NovaBridge Biosciences (NBP) Earnings

Management highlights

Management Statement and Operational Highlights: - In the first half of 2024, I-MAB divested operations in China on April 2, established a U.S.-based global biotech model, and extinguished $200 million of redemption obligations. - Streamlined the organization, built a new U.S.-based leadership team including CFO Joe Skelton and CMO Phillip Dennis. - Advanced three oncology programs: uliledlimab, givastomig, and ragistomig. - Secured PWCUS as corporate auditor. - For uliledlimab, made progress in combination study plans and milestones. - For givastomig, expect to present Phase I dose expansion data at ESMO 2024 and top line data from combo study in second half of 2025. - For ragistomig, early Phase I data showed encouraging efficacy and manageable safety.

Guidance

Guidance: - Expect to initiate first patient dose in the uliledlimab plus pembro plus chemotherapy combination study in the first half of 2025 and provide top line PFS data from the randomized Phase II study by TJ Bio in the second half of 2025. - Plan to present new top line data from the givastomig Phase I monotherapy dose expansion study at ESMO 2024 and provide top line data from the givastomig combo study in gastric cancers in the second half of 2025. - Ragistomig enrollment in selected indications and different dose schedules ongoing with encouraging early efficacy.

Segment performance

Segment Performance: No specific absolute financial performance or revenue contribution percentages for product segments were detailed in the transcript.

Risks & headwinds

Risks: - Statements made during the call include forward-looking statements which involve risks and uncertainties that can cause actual results to differ materially. Market data used in the presentation involves assumptions and limitations, and internal assumptions about potential market opportunities may not be verified by independent sources.

Analyst Q&A

• Q: Hey everybody, thanks for taking my questions. I maybe had a couple on givastomig, first one on the upcoming ESMO update. Wondering if you could just help set expectations in terms of the data set we’ll see, patient numbers and any new learnings around the monotherapy profile there. Then second question, appreciate the comparison to zolbetuximab, but wondering if you had any thoughts on how giva maybe compares to the growing Claudin 18.2 ADC landscape and where it could differentiate versus those programs.

  A: Thank you for your question, Joe. We’ll turn that question over to our Chief Medical--go ahead, Tyler? Tyler Ehler : I was just going to say, we’ll turn that question over to our Chief Medical Officer, Dr. Phillip Dennis. Phillip Dennis: Thanks Tyler, and thanks for the question. The data presented at ESMO again will be data from the dose expansion cohorts with gastric cancer. This will be with approximately 30 patients, and the profile is again one of exquisite safety and again a notable ORR. But importantly, I think you raise an important question. The way we envision giva’s development, given its tolerability, is to combine it with frontline therapy with nivolumab and regimens such as Folfox. I think that is the basis for the differentiation with other 18.2-targeted assets. While we know that ADCs, given their toxic payload, can have a notable objective response rate, which again if we compared giva against the ADC that is being developed by AstraZeneca, our ORR is inferior; but arguably, our tox profile is much better suited for combination in frontline studies, and I think that’s the differentiating feature. I think for an ADC targeting 18.2, for movement to frontline therapy, one would have to make accommodations in the standard of care chemotherapy because it simply would be very difficult to tolerate an ADC plus every drug that’s in Folfox, for example, so I think that’s a differentiating feature where we can be more readily combined with frontline therapy.

• Q: Hi, this is [indiscernible] for Kelly Shi. Congrats on the progress in the first half of ’24. I just have two quick questions. First, what is your targeted finish date for the transitioning to the U.S.-based auditor? What should we think about expenses going forward split between the U.S. and China? My second question is for the pipeline strategy, as you’re thinking about expansion to your--adding more assets to your pipeline, are you still focusing on the oncology space or looking to expand to other therapeutic areas? Thank you.

  A: Thank you for your question. Was it possible to repeat the first question, and then we’ll turn the question over to Sean, our interim CEO to answer? Unknown Analyst: Sure. The first question is what’s your target finish date regarding fully transitioning to a U.S.-based auditor? Sean Fu: Yes, thanks for that question. We have completed the transition, and PWCUS is now our corporate auditor and we’ve been working closely with them since the completion of the transition. This is an important accomplishment. Together with other corporate developments after the divestiture, they started to see the change in, as a company, how I-MAB is allocating resources. The going burn rate - I think that’s part of the question you asked earlier - the going burn rate will be considerably lower compared to what you saw in the first and second quarters of this year, because we have streamlined our organization to focus on clinical development programs going forward. The other question, you asked about the pipeline strategy - yes, we are actively looking to further enhance our pipeline through external collaboration or licensing opportunities, and obviously given that the three assets internally are all oncology focused, our team has significant oncology asset development experience that we are starting our reviews, our explorations in the oncology space, but we are not limiting ourselves just to oncology. For adjacent modalities, we are also open for discussion and collaboration, but oncology is one area we obviously see synergy. I think the final part of the question has to do with going forward, the pipeline strategy. We are squarely focused on execution of our internal pipeline, the three that we explained in detail today by Phillip, and we are excited about this pipeline, so we’re looking to license in and we’re looking for collaboration opportunities from external partners. Important to note that when we think about the BD strategy, we are looking for assets that have the potential to enter or are already in clinical stage, therefore we can expect it to bring a near term value inflection for I-MAB in the next year.

• Q: Hi, thank you. Congratulations on the progress. Thank you for taking my question. Just two quick ones from me. For the uliledlimab combination study, could you talk a little bit about what you need to see on the efficacy front for this new study, and what are some of the external signals you’re using to benchmark your go/no-go decision? Then as an additive question, in the second half the Phase II PFS data from the TJ Bio study, just curious on how you’re going to leverage that data moving forward and what you need to see there. Thank you very much for taking my questions.

  A: Thank you for your question, Andres. I will direct your question to our Chief Medical Officer, Dr. Phillip Dennis. Phillip Dennis: Thanks. I will address the questions in order, and if I don’t do so completely, please make sure I address all of them. In terms of benchmarks for efficacy in our Phase II, the sense is the comparison is Keynote 189, where we know the median PFS is about nine months, and we know the ORR can vary depending on the PD-L1 expression, so basically what we’re looking for is clinically meaningful improvements, incremental improvements that are clinically meaningful over the standard of care, Keynote 189. Moreover, in our proposed Phase II, we’ll be assessing CD73 retrospectively and we will be focused heavily on whether or not the signals that we are seeing are predominantly in that CD73 positive group. Now in terms of external benchmarks, as the slide showed, we’re very interested in outcomes from competitor studies because positive outcomes from these competitor studies will really validate the adenosine pathway, and these studies include studies with oleclumab that is being developed by AstraZeneca in earlier stages of disease, resectable disease, Stage 3 unresectable disease as well as antibodies, again CD39 in small molecules, so we think that this will help again propel the field forward, give us confidence in uli, in the pathway, and I think with the signal that we hope to see from our study, from our proposed study with pembro chemo and with the TJ Bio doublet study, that is in the CD73 selected population, we will get support for our hypothesis that it’s the patients that have high CD73 expression that benefit most from uli.