Earnings Labs

Northpointe Bancshares, Inc. (NPB)

Q2 2021 Earnings Call· Tue, Aug 31, 2021

$17.68

+0.63%

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Transcript

Jielun Zhu

Management

Thank you, everyone, thank you for standing by. And welcome to I-MAb 2021 Interim Business Update and the Financial Results Conference Call. Earlier today, we issued a press release detailing I-Mab's significant pipeline progress and the corporate highlights during the first half of 2021 and upcoming milestones for the rest of 2021, as well as a review of our financial results for the first six months in 2021. The press release can be accessed on the Investor portion of our website. Joining me today on the call from I-MAb's senior management team are Dr. Jingwu Zang, our Founder, Chairman and Director and Dr. Joan Shen, our Chief Executive Officer. Dr. Zang will provide a high level overview of our recent achievements and the strategy going forward. He will then highlight the progress we have made in our key clinical programs and upcoming milestones and catalysts. Dr. Shen will then comment on the status of other important clinical assets and corporate achievements. I will then provide a brief summary of our financial results and our preparation for the dual listings in Greater China before we take questions from the audience for Q&A. Now without much ado, I will turn the call over to Dr. Zang, our Founder for - to start the call. Dr. Zang?

Jingwu Zhang Zang

Management

Thank you, Jielun. Thank you all for joining the call today. We are very excited to report to you the remarkable progress that company has made since the beginning of this year. First of all, let me set a stage to tell you where we focus our efforts and resources at a corporate level to generate the most value for the company and our investors. The three of us today will then walk you through the progress in detail. Now on Slide 3. Our corporate focus is twofold with the overarching goal to move our clinical pipeline towards product portfolio. On one hand, we focus on team execution to rapidly advance the pre-BLA and a innovative late stage core assets such as felzartamab, TJ101, TJ107, lemzoparlimab, uliledlimab towards BLA or registrational trials. In parallel, we have been developing the next generation of even more innovative immuno-oncology assets through what we call our second wave innovation characterized as a novel differentiated bi-specific antibodies and third wave innovation characterized as a super antibody enabled by transformative technologies. Now as a result, our pipeline today is not only innovative and globally competitive but also clinically advanced with the first BLA to be submitted in fourth quarter this year. On the other hand, we are building our future to bring the company to the next level on a clinical stage biotech to a global biopharma. In that regards, we have made great progress in building our manufacturing facility in Hangzhou and a commercialization capability to prepare for product launch in China. Now let me walk you through the pipeline developments and the recent progress. On Slide 5, we provide an overview of I-MAb's pipeline. The progress within the past 12 months especially since the beginning of this year has rapidly advanced the pipeline to…

Joan Huaqiong Shen

Management

Thank you, Dr. Zhang. So yes, for our Plonmarlimab in TJM2 as we have revealed earlier this month, our interim analysis results from our Phase 2/3 studies. This is a study designed for treating cytokine releasing syndrome associated with severe COVID-19 and the primary endpoint and the secondary end points in from the interim analysis have shown a very positive trend. So, in particularly, the patients without ventilation and baseline have positive trends of 7% differences. It has been observed in the treatment group of reimbursed placebo, which is very comparable to the effect size observed in lenzilumab, which is another GM-CSF from Humanize and the mortality rates is 5% in Plonmarlimab comparing with 13 in placebo arm at by day 30 and then approximately 10% improvement in recovery rates by day 14 and then day 30 in Plonmarlimab compared with placebo arm. So all of these are very major primary and secondary endpoints and then safety wise, it's well tolerated. And then also is worth to note that the biomarkers listed in the slides have shown a positive trend also towards the clinical outcome. So moving forward, considering the Delta outbreak still ongoing in U.S. and other countries, we are continuing this Phase 2/3 studies in United States, but in the same time, we are also seeking to explore additional indications associated with CRS particularly where inspiration for CRS associated with success led by Professor Zhang Wenhong from Huashan Hospital in Shanghai and then our R&D is prepared to submit before end of this year. Next. Slide 12. Yes, so for this our cycle. So, yes, so for this, our efineptakin alpha, which is TJ107, we have been licensing from our partner Genexine from Korea. Since then we have conducted two studies. First is Phase 1b studies for the patients with lymphopenia after chemo or radiation therapies. And this study, the full results have demonstrated it's - the safety profile and PK-PD correlations and the full dataset has submitted to ASCO this year and it will be published. Then the second study is our GBM study is for - Phase 2 studies for the GBM patients. This has been in full enrollment of this year and then another exciting news is our partners Genexine and its subsidiaries and NID have issued a very exciting results both in GBM and also in another treatment in combination within PD1, so based on those data sets, we are in full preparation for research studies, which is for also pembrolizumab combination therapy in our additional studies, in the study tumors as a basket trial design in particularly to look at the in GM-BC and head and neck cancer patients and also guided by biomarkers. So these studies will also be initiated towards the end of this year. So I will get back to Dr. Zhang to continue the rest of the presentation. Dr. Zang please.

Jingwu Zhang Zang

Management

Yes. Thank you, Dr. Shen. Now let's move on to discuss about our efforts and progress in generating the next generation of innovative assets to expand our pipeline. On Slide 13 while we focus on delivering the clinical milestones of the first wave clinical assets, including the six core assets as we just discussed, the company has made significant progress in generating the second and the third wave innovative assets. The first wave innovative assets are represented a portfolio of highly differentiated monoclonal antibodies or fusion proteins, such as lemzoparlimab, uliledlimab, felzartamab, enoblituzumab and so on with one exception, they are all in Phase 2 or Phase 3 clinical trials and they are very advanced. The second wave innovative assets are represented by bi-specific antibodies with either first in class or best in class potential. The two most advanced bi-specific antibodies TJL14B that's PD-L1 4-1BB and a TJ-CD4B that's Claudin 18.2 4-1BB are in Phase 1 clinical trials in the U.S. Now the third wave innovative assets are characterized by emergent portfolio of the super antibodies that are enabled by transformative technologies, some of the drug candidates are expected to advance to the R&D stage by the end of 2022 or 2023. We believe they represent truly cutting edge drug candidates in the field of oncology globally. On Slide 14, our bi-specific antibody portfolio is designed to convert immunologically cold tumors that are resistant to immunotherapy, hot tumors or better treatment efficacy. More importantly, this bi-specific antibodies are enabled to address the current unmet medical need in oncology, where a majority of cancer patients do not respond to checkpoint inhibitors. Two most advanced assets, as I mentioned earlier enter Phase 1 clinical trials in the U.S. early this year, both use the conditional activation of 4-1BB, which is a important…

Joan Huaqiong Shen

Management

Yes, thank you Dr. Zhang, yes, I just want to expand a little bit on how we as a company, continue to grow, to take on the responsibilities as a reputable company. And because of that we have obtained numerous awards for our innovation and then our growth. So on this slide just to mention a few, as you can see. So the first one is the Institutional Investor award for top ranking and top CFO and secondly is the T plus Excellent Employer award. And then thirdly is the Top 50 Enterprises of Technology Power. Those are just representing an - of our recognitions by the industry and the society. Next slide. And as Dr. Zhang also mentioned, as we take on the steps for advancing our company, we also need to become diversified and highly governance standard and socially responsible corporate. So we received highest first time ESG rating among China based biotech companies from MSCI 2020 as you can see from the first one. And we also build a Women Leadership Councils to promote female leader's career development. We now have two-thirds of female employees and over 30% of women Board of Directors. We have also newly formed independent ESG committee with me and two other independent Board members as the committee to set over the ESG strategies. We also made multiple donations for disaster reliefs include donations of medical supplies at a COVID-19 outbreaks and donations to Henan Charity General Federation for the rescue and restructuring of the flood-hit regions in Henan Province and et cetera. So our company continue to build the infrastructure as well that - the overall interest organization and governance to become more repeatable and representative and of our societies. So from here, I will let to the - Jielun to continue the financial report. Jielun please.

Jielun Zhu

Management

Thank you, Dr. Shen. Now let me turn to review our financial results for the six months ended June 30, 2021 that's on Slide 23. First of all, as of June 30, 2021 total cash meaning cash, cash equivalents, restricted cash and short-term investments totaled RMB 4.8 billion or 790 - US$739.2 million compared with RMB4.8 billion as of December 31, 2020. We are very well capitalized for the size of the opportunities in front of us and our vision to become a fully integrated biopharma company. Our strong cash balance provides sufficient funding and the strategic flexibility through major value-creating milestones in relation to TJ202, TJ101, TJC4 and TJD5 over the next one or two years. Now let me turn to the revenue side. For the six months ended June 30, 2021 net revenues were RMB17.8 million or US$2.8 million compared with nil for the six months ended 2020. Revenues generated for the six months ended June 30, 2021 solely consisted of revenues recognized in connection with I-Mab's strategic collaboration with AbbVie and our collaboration with AbbVie has been going very well. Now let me turn to the R&D expenses. Total R&D expenses, meaning the core R&D expenses plus the ESOP related share-based compensation for the six months earlier this year were RMB593 million or US$91.8 million compared with 442.3 million for the same period in 2020. The increase in total R&D expenses was primarily due to the increased CRO service fees to advance the company's broad pipeline, especially for key assets including lemzoparlimab TJC4, uliledlimab TJD5 and eftansomatropin alfa TJ101. Now within the total R&D expenses. As you can see, we've broken down for you the cash versus non-cash expenses, so the non-cash share-based compensation expenses accounted for RMB112.7 million or US$17.5 million for the six months ended…

Operator

Operator

Thank you for the detailed in-depth update. Now we will start the Q&A session. So if you have questions, please use the raise your hand function via Zoom. We will coming to you in orders. Our first question comes from Kelly Shi. Kelly please.

Kelly Shi

Analyst

Congrats on the progress. And thank you for taking my questions. Lemzoparlimab, what level of detail should we expect for the topline readout of early China trial at ASH and what is the efficacy bar for this program to move forward? And my second question is for the partnership with AbbVie. When will you expect the next milestone payment and also and in solid tumor trials in discussion that will be led by AbbVie in the U.S. Thank you very much.

Jingwu Zhang Zang

Management

Yes. Thank you, Kelly. This is Jingwu. Let me first address your first question. Now our U.S. trial of lemzoparlimab in combination with rituximab in patients with non-Hodgkin's lymphoma showed really excellent clinical results. Firstly, it has further confirmed the safety profile of lemzoparlimab and again in this trial, the safety is very good and we did not give patients a priming dose because it was not needed because of the safety profile. Secondly, we observed very encouraging clinical efficacy signals although at this time, I'm not in a position to give you all the details, but as I mentioned, the past few months we submitted abstract to ASH this year and we are prepared to release that clinical data at ASH in November and hopefully if possible, we will find out opportunity to release the data earlier. Now Kelly, let me emphasize three points regarding lemzoparlimab. First of all, internally in terms of the speed of clinical development. As we discussed, our ambition is to launch lemzoparlimab as the first CD47 antibody product in China and also help AbbVie to achieve the global registration and we have been accelerating multiple clinical programs by leveraging the advantages in both U.S. and China. Now, as a result, we have a three parallel lines of clinical development, non-Hodgkin's lymphoma, AML, MDS and solid tumors. And we have made remarkable progress in all three lines. Now, most importantly, we're very excited that the current progress may potentially lead to registrational trials in 2022 next year, and this is a really good speed to move this asset into a late stage or pivotal stage of development. Now, second point is that in terms of safety advantages of lemzoparlimab, so far there are a total of 86 patients have been dosed in the U.S. in…

Jielun Zhu

Management

Sure. Thank you, Dr. Zang and thanks, Kelly for the question. So let me address your question regarding the AbbVie payments. We expect to receive three payments - three milestone - of three additional milestone payments in the next 12 to 18 months. The next milestone payment we expect to be - to receive second half of this year. That's a $50 million payment and then the following two payments successively will be received sometime next year, those two are related to the initiation of pivotal trials to be initiated by AbbVie in the U.S. The total from the three payments will be $175 million in total. In addition to that as Dr Zang alluded to earlier in the presentation. We also have the 10 billion. We also have the bi-specific program, which is part of the scope of the partnership we signed last year. They will also if we move forward with AbbVie on that, they will also bring additional upfront payment and milestone payments. Now let me broaden my answer a little bit. In addition to our continued payment streams from AbbVie, we also have existing partnerships with other players like CSPC in China. In addition, we are also as we discussed in the earlier part of the presentation, we are also looking at potential partnerships for TJD5 uliledlimab and a commercial partnership in relation to the long-acting growth hormone and perhaps other assets - innovative assets in our pipeline. Those additional milestone payments from existing partners and also new milestone payments and upfront payments from potential new partners will bring hundreds of millions of dollars over the next one or two years if things progress well. So we are very confident about our - about the visibility and the stability of our top line and the earnings as we move forward, because we have a model where we can realize significant value of our pipeline assets before they are even brought to the market by doing the PoC studies in the U.S. and striking very, very good partnerships with players - big players outside of China. So I just want to emphasize that, and it's important to look at that as we move forward in our next few reporting cycles.

Operator

Operator

Thank you for the time. Thank you, gentlemen. Our next question comes from Louise Chen. Please go ahead, Louise.

Jennifer Kim

Analyst

This is Jen Kim on for Louise, thanks so much for taking our questions and congrats on all the progress. We have one broader question. So there have been a lot of headlines regarding, I guess regulatory uncertainty around China. Can you walk us through how you're navigating through this uncertainty and how you think about your fundamental value as an innovative player in the biotech space? Thanks.

Jingwu Zhang Zang

Management

Thank you, Louise. I would ask Jielun to elaborate on this question.

Jielun Zhu

Management

Thank you for the question. A very, a very good question. I'll try to answer your question, perhaps on a - on three to four different levels. First, let me start with the broad macro picture, which we have no control over. But it's important anyways. I think the regulations in China, they are targeting the Internet giants. They show their tendency to monopolize as well as sort of sensitive industries like the tutor industry and the food delivery and so on and so forth. But based on our own experience dealing with regulators and different levels of government in China, we strongly believe that biotech is not only an industry that they would not target, but is actually one of the industries that they are actively promoting. It is very important to realize that biotech industry is one of the high tech industries in China, which will help create lot of social benefits and externalities for the government in China. So it's important to realize that and also because biotech industry is not an industry where foreign ownership is banned or restricted. So most of - as I remember, as far as I can remember all of the biotech companies do not need to adopt a VIE structure or VIE structure, which is also, I believe, one of the topics that brought some concerns from investors. So short answer on the macro picture is we think and I think most of our peers would agree that biotech industry will actually receive increasingly more support from the government in the - from different levels of government in China. And I would add to this point that recently if you look at some of the western KOLs for example Ray Dalio from Bridgewater, the head of MSCI China and the Capital…

Operator

Operator

Thank you, Jielun. Due to time limitation, we will take one last question. So last question will come from Joe Catanzaro. Joe please.

Joseph Catanzaro

Analyst

Great, thanks. Thanks so much for taking my questions and congrats on all the progress. Maybe two quick ones for me. So you guys are pretty active on the BD front with the number of platform related deals in the first half of the year. Jingwu you maybe alluded to it, but other deals could we expect in 2021 and I guess, I'm specifically thinking about uliledlimab and what partner deal terms you're interested in there and maybe whether we could see a potentially similar deal term and structure as the AbbVie lemzo partnership. And then as a follow-up. Dr Zang, you mentioned longer-term value creation coming from the growing early stage pipeline. So, maybe as we look beyond some of the mid-later stage assets, what programs do you see is having significant opportunity for value creation with some early proof of concept data over the next couple of years. Thanks.

Jingwu Zhang Zang

Management

All right, thank you, Joe. Great questions, let me first address your first question, on the BD side of things. We are actually working on several assets for potential BD partnerships globally and also domestically in China. The - on the global front, we have been discussing with potential global partners for partnerships for TJD5, uliledlimab, as I mentioned earlier. We're actually in discussion with several other companies for bi-specific antibodies or even newer assets coming from our pipeline. So those deals are very similar to the deals we made last year with AbbVie on lemzoparlimab and we're very excited and moving forward - continue moving forward with those discussions and at one point, we will feel comfortable to release the terms and discuss those deals. So that's one, and on the second front, we are in-turn sheet with several, several companies and we are about to select one company to solidify our commercial discussion for TJ101, our long-acting growth hormone. And this is going to be a big and visible deal in China and exemplifies or signifies how biotech companies like I-MAb working together or partnering with big pharmaceutical groups in China in order to maximize the value of commercial products like long-acting growth hormone. And at the same time, this year, we have successfully closed six, seven BD deals and those are relatively early stage assets, I will talk about Messenger RNA platform, I will talk about complex intracellular platform, so those deals will help us to build the third wave innovation with the super antibodies as mentioned earlier. So, all together, we are very active on the BD front globally and domestically in China and hopefully, before the end of this year, we might be in a position to close a few deals, if not, will be…

Joan Huaqiong Shen

Management

Okay. Yes, thanks, Zang. I just want to probably elaborate a little bit more on both compounds, which are both in the Phase 3 stages. So, for our TJ107, which is being produced a lot of data from our partner Genexine and its subsidiaries NID. So in particularly on their, you can check that out from their webpage at their report on the GBM studies, the ARC increases by one to four folds. And a one-year survival rate of 83.3%, which is definitely above the standard of care. So another important data we also presented on last year's strategic showed a combination treatment with pembro achieved an ORR of 28% on the [technical difficulty] of TNBC. So this is also very encouraging. So we are going to - we have submitted the IND to pursue the basket trial design on this TNBC as well as head and neck cancers and also a few other tumor types guided by our translational medicines. And so this is one study, the other one in Enoblituzumab which Dr also - Dr. Zang mentioned earlier, we had quite a few exciting datas coming out of our translational medicine work in addition to MacroGenics Phase 2 data, we believe it has great potentials for combination treatments for solid tumors, especially its combination with checkpoint inhibitors as well as other chemo combos. So, we are also submitting the IND actually September for a basket trial design for pursuing the solid tumor types, including lung cancers. So these two are also in full speed for our Phase 2 hopefully in near future, we can accelerate it to the registrational trials. So, I wanted to start from here.

Operator

Operator

Thank you, Dr. Zang and Dr. Shen and thank you everyone for joining our meeting today, so if you have further questions about I-MAb, please feel free to reach our IR team, and we hope to connect with you in other format soon. Have a good day, Bye-bye.

Jingwu Zhang Zang

Management

Thank you.

Joan Huaqiong Shen

Management

Thank you.

Jielun Zhu

Management

Bye.

Jingwu Zhang Zang

Management

Thank you, every one or good day or good night. Bye-bye.

Joan Huaqiong Shen

Management

Bye.