Andres Maldonado

Andres Y. Maldonado asked about differentiating between patients with finite versus chronic intermittent OJEMDA treatment courses, and what factors (e.g., depth of initial response, retreatment outcomes) influence these patterns. He also inquired about the internal bar for Emi-Le's magnitude and durability of response in ACC and what regulators might consider sufficient for accelerated approval.

Answer

CEO Jeremy Bender explained that while FIREFLY-1 had a regimented approach with a potential 24-month treatment break, real-world commercial use of OJEMDA is largely 'treat to progression,' leading to strong persistence. He anticipates continued persistence, potential treatment breaks for stable tumors, and frequent retreatment due to genetic tumor stability. For Emi-Le, Jeremy Bender highlighted the need for a clinical data package consistent with approval in ACC, given the high unmet need. Head of Research and Development Michael Vasconcelles added that they would seek a robust single-arm dataset defining monotherapy objective response rate with sufficient durability and patient numbers to clearly differentiate Emi-Le from current poor benchmark therapies.

Andres Y. Maldonado first asked about differentiating between patients with finite versus chronic intermittent OJEMDA treatment courses, specifically regarding factors like initial response depth or retreatment outcomes. He then followed up by asking about the internal bar for Emi-Le's magnitude and durability of response in ACC and what regulators would consider sufficient for accelerated approval.

Answer

CEO Jeremy Bender explained that while FIREFLY-1 had a regimented approach, real-world use shows strong persistence, often "treat to progression." He anticipates continued persistence, potential treatment breaks, and retreatment due to genetically stable tumors. For Emi-Le, he noted the need for a clinical data package consistent with an approvable package for a rare population with few options. Head of R&D Michael Vasconcelles added that for ACC, they would expect a robust single-arm dataset defining monotherapy objective response rate with sufficient durability and patient numbers, clearly delineating performance against very poor existing therapies.

Andres Maldonado from H.C. Wainwright & Co. asked about OJEMDA's long-term positioning against other therapies like MEK inhibitors and the company's appetite for business development given its strong cash position.

Answer

CEO Dr. Jeremy Bender explained the goal is to establish OJEMDA as the second-line standard of care for BRAF fusion pLGG by demonstrating a superior profile to entrenched off-label therapies. COO & CFO Charles York added that business development is critical for long-term growth and the company is actively evaluating opportunities with a high bar for investment, noting that adding one more program to the pipeline would be a great start.

Andres Maldonado asked about the assumptions underlying the FIREFLY-2 enrollment guidance, particularly regarding potential off-label frontline use of OJEMDA. He also questioned the conviction behind using an ADC modality for the unique PTK7 target.

Answer

CEO Jeremy Bender stated the FIREFLY-2 enrollment projection is based on real-time site enrollment rates and is not influenced by the very modest off-label frontline use observed. Regarding DAY301, he explained that conviction in the PTK7 target was established by a prior ADC program (cofetuzumab pelidotin) that showed efficacy, and Day One's thesis is that DAY301's different payload and properties will yield a superior therapeutic index.

Andres Maldonado of H.C. Wainwright & Co. asked about the ex-U.S. launch strategy with Ipsen and the development plan for the PTK7 ADC (DAY301), specifically regarding potential combination therapies.

Answer

CEO Jeremy Bender highlighted the strategic alignment with Ipsen for ex-U.S. registration, noting OJEMDA's unique Type 2 RAF inhibitor mechanism. Both Bender and Dr. Samuel Blackman, Head of R&D, stated the immediate focus for DAY301 is on demonstrating monotherapy activity before exploring combinations.

Andres Maldonado inquired about the potential for securing a commercial partner for Europe and how the company is prioritizing the development of apitegromab in additional indications.

Answer

CEO David Hallal firmly stated that securing a partner is not a priority, as the management team is highly experienced and fully capable of executing a global launch directly. He reiterated that decisions on expanding into new indications will be data-driven, with further updates to be provided by the R&D team later in the year.

Andres Maldonado asked how potential commercial partnerships, especially for uliledlimab, align with the new corporate vision.

Answer

CEO Raj Kannan explained that the company's current strategy is to leverage its strong balance sheet to advance its key assets independently. He believes it is premature to seek partners until more mature data is generated, which would maximize shareholder value. While I-Mab receives inbound interest, it is not actively pursuing a partnership at this time.

Andres Maldonado from H.C. Wainwright requested more detail on the expected cash burn rate for 2023 and asked about the timing and financial considerations for bringing additional pipeline assets into the clinic.

Answer

Richard Yeh, Interim CFO and COO, projected the net cash burn rate for 2023 to be in the range of US$130 million to US$140 million, noting this would provide a cash runway of at least three years. Andrew Zhu, Acting CEO, added that while the company has a productive internal discovery engine, the current focus is on advancing the prioritized key assets to realize their value. He stated that the bar for in-licensing external assets is currently high but that this is a dynamic process that will be reassessed as the company generates cash flow from business development deals.

Andres Maldonado asked for clarification on the commercialization strategy for felzartamab, questioning whether the hybrid model would be limited to multiple myeloma or also extend to autoimmune diseases, and what the expectations were for the deal size.

Answer

Jingwu Zang, Founder, Chairman and Acting CEO, confirmed that active discussions for a commercial partnership for felzartamab do include autoimmune disease indications, citing exciting recent data from MorphoSys. He stated the goal is to maximize the asset's value but declined to disclose the potential size of the partnership due to the confidential nature of ongoing negotiations.

Andres Maldonado asked how I-Mab's commercialization efforts will evolve in the coming year beyond manufacturing, and requested more details on the cash burn rate and any expected revenue milestone payments.

Answer

Jielun Zhu, Chief Strategy Officer, detailed the near-term portfolio strategy focused on hematologic oncology, aiming to cover 200-250 major hospitals and projecting $300-$400 million in revenue from 2023-2025. John Long, CFO, provided financial specifics, stating the 2021 operating cash burn was $165 million, with a projected burn of $180-$220 million for 2022-2023. He noted the current $671 million cash balance, plus over $250 million in expected milestone payments by 2025, is sufficient to fund operations for at least three years.