we have a commercial team of over 320 team members covering over 1,000 hospitals. And from 2021 to the third quarter last year, we have got a cumulative revenue of USD 310 million. Despite a cash, we have ability to generate revenue, the company still keep strict cost-effective operation and culture. The few slides talking about hemato-Oncology franchise. So we have a comprehensive coverage in the liquid tumor space, both indications and mechanism of actions from multiple myeloma to non-hodgkin's lymphoma to leukemia. So far, we have approved the BTK inhibitor and tafasitamab as our cornerstone product. On top of that, we have a small molecule, BCL-2 inhibitor and also is like is the molecular group and also large molecule and CD3/CD20 antibody and CCR8 antibody [indiscernible] and as well as T-cell lymphoma from B to T cell. And our user like is also covering multiple myeloma and BCL2 inhibitor covering leukemia such as AML. And Orelabrutinib is marketed BTK inhibitor has potential best-in-class clinical advantage, including the significant BDK target coverage close to 100% at 50 milligram and above. And due to the target selectivity, we have much improved safety profiles. For example, we don't have the cardiovascular liability at AFIP Februation and for all the clinical trials we observed so far is once a day dosing. And we have 3 market indications in China under coverage of AIDL. And we have the first and only BTK inhibitor for marginal zone lymphoma. And we also proved Singapore for MCL. And 2024, we have 3 NDA submissions for Orelabrutinib, the MCL in U.S. and first-line CLL in China and the MZL in Singapore. And also, we have a number of ongoing clinical trials to focus on the first line and the imitations outside of China. And as mentioned, and for Orelabrutinib, we already have a commercial team effectively have covering the hospitals and the clinical centers in China. Orelabrutinib has a unique structure design provides much improved target selectivity. On the right-hand side is the design of Orelabrutinib. Comparing to other irreversible BTK inhibitors, the key feature is in the middle. There is a single ran on core because of single ran core compared with double RIN in the middle, the [indiscernible] has less hydrogen bonding sites is more stable and a smaller angle in the molecule and that offers targeted selectivity for those BD or the other kinases. And also because the elimination of the double RIN, were limited the Chiral Center. So the [indiscernible] itself is target-specific and is stable and easy to synergies. So indeed, the Orelabrutinib is very targeted selective among panel scan of 456 kinase at a micro model, it only hits BTK. Like other beauty inhibitors, is other target besides BTK? So that's why Orelabrutinib can be used for not only cancer indication, but also for autoimmune diseases. So Orelabrutinib is a potential best-in-class BTK inhibitor for B-cell lymphoma. Those are the indications, CLL, SLL, MCL MZL, Orelabrutinib, all have class-leading efficacy in ORR, overall response and also in CR, like CLL, other BTK inhibitors, barely had a CR above 10%. We have a 30-some percent of CR and PFS for MCL as well as OS for MDL. And another big advantage is safety profile. And I just mentioned the AFIP Fabrication is a significant cardiovascular adverse effect associated with other BTK inhibitors, but we don't see it in -- by now, we have over 1,000 patients in the clinical trials. And we have much reduced diarrhea and infections. So let's switch the gear to the second key molecule that we internally discovered that is BCL-2 inhibitor, ICP-248. And this molecule design again provide very unique metrics. For BCL2 inhibitor, by far, the only approved drug is a Venetoclax. And there's metabolic soft spot in the middle as appointed by the error, and so Venetoclax has active metabolite M207 count 12% in human plasma. Both Venetoclax compound and the active metabolites have a sleep inhibition, therefore a drug-drug interaction potential and also inhibit the PGPC inhibition by Venetoclax active metabolites. So our design [indiscernible] and we limited the active metabolite by blocking the metabolic hard spot and of course, reduced drug-drug interaction potential, significantly improved the PPI efficacy. And so far, we observed very good safety profile. So this is early clinical results showing 28 understanding efficacy. On the left is we have 6 patients at 100 milligram dose and 6 out of 6 showing all 100%. And this year, it's 3 out of 6, 50% of complete response as well as 33% the MRD and detection. So comparing to market the drug and the west on the clinical trials and 248 has outstanding performance in terms of efficacy. We're excited about the drug. And on the right-hand side, showing the BCL2 inhibitor 248 has great synergy with Orelabrutinib in the animal models. So for 248, we are going to develop a lung for leukemia and develop in combo with Orelabrutinib for a number of indications for AHL, particularly in the large initiations, such as first-line CLL, SLL and we have a plan to develop it in China and the global market. So in addition to the 2 molecules, we continually enriching our liquid cancer portfolio and the modality. And we have for other molecules listed here, tafasitamab, C9 antibody we just mentioned. And the CD3/CD20 antibody, and potential first best-in-class, and we have a sort formulation developed with KMET together. And so far follicular and DLBCL patients, we see 100% OR as well. CTRA, first-in-class target, and we are evaluating both liquid cancer solid tumor. We have observed the PR single drug response and molecule job for 90 and in clinical development for both multiple myeloma and HL. So now let's move to the autoimmune disease portfolio. Autoimmune disease, we have asset covering B-cell, the Orelabrutinib and T cell pathway the TYK2 inhibitors. B-cell, we mentioned we have SLE Phase III positive that's first BTK inhibitor for SLE being showing efficacy and MS finished Phase II. And also positive as well as ITP, we are in Phase III registrational trial, we are going to finish the patient enrollment and have clinical results next year. AMST we’re in Phase II trials. So for the T cell pathway, we have 2to 3 inhibitors will cover a number of inpatients. 332, which just finished Phase II for atopic dermatitis, and we got a positive result, we'll show you later. Throughout 488 we’re doing Phase II for Sclerosis. So autoimmune disease has enormous medical need. And there are over 150 indications globally, 500 million patients. And in China, also over 40 million patients. Autoimmune disease have 6 categories as listed here. And we have covered 4 out of the 6 dermatology hematology, neurology, rheumatology, and the orange covered or the indications currently in Phase II and Phase III ongoing by our assets. Orelabrutinib we just mentioned for MS is best-in-class efficacy and excellent brain penetration, ITP in Phase III registrational trial, and we are striving to finish the clinical trials next year and have lunch. And also SLE, we have Phase II B work at interim results for this year and MSD the Phase II B trial. And as we mentioned before, Orelabrutinib evaluated in the 6-month MS study at 3 doses, 50-milligram QD, 50-milligram BID and 80-milligram PD and all met primary endpoint. 80-milligram give us 92.3% efficacy. This is a class-leading and because it really has a good brand penetration, and we are still figure out a way for the MS. We think the compound by acting on B-cell and microglia will give really benefit for a variety of MS patients. And let's switch the gear to TYK2 inhibitors. We have 2 inhibitors, 332 and 488. Left-hand side is the structure of a JAK family. And you can see the TK2 had JAK1, is the kindest magic to aesthetic domain. And our 332 inhibits TK2 very potently 0.5-nanometer JAK1 19-nanometer is 44 higher, and JAK2 is over 190 nanomol of 400 for selectivity. For Fit only fits JAK2 5-nanometer, TYK2 not hitting any of the JAK2s. So 332 will perform the Phase II for atopic dermatitis AD because AD is a serious disease. Globally, over 2 million patients, especially the young patient is credit severe disease, reduce quality of life because of itching at night, you lose sleep and the cause depression and even the suicide globally by 2028. There is a huge market over USD 20 billion. On the right-hand side is showing why we choose to do AD since the AD pathway need, the hydrodimer of TYK2 and JAK1. So 332 has major TYK3 inhibition plus minor JAK1 indication. We think that provides a better efficacy and a new possibility for effective treatment of AD. And indeed, this is a Phase II result we just released. And the primary endpoint is the percentage change from baseline is ESI. So the Y exit is ESI score. And comparing to placebo, the 2 doses, 80 milligram QD and 120-milligram QD give us a significant, decrease of the ESI scores, 78.2%, 72.5% comparing to the placebo 16.7%. And the middle graph shows how quick the response is. And first week, we already see significant decrease of ESI score so as second weight and week 4, even more. Right-hand side showing the ESI 50 and the 75 is the Phase III clinical endpoint. We see both doses and both ESI50 and 75, showing a significant decrease comparing to the placebo. And we are showing the best efficacy of AD 332 offers. And on the left-hand side is a comparison with UPA [indiscernible] and UPA is pure JAK1 inhibitor. Efficacy is pretty good for AD. And 332 in any cases, the free treatment compared to UPA 4-week treatment of 50 milligram, we see this better in ESI 75, ESI 90 and ID080 and also the itching score in AIS. So we see the better efficacy for the every parameter. On the right hand, we comparing with all the AD drugs approved, JAK1, IL-4, IL-13. And at 4 weeks, 332 has the whole leading better efficacy comparing to the 16-week, 12-week treatment. So we are really happy that our hypotheses turn to be right. And this left hand is the itching score. And because Dupi, the IL4, which works okay is actually being marketed. But the first 2 weeks, it has a delayed response. It doesn't do much for reducing each the disease. And we look at it from day 2 to day 14. And we see from day 2, we already see a significant decrease of ARS score and the last to the 14 days of course, by 4 weeks, and it showed even more improvement. Right-hand side is improvement of patient quality of life. Based on those data, of course, we see very significant improve of the quality of life, both at 80 and 120 milligram QD. And here is the safety tolerability profile just mentioned that UPA has a good efficacy, but that has a black label for the safety. So here on the top slide is the total adverse effect we call it TRAE. And comparing to placebo, 80 and 100 milligram just no difference from placebo, very similar. At the bottom, it's severe infection, the infection cases, which is understanding problem for UPA, and we don't see any severe infections in 80 and 120 milligram, no different from placebo. If we see anything at 80 milligram is better than placebo. Of course, we did not see any the black label for UPA like thrombosis, like severe infection and et cetera. So 3 studies we give excellent safety, tolerability profile and also the efficacy profile. So our solid tumor very quickly, and we have precision medicine. We have also immuno-Oncology first-class assets. And I'm going to go quickly ship you through where in phase I seeing excellent safety profile we are doing with EDF third generation for lung cancer right now. And CCR8, we are doing both liquid cancer started tumor. We already see single rather efficacy. So next is our robust growth outcome. So in short term, before 2023, we have 2 drugs launched. And in short to midterm, listed middle will have a number of 5, 6 drugs will be launched in the next 3 to 4 years. Orelabrutinib will continuously developed oncology outside of China, in China first indication. Tafasitamab will be launched about a year in Mainland China. 248 will be a high-priority project developed in China and global and also the antibodies will put effort development. For autoimmune disease, we just mentioned Orelabrutinib 332, and 488 that will cover a lot of big indications by the 3 common, we have others in the preclinical stage. And on the right-hand side, we continue to push our clinical pipeline. And in discovery, that's our strong point. We have established new platforms like a large molecule, bispecific antibody, conjugation protein degradation, were also expanded to the CS autoimmune disease franchise. Finally, it's 2024 for milestones catalyst. This mentioned during the talk this year, we have a lot of milestones ADA submission for Orelabrutinib. There are 3, tafasitamab; we have ADA submission this first half of year. 332 we'll move to Phase III and also other progress is all moving pretty well. Thank you for your attention.