INVZ

• Travere Therapeutics Partnership for Sivore Brutinib (Ever-001)

• Strategic fit is strong, as Travere is a recognized leader in rare kidney disease with established nephrology-focused clinical development, regulatory, and commercial capabilities, demonstrated by their FDA approvals for sparsantan/filspari for FSGS and IgA nephropathy.
• Travere shares Everest's view that Sivore Brutinib is a pipeline-in-a-product opportunity across multiple immune-mediated kidney diseases, not just the lead indication of primary membranous nephropathy (PMN).
• Division of responsibilities: Travere leads development and commercialization in licensed territories outside Greater China and select APAC markets; Everest retains responsibility for its home territories, with joint governance coordinating global seamless development.
• PMN is the lead indication with existing compelling proof of concept; additional priority indications include immune-mediated FSGS, minimal change disease, and other renal indications, with development sequence guided by data, scientific rationale, and regulatory input.

• Platform and Pipeline Progress

• Everest has a proprietary AI-enabled mRNA discovery platform focused on mRNA therapeutics, with an active strategy to repeat the Sivore Brutinib partnership model for additional assets and advance internal pipeline programs.
• mRNA cancer vaccine portfolio includes two clinical-stage programs and one preclinical immunomodulatory program: off-the-shelf tumor-associated antigen (TAA) vaccines and personalized cancer vaccines (PCVs). EVM-14, the lead TAA candidate targeting five antigens for squamous cell carcinomas, is in ongoing Phase 1 dose escalation in the US and China. EVM-16, the PCV candidate, has completed a Chinese investigator-initiated trial, with a Phase 1/2 trial planned for initiation in H2 2024 in first-line non-small cell lung cancer maintenance in combination with PD-1 inhibitors.
• In vivo CAR-T program uses an antibody-conjugated LNP mRNA delivery approach targeting CD19, aiming to convert autologous personalized CAR-T therapy into an off-the-shelf, scalable, cell-free product without requiring lymphodepletion. The program has achieved 40% to 80% CAR-T transfection efficiency of T cells in non-human primates, with compelling B-cell depletion even at the 40% level, and is currently conducting multiple investigator-initiated trials in China.

• For the EVM-16 personalized cancer vaccine program: First patient dosing in the first-line non-small cell lung cancer maintenance combination trial is expected in H2 2024, with initial data readout expected in 2027. • For the EVM-14 TAA cancer vaccine program: Phase 1 dose escalation in the US and China is expected to complete before the end of 2024, with data readout also expected in 2027. • For the in vivo CAR-T program: Preliminary data from ongoing Chinese investigator-initiated trials is expected within the next 6 to 12 months, and the US IND filing remains on track to be submitted before the end of 2024. • Additional external business development opportunities to replicate the Sivore Brutinib partnership model are actively being pursued, alongside advancement of internal platform assets.

No financial segment performance data for product segments was shared in this webcast transcript.

• The full mechanistic hypothesis of BTK inhibition across multiple immune-mediated renal indications beyond PMN has not yet been clinically validated, and development results may not confirm the broader utility of Sivore Brutinib. • Clinical proof of concept for off-the-shelf TAA mRNA cancer vaccines has not yet been generated, and trial results may not support further development. • The in vivo CAR-T development field still faces key unresolved hurdles, including achieving complete, durable B-cell depletion with a good safety profile, and enabling effective re-dosing for relapsed disease; clinical results may not meet expected efficacy or safety targets. • Success of all pipeline programs depends on generating high-quality clinical data that satisfies regulatory requirements, which is inherently uncertain for early-stage biotech assets.

Q: Why was Travere the right partner for Sivore Brutinib, and how are responsibilities split between the two companies?

A: Travere is a recognized leader in rare kidney disease with deep nephrology-focused development, regulatory, and commercial experience, and it shares Everest's view of Sivore Brutinib as a pipeline-in-a-product across multiple renal indications, creating strong strategic fit. Travere leads development and commercialization for territories outside Greater China and select APAC, Everest leads in its home territories, and a joint governance structure coordinates global activities. PMN is the lead indication, with additional indications prioritized based on data and regulatory input.

Q: What is the differentiation of Sivore Brutinib, and when will we see meaningful validation for Everest's AI-enabled mRNA platform?

A: Sivore Brutinib's selective reversible covalent BTK profile delivers rapid immune activity control, targeted B-cell modulation, and an oral profile suitable for chronic use, differentiating it from existing and emerging treatments. For the mRNA platform, the EVM-16 PCV trial initiates in H2 2024 with data in 2027, EVM-14 TAA Phase 1 completes by end-2024 with data in 2027, and in vivo CAR-T data is expected in the next 6-12 months. Off-the-shelf TAA vaccines offer immediate accessible treatment, while PCVs already have more existing clinical validation and target earlier-line disease for faster proof of concept.

Q: What is Everest's advantage in in vivo CAR-T, and what is the key industry hurdle to solve?

A: Everest uses antibody-conjugated LNPs to deliver mRNA targeting broader T cell subsets, with an LNP profile that preferentially targets the spleen and deselects the liver, plus mRNA modifications that silence off-target liver expression. This creates an off-the-shelf, scalable, cell-free alternative to conventional ex vivo CAR-T that does not require lymphodepletion. The key open industry hurdle is achieving safe, complete, durable B-cell depletion, plus enabling effective re-dosing if disease relapses; Everest expects preliminary answers to these questions from ongoing trials in the next 6-12 months, with a US IND on track for end-2024.

Q: How has global pharma's evaluation of China-originated innovation changed in recent years?

A: Global pharma has greatly expanded local on-the-ground presence in China, with dedicated search, evaluation, transaction, and R&D resources focused on Chinese innovation, organized by therapeutic area to deepen due diligence. Evaluation criteria now consistently emphasize strong intellectual property, solid CMC/manufacturability, strong translational data, and clear commercial fit alongside trust and collaborative alignment between partners, which were key factors in the Travere partnership for Sivore Brutinib.