KOSDAQBiotech & Pharma476040

Organoidsciences

₩7,100▼ 1.66%2026-10-02 close
Market Cap
₩46.5B
Turnover
₩100M
Volume
20,000 shares
Shares out.
6.6M
PER
—
PBR
—
EPS
-₩2,800
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

Revenue Growth Coexists With Widening Losses

Organoid evaluation solution revenue is expanding, but clinical trial and overseas expansion investments are simultaneously widening operating losses and cash burn.

  1. 1

    2025 revenue rose about 23% year over year to KRW 2.41 billion, while operating loss widened to KRW 16.2 billion

  2. 2

    In 2Q26 net loss widened well beyond the operating loss, pointing to a growing non-operating burden

  3. 3

    The intestinal organoid therapeutic ATORM-C received Phase 1 IND approval for Crohn's disease and showed early efficacy signals in an advanced regenerative medicine study for Behcet's enteritis

  4. 4

    A third-party capital raise in April 2026 and lock-up releases in May 2026 overlapped, highlighting ownership structure changes and potential supply pressure

  5. 5

    The global shift toward replacing animal testing is cited as a backdrop for expanding demand for evaluation solutions such as ODISEI

02

Business structure

OrganoidSciences was founded in 2018, originating from the organoid center of CHA Bundang Medical Center, and became the first company to list on KOSDAQ under Korea's newly created deep-tech special listing track in May 2025.

Its business is split into two pillars: the ATORM regenerative therapeutic platform, which engrafts organoids directly into damaged tissue to induce regeneration, and an organoid-based drug and material evaluation solutions business.

The therapeutic pipeline centers on the intestinal disease candidate ATORM-C, alongside ATORM-S for salivary gland hypofunction and additional liver and endometrium organoid candidates under development.

The evaluation solutions portfolio includes the spatial-biology gene analysis platform ODISEI, the researcher-facing culture service Organoize, the pharma-facing drug evaluation platform ADIO, and the material evaluation service organoEZ.

According to first-quarter 2026 revenue composition, domestic ODISEI sales accounted for more than half of revenue while organoEZ, combining domestic and export sales, made up roughly the other half, indicating some concentration in specific services.

Its joint-venture subsidiary PODO Therapeutics, formed with Severance Hospital, has commercialized ONCOSAYS, a body-fluid-based anticancer drug response prediction solution, while its German subsidiary Lambda Biologics is entering the European market with an antibody-drug conjugate evaluation platform.

Roughly twenty institutions, including Severance Hospital, use ODISEI, and the company signed a joint organoid-based drug development research agreement with JW Pharmaceutical in 2022.

The competitive landscape remains an early-stage market mixing domestic organoid startups such as MBD, QPeak Bio, and Cellbiotech with global organoid-on-chip companies, with the establishment of standardized regulatory validation frameworks flagged as a key variable for the industry's overall growth.

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₩300M-₩3.9B−1220.5%
2025Q4₩1.2B-₩3.8B−313.3%
2026Q1₩100M-₩4.2B−2955.2%
2026Q2₩600M-₩4.4B−728.2%
Annual results
YearRevenueOperating profitNet income (parent)Op. marginROEDebt-to-equity
2024₩2B-₩12.2B-₩11.2B−626.4%−73.4%69.3%
2025₩2.4B-₩16.2B-₩15.4B−673.2%−62.3%49.7%

Consolidated basis (financial statements including subsidiaries) · Final figures from DART filings · Net income attributable to owners of the parent · Data as of 2026-09-05

04

Earnings analysis

Consolidated 2025 revenue came to KRW 2.407 billion, up roughly 23% from KRW 1.953 billion in 2024, yet operating loss widened to KRW 16.20 billion from KRW 12.23 billion, and net loss attributable to owners grew to KRW 15.37 billion from KRW 11.25 billion.

The operating margin deteriorated further, from -626.4% in 2024 to -673.2% in 2025, reflecting rising R&D spending, listing-related costs, and overseas expansion investment that outpaced revenue growth.

Over the most recent four quarters (3Q25 through 2Q26), revenue swung sharply from KRW 320 million to KRW 1.227 billion, then to KRW 144 million and KRW 598 million, a pattern consistent with the project-based nature of evaluation solution contracts.

In contrast, operating loss expanded steadily each quarter, from KRW 3.907 billion to KRW 3.845 billion, KRW 4.243 billion, and KRW 4.354 billion, suggesting fixed-cost items have been rising regardless of revenue swings.

Notably, the 2Q26 net loss attributable to owners of KRW 6.725 billion significantly exceeded that quarter's operating loss of KRW 4.354 billion, indicating non-operating factors played a meaningful role in widening the bottom-line loss.

Full-year 2025 operating cash flow was negative KRW 13.99 billion, a faster cash-burn pace than the negative KRW 9.14 billion in 2024, contrasting with total equity that rose from KRW 15.29 billion to KRW 24.84 billion over the same period on listing and capital-raising proceeds.

The debt ratio declined from 69.3% in 2024 to 49.7% in 2025, a change driven more by equity expansion than by debt reduction.

05

Industry analysis

The global organoid market is projected to grow at a compound annual rate of 21.9% to roughly $12.2 billion by 2030, as the US FDA and European EMA roll out roadmaps and draft guidelines to reduce reliance on animal testing, driving a shift in demand toward organoid and biomimetic-chip-based new approach methodologies (NAMs).

In October 2025, an anticancer drug candidate reportedly received FDA IND approval based solely on organoid data without animal testing, adding a concrete precedent to this industry transition.

In response, OrganoidSciences launched the K-NAMs platform together with more than 22 industry, academic, and research institutions to pursue test-method standardization, regulatory-compliance validation, and a foundation for commercialization.

At the same time, some observers note that Korea's domestic ecosystem, despite strong underlying technology, has lagged in establishing standardized validation frameworks and regulatory alignment, slowing real-world industrial adoption.

In terms of competitive positioning, OrganoidSciences holds a distinctive status as the sole Korean company whose organoid-based regenerative therapeutic technology was designated a national strategic technology by the Ministry of Trade, Industry and Energy in 2023, and it was also selected by the Animal Free Initiative as Korea's first certified NAMs testing institution.

The regenerative therapeutics segment remains an early-stage market globally where no company, domestic or international, has yet reached full commercialization, making the pace of clinical and regulatory data accumulation the key competitive variable.

06

Outlook

The company obtained short-term efficacy data for Behcet's enteritis patients in an advanced regenerative medicine study of its intestinal therapeutic candidate ATORM-C, and it resubmitted a Phase 1 IND for the Crohn's disease indication at the end of December 2025, receiving MFDS approval roughly three months later according to company statements.

Following this, the company aims to begin a domestic Phase 1 trial and has set targets to file an FDA IND in 2026 and complete a global Phase 2 trial by 2028.

Its subsidiary PODO Therapeutics expects, per company commentary, that ONCOSAYS revenue from major domestic hospitals will ramp up in the second half of 2026, based on clinical data from more than one hundred patients.

In a December 16, 2025 report, Korea Investment & Securities projected that the mid- to long-term growth story would take shape as clinical progress in the regenerative therapeutics pipeline builds on ODISEI's stable revenue base, and it cited the company's own target of achieving KRW 10 billion in revenue and turning profitable by 2027; that report, however, did not issue an investment rating or a target price.

The company launched its K-NAMs platform at BIO KOREA 2026 held at COEX in April 2026 to expand the market for evaluation solutions such as ODISEI, and it is also pursuing expansion into Southeast Asian regenerative medicine markets including Thailand.

These targets remain contingent on clinical and regulatory procedures still in progress, and their actual achievement and timing will need to be confirmed through future disclosures.

07

Valuation

PER
—
PBR
—
ROE
-60.8%
EPS
-₩2,800
BPS
—
Dividend per share
₩0

Because the company continues to post operating losses, earnings-based valuation metrics remain undefined, a pattern common among early-clinical-stage biotech companies.

The share price trades at a level that reflects a premium over net asset value, and this level has shifted over time as capital expansion and widening losses have proceeded in parallel since listing. No dividend has ever been paid, so dividend-related metrics carry little meaningful signal at this stage.

In assessing valuation, factors such as the sustainability of evaluation-solution revenue growth from ODISEI and related services, the pace of regulatory progress in the ATORM-C clinical program, and the potential need for further capital raises warrant consideration alongside any single-point valuation multiple.

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 2026-09-05

08

Bull factors

Commercialized Revenue Base From Evaluation Solutions

Organoid evaluation solutions such as ODISEI, ADIO, and organoEZ have already reached commercialization, with roughly twenty client institutions including Severance Hospital.

Unlike typical drug developers whose entire revenue hinges on clinical success, this gives the company a relatively steadier cash-generating segment. The accelerating global shift toward reducing animal testing is cited as a factor that could expand demand for this business line.

National Strategic Technology Status and Clinical Progress

OrganoidSciences is the sole Korean company whose organoid-based regenerative therapeutic technology was designated a national strategic technology in 2023.

Its flagship candidate ATORM-C showed signals of ulcer healing and symptom improvement in an advanced regenerative medicine study targeting Behcet's enteritis, and it has received Phase 1 IND approval for a Crohn's disease indication, positioning it to advance into formal clinical trials. This early data and institutional standing could serve as a basis for expanding the broader pipeline.

Diversified Global Expansion Options

The German subsidiary Lambda Biologics is entering the European market with an ADC evaluation platform, joint-venture PODO Therapeutics is building a foothold in the domestic hospital market with ONCOSAYS, and the company is also pursuing entry into Southeast Asian regenerative medicine markets including Thailand.

With multilateral partnerships forming, including cooperation with European partner Midas Pharma, the company has established multiple growth paths that do not depend solely on the success of a single pipeline asset.

09

Bear factors

Widening Losses and Accelerating Cash Burn

The 2025 operating loss widened to KRW 16.2 billion from the prior year, and operating losses grew steadily each quarter over the most recent four-quarter window. Operating cash flow also deteriorated to negative KRW 14.0 billion in 2025 from negative KRW 9.1 billion in 2024.

Despite revenue growth, the structure in which fixed-cost-like spending rises in tandem increases reliance on external capital raising.

Small Revenue Base With Quarterly Volatility

Revenue over the most recent four quarters swung between KRW 144 million and KRW 1.227 billion, a pattern likely tied to project-based recognition of evaluation-solution contracts.

The absolute revenue base remains small, suggesting it will take considerable time before revenue generation can outpace the fixed-cost base.

Ownership Structure Shifts and Supply Overhang

Following a third-party capital raise decided in April 2026, May 2026 saw the release of 1,088,750 shares (17%) that had been under a one-year post-listing lock-up commitment, along with the release of 2.4 million shares (10%) tied to the Chinese-affiliated controlling shareholder, Hengsheng Universal Trading.

The combination of a Chinese corporate entity as the controlling shareholder and large-scale lock-up releases is a factor worth monitoring for potential supply pressure from future share sales.

10

Risk factors

Clinical and Regulatory Risk

The regenerative therapeutics pipeline, including ATORM-C, remains at an early stage of advanced regenerative medicine studies and Phase 1 trials, and commercialization, even by the company's own target, would not occur before 2027.

The advanced regenerative medicine pathway differs from conventional drug approval, and there is an ongoing possibility of schedule delays during discussions with regulators.

Financing and Dilution Risk

Amid persistent operating losses and cash burn, the company raised operating funds through a third-party capital increase in April 2026. If the loss structure continues, further capital raises involving additional equity dilution may become necessary, a factor that could affect existing shareholders' equity value.

Market and Competitive Risk

The global organoid market is growing, but it remains an early-stage sector with intensifying competition from domestic and international startups.

Much of the company's growth expectations depend on the policy trend of replacing animal testing, so if the pace or direction of related regulations diverges from expectations, it could affect the business plan.

11

What to watch next

  1. Around November 2026 (expected)

    The 3Q26 earnings disclosure should be checked to see whether revenue growth continues and whether the trend of widening operating losses changes.

  2. Second half of 2026

    This is the period to check whether and to what extent PODO Therapeutics' ONCOSAYS begins generating revenue at major domestic hospitals.

  3. From late 2026 onward

    Progress on the initiation of the domestic Phase 1 trial and first patient dosing for the ATORM-C Crohn's disease indication warrants tracking.

  4. Sometime in 2026 (company target)

    Whether and when the company files the targeted FDA IND should be confirmed.

  5. Second half of 2026

    Additional disclosures of share sales from the controlling shareholder or early investors among the recently unlocked shares should be monitored.

12

Overall view

OrganoidSciences is growing revenue through commercialized evaluation solutions such as ODISEI and organoEZ while advancing its ATORM regenerative therapeutic pipeline, the only one in Korea holding national strategic technology status, into clinical stages.

Yet as the 2025 results show, revenue growth has been accompanied by widening operating losses and accelerating cash burn, a pattern that has continued through quarterly data into the first half of 2026.

Entry into Phase 1 trials for the Crohn's disease indication and the expansion of PODO Therapeutics' hospital revenue are likely to serve as tests of the company's future business structure.

At the same time, capital and ownership-related variables in 2026, including the equity raise, large-scale lock-up releases, and the Chinese-affiliated controlling shareholder structure, also warrant attention.

While the industry backdrop of a global shift away from animal testing is favorable, the pace at which this translates into actual revenue and profit improvement will depend on future clinical and commercialization timelines.

Ongoing monitoring of upcoming quarterly results and clinical or financing-related disclosures is warranted before drawing any investment conclusions.

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. thevc.kr
  2. jobkorea.co.kr
  3. jobplanet.co.kr
  4. markets.hankyung.com
  5. incruit.com
  6. comp.fnguide.com
  7. jobplanet.co.kr
  8. m.dailypharm.com
  9. seoulexchange.kr
  10. stockplus.com
  11. m.thinkpool.com
  12. markets.hankyung.com
  13. butler.works
  14. investing.com
  15. m.thinkpool.com
  16. itooza.com
  17. eugenefn.com
  18. hankyung.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.