Guggenheim 3rd Annual Healthcare Innovation Conference - ADAGENE INC

Financial Performance:

• Raised $70 million earlier in the year to support development programs.
• Cash runway extends into the second half of 2028.
• Sanofi, the company's second-largest equity shareholder, provided an equity investment and expanded its collaboration.
• No specific revenue, EPS, or profit margin figures provided as the company is in the clinical development phase.

Guidance and Future Outlook:

• Phase 2 (Project Artemis/Project Optimus): Data expected in H1 2027 for late-line MSSCRC without liver metastasis; results will inform FDA interactions for a potential Phase 3 initiated in H2 2027.
• Phase 2 (Singapore Neoadjuvant): Data anticipated in 2027 from the investigator-sponsored trial (IST).
• Phase 3 Design: A randomized trial with Overall Survival (OS) as the primary endpoint is planned; potential for accelerated approval via ORR as a co-primary endpoint pending FDA discussion.
• ADG138: Chinese FDA clearance received for the double-mask T-cell engager (CD3/ER2); early clinical data expected in 2027 following initial patient enrollment in China.

Business Segments and Product Lines:

• Lead Asset (ADG126/Muza): A masked anti-CTLA-4 antibody featuring proprietary SafeBody technology, designed to improve therapeutic index via protease-sensitive masking and high-dose administration (up to 20 mg/kg).
• Key Clinical Trials:
  • Late-line MSSCRC (No liver mets): ADG126 + Pembrolizumab showed 15–36% response rate (confirmed), 4–5 month median PFS, and ~20 month median OS with <10% discontinuation due to adverse events.
  • Neoadjuvant CRC: Investigator-sponsored trial testing high-dose ADG126 + Pembro to avoid surgery delays and induce deep responses.
  • Hepatocellular Carcinoma (HCC): Phase 1b2 data (Roche basket) showed 50% response rate (n=6) vs 20% control when added to AtezoBev; improved PFS and OS trends.
• Partnerships: Expanded collaboration with Sanofi; partnership with Third Arc Bio applying SafeBody to T-cell engagers (deal signed in 2025); collaboration with Insight to combine ADG126 with PD-1/TGF-β bispecific.

Market and Competitive Landscape:

• Differentiation: ADG126 binds a distinct epitope compared to first-gen antibodies (Ipilimumab, Tremelimumab, RelAT), offering ~10x higher ADCC and best-in-class masking efficiency.
• Unmet Needs: Targets specific populations with poor outcomes (late-line MSSCRC without liver mets, neoadjuvant CRC, HCC) where standard of care (Keytruda single agent or Chemo) has <4% response rates or high toxicity.
• Competitive Context: Peers (e.g., Agenus, BMS) are active in similar spaces; ADG126 aims to differentiate via higher response rates and durable OS curves in specific sub-segments.

Risks and Challenges:

• Regulatory Uncertainty: Phase 3 control arm (Lonsdorf-Bev vs. Regorafenib/Fruquintinib) and specific label indications (e.g., restriction to patients without liver mets) require final FDA agreement.
• Clinical Execution: Future outcomes depend on the durability of responses and Event-Free Survival (EFS) data in neoadjuvant settings; Phase 2 results must sufficiently support Phase 3 initiation.
• Market Dynamics: Rapid evolution of the CRC and HCC landscapes with new ADCs and mechanisms; potential competition from masked/unmasked competitors.

Management Commentary and Tone:

• Tone is confident and optimistic, emphasizing the "best-in-class" nature of the SafeBody platform and the significant therapeutic window expansion of ADG126.
• Management expressed high conviction in the strategy to carve out unique indications (e.g., "no liver metastasis") and cited strong prior FDA interactions as validation.
• Emphasis placed on safety (low discontinuation rates) as a critical enabler for high-dose therapy in curative-intent settings.

Analyst Questions and Answers:

• Phase 3 Readiness: Early Phase 2 data (H1 2027) is considered sufficient to trigger Phase 3 planning discussions.
• Neoadjuvant Strategy: Differentiation lies in deeper responses and safety; the company plans to test higher doses/more cycles than competitors (e.g., Agenus) to maximize efficacy.
• HCC Outlook: Confidence remains high in adding ADG126 to AtezoBev to exceed current ~20-30% response rate benchmarks, though large sample sizes will be needed to confirm superiority over Nivo-Bev.
• Platform Expansion: Management highlighted the versatility of SafeBody beyond mAbs into T-cell engagers, citing the Third Arc Bio deal as proof of concept.

Other Key Points:

• Catalyst Timeline: Key events for the next 12-18 months include the H1 2027 Phase 2 readouts (Project Artemis and Singapore IST) and potential early data from ADG138.
• Dosing Strategy: Unique high-dose schedules (20 mg/kg loading followed by 10 mg/kg) utilized to overcome toxicity limitations of first-gen CTLA-4 inhibitors.
• Geographic Strategy: ADG138 will enroll first in China before global expansion, leveraging local regulatory clearance.