Full Year 2022 I-Mab Earnings Call

Forward looking statements relating to the company's future performance and are.

Speaker 1: Discussion will contain forward looking statements relating to the company's future performance. And I made under the safe harbor provisions of the US private securities litigation reform act. Of 1995.

Speaker 1: Such statements are not guarantees of future performance and are subject to certain risks and uncertainties, assumptions, as well as other factors.

Speaker 1: 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 in today's discussion.

Speaker 1: The general discussion of the risk factors that could affect IMA's business and financial results is included in certain filings of the company of the Securities and Exchange Commission. The company does not undertake any obligation to update this forward looking information except as required by law. We also discuss specific non-GAAP financial measures during today's call.

Speaker 1: the presentation of which is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with US GAP. We see the financial results press release issue today for a definition of non-GAAP financial measures and a reconciliation of gap to non-GAAP financial results.

Speaker 1: And with that, I'll now turn the call over to Dr. Andrew Jewell. All right, I can see you all. Dr. Jewell, please go ahead.

Speaker 2: Thank you, Tyler.

Speaker 2: It's a pleasure to welcome all of you to our call today.

Speaker 2: I want to take this opportunity to discuss our key business updates and major progress in car asset development for the year ending December 31, 2022.

Speaker 2: Since the start of 2022, the company faced multiple challenges, including but not limited to geopolitical issues such as ADRB listing risk, 67%ietlvapress inflation, elements of

Speaker 2: macroeconomic factors including interest rate hikes.

Speaker 2: air and designing pandemic.

Speaker 2: In response to these challenges, the company made several strategic efforts to reposition the overall business and prioritize its pipeline.

Speaker 2: These measures resulted in a streamlined corporate structure and workforce, as well as focused development of five key assets, leading to a significant reduction in the cash burn rate in 2022 and beyond.

Speaker 2: These efforts have allowed us to achieve critical milestones for our prioritized pipeline and deliver near term value.

Speaker 2: In terms of the AER delisting risk, on December 15th, 2022, the PCA will be issuing a report.

Speaker 2: that visited the previous determination and removed mainland China and Hong Kong from the list of jurisdictions where it is unable to inspect or investigate completely registered public accounting firms.

Speaker 2: For this reason, the company does not expect to be identified as a commission-identified issuer under the HFCAA. The company operates via the annual report on Form 20F for the fiscal year 2022.

Speaker 2: This has removed a significant headwind the company faced in 2022.

Speaker 2: With the above mentioned strategic efforts on the pipeline development plan in 2022, we achieved 13 key clinical milestones, including positive results, including positive data readouts for three of our key assets, the Lenzo party map.

Speaker 2: Usually left the map and give a stomach.

Speaker 2: Here, we highlight the five key clinical assets that we have prioritized.

Speaker 2: These assets are novel, highly differentiated, and among the frontrunners globally and all in China.

Speaker 2: First of all, as pencil metrics are for our long-acting growth hormone, we completed the enrollment of 168 patients for our phase 3 trial in the first half of 2020. You can go to this channel by clicking the link on the top right of your screen.

Speaker 2: We expect to have a data readout in the second half of 2023, followed by subsequent BLA submissions.

Speaker 2: In November 2021, we announced a commercial partnership with Jia

Speaker 2: Second found darby map. They differentiated CD surveyated in body.

Speaker 2: In addition to the completed Phase II registration study, our Phase III study for second myeloma myeloma is on track, despite the impact of COVID-19.

Speaker 2: Continue to make progress with the local manufacturing plan in preparation for BLA creation and seek a potential commercial partnership.

Speaker 2: Next, we have three key assets that I will discuss in more detail later.

Speaker 2: Lenzocarimab, a differentiated CD47 antibody, has reached the phase 3 stage.

Speaker 2: Usually, let's say that a differentiated CD73 antibody and a global front runner has demonstrated impressive anti-tumor activity in a phase 2 trial.

Speaker 2: The clinical response is correlated with tumor CD73 expression.

Speaker 2: Next, GWAS-STOMIC, a CLOG 18.2 4,1BV bi-specific antibody with a fail-safety profile and single-agent Africa signal.

Speaker 2: I would like to start by highlighting our highly differentiated CE47 antibody limnoparty map which has certainly attracted so much attention in the immuno-oncology field.

Speaker 2: because of its leading position to be among the first CD47 antibody drugs potentially approved for immunological malignancies.

Speaker 2: I would like to remind you that blemso-parlimat is differentiated by design to avoid binding to red blood cells while maintaining strong anti-tumor activity.

Speaker 2: This differentiation includes the expected favorable safety profile with no priming those required, less RBC-mediated safety fat, and compelling anti-tumor activity across several places.

Speaker 2: This molecular differentiation has been validated pre-connoitcally and has translated into clinical advantages that are being validated.

Speaker 2: I should also add in September 2022,

Speaker 2: AbbVie and IMAP entered into an amendment to the original license and collaboration agreement.

Speaker 2: As a result, both parties are continuing to collaborate on the global development of anti-CD47 therapy.

Speaker 2: Here I want to highlight LEMSL-ParleyMap safety differentiation with clinical data.

Speaker 2: In a systemic safety data review of approximately 200 patients who were treated with Lengel's Partumap either as monotherapy or in various combinations.

Speaker 2: We have seen a compelling safety profile today.

Speaker 2: Overall, the safety data from both the U.S. and China studies continue to be favorable when administered without a priming dose regimen.

Speaker 2: MTD was not reached in any dose regimen.

Speaker 2: Mild TRE in solid tumor and NHL, and we have seen a good safety profile in combination with emphysema in AML and MDS. No grade 5 technological TRE has been reported.

Speaker 2: In the phase two study in the MDS, we have observed a favorable safety profile shown on the right.

Speaker 2: Of note, this study enrolled more patients with worse baseline conditions than the comparable conical trials conducted in Western countries.

Speaker 2: due to the underlying disease that is heavily influenced by clinical practice in China.

Speaker 2: In this group, 74% of patients had grade 3 and above anemia.

Speaker 2: and 51% of the patients have grade 3 and above thrombocytopenia at baseline.

Speaker 2: The overall safety results showed thatersen pounds of Calosphate is did not have increased

Speaker 2: even without the priming dose.

Speaker 2: was well tolerated in combination with azizutine. And the safety profile was comparable with that of azizutine monotherapy.

Speaker 2: Next, I would like to highlight the clinical efficacy results presented at ASMO 2022.

Speaker 2: Of the 53 patients enrolled as of March 31, 2022,

Speaker 2: For patients who began treatment six months or longer prior to the analysis, the overall response rate and complete response rate were 86.7% and 40% respectively.

Speaker 2: For those who began treatment four months or longer,

Speaker 2: The ORR was 86.2% with a CRRR of 31%.

Speaker 2: I'm happy to share that the updated results from the most recent data analysis of 62 patients have demonstrated consistent clinical efficacy, including ORR and CRR, with no new safety signals identified.

Speaker 2: We are planning to present the updated data at a major scientific meeting in the second half in 2023.

Speaker 2: Here, I would like to summarize the key progress on Lenzoparlimap. We have observed consistent and favorable safety profiles in more than 200 patients with hematologic and solid tumors treated with Lenzoparlimap.

Speaker 2: Our phase two MDS trial demonstrated a consistent efficacy trend, including ORR and CRR, with a longer follow-up time since the asthma data presentation in September 2022. Let's look at a map in combination with aziridine has...

Speaker 2: and IMAP entered into an amendment to the original licensing collaboration agreement.

Speaker 2: As a result, both parties are continuing to collaborate on the global development of anti-CD47 therapy.

Speaker 2: Next, I'd like to turn to ULI Legend Map, another global front runner that we are developing with a focus on non-smile cell lung cancer.

Speaker 3: As previously reported.

Speaker 3: to be torqued. That was all.

Speaker 2: to avoid the hook effect.

Speaker 2: So what is the Hooke effect? Simply put, the Hooke effect is characterized by an abnormal phenomenon that a drug molecule paradoxically loses the effect at higher doses.

Speaker 2: as shown in the figure on the right side.

Speaker 2: ULI-Lagamat achieved complete enzymatic inhibition without the Hooke effect.

Speaker 2: In contrast, OlicoBam could only achieve partial inhibition with home effect with higher concentrations.

Speaker 2: Usually, let's map differentiation comes from a unique binding epitope at the C-terminus.

Speaker 2: We believe the differentiation gives the UD-Laznab the potential to be best in class with an improved therapeutic window and more flexibility when combined with other anti-tumor drugs.

Speaker 2: We have observed robust efficacy data in stage O non-small cell lung cancer with high CD73 expression. And we are currently conducting, focusing our efforts on a biomarker-guided PTO trial in advanced non-small cell lung cancer in the second half of 2023.

Speaker 2: On the left side of this slide is our PK study. It really demonstrated linear PK profiles at 5 milligrams per kilogram weekly or higher, indicating target separation.

Speaker 2: At 30 milligrams per kilogram, separation and complete inhibition of CD73 activity were observed in human tumor biopsy samples.

Speaker 2: Studies of ulelectomab in combination with an anti-PD-1 or PD-L1 have shown treatment is safe and well tolerated with no dose limiting toxicities observed.

Speaker 2: Most treatment related adverse events were either Grade 1 or Grade 2.

Speaker 2: UV-LEDMAP RP2D has been determining to be 30 milligrams per kilogram every three weeks.

Speaker 2: in combination with Tariq Pabimab at 240 minimum every three weeks.

Speaker 2: This slide highlights the clinical experience of our US phase 1 study of ULE-Lectomy map in combination with the T-cell in refractory solid tumors.

Speaker 2: Among 13 efficacy-evaluated patients, three responses were seen, including one PR with an overall response rate at 23% and the disease control rate at 46%.

Speaker 2: More importantly shown on the right.

Speaker 2: All three responders were identified to exhibit higher expression of tumor 73, CD73, as compared to non-responders.

Speaker 2: This provides the initial indication that high CD73 expression may correlate with the clinical activity of utilizing that.

Speaker 2: Here, I want to highlight the latest clinical development update on the ilegal legend map.

Speaker 2: As of December 2022,

Speaker 2: Seventy patients have been enrolled in the phase two study of urelaximab in combination with toric

Speaker 3: as a high-level summary.

Speaker 2: At the time of the first data cut off in March 2022, ORR was 26% and the DCR was 74% for the first 19 available patients.

Speaker 2: Remarkably, in patients with high CT73 expression defined as at least 35% expression level in tumor cells or immune cells.

Speaker 2: A much higher OR was observed.

Speaker 2: With a 57% or and DCR and 100%.

Speaker 2: Similar applicant data in relation to CT73 expression were obtained in August 2022 with 32 evaluations.

Speaker 2: and December 2022 with 45 evaluations.

Speaker 2: showing a consistent trend of efficacy signal with an overall ORR greater than 30% in all patients and an ORR approximately 50% in CD73 high expression patients. As compared to approximately 10 to 15%

Speaker 2: response of urelectomyep and PD-1 combination therapy correlated with high tumor CD73 expression in patients with advanced non-small cell lung cancer.

Speaker 2: I want to summarize the development of uleletinimab on this slide. Uleletinimab is a differentiated 50-73 antibody with best-in-class potential.

Speaker 2: It can achieve complete CD73 inhibition without the hope effect. Uli's Latinimab has a favorable safety profile and the combination of Uli's pro-calimab demonstrated robust anti-tumor activity in non-small cell lung cancer.

Speaker 2: with the chemical responses correlating with CD73 expression.

Speaker 2: With regard to our further development plan for utilizing the map.

Speaker 2: A data readout for the 70 patients in our phase two study is expected for ORR in the first half of 2023 and for PFS in the second half of 2023. The company PLEP presented data at a major scientific venue in 2023.

Speaker 2: A further clinical development plan is being finalized to include a biomarker-guided people to trial of Uli Leggen map in combination with the PD-1 therapy in stage 4 non-small cell lung cancer in second half of 2023 in China.

Speaker 2: and a global study of UV-Litrimimab in combination with a PD-1 therapy and chemo regimen in advanced non-small cell lung cancer.

Speaker 2: In parallel, a companion diagnostic kit is being developed with WU-SHI diagnostic and is on track for the planned study.

Speaker 2: In parallel, a companion diagnostic kit is being developed with WU-SHI diagnostic and is on track for the plant studies. Thank you for your attention.

Speaker 2: The company has been actively engaging in a potential global partnership in sync with the planned global study. The last asset I'd like to touch on today is G-Wolf's stone mix.

Speaker 2: novel CAUTIIN 18.2 4,1BB bite-specific antibody that has also made significant clinical progress. People still make a novel bite-specific antibody with one arm targeting CAUTIIN 18.2 and the other targeting 4,1BB through conditional or local activation. At any time, we try to make new universities available and we have Lights on and see Consistency occurred in natural sites at various olderworlds, Yeah, I have a

Speaker 2: The key differentiation of DIVO stone-make is twofold.

Speaker 2: of people's stone makers too full. Firstly, us

Speaker 2: It binds the tumor with a wide range of clouding 18.2 expression levels, including lower expression.

Speaker 2: as demonstrated on the right in preclinical models.

Speaker 2: Secondly, the 4-1-DB arm of Givo Stormic is designed to function upon local tumor engagement as a mechanism of conditional activation.

Speaker 2: This feature makes genostomic, a unique T-cell activator only localized at the tumor site without systemic toxicity. For example, liver toxicity and systemic cytokine release that are typically associated with the tumor site.

Speaker 2: with 4-1-BV.

Speaker 2: Here, I'd like to take a moment to highlight people's stomach's unique differentiation.

Speaker 2: Compare it to other Cloudy 18.2 target agents.

Speaker 2: The differentiated molecular design makes G-BOT domain unique among clouding 18.2 target agents including A.D.C. and so we touch upon.

Speaker 2: DOBY-TEXMAP, a cloudy 18.2 monoclonal antibody.

Speaker 2: Givostomit has the potential to target a broader population, including those with lower cladding and making point to expression.

Speaker 3: In contrast,

Speaker 2: The anti-tumor activity with ZOBY and ADC is rather limited to patients with higher clotting taking point to expression in the tumor.

Speaker 2: with ZOBY and ADC is rather limited to patients with higher cladding 18.2 expression in the tumor. Secondly,

Speaker 2: The 4-1BB arm of the CICBIA domain is designed to function upon local tumor engagement as a mechanism of conditional activation.

Speaker 2: This feature makes GEOSTOMAKE a unique T-cell activator with no systemic toxicities, including hepatic toxicity and cytokine release syndrome.

Speaker 2: In addition, people's domain exhibits less gas-free intestinal toxicity.

Speaker 2: Then that is commonly observed for other Cloud 18.2 targeted therapeutics.

Speaker 2: Together, GIVO-STOMA is clinically positioned to target gastric and pancreatic cancers that have lower cladding 18.2 expression and are considered not eligible for treatment by ZOBY or cladding ADC respectively. And those with high 18.2 expression by offer.

Speaker 2: The preliminary clinical data are consistent with the differentiation of people's stomachs.

Speaker 2: Here I want to summarize the ongoing phase one dose escalation trial of GBOSTO-MADE in patients with advanced ovestic polytumors.

Speaker 2: By the end of 2022, eight dose cohorts have been completed up to 15 mg per kg without encountering dose limiting toxicity.

Speaker 2: Most treatment-related adverse events are Grade 1 or Grade 2.

Speaker 2: There is a dose-dependent increase of drug exposure and soluble 4,1-BB in serum.

Speaker 2: Suggestive of a favorable PKPD profile and potentially a longer dosing interval with a durable key cell activation.

Speaker 2: I have 5 milligrams per kilogram all above.

Speaker 2: C12 reaches its target concentration in over 90% of the patients observed.

Speaker 2: Meanwhile, PD data indicates that T cell activation occurs only at tumor size. As mentioned, we have disclosed a PR at 5 mg per kilo last July . We have also confirmed that the T cell activation occurs only at tumor size. We have also confirmed that the T cell activation occurs only at tumor size.

Speaker 2: And we have seen additional single agent efficacy signal, including PR and stable disease in different cohorts as well.

Speaker 2: We expect to share the Phase 1 data in the second half of 2023, and we continue to engage in discussions.

Speaker 2: We expect to share the Phase 1 data in the second half of 2023, and we continue to engage in discussions for a potential global partnership.

Speaker 3: Finally, I would like to highlight the expected catalyst in the near future.

Speaker 2: The first area is really to deliver our pre-BLA assets.

Speaker 2: We expect a Phase III data readout of ephemeral metropin in the second half of 2023, followed by subsequent BLA submissions,

Speaker 2: We are particularly excited about this asset and the market opportunity that exists in China.

Speaker 3: We're also on track with phase three full-felt argument and a potential commercial partnership.

Speaker 2: The second area is on the clinical development of lens or party map.

Speaker 2: We will initiate the phase III clinical trial for lambs of parting map as a first line MDS pigment. We will initiate the phase III clinical trial for lambs of parting map as a first line MDS

Speaker 2: We expect our Phase III study in China will support a planned BLA submission with the goal of being first to market and first in class in China.

Speaker 2: Next is urelecimab, our exciting CD73 antibody. This year, we expect an additional data readout for urelecimab phase 2 non-small cell lung cancer trial while planning to initiate a new test.

Speaker 2: a biomarker guided people to study in stage four non-sponsor lung cancer in the second half of 2023.

Speaker 2: We continue to engage in discussions for a potential global partnership. Finally, we continue to be excited by the development we see in geostormic.

Speaker 2: We are currently completing our Phase 1 clinical trial and continue to engage in discussion for a potential partnership.

Speaker 3: Lastly, we expect to initiate new INDs this year.

Speaker 2: As a reminder, I have not even touched on the multiple preclinical state assets we have in development.

Speaker 2: The company continues to focus on fundamentals with innovative strategies.

Speaker 2: With that, I'm happy to turn it over to Richard, who will discuss our financials. Richard? Hey.

Speaker 4: Thank you, Andrew. Let me turn to review our financial results for the full year and December 31, 2022.

Speaker 4: As of December 31, 2022, our pet and cat equivalents and short-term investments were RMB USD 3.5 billion or USD 514 million.

Speaker 4: Compare with 4.3 billion RMD or 671 US dollars as of December 31st, 2021.

Speaker 4: IMAP's strong cash balance is expected to provide a company with adequate funding to support key business operations over the next three years.

Speaker 4: Total revenue for the full year of 2022 were RMB minus 221.6 million or 32.1 million US dollars compared with RMB 88 million for the full year of 2021. The decreasing 2022 net revenue

Speaker 4: was primarily due to a one-off accounting treatment of US dollar, $48 million, recorded in the second half of 2022, following the amendment to the original license and collaboration agreement with AbbVie in August 2022.

Speaker 4: Further details can be found in our annual financial results.

Speaker 4: The decrease was partially offset by the revenue of

Speaker 4: 92.6 million RMB or $13.4 US dollars from license and collaboration arrangements and the supply of pipeline products.

Speaker 4: Now let me turn to the R&D expenses. Research and development expenses for the full year of 2022 were R&D $904.9 million or $131 million US dollars compared with R&D $1.2 billion for the full year of 2021.

Speaker 4: administrative expenses for the full year of 2022 were RMB 720 million RMB or 104.4 US million US dollars compared with 800 million 899 million US RMB for the full year of 2021.

Speaker 4: The decrease was primarily due to lower share-based compensation expenses in relation to the management personnel and optimized control of operations and administrative expenses.

Speaker 4: Net other expenses for the full year of 2022 were RMB $126.6 million or $18.4 million US compared with net other income of $83.2 million RMB for the full year of 2021. The change was primarily caused by unrealized RMB $126.6 million US.

Speaker 4: exchange losses due to fluctuation in the exchange rate of RMB against the US dollars in 2022. I would like to reiterate that we maintain a strong cash position of $514 million US dollars that we held at the end of 2022.

Speaker 4: Our current cash position combined with potential upcoming milestone payments from the previous all licensing deals and the collaborations is expected to further strengthen our cash reserves.

Speaker 4: current cash position combined with potential upcoming milestone payments from the previous all licensing deals and the collaborations is expected to further strengthen our cash reserves. This has been largely achieved by the federal government and by the federal government.

Speaker 4: by our move to focus on five key clinical assets in our pipeline through our reprioritization effort in mid-2022. We also streamlined our corporate structure. This has also been included in streamlining our workforce through a headcount optimization that was in line with the reprioritization of our pipeline.

Speaker 4: Reducting our overall operating expenses in a corporate structure.

Speaker 4: With this, we have implemented cost initiatives that we intend to maintain and committed to as we were determined to maintain operational efficiency and a very lean operational budget.

Speaker 4: Overall this represents about 20% reduction in cost in 2022.

Speaker 4: We are expected to further reduce in 2023 as we continue to focus on where we can deliver the most important value to our shareholders.

Speaker 4: In closing, our current strong cash position will provide us with ample flexibility to support our R&D activities in the next three years.

Speaker 4: With that, I would now like to turn the call back to Tyler and begin our Q&A sessions.

Speaker 4: I would like to turn the call back to Tyler and begin our Q&A sessions. Tyler?

Speaker 1: Thank you, Richard, and thank you, Dr. Joo, for your time and for your insights today. Next, we will begin our Q&A section. If you do have any questions, please use Zoom's raise your hand feature. I will unmute you for your questions.

Speaker 1: First question we see is from Kelly. Kelly, please go ahead.

Speaker 5: Thank you, Tyler, and thank you for taking my questions. My first question is, has iNED been able to resolve its delisting risks fully and also has follow-up? Yeah, hey, Kelly, thank you for your question.

Speaker 4: I think most of the delisting risk has been mitigated by our work with our current auditor through the PCAOB new rules. Our delisting risk has been largely mitigated throughout last year.

Speaker 5: Thanks. And also, regarding the phase 2 trial of CD73 antibody in states for non-small cell lung cancer, the updated 70 patients have been enrolled by the end of last year. I'm curious, could you share more information regarding the patient's baseline characterism?

Speaker 2: Let me take that question. So Kelly, as I indicated in my presentation, the data that I presented, the one with 70 patient cohorts.

Speaker 2: That's specifically targeting the treatment-naive stage 4 non-swabtelline cancer. So they are definitely naive to all the treatments, including PD-1.

Speaker 2: And so I'll take, yeah. Sorry, go ahead. Do you have a follow-up question? Oh no, sorry, go ahead. Yeah, so basically I think in our study exclusively look at that particular cultivation, you know, for our activity and also our ability in our phase two trial.

Speaker 1: Okay, thank you. Thank you, Kelly. And I'm showing Joe had zero. Joe, please go ahead.

Speaker 1: Hey guys, hopefully you can hear me okay. Maybe just one quick one from me on Give a Stonemake. I know you touched on this a bit in the prepared remarks, but the Clodin 18.2 space has obviously become highly competitive. So maybe for two questions around this. First, how do you think about the data that we've seen for Zolotuximab and the implications around Clodin 18.2 as a target?

Speaker 2: in the first line metastatic gastric cancer space.

Speaker 2: With the addition of ZOBY to the standard chemo backbone, both studies convincingly demonstrated the improved benefit.

Speaker 2: I think clearly we have validated clotting being a relevant therapeutic target in gastric cancer. So I think that part I personally feel that there's actually no argument. I think anti-clotting 18.2 antibody has a role. This will

Speaker 2: definitely benefit patients with metallurgic cancer.

Speaker 2: But also as you know, both trials select patients based on cladding 18.2 expression and the criteria they use is actually 2 plus plus 3 plus of at least 75 percent.

Speaker 2: So you can imagine, you know, I think if you look at this population very carefully, this probably will be applicable for about 30% of the patient with high clogging 18.2 expression.

Speaker 2: So my feeling is that I think DOBY will have the role in certain patients and also for those who have low PD-L1 expression, this may become the major target therapy in combination with chemo. I think DOBY will have the role in certain patients and also for those who have low PD-L1 expression, this may become the major target therapy in combination with chemo.

Speaker 2: Having said that, we also feel strongly that G-MOS stonemake has a very, very unique position in a very crowded, clouding 18.2 therapeutic target space in gastric and potentially maybe in other tumor types. There is a recordpay call onctrl line of G-MOS 2516 and the still thank G-MOS Video, Ricky

Speaker 2: because the unique molecular design really allows this molecule to cover a wider population with different levels of clouding 18.2 expression, in particular the lower 18.2 expression. We demonstrated that in preclinical models.

Speaker 2: seen anti-tumor activity.

Speaker 2: In coding 18.2 low expression patients, granted our pile is still actually just ongoing. It's a phase one study. But nevertheless, we are encouraged by the early access signal. On the other side of the spectrum is really the safety profile with our unique.

Speaker 2: as I indicated in my presentation, our molecule will only become active when the molecule is engaged with the tumor associated antigen, in this case, causing 18.2 positive tumor cells. In this case, as the 4-MBV will get activated, the cell will be activated.

Speaker 2: So in this way, it actually spares the systemic toxicity including hepatic and also cytokine relief syndrome. This is actually commonly seen with other TCL invader modalities including 4-1BV base. So we think our molecule also has the added advantage even in the

Speaker 2: tumor types, we definitely have the potential to explore the combination of our drug without a combination chemotherapy in other tumor types. And lastly, as you know,

Speaker 2: there is actually the so-called class specific side effects associated with calling 18.2 target agents because the GI toxicity is actually very remarkable. Now the warm imaging is commonly observed. Some of them could be actually incredibly challenging to manage. In our trial, we only observed very mild catealingly that

Speaker 2: but also in combinations on the road.

Speaker 6: Thank you, Joel. Thank you, Dr. Gu, and thank you, Joel, for that question. Next, we'll have Louise Chen. Louise. Hi. Thank you. Hi. Thanks for taking my question. So do you have any concerns regarding the toxicity of 4-1BD agonists?

Speaker 2: These features have prevented high target engagement in past programs. So can we expect more results from this dose escalation study? Thank you. Yeah, I think, Luis, I'll take your question. Again, it's a very, very important question when it comes to the tower belly, the safety of any vice-specific.

Speaker 2: upon causing 18.2 engagement at the tumor site?

Speaker 2: So for this reason, we actually spare the systemic toxicity commonly associated with OMVV and also other agonist treatments. So in that sense, the toxicity concern associated with other OMVV antibodies

Speaker 2: or actually other TCL engager, including CD3 phase, definitely we actually have a very favorable safety profile as shown in our phase one ongoing phase one trial. Because we're not actually seeing the systemic toxicity, including the pattern of toxicity.

Speaker 2: Chitin-high relief syndrome. And also the added bonus for our vice-specific is that RPI toxicity also is on the mild side.

Speaker 3: Thank you, Luis, for that question. I will take one last question since we're a bit over time. Andres Maldonado. Andres, please go ahead. All right.

Speaker 2: Hi guys, thanks for my question. A quick one from me. Could you provide additional color on how we should be thinking about your expected cash burn rate in 2023? And a quick follow up to that is obviously you've been focusing on the four highlighted programs from your prepared remarks. So just curious from a timing wise and a financial perspective, where do you expect to feel comfortable in bringing in additional assets?

Speaker 4: pipeline question. So with this regard, as we have mentioned, that in 2022, we actually spent a lot of time actually optimizing our cost structure is mostly so first of all, we actually focus on the five key assets and second, really optimizing the organizational structure.

Speaker 4: So this year we're further going to reduce the overall cost as we just mentioned in the call. That our expected current net burn rate for 2023 is expected to be in the range of 130 to 140 million US dollars. This will further optimize our current net burn rate for 2023.

Speaker 4: our operational structure so that our cash position can retain us at least for additional three years or more years of cash operation. So given that we have other pipeline products that Andrew will discuss to develop and we really focus our key assets.

Speaker 2: Yeah, so I think this is a very, very important question for the R&D operation. I think a few things that I would like to share with you.

Speaker 2: As you know, IMAP actually has a very, very innovative discovery engine. We actually produce quite a lot of innovative assets internally. But also for reasons that we discussed today, we've been actually really trying to focus on the key assets that we can actually...

Speaker 2: generate more value, move the program to the next level faster, but also realize the value of these assets hopefully earlier so that the company will benefit, the shareholders will benefit, or more importantly, patients will benefit from this strategy.

Speaker 2: By having said that, we never stop looking at innovative assets from outside. It's just, you know, right now, we've cut the current situation. Our bar is higher. We definitely want to take a more critical look when it comes to the licensing efforts from outside.

Speaker 2: But this is a dynamic process. Clearly, we are aiming to also generate additional cash flow with our PDU. So I think clearly we will reassess the strategy as we proceed with the new year in 2023. But right now, we definitely want to make sure we focus on the internal assets.

Speaker 2: But definitely, we will actually look at the key assets that potentially have value and also have potential market more critically. This is our current position.

Speaker 3: Thank you, Dr. Drew and thank you Richard. With that, we will conclude today's call. I'd like to thank you all for dialing into today's financial results results and business update conference call. Yeah, thanks everyone for joining them. You may now disconnect.

Full Year 2022 I-Mab Earnings Call

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Full Year 2022 I-Mab Earnings Call

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Friday, March 31st, 2023 at 12:15 PM

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