Q1 2022 CASI Pharmaceuticals Inc Earnings Call

Good morning, everyone and welcome to the Kashi Pharmaceuticals, first quarter 2022 business update and financial results Conference call.

Good morning, everyone, and welcome to the CASI Pharmaceuticals first quarter 2022 business update and financial results conference call. All participants will be in a listen-only mode. Should you need assistance, please send to a conference specialist by pressing the star key followed by zero.

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After todays presentation, there will be an opportunity to ask questions.

After today's presentation, there will be an opportunity to ask questions. To join the question queue, you may press star and then one using a touch tone telephone. To withdraw your questions, you may press star and two. We've got the note today's event is...

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Please also note today's event is being recorded.

At this time I'd like to turn the floor over to raise day Vice President of Kathy Pharmaceuticals. Please go ahead.

At this time, I'd like to turn the floor over to Ray Zhang, Vice President of Cassi Pharmaceuticals. Please go ahead.

Thank you Jamie good morning, and welcome to Casey's Fourthquarter, 2022 conference call.

Thank you, Jamie. Good morning. Welcome to the fourth quarter 2022 conference.

Earlier today, Cassie issued a price release providing the details of the company's business updates and financial results. The culture ended March 21, 2022.

Earlier today <unk> issued a press release, providing the details of the company's business updates and financial results for the quarter ended March 31st 2022.

This price release is available in the investor relations section of the company's website.

Press release is available in the Investor Relations section of the company's website.

Today's call will be led by Dr. Charlie <unk>, our chairman and C O along with me certain dairy job our president Dr. Alex So keeping our exactly what vice President I'm, the Chief Medical Officer, and Dr. Jim <unk>, our chief business Development Officer.

Today's call will be led by Dr. Wei Wuhe, our Chairman and CEO , along with Mr. Larry Zhang, our President, Dr. Alex Zukirsky, our Executive Vice President and Chief Medical Officer, and Dr. Jim Goshenius, our Chief Business Development Officer.

He will also be available to answer questions. During the Q&A portion of this call.

They will also be available to answer questions during the Q&A portion of this call.

As a reminder, we will be making forward looking statements, including our business plans objectives and milestones.

As a reminder, we will be making forward-looking statements, including our business plans, objectives, and milestones.

Forward looking statements are not a guarantee of future performance and therefore, you should not put undue reliance upon them.

These forward-looking statements are not a guarantee of future performance. And therefore, you should not put on your...

These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those projected or implied in our forward looking statements.

These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those projected or implied in our forward-looking statements.

For description of the important factors that could cause actual results to differ, we refer you to the statement in our ICC FED.

A description of important factors that could cause actual result to differ.

We refer you to the statement of ICC filings.

It is now my pleasure to turn the call over to all the chairman and CEO .

It is now my pleasure to turn the call over to our chairman and CEO , Dr. Wei Wuhan.

Uh huh.

Thank you Ray good morning, everyone and thank you for joining us I won't began the call with an update on the business followed by our lead programs and near term catalyst.

Thank you, Ray. Good morning, everyone. And thank you for joining us.

I will begin the call with an update on the business followed by our lead programs and near term capitalists concluding with our...

<unk> with our financial highlights.

We have experienced significant challenges during the first quarter of 2022, mainly due to the reason COVID-19 Lockdown in China.

We have experienced significant challenges during the first quarter of 2022, mainly due to the recent COVID-19 lockdown in China, including Shanghai, where we generated...

Including Shanghai.

We we generate significant revenues the restrictive measures put in place secondary to the COVID-19 surge are extensive.

The restrictive measures put in place secondary to the COVID-19 surge are extensive and shift the hospital priorities away from the non-COVID related care and procedures.

Ship the hospital priorities away from that non COVID-19 related kiss and procedures.

Locked down in several cities continues as of today and May have a negative impact on the cells of our products for the second quarter and the whole year.

The lockdown in several cities continues as of today and may have a negative impact on the sales of our products for the second quarter and the whole year.

Restrictions also adversely impacted the enrolling patients for the C. N C. G 19 phase II studies.

The restrictions also adversely impacted the enrolling of patients for the CNCT 19.

Despite these challenges we continue to make progress across a number of our priorities.

Despite these challenges, we continue to make progress across a number of our priorities.

If a bowler increased by 58% compared to the Sam period last year.

Cells of Ivomela increased by 58% compared to the same period last year.

Our strategic focus in 2022 were continued to be.

Our strategic focus in 2022 will continue to be to advance the development and commercialization of the portfolio.

To advance the development and commercialization of the portfolio.

Through our partnership ventures, the CNCT 19 NDA submission to the NNPA is still on track with potential minor delay due to COVID-19 lockdown in cities where we are.

Through our patented benches.

<unk> did 219 NDA submission to the N N P. H is still on track.

With potential minor delay due to COVID-19 lockdown in cities.

We are we are conducting trials.

We anticipate the start of BI 1206 phase 1 trial in China.

We anticipate the start of <unk> 12, or six phase one trial in China.

We expect the C. D 5339 to receive clinical trial application approval from the N M. P. Eight during 2022.

We expect CD5339 to receive clinical trial application approval from the NMPA during 2022.

Meanwhile, our CID 103 phase 1 study continues.

Meanwhile, our C I D. One of those three.

One study continues.

We are excited by our momentum and will continue to execute on several key milestones across our broad portfolios in the quarters ahead.

We are excited by our momentum and will continue to execute on several key milestones across our broad portfolio in the quarters ahead.

Now let's move to Cassie's first commercialized product, Evo Molla...

Now, let's move to Kathy's first commercialized products Eva Mt.

We are pleased to report $9 million in breath in Eva Valla sells for the first quarter of 2022.

We are pleased to report $9 million in evamala sales for the first quarter of 2022.

Even though <unk> is approved in China for use as a high dose conditioning treatment.

EVAMALA is approved in China for use as a high-dose conditioning treatment prior to hematopoietic stem-style transplantation in patients with multiple mites.

Two human top Floyd stem cell transplantation.

In patients with multiple myeloma.

<unk> is a proprietary formulation with patent protection until at least 2030.

evamela is a proprietary formulation with pattern protection until at least 2030 is currently the only psychotextran-enabled formulation of injectable malpoline commercially available in China.

Currently the Ani side CRO tax Tran enabled formulation of injectable mouthful it commercially available in China.

Our experience our experienced specialty sales and marketing team in the hematology oncology market in China is a major competitive advantage.

our experienced specialty sales and marketing

in the hematology oncology market in China is a major competitive advantage.

We have established.

we have established access to a substantial number of key opinion leaders who can advise

Access to a substantial number of key opinion leaders, who can advise us on the unmet medical needs of our patient population.

on the unmathematical needs of our patient population.

Cassie continues to pursue a similar strategy with respect to marketing efforts and the physician visits to further adopt pacing of stem cell transplantation as a standard of care in the multiple myeloma treatment setting.

Cassie continues to pursue a similar strategy with respect to marketing efforts and the physician-based

to further the adaptation of stem cell transplantation as a standard of care in the multiple myeloma treatment.

And well continue working to address the persistent high unmet need in this patient population.

and will continue working to address the persistent high AMAT need in this patient population.

C N C. T 19, our CD 19 car T treatment.

BNCT-19, our CD19 CAR T treatment. I'll pop in that.

Our our partner debentures cell therapy continues the development of <unk> 19.

continues the development of CNCC-19, an apologous CD-19 Kachi investigative product for which Cassie has co-commercial and profit-sharing rights.

Apologize CD 19 car T investigative product for which Cathy has coal commercial and profit sharing rights.

D and C. T 19 is being developed as a potential treatment for patients with Hematological malignancies, which express CD 19, including B cell.

CNCT19 is being developed as a potential treatment for patients with hematological malignant disease.

which express CD19, including B-cell leukemia, B-A-L-L, and the B-cell non-hatching lymphoma.

Leukemia.

A L L a and b cell non hodgkin lymphoma.

In January C. N C. T 19 received orphan drug designation.

In January , CNCT-19 received orphan drug designation by the US FDA.

By the U S F D a.

C. N T 19 is being locally developed and will be locally manufactured.

CNCT-19 is being locally developed and will be locally manufactured.

Which distinguishes this program from other Hudson 19 therapies.

which distinguishes this program from other COVID-19 therapy.

And manufactured in part outside of China.

developed and manufactured in part outside of China. The pricing of cell therapy and other innovative drugs in China is a crucial issue for patients.

The pricing of cell therapy, and other no the innovative drugs in China is a crucial issue for patients.

Similar CD 19 car T developed and manufactured utilize the imported components are subject to certain ex China, CMC and high cost of goods, making the price point significantly higher than where we believe the price of C. N C. T 19 wealthy.

Similar CD19 cards developed and manufactured utilizing imported components are subject to certain ex-China CMC and high cost of goods.

making the price point significantly higher than where we believe the price of CNCT19 will.

<unk> has completed the phase one studies in P. A L L a and b.

Juventus has completed the phase one studies in BALL and B-cell nanohatchkin lymphoma in China, and is currently enrolling the phase two registration studies for both indications.

B cell non Hodgkin lymphoma in China and.

Currently enrolling the phase III registration studies for both indications.

Throughout 2021, our commercial franchise has sorrowing appear for the anticipated.

Throughout 2021, our commercial franchise has thoroughly prepared for the anticipated China NDA firing of CNCT-19 CAR-T program, which we currently expect to be in the second half of 2022.

China NDA firing of C. N C T 19 car T program.

Which we currently expect to be in the second half of 2022.

Next I will address other product candidates in our pipeline.

Next, I will address other product candidates in our pipeline.

Yeah, 12 O six.

Along with our partner in that we continue to progress the development and regulatory framework for P. I 12 O six in China.

Along with our partner BioInvent, we continue to progress the development and regulatory framework for BI 1206 in China.

We in licensed the <unk> 12, or six our first in class fully human monoclonal antibody that target FC gamma ought to be receptive.

We in license BI 1206, a first in class fully human monochrome antibody that target FC gamma R2B receptor for the grade.

For the great Greater China market.

Yeah, I 12 O six has a novel motto mode of action blocking the symbol inhibitory antibody checkpoint receptor FC gamma.

BI-1206 has a novel model mode of action, blocking the single inhibitory antibody checkpoint receptor, FC gamma, R2B.

Ought to be.

To unlock anti cancer immunity in both liquid and solid tumors.

to unlock anti-cancer immunity in both liquid and solid tumor.

FC Gamma receptors.

If the gamma receptors are antibody checkpoints that modulate the efficacy of tumor cell direct targeting and the possibility of?

Antibody checkpoints that modulate the efficacy of tumor cell direct targeting antibodies and immune checkpoint targeting antibodies you used in cancer immunotherapy.

and a new checkpoint targeting antibodies used in cancer immunotherapy.

Yeah. Its volvos six can potentially be used with or therapeutic monoclonal antibodies that rely on a D. C C and C D C for efficacy.

BI-12-06 can potentially be used with all therapeutic monoclonal antibodies that rely on ADCC and CDC for efficacy.

D. I 12 O. Six is currently being investigated outside of China in two phase one two trials one is evaluating the $12 six combination with road map for the treatment of non Hodgkin lymphoma.

DI-1206 is currently being investigated outside of China in 2 Phase 1-12.

One is evaluating the BI-1206 combination with ROTUXIMAB for the treatment of non-Hodgkin lymphoma, which includes patients with follicular lymphoma, mental cell lymphoma, and marginal zone lymphoma who have relapsed or are refractory to ROTUXIMAB.

Which includes patients with Follicular lymphoma.

Mantle cell lymphoma, and marginal zone lymphoma.

Who have relapsed or refractory to rituxan.

Our second phase one two trial is investigating <unk> 12, or six in combination with anti PD one therapy keytruda.

A second phase 1-2 trial is investigating BI-1206 in combination with anti-PD1 therapy, CUTUDA, in solid tumor.

In solid tumors.

And then P. A granted by 12 O six Cta approval in December 2021.

The NNPA granted BI-1206 CTA approval in December 2021.

Early this year the U S FDA granted orphan drug designation or by $12 six for the treatment of Follicular lymphoma. The.

Early this year, the USFDA granted orphan drug designation for BI-1206 for the treatment of follicular lymphoma.

the most common form of slow growing non-Hodgkin lymphoma.

The most common form of slow growing now.

Skin lymphoma.

Together was buy in that we plan to continue to develop the <unk> 12 O six in both Hematological malignancies, and solid tumors with Cassie responsible for development and commercialization in greater China.

Together with BiInvent, we plan to continue to develop the I-1206 in both hematological malignancies and solid-tube.

with Cassie responsible for development and commercialization in Greater China.

our lead indication will be will be 1206 in combination with ROTUXINMAC.

Our lead indication will be.

They'll be 12 of $12 six income by Nathan with Rituximab.

In patients with with relapsed and refractory in NHL.

impatience with relapse and the reflectories in NHL.

We anticipate the startup Dr. Paul Bostick space, One chart in China in the second quarter of 2022.

We anticipate the start of BI-1206 phase one trial in China in the second quarter of 2022.

with the first patient in Q4 2022.

With the first patient in in Q4 of 2022.

Now what about C D Fibs iii's reading dialing.

Now award about CD 533 now.

In 2021, we acquired C. DS Five's reached three nine a first in class D. C. P. P 97 inhibitor Franck cleaves therapeutics for the greater China market.

In 2021, we acquired a CP5339, a first-in-class VCP-P97 inhibitor from cleave therapeutics for the greater China market.

<unk> 5339 represents a promising new agent for selectively targeted V. C. P. P 97 in cancer.

CB5339 represents a promising new agent for selectively targeting VCP-P97 in Kansas.

And it is a complementary addition to our pipeline of hematology, oncology.

And it is a component Tory addition to our pipeline of hematology oncology assets.

Cleave is responsible for the ex-China development of CB5339, an oral second generation small molecule, VCPP97 inhibitor, and is evaluating the molecule in phase one clinical trial in patients with acute myeloid leukemia and MDA.

<unk> is responsible for the ex China development of C. B 5339, and the oral second generation small molecule V. C. P. P ninety-seventh inhibitor.

And as in evaluating the molecule in phase one clinical trial in patients with acute myeloid myeloid leukemia and and M. D S.

Together with Cleeve, where.

Together with CLEVE, we plan to develop CD5339 in AML as the initial indication with Kathy responsible for development and commercialization in Great China.

We plan to develop C D.

5339 in AML as the initial indications.

With Kathy responsible for development and commercialization in great China.

C D 5339, Cta application for the multiple myeloma mild myeloma indication is in preparation after receiving an acceptance letter for the CB 5339 R&D package.

CB5339 CTA application for the multiple myeloma indication is in preparation after receiving an acceptance letter for the CB5339 IND package.

from the China Center for Drug Evaluation.

The China Center for drug drug.

Evaluation.

We look forward to the joint development of CB Fives reached three nine with our focus on helping to accelerate the development program by initiating tries for current and potential new indications in China.

We look forward to the joint development of CB5339 with our focus on helping to accelerate the development program by initiating tries for current and potential new indications in China.

The I D Wild Street, our anti CD 38 program.

CID-103, our anti-city 38 program.

See I D y L. Three is a fully human I G. One anti CD 38 monoclonal antibody.

CID-103 is a fully human IG-1 anti-CD38 monoclonal antibody, recognizing a unique epitome that has demonstrated encouraging preclinical efficacy and safety profile compared to other anti-CD38 monoclonal antibodies.

Recognizing our unique epitope that has demonstrated encouraging preclinical efficacy.

And safety profile compared to other anti CD 38 monoclonal antibodies.

Kathy men tense exclusive grow global rights and is developing the idea one was three for the treatment of patients with multiple myeloma.

Cassie Mankin's exclusive growth global rights and is developing CID 103 for the treatment of patients with multiple myeloma.

In June of 2021.

In June of 2021, we enrolled the first patient in our phase one dose escalation and expansion study of CID-103. The phase one study in patients with previous treated relapsed or refractory multiple myeloma is currently ongoing in France and in UK.

We enrolled the first patient in our phase one dose escalation and expansion study of <unk> one O suites.

The phase one study in patients with previous treated relapsed or refractory multiple myeloma is currently ongoing in France and in U K. This.

This phase one trial is expected to generate valuable information and has the potential to provide early evidence of clinical activity in the treatment of patients with multiple myeloma.

This phase one trial is expected to generate valuable information and it has the potential to provide early evidence of clinical activity in the treatment of patients with multiple myeloma.

So a key part lastly, onsite T. PA, we are in process of regulatory submissions for two indications.

Lastly, we are in process of regulatory submissions for two indications.

Now this completes the update of our key pipeline as

Now this completes the update of our key pipeline assets.

Next we are going to provide updates on our financials.

Next, we are going to provide updates on our financial

And Ray is actually going to Gabe.

And Ray is actually going to give everybody the financial highlights Ray.

Everybody the financial highlights.

<unk>.

Thank you Doctor, we saw continued growth and strong performance across our business today I will briefly summarize our financial results and provide key highlights for the fourth quarter.

Thank you, Dr. He. We saw continued growth and strong performance across our business. Today, I will briefly summarize our financial results and provide key highlights for the first quarter.

Revenue was consist of product sales of Eva MELA.

Revenues consist of product sales of EvoMela. Revenue was 9 million for the quarter ended March 31, 2022. 58% of the increase compared to 5.7 million for the quarter ended March 31, 2021.

Revenue was 9 million for the quarter ended March 31st 2022, 58% of the increase compared to $5 7 million for the culture ended in March 31st 2021.

Cost of revenue.

Cost of revenue was $3.8 million for quarter-ended, March 31, 2022, compared to $2.4 million for the same period last year.

Three 8 million for quarter ended March 31st 2022, comparing to two plenty 4 million for the same period last year.

Which includes rocky payment of 1.8 million in first quarter of 2022, and one 1 million for the same period.

which includes a royalty payment of 1.8 million in fourth quarter 2022 and 1.1 million for the same period in 2021.

2021.

We closed this quarter with $29 3 million cash and cash equivalent.

We close this quarter with 29.3 million cash and cash equivalent. We have sufficient resources to fund our operations beyond 2020.

Sufficient resources to fund our operations beyond 2022.

By implementing management and budgetary control, we continue to be thoughtful.

by implementing management and budgetary control. We continue to be solidified.

How we deploy our cash with a focus on creating shareholder value.

on how we deploy our cash with a focus on creating shareholders.

Next I would like to address two items, which uncertain our investments radar.

Next, I would like to address two items which I'm certain are our investment readers.

Already this year, Kathy announced the receivable often he thinks its a lighter from the listing qualifications department of the NASDAQ stock market.

Early this year, Casey announced the receiver of the Defensives and Lighters from the Listing Qualifications Department of the NASBAC stock market.

We continue to actively monitor the closing price of cases common stock.

We continue to actively monitor the closing price of Kansas common stock and are considering available options, including a reverse stock split.

Considering available options, including a reverse stock split.

In Cassie's recent proxy statement, Cassie has submitted a reverse structurally proposal to shareholders for approval.

And kind of his recent proxy statement chassis has submitted a reverse stock split proposal to shareholders for approval.

Next I would like to address the recent events related to the holding foreign companies accountable Act, which refers to H I C E O.

Next, I would like to address the recent event related to the Holding Foreign Companies Accountable Act, which refers to HSCAA.

According to the H I T E. After being conclusively identified at the commission identify the insurer for three consecutive years, there will be a initial treating prohibition well.

According to the HIV CIA, after being conclusively identified as a commission identified the issuer for three consecutive years, there will be an initial treating prohibition.

while working with the auditor to address a method to comply with the public company accompanying oversight of all the rules.

Well looking at this with the auditor to address a method to combine that as a public company accounting oversight the Baltic Ruche and.

In the meantime, we will actually notes that China Securities Regulatory Commission is holding talks with you asked directly tourists Oh audit cooperation and there is expectation that an acceptable resolution regarding this matter will be reached between the two respective government entities.

In the meantime, we would like to note that China's Securities Regulatory Commission is holding talks with US regulators over audit cooperation. And there is expectation that an acceptable resolution regarding this matter will be reached between the two respective governments and the two sides.

We're continuing to monitor developments and evaluate all strategic options, which include but are not limited to adding business processes and controls to meet that requirement over the H M D. A.

We continue to monitor developments and evaluate all strategic options, which include, but are not limited to adding business processes and controls to meet the requirement of the HFCAA.

Now I would like to turn the call back over to the operator to open up the line for questions.

Now I would like to turn the call back over to the operator to open up the line for questions. Jimmy.

Jimmy.

Ladies and gentlemen at this time, we'll begin the question and answer session to ask a question you May Press Star then one using a touchtone telephone if you are using a speaker phone. We do ask you. Please pickup your handset prior suppressing the keys to ensure the best sound quality.

Ladies and gentlemen, at this time, we'll begin the question and answer session. To ask a question, you may press star and then one using a touchtone telephone. If you are using a speakerphone, we do ask you please pick up your handstep prior to pressing the keys to ensure the best sound quality. To withdraw your questions,

To withdraw your questions you May press star two.

Once again that is star then one to join the question queue. At this time, we will pause momentarily to assemble the roster.

Once again, that is star and then one to join the question queue. At this time, we will pause momentarily to assemble the roster.

And our first question today comes from Justin <unk> from <unk>. Please go ahead with your question.

And our first question today comes from Justin Dilling from BTIG. Please go ahead with your question.

Hi, good morning, and congrats on the quarter I was just curious on C. N. C. G 19, if you have an idea from your partner event. This whether they'd be on track for filing the NDA potentially within the next 12 months or if you think that potentially the cove.

I way we good morning and congrats from the quarter. Um, I was just curious on the NCT 19 if you have an idea from your partner Juventus, whether they'd be on track for filing the NDA, uh, potentially within the next 12 months, or if you think that potentially the COVID-19 pandemic may disrupt, um, the filing or delay it.

19, pandemic may disrupt the filing or delay it.

Yeah.

Yeah, yeah, thank you, Justin. So I, you know, sorry, I was interrupted a little bit. So your question is really the regarding the COVID-19 impact on the, on the delay. I don't know. Alex, do you want to address that question?

Yeah.

Justin So I Oh, sorry.

Sorry, I was interrupted a little bit. So your question is really regarding the COVID-19 impact on the on the delay.

No.

Artist do you want to address that question.

All right.

Sure sure Justin Justin This is Alex.

As we anticipated, there might be some slight delay, but we are reasonably confident that within the next 12 months, our partner Juventus will be able to complete the filing.

As.

We anticipated there might be some slight delay, but we are reasonably confident that within the next 12 months our partner to Ventas will be able to complete the filing.

unless there is substantial additional disruption secondary to COVID-19 impact in China.

Unless there is substantial additional disruption secondary to COVID-19 impact in China. If there is further disruption and any delay that we can foresee we'll obviously inform the investors through the appropriate channels.

If there is further disruption and any delay that we can proceed, we'll obviously inform the investors through the appropriate channels.

Yeah.

Great that's very helpful and and obviously ever MELA has continues to be very strong in the revenues.

Great. That's very helpful. And obviously, Avomela has continues to be very strong in the revenues, was just curious on how you're seeing, you know, in real time, how the COVID situation may impact the sales of Avomela in the future, whether you're seeing, you expect to see any disruption there.

I was just curious on how you are seeing.

So in real time, how the Covid situation may impact.

The sales of Eva MELA and in the future, whether you're seeing you expect to see any disruption there.

Yeah, Pablo Larry can address to you. This question since he's in charge of our commercial or Larry.

Yeah, Pavel, Larry can address you this question since he's in charge of a commercial. Larry, do you want to address?

Do you want to.

Address.

Absolutely. Thank you don't pay them for the class shape, you can see in our first quarter revenue came in strong compared to the same period.

Absolutely. Thank you Justin for the question. You can see in our first and the quarter and the revenue is keeping strong compared to the same period of last year and we believe the entire year and our sales and we will keep in the relatively growth. However, as in our chemie and the CEO Dr her mentioned that.

And a year and we believe the entire year in our sales and then we will keep a relatively.

However, as our chairman and CEO, Dr. Herb mentioned that the COVID-19 impact is there, especially in a locked down in Shanghai and some of the big cities.

COVID-19 impact is there, especially in the lockdown in Shanghai and some other big cities.

and we will pay close attention to the impact, what the impact would be. We still don't know for how long and the pandemic will continue, especially for the lockdown in the big cities.

And we will pay close attention and two the impact what the impact would be.

We still don't know enough all how long and at the pandemic because it's a well continue especially for the lockdown in the Big City.

And hopefully we'll go over quickly, but we still don't know.

Hopefully it won't go over quickly.

I still don't know so we will see.

All the best and to Canada, the business and are on track and we are so it's not normal.

all the best and to get to the business and on track and we assume as normal as we can. Thank you.

Thank you.

Great.

great okay there's still a lot of uncertainty on the big city because most transplant happens in big city but unfortunately right now the major lockdown is in the big city

Okay.

Yeah.

A lot of uncertainty on the big cities, because most transplant happens in big cities.

Unfortunately, right now the major locked out is in the big cities.

So there's still a lot of uncertainty that that really is not under our control ourselves people are not even allowed to visit patients, you know, visit the doctors right now.

So theres still a lot of uncertainty that that really is not under our control ourselves people are not even allowed to visit patients visit their doctors right now.

In Beijing, and Shanghai, So it'd be two pretty big revenue center for us.

in Beijing and Shanghai so the you know two pretty big you know revenue center for.

Got it well hopefully this situation.

Got it. Well, hopefully the situation improves in the future, and thanks so much for taking the questions.

In the future and thanks, so much for taking my questions.

Thank you.

And our next question comes from Sean Lee from H C. Wainwright. Please go ahead with your question.

And our next question comes from Sean Lee from HDWainwright. Please go ahead with your question.

Good morning, guys and thanks, Thanks for taking my question and on highway.

Good morning, guys, and thanks for taking my question. Hi, Wei Wu. Just a quick question on the.

Just a quick question on the.

C I T. One O three study so with the first patient in last year and almost a year into study just wondering when can we expect to see some of the first results from them.

So with the first patient in last year and almost a year into study, I'm just wondering when can we expect to see some of the first results from it?

So Sean this is Alex we are current.

So, Sean, this is Alec. We are currently at a relatively high level in dose escalation. We believe that within the next...

We're currently at a relatively high level in the dose escalation, we believe that within the next.

In the next one to two dose escalations, we will potentially hit the recommended phase two dose.

One all doses in the next one to two dose Escalations, we will potentially hit the recommended phase two dose that data will be determined on the safety profile and the PK profile.

that data will be determined on the safety profile and the PK profile.

As soon as there is data available to be put into the public domain, we will seek the most appropriate medical scientific meeting to either have a presentation or poster put out to make sure that we get the information out to the public. We'll keep you informed of the status of any presentation that will occur in the future.

As soon as there is data available to be put into the public domain, we will see the most appropriate medical scientific meeting.

To either have a presentation our poster.

Put out to make sure that we.

We get the information out to the public we will keep you informed.

The status of any presentation that will occur in the future.

Thanks. And beyond that, is there any other clinical milestones that we can expect over the next 12 months?

Thanks and beyond that.

Any other clinical milestones that we can expect over the next 12 months.

Oh wait.

We will do you want me to address that.

Yes.

Okay sure.

Okay, so the milestones would be the initiation of the BI1206

The milestones would be the initiation of the B 12.

12 O six.

study. As Wei Wu has outlined, we have gotten approval from the NMPA to start. We are actively looking forward to receiving study drug in China and we anticipate getting the study started in the second quarter with the first patient enrolled in Q3.

<unk>.

As Weibo has outlined we have gotten approval.

From the N M P a to start.

We are actively looking forward to receiving study drug in China, and we anticipate getting the study started in the second quarter with the first patient enrolled in Q3 so.

targeting a July first patient in, however, depending upon

Targeting of July 1st patient 10, however, it depending upon the COVID-19 impact that could be delayed slightly or the b or the C or the clean vials 5339 program.

COVID-19 impact, that could be delayed slightly. For the CLEVE VILE 5339 program, we have submitted the regulatory applications. We are working with our partner, and we hope to get that program started as soon as possible. Some things are out of our control, such as the timeline for the regulatory review. So we'll have at least

We have submitted the regulatory applications, we are working with our partner.

We hope to get that program started as soon as possible.

Some things are out of our control such as the timeline.

For the regulatory review so we will have at least two programs that will be getting started.

two programs that will be getting started in the second and hopefully third and fourth quarter. For Thyotipa, we are in the midst of discussions on the regulatory submission and the path forward with the CDE, and we hope to have some more information ready for the analysts and investors in the next quarter or so.

In the second and hopefully third and fourth quarter.

<unk>, we are in the midst of discussions on the regulatory submission in the air and the.

Path forward with the C D E and we hope to have some more information ready for.

The analysts and investors.

Next quarter or so.

Thanks for the clarity.

That's all I have.

Thank you Sean.

And our next question comes from Trevor I'll read from Oppenheimer. Please go ahead with your question.

And our next question comes from Trevor Alred from Oppenheimer. Please go ahead with your question.

Hey, good morning, Thanks for taking my question.

Hey, good morning. Thanks for taking my question. So I guess it's just two quick ones for me. Can you remind us where the enrollment sites are for CID 103 and CNCT 19 and do you expect to see a follow up impact from COVID? And then also, do you expect to enroll sites for BI 1206 in areas which might have lower COVID impact?

So I guess just two quick ones for me can you remind us where the enrollment sites. Our hersey idea one of three inches Tnt's C. N C T 19 and if.

Do you expect to see a follow up impact from.

From Covid and then also do you expect to enroll sites or B I E 12, six in areas with Mike, which might have lower COVID-19 impact. Thanks.

So for the CRT D. One O three.

So for the CID 103, the sites are located in France and in the UK, and we are looking at expanding the sites because we're looking for specific patient populations into the other Eastern European countries.

The sites are located in France, and in the U K and we are looking at expanding the sites because of we're looking for specific patient populations into the other eastern European countries.

In terms of the <unk> six.

in terms of the BI 12.6.

Yeah.

It is difficult to predict at this point in time.

is difficult to predict at this point in time, you know, where the

Where the.

The COVID-19 pandemic.

COVID-19 pandemic will impact next, but we have chosen and selected what I think are some of the best centers to execute the 1206 plus Rituximab program in China. In terms of the Juventus CNCT19, likewise they have placed their study.

It will impact next but we have chosen and selected what I think are some of the best centers to execute the <unk> 12, or six plus Rituximab program.

In China in terms of.

Did you Ventas C N C T nine cool lie.

Likewise, they have placed their study.

So based.

based therapy study in some of the most, I think, prestigious institutions in China. And that is ongoing. So indeed, there is some slight impact, but we're getting very close to completing the accrual and the long-term follow-up, which the CDE has requested for this patient population.

If he study in some of the most and I think prestigious institutions.

In China and that is ongoing so indeed, there is some slight impact, but we're getting very close to completing the accrual and the long term follow up which is C. D E has requested.

For this patient population so hopefully.

So hopefully, there won't be any further delay. If there is, it'll be slight on the CNCT-19 side. But I'm optimistic that we'll be able to meet the submission deadline, as outlined by Dr. Key earlier.

There won't be any further delay.

If there is it'll be slight on the CN since the 19th.

But I'm optimistic that we will be able to meet the submission deadlines as outlined by Doctor who earlier.

Okay, great. Thanks very much.

And ladies and gentlemen, with that we will be ending today's question and answer session I'd like to turn the floor back over to the management team for any closing remarks.

And ladies and gentlemen, with that, we will be ending today's question and answer session. I'd like to turn the floor back over to the management team for any closing remarks.

Well. Thank you again for joining today's call.

But thank you again for joining today's call. There's no doubt in my mind that we are on

There's no doubt in my mind that we are on.

Our course and building a fundamentally strong biopharmaceutical company, we look forward to leveraging our existing commercial infrastructure.

our course in building a fundamentally strong biopharmaceutical

We look forward to leveraging our existing commercial infrastructure.

Pursue pre commercial launch activities for this COVID-19 program drive expanded pipeline progress and continue to observe sturdy Evo Malibu us with.

pursue pre-commercial launch activities for this CAR T-19 program, drive expanded pipeline progress and continue to observe sturdy environmental growth.

We thank each of you for your continued support in CASI during this exciting period. Thank you.

We thank each of you for your continued support and Cassie during this exciting period.

Thank you.

Brighter.

You May now conclude this call.

Ladies and gentlemen, with that we'll end today's presentation. We do thank you for joining.

Ladies and gentlemen, with that, we'll end today's presentation. We do thank you for joining. You may now disconnect your line.

May now disconnect your lines.