KOSDAQBiotech & Pharma340450

GC Genome

₩8,890▼ 4.10%2026-10-02 close
Market Cap
₩210B
Turnover
₩5.1B
Volume
580,000 shares
Shares out.
23.7M
PER
22.9×
PBR
1.5×
EPS
₩241
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

GC Genome: Post-Turnaround, Global Expansion Underway

GC Genome turned profitable in 2025 on the back of prenatal testing and multi-cancer early detection, and is now pursuing further growth through entry into the US and Japanese markets.

  1. 1

    2025 consolidated revenue reached KRW 31.5bn (+21.8% YoY), with operating profit of KRW 1.24bn, turning positive from a prior-year loss

  2. 2

    The company has posted operating profit for four consecutive quarters (Q3 2025–Q2 2026)

  3. 3

    The company plans to expand ai-CANCERCH hospital clients from 120 to 166 by year-end

  4. 4

    PanCancerSearch, a liquid biopsy pipeline product, is in a US clinical trial, with an FDA Breakthrough Device Designation filing planned for Q4 2026

  5. 5

    The company is also pursuing Japanese market entry via MHLW certification for its non-invasive prenatal test

02

Business structure

Founded in 2013 as a subsidiary of the GC Biopharma group, GC Genome is a clinical genomics specialist. Per its 2023 audit report, GC Biopharma held a 25.57% stake as the largest shareholder, with GC Holdings holding a 12.44% stake as the second-largest.

Its business spans three segments: obstetric testing, cancer and health-screening testing, and rare-disease testing, with the non-invasive prenatal testing service 'G-NIPT' forming the most stable revenue base.

Its key growth driver is 'ai-CANCERCH,' an AI-based multi-cancer early screening test that can simultaneously screen for six or more cancer types, including colorectal, lung, and liver cancer, from just 10ml of blood.

Its next-generation pipeline is 'PanCancerSearch,' a liquid-biopsy-based early detection service targeting pancreatic and other cancers, currently in clinical trials in the US led by affiliate GC LabTech.

Overseas expansion centers on Japan and the United States: in Japan, the company is developing the multi-cancer screening market in partnership with GC Lymphotec, while in the US it has signed a distribution memorandum of understanding with liquid biopsy and oncology diagnostics firm Guardant Health.

In the global competitive landscape, the company is compared with liquid biopsy leaders Guardant Health, GRAIL, and Exact Sciences, while domestic peers include Body Tech Med, EDGC, Cytogen, and Genecurix.

According to a Pharm Edaily report, the early cancer screening market still has no significant technology gap between domestic and global companies, so the goal is to grow into a competitive diagnostics firm on the global stage.

Per the 2023 audit report, the GC Medical Foundation accounted for 10% of GC Genome's revenue as an external customer, indicating some revenue reliance on affiliated group customers.

03

Earnings trend

Quarterly revenue · Operating profit
RevenueOperating profit
Annual revenue · Operating profit
RevenueOperating profit
Quarterly results · Last 5 quarters
QuarterRevenueOperating profitOp. margin
2025Q2———
2025Q3₩8.8B₩800M8.7%
2025Q4₩8.1B₩200M2.5%
2026Q1₩7.4B₩100M1.9%
2026Q2₩8.3B₩400M5.2%
Annual results
YearRevenueOperating profitNet income (parent)Op. marginROEDebt-to-equity
2024₩25.9B-₩1.2B-₩1.3B−4.8%−3.8%22.8%
2025₩31.5B₩1.2B₩4B3.9%5.2%8.1%

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

GC Genome's 2025 consolidated revenue was KRW 31.53bn, up 21.8% from KRW 25.89bn in 2024. Operating profit turned positive at KRW 1.236bn in 2025, a clear reversal from an operating loss of KRW 1.234bn in 2024, with the operating margin improving from -4.8% to 3.9%.

Net income attributable to owners swung from a loss of KRW 1.257bn in 2024 to a profit of KRW 4.044bn in 2025, with the increase in net income notably outpacing the improvement in operating profit.

On a quarterly basis, revenue was KRW 8.835bn with operating profit of KRW 0.773bn in Q3 2025, KRW 8.078bn revenue and KRW 0.201bn operating profit in Q4 2025, KRW 7.436bn revenue and KRW 0.140bn operating profit in Q1 2026, and KRW 8.288bn revenue and KRW 0.433bn operating profit in Q2 2026 — four straight quarters of operating profit.

However, net income attributable to owners in each of those quarters (KRW 1.435bn, KRW 2.386bn, KRW 0.814bn, and KRW 0.781bn, respectively) was consistently and substantially higher than operating profit, suggesting non-operating items played a meaningful role in bottom-line results.

On the balance sheet, total equity expanded sharply from KRW 33.08bn in 2024 to KRW 78.27bn in 2025, while total liabilities declined from KRW 7.54bn to KRW 6.35bn, lowering the debt ratio from 22.8% to 8.1%.

Operating cash flow also improved from KRW 0.378bn in 2024 to KRW 1.297bn in 2025, broadly tracking the earnings recovery.

05

Industry analysis

The global cancer diagnostics market is in a rapid growth phase. According to Grand View Research, the global cancer diagnostics market is expected to grow to USD 162.3bn by 2030, at a compound annual growth rate of 6.16%.

On the technology front, diagnostics are shifting from tissue biopsy toward liquid biopsy, a trend that improves diagnostic accessibility while satisfying efficiency, cost-effectiveness, and simplicity.

Multi-cancer early detection remains a nascent field without standardized methodology, and one domestic brokerage report assessed that standardized early detection methods are still lacking for many cancer types, and demand for early cancer diagnosis is structurally set to expand domestically just as it has in the US.

In the domestic prenatal testing market, rising maternal age and preference for non-invasive testing support demand, while in the US lung-cancer early detection segment, a Pharm Edaily report noted that Guardant Health, GRAIL, and Exact Sciences lead the market, but none of them has yet commercialized a lung-cancer early detection product, leaving room for later entrants.

Nonetheless, competition is intensifying as multiple global and domestic firms simultaneously pursue liquid biopsy and multi-cancer screening technology, leaving GC Genome with the ongoing task of continuing to prove its price competitiveness and data reliability.

06

Outlook

In a June 2026 report, Sangsangin Securities analyst Ha Tae-gi forecast that given the seasonal characteristic of revenue concentration in the second half, full-year 2026 revenue would rise 21.0% year-on-year to KRW 38.2bn, with operating profit reaching KRW 3.4bn.

The report also projected that obstetric testing revenue, which grew 29.7% to KRW 8.5bn last year, would rise 26.2% to KRW 10.7bn this year, and anticipated that obtaining MHLW certification for non-invasive prenatal testing around July-August would allow full entry into the Japanese market.

In health screening, the company currently provides ai-CANCERCH to 120 hospital clients and plans to expand this to 166 by year-end.

For US expansion, the report noted that a US clinical trial of 1,500 subjects led by affiliate GC LabTech began in May, with about 30% completed as of the report, and that the trial could be completed within Q3 with data secured by August-September, potentially leading to a presentation of results at international conferences such as ESMO in October.

It further noted that based on this, GC Genome plans to file for FDA Breakthrough Device Designation in Q4, with the report expecting a decision as early as 2027, and that the company aims for commercialization by 2028 following FDA approval and securing a CPT code.

These timelines remain forward-looking plans and forecasts, subject to change based on actual regulatory and clinical outcomes.

07

Valuation

PER
22.9×
PBR
1.5×
ROE
7.1%
EPS
₩241
BPS
₩3,653
Dividend per share
₩0

GC Genome appears to trade at a premium to net asset value, which can be interpreted as reflecting the 2025 turnaround to profitability, revenue growth, and expectations around US and Japanese market entry.

Looking at the multi-year earnings trend, the company moved from an operating loss and net loss in 2024 to an operating profit and net profit in 2025, and this profit recovery phase appears to be influencing how the market values the stock.

The company currently does not pay a dividend, so dividend-related metrics carry limited reference value at this time.

As is typical for small-cap bio-diagnostics names, valuation multiples relative to earnings have historically fluctuated both above and below sector averages, and the market's valuation benchmark may continue to shift depending on the progress of clinical trials and regulatory approvals for new pipeline products.

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

Stable Growth in Core Businesses

The G-NIPT prenatal testing service continues to post revenue growth on rising maternal age and demand for non-invasive testing, with 2025 revenue up 29.7% year-on-year. The ai-CANCERCH multi-cancer screening test is also steadily expanding its hospital client base, supporting growth in the health-screening segment. These two pillars provide a stable foundation underpinning overall company performance.

Overseas Expansion Pipeline Taking Shape

In the US, PanCancerSearch is in clinical trials with an FDA Breakthrough Device Designation filing planned for Q4, and a distribution MOU with Guardant Health is already in place. In Japan, entry into the non-invasive prenatal testing market via MHLW certification is being pursued. These multi-pronged overseas efforts represent a potential factor for reducing reliance on the domestic market.

Improved Balance Sheet

Total equity expanded substantially in 2025 and the debt ratio fell from 22.8% to 8.1%, improving financial stability. Operating cash flow also remained positive and expanded. This could serve as a positive factor in securing investment capacity needed for future R&D or overseas expansion.

09

Bear factors

Earnings Seasonality and Reliance on Non-Operating Items

Because revenue is concentrated in the second half of the year, quarterly earnings show significant volatility. In each of the past four quarters, net income attributable to owners substantially exceeded operating profit, suggesting non-operating items had a meaningful impact on the bottom line. The task remains to continue confirming earnings power from core operations alone.

Valuation Premium and Small-Cap Characteristics

The company appears to trade at a premium to net asset value, and given its small market capitalization, share price volatility can be significant. As it does not pay a dividend, dividend-related investment appeal is limited. If future earnings fall short of expectations, the possibility of a valuation adjustment cannot be ruled out.

Intensifying Global and Domestic Competition

Liquid biopsy and multi-cancer early detection is a market where global majors such as Guardant Health, GRAIL, and Exact Sciences compete alongside numerous domestic firms simultaneously. Given assessments that the technology gap is not large, entry by later movers and price competition could intensify. This is a factor that could affect the pace of GC Genome's market share expansion.

10

Risk factors

Regulatory and Approval Risk

The FDA Breakthrough Device Designation filing is planned for Q4, but a decision is not expected until as early as 2027, leaving room for approval delays or denial. The timing of MHLW certification in Japan has also not yet been finally confirmed. Overseas regulatory approvals may not proceed as planned by the company.

Clinical and Technology Risk

The ongoing US clinical trial of 1,500 subjects is expected to serve as key evidence for PanCancerSearch's commercialization, but it is still an early stage with only about 30% completed, so final results cannot be predicted.

If clinical results fall short of expectations, the entire subsequent approval and commercialization timeline could be delayed. The ai-CANCERCH multi-cancer test also faces the ongoing technical challenge of expanding the number of cancer types it can detect.

Financial and Execution Risk

The structure in which net income substantially exceeds operating profit persists, so the sustainability of non-operating gains needs to be monitored. Execution of expansion plans, such as the target to grow ai-CANCERCH hospital clients to 166 by year-end, also needs to be confirmed.

As a small-cap stock, share price volatility driven by liquidity and supply-demand dynamics is another point to note.

11

What to watch next

  1. Around October 2026

    Check whether PanCancerSearch's US clinical trial results are presented at international conferences such as ESMO, and review the content of the data.

  2. Q4 2026

    Confirm via disclosures/IR whether and when the company files for FDA Breakthrough Device Designation.

  3. Mid-November 2026

    Q3 2026 earnings disclosure will show the effect of second-half revenue concentration and the trend in operating margin.

  4. Year-end 2026

    Verify whether the target of expanding ai-CANCERCH hospital clients to 166 is actually achieved.

  5. In the near term after September 2026

    Watch for an official announcement on whether MHLW certification for the non-invasive prenatal test has been obtained.

12

Overall view

GC Genome posted 2025 consolidated revenue of KRW 31.5bn and operating profit of KRW 1.24bn, turning positive from a prior-year loss, and has maintained operating profit for four consecutive quarters.

Its core businesses—prenatal testing (G-NIPT) and multi-cancer early detection (ai-CANCERCH)—underpin stable growth, while the US PanCancerSearch clinical trial, the planned FDA Breakthrough Device Designation filing, and Japanese market entry via MHLW certification stand out as key variables for future growth.

However, the pattern of quarterly net income substantially exceeding operating profit warrants monitoring for the sustainability of non-operating gains, and the seasonal concentration of revenue in the second half should also be factored into any interpretation of results.

The global liquid biopsy market shows clear growth, but competition is likely to persist given the simultaneous presence of large global players such as Guardant Health, GRAIL, and Exact Sciences alongside numerous domestic rivals.

The balance sheet improved in 2025 through capital expansion and a lower debt ratio, which could be a positive factor in securing investment capacity for future R&D and overseas expansion.

Investors will want to continue tracking verifiable facts such as clinical data, regulatory timelines, and actual achievement of client expansion targets going forward.

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. pharm.edaily.co.kr
  2. thebionews.net
  3. biotimes.co.kr
  4. newsmp.com
  5. newsmp.com
  6. butler.works
  7. m.irgo.co.kr
  8. m.thinkpool.com
  9. invest.zum.com
  10. comp.fnguide.com
  11. investing.com
  12. tossinvest.com
  13. stockplus.com
  14. press9.kr
  15. catch.co.kr
  16. thevc.kr
  17. gcgenome.com
  18. m.gcgenome.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.