Brokerage : Mirae Asset Securities
Analyst : Seungmin Kim
Investment Rating : Not Rated
Target Price : –
Core Momentum : Re-rating of the IGF1R-targeting Grabody-B platform following Denali’s initial BBB shuttle FDA approval, alongside upcoming ABL001 Phase 2/3 trial data readout in April
📊 1. [Valuation & Key Financial Metrics]
- Investment Rating & Target Price: Not Rated (No Target Price provided), Current Price KRW 172,300 (As of 2026-03-25)
- Historical Financials (K-IFRS Separate, Net Profit represents controlling interest):
- 2021: Revenue KRW 5 Billion, Operating Profit KRW -52 Billion (OP Margin -1,040.0%), Net Profit KRW -44 Billion, EPS KRW -927, ROE -59.4%, P/E -23.8x, P/B 18.6x, Dividend Yield 0.0%
- 2022: Revenue KRW 65 Billion, Operating Profit KRW 0 Billion (OP Margin 0.0%), Net Profit KRW 4 Billion, EPS KRW 81, ROE 6.1%, P/E 283.9x, P/B 15.7x, Dividend Yield 0.0%
- 2023: Revenue KRW 64 Billion, Operating Profit KRW -3 Billion (OP Margin -4.7%), Net Profit KRW -2 Billion, EPS KRW -52, ROE -3.4%, P/E -472.9x, P/B 15.8x, Dividend Yield 0.0%
- 2024: Revenue KRW 33 Billion, Operating Profit KRW -59 Billion (OP Margin -178.8%), Net Profit KRW -55 Billion, EPS KRW -1,088, ROE -45.5%, P/E -27.5x, P/B 9.6x, Dividend Yield 0.0%
- 2025: Revenue KRW 79 Billion, Operating Profit KRW -39 Billion (OP Margin -49.4%), Net Profit KRW -37 Billion, EPS KRW -671, ROE -22.5%, P/E -298.3x, P/B 69.9x, Dividend Yield 0.0%
- Stock Metrics: KOSDAQ 1,159.55pt, Market Cap KRW 9,647 Billion, Outstanding Shares 56 Million shares, Floating Ratio 75.5%, Foreign Ownership 12.0%, 12-Month Beta 1.00, 52-Week High/Low KRW 245,500 / KRW 33,000
🚀 2. [Market Opportunities & Business Outlook]
- Commercial Validation of BBB Shuttle via Denali’s FDA Approval:
- Denali Therapeutics’ (DNLI US) tividenofusp alfa (brand name: AVLAYAH) received FDA accelerated approval for MPS II (Hunter syndrome), marking the first FDA approval for a TfR-based BBB penetration platform.
- Establishes regulatory precedence for CSF biomarker-based accelerated approval pathways.
- Inclusion of anemia and neurotoxicity monitoring on AVLAYAH’s label is expected to reinforce positioning for next-generation BBB shuttles with superior safety profiles.
- Structural Competitive Advantages of IGF1R-Based Grabody-B:
- Brain Expression: IGF1R (32.7%) vs. TfR (5.6%).
- Aging Stability: Expression remains unaffected by aging (whereas TfR expression declines with age).
- Safety: Absence of anemia or hematologic toxicity risks and non-interference with endogenous IGF1R signaling.
- Transcytosis Pathway: Employs multiple endocytic routes (CME, FEME, caveolae) and bypasses Rab5-associated lysosomal degradation.
- Backed by out-licensing agreements with Sanofi (2022), GSK (Apr 2025), and Eli Lilly (Nov 2025), with cumulative milestone values surpassing KRW 9 Trillion.
- April Readout for ABL001 (Tovecimig) Phase 2/3 Trial:
- Partner Compass Therapeutics (CMPX US) is scheduled to disclose COMPANION-002 Phase 2/3 data (n=168) in 2L biliary tract cancer in April.
- Following confirmation of primary endpoint ORR statistical superiority (17.1% vs. 5.3%, p=0.031), trial design indicates high probability of PFS statistical significance, with RPSFT-adjusted OS expected to serve as key regulatory evidence.
📝 Editor’s Comment (Perspective)
The covering analyst views ABL Bio as a frontline biotechnology developer holding structurally differentiated IGF1R-based Grabody-B technology within the newly validated BBB shuttle therapeutics landscape. This perspective prioritizes the commercial and regulatory de-risking of the BBB shuttle modality, alongside the simultaneous validation of both its CNS delivery platform and its clinical bispecific antibody asset (ABL001), over short-term trading volatility.
To verify whether this investment thesis continues to materialize, primary focus should be directed toward the upcoming COMPANION-002 Phase 2/3 data readout (specifically PFS and RPSFT-adjusted OS) by Compass Therapeutics in April, as well as the operational clinical progress and potential deal expansions across partnered Grabody-B assets with Sanofi, GSK, and Eli Lilly. These operational milestones can be monitored through upcoming medical congress presentations, partner disclosures, and official regulatory filings.
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