Half Year 2023 I-Mab Earnings Call
I will provide you with a high level update on our performance in the first half of 2023 and importantly <unk>.
Frame, our strategic direction and plan.
I will ask John Hayslip, our Chief Medical Officer to provide you with an update on the two prioritize clinical assets in oncology that we plan to rapidly advance in the U S and globally and.
And finally review the recently released positive phase III results from our lead program in China.
Richard <unk>, our interim Chief Financial Officer will review the financial results for the first six months of 2023, and then hand it back to me for closing remarks.
The first eight months of 2023 have been productive for imap.
We made significant progress on our innovative assets, including only the law map, our differentiated CD 73 antibody.
<unk>, our novel, Claude and the $18 two and four one BD bi specific antibody.
And F 10, Somatotropin Alpha our long acting human growth hormone that reported out positive phase III results today.
As we look to building out the future for IMF App, we plan to focus on three strategic pillars.
First <unk>.
Rapid advance our two promising clinical assets globally within oncology.
To maintain our strong balance sheet.
And three focus on establishing a new operating model to become a U S based global biotech company.
Taking them one at a time.
One we plan to advance <unk>, our novel, <unk>, 73, antibody and <unk>, our differentiated cloud and $18 two and four one BB by specific antibody in the U S and globally.
We believe that both <unk> and <unk> each have interesting biology, encouraging early clinical data and differentiated characteristics that enable them to sustain or from other drugs in development.
We believe that early lead Lamar could be a critical value driver for imap and.
If approved could be a unique and differentiated immuno oncology agent.
Which has the potential to be the preferred adjunct to immunotherapies across a wide range of tumors.
Our goal is to submit an IND in the first half of 2024 for <unk> in combination with chemotherapy and checkpoint inhibitors in newly diagnosed patients with advanced non small cell lung cancer.
John will further provide details on the data that we presented at <unk> and why these results give us the confidence that <unk> can be a differentiator entrant.
And a significant value driver for imap.
We believe that <unk> has the potential to be a differentiated agent in gastric cancer.
This unique bi specific antibody was designed to target clouding, 18th two positive tumors.
And stimulate protein immune for one BB signaling.
<unk> was designed to selectively target <unk> expressing cells in the tumor microenvironment.
Potentially reducing the risk of systemic toxicity.
What an $18 to targeted therapies could represent an important new treatment option, especially for patients with gastric cancers, including tumors of the gastro esophageal Junction R. G E J.
Soft AGL cancer.
With encouraging signs of monotherapy efficacy, including in tumors with lower levels of cloud and $18 two expression.
We believe that <unk> has the characteristics.
Would potentially position the program as a leading candidate and these tumors, where there remains a significant unmet medical need.
Our goal is to initiate a phase <unk> dose escalation study in the U S, Japan and China in combination with standard chemotherapy and immunotherapy regimens for patients with treatment naive gastric J J and esophageal cancer in the first half of 2024.
John will review our early results and explain why we believe our program could potentially be a valuable treatment option for patients.
Lastly, we're pleased to report hot off the press positive phase III data from <unk> Somatotropin Alpha our long acting human growth hormone candidate being developed for the market in China.
This represents a significant milestone for the company as it is the first completed phase III data that we have reported.
The new <unk> Alpha data met the primary endpoint and achieved non inferiority compared to Novo Nordisk Nordic token.
These results and the compounds weekly delivery formulation should position F 10, somatotropin alpha to be a key player in the human growth hormone market in China.
Which is a market currently dominated by once daily Injectables.
This multibillion dollar market in China is expected to grow over the next five to eight years with long acting growth hormones estimated to significantly build market share.
As you May know, we have an agreement in place with <unk> to commercialize <unk> Alpha in China.
We have two other clinical assets, specifically being developed for the China market.
Saar to map, our CD 38 antibody and.
And Lemzo part of map, our CD 47 antibody.
We expect to commercialize these assets through partners and John will review the clinical results to date and provide an overview of next steps with these programs being developed for the China market.
Now moving on to our second strategic pillar.
Continued to maintain a strong balance sheet.
$414 million cash balance adequately supports the execution of the company's strategic plan.
We've begun streamlining our spend for the second half of this year to support our.
Key global assets and oncology.
And rationalizing our spend in other areas.
In addition, we will continue monetizing non global core assets and make the difficult choices where needed in our pipeline to ear from our cash for the most promising programs, including exploring external opportunities.
And now the third strategic pillar.
We're focused on establishing a new operating model as a U S based global biotech company.
As this will position us to unlock the inherent value in our single largest pharmaceutical market in the world.
And the area in particular, where our stakeholders expect to derive the most value from our innovative assets.
We embarked on this change by building on our company's strong foundation from a core set of differentiated oncology assets.
A strong balance sheet.
And a skilled R&D organization in China.
As I just noted.
We also remain open to bringing in new assets that we view as value driving to complement our existing pipeline.
We recognize that to make this company into a truly U S based global biotech it'll involve significant changes ranging from governance stock market listing culture to talent management.
It is important to emphasize.
So that the full IMI board and I are in full alignment with regard to the future direction of the company.
I look forward to providing you with those updates on our progress on this strategic pillar in early 2024.
Now before I hand, the call over to John I would like to recognize the leadership of Dr. Andrew Xu during his time as interim CEO .
Also I am grateful for the dedication and hard work shown by the entire imap team.
With that overview.
I'd like to hand, it over to John to provide clinical details.
On our key global assets and the novel program has been developed specifically for the China market.
John .
Thank you Raj and good day to everyone on the call. My name is John Henry spoke and I'm pleased to provide you with a clinical overview.
First I'd like to provide updates about Hulu.
Our series 73 targeting antibody designed to block a key pathway that tumor cells may use to evade immune system adenosine production.
As previously reported <unk> is differentiated by design to avoid hook affect biology, which is a potential liability of other competitive drugs in development.
Simply put the hook effect may prevent other drugs from achieving complete inhibition of enzyme function.
<unk> is designed to allow up to 100% inhibition due to its unique functionality.
At the American Society of clinical oncology meeting in June of this year, we shared encouraging clinical and translational findings from a phase one b two study, indicating patients with advanced non small cell lung cancer, receiving truly lessen the mab and PD one inhibitor towards power map.
<unk> was well tolerated using an every three week dosing regimen in combination with tour polymer.
Most treatment related adverse events were grade one or two in severity.
And the 67 efficacy evaluable patients the objective response rate or <unk> was 31%, regardless of CD 73, or PD lone expression.
Notably patients, whose tumors have high levels of <unk> 73 expression experienced a higher response rate than those with lower CD 73 expression. The response rate increased to 63% in patients who had both high levels of <unk> 73 expression and a PD lone tumor proportional score.
Or TPS of greater or equal to 1%, whereas patients with low <unk> 73 expression had an O R 22%.
We are excited by these preliminary findings of a correlation between higher CD 73 expression and an increased response rate.
With this chemotherapy free really level of avid checkpoint inhibitor combination.
Data from other studies have suggested that chemotherapy may increase CD 73 expression in cancer cells, and we are eager to begin combination studies of <unk> with chemotherapy in the near future.
Additionally, at the time of the data cutoff with a median follow up of 10 four months 18 of the 21 patients whose tumors had achieved an objective response remained on treatment and the median duration of response was not yet reached.
Progression free survival and overall survival data will be analyzed when the data are fully mature.
Additionally, we continue to enroll patients with previously treated ovarian cancer to the combination regimen of <unk> inventory Palomar and expect to report preliminary results in 2024 for this phase II cohort of patients.
Building upon these encouraging clinical findings and other non clinical investigation, we plan to file a new IND with the FDA.
To expand the map program and combine with chemotherapy and checkpoint inhibitors for patients with newly diagnosed advanced non small cell lung cancer.
Owing to the potential effects of chemotherapy to up regulate <unk> 73 in tumors. We hope this combination may benefit an even broader group of patients potentially regardless of pretreatment TV 73 expression.
I'd like to emphasize this important point, we plan to evaluate uli, let the mab with chemotherapy and checkpoint inhibitors in patients regardless of the CB 73 expression before initiating treatment.
Non small cell lung cancer is one of the most common and deadly cancer diagnoses globally, and we believe that <unk> has the potential to improve upon currently available care.
We plan to discuss further details regarding the planned studies in the first half of 2024. After we have had initial discussions and alignment with regulatory agencies.
Next I'd like to provide an update on <unk> or Claude and $18. Two by four one BB by specific antibody a program that has made significant clinical progress as.
As you May know other groups have attempted to develop <unk> engaging drugs in the past because <unk> has a strong stimulus to the immune system.
Unfortunately earlier attempts to develop <unk> drugs cause severe toxicity, because the widespread effects of for long BB stimulation cannot be tolerated by patients.
Therefore, we developed a unique approach of this bi specific antibody and that is first binds to tumor cells expressing in the cloud and $18 two protein and then the <unk> can stimulate immune cells and the immediate environment of the tumor more specifically <unk> was designed to do two important things.
First to become conditionally active only upon consumer engagement, while remaining silent elsewhere to avoid or minimize liver toxicity and systemic immuno toxicity, commonly seen with 41 BB antibodies as a drug class and second to effectively maintained strong similar binding and anti tumor activity.
Attributable to a synergistic effect of the bi specific cloud and $18 two antibody and <unk> antibodies.
We believe <unk> has achieved our design goals for this molecule based on early clinical data.
This July the journal immune immunotherapy of cancer or <unk> published a paper detailing the significant potential of <unk> and tribute in gastric cancer and its unique molecular design and properties.
Looking forward I am happy to report that the first clinical abstract for <unk> has been accepted for presentation at the European Society of medical oncology or ESMO in October of this year.
While the specifics of the study results are embargoed until the meeting I'm happy to report that in the dose escalation phase one study objective.
Our responses have been observed with single agent Juba Stelmach amongst patients who have received multiple previous treatments for their cancer, including chemotherapy and checkpoint inhibitors.
A dose expansion cohort in this phase one study continues to enroll patients with previously treated cohort and $18 two positive gastric or gastroesophageal junction or GE Jay.
<unk> is our collegial cancer with <unk> monotherapy and interim results for these patients are anticipated in the first half of 2024.
Additionally, based upon these encouraging observations and recent non clinical studies, indicating a positive benefit for the combination we plan to launch new investigations of the combination of <unk> with standard chemotherapy and immunotherapy regimens for patients with treatment naive gas.
<unk> J J and esophageal cancer.
We anticipate enrollment to be again by the first half of 2024 and plan to provide further details once we finalize the trial design.
Speaking of our clinical bio specific programs T. J L. 104, B was designed to treat PD, one or PDL, one antibody resistant tumors like <unk> antibody acts by inducing conditional activation of <unk> when it binds to its target in this case PD.
One it.
The phase one dose escalation study is underway in patients with progressive locally advanced or metastatic solid tumors that have relapsed or are refractory falling prior lines of treatment.
A preliminary efficacy signal has been observed.
And a maximal tolerated dose has not yet been reached.
The dose expansion portion of the phase one study is underway in the U S and South Korea the.
The program is being developed in collaboration with ABL bio.
Today, we reported the first positive phase III results from an <unk> sponsored program with the successful trial of F 10, Somatotrophin Alpha with weekly dosing for children with human growth hormone deficiency.
The results were sharing today highlight that the phase III study met its primary endpoint of annualized height velocity or HV at week 52, and demonstrated that <unk> somewhat chopa alpha was non inferior to novo nordisk, nor the trophy.
As a reminder.
<unk> so much open alpha was given as a weekly injection, while Neurotrope one was given as a daily injection in the study.
The mean HV was 10 76 centimeters per year for EFT, Hence homotropic alpha.
Versus 10, two eight centimeters per year for an order trophy with a non inferiority P value of less than 0.0001.
<unk> so much open alpha was well tolerated and no drug discontinuation were reported due to treatment emergent adverse events.
We believe the safety profile of <unk>. So much open alpha appears comparable to Nordstrom opened in this study.
These data create a strong clinical database supporting the potential clinical utility of <unk> long acting human growth hormone candidate.
We plan to submit a BLA in China in 2024.
Next I'd like to turn to Phil's Artemev, a fully human monoclonal antibody directed against <unk> 38 in development for the treatment of multiple myeloma.
We have successfully completed the first trial with registration potential in China for <unk> to map as a third line treatment for multiple myeloma.
Our study confirmed the efficacy of <unk> with additional benefits such as a shorter infusion time and lower infusion related reaction rate than reported for Derek tumor map and its IV form.
These product attributes may allow <unk> to be used in an outpatient clinic setting and together create a potentially differentiated product profile.
We are evaluating our regulatory strategy and plan to provide an update following further discussions with the China Cte we.
We plan to share additional clinical data after those discussions are completed.
In terms of the phase III randomized study of <unk> in combination with Lenalidomide for patients who have received one prior line of treatment.
Enrollment was completed in September of 2021.
The primary endpoint for this study is progression free survival and we expect this study to readout in 'twenty to 'twenty four followed by our planned BLA submission.
Lastly.
Development of <unk> focused on China as to the potential to be the first in class <unk> 47 antibody for hematologic malignancies in this market the.
The phase III program is evaluating <unk> in combination with <unk> as first line treatment for patients with newly diagnosed higher risk Myelodysplastic syndrome.
Enrollment in the Phase III trial was initiated in April of 2023.
The company will continue to review follow up data from our phase II clinical study in higher risk Mds, while at the same time analyzing details from trials evaluating other CD 47 targeted agents as they are released to inform our decisions on the future steps for the program.
I'll now hand, the call over to Richard to discuss our financial results.
Yes.
Thank you John .
I'll review, our first half when appropriate.
Yes.
Oh $2 38.
The company.
Okay.
Restricted cash and short term.
RMB $414 6 million U S dollars.
480.
89 million.
As of December 31st.
2022.
Demand is strong.
Yes.
To provide the company with adequate funding to support the execution of the companies.
Strategic.
You may have seen today, we also announced.
Also as a song.
Graham.
<unk>.
Okay.
Okay.
Of the company.
Total revenue for the first six months of 2023 were $2 7 million U S dollars compared with a seven point some.
Some of them into U S dollars for the same period in 2022.
Revenue consists of revenues recognized in connection with the strategic collaboration with Abbvie and the revenues generated from the supply.
Additional products to Abilene, and accumulative immuno biosciences or high bio.
Now, let me turn to the R&D expenses research and development expenses for the first six months of 2023 was 61 six.
Dollars compared with 67 six <unk> for the same period in 2022.
The increase was primarily due to reduced payroll expenses and share based compensation expenses.
Partially offset by a slight increase in chemistry manufacturing and.
Full service fee.
At administrative expenses for the first six months of 2023 were $33.
S dollars compare with <unk>.
<unk>.
If the poor.
For the same period in 2022.
The increase was primarily due to lower payroll expenses and shares.
Compensation expenses.
I'll take one and lower expenses.
Services.
non-GAAP adjusted net loss, which exclude the share based compensation expenses.
With six months of 2023.
With $87 million compared with 106.
Hello.
For the comparable period in 2022.
At June 32023.
<unk> has approximately.
190 million shares outstanding.
Hey, John .
Exploration.
14 $46 million, although Q.
June 32020, which allow us to execute our strategic plan.
Lastly, please note that the conversion of certain RMB amounts into us dollars for historical periods presented in this call may not be identical to the ones that previous announced due to the differences in particular exchange rate used by the company for this when compared to the historical exchange rates.
With that I would like to turn the call over to Raj for there.
A few closing remarks right.
Yeah.
Thank you Richard.
To conclude I am even more convinced than before that I've made the right choice to join Imap and that we're on the right track with.
With the strategic plan looking ahead, we intend to advance our two lead oncology assets.
<unk>.
Rapidly into additional studies in the U S and beyond in the first half of 2024.
We plan to maintain a strong balance sheet by continuing to streamline and rationalize our spend to advance the most promising programs.
And we intend to focus on a new operating model to establish a U S based global biotech company with the full support of the board.
We're excited about <unk>, new strategic plan and look forward to providing you with periodic updates on our progress.
You all for taking the time to join US today I'll now turn the call over to Tyler for the Q&A session.
Thank you Raj as we begin our Q&A session. If you do have any questions. Please you assumes raise your hand feature on mute you for your questions.
I'd like to direct our first question to Kelly sure Kelly. Please go ahead.
Thank you Tyler and congrats on the great progress and thank you for taking my questions. Firstly could you comment on the safety profile of your weekly injection.
Growth hormone from phase III trial and in comparison to other <unk>.
That is fairly clean programs and also Korea.
That is now at the projected timeline for regulator approval and also commercial lunch and I also have a follow up thanks.
Yes, Kelly. Thank you for that question, we are quite excited about the potential of <unk>. So we're tripping alpha as the as the weekly options for our patients and given the strong results that we just disseminated.
I believe this will be a valuable option in the China market, especially in a growing multibillion.
Growth hormone market.
I think I'll, let John comment on it and then Andrew if you wanted us to comment more on.
On Kelly's question and how it compares to other drugs in development that would be great. John . Thank you Raj. Thank you Kelly for the question.
As Raj mentioned this trial is a randomized head to head trial against Novo Nordisk Nordic Troponin and as we review the results coming from this trial. We are quite pleased by the safety profile. We've observed in this trial as compared to Nordstrom open.
In addition, I think we're pleased with how the safety profile of this drug looks compared to other drugs in the field.
We will look forward to disclosing those more completely in the future as we disclosed a full dataset.
I'd like to ask Scott, Andrew if you'd like to add any additional comments.
Andrew are you on.
Yes.
Hear me.
Yes, we can hear you yeah, Kevin Thank you for the question.
As you know, we just actually release that resolves.
All of the secondary endpoints, including safety and also various variables of the clinical data are being actively analyze and right. Now we can definitely say that safety profile I'll compare very very comparable to the weekly injection.
We will share the data.
Alright, very soon with.
With regard to the second part of the question we are actively pursuing the BLA submission.
Definitely we think in a with the phase III data provide the solid foundation.
For us engaged in this process and obviously, we're starting the engagement with regulatory agencies. So hopefully we will have additional timeline to report so thank you.
Yes, Andrew I, just wanted to make one clarification I think the safety profile compared very favorably to the once daily.
Injection.
Got it.
Correct.
Thank you for your question Kelly with that I would like to direct the next question to Joe Catanzaro, Joe. Please go ahead.
Hey, guys. Hopefully you can hear me, Okay, I guess I had two questions maybe first one on give us domain.
And particularly as it relates to quad and expression levels.
I'm wondering with the potential approval of <unk> I guess next year, whether based on what you've seen thus far whether there is opportunity to maybe capture a broader cord and expression range.
With give assuming thanks, and I have a follow up.
Yes, Thanks, Joe.
As you can tell we're very excited about this particular program, including our T. J <unk> that we're collaborating with ABL bio but in particular, we continue to believe that GE EBA steelmaking is quite differentiated from from the agents that are in development I'll ask John to comment more on the specific area of cloud and <unk>.
0.2 that you specifically referred to John Thank you Joe So.
As I alluded to in my comments.
Non clinical time early in the development of <unk>.
<unk> seen that <unk> can be <unk>.
<unk>.
<unk>.
Biologic effect down to very low levels of Claude and expression.
And in addition, you will see in our clinical data, we've seen clinical benefit in patients who have quite low levels of Claude and expression.
We're optimistic that the program is early still but we're optimistic that <unk> may be able to bring benefits to our broader a much broader group of patients with lower carbon 18.2 expression as well.
Great. That's helpful and maybe my follow up question quickly on Monza <unk> and the ongoing phase III trial in Mds in China.
It sounds like Theres, a lot of considerations there and the situation is fluid, but I guess now knowing the outcome of Mcgrath <unk> enhance trial.
Wondering how you think about what ultimately we could see from that trial and how it influences your decision with with <unk>.
<unk> clinical strategy. Thanks.
Thanks, Joe for that question.
This was an intense discussion as well within the company as you can imagine with the.
Recent results from the other CD 47 targeting agents I think it would be premature for us to make a decision on our molecule. We continue to believe that our molecule is differentiated.
And we continue to enroll in our ongoing phase III study in China, We do plan to review interim data early next year and complete an advisory panel to review all of the class data as it becomes available and to compare with what we have and then I would think our shareholders would appreciate that to make an informed decision in the first half of.
<unk> next year.
Advancing a molecule.
So we will certainly.
Further analyze the details of the enhance study as well as the data becomes available in the public markets.
Okay perfect I appreciate you taking my questions. Thanks, so much.
Thanks, Joe Thank you Joe I'd like to direct your next question to Louise Chen Luis Please go ahead.
Hi, Thank you for taking my questions here and congratulations on the progress this quarter. So Raj I wanted to ask you. If you could elaborate more on your vision for <unk> and how long it will take you to reach our objectives.
Leon CD 47, again, just curious where you stand with your outside of China opportunity with Abbvie here and when you might reveal more details on your next generation <unk> 47 or is that project on hold right now and then I know you mentioned that <unk> is stomach ESMO presentation, but are there any other important data.
And patients throughout the end of the year at health care conferences that should be on our radar. Thank you.
Yes.
Luis for all those questions I'm going to remember every one of them as much as possible and if I do forget. Please reiterate it we were frankly, writing those questions now.
So the first one is what's the timeline that I expect to deliver on the strategic objectives of the plan that I laid out I think as you will see in the next couple of years, there's quite a few.
Catalysts that are going to become available.
Our stakeholders and so I think I give myself 24 months to be able to start looking at the strategic plan and the progress that we've made so that'll be an important timeline for investors to understand that this is not going to happen overnight, but the shift in our focus and how we're thinking about making industry U S based global buyer.
Tech is going to take time, but again I think if I had to put.
Pen to paper and think about the timeline that should be important it should be by the end of 2025 second half of 2025, we should be in a good position to look back and say.
How is the strategy working and how is it.
Enhancing the value for our shareholders. So that was the first question I believe.
<unk>.
The second question is on Lemzo outside of China.
As you can imagine.
As we've said before right.
Abbvie has terminated the development global development of Lemzo, but we have the rights to China. So we continue the trial in China. At this time, we have no plans to initiate a study until we see the interim data we analyze the class eight of the other CD 47 targeting agents and we meet with an expert panel.
To be able to understand if our molecule is truly differentiated from the <unk> 47, and we can come back at that time Louise to clearly articulate as to if we're going to if we're going to move forward with lens or the backup compound.
And then.
Last question lease was.
On the.
I'm sorry.
Yes, yes.
Anything on the.
Cyber Meso I know you mentioned can you that's stemming from as well, but any other of your main compounds are going to be presenting new data at conferences throughout the remainder of the year.
As far as we know I don't think there is anything that jumped out to us for the rest of the year, but I'll, let John comment on it John Yes. Thank you. So as I mentioned, we plan to present, the <unk> dose escalation clinical findings at the European Society of medical on collagen and.
October this year.
Also as I mentioned, we anticipate the.
Dose expansion cohort the continued enrollment of patients with gastric J&J and Miss off the Geo cancer. We expect to have interim results early next year from that cohort of patients. So it will be reviewing those results and bringing those forward as quickly as possible, but for the remainder of 2023.
No additional conferences to add at this time.
Okay, great. Thank you very much.
Thank you Luis Thank you Luis next question, we will direct to Ethan Makowsky Ethan. Please go ahead.
Hi, everyone. This is actually Nathan.
Sure.
So maybe maybe a quick one on <unk>.
The commercial opportunity.
Sam.
Are you guys thinking of pricing is similar to the current standard of care in China, Jonathan any thoughts there.
Hi, Gil I think it would be a little premature right now to comment on price.
But I do know that we're excited about the profile of the compound itself in terms of the benefit that it brings to patients and we're excited about the growing large commercial opportunity that we have available for the human growth hormone product. So I think we're going to price. It competitively I can I can definitely show you that but.
I think.
It's a little too early for us to actually.
Comment on price publicly before we've even filed the product.
And maybe a quick follow up question on give us stomach so signaling for <unk>.
Usually requires <unk> of the ligand, which.
Links to these weird looking bell curves.
A little bit like the hook effect I'm. Just wondering have you seen that in preclinical studies that give us so meg or especially been an issue.
Thank you.
Okay.
John do you want to take that sure yes. Thanks, Joe.
Good to hear from you so.
This has not been a non clinical work does not have a preclinical issue for <unk>.
And further in the <unk>.
Early clinical findings, we continue to see.
Systemic.
Banco dynamic effect.
Soluble <unk>.
In a predictable manner. So we've been quite confident about what we've observed to date with <unk> regarding the PD effects.
Okay.
Thanks for taking my question.
Thank you Phil next up.
To direct our next question too under ish Maldonado Andress. Please go ahead.
Hi, Thank you very much for taking my questions and congrats on the progress just one quick one maybe for Raj for months.
Could you elaborate on where do any initial guidance for finding commercial pipeline.
Commercial partnerships for the pipeline Paul with your new vision of the company.
Prior.
Joining me here with a lot of talk on partnering will allow Nab I'm curious on your thoughts on the potential for partnerships outside of Europe .
And how they align with Univision.
Yes.
Yes, thank you for that question.
I think as I look within.
Within the company and talk with my colleagues in R&D and business development.
We're excited about our assets.
We think they have interesting biology, they have produced this early.
<unk> clinical data and I think we have a very healthy balance sheet to be able to take them forward on our own at this time I think it would be.
In.
My estimation premature to start talking about partnering till we actually produce mature data either proof of concept or the ability to actually have a higher probability of success and taking these to market and I think at that time would be ideal.
Talk about if appropriate depending on what else do we have in terms of opportunities to be able to talk about do we need a partner and why.
But I will say also as a note.
We continue to get incoming inquiries of interest on.
These assets and we continue to engage with this.
Outside partners, but that doesn't mean that we are keen on partnering until it makes strategic sense and we believe that that option produces the highest value for our shareholders in the near to midterm.
Okay.
Thank you for your question Andreas.
Does that answer your question Andreas.
Yes, thank you very much.
Thank you.
I would like to direct the next question too to show you show you. Please go ahead.
Hi, This is Jerry from TICC and thanks for taking my question.
I have a quick one on the <unk>.
<unk> 73 antibody. So we see very encouraging results of this antibody in first line.
Non small cell lung cancer.
<unk> phase II trial, there are about 16 out of 60 ish patients has both high CD 73, and PDL one expression.
And the LR reagents, we need for this population.
You predict similar percentage.
Target patient population in a real words or like what's the.
<unk> population.
On average for this boats.
Double positive.
Patient population in the real world.
Also for the pivotal trial I just wanted to ask.
About the design for this trial.
I feel like for the.
Patients that with really low GPS expression, you see like the responses in animal.
Adding the chemo on top of the immune checkpoint inhibitors do you see any evidence pre clinically or clinically, adding chemo can boost the sensitivity of Keith PDL, one negative patients in the response to <unk> 73.
Yes sure.
Very good questions.
Let me just take the first comment and then ill pass it on to John I think all of the results that we've generated in the program to date give us the confidence, especially in advancing that program in the settings that John articulated in his prepared remarks.
So I think our intent would be to go to a broader group of patients.
While we will continue to assess the PD one PDL one status in Cds <unk> status.
But that's just a subset of what we would be focused on.
John do you want to comment more on that and the second question that you had yes, I would just add that.
We've been working with Wuxi diagnostics throughout the development program regarding the CD 73.
Biomarker assay and so the trial that we reported we enrolled we allow patients to enroll who had newly diagnosed non small cell lung cancer, who were not eligible or who refused to receive chemotherapy in other words the patients were allowed to enroll before today.
Even knew their CD 73 expression, so $2 73 expression to the broader group.
<unk> was not an entry criteria. So we would believe we're within the setting of a modest sized clinical trial.
The rates that we observed may be consistent with what we would generally observed in future studies, though of course, the precision around that we need larger studies to increase our confidence so I think the rates are.
I think thats, what we know about the rates of the double high population, but as Raj said importantly, as as we move the program forward.
Do see as you mentioned with checkpoint inhibitors, which themselves are not so efficacious as monotherapy for patients with lower PD lone expression, but when you combine checkpoint inhibitors with chemotherapy and the benefit of chemo checkpoint inhibitors expands to the really the broad population of newly diagnosed.
<unk> for lung cancer, and so we're optimistic that as we move forward and combinations with chemotherapy.
Similar rate that rates of benefit like that may extend to the broader patient population and not just those who were elevated prior to the initiation of treatment.
Thank you for your question sorry.
I'd like to direct the next question to Bingo Bank. Please go ahead.
Thank you for taking my questions. This is <unk> from China Renaissance Im still interesting about.
Yes.
Call it $80 to inform BB by specific antibody because I realize that the status quo to $80. Two antibodies is going to be listed in U S. Probably second half of this year and also sellers is looking for listing in China as well. So I'm wondering if club villa products being commercialized what is the effect on our future.
Clinical plan and also I realize that.
For clothing and apparel space antibody there are many combination Ana market, let's say for example, <unk> 82.
Two with some with Cds, III or clothing with PD lumber interest to know more biologics behind why we choose them claudian form BB.
The other.
Thank you.
Thank you for your question Ming Zhao.
I think as we.
Yes.
As you are talking about the positive is there is a lot of interest in the cloud and $18 two space itself.
Highly relevant tumor antigen and as you said there is a lot of work going on and we're excited about the differentiation that <unk> has as we articulated in our prepared remarks, John do you want to.
Specifically address some of the differences that you assume it has to be Joe product in his question.
Thank you so maybe first I'll just touch upon we are aware of.
A lot of the work being done in the field and I'll just first touch on car T cell therapies, which may hold significant potential cost and Tolerability may relegate that approach to patients.
Received previous treatments in the past.
Similarly, we have seen some early reports from ADC type therapies, and some of those encouraging results but.
But really we think it's too early to know about those drugs. So eventually you get to the market or not and in the past for example, ADC type drugs have not always combined well with established treatment.
Therefore, our oftentimes use after established treatment.
Have been exhausted.
Just finally to touch on the monoclonal antibodies in development, which you mentioned and which may commercialize in the next year or so.
This.
These results are indeed important.
But as I mentioned earlier, we look for <unk>. We're about to begin combination studies, we intend to study with chemotherapy and with checkpoint inhibitors and as I mentioned also we've seen benefit and even monotherapy in patients across a wide range of cloud and <unk>.
Depression, including patients with quite low expression.
Received model therapy benefit.
We are quiet.
But what we've seen to date with <unk> and the ability that <unk> could help address the unmet needs for a wide range of patients and we look forward to initiating those studies to combined with current standard frontline treatments.
Hey, Roger can I add one point to John's comment Andrew sure Yeah, So being obviously touching a very very critical point, we are fully aware of the competitive landscape in the cloud and target area.
However, as John pointed out I think definitely archrock constantly cover a broad range of cloud and expression level.
And the second attractive feature is really the safety profile as you know.
So there'll be perhaps a mab and all of the quality harvest. It naked antibodies. They have the class specific toxicity profile.
In particular, the Gi side effects is equity.
Challenging conditions to manage.
So our data so far are really highlight the favorable safety profile of People's filming.
I think he don't combined with these two features I think even in the first line setting even with the pending Dolby parts of novel Ruble, We still think we can actually our position our drug.
Very broadly in the first line gassy esophageal space, just because of the broader car range with clothing expression as well as the favorable safety profile just want to clarify that point.
Okay.
Okay. Thanks.
Just just one other thing I just wanted to say is right. We will have more details of the data presented at ESMO, which will be interesting as well for you to take note of.
Thank you Bing.
Our next question I'd like to direct it to Trisha and Jeff just one please go ahead.
Okay. So thank you very much volume chance and my question is about our early.
Early stage pipelines. They landman, so could you elaborate more about the pipelines that are going between the R&D stage. Thank you.
Yes, so great question I think.
The early pipeline in China has been.
The China.
Specifically the talent in China has been a complete foundation in our core driver for innovation.
And how <unk> has progressed to date that being said I think.
As you look here.
The prepared remarks that we have today and the shift in the focus and the strategy is to really focus on those drugs that are in the clinic today to be able to accelerate the development and bring it to market I think that is a huge shift while we will continue to look at assets that can be earlier stage right now in terms of the shareholders and value inflection we're looking at.
The next two to five years in terms of how we can maximize the value of the company for our shareholders.
Who have been with us for these years right. So you'll see more information as we progress to late stage compounds, we feel comfortable on the likelihood and the success of those compounds getting to market.
Participating in the market you will see more data on how we started focusing on preclinical and early stage compounds does.
Does that answer your question.
Yes. Thank you.
Thank you Joanne we'll take one last quick question, we have three minutes left I'd like to direct the last question through one single Walgreens. Please go ahead.
Hello, everyone. This is lumpy from Citi research.
Thank you for taking my question and I have two more questions.
140.
Okay.
Cynthia 40, Standalone project and.
We know Julien.
Exxon caught your head count.
Yes projects due to spending.
Efficacy so.
To give you guys more color on that.
At <unk> the gap between the phase II.
The phase III trial.
And Insulet and we know the.
As a primary endpoint for our phase three trial.
Overall survival.
Okay.
Can you comment more about.
Improvements implemented.
Alright, two to the benefit.
Yes.
Yes, with the first question and the second half.
All right.
<unk> seven right Jack.
And therefore.
For our come in.
The pivotal study as well.
Open grid right <unk>.
Yes.
<unk>.
Single.
Got it.
Should it be.
Head to head.
Thank you.
Okay.
So thank you for the question on Lenzo, and then <unk> as well.
So let me just.
I reiterate the Lenzo one right so.
We have seen the announcements from the CD 47 targeting companies recently and as we said this was.
Obviously, great interest to us in terms of the.
The announcement itself and how that impacts our program as we said before I think it's a little premature for us to.
Think about a decision whether we should continue.
Stop the molecule development.
We continue to enroll our ongoing phase III study in China, We continue to believe that our molecule is differentiated.
But as we said.
We are also going to review the interim data, we're going to look at the full data from these CD 47 that have announced their trial.
Termination fully and then meet with experts to be able to make an informed decision on CD 47, so that that I think is the crux of how we're thinking about our program. As we said this is only in China, we are not progressing with lemzo anywhere else outside of China until we get that information in our.
Hans.
On the lead question, let me pass it on to John .
To address that question in particular, thank you Raj So I'd just add regarding <unk> and the potential development pathways we have.
<unk> respect for the regulatory agencies certainly they have.
A challenging task and regulatory guidance changes from time to time. So at this point, we wouldn't cut we would not comment further regarding the specific regulatory pathway for Hulu the math until after we reached alignment with the regulators and then will speak further about it.
After that time.
So does that answer your question.
Yes. Thank you.
Thank you. Thank you and with that we're running a little over time. So we will conclude today's call. If there any follow up questions. Please feel free to reach out to your local IR representative and we will get back to you as quickly as possible. Thank you everyone have a great day. Thank you.