Half Year 2022 I-Mab Earnings Call
Operator: Finally, Mr. Zhongnong will then provide a summary of our financial results for the six months ended June 30, 2022, before we turn the call over to the operator to take your questions.
We'll provide will then provide a summary of our financial results for the six months ended June 32022.
Tyler: Thank you to Dr. Zhang, thank you to Dr. Zhu, and thank you to John for your discussion, today.
Before we turn the call over to the operator to take your questions.
Operator: Please note that today's discussion will contain forward-looking statements relating to the company's future performance and are intended to qualify for the safe harbor from liability as established by the U.S. Private Securities Litigation Reform Act. Such statements are not guarantees of future performance and are subject to certain risks and uncertainties, assumptions, and other factors. Some of these risks are beyond the company's control and could cause actual results to differ materially from those mentioned in today's press release and this discussion. A general discussion of the risk factors that could affect I-Mab's business and financial results is included in certain filings of the company with the Securities and Exchange Commission.
Please note that today's discussion will contain forward looking statements relating to the companys future performance and are intended to qualify for the safe Harbor from liability as established by the U S. Private Securities Litigation Reform Act.
Such statements are not guarantees of future performance and are subject to certain risks and uncertainties assumptions and other factors.
Some of these risks are beyond the company's control and could cause actual results to differ materially from those mentioned in today's press release and this discussion.
A general discussion of the risk factors that could affect <unk> business and financial results is included in certain filings of the company with the Securities and Exchange Commission.
Operator: The company does not undertake any obligation to update, the forward-looking information except as required by law.
The company does not undertake any obligation to update this forward looking information except as required by law.
We'll also discuss specific non-GAAP financial measures for comparison purposes only during today's call. Please.
Operator: We'll also discuss specific non-GAAP financial measures for comparison purposes only during today's call. Please see the financial results news release issued earlier today for a definition of non-GAAP financial measures and a reconciliation of GAAP to non-GAAP financial results.
Please see the financial results news release issued earlier today for a definition of non-GAAP financial measures and a reconciliation of GAAP to non-GAAP financial results with that I'll now turn the call over to Dr. Jay <unk>, our founder Chairman and acting CEO Dr. Zhao Please.
Operator: With that,
Operator: I'll now turn the call over to Dr. Zheng Lijun, our Founder, Chairman, and Acting CEO.
Please go ahead.
Dr. Zheng Lijun: Dr.
Tyler: And thank you, everyone, for the questions.
Thank you Talbott.
Thank you to everyone for joining us.
It is a pleasure to welcome all of you to our call today to discuss our business update and our financial results for the six months ended.
Dr. Zheng Lijun: Zheng, please go ahead.
Tyler: Thank you for all our stakeholders for dialing in.
Dr. Zheng Lijun: Thank you, Tyler.
June 30 is 2022.
Since the start of 2022 calendar year.
We have been facing challenges similar to many of peers across the.
Dr. Zheng Lijun: Thank you to everyone for joining us.
Tyler: If there are any questions, please contact your local IR representative.
Across the industry.
Company has acted effectively to reposition itself to focus on fundamentals.
Dr. Zheng Lijun: It is a pleasure to welcome all, of you to our call today to discuss our business updates and financial results for the six months that ended on June 30, 2022.
Tyler: Thank you.
Today.
Dr. Zheng Lijun: Since the start of the 2022 calendar year, we have been facing challenges similar to many of our peers across the industry.
Tyler: Thank you all.
We'll report how the company is laser focused on key business priorities and a high value milestones and catalysts as we continue to drive value.
Dr. Zheng Lijun: The company has acted effectively to reposition itself to focus on our fundamentals.
Dr. Zheng Lijun: Today, we will report how the company is laser-focused on key business priorities and high-value milestones and catalysts as we continue to drive value for our shareholders.
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On the pipeline development fronts, we met seven key clinical milestones, including positive data Readouts for three of our key assets Uli laterally Matt.
Dr. Zheng Lijun: On the pipeline development front, we met seven key clinical milestones, including positive data readouts for three of our key assets, Unilaterally Map, Lancer Party Map, and TGA CD4B. Our goal is to prioritize our resources on the value driver assets in our pipeline.
So polymath and T J C diff will be.
Our goal is to Palletize, our resources on the value driver assets in our pipeline to this end, we will focus on five clinical assets in a tank clinical trials ongoing.
Dr. Zheng Lijun: To this end, we will focus on five clinical assets and attend clinical trials, some of them are ongoing and some of them are yet to start.
Ongoing and some of that yet to start.
Dr. Zheng Lijun: For Lancer Party Map and Unilaterally Map, we will present more data on Lancer Party Map from our Phase II clinical trial in combination with AZA and MDS patients in China at East Mall in early September and plan to initiate a Phase III clinical trial in China.
Forlenza, Panamax Uli likely Matt we will present more data.
Atlanta Panamax on our phase III clinical trial in combination with <unk> in Mds patients in China at ESMO in early September .
<unk> to initiate a phase III clinical trial in China.
With the rapid progress in our cohort expansion phase III lung cancer study of Uli likely map, we expect to present more data later this year.
Dr. Zheng Lijun: With the rapid progress in the cohort expansion Phase II, lung cancer study of Unilaterally Map, we expect to present more data later this year.
On our new.
Dr. Zheng Lijun: Our new start project, TGA CD4B, is also progressing well in a Phase I clinical study in the U.S, and China.
Start projects.
<unk>.
It is also progressing well in our phase one clinical study in the <unk>.
The us and China Dr.
Dr. Zheng Lijun: Dr. Andrew Zhu will further highlight this asset later in today's discussion.
Dr. Andrew Xu.
Further highlight this asset later in today's discussion.
Dr. Zheng Lijun: Now, with the progress on Unilateral I-Mab and TJCD4B, we expect to facilitate our BDDOs, as part of our business strategy and as one of our key priorities.
Now with the progress on newly laterally map and <unk>, we expect to facilitate our BD deals as part of our business strategy and as one of our key priorities.
As a result of the progress made in the first half of 2022, and our continued progress to be made in the second half of 2022, we expect to deliver two osprey, BLA submissions or approvals fulfill soft map.
Dr. Zheng Lijun: As a result of the progress made in the first half of 2022 and a continued progress to be, made in the second half of 2022, we expect to deliver two or three PLA submissions or approvals for Phase I-Mab, if it can so much help in alpha, along with four to five new drug molecules moving towards the R&D stage or into a Phase I clinical trial in the next three years.
So med dropping offer along with four to five new drug molecules moving towards the R&D stage into a phase one clinical trial in the next three years.
Dr. Zheng Lijun: Our pipeline has significantly advanced to a completely different stage from when we, looked back to our IPO two and a half years ago. It is not only globally competitive with the potential first-in-class assets such as Lanswell, PolyMab and Unilateral I-Mab, but also advanced with two assets near PLA and product launches within the next three years.
Our pipeline has significantly advanced to a completely different stage when we look back to our peak hour.
Our IPO, two and a half two.
Two five years ago it.
It is not only globally competitive.
With a potential first in class assets, such as lines of Panama and ULE largely met by also advanced with two assets year, PRA and our product launches within the next three years.
Dr. Zheng Lijun: Meanwhile, a portfolio of new molecules is moving towards the clinic.
Meanwhile.
Our portfolio of new molecule is moving towards the clinic.
On a corporate development fronts during the reporting periods, we have seen a clear path to commercialize.
Dr. Zheng Lijun: On the corporate development front, during the reporting period, we have seen a clear, path to commercialize Phase I-Mab and, if that is so much helping alpha, we will partner with the leading domestic big pharma companies with proven commercialization capabilities and established sales forces and channels for IFTAN and Phase I-Mab.
Sales fell soccer map.
<unk> somewhat trumping alpha.
We will partner with a leading domestic big pharma companies with a proven commercialization capabilities and established sales forces and channels for Epipen NFS Fail-soft map.
Dr. Zheng Lijun: We have already established a commercial partnership with Jump Can for IFTAN, a market leader in, the pediatric therapeutic area in China, and have been working with them to prepare for the PLA and a subsequent product launch.
We have already established a commercial partnership was jumped can or <unk>.
A market leader in pediatrics therapeutic area in China.
We're working with them to prepare for the BLA and a subsequent product launch.
Dr. Zheng Lijun: We're working on a similar commercial partnership for Phase I-Mab. Therefore, with the commercial partnership strategy, we'll be able to avoid draining, significant resources into building a large sales forces and establishing our own commercialization capability for these two near-market products in this difficult time when our cash runway is essential.
We are working on a similar commercial partnership.
Our SaaS map, therefore, with the commercial partnership strategy, we'll be able to avoid.
Training significant resources into building, a large sales forces and establishing our own commercialization capability to near market products.
This difficult time, when our cash runway is essential.
We must focus on our competitive advantages to prioritize our resources in the development of our high value assets. Additionally, I'm pleased to report that our state of art GMP manufacturing facility owned by Imap Hangzhou is operational and has a.
Dr. Zheng Lijun: We must focus on our competitive advantages to prioritize our resources in the development, of our high-value assets.
Dr. Zheng Lijun: Additionally, I'm pleased to report that our state-of-the-art GMP manufacturing facility, owned by I-Mab Hanzhou is operational and has successfully manufactured batches of clinical-grade material, including Lancet Polymer.
<unk> manufactured batches of clinical grade material, including.
I'll answer part of that.
Our phase II facility is on track to be completed by 2020 for commercial production.
Dr. Zheng Lijun: Our Phase II facility is on track to be completed by 2024 for commercial production. Now I would like to emphasize that we maintain a strong cash position with $586 million cash, on hand.
Now I would like to emphasize that we maintain a strong cash position.
$586 million.
Cash on hands on top of that we will continue to receive.
Dr. Zheng Lijun: On top of that, we will continue to receive potential milestone payments from the existing, licensing deals, including the development milestones from the amended deal with AbbVie and the Jumper King deal. As we continue to deliver the project milestones within the next several years, we expect to, collect a significant amount of milestone payments as agreed in the respective agreements.
<unk> milestone payments from existing or licensing deals, including the development milestones on the amended deal.
With ABB and Jamba King deal.
As we continue to deliver the project milestones within the next several years, we expect to collect.
A significant amount of milestone payments as a REIT.
Respective agreements.
Dr. Zheng Lijun: As a result, our cash is sufficient to fund business operations through 2025 for over, three years.
As a result, our cash is sufficient to fund business operations through 2025 for over three years.
On the capital market fronts. During this reporting period. The company has completed process by its previous commitments to.
Dr. Zheng Lijun: On the capital market front, during this reporting period, the company has completed the process, by its previous commitment to engage in a US-based public accounting firm that is subject to inspection by the Public Company Accounting Oversight Board, the PCAOB, for the preparation of its audit reports commencing from the fiscal year of 2022.
To engage in a U S based public accounting firm that is subject to inspection by the public company accounting oversight board the.
<unk> for the preparation of its audit reports.
Commencing from the physical year 2022.
Dr. Zheng Lijun: Now on August 26, 2022, the PCAOB of the US signed a statement of protocol with the China, Securities Regulatory Commission and the Ministry of Finance of the People's Republic of China governing inspections and investigations of audit firms based in mainland China and Hong, Kong.
No.
August 26 2022 <unk>.
The U S signed a statements our protocol with the China Securities Regulatory Commission and a ministry of finance of the People's Republic of China Galvani inspections.
Investigations of audit firms based in mainland, China and Hong Kong.
Dr. Zheng Lijun: We have noted this is a significant step towards resolving the delisting issue.
We haven't noted this is a significant step towards resolving the delisting issue.
Dr. Zheng Lijun: The company has now taken a stance to continue implementing the ongoing work to achieve audit, switch as planned, while waiting to see how the agreement is evolving between the two governments. This development may ultimately mitigate delisting risks under HFCAA, however, our goal is to, ensure the delisting risk is completely resolved for the fiscal year of 2022. Therefore, the company will either maintain the status quo after the agreement is executed, within the next few months, or we switch to a US-based auditing firm to meet the PCAOB requirements as originally planned.
The company has now taken a stance to continue implementing the ongoing work to achieve audits switch as planned.
Why waiting to see how the agreements is evolving between the two governments.
This development may ultimately.
Mitigate delisting risks on the HR.
<unk> Caa however, our goal is to ensure the delisting risk is completely resolved for the fiscal year of 2022. Therefore, the company will either maintain the status quo. After the agreement is executed within the next few months always switch.
Due to our U S based auditing firm to meet <unk>.
<unk> requirements as originally planned.
Okay.
Now here I would.
Dr. Zheng Lijun: Now here, I would like to emphasize IMAP's unique business model for value proposition.
Like to emphasize.
<unk> unique business model for value proposition.
Dr. Zheng Lijun: IMAP has a powerful and proven R&D engine that is our competitive advantage.
<unk> has a powerful and proven R&D engine that is our competitive advantage unmatched.
Dr. Zheng Lijun: IMAP's innovation comes in three ways.
Innovation comes in three ways.
Dr. Zheng Lijun: Lancer PartyMap and UnilaterallyMap are the best examples of IMAP's first wave of innovation.
So Panama and Uli largely map are the best examples of IMAX first wave of innovation.
Dr. Zheng Lijun: They are now in phase two and are ready to move towards phase three, while we complete a global, deal for Lancer PartyMap and are working on a potential deal for UnilaterallyMap.
We are now in phase III and are ready to move towards phase III, while we complete the global deal for <unk> and are working on a potential deal or uli likely map.
The second and third waves outcome comprised of a novel bi specific antibodies are uniquely format tubes.
Dr. Zheng Lijun: The second and third waves are comprised of novel bi-specific antibodies or uniquely, formatted therapeutic drug molecules. Some of them are already in clinical trials and others are in preclinical development.
Fit therapeutic drug molecules. So none of them are already in clinical trials.
Others in preclinical development, we expect to have a four to five new molecules moving towards the clinic within the within the next three years.
Dr. Zheng Lijun: We expect to have four to five new molecules moving towards the clinic within the next, three years.
Dr. Zheng Lijun: With the competitive advantage of R&D and progress in pipeline development, I-Mab's, value proposition is really two-pronged. One is to out-license the global rights of innovative assets after early clinical validation. Lenso PartyMab is a one-prime example. As a result, the company has received accumulated cash amounts of $249 million so far from multiple deals and will continue to receive additional development milestone payments as we deliver upon those agreed project milestones.
With the competitive advantage of our R&D and progress and pipeline development.
<unk> value proposition is really two crunched, one way is to our license to global rights of our innovative assets after early clinical validation.
And so part of map is one Prime example, as.
As a result, the company has received.
<unk>.
Accumulated cash.
Cash amounts.
240 $49 million, so far off on the multiple deals and we'll continue to receive additional development milestone payments as we deliver upon those reads.
Dr. Zheng Lijun: In addition, we continue to explore potential partnerships for Uli-Latin-Mab and TJCD4B bispecific antibody.
Milestones.
Additionally, we continue to explore potential partnerships for uli lateral map and a T J <unk>.
CDP will be bi specific antibody.
Next.
We expect to create value through a commercial partnership deals in China.
Dr. Zheng Lijun: Next, we expect to create value through commercial partnership deals in China. More specifically, we develop the clinical assets towards a commercial stage in China and partner with pharmaceutical companies that have established cell sources and sales channels to rapidly gain market share. As exemplified in the commercial partnership with Jumptan for Yiftan Growth Hormone, we typically receive upfront payments as well as milestone payments and a 50-50 profit split for our products to be marketed in China. We're now working on a potential commercial partnership for CellSat-Mab.
Most specifically, we develop the clinical assets towards commercial stage in China.
And partner with pharmaceutical companies that have established cell sales forces and sales channels to rapidly Gan.
Market share.
As exemplified in the.
Commercial partnership where jumped can for <unk> growth hormone, we typically receive upfront payments as well as milestone payments and a 50 50 profit split.
For our products to be marketed in China.
We're now working on a potential commercial partnership for cell sarcoma.
This model of our value proposition is a unique and relies on IMAX R&D competitive advantages immuno oncology and <unk>.
Dr. Zheng Lijun: This model of, value proposition is unique and relies on IMAP's R&D competitive advantages in immuno-oncology and business development capabilities.
Dr. Zheng Lijun: At IMAP, with multiple successful examples in the past few years, this value proposition model has been proven and it works well in our hands.
Business development capabilities.
And I am app with multiple successful examples in the past few years.
This value proposition model has been proven and it works well in our hands, we will continue to deliver.
Dr. Zheng Lijun: We will continue to deliver the expected results.
The expected results. This model also helps power ties and focus our resources on higher value business activities why.
Dr. Zheng Lijun: This model also helps prioritize and focus, our resources on high-value business activities while it avoids spending resources to build our own commercialization capability.
<unk> spending resources to build our own commercialization capability.
Dr. Zheng Lijun: Now since the beginning of this year, we have been focused, we have been facing the same challenges as many other companies have faced in this market.
Now since the beginning of this year, we're being focused we're being facing.
<unk> challenges as many other companies have faced in this market.
Dr. Zheng Lijun: So how do we best position the company to not only survive but also thrive in this, turbulent market as we continue to strengthen our fundamentals?
So how do we best positioned the company to not only survive, but also thrive in this turbulent market.
Dr. Zheng Lijun: For IMAP, this means being laser-focused on delivering value drivers in the next three years.
As we continue to strengthen our fundamentals.
This means being laser focused on delivering value drivers in the next three years. So we work to bring the most value to our shareholders.
Dr. Zheng Lijun: So we work to bring the most value to our shareholders.
Dr. Zheng Lijun: Now the first aspect is to prioritize our resources on the value driver assets in our pipeline and create near-term value for our shareholders. As I have already mentioned, our pipeline is rich, but we must focus on assets that, we believe have the most potential. Through our systemic science and business review, we have prioritized five high-value, assets associated with 10 clinical trials. Some of these trials are ongoing, while others have yet to be initiated.
Now the first aspect is to prioritize our resources on a value driver assets in our pipeline and create near term value for our shareholders.
As I have already mentioned our pipeline is rich, but we must focus on assets that we believe have the most potential.
Through our systemic signs and business review, we have prioritized five high value assets associated with the tank clinical trials. Some of the some of these trials are ongoing while others have yet to be initiated.
Dr. Zheng Lijun: For these key assets, we expect three potential BLAs in the next three years, more BDDOs, to reinforce our value creation model, and it extends our cash runway beyond three years.
But this key assets, we expect three potential <unk> in the next three years more BD deals to reinforce our value creation model and it extends our cash runway beyond three years.
Dr. Zheng Lijun: Now, the second aspect is our continued hunts for commercial partnerships. This includes partnerships for the near-term commercialization of valsartamide for multiple, myeloma and F10 long-acting growth hormone for PGHD.
Now at the SEC.
<unk> aspect is our continued hands for.
Commercial partnerships. This includes partnership for the near term commercialization of <unk> for multiple myeloma and <unk>.
<unk> long acting growth hormone for PGA HD.
As discussed earlier.
Dr. Zheng Lijun: As discussed earlier, we will choose to partner with the leading domestic pig farmer companies, with proven commercialization capabilities with established sales forces and channels.
We would choose to partner with a leading domestic big pharma companies with a proven commercialization capabilities with established sales forces and channels.
Dr. Zheng Lijun: We have already established a commercial partnership with JumpGain, a market leader in the pediatric, therapeutic area in China, for F10 long-acting growth hormone.
We have already established a commercial partnership will jump again, a market leader in pediatrics.
So a good area in China for <unk>.
<unk>.
Long acting growth hormone, we're now in the process of.
Dr. Zheng Lijun: We're now in the process of contemplating a potential commercial partnership deal for valsartamide.
Contemplating a potential.
Commercial partnership deal Bolthouse Ahmed.
The third aspect is to continue investing in our next generation pipeline assets. This area is one of our core.
Dr. Zheng Lijun: The third aspect is to continue investing in our next-generation pipeline assets. This area is one of our core strengths. These next-generation assets include novel bispecific antibodies and immune adjuvants, which we believe have the potential to lead global trends in immuno-oncology.
Strengths.
This next generation of assets in crudes.
Novel Bi specific antibodies and immune adjuvant, which we believe have the potential to lead global trends in immuno oncology, we're underway to generating.
Dr. Zheng Lijun: We're on the way to generating a novel portfolio of next-generation programs to bring four, to five such new drug molecules to R&D and the clinic within the next three years.
A novel portfolio of our next generation programs to bring four to five such new drug molecules to R&D and the clinic within the next three years.
It is also worth mentioning again.
Dr. Zheng Lijun: This also was mentioning, again, our current cash runway with cash on hand, plus the expected, milestone payments over three years, and is sufficient to support our core business activities as I just laid out.
Our current <unk>.
Current cash runway with cash on hand, plus the expected milestone payments over three years and is sufficient to support our core business activities as I've just laid out.
With that overview I'd like to ask Andrew.
Dr. Zheng Lijun: With that overview, I'd like to ask Andrew to take a deep dive into our key pipeline, assets and provide our expectations for the rest of 2022.
To take a deep dive into our key pipeline assets and provides our expectations for the rest of 2022.
Dr. Zheng Lijun: Andrew, over to you.
Andrew over to you.
Thank you Dr. Zhao.
Dr. Andrew Zhu: Thank you, Dr. Zhang.
It's my pleasure and privilege to speak with all of you today.
Dr. Andrew Zhu: It's my pleasure and privilege to speak with all of you today.
The focus of my discussion will be on our pipeline development I will highlight the recent progress an update as well as the near term prospects of this very exciting pipeline.
Dr. Andrew Zhu: The focus of my discussion will be on our pipeline development. I will highlight the recent progress and update, as well as the near-term prospect of this, very exciting pipeline. At IMAP, we have 20 assets in development and 10 assets that are in clinical stage.
Now we have assets in development and 10 assets that are in clinical stage.
Dr. Andrew Zhu: Today, I would like to highlight five prioritized assets in our pipeline because they are value, drivers. These assets are novel, highly differentiated, and are highly competitive, either globally, or in China. The five value driver assets include the two late-stage assets, Feldsark-Mab and F-Tensor, matchup in ARPA, with their BLA to be delivered in 2023 and 2024. And the two Phase II and Phase III ready global assets, Lambda PolyMab and UV Ledley-Mab, alongside with our new star, the best specific CD4B.
Today, I would like to highlight five prioritize our science in our pipeline because they are value drivers.
These assets are not alone.
Differentiated.
Our highly competitive either globally or in China.
The five value driver assets include the two late stage assets sales are to map in terms of matrix and ARPA with their BLA to be delivered in 2023 and 2024.
And the two phase II and phase III ready global assets, Lemzo Party map and ube laterally map.
Alongside with our new Star the best specific.
CD <unk>.
Dr. Andrew Zhu: I'll go through each asset in more detail.
I'll go through each asset in more details.
Dr. Andrew Zhu: First, let me start to highlight our two pre-BLA assets, Feldsark-Mab and F-Tensor matchup, in ARPA.
First let me start to highlight our two <unk> assets fell to <unk> map and as tangible metrics are up.
Dr. Andrew Zhu: Feldsark-Mab is our most advanced asset. We have successfully completed the registration trial in China for Feldsark-Mab as a third-line, treatment for multiple myeloma. Our study confirmed the efficacy of Feldsark-Mab with additional benefits, such as lower infusion-related, reaction rate and shorter infusion time. This allows the use of Feldsark-Mab in outpatient setting. In January 2022, the company signed a partner agreement with Hangzhou Qingdao government, in China to manufacture Feldsark-Mab locally to accelerate its commercialization. The local manufacturing plant is expected to significantly reduce the cost of goods, and allow Feldsark-Mab to be commercially more competitive.
Yeah.
So I'll talk about this our most advanced asset we have successfully completed the registration trial in China hotels arent as a first line treatment for multiple myeloma.
Our study confirm the efficacy of sales are to map.
With additional benefits such as lower infusion related reaction rate and shorter infusion time.
This allows the user belt argue map in outpatient setting.
In January 2022.
The company signed a partner agreement with Hangzhou.
Qingdao government in China too.
<unk> met.
The Hangzhou Chengdu, Hong government in China auto manufacturer FEMSA, Arca Mab locally to accelerate is commercialization.
The nominal local manufacturing plant is expected to significantly reduce the cost of goods and allow <unk> to be commercially more competitive.
In terms of the second line treatment for multiple myeloma, a randomized phase III registration trial sales arent map in combination with Lenalidomide completed patient enrollment in September 2021.
Dr. Andrew Zhu: In terms of the second-line treatment for multiple myeloma, a randomized phase III registration, trial of Feldsark-Mab in combination with lenalidomide completed patient enrollment in September 2021.
When the top line data is fully mature we expect this data to support our BLA submission in 2023.
Dr. Andrew Zhu: When the top-line data is fully mature, we expect this data to support our BLA submission, in 2023.
In parallel we are exploring a possible study <unk> in combination with Lemzo party map from multiple myeloma.
Dr. Andrew Zhu: In parallel, we are exploring a possible study of Feldsark-Mab in combination with lenidoprotein, map for multiple myeloma.
Dr. Andrew Zhu: We expect to publish the preclinical data of Feldsark-Mab in combination with Lenzol, at ASH 2022.
We expect to publish the preclinical data sales arent mapping combination with Lemzo at Ash 2022.
Multiple myeloma remains a significant unmet medical need in China, considering the relevance of this therapeutic targets. It is important to note. There are approximately 20000, new cases of multiple myeloma each year in greater China.
Dr. Andrew Zhu: Multiple myeloma remains a significant unmet medical need in China. Considering the relevance of this therapeutic target, it is important to note there are, approximately 28,000 new cases of multiple myeloma each year in greater China, with approximately 100,000 second-line or third-line relapse or refractory multiple myeloma patients in China as of 2021.
With approximately 100002nd line or third line relapse or refractory multiple myeloma patients in China as of 2021.
This represents an annual growth of approximately 2% to 3% per year.
Dr. Andrew Zhu: This represents an annual growth of approximately 2 to 3% per year.
So it's hard to map is uniquely positioned as the only locally manufactured CD 38 antibody product with a DC profile, where it can be administered in an outpatient setting because of the shortened infusion time and Lori infusion rate.
Dr. Andrew Zhu: Feldsark-Mab is uniquely positioned as the only locally manufactured CD38 antibody product, with a distinct profile, where it can be administered in an outpatient setting because of the short infusion time and lower infusion rate.
Dr. Andrew Zhu: We have also demonstrated compelling efficacy, including in elderly patients with multiple, myeloma.
We have also demonstrated compelling efficacy, including in elderly patients with multiple myeloma.
Dr. Andrew Zhu: Next is Eftensometropin RFO, TJ101, our differentiated lung-acting growth hormone as a weekly treatment, versus commonly used daily injections. Eftensometropin RFO is the only natural lung-acting growth hormone in its proprietary fusion protein, format, i.e., a pure protein-based molecule, and it's not chemically linked with PEG or other linkers. Its safety, tolerability, and efficacy have been well-demonstrated in a phase II clinical, trial conducted in Europe. As shown in the figure in the middle panel, a weekly or biweekly treatment with Eftenso, RFO showed comparable efficacy to daily genotropin injection.
Next is a tangible matching our follower TJ 101, our differentiated long acting growth hormone is a weekly treatment versus commonly used daily injections.
As it has all metrics are obviously only natural long acting growth hormone is protect proprietary fusion hurting format.
E a pure Permian based molecule and is not chemically linked with pad or other <unk>.
Is safety Tolerability and efficacy has been well demonstrated in our phase II clinical trial conducted in Europe .
As shown in the figure in the Middle panel we.
Kelly.
Our bi weekly treatment with a pencil ARPA showed comparable efficacy to daily hoping injection.
Our registrational phase III colored trial is ongoing and we have completed.
Dr. Andrew Zhu: Our registration phase III color trial is ongoing, and we have completed patient enrollment, in May of this year and are on track for BLE submission in 2023 or 2024.
<unk> enrollment in May of this year and are on track for BLA submission in 2023 or 2024.
There are advantages using a weekly versus daily injection for treatment of pediatric growth hormone deficiency.
Dr. Andrew Zhu: There are advantages using a weekly versus daily injection for treatment of pediatric, growth hormone deficiency. This includes improved patient compliance, with patients more likely to consistently, take their treatment in a weekly or biweekly schedule versus a daily setting.
This includes improved patient compliance with patients more likely to consistently take their treatment and a weekly or bi weekly schedule versus a daily setting.
In 2021, we entered into a strategic commercial partnership with Jonathan can to leverage Tom <unk> commercial network as the commercial leader in.
Dr. Andrew Zhu: In 2021, we entered into a strategic commercial partnership with Jomcan to leverage Jomcan's, vast commercial network as a commercial leader in pediatric therapeutic area. Our agreement includes upfront and potential milestone payment of U.S. dollars, $315 million, as well as a 50-50 profit sharing, although double-digit royalties on revenues.
In pediatric therapeutic area.
Our agreement include upfront and potential milestone payment of USD $315 million as well as a 50 50 profit sharing.
Our low double digit royalties on revenues.
Dr. Andrew Zhu: This partnership represents one of China's biopharma market's largest deals, which is, a testament to the product's potential and to IMAP's development capabilities.
This partnership represents one of China's biopharma markets large largest deals.
Which is a testament to the product's potential and to IMAX development capabilities.
Dr. Andrew Zhu: Meanwhile, we expect Eftenso Measurement RFO to be highly competitive on 3.4 million addressable, patient populations.
Meanwhile, we expect a hands on management ARPA to be highly competitive.
$3 4 million addressable patient populations.
We believe the China growth hormone deficiency market is large enough to give chumps can't deny that it's fighting change.
Dr. Andrew Zhu: We believe the China growth hormone deficiency market is large enough to give Jomcan and, IMAP a fighting chance, and we have a real chance to take a substantial share of the market.
And we have a real chance to take a substantial share of the market.
Dr. Andrew Zhu: Furthermore, given the lack of a pack and of chemical linkers, Eftenso is the only long-acting, growth hormone in the pure protein format, which offers potential safety benefits.
Furthermore, given the lack of APAC and of chemical encouraged as tangible is the only long acting growth hormone to pure <unk> format, which offers potential safety benefits.
Dr. Andrew Zhu: Next, I would like to highlight our highly differentiated CD47 antibody, including Lemzopartumab, and a new CD47 antibody therapy. I would like to remind you that Lemzopartumab is differentiated by design to avoid binding, to red blood cells while maintaining strong anti-tumor activity. This molecular differentiation has been validated pre-clinically and has translated into clinical, advantages that are being validated.
Next I would like to highlight our highly differentiated CD 47 antibody, including Lemzo Party map and a new CD 47 antibody therapy.
I would like to remind you that lemzo is differentiated by design to avoid binding to red blood cells, while maintaining strong anti tumor activity.
This is molecular differentiation has been validated pre clinically and has translated into clinical advantages that are being validated.
IMS priority for Lenzo is to achieve the first registration of Lenzo in his clients in China.
Dr. Andrew Zhu: I-Mab's priority for LENZO is to achieve the first registration of LENZO in this class in China. This will allow LENZO PolyMab to be the first, CD47 to the market in China and potentially the first globally approved CD47 therapy.
This will allow lenzo carty map to be the first 40 to <unk> 47 to the market in China.
And potentially the first globally approved CD 47 therapy.
Dr. Andrew Zhu: Multiple clinical studies of LENZO are ongoing in parallel in both the U.S. and China.
Multiple clinical studies of Lenzo are ongoing in parallel in both U S and China.
Dr. Andrew Zhu: As seen here, you can take a look at our global clinical development plan.
As in here you can take a look at our global clinical development plan outside of China, We have partner with apathy, who is spearheading global efforts in the development of renewal CD 47 antibody analysis discuss the amended partnership partnership on the next slide.
Dr. Andrew Zhu: Outside of China, we have partnered with Apovee, who is spearheading global efforts in the development of a new CD47 antibody, and I will discuss the amended partnership on the next slide.
In China <unk>.
Dr. Andrew Zhu: In China, I-Mab is leading the efforts in the CD47 space.
<unk> is leading the efforts in the 47 space.
Dr. Andrew Zhu: The most significant study is the Phase II clinical trial in MDS-AML.
The most significant study is the phase II clinical trial in Mds AML. This trial in combo with <unk>.
Dr. Andrew Zhu: This trial, in combo with ACA, our plan remains to initiate a registration trial for MDS patients by the end of 2022.
Our plan remains to initiate a registration trial for Mds patients by the end of 2022.
Dr. Andrew Zhu: We believe the differentiating feature of LENZO PolyMab has gained preliminary clinical, validation. The differentiation includes the expected favorable safety profile with no priming dose required, less RBC-mediated sink effects, and compelling anti-tumor activity across several trials, which is consistent with LENZO PolyMab's differentiation. The unique glycosylation around the binding site of LENZO serves as a natural barrier to prevent, LENZO from engaging RBC. This means that red blood cells are only minimally accessible by LENZO. By contrast, the binding site on tumor cells does not have similar glycosylation, and is fully exposed, which explains why LENZO binds strongly to tumor cells.
We believe the differentiating feature of Lessor Party, Matt has gained preliminary clinical validation.
The differentiation includes the expected favorable safety profile with no priming dose required less RPC mediated simply facts and compelling anti tumor activity across several trials, which is consistent with London part of maps differentiation.
The unique client constellation around the binding side of Lenzo surface, a natural barrier to prevent lenzo from engaging RPC.
This means that red blood cells are only minimally assessable by led by.
By contrast, the binding site on tumor cells does not have similar glycol solution and is fully exposed which explains why lemzo buying strongly to tumor cells.
Dr. Andrew Zhu: In a systemic safety review of approximately 200 patients up to date who were treated either, with LENZO alone as monotherapy or in various combinations, we have seen a compelling safety profile today.
In a systemic safety review of approximately 200 patients up to date.
Treated either with <unk> alone as monotherapy OE in various combinations.
We have seen a compelling safety profile today.
Overall, the safety data from both the U S. China studies continue to be favorable when administered without a priming dosing regimen MTV was not reached in any of those regimen mild PRA solid tumors NHL good safety profile in combination with Azacitidine.
Dr. Andrew Zhu: Overall, the safety data from both the U.S. and China studies continue to be favorable when administered without a priming dosing regimen. MTD was not reached in any dose regimen. Mild TRAE in solid tumors at NHL, good safety profile in combination with azithidine in AML-MDS, and no grade 5 hematological TRAEs have been reported.
In AML, Mds and no grade five hematological TRA as been reported.
Here I would like to highlight some of the high level data from our phase two trial of <unk> in combination with <unk> in first line higher risk Mds patients in China that we shared at our R&D day in July .
Dr. Andrew Zhu: Here, I'd like to highlight some of the high-level data from our phase 2 trial of LENZO PolyMab in combination with ACA in first-line higher-risk MDS patients in China that we shared at our R&D date in July. In this patient group, we have again seen good safety profile with LENZO PolyMab well-tolerated, in combination with ACA, despite the more severe baseline features related to underlying disease in this cohort.
In this patient group, we have again seeing good safety profile with Lenzo part of map well tolerated in combination with HCA.
Spike the more severe.
This line features related to underlying disease in this cohort.
We have also observed comparable efficacy to <unk> map within overall are of 87% and the CR rate between 31 and 40% depending upon the treatment duration.
Dr. Andrew Zhu: We have also observed comparable efficacy to megalomimab with an ORR of 87% and a CR, rate between 31 and 40% depending upon the treatment duration.
We plan to present this detailed dataset in a perfect presentation at ESMO on September 10, 2022 for the Organisers embargo policy.
Dr. Andrew Zhu: We plan to present this detailed dataset in a proffered presentation at ASIMO on September, 10, 2022, per the Organizer's Embargo Policy.
Dr. Andrew Zhu: Additionally, as mentioned, we plan to initiate a Phase III registration trial before the, end of 2022, and we have already submitted the communication package to CDA to push this registration trial forward.
Additionally, as mentioned we plan to initiate a phase III registration trial.
Before the end of 2022.
And we have already submitted the communication package the Cta to push this registration trial forward.
Dr. Andrew Zhu: Importantly, AbbVie and I-Mab have entered into an amendment to the original license, and collaboration agreement.
Importantly.
<unk> and <unk> have entered into an amendment to the original license and collaboration agreement.
Both parties will continue to collaborate on the global development of anti <unk> seven antibody therapy.
Dr. Andrew Zhu: Both parties will continue to collaborate on the global development of anti-F47 antibody, therapy. For the new anti-F47 antibody therapy, the company will be eligible to receive and AbbVie, will pay up to U.S. dollar 1.3 billion in development, regulatory, and sales milestone payments, and the tiered royalties will be raised from mid to high single-digit percentage on global net sale outside of greater China.
For the new entire 46, 47 antibody therapy. The company will be eligible to receive an abbvie will pay off to U S. Dollar $1 3 billion in development.
Regulatory and sales milestone payments and.
And the tier to Brian Hayes will be at rates from mid to high single digit percentage on global net sales outside of greater China.
The company retains the exclusive right to develop and commercialize <unk> licensed products under the agreement in greater China.
Dr. Andrew Zhu: The company retains the exclusive right to develop and commercialize all licensed products, under the agreement in greater China.
Dr. Andrew Zhu: Globally, AbbVie will focus on the new therapy, which is currently under development, and, discontinue the Phase I study of lamzopartimab.
Globally Abbvie will focus on the new therapy, which is currently under development.
And discontinue the phase one study of labs are part of that.
In parallel in China, and that will continue advancing is leading position Lemzo Party MA with a focus on the initiation of a phase III clinical trial in patients with Mds in China.
Dr. Andrew Zhu: In parallel in China, I-Mab will continue advancing its leading position on lamzopartimab, with a focus on the initiation of a Phase III clinical trial in patients with MDS in, China. Today, Phase I and Phase II clinical studies of lamzopartimab in U.S. and China with nearly, 200 patients have supported a good safety profile without the need of a priming dosing regimen.
Today phase, one and phase II clinical studies of <unk> U S and China with nearly 200 patients.
Have supported a good safety profile without the need of a priming dosing regimen.
Dr. Andrew Zhu: Lamzopartimab in combination with ACEA has shown to be efficacious in patients with higher, rates of MDS in the Phase II study.
Linda <unk> combination with HCA has shown to be efficacious in patients with higher risk Mds.
In the phase II study.
Next is <unk> another global front runner that we are developing for solid tumors with a focus on non small cell lung cancer and ovarian cancer.
Dr. Andrew Zhu: Next is the Uli-Latvimab, another global frontrunner that we are developing for solid tumors with, a focus on non-small cell lung cancer and ovarian cancer.
As previously reported Uli laterally Mab is differentiated by design to avoid the hockey fan.
Dr. Andrew Zhu: As previously reported, Uli-Latvimab is differentiated by design to avoid the hokey fat. So the hokey fat is simply characterized by an abnormal phenomenon where a drug molecule, paradoxically loses its effect at higher doses.
So the hopefully the hockey fab it simply characterized by an abnormal phenomena, where a drug molecule paradoxically Lucy SEC fad at higher doses.
Dr. Andrew Zhu: Uli-Latvimab's differentiation comes from a unique binding epitope at the C-terminus, is. We believe the differentiation gives urelethymab a better therapeutic window and more flexibility when combined with other anti-tumor drugs.
Judy laterally maps differentiation comes from a unique binding epitope epitope LTC terminals.
We believe the differentiation gives unilaterally mab burghers therapeutic window and more flexibility.
When combined with other anti tumor trucks.
Dr. Andrew Zhu: In addition, urelethymab has potential advantages over small molecules with a non-competitive inhibitory effect that is not blunted by the high level of CD73 enzyme substrate abnormally accumulated in the tumor microenvironment, which could be expected for small molecule competitive blockers.
In addition, you will be lessened map has potential advantages over small molecules with a noncompetitive inhibitory fab that is not blunted by the high level of <unk> 73 enzyme substrate abnormally accumulated in the tumor micro environment.
Which could be expected for a small molecule competitive bloggers.
In the Phase one study presented at Astro in June 2021, where patients with solid tumors were treated with <unk> in combination with the teasel among the 30 evaluable patients.
Dr. Andrew Zhu: In the Phase I study presented at SCO in June 2021, where patients with solid tumors were treated with ULE in combination with the Tizol, among the 30 evaluable patients, ORR was at 23% and DCR was at 46%. The results, although preliminary, are very encouraging.
<unk> was at 23% and ECR was at 46%.
Dr. Andrew Zhu: We are conducting two Phase II, clinical studies in both the U.S. and China.
The results, although preliminary Ah.
Very encouraging.
We are conducting two phase II clinical studies in both the U S and China I hope to share the data as soon as possible.
Dr. Andrew Zhu: I hope to share the data as soon as possible.
Dr. Andrew Zhu: I also want to mention, alongside the planned data readout, we continue to explore global, partnership opportunities.
I also want to mention alongside the planned data readout.
We continue to explore a global partnership opportunities.
Dr. Andrew Zhu: With the data cutoff as of March 29th of this year, we recently shared this key patient cohort in the urelethymab trial, where we saw encouraging efficacy signals in advanced non-small cell lung cancer patients who were unsuitable for or did not decline standard chemotherapy treatment. In this cohort, most of the patients have stage IV non-small cell lung cancer. Approximately 80% of the patients in this cohort had low PT1 expression in baseline tumor samples. And that is tumor proportion score, TPS, 1 to 49% or negative at TPS less than 1%.
Yeah.
With the data cutoff as of March 29 of this year, we reasonably sure. This key patient cohort in the Uli Latin map trial, where we saw encouraging efficacy signals in advanced non small cell lung cancer patients who are unsuitable for or the decline of standard chemotherapy.
<unk>.
In this cohort most of the patients have stage four non small cell lung cancer, approximately 80% of the patients in this cohort low PD lone expression in baseline tumor samples.
Dr. Andrew Zhu: These patients are generally considered less responsive to PT1 therapy.
And that is tumor proportion score TPS, 1% to 49% on negative at TPS less than 1%.
These patients are generally considered less responsive to PD one therapy for example in the Keno zero four to study patients with low TPS I E. 149% are cheaper response rate.
Dr. Andrew Zhu: For example, in the keynote 042 study, patients with low TPS, i.e.
Dr. Andrew Zhu: 1 to 49%, achieved a response, rate of 16.9%, and patients with negative TPS appear to benefit even less likely.
69% and patient with negative <unk> appear to benefit even less likely.
After 19 efficacy evaluable patients in our study the response rate is 26% and TCR, 74% with five and nine stable disease observed with a median follow up.
Dr. Andrew Zhu: Of the 19 efficacy-evaluated patients in our study, the response rate is 26% and DCR 74%, with 5 PR and 9 stable disease observed, with a median follow-up of 3.3 months.
Dr. Andrew Zhu: Interestingly, in this study, 7 out of 19 patients, 37%, had a high expression of CD73, using 35% as a cutoff.
Three three months.
Interestingly in this study seven out of 19 patients, 37% had a high expression of <unk> 73, using 35% as a cutoff.
Dr. Andrew Zhu: When looking at patients with high CD73 expression, we noticed our disease control, rates at 100% and also overall response rate at 57%. We have 4 out of 7 patients exhibited a PR.
When looking at patient with high CD 73 expression. We note is rpc's control raise at 100% and also <unk>.
Or overall response rate at 57%.
We have four out of seven patients exhibited APR.
Dr. Andrew Zhu: In contrast, in the 11 patients with low CD73 expression, only 1 PR was observed, observed.
In contrast in 11 patients with low <unk> 73 expression only one PR was observed.
Dr. Andrew Zhu: We're very happy to share some updates on our expanded Phase 2 clinical trial. At this moment, we have 47 non-spot cell lung cancer patients enrolled, and we're targeting the enrollment of 60 patients by October. We continue to observe encouraging efficacy signals in these 47 patients, and a correlation of CD73 expression with clinical efficacy.
We're very happy to share some updates on our expanded phase two clinical trial at this moment, we have 47, non small cell lung cancer patient enrolled and we're targeting the enrollment of 60 patients by October .
We continue to observe encouraging efficacy signals in these 47 patients.
<unk> a correlation.
CD 73.
Expression with clinical efficacy.
We expect to have a more complete data readout.
Dr. Andrew Zhu: We expect to have a more complete data readout by the end of this year or early next year.
By the end of this year or early next year.
We have reached an agreement with Wuxi diagnostics to develop a <unk> 73 vitro diagnostic kit for the patient selection of Uli Latin maps ongoing phase II and planned phase III clinical studies in non small cell lung cancer.
Dr. Andrew Zhu: We have reached an agreement with WuXi Diagnostics to develop a CD73 retrodiagnostic kit for, the patient selection of ULEADLY-Mab's ongoing Phase 2 and planned Phase 3 clinical studies in non-spot cell lung cancer. We are excited by this preliminary confirmation of a correlation between higher CD73 expression and an increased OR.
We are excited by this preliminary conformation of a correlation between higher CD 73 expression and then increased our.
Dr. Andrew Zhu: In parallel, we are exploiting a potential global partnership of ULEADLY-Mab.
In parallel we are exploiting a potential global partnership of yearly laterally map.
The last compound I'd like to touch on today is our T. J C. Diff will be the novel clogging 18th to see <unk> BB by specific antibody that has made significant clinical progress as well.
Dr. Andrew Zhu: The last compound I'd like to touch on today is our TJCD4B, the novel clotting 18.2 and 41BB bispecific antibody that has made significant clinical progress as well. Of note, TJCD4B is a novel clotting 18.2 and 41BB bispecific antibody capable of binding to tumor cells expressing clotting 18.2 and stimulating intertumoral T cell by the 41BB arm, which is designed to become active only upon tumor engagement, to avoid systemic toxicity.
Of note <unk> is a novel Clogging 18 point tool and <unk> BB by specific antibody capable of binding to tumor cells expressing clouding 82, and stimulating intra tumoral T cell <unk>, which is designed to become active only upon too.
Our engagement to avoid systemic toxicity.
Dr. Andrew Zhu: Previous generation of 41BB agonist antibodies encounter significant challenges. For example, for ULEADLY-Mab, the hepatic toxicity was a major concern.
Previous generation of on DB agonist antibodies encountered significant challenges for example for your lab.
Hepatic toxicity was a major concern.
Dr. Andrew Zhu: And for uteromelomab, less efficacy was observed.
And for Nuomi roadmap less efficacy was observed.
<unk> has several distinct advantages that it can draw upon it binds to <unk>.
Dr. Andrew Zhu: Our TJCD4B has several distinct advantages, that it can draw upon. It binds to a distinct 41BB epitope that only triggers 41BB signaling upon clotting 18.2 binding.
Only triggers following BB signaling upon clouding 18, two binding.
Dr. Andrew Zhu: Our antibody is a unique conditionally active 41BB antibody that could stimulate the 41BB signaling only when the bispecific antibody engages the clotting 18.2 positive tumor cells.
Our antibody isn't unique conditionally acid <unk> antibody that could stimulate <unk> signaling only when the bi specific antibody engages the CD the clouding 18 point to positive tumor cells.
Dr. Andrew Zhu: And therefore, our bispecific antibody greatly reduced the, systemic and liver toxicity, which are observed in other conventional 41BB antibodies.
And therefore, our bi specific antibody greatly reduce the systemic and liver toxicity, which are observed in other conventional <unk> antibodies.
The results from the TRP costs inside among key showed that this bi specific antibody was well tolerated at the highest has the bills and 100 Meg per kg.
Dr. Andrew Zhu: The results from the GLP talks in Sinomonkey showed that this bispecific antibody was well-tolerated at the highest tested dose at 100 mg per kg.
Dr. Andrew Zhu: Conditional T cell activation upon TAA engagement allows for localized immune activation in the tumor microenvironment and drastically reduces the peripheral T cell activation and hepatic as well as systemic immunotoxicity without compromising anti-tumor activity. Additionally, this allows for minimal systemic toxicity.
Conditional T cell activation upon Ta engagement allows for localizing new activation in the tumor microenvironment and drastically reduces the peripheral T cell activation and hepatic as well as systemic immuno toxicity without compromising anti tumor activity.
Dr. Andrew Zhu: We believe this platform has the, potential to assess multiple targets for their therapeutic development.
Additionally, this allows for minimal systemic toxicity.
We believe this platform has the potential to assess multiple target for their therapeutic development.
And one of the core assets in our highly innovative bi specific antibody pipeline.
Dr. Andrew Zhu: As one of the core assets in our highly innovative bispecific antibody pipeline, TJCD4B is currently, undergoing phase one clinical evaluation in both the U.S. and China. In parallel, our ongoing dose escalation study is progressing very smoothly. TJCD4B is now at 8 mg per kg in the U.S. trial and 5 mg per kg in the China trial.
T J C. Diff Obi is currently undergoing phase one clinical evaluation in both the U S and China in parallel.
Our.
Our ongoing dose escalation study is progressing very smoothly <unk> now at eight Meg per kg in the U S trial, and <unk> <unk> per case, the China trial.
So far we have already observed one PR a patient with Aesop esophageal gastric cancer will fail. The standard three prior lines of therapy. In addition, we have all observed three stable disease.
Dr. Andrew Zhu: So far, we have already observed one PR, a patient with esophageal gastric cancer, who failed the standard three prior lines of therapy. In addition, we have observed three stable diseases, and we currently have no unexpected safety signals encountered.
And we currently have no I expect a $66 million contract.
Dr. Andrew Zhu: This study is on track to generate more data by year-end.
This study is on track to generate more data by year end.
Dr. Andrew Zhu: I would like to reemphasize our goal of translating cutting-edge science into innovative, drugs to specifically address areas of unmet medical need.
I would like to reemphasize, our goal of translating cutting edge science into innovative drugs to.
Dr. Andrew Zhu: To achieve this goal, we focus on three waves of discovery to generate potential first-in-class and best-in-class assets.
Typically address areas of unmet medical need.
To achieve this goal we focus on the three waves of discovery to generate potential first in class and best in class assets.
Dr. Andrew Zhu: The first wave is monoclonal antibody or fusion proteins with unique differentiation, including the unique programs such as LAMSO and ULEAP, all of which have been in phase two already for phase three.
The first wave is monoclonal antibody or fusion proteins with unique differentiation, including the unique programs such as <unk> and unique all of which have been in phase two already for phase III.
Dr. Andrew Zhu: In addition, we're also developing novel monoclonal antibodies that target the driver immune checkpoint pathways and are designed to synergize with the existing clinical assets as combo therapies.
In addition, we're also developing novel monoclonal antibodies that target is the driver of immune checkpoint pathways.
And our designs to synergize with existing clinical assets as combo therapies.
Dr. Andrew Zhu: The second wave is bispecific antibodies, and these are in phase one or in the IND enabling stage. These assets are designed to target specific cancers such as gastric, pancreatic, and ovarian, and to target PD-1 resistant cancers by turning a cold tumor to a hot tumor.
The second wave is bi specific antibodies and these are in phase one or in the IND, enabling stage.
These assets and RP fine to target specific cancers, such as.
Gastric pancreatic and ovarian and to talk a PD, one or PD, one resistant cancers by turning a cold tumor to a hot tumor.
Dr. Andrew Zhu: The third wave is super antibodies that were enabled by new technologies and formatted with novel modalities.
The third wave is super antibodies that were enabled by new technologies and formatted with novel modalities.
Dr. Andrew Zhu: Most programs are now in the preclinical stage.
Most programs now in the preclinical stage among them. The email address <unk> are an area of focus which is designed to prime and amplify immune response in tumors by different cytokine adwords such as.
Dr. Andrew Zhu: Among them, the immune adjuvants are an area of, focus, which is designed to prime and amplify immune response in tumors by different cytokine adjuvants, such as, I think, NAPKIN-alpha and a few new assets.
As a napkin ARPA and a few new assets.
Dr. Andrew Zhu: Here, I would like to cover the two newcomers to our innovative pipeline.
Here I would like to cover the two newcomers.
Our innovative pipeline on the left is our <unk> 41.
Dr. Andrew Zhu: On the left is our, C6-4B, which is the third bispecific molecule developed, leveraging our conditional 4-MBP platform, which has the advantage of minimizing liver toxicity with an increasing therapeutic window. It is specifically designed to simultaneously target clotting-6 expressed by tumor cells, and 4-1BB expressed by T-cells to mediate the T-cell killing of clotting-6 expressing tumor cells. Clotting-6 is regarded as an attractive target due to its tumor-specific expression pattern, shown on the middle lower panel.
Is the <unk> bi specific molecule developed leveraging our condition for conditional for IBD platform.
Which have the advantage of minimizing liver toxicity with an increasing therapeutic window.
It is specifically designed to simultaneously target clotting six expressed by tumor cells and for what may be expressed by T cells to mediate a T cell, killing of clouding six expressing tumor cells.
Colorado Clotting six is regarded as an attractive target due to his tumor specific expression pattern shown on the middle and lower panel. It is specifically expressed in ovarian cancer, along with testicular cancer.
Dr. Andrew Zhu: It is specifically expressed in ovarian cancer along with testicular cancer.
We have now demonstrated T. J C. D C. Six won't be can active T cells through full on BB stimulation only upon CD.
Dr. Andrew Zhu: We have now demonstrated Tdc64b can active T-cells through 4-1BB stimulation only upon, clotting-6 engagement, providing a more localized immune activation in tumors with good efficacy and reduce systemic toxicity.
Only upon clouding six engagement, providing a more localized E mail activation in tumors.
Without with good efficacy and reduce systemic toxicity.
On the right is our PD L. One I asked.
Dr. Andrew Zhu: On the right is our Tdl1-IS.
Dr. Andrew Zhu: And this is a novel PD-L1 interferon alpha antibody cytokine fusion protein, which is, specifically designed for the treatment of PD-L1, PD-1 resistant tumors through the addition of a strong immune adjuvant interferon alpha in attempt to convert co-tumors to hot tumors on top of a PD-L1 antibody to achieve superior anti-tumor activity.
This is a novel PD <unk> interferon alpha antibody cytokine fusion protein, which is specifically designed for the treatment of PD Lone PD one resistant tumors through the addition of a strong E mail ackman interferon alpha.
In our attempt to convert cold tumors to hot tumors on top of a PD lone antibody to achieve superior anti tumor activity.
Dr. Andrew Zhu: Tdl1-IS was developed using affinitive TMEA technology and is now under preclinical development. Tdl1-IS is a pro-drug in that interferon alpha 2b moiety is masked by a PET group through, a protease cleavable linker, rendering the drug inactive in the systemic circulation, thus strongly reducing the systemic toxicity.
T J.
<unk> was developed using affinity is EMEA technology is not under our preclinical development.
T J <unk> F is a prodrug in that interferon Alpha <unk> moiety is masked by pet group through a protease cleavable linker rendering the drought inactive in the systemic circulation, thus strongly reducing the systemic toxicity.
We hope that these preclinical assets will reach to the IND, enabling stage.
Dr. Andrew Zhu: We hope that these preclinical assets will reach to the ID enabling stage very soon.
Very soon.
With that I would like to turn the call back to Dr. John <unk> piece.
Dr. Andrew Zhu: With that, I would like to turn the call back to Dr. Zhang.
Dr. Andrew Zhu: Dr. Zhang, please.
Thank you Andrew.
Dr. Zheng Lijun: Thank you, Andrew.
Dr. Zheng Lijun: Now I would like to talk about what will be the next second half of 2022 look like in, terms of key milestones.
Now I would like to talk about.
What would be the next second half of 2022 look like in terms of key milestones.
Dr. Zheng Lijun: The first area is to deliver on the key pipeline milestones or catalysts.
The first area is to deliver on our key pipeline milestones or catalysts on the clinical development fronts.
Dr. Zheng Lijun: On the clinical development front, we will initiate the planned phase three clinical, trial for Lansopalumab as a first-line MDS treatment. We have already submitted application package and are in the process of communicating with, the CDE.
We will initiate the plan.
Phase III clinical trial call answer part of that.
First line Mds treatment.
We have already submitted application package and.
In the process of communicating with the CBE.
Dr. Zheng Lijun: In addition, we expect to achieve a few new data readouts, including Lansopalumab MDS, phase two clinical trial at eSmoke in December.
In addition, we expect to achieve a few new data readouts, including Lenzo, Panama, Mds phase III clinical trial.
In the.
In December .
Additional and also additional.
Dr. Zheng Lijun: And also additional data readouts for Ulilatumab phase two non-small cell lung cancer trial.
<unk> data Readouts 44, unilaterally map phase II non small cell lung cancer trial.
Dr. Zheng Lijun: And also a preliminary clinical data readout for TJCD4B, as Andrew already mentioned.
And also.
A preliminary clinical data readouts or T J <unk> as Andrew already mentioned.
Dr. Zheng Lijun: We also plan to initiate three new clinical trials in the U.S. and China.
We also plan to initiate three new clinical trials in the U S and China.
The second area is to deliver.
Dr. Zheng Lijun: The second area is to deliver key BD milestones, including potential our licensing BD deals, for urelazumab, alongside the possibility for bi-specific antibodies to be our license.
Key BD milestones, including potential our licensing BD deals for ULE likely map alongside the possibility for bi specific antibodies to be our licensed Additionally, as I mentioned earlier, we are working on a potential commercial partnership Bolthouse Akamai App in China.
Dr. Zheng Lijun: Additionally, as I mentioned earlier, we are working on a potential commercial partnership, for valsartanab in China.
The BD deliverables, however, take.
Dr. Zheng Lijun: The BD deliverables, however, take time and are dependent on negotiations with our potential, partners.
Take time and dependents.
Negotiations work with our potential partners.
Dr. Zheng Lijun: We will do our best as it is critical to our business.
We will do our best as it is critical to our business.
Last but not least.
Dr. Zheng Lijun: Last but not least, as previously mentioned, we have completed the process to engage a, U.S.-based public accounting firm that is subject to inspection by the PCAOB for the preparation of its audit reports.
As previously mentioned we have completed.
Process to engage a U S based public accounting firm that is subject to inspection by the <unk>.
Operational beds audit reports.
Dr. Zheng Lijun: The new development is that U.S. and China regulatory bodies signed a state of protocol, relating to the inspection of audit firms based in mainland China and Hong Kong.
The annuity Rama is the U S and China regulatory bodies signs a state of protocol relating to.
The inspection of the audit firms based in mainland China and Hong Kong.
Dr. Zheng Lijun: This may ultimately remove the delisting risks in the event of the state of protocol, does not meet the deadline for the company to mitigate delisting risks from the audits of a 2022 financial report, we will finalize the change to a U.S.-based auditor as originally planned.
May ultimately removed.
The listing risks.
Advance of.
The state of.
Protocol does not meet the deadline for the company to mitigate the listing rates.
From the audit of our 2022 financial reports, we will finalize the change to a U S based the auditor.
As originally planned.
Dr. Zheng Lijun: Additionally, our manufacturing facility of IMAP Hanzhou has already successfully manufacturing, batches of clinical trial material, and our R&D center has been operational in San Diego with a focus on translational medicine.
Additionally, our manufacturing facility of Humps Imap pound so.
Has already successfully manufacturing batches of clinical trial material and our R&D center as being operational in San Diego was a focus on translational medicine.
Dr. Zheng Lijun: So we are determined with the refocused strategy to deliver these critical milestones to drive, pipeline value for our shareholders.
So we're determined with our refocused strategy to deliver this critical milestones to drive pipeline value share.
Shareholders.
No.
Dr. Zheng Lijun: Now I would also like to highlight IMAP's current value proposition.
Also like to highlight.
<unk> current value proposition.
Dr. Zheng Lijun: Firstly, we have two late-stage assets near BLA and commercialization in China with very, significant market value.
Firstly.
Two late stage assets near BLA and commercialization in China.
Significant market value.
Dr. Zheng Lijun: For Fair Startmap, we're exploring a potential commercial partnership with this asset.
For <unk>, we're exploring a potential commercial partnership for this asset.
Uh huh.
Dr. Zheng Lijun: If then, Sumitraoping Alpha is expected to become a major player in China's gross home, market with BLA expected by 2023-2024.
If then submit chopping alpha is they expect to become a major player in.
In China gross Homo market with PRA expected.
123, 2024 and.
Dr. Zheng Lijun: And we are working with our commercial partner, Jumptan, on the product launch preparation.
And we are working with.
Our commercial partner <unk>.
On the product launch preparation.
Dr. Zheng Lijun: Secondly, our leading global assets, including Lancer PilotMap and Unilateral Map, have a, significant value to be realized as they advance towards Phase 3 development.
Secondly, our leading global assets.
Including a polymath unilaterally map have a significant value to be realized as they advance towards phase III development.
Dr. Zheng Lijun: For Lansopalumab, we're on track to initiate a phase 3 clinical trial in China for a first-line, MDS treatment by the end of 2022, depending upon the regulatory process and the preparation of the clinical sites around the country.
Forlenza polymath, we're on track to initiate a phase III clinical trial in China.
For first line Mds treatment by the end of 2022.
Pending upon the regulatory process and the preparation of the clinical sites around the country.
Dr. Zheng Lijun: We amended our agreements with AbbVie for a new CD47 antibody therapy with $1.3 billion, milestone possibilities.
We amended.
Agreements with ABB.
For UCD 47 antibody therapy.
A $1 $3 billion in milestones.
<unk>.
Dr. Zheng Lijun: For Ulilatelimab, we're expanding our lung cancer phase 2 clinical trial with encouraging, clinical results. We expect to provide another phase 2 data readouts of 60 lung cancer patients very soon, and continue exploring a potential global partnership.
For Uli lapping a map we're expanding our.
Lung cancer Phase II clinical trial was encouraging clinical results, we expect to provide.
Another phase III data readouts of the 60.
Lung cancer patients very soon and continue exploring a potential global partnership.
Dr. Zheng Lijun: Thirdly, we have not talked about other clinical stage assets and multiple preclinical assets, under development in our pipeline.
Thirdly.
We have not talked about other clinical stage assets and multiple preclinical assets under development in our pipeline.
Dr. Zheng Lijun: One of our priorities is to bring some of those assets to clinical validation.
One of our priorities is to bring some of those assets to clinical validation.
Dr. Zheng Lijun: The potential value of this portfolio is not being considered in our market capitalization, today.
Tangible value of this portfolio is not being considered in our market capitalization today.
Dr. Zheng Lijun: Fourthly, although delayed due to various reasons, we continue pushing hard with additional, BD deals for Ulilatelimab, TGA, CD4B, and additional new assets from our pipeline, along with a commercial partnership for Felsacna.
Fortunately.
Although delays due to various reasons, we continue pushing hard.
With additional BD deals.
Or is he likely map T J C.
<unk>.
Additional new assets from our pipeline along with commercial partnership for first half net.
It's worth mentioning as of June 32020 to our cash position is $586 million.
Dr. Zheng Lijun: It's worth mentioning, as of June 30, 2022, our cash position is $586 million, which will, be sufficient to support our business operations for over the next three years. Plus, we will receive additional milestone payments from the completed partnerships.
<unk> will be sufficient to support our business operations over the next three years plus.
We will receive additional milestone payments.
So on the completed.
Our partnerships.
John: With that, I will turn it over to John to briefly review our financials.
With that I will.
I'll turn it over to John to briefly review our financials John .
John: John?
John: Thank you, Dr. Zhang, and thanks to everyone for listening today.
Thank you.
And thanks to everyone for when you see today.
John: First, let me provide an overview of our financial results for the first six months ended June, 30, 2022. As of June 30, our cash and cash equivalents and short-term investments amounted to $3.9, billion RMB, or $586 million US dollars, compared with $4.8 billion RMB for the first six months in 2021.
First let me provide an overview of our financial results for the first six months ended June 30 of 2022.
As of June 30.
Cash and cash equivalents in short term investments amounted to $3 9 billion RMB.
586 million U S dollar.
<unk> four 8 billion for the first six months in 2021.
John: In the first six months, our total net revenues were $51.9 million RMB. It consisted of revenues from the current strategic collaborations and from the supply, of investigational products under the collaboration agreement.
In the first six months.
Total net revenues were $51 9 million on B. These consisted of revenues from the current strategic collaborations.
From the supply.
Additional products under the collaboration agreement.
John: Now, let me turn to R&D expenses. R&D expenses during this period were $453 million RMB, or $67.6 million US dollars, compared with $4.8 billion RMB.
Now, let me turn to R&D expenses funding.
<unk> expenses during this period.
<unk> hundred 53 media on the $67 6 million U S dollar.
John: 593 million RMB for the comparable period last year. The significant decrease was mainly driven, by the reduced demand of investigational products as we have prepared sufficient stock and lower share-based compensation expenses in 2022.
<unk>.
593 million on the for the comparable period of the year.
The significant decrease was mainly driven by the reduced demand investigational products.
Peter sufficient stock.
And lower share based compensation expenses in 2022.
The administrative expenses.
John: Administrative expenses for the first six months were 392 million RMB or 58.6 million U.S. dollars compared with 452 million RMB for the comparable period in 2021. The decrease was mainly due to lower share-based compensation expenses and savings from our cost expenses initiatives implemented during this period.
First demand.
392 million or 58 6 million U S dollar.
Compared with 452 media on the both comparable period in 2021.
The decrease was mainly due to lower share based compensation expenses.
Savings from our cost efficiency initiatives implemented during this period.
John: For the first six months, our total net loss was 1,047,000,000 RMB on a gap basis, inclusive of 181,000,000 RMB equity losses in our Hangzhou affiliate. The net loss on a non-gap basis was 848,000,000 RMB. The difference between gap and non-gap, was mainly driven by the non-cash share-based compensation expenses booked during this period.
For the first six months.
Our total net loss was $1 billion put into the media on the on the GAAP basis inclusive.
81 million on the exit losses in our Hangzhou opinion.
The net loss on a non-GAAP basis was 800 put the media on the.
But the difference between GAAP and non-GAAP was mainly driven by the noncash share based compensation expenses booked during this period.
John: Next page, as mentioned by Dr. Zhang, we want to reiterate that the company maintains, a strong cash balance with 586 million U.S. dollars on hand. Our current cash position combined with potential upcoming milestone payments from previous authorizing deals and collaborations is expected to further strengthen our cash reserves.
Next page.
As mentioned by Dr. John we want to reiterate that the company maintenance.
John cash centers with 586 million U S dollar.
Our current cash position combined with potential upcoming milestone payments from previous of licensing deals and collaborations is expected to further strengthen our cash reserves.
John: We are quite confident that our cash position remains sufficient to support key business, activities beyond 2025. The cash runway does not factor in potential upsides from additional cash related to potential new business payouts or new financing arrangements. We believe that our cash position provides us with ample insurance and flexibility, to support key fund activities over the next three years and beyond.
We are confident that our cash position remains sufficient to support key business activities beyond 2025 at the.
The cash runway does not factor in any potential upside from.
From additional cash related to potential new business or new financing arrangements.
We've been here with us.
Our cash position provides us with ample insurance and flexibility to support key on the activities over the next two years and beyond.
John: Last and importantly, I'm happy to report that with our prioritization strategy, we have implemented cost initiatives to save about 17% expenses compared to our original budget. This represents a positive cash impact of 32 million U.S. dollars to the company. We will continue to implement our cost and expenses initiatives and further reduce the, company's cash spend rate in the second half of 2022 and beyond. By the end of this year, we are on track to maintain our strong cash position and keep the balance at over 500 million target. This would allow us for an estimated runway of over three years, with potential additions, to our cash position along the way.
And importantly, I'm happy to report that with our prioritization strategy, we have implemented cost initiatives to see about 17% expenses compared to our original budget.
This represents a positive cash impact the.
$32 million to the company.
We will continue to implement our cost and expenses initiatives.
And further reduce the company's cash burn rate in the second half of 'twenty going into Europe .
But at the end of this year, we are on track to maintain our strong cash position and to keep the balance with over 500 million target.
This would allow us for estimated runway of over three years with potential additions to our cash position along the way.
With that I'd.
Tyler: With that, I just turn the call back to Tyler for Q&A sessions.
Turn the call back to Tyler for Q&A sessions.
Tyler: Tyler, please.
Therapies.
Tyler: Thank you, John, and thank you, Dr. Zhang, and thank you, Dr. Zhu, for that helpful overview, of our interim earnings.
Thank you John and thank you Dr is wrong and thank you Dr.
Thats helpful overview of our <unk> with that if there are any questions. Please use the raise hand function.
Tyler: With that, if there are any questions, please use the raise hand function.
Tyler: I see a couple of hands raised.
A couple of hands raised first question goes to <unk> from Jefferies. Please go ahead.
Tyler: First question goes to Kelly Xu from Jeffries.
Kelly Xu: Kelly, please go ahead.
Kelly Xu: Hello, thanks.
Kelly Xu: Thank you for taking my questions.
Alright.
Thank you for taking my question can you share more details about this new city bodies novel antibody therapy regarding non client deny and developmental stage as well how would I think differentiator from mango and also what the triggers are switched to this molecule from landfill.
Kelly Xu: Can you share more details about this new CD47 antibody therapy regarding molecular, design and the developmental status?
Kelly Xu: How does it differentiate from Lenzo, and also what triggers the switch to this molecule, from Lenzo?
Kelly Xu: I also have a follow-up.
I also have follow up thank you.
Kelly Xu: Thank you.
Dr. Zheng Lijun: Yeah, thank you, Kelly.
Thank you Kelly.
Dr. Zheng Lijun: Well, under the partnership with AbbVie, we have now a new CD47 molecule. Both parties have decided to continue to collaborate on a global development of this new molecule, which is in active development.
Well under the.
Partnership with Abbvie.
We're having now a new CD 47 molecules.
Both parties.
<unk>.
Decided to continue collaborate on a global developments of this new molecule, which is in the.
In active development.
Dr. Zheng Lijun: I also mentioned that the amended agreements around this new molecule is about $1.3 billion, and IMAP owns the exclusive China rights of the new molecule.
I also mentioned that.
The amended agreement around this new molecule is about.
One 3 billion.
<unk> owns the executive.
Exclusive China rights of the new molecule.
Dr. Zheng Lijun: Now, in terms of the properties of this new molecule and the detailed information, we, are under a confidentiality agreement with AbbVie, and both parties are quite strict about this confidentiality agreement to share data and everything.
In terms of the.
The properties up this new molecule and a detailed information we are.
Under a confidentiality agreements with.
Anthony.
And both parties are quite strict about this is confidential at comprehension <unk> agreement.
To share data and everything so at this point we're not.
Dr. Zheng Lijun: So at this point, we're not able to disclose more data, but we hope that as we move forward, as we generate more data, we'll be able to identify an appropriate time to disclose the data.
Able to disclose more data.
But we hope as we move forwards.
As we generate more data would.
We'll be we'll be able to identify a appropriate time to disclose the data.
Dr. Zheng Lijun: Now, as discussed today, Lenzo Partimap has a leading position in China. It's a very competitive position based on around 200 patient safety data and the recent, phase two efficacy data, as Andrew talked about.
No.
As discussed today Alonso, Panama has a leading position in China.
<unk> competitive position based on around 200 patient safety data and.
The recent phase II efficacy data as Andrew talked about so we are we're committed to initiating a phase III clinical trial very soon.
Dr. Zheng Lijun: So we are committed to initiating a phase three clinical trial very soon while working, with AbbVie on the new molecule.
While working with Abbvie on the on the new molecule.
Dr. Zheng Lijun: So at this point, that's all we can talk about.
So.
As you know at this point.
That's all we can talk about.
Kelly Xu: Thank you for the information.
And I think they are putting information also just quickly for the phase III trial in Mds.
Kelly Xu: Also, just quickly, for the phase three trial in MDS, where are you going to start enrolling, and how many patients do you plan to enroll?
Why are they going to starting on land how many patients are planned to be involved and also had asthma or do we expect the mall data beyond what has been released.
Kelly Xu: test.
Webcast. Thank you.
Yes, Thank you Kelly.
That question, maybe I can ask Andrew to.
To address Andrew.
Kelly Xu: Thank you.
I think as a result, thanks Kelly if we are interested in our phase III trial.
Kelly Xu: Thank you, Kelly.
As all of you are fully aware Mds is a very challenging therapeutic space.
At this moment.
Dr. Zheng Lijun: That question, maybe I can ask Andrew to address.
Visiting ECA remains to be the standard treatment.
Dr. Andrew Zhu: Andrew.
So as a result, our phase III clearly, we will use as a comparator arm.
Dr. Andrew Zhu: Thank you, Dr. Zhang.
And we are currently in active discussion.
Cte regarding.
The proposed phase III optimal design, and we will definitely take into the consideration of the optimal endpoints.
We are considering or CR, we are considering DFS and also as a potential primary endpoints.
And obviously the selection, we will definitely dictate the sample size.
We are also taking a very close look at the potential stratification. So that we can actually balance the prognostic.
Variables in both arms.
So all these details are actually.
Currently ongoing with CPE and also we hope that we can share with you in more details very soon.
And also we are confident that we can actually maintain.
Our initial target.
Initiation of our phase III.
Hopefully by the end of this year. Thank you.
Dr. Andrew Zhu: Thanks, Kelly, for your interest in our Phase III trial.
Thank you Kelly for your question and thank you Dr. Zhao and Azure for detailed response next we have.
Dr. Andrew Zhu: As all of you are fully aware, MDS is a very challenging therapeutic space.
Dr. Andrew Zhu: At this moment, as is easy in ACA, remains to be the standard treatment.
Dr. Andrew Zhu: So as a result, our Phase III clearly will use ACA as our comparator arm.
Dr. Andrew Zhu: And we are currently in active discussion with CDE regarding the proposed Phase III optimal, design.
Andreas Muller another from HC Wainwright unrest. Please go ahead.
Dr. Andrew Zhu: And we will definitely take into consideration of the optimal endpoints.
Alright, Thanks for taking my questions and congrats on the progress.
Dr. Andrew Zhu: We are considering a CRR.
So starting with well start to map in your considerations on the use of a hybrid.
<unk> model.
Safe to assume this will be for multiple myeloma only or what are your thoughts on how this extends the autoimmune diseases.
Just curious on what should be our expectations in terms of deal size them. There. Thank you very much.
Dr. Andrew Zhu: We are considering EFS and also OS as potential primary endpoints. And obviously, the selection will definitely dictate the sample size.
Yes. Thank you this is <unk> I can.
I can answer that question.
Dr. Andrew Zhu: We are also taking, a very close look at the potential stratification so that we can actually balance the prognostic variables in both arms.
<unk>.
We are in active discussion with potential commercial partners.
Four.
Commercial commercial deal for Charles how to map.
Dr. Andrew Zhu: So all these details are actually currently ongoing with CDE.
This potential partnership.
Does in crudes autoimmune disease indications.
This is pretty much based on.
More forces.
Recent data autoimmune nephrite nephritis.
Yeah.
So.
Data <unk>.
Published by more forces.
Very exciting indicating that treatments with akamai.
Doug.
<unk> clinical benefit in that.
<unk>.
Disease setting.
So we believe that this commercial partnership.
We're help too.
Maximize the value of sales automat leveraging.
Our partners strengths.
So to put together.
This commercial partnership.
We're in crude.
Multiple myeloma and also autoimmune indications at this point, we're not in a position to disclose the size of the.
Commercial partnership as we are.
And the confidentiality.
In negotiating with a potential partner.
Thank you.
Thank you Dr. Zhao for taking my question and thank you Andre for your question next we have Wayne will from Cantor.
Go ahead.
Okay.
Hi, This is a way on for Louise.
That's on all the progress and thanks for taking our questions. So our first question is could you share more details about the T. J <unk> and therefore, when the platform how does it compare to significantly by <unk>.
And then secondly was our cost saving initiatives what is their cash burn rate by 2022 and 'twenty three thank you.
Thank you.
While it may be the first question I will ask Andrew to address.
Sure that is all thank you Wang for their interest in question.
As we're all aware bi specific T cell engage our platform has attracted more attention lately, particularly with the approval.
The recent city three base buys from.
From Roche and also changing recently.
I think if you compare the advantage of the CD three based T cell in data versus fee from BB clearly.
The <unk> platform has the advantage.
In that.
T cell engagement.
Only related to the mature T cells. In addition.
Our platform has the added advantage of engaging T cell only upon the tumor and they didn't buy it for example in our clouding 18 point tool for on the molecule.
Is only a pom.
The binding of CD, Claudia 82 positive tumor cells.
We will allow the T cells to be active.
The tumor side.
So definitely this will allow for more favorable safety profile, we can spare the systemic toxicity that Saturday.
It has been reported in our in our <unk> III platform, including.
Cytokine release syndrome.
And also we do actually maintain the anti tumor activity. So we feel very strongly our platform strength the balance of actually improving the safety profile, but also maintaining the anti tumor activity.
In our trial definitely right now is progressing very smoothly.
We have.
Escalated dose up to a mid dose level without encountering DLP.
We hope in <unk>.
Our clinical experience will validate the utility of this platform.
And also more importantly, if we can really validate this platform with our ongoing phase. One trial is really opens the doors of targeting additional more relevant tumor specific antigens using the similar platform.
Thank you.
Thank you Andrew maybe four.
For the second question.
I would ask John to address John Thank.
So that's done well, let me give you a brief.
Answer to your question about the caisson.
<unk>.
The actual cash burn in the first half was around $85 million and we expect to reduce the cash burn in the second half with the implementation of our cost and expenses initially.
Initiatives just discussed.
The cash burn rate, we expect to.
<unk> mentioned that in the range of $150 million 260 million for 2022.
So next year essentially three.
We'll continue to execute on our priorities prioritization strategy and expense initiatives.
Including facility consolidation.
On the project prioritization and headcount review.
We target to further reduce operating cash burn.
To around one times media going forward.
Thank you Ed.
Yeah.
Thank you for that thoughtful question and thank you John and Andrew for the detailed responses in the interest of time, we'll ask one more question our LOE from Piper Albert. Please go ahead.
Hi, This is Alberta on for Joe Ken's Ror, Thanks for taking our questions today.
I had a question on the led the Mab cohort expansion.
Where are you when the enrollment stages and when will you provide future updates and maybe a follow up after that.
Yes. Thank you. Thank you.
Andrew.
Andrew could you could you address that question.
Sure available. Thank you very awkward for that question.
So indeed, our <unk> 73 antibody unilaterally map is continuing with the current phase II trial.
Since the initial report that we share with you 19 patients in the treatment naive non small cell lung cancer cohort.
Definitely we have demonstrated encouraging efficacy signal within or approaching 26%.
And also.
Interestingly, we have demonstrated the potential correlation of baseline 673 expression.
The overall response in the initial cohort.
Since then we have continue.
The efforts are trying to rapidly expand this cohort to gain additional confidence of the clinical efficacy, but also.
Giving given additional gauge the utility baseline CD 73 expression in terms of predicting the overall response.
Dr. Andrew Zhu: And also, we hope we can share with you in more details very soon.
So.
I think I'm very happy to share with you at this moment that we have definitely continue the enrollment of up to 47 patients.
We are targeting to finish the target enrollment of this cohort up to 60 patients by October .
So with adequate follow up we hope we can share that data with the rule by the end of this year or early next year.
But at this moment, even with the 47 patients at this stage.
I think I am very happy to share with you with a high level data.
The trend of the <unk> still holds and also.
Interestingly at.
The baseline expression of <unk> 73 continues to show the trend of correlating with the overall response rate.
So obviously, we'd like to see these data to be more mature.
Yes.
Okay, great. Thank you and I was also wondering if you would be sharing more details on the potential phase III design.
Dr. Andrew Zhu: And also, we are confident that we can actually maintain our initial target initiation of our Phase III, hopefully by the end of this year.
Yeah No Elmer.
Our goal is definitely trying to move forward based on the existing data. So that we can actually design the crisco critical registration trial.
It is a very clear we will target non small cell lung cancer is a tumor type and we will also targeting the advanced.
Non small cell lung cancer.
Yeah.
I think with regard to the specific phase III design as you know this is a very competitive space as well with multiple agents available. So we are taking.
A very close look at the adequate space that we can leverage with the phase III design currently we are in close.
A discussion with the Kols in China and also in the U S.
So we hope that we can share with you with the final phase III design relatively soon.
Note.
We are currently developing a diagnostic kit in collaboration with Wuxi diagnostics.
So that we can have a <unk> 73 expression diagnostic kit.
That hopefully will be implemented timely with our phase III trial apologies activation. Thank.
Thank you Albert.
Dr. Andrew Zhu: Thank you.
Thank you Albert for your question and thank you Andrew for our T cell response with that I'd like to conclude and our Biopharma financial results and business update conference call from six months ended June 32022.
Dr. Andrew Zhu: Thank you, Kelly, for your question.
Tyler: And thank you, Dr. Zhang and Andrew, for that detailed response.
You took Arkansas. Thank you to Dr. Julia and thank you to John for discussion today and thank you everyone for the questions and thank you for all our stakeholders for dialing and if there are any questions. Please contact your local IR representative.
Tyler: Next, we have Andres Maldonado from H.C. Wainwright.
Andres Maldonado: Andres, please go ahead.
Andres Maldonado: Great.
Andres Maldonado: Thank you very much.
Andres Maldonado: Thanks for taking my questions and congrats on the progress.
Andres Maldonado: So starting with CELF-Artemab, in your considerations on the use of a hybrid, commercialization model, is it safe to assume this will be for multiple myeloma only?
Andres Maldonado: Or what are your thoughts on how this extends to autoimmune diseases?
Andres Maldonado: And curious on what should be our expectations in terms of the field size in there?
Dr. Jingwu: Yeah, thank you.
Ed.
Dr. Jingwu: This is Jingwu.
Andres Maldonado: Thank you.
Dr. Jingwu: I can, you know, I can answer this question.
Andres Maldonado: And I was also wondering if you would be sharing more details on the potential phase three design?
Dr. Andrew Zhu: Thank you, Albert.
Okay.
Dr. Jingwu: We are in the active discussion with potential commercial partners for a commercial deal, for CELF-Artemab. This potential partnership does include autoimmune disease indications.
Andres Maldonado: Yeah, no, Albert, you know, our goal is definitely trying to move forward based on the existing, data so that we can actually design the critical registration trial.
Tyler: Thank you, Albert, for your question, and thank you, Andrew, for that detailed response.
Dr. Jingwu: This is pretty much based on Morphosis' recent data on autoimmune nephritis. So the data published by Morphosis are quite exciting, indicating that, treatments with CELF-Artemab does provide clinical benefit in that disease setting.
Dr. Andrew Zhu: That is very clear.
Tyler: With that, I'd like to conclude IMAB Biopharma's financial results and business update conference, call for the six months ended June 30, 2022.
Thank you.
Dr. Jingwu: So, you know, I think I'm very happy to share with you, at this moment, we have definitely, continued the enrollment up to 47 patients.
Dr. Andrew Zhu: We will target non-small cell lung cancer as a tumor type.
Thank you all.
Dr. Jingwu: We are targeting to finish the target enrollment of this cohort up to 60 patients by October. So with, you know, adequate follow-up, you know, we hope we can share the data with you, by the end of this year or early next year.
Dr. Andrew Zhu: And we will also target in the advanced non-small cell lung cancer.
Dr. Jingwu: But at this moment, even with the, you know, 47 patients at this stage, you know, I think, I'm very happy to share with you with a high-level data that the trend of the ORR still holds.
Dr. Andrew Zhu: I think with regard to the specific phase three design, as you know, this is a very, competitive space as well with multiple agents available.
Dr. Jingwu: And also, interestingly, that the baseline expression of CD73 continues to show the trend, of correlating with the overall response rate.
Dr. Andrew Zhu: So we are taking a very close look at the adequate space that we can leverage the phase, three design.
Dr. Jingwu: So obviously, we would like to see this data to be more mature.
Dr. Andrew Zhu: Currently, we are in close discussion with the KOL both in China and also in the U.S.
Dr. Jingwu: Okay, great.
Dr. Andrew Zhu: So we hope that we can share with you with the final phase three design relatively soon.
Dr. Andrew Zhu: But of note, we are currently developing a diagnostic kit, you know, in collaboration, with WuXi Diagnostics so that we can have a CD73 expression diagnostic kit that hopefully will be implemented timely with our phase three trial upon its activation.