Release Date: August 28, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- I-MAB (IMAB, Financial) successfully divested its operations in China, establishing a new operating model as a US-based global biotech company.
- The company extinguished $200 million of a $215 million redemption obligation, significantly improving its financial position.
- I-MAB (IMAB) has a strong cash balance, with a reported cash runway extending into 2027, supporting several important clinical milestones.
- The company has advanced its three oncology programs, with upcoming milestones and collaborations with Bristol Myers Squibb, TJ Bio, and ABL Bio.
- I-MAB (IMAB) has streamlined its workforce and transitioned to a US-based leadership team, enhancing its operational efficiency and focus.
Negative Points
- The company incurred significant cash outflows related to the divestiture of China operations, including $47.8 million in the first quarter of 2024.
- There are risks and uncertainties associated with forward-looking statements, which could cause actual results to differ materially.
- The company faces competition in the immuno-oncology space, with other CD73 programs and Claudin 18.2 ADCs potentially impacting its market position.
- I-MAB (IMAB) has a high dependency on the success of its clinical trials, with key milestones and regulatory approvals still pending.
- The transition to a US-based operating model and leadership team may present integration and operational challenges in the short term.
Q & A Highlights
Q: Can you provide details on the upcoming ESMO update for givastomig, including patient numbers and new learnings about the monotherapy profile?
A: The data presented at ESMO will be from the dose expansion cohorts with gastric cancer, involving approximately 30 patients. The profile will highlight exquisite safety and a notable objective response rate (ORR). Givastomig's tolerability allows it to be combined with frontline therapy, differentiating it from other Claudin 18.2 targeted assets, such as ADCs, which may have higher ORRs but also higher toxicity profiles.
Q: How does givastomig compare to the growing Claudin 18.2 ADC landscape?
A: While ADCs targeting Claudin 18.2 may show higher ORRs, givastomig's superior toxicity profile makes it better suited for combination with frontline therapies like nivolumab and Folfox. ADCs, due to their toxic payloads, would require adjustments in standard chemotherapy regimens, which is not the case for givastomig.
Q: What is your targeted finish date for transitioning to a US-based auditor, and how should we think about future expenses split between the US and China?
A: The transition to PwC US as our corporate auditor is complete. Future expenses will be considerably lower as we have streamlined our organization to focus on clinical development programs. The burn rate will be lower compared to the first and second quarters of this year.
Q: What is your pipeline strategy regarding expansion? Are you focusing solely on oncology or considering other therapeutic areas?
A: We are actively looking to enhance our pipeline through external collaborations or licensing opportunities, primarily in oncology due to our team's expertise. However, we are also open to adjacent modalities. Our focus is on assets that are in or near clinical stages to bring near-term value inflection.
Q: For the uliledlimab combination study, what efficacy benchmarks are you using for go/no-go decisions?
A: We are benchmarking against Keynote 189, where the median PFS is about nine months. We are looking for clinically meaningful improvements over this standard of care. We will also assess CD73 expression retrospectively to focus on signals in the CD73 positive group.
Q: How will you leverage the Phase 2 PFS data from the TJ Bio study?
A: Positive outcomes from competitor studies will validate the adenosine pathway, supporting our hypothesis that patients with high CD73 expression benefit most from uliledlimab. This data will help propel the field forward and give us confidence in our approach.
Q: What are the key milestones for givastomig and uliledlimab in the near future?
A: For givastomig, we expect to present updated Phase I dose expansion data at ESMO 2024 and provide top-line data from the combination study in gastric cancers in the second half of 2025. For uliledlimab, we expect to initiate the first patient dose in the combination study in advanced non-small cell lung cancer in the first half of 2025 and provide top-line PFS data from the TJ Bio study in the second half of 2025.
Q: What are the financial highlights and future cash runway expectations?
A: As of June 30, 2024, our cash balance was $207.5 million. We believe our cash runway will take us into 2027, including several important clinical milestones. We have streamlined our workforce and optimized our financial operations to support this extended runway.
Q: How has the divestiture of operations in China impacted I-MAB's strategic focus?
A: The divestiture has allowed us to establish a new operating model as a US-based global biotech company. We have streamlined our organization, built a new US-based leadership team, and completed key governance and corporate development milestones. This strategic shift enables us to focus on executing our differentiated pipeline and exploring new opportunities.
Q: What are the key messages you want to leave investors with?
A: I-MAB is focused on developing differentiated immunotherapies for cancer. 2024 has been transformational, and we are executing on the Board's strategic vision. We have advanced our oncology programs, streamlined our organization, and built a strong US-based leadership team. We are well-positioned to make meaningful progress in the second half of 2024 and beyond.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
