KOSDAQBiotech & Pharma298380

ABL Bio

₩51,800▼ 3.36%2026-10-02 close
Market Cap
₩2.9T
Turnover
₩13.7B
Volume
260,000 shares
Shares out.
56M
PER
—
PBR
23.2×
EPS
-₩1,497
Dividend Yield
0.00%

PER, EPS, PBR and BPS are calculated in-house from the last 4 quarters (2025Q3–2026Q2) · Dividend yield is based on ₩0 per share · Prices as of the 2026-10-02 close

01

Report overview

A BBB Shuttle Backed by Three Big Pharmas Enters Its Proving Phase

Platform licensing deals running from Sanofi to GSK and Eli Lilly are the source of revenue and cash, but the actual drug output now faces its first real gates: the ABL001 regulatory filing and the start of the ABL111 Phase 3.

  1. 1

    Revenue depends on when upfront payments and milestones are recognized, so quarterly swings are extreme: from KRW 75.7bn revenue and KRW 40.7bn operating profit in Q2 2025 to zero revenue and a KRW 29.7bn operating loss in Q4 2025.

  2. 2

    In November 2025 the company signed a Grabody platform deal with Eli Lilly worth up to USD 2.602bn, securing a USD 40mn upfront, while Lilly separately invested USD 15mn in equity. The upfront is recognized as revenue progressively over the early research period.

  3. 3

    Lead commercial candidate ABL001 met objective response rate and progression-free survival endpoints in its biliary tract cancer Phase 2/3, but overall survival missed statistical significance because of crossover. Regulatory path uncertainty remains.

  4. 4

    For first-line gastric cancer, ABL111 agreed with the US FDA to skip Phase 2 and begin a registrational Phase 3 in December 2026. Development speeds up, but so does the cost burden.

  5. 5

    Annual losses continue, but the balance sheet improved versus 2022-2023 with KRW 156.7bn of equity and a 79.3% debt-to-equity ratio at end-2025, and the company stated cash and equivalents stood at roughly KRW 190bn at the end of Q1 2026.

02

Business structure

ABL Bio develops pipelines on its bispecific antibody platform 'Grabody' and monetizes them through licensing, collecting upfronts, stage milestones and royalties. Most revenue comes from licensing income; the company has no self-marketed product yet.

The two pillars are Grabody-B, a blood-brain barrier shuttle, and Grabody-T, a 4-1BB bispecific platform for immuno-oncology. Grabody-B uses a carrier antibody targeting the insulin-like growth factor 1 receptor on the blood-brain barrier to improve drug delivery into the brain.

Ten pipelines including ABL301 (Sanofi), ABL001 (tovecimig), ABL111 (givastomig), ABL503, ABL105, ABL104, ABL103, ABL202, ABL206 and ABL209 are in clinical projects across the US, China, Australia and Korea.

Its customers are global pharma companies rather than patients: from the January 2022 ABL301 deal with Sanofi to the November 2025 Eli Lilly platform agreement worth up to USD 2.602bn, cumulative licensing value reaches about USD 6.5bn.

ABL001 was licensed to Compass Therapeutics in 2018, while Handok holds the Korean rights. Bispecific ADCs and dual-payload ADCs are developed through wholly owned US subsidiary NEOK Bio, with ABL206 and ABL209 having obtained Phase 1 IND clearance and initial data expected in 2027.

Competition spans domestic antibody and ADC developers as well as global pharma and biotech holding rival brain-shuttle technologies, and management has noted that interest in the field intensified after a competing candidate's clinical readout.

03

Earnings trend

Quarterly revenue · Operating profit
RevenueOperating profit
Annual revenue · Operating profit
RevenueOperating profit
Quarterly results · Last 5 quarters
QuarterRevenueOperating profitOp. margin
2025Q2₩75.7B₩40.7B53.8%
2025Q3₩1.4B-₩22.4B−1552.8%
2025Q4₩0-₩29.7B—
2026Q1₩13.1B-₩17.2B−131.1%
2026Q2₩19.7B-₩16.8B−85.3%
Annual results
YearRevenueOperating profitNet income (parent)Op. marginROEDebt-to-equity
2022₩67.3B₩900M₩3.2B1.3%4.6%166.4%
2023₩65.5B-₩2.6B-₩2.6B−4.0%−3.6%116.2%
2024₩33.4B-₩59.4B-₩55.5B−177.8%−33.2%38.7%
2025₩79.3B-₩40.4B-₩37.8B−50.9%−24.4%79.3%

Consolidated basis (financial statements including subsidiaries) · Final figures from DART filings · Net income attributable to owners of the parent · Data as of 2026-09-04

04

Earnings analysis

Earnings are driven by contract events, not product sales. Full-year 2025 revenue was KRW 79.3bn, well above KRW 33.4bn in 2024, yet the company still posted a KRW 40.4bn operating loss and a KRW 37.8bn net loss attributable to owners.

By quarter, Q2 2025 delivered KRW 75.7bn revenue and KRW 40.7bn operating profit, followed by KRW 1.4bn revenue with a KRW 22.4bn operating loss in Q3 2025 and zero revenue with a KRW 29.7bn operating loss in Q4 2025.

The roughly KRW 13.1bn booked in Q1 2026 was part of the Lilly upfront, and the company said related revenue would be recognized progressively through this year.

Q1 2026 showed KRW 13.1bn revenue with a KRW 17.2bn operating loss and Q2 2026 KRW 19.7bn revenue with a KRW 16.8bn operating loss, so revenue edged up while quarterly operating losses narrowed versus late 2025.

Historically, 2022 was profitable with KRW 0.9bn operating profit and KRW 3.2bn net profit, 2023 had KRW 65.5bn revenue with a small KRW 2.6bn operating loss, and 2024 saw revenue collapse and the operating loss widen to KRW 59.4bn, showing how upfront recognition can flip the entire income statement.

Operating cash flow improved from minus KRW 69.4bn in 2024 to minus KRW 41.3bn in 2025 but remains an outflow.

Leverage fell from a 166.4% debt-to-equity ratio in 2022 and 116.2% in 2023 to 79.3% in 2025, with equity rising from KRW 74.1bn in 2023 to KRW 156.7bn in 2025, and the company guided that cash and equivalents were about KRW 190bn at the end of Q1 2026 after receiving the Lilly upfront and equity investment.

The direction of profits therefore hinges on the timing of the next upfront or milestone rather than on cost cutting.

05

Industry analysis

Delivering drugs into the brain has long been the bottleneck in central nervous system drug development, and blood-brain barrier shuttle technology has recently become a focal investment area for big pharma.

One market research estimate puts the commercial value of BBB shuttle technology at roughly KRW 13tn by 2032 with a 21% compound annual growth rate, with global pharma actively pursuing research and licensing.

In Korea, bispecifics and ADCs have become the core of outbound licensing, and ABL Bio is among the few companies holding both modalities. Platform deals, however, live and die by partner priorities.

In January 2026 Sanofi noted in its results materials that ABL301 had been deprioritized, and Eugene Investment & Securities wrote in a February 2026 report that entry into Sanofi's global Phase 2 could take at least one to two more years.

In oncology, CLDN18.2 is an already contested target, and the same report assessed that ABL111 shows differentiated efficacy and safety versus a marketed drug in low-expression patients. The first-line gastric cancer market the company targets is cited at around KRW 4.5tn.

In short, end demand from big pharma investment in CNS and ADC is expanding, while individual pipelines sit at a stage where clinical data and partner strategy determine outcomes.

06

Outlook

The nearest checkpoint is the ABL001 filing. In its Q2 2026 results in August 2026, Compass Therapeutics said it would receive FDA feedback and was considering a BLA submission within the year.

Separately, CEO Lee Sang-hun said in a July 2026 interview that the target was to file early next year, so the timing carries a range.

The final analysis lifted the objective response rate to 18.0%, and the data are slated for an oral presentation session at the European Society for Medical Oncology congress in October 2026.

Second is ABL111: the company agreed with the FDA to skip Phase 2 and start a registrational Phase 3 in December 2026, and management said the Phase 3 would take two and a half to three years while pursuing licensing in parallel. Costs are split evenly with partner NovaBridge, according to the company.

On the platform side, ABL Bio announced it is pursuing additional licensing while advancing siRNA-optimized Grabody-B research and a next-generation shuttle, and it said Lilly would visit for a joint meeting around November-December 2026. In ADCs, initial Phase 1 data for NEOK Bio's ABL206 and ABL209 are expected in 2027.

07

Valuation

PER
—
PBR
23.2×
ROE
-44.3%
EPS
-₩1,497
BPS
₩3,071
Dividend per share
₩0

Profit-based multiples do not apply. The last four quarters (Q3 2025 to Q2 2026) sum to a net loss, so no price-to-earnings figure is produced, and there is no dividend, leaving no yield to compare.

Relative to book value, the shares trade at a premium well above the average for listed Korean pharma and biotech names, reflecting both the usual reality that an R&D company's equity base does not capture pipeline value and market expectations attached to cumulative licensing agreements of roughly USD 6.5bn.

Because revenue can swing from zero to tens of billions of won depending on when upfronts are recognized, earnings-based multiples are unstable, and the market mostly relies on summing the value of individual pipelines.

DS Investment & Securities said in April 2026 that commercialization of ABL001 would be meaningful in terms of pipeline expansion and proof of business execution.

Ultimately the valuation debate is less about the multiple itself than about differing assumptions on how much of the milestone potential converts into actual cash.

PER, EPS, PBR and BPS are all calculated in-house (the same method as Naver and Toss) · Dividend yield = cash dividend per share from DART filings (supplemented by KRX) ÷ current price · As of 2026-09-04

08

Bull factors

Three big pharmas chose the same platform

Following the 2022 Sanofi deal, the company signed a platform agreement with Eli Lilly in November 2025 worth up to USD 2.602bn. Before that it had licensed the Grabody-B platform to GSK in a deal worth GBP 2.2401bn including upfront and near-term milestones.

Multiple global pharma companies contracting on the same platform is repeated evidence of passing technical due diligence. The company has stated it continues to pursue further licensing deals.

Modality expansion from antibodies to siRNA

Research partner Ionis presented at a May 2026 conference that intravenous dosing of an siRNA-Grabody-B conjugate produced dose-dependent target gene reduction in the cerebrum, striatum, thalamus and cerebellum, contrasting with siRNA alone which was barely detected in the brain.

The company said delivery to peripheral tissues such as muscle and heart was also observed, prompting review of expansion into related disease areas. The more modalities the shuttle can carry, the wider the pool of potential licensees. Dual-shuttle work using the transferrin receptor and CD98hc is also in preclinical stages.

Funding runway and narrowing losses

The company said it held about KRW 190bn in cash and equivalents at the end of Q1 2026 after receiving the USD 40mn Lilly upfront and USD 15mn equity investment.

Quarterly operating losses narrowed from KRW 29.7bn in Q4 2025 to KRW 17.2bn in Q1 2026 and KRW 16.8bn in Q2 2026, while annual operating cash outflow shrank from KRW 69.4bn in 2024 to KRW 41.3bn in 2025. Management explained that ABL111 Phase 3 costs are shared equally with the partner and spread over several years.

09

Bear factors

Uncertainty in the ABL001 approval path

Median overall survival was 8.9 months for the combination versus 9.4 months for the control arm, which the company attributed to 31 of 57 control patients crossing over. Industry observers have questioned whether regulators will approve a drug whose overall survival did not reach statistical significance.

The filing timeline also remains at the stage where the partner says it is considering submission within the year.

Partner dependence and prioritization risk

Sanofi stated in its January 2026 results materials that ABL301 had been deprioritized. When development and commercialization are led by partners, pipeline value can be reset by factors outside the company's control.

Eugene Investment & Securities projected in February 2026 that Sanofi's move into global Phase 2 could take at least one to two more years. Most key assets including ABL001, ABL111 and ABL202 share the same structure.

Discontinuous revenue recognition

Revenue was zero in Q4 2025 and just KRW 1.4bn in Q3 2025, while Q2 2025 booked KRW 75.7bn of revenue and KRW 40.7bn of operating profit all at once.

Under such a structure, a single quarter's profit or loss does not represent the underlying trend, and annually the company swung from profit in 2022 to losses through 2023-2025. The Lilly upfront is likewise recognized in stages over the early research period.

10

Risk factors

Regulatory risk

Partner Compass planned an FDA meeting in early August 2026 and, based on the outcome, to pursue a filing within the year. If regulators demand additional data or a confirmatory trial, commercialization could be pushed out substantially. Tovecimig holds Fast Track and orphan drug designations, but designation alone does not guarantee approval.

Financial and funding needs

Operating cash flow was negative for three straight years: minus KRW 28.4bn in 2023, minus KRW 69.4bn in 2024 and minus KRW 41.3bn in 2025. Management explained that assuming total ABL111 Phase 3 costs of about KRW 500bn, its own share would be roughly KRW 250bn spread over several years. If milestone inflows are delayed, the need for additional funding could grow.

Competitive and technology risk

Both BBB shuttles and CLDN18.2 targeting are globally contested areas. The technology is described as one of the areas where global pharma is investing most intensively, so relative standing can shift with rivals' clinical results.

In 2026 there was also a case where a contract with partner IntoCell was terminated amid a patent issue on an in-licensed material. There is always the possibility that preclinical data fail to translate into the clinic.

11

What to watch next

  1. October 2026

    Tovecimig (ABL001) clinical data are scheduled for an oral presentation session at the ESMO congress. The key is how detailed metrics such as duration of response and the regulatory rationale are presented.

  2. Mid-November 2026

    Q3 2026 quarterly report disclosure. Since the Lilly upfront is recognized progressively over the early research period, watch whether quarterly revenue and the narrowing of operating losses continue versus the first half of 2026.

  3. November-December 2026

    A joint meeting with visiting Lilly researchers is scheduled. It is also a point at which progress on the additional Grabody-B licensing the company says it is pursuing may become visible.

  4. December 2026

    The registrational Phase 3 for ABL111 is due to start. Watch whether first patient dosing and trial design proceed as announced and how the cost-sharing structure flows into the financial statements.

  5. Q4 2026 to early 2027

    Compass said it is considering filing within this year, while the company cited early next year as its target. Whether and when the filing is actually accepted marks the fork in the commercialization roadmap. Initial Phase 1 data for NEOK Bio's ABL206 and ABL209 are also due in the same window.

12

Overall view

ABL Bio earns money from platform licensing rather than drug sales, and that structure is visible directly in its financial statements. The KRW 79.3bn of 2025 revenue and the KRW 40.7bn single-quarter operating profit in Q2 2025 came from upfront recognition, and must be read alongside Q4 2025 when revenue was zero.

In the first half of 2026, recognition of the Lilly upfront began, producing quarterly revenue of KRW 13.1bn and KRW 19.7bn and narrower quarterly operating losses, though the company remains loss-making.

The bull case rests on cumulative licensing agreements of about USD 6.5bn, roughly KRW 190bn of cash at the end of Q1 2026, and shuttle platform extensibility now demonstrated as far as siRNA delivery.

The bear case rests on ABL001 missing overall survival, Sanofi deprioritizing ABL301, and revenue recognition that is discontinuous and dependent on partner timelines.

Over the next six months, three verifiable facts arrive in sequence: the ESMO data release, whether the BLA is submitted, and the start of the ABL111 Phase 3. This report is for information purposes only and contains no buy or sell recommendation on any security.

13

Sources

  1. Korea Exchange (KRX) — Prices · Market Cap · Volume
  2. FSS electronic disclosure system (DART) — Financial statements · Dividend filings
Show 18 more articles and sources
  1. sentv.co.kr
  2. ablbio.com
  3. ideal-life.co.kr
  4. hankyung.com
  5. m.irgo.co.kr
  6. medicaltimes.com
  7. dailyinvest.kr
  8. hitnews.co.kr
  9. ablbio.com
  10. hitnews.co.kr
  11. alphasquare.co.kr
  12. investing.com
  13. insight.goover.ai
  14. kind.krx.co.kr
  15. bullstory.io
  16. comp.fnguide.com
  17. kr.investing.com
  18. m.thinkpool.com

Report written 2026-09-05 · Data as of 2026-09-04

This content is AI analysis of market data and web search results, provided for information only. It is not a solicitation or recommendation to invest. Investment decisions and their consequences are the investor's own responsibility. Data may be delayed or contain errors.