GUGGENHEIM 3RD ANNUAL HEALTHCARE INNOVATION CONFERENCE - ADAGENE INC

Based on the transcript provided, here is the summary of forward-looking statements:

• Explicit Guidance:

  • No explicit financial guidance (revenue, earnings, margins, capex, or share count) was provided.
  • Cash Runway: Management expects cash reserves to extend through the second half of 2028, following a $70 million raise earlier in the year.

• Business-Segment Outlook:

  • Lead Asset (ADG126/MUZA):
    • Phase 2 Project Optimus (Late-line MSSCRC, no liver mets): Enrollment completed; data readout expected in the first half (H1) of 2027. Primary endpoint is response rate; secondary endpoints include safety, duration of response, and early PFS.
    • Phase 3 Project Optimus: Management expects to initiate Phase 3 trials in the second half (H2) of 2027, following discussions with the FDA after H1 2027 data readout. Design will be randomized with Overall Survival (OS) as the primary endpoint, potentially with ORR as a co-primary endpoint for accelerated approval.
    • Neoadjuvant CRC: Data from the Investigator-Sponsored Trial (IST) in Singapore is expected in 2027. The study tests a high-dose schedule (20 mg/kg loading followed by 10 mg/kg Q3W) to maximize pathological responses and Event-Free Survival (EFS). A potential Phase 2 initiation is possible following supportive IST data.
    • Hepatocellular Carcinoma (HCC): Following Phase 1b2 data showing a 50% response rate in small cohorts (vs. ~20% control), management is seeking a response rate of 40–50% or higher in a large-sample Phase 2 setting to advance to first-line registration.
  • Collaborations:
    • Insight Biologics: Evaluating ADG126 + PD-1/TGF-beta bispecific; Insight sponsors the trial and controls data timing. Enrollment is active.
    • Sanofi: Collaboration expanded in 2022 and equity investment made; remains a key partnership.
    • Third Arc Bio: Deal announced for T-cell engagers with SafeBody platform; collaboration expanded recently.
  • New Assets:
    • ADG138: Double-mask T-cell engager (CD3/ERBB2) received clearance from the Chinese FDA; patient enrollment in China will commence before potential global expansion. Early clinical data expected in 2027.

• Market and Competitive Outlook:

  • Late-line MSSCRC: Positioned to address the poor standard of care (current response rates with single-agent PD-1 are near 0% to 3%). Differentiation target is durable responses and OS "tail" benefits.
  • Neoadjuvant CRC: Addresses a "technically no FDA-approved therapy" landscape; aims to provide a chemo-free regimen with deep responses to improve EFS post-surgery.
  • HCC: Seeks to improve upon current standards of care (AtezoBev at ~20-30% response rate; Nivo-EP at ~36%); target is to validate adding a CTLA-4 inhibitor to PD-1/VEGF regimens.
  • Differentiation: ADG126 utilizes a proprietary epitope (10x higher ADCC than Ipilimumab) and "SafeBody" masking technology to improve the therapeutic index, allowing for higher dosing (up to 20 mg/kg) with discontinuation rates <10%.

• Macro / Industry Outlook:

  • Regulatory Pathways: Management expresses high confidence in FDA alignment regarding carving out the specific indication (MSSCRC without liver metastases). They anticipate the FDA may allow ORR as a co-primary endpoint to support accelerated approval.
  • Geography: Initial global expansion for ADG138 will be contingent on China enrollment success before potential scope expansion.

• Strategic Initiatives:

  • Capital Markets: Maintaining active Business Development (BD) focus; seeking partnerships to expand SafeBody platform applications (monoclonals and T-cell engagers) similar to recent Sanofi and Third Arc Bio deals.
  • Clinical Advancement: Progression from Phase 1 to Phase 2 and Phase 3 is tightly coupled with H1/H2 2027 data milestones for ADG126.
  • Platform Expansion: Leveraging SafeBody technology for new indications (HCC, T-cell engagers) and earlier disease settings (neoadjuvant) to de-risk the asset pipeline.

• Risks and Headwinds to Outlook:

  • Clinical Maturity: Early readouts (ORR, PFS) in Phase 2 may not be sufficient to confirm survival benefits; OS data will be too early in Phase 2.
  • Regulatory Uncertainty: The Phase 3 control arm and endpoint structure (OS vs. ORR) are still to be determined pending further FDA interaction.
  • Safety Profile: In neoadjuvant settings, safety is critical to ensure surgery is not delayed or derailing the only potential cure for patients.
  • Data Variability: Small sample sizes in current HCC and Phase 1b2 data require confirmation in larger Phase 2 trials to validate the 40-50% response rate targets.
  • Collaboration Control: For the Insight Biologics partnership, the timing of data readouts is controlled by the partner, not Adagene.

• Management Tone on the Future:

  • Confidence: Management expresses "very good," "high," and "solid" confidence in the data (10x ADCC, 20-month OS in Phase 1), the regulatory path (FDA alignment), and the platform's differentiation.
  • Strategic Focus: Aggressive tone regarding BD and clinical expansion, aiming to capitalize on the "unmet medical need" in late-line and neoadjuvant CRC, as well as HCC.
  • Hedges: Tone remains scientific and cautious regarding specific survival outcomes until larger datasets (Phase 2/3) are generated, acknowledging that "early read should be sufficient" only as a starting point for further FDA discussions.

• Miscellaneous:

  • Clinical Trial Naming: Phase 2 trial for late-line CRC is referred to as "Project Optimus"; neoadjuvant trial is "Project Artemis" (referenced in context of prior end-of-phase meeting) or IST.
  • Dosing Specifics: Phase 2 will test 10 mg/kg Q3W vs. 20 mg/kg Q6W in combination with Keytruda.