KOSDAQBiotech & Pharma365270

curacle

₩10,250▼ 1.25%2026-10-02 close
Market Cap
₩226B
Turnover
₩400M
Volume
40,000 shares
Shares out.
22.2M
PER
—
PBR
3.5×
EPS
-₩368
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

After the MT-103 Deal, Attention Shifts to Follow-on Pipelines

Curacle has reached a turning point by out-licensing its bispecific antibody MT-103, but its accumulated loss structure and the fate of follow-on pipelines remain the key variables.

  1. 1

    In May 2026, Curacle out-licensed bispecific antibody MT-103 to US-based Memento Medicines for up to KRW 1.56 trillion, with Curacle's attributed share at about KRW 781.8 billion (upfront of roughly KRW 5.8 billion)

  2. 2

    Q2 2026 revenue reached KRW 7.18 billion with operating profit of KRW 2.36 billion, marking the first profitable quarter in the period shown

  3. 3

    Completed the absorption merger of API firm Daesung Pharmtech in February 2026 to address listing-maintenance revenue requirements and build an internal revenue base

  4. 4

    Core kidney-disease candidate CU01 showed a 21-22% reduction in uACR versus placebo in its Korean Phase 2b trial, with follow-up data presented at ADA 2026

  5. 5

    Operating and net losses have persisted every year from 2022 through 2025, with annual revenue remaining minimal until recently

02

Business structure

Curacle is a Kosdaq-listed biotech developing therapeutics for intractable vascular diseases by targeting vascular endothelial dysfunction. Built on its small-molecule discovery platform SOLVADYS and antibody discovery platform EAGLES, the company holds a total of 16 pipelines including CU01, CU06, MT-101, and MT-103.

Its core assets are CU01, a diabetic nephropathy treatment, and CU06 (rivasterat), an oral retinal disease treatment, while its antibody pipelines are co-developed with antibody specialist MabTics.

Curacle previously out-licensed CU06 to French ophthalmology specialist Thea Open Innovation in 2021, but received a rights-return notice in 2024, creating a revenue gap; its core pipeline subsequently shifted to CU06 alongside neurodegenerative candidate CU71 and CU01.

In May 2026, Curacle out-licensed the bispecific antibody MT-103, co-developed with MabTics, to US-based startup Memento Medicines, marking its antibody pipeline's first commercialization achievement.

Under this deal, Curacle and MabTics split contract proceeds 50-50, with Curacle's attributed contract value at roughly KRW 781.8 billion.

Separately, in February 2026 Curacle absorbed API specialist Daesung Pharmtech, a company with more than 20 years of history, via a small-scale merger through new share issuance, adding API development, import, and distribution functions to its R&D-centered business to diversify revenue.

Competitively, the retinal disease market has long been dominated by anti-VEGF monoclonal antibodies such as Regeneron/Bayer's Eylea and Roche/Novartis's Lucentis, though the emergence of Roche's bispecific Vabysmo signals a shift toward bispecific-antibody approaches.

03

Earnings trend

Quarterly revenue · Operating profit
RevenueOperating profit
Annual revenue · Operating profit
RevenueOperating profit
Quarterly results · Last 5 quarters
QuarterRevenueOperating profitOp. margin
2025Q2—-₩5.3B—
2025Q3—-₩2.9B—
2025Q4₩0-₩4.7B—
2026Q1₩1B-₩3B−285.9%
2026Q2₩7.2B₩2.4B32.8%
Annual results
YearRevenueOperating profitNet income (parent)Op. marginROEDebt-to-equity
2022₩3.6B-₩12B-₩11.4B−334.4%−24.7%20.5%
2023₩10.3B-₩10.5B-₩11.6B−102.1%−27.7%66.7%
2024₩1.6B-₩12.6B-₩14.9B−773.9%−49.7%97.9%
2025₩7,101,468-₩16.5B-₩18.1B−232393.8%−48.8%43.5%

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

Curacle's annual revenue rose from KRW 3.58 billion in 2022 to KRW 10.29 billion in 2023, then plunged to KRW 1.63 billion in 2024 and shrank further to just KRW 0.071 billion in 2025. This revenue cliff was a direct result of the discontinuation of follow-on revenue recognition after the CU06 license was terminated.

Operating losses widened even as revenue fell, from KRW 11.98 billion in 2022 and KRW 10.51 billion in 2023 to KRW 12.63 billion in 2024 and KRW 16.50 billion in 2025, with the net loss attributable to owners reaching KRW 18.11 billion in 2025.

Operating cash flow was negative in all four years, with the largest outflow of KRW 13.45 billion recorded in 2025.

On a quarterly basis, operating losses continued from Q2 through Q4 2025 at KRW 5.32 billion, KRW 2.85 billion, and KRW 4.69 billion respectively, and Q1 2026 still posted an operating loss of KRW 3.0 billion despite KRW 1.05 billion in revenue.

However, Q2 2026 revenue jumped to KRW 7.18 billion, generating an operating profit of KRW 2.36 billion and a net profit attributable to owners of KRW 3.23 billion — the first profitable quarter in the period shown.

This appears to reflect the combined effect of API revenue from the Daesung Pharmtech merger and revenue recognition tied to the MT-103 deal, though on a trailing four-quarter basis (Q3 2025 through Q2 2026) the company still posted a cumulative net loss attributable to owners of KRW 7.59 billion, meaning a single profitable quarter does not by itself signal a full annual turnaround.

Equity fell from KRW 46.17 billion in 2022 to KRW 29.95 billion in 2024 before recovering to KRW 37.09 billion in 2025, reflecting capital raised through a rights offering and new shares issued for the Daesung Pharmtech merger despite continued net losses.

05

Industry analysis

In the retinal disease treatment market where Curacle operates, anti-VEGF monoclonal antibodies such as Regeneron/Bayer's Eylea and Roche/Novartis's Lucentis have long dominated, though the market is seen shifting toward bispecific antibodies following the emergence of Roche's Vabysmo.

Against this backdrop, Curacle's success in out-licensing its bispecific antibody MT-103 even at the preclinical stage is viewed as evidence of its antibody platform's commercial potential.

In the diabetic nephropathy (DN) market, RAAS inhibitors, SGLT-2 inhibitors, and Kerendia (finerenone)-class MRAs have become standard of care, yet residual risk—persistent proteinuria or declining renal function—remains even among patients on standard therapy, creating demand for additional treatment options.

CU01 targets this niche, having shown additional proteinuria reduction in a sub-analysis of patients already on standard combination therapy.

Korea's API market is described as showing steady growth according to market researcher IMARC, and Curacle entered this stable-revenue market segment through the Daesung Pharmtech merger.

Across the global biotech industry, deal structures involving out-licensing early-stage pipelines to venture-capital-backed NewCo entities have been increasing, and MT-103's counterparty Memento Medicines is itself such a NewCo, backed by venture capital firms including RA Capital and Forbion along with Sanofi Ventures.

06

Outlook

Curacle has selected a global contract research organization (CRO) for a US Phase 2b trial of its oral retinal disease treatment CU06 (rivasterat) and is preparing an IND filing for that Phase 2b trial sometime in 2026.

Based on its diabetic nephropathy Phase 2b results and the ADA 2026 presentation, CU01 will reportedly pursue domestic out-licensing first, with overseas licensing to be considered after global patent registration.

Antibody pipeline MT-101, targeting acute kidney injury and chronic kidney disease, remains at the preclinical stage, with licensing discussions reportedly ongoing with multiple partners.

Memento Medicines, which acquired MT-103, aims to enter global Phase 1 trials in 2027, making the timing of future milestone-related revenue recognition a point to watch.

In June 2026, Curacle signed a memorandum of understanding with AI drug discovery firm Aimble to combine its SOLVADYS platform with Aimble's AI technology for joint discovery and optimization of new small-molecule candidates, a move interpreted as an effort to improve discovery efficiency amid recently reduced R&D spending.

Whether the API revenue base secured through the Daesung Pharmtech merger remains stable over the coming quarters, beyond meeting listing-maintenance revenue requirements, is also worth monitoring.

07

Valuation

PER
—
PBR
3.5×
ROE
-22.6%
EPS
-₩368
BPS
₩2,888
Dividend per share
₩0

Given Curacle's continued annual net losses through recent periods, conventional earnings-based valuation metrics are difficult to apply meaningfully.

The level of share price relative to net assets varies depending on the calculation method, with the exchange's official figure showing a higher premium than the company's own calculation, a methodological difference worth noting.

The company does not pay cash dividends, so dividend-related metrics carry structurally limited relevance.

While the most recent quarter (Q2 2026) turned profitable at both the operating and net income levels, the trailing four-quarter total remains in net loss territory, leading some to view it as premature to read a single profitable quarter as a definitive annual turnaround.

Several brokerages have suggested that the MT-103 licensing deal marks the start of a valuation re-rating phase, but this reflects each firm's own assessment and could shift depending on whether follow-on pipelines actually secure licensing deals.

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

Demonstrated Commercialization Capability of the Antibody Platform

Curacle achieved its antibody pipeline's first commercialization milestone by out-licensing the preclinical-stage bispecific antibody MT-103 for up to KRW 1.56 trillion.

Shinhan Investment Corp described the company as a strong niche biotech with a track record of a large-scale global licensing success with a promising NewCo. This achievement has fueled expectations that licensing discussions for follow-on pipelines such as MT-101 and CU01 could accelerate.

Accumulating Efficacy and Safety Data for CU01

In its Korean Phase 2b trial, CU01 achieved statistically significant reductions in uACR versus placebo of 21.45% in the low-dose group and 22.21% in the high-dose group, with eGFR tending to be maintained over the treatment period.

The absence of hyperkalemia, an issue that has affected existing therapies, is seen as a positive for its competitive scalability. At ADA 2026, additional proteinuria reduction was confirmed even among patients on standard combination therapy, leading to a new use-patent filing.

Revenue Diversification via the Daesung Pharmtech Merger

In February 2026, Curacle absorbed API specialist Daesung Pharmtech, adding a stable revenue source to its R&D-centered drug development business. This is also reported to address Kosdaq listing-maintenance revenue requirements that took effect in 2026.

API revenue began appearing in results from Q1 2026, and a large revenue increase in Q2 is interpreted as having contributed to the quarter's turn to profitability.

09

Bear factors

Accumulated Losses and Continued Cash Burn

Curacle recorded operating and net losses for four consecutive years from 2022 through 2025, with operating cash flow remaining negative every year. While the company turned profitable in Q2 2026, the trailing four-quarter total remains in net loss.

R&D spending has also trended downward recently, so whether the profit improvement stems from a genuine strengthening of the core drug pipeline warrants confirmation in subsequent quarters.

Limited Disclosure on the Deal Counterparty

MT-103's counterparty, Memento Medicines, is a newly formed NewCo, and Curacle's disclosure did not go beyond identifying the counterparty as US-based Memento, without further detail. Dailypharm noted that information on the counterparty was overly limited, contrasting it with similar deals by other domestic biotechs.

Actual milestone monetization depends on Memento's clinical progress, and the NewCo's plan to enter global Phase 1 trials in 2027 could face delays.

History of a Reversed Licensing Deal

Curacle out-licensed CU06 to France's Thea Open Innovation for roughly KRW 190 billion in 2021, but received a contract termination and rights-return notice in May 2024. That event effectively pushed the company's revenue to near zero and raised concerns about being designated an administrative issue stock. New agreements such as MT-103 cannot be considered entirely free of similar risk of amendment or termination.

10

Risk factors

Clinical and Regulatory Risk

Unexpected delays or shifting results could occur at future clinical and regulatory stages, including IND approval for CU06's US Phase 2b trial and CU01's continued development and regulatory discussions.

The market dominance of competing therapies (anti-VEGF, bispecific antibodies, SGLT-2 inhibitors, MRAs) is also a variable that could affect commercialization success.

Financial and Capital Risk

Curacle has a history of raising funds through convertible bonds and rights offerings, and given its persistent net-loss structure, the possibility of needing additional capital in the future cannot be ruled out.

Its debt ratio has also swung sharply between roughly 20% and 90%-plus across different years, a point worth noting from a financial stability perspective.

Counterparty and Disclosure Risk

Transactions with venture-capital-driven NewCo partners such as Memento Medicines, the counterparty for MT-103, may involve a more limited level of disclosure than deals with established pharmaceutical companies.

Since staged revenue realization through milestones and royalties depends on the partner's funding and development progress, there is a time lag and uncertainty before the full contract value translates into actual cash flow.

11

What to watch next

  1. During H2 2026

    Watch for CU06's US Phase 2b IND filing and its progress. Any filing delay or design change could affect the broader subsequent development timeline.

  2. By Q4 2026 (within the year)

    Confirm whether MT-101 or CU01 secures an additional out-licensing deal, as flagged by some brokerages. Actual deal execution would serve as concrete validation of follow-on pipeline value.

  3. Around November 2026 (Q3 report filing)

    Reassess the sustainability of post-merger API revenue and any MT-103-related revenue recognition in Q3 results. This will help gauge whether Q2's turn to profit was a one-off factor or a sustained trend.

  4. H2 2026 through 2027

    Monitor Memento Medicines' actual progress against its stated goal of entering global Phase 1 trials for MT-103 in 2027. Any delay in clinical entry would likely push back the timing of milestone-related revenue recognition.

  5. Around March 2027 (FY2026 annual report)

    Check whether the FY2026 annual settlement meets listing-maintenance revenue requirements (e.g., annual revenue of KRW 3 billion) and how the Daesung Pharmtech integration effect is reflected on a full-year basis.

12

Overall view

Curacle has shown the typical profit-and-loss structure of a clinical-stage biotech, posting operating and net losses every year from 2022 through 2025, and it faced a near-total collapse in revenue during 2024-2025 after the termination of its CU06 licensing contract.

Against this backdrop, the company built an API revenue base through the February 2026 absorption of Daesung Pharmtech and created a turning point in May with the large-scale out-licensing of bispecific antibody MT-103.

As a result, Q2 2026 marked the first quarter in the period shown with both operating profit and net profit turning positive, though the trailing four-quarter total remains in net loss and whether this profitability is sustainable has yet to be confirmed.

Several brokerages have offered positive assessments citing CU01's Phase 2b data, its ADA 2026 presentation, and expectations for further MT-101 licensing, but these are each firm's own outlook and outcomes will depend on whether deals and milestones are actually realized.

At the same time, factors requiring balanced scrutiny include limited disclosure regarding new NewCo partners like Memento Medicines, the history of the terminated Thea contract, and ongoing cash burn.

Investors will want to track, in sequence, the CU06 IND filing, any further licensing deals, and the sustainability of revenue in the Q3 results.

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. m.thinkpool.com
  2. markets.hankyung.com
  3. m.irgo.co.kr
  4. finance.finup.co.kr
  5. biotimes.co.kr
  6. m.newsprime.co.kr
  7. getnews.co.kr
  8. dailypharm.com
  9. pharmnews.com
  10. kind.krx.co.kr
  11. m.thinkpool.com
  12. kind.krx.co.kr
  13. m.irgo.co.kr
  14. kind.krx.co.kr
  15. kind.krx.co.kr
  16. dart.fss.or.kr
  17. judal.co.kr
  18. newsis.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.