KOSDAQBiotech & Pharma304360

S.Biomedics

₩21,150▼ 2.08%2026-10-02 close
Market Cap
₩260.9B
Turnover
₩300M
Volume
20,000 shares
Shares out.
12.5M
PER
—
PBR
7.8×
EPS
-₩974
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

TED-A9 Two-Year Data, US Phase 3 Ahead

S. Biomedics has secured 24-month follow-up data for its Parkinson's disease cell therapy TED-A9 and is preparing to enter US Phase 3 trials, while revenue has grown modestly even as operating losses have widened each quarter.

  1. 1

    The 24-month topline data from the TED-A9 Phase 1/2a trial confirmed motor function improvements that expanded over time.

  2. 2

    In April 2026 the company raised roughly KRW 40 billion via convertible preferred stock and convertible bonds under zero-interest, no-refixing terms with institutional participation.

  3. 3

    Consolidated revenue rose for a fourth consecutive year in 2025, but operating losses widened in parallel.

  4. 4

    The company aims to submit a Phase 3 IND for TED-A9 to the US FDA sometime in 2026, while pursuing Korea's regenerative medicine law revision and consultations with Japan's PMDA.

  5. 5

    Subsidiary Esthepharm's filler and anti-aging cosmetic products form the practical backbone of consolidated revenue.

02

Business structure

Founded in 2003, S. Biomedics is a cell therapy developer built on two core platforms: TED, which precisely differentiates embryonic stem cells into target cell types, and FECS, which forms three-dimensional cell spheroids.

Its core pipeline includes the Parkinson's disease cell therapy TED-A9, the spinal cord injury therapy TED-N, the critical limb ischemia therapy FECS-Ad, and the eye wrinkle therapy FECS-DF, several of which have entered domestic clinical trials.

Its commercialized product is Cure Skin, an autologous fibroblast-based treatment for acne scars, which is sold through general hospitals, university hospitals, private dermatology and plastic surgery clinics.

However, the practical revenue backbone of the consolidated group lies with subsidiary Esthepharm, which was established in 2016 and manufactures and sells anti-aging cosmetic products including fillers and fibroblast-culture cosmetics. Esthepharm's cosmetic products dominate revenue, while S.

Biomedics' cell therapy business remains at a research stage with limited commercial sales.

On the competitive front, few global companies are advancing embryonic or induced pluripotent stem cell-based Parkinson's therapies into late-stage trials, and Bayer subsidiary BlueRock Therapeutics's bemdaneprocel, which moved directly from Phase 1 into Phase 3 without a Phase 2 trial, is viewed as the closest benchmark.

The company is building manufacturing capability through its Paju GMP facility and a partnership with global CDMO Catalent for commercial-grade process validation, technology transfer, and staged scale-up under a dual manufacturing structure.

This is linked to a multi-track commercialization strategy centered on the United States, Korea, and Japan that leverages each country's regulatory framework in parallel.

03

Earnings trend

Quarterly revenue · Operating profit
RevenueOperating profit
Annual revenue · Operating profit
RevenueOperating profit
Quarterly results · Last 5 quarters
QuarterRevenueOperating profitOp. margin
2025Q2₩4.8B-₩2B−42.6%
2025Q3₩3.2B-₩1.9B−59.4%
2025Q4₩4B-₩2.7B−66.4%
2026Q1₩4.4B-₩3B−68.0%
2026Q2₩4.8B-₩3.7B−76.5%
Annual results
YearRevenueOperating profitNet income (parent)Op. marginROEDebt-to-equity
2022₩12.1B-₩3.7B-₩6.3B−30.9%—2253.3%
2023₩13.1B-₩6B-₩7.5B−45.7%−108.5%160.3%
2024₩13.7B-₩5.4B-₩5.8B−39.6%−49.1%143.6%
2025₩16.5B-₩8.3B-₩8.1B−50.4%−93.6%146.4%

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

Consolidated revenue rose for a fourth consecutive year to KRW 16.55 billion in 2025, up from KRW 13.73 billion in 2024, KRW 13.11 billion in 2023, and KRW 12.11 billion in 2022.

Operating losses, however, widened from KRW 3.75 billion in 2022 to KRW 5.99 billion in 2023, KRW 5.45 billion in 2024, and KRW 8.34 billion in 2025, showing that losses grew even as revenue expanded.

The operating margin deteriorated to -50.4% in 2025 from -39.6% in 2024, -45.7% in 2023, and -30.9% in 2022, while the net loss attributable to owners grew from KRW 5.82 billion in 2024 to KRW 8.12 billion in 2025.

On a quarterly basis, revenue eased from KRW 4.81 billion in 2Q25 to KRW 3.25 billion in 3Q25 before recovering to KRW 4.03 billion in 4Q25, KRW 4.40 billion in 1Q26, and KRW 4.82 billion in 2Q26.

Operating losses, however, widened each quarter over the same period-from KRW 2.05 billion in 2Q25 to KRW 1.93 billion in 3Q25, KRW 2.68 billion in 4Q25, KRW 2.99 billion in 1Q26, and KRW 3.69 billion in 2Q26-suggesting that rising R&D spending ahead of the US Phase 3 trial is flowing directly into the bottom line.

Notably, the 2Q26 net loss attributable to owners reached KRW 6.84 billion, far exceeding both the prior quarter (KRW 2.37 billion) and the year-earlier quarter (KRW 3.00 billion), the largest of the past five quarters.

As a result, the cumulative net loss attributable to owners over the trailing four quarters (3Q25-2Q26) totaled KRW 12.06 billion.

Operating cash flow remained negative for four straight years, at -KRW 3.21 billion, -KRW 6.15 billion, -KRW 3.50 billion, and -KRW 3.98 billion from 2022 through 2025, underscoring continued cash burn tied to clinical investment.

On the capital side, owners' equity swung from a deficit of KRW 3.78 billion in 2022 (capital impairment) to KRW 6.93 billion in 2023 and KRW 11.86 billion in 2024, before declining again to KRW 8.68 billion in 2025 as accumulated deficits partly offset capital raised.

05

Industry analysis

The Parkinson's disease treatment market remains an area of unmet need where no fundamentally curative therapy has been commercialized, and cell therapies differ from existing approaches in that while conventional treatment centered on levodopa and deep brain stimulation only managed symptoms, cell therapy aims to replace lost dopamine neurons.

Only a handful of global companies are advancing embryonic or induced pluripotent stem cell-based Parkinson's therapies into late-stage trials, with BlueRock Therapeutics' pipeline noted above cited as the leading comparable case.

The global stem cell market is projected to grow at an average annual rate of 14.9% to roughly KRW 58.8 trillion by 2030, suggesting the industry itself remains in an early growth phase.

In Korea, an amendment to the Act on the Safety and Support for Advanced Regenerative Medicine and Advanced Biological Medicine has been referred to the National Assembly's Health and Welfare Committee, and its passage would affect the domestic early-treatment and commercialization pathway for embryonic stem cell-based therapies.

Japan is regarded as a representative market where iPSC-based Parkinson's cell therapies are being developed under a conditional approval process, with an early-approval, early-treatment structure functioning in practice in regenerative medicine, making it a focal point for an Asian commercialization foothold.

On competitive intensity, some analysis suggests that cell therapy competitiveness is determined less by clinical results alone than by stable production, long-term engraftment, manufacturing reproducibility, and quality control. Within this landscape, S.

Biomedics is pursuing dual manufacturing through its Paju GMP facility and its CDMO partnership with Catalent to secure commercialization competitiveness.

06

Outlook

In June 2026, the company released 24-month follow-up topline data from the domestic Phase 1/2a trial of TED-A9, reporting that favorable safety was maintained through two years post-transplant while motor symptom improvement continued.

In particular, the high-dose group's motor function score improved progressively, declining by 15.5 points at 12 months, 16.5 points at 18 months, and 18.5 points at 24 months, and the company stated that no cell transplant-related adverse events had been reported through the 24-month mark.

Building on this, and referencing a competitor's pathway that skipped Phase 2 and went directly into Phase 3, the company aims to submit an IND to the US FDA within the year for a commercial-stage clinical trial of TED-A9.

In an April 30, 2026 report, DS Securities projected that the company targets an October 2026 Phase 3 IND filing, which if successful could lead to a regulatory filing in 2029 and launch in 2030.

Domestically, passage of the regenerative medicine law amendment is expected to let the company leverage its existing manufacturing license as a substitute for a separate cell-processing facility license, while in Japan the company is reviewing the feasibility of a conditional approval pathway through preliminary consultations with the PMDA.

The company was also recently selected as a participating institution in the Ministry of Health and Welfare's 2026 Korea-US Innovation R&D support program, under which it plans to build an AI-NAMs platform with Johns Hopkins University using human brain organoids and AI-based multimodal analysis.

On financing, in April 2026 the company resolved to issue KRW 17.8 billion in convertible preferred stock and KRW 22.2 billion in convertible bonds, under zero-interest, no-refixing terms that removed dilution concerns for existing shareholders.

07

Valuation

PER
—
PBR
7.8×
ROE
-63.6%
EPS
-₩974
BPS
₩2,450
Dividend per share
₩0

S. Biomedics remains in a phase where conventional earnings-based valuation metrics are difficult to apply, given continued operating losses.

Its shares trade at a level that reflects a substantial premium to net asset value, suggesting that clinical data and commercialization expectations are the central variables driving valuation.

The company pays no dividend, reflecting a capital allocation structure typical of growth-stage biotech firms that prioritize R&D investment and commercialization readiness over shareholder returns.

In an April 30, 2026 report, DS Securities issued a buy rating with a target price of KRW 65,000, reflecting its US-Korea-Japan commercialization strategy, while noting that its probability-of-success assumptions could be revised following the May-June clinical data readout.

This reflects that brokerage's own judgment, and readers should bear in mind that the basis for such valuations could shift depending on the outcome of the FDA IND filing and other regulatory events ahead.

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

Improving quality of long-term follow-up data

The 24-month topline data for TED-A9 showed the high-dose group's motor function scores improving progressively at the 12-, 18-, and 24-month marks. The company stated that no cell transplant-related adverse events have been reported through two years post-treatment.

This long-term safety and efficacy data is being used as the basis for discussions on entering US Phase 3 trials.

Large-scale financing on favorable terms

In April 2026, the company raised approximately KRW 40 billion through convertible preferred stock and convertible bonds. The financing carried zero-interest, no-refixing terms, which relatively limited immediate dilution concerns for existing shareholders. Tiger Asset Management participated as an anchor investor and Dongkook Pharmaceutical as a strategic investor.

Filler business supporting the revenue base

Consolidated revenue rose for four consecutive years from 2022 to 2025. This growth appears to be driven mainly by sales of filler and anti-aging cosmetic products from subsidiary Esthepharm.

With the cell therapy segment yet to generate commercial revenue, this business serves as a cash buffer for the group as a whole.

09

Bear factors

Widening operating losses

Operating losses expanded every year, from roughly KRW 3.75 billion in 2022 to KRW 8.34 billion in 2025. On a quarterly basis, losses also widened each quarter from 2Q25 through 2Q26. R&D spending in preparation for US Phase 3 trials is acting as a direct pressure on the bottom line.

Uncertainty over the US clinical pathway

The company is targeting a direct path to Phase 3 without a Phase 2 trial, similar to a competitor, but this depends on FDA approval. The possibility that the target IND filing timeline could slip cannot be ruled out.

Depending on the outcome of regulatory discussions, the trial design or development schedule could still be adjusted.

Continued reliance on external financing and dilution risk

Operating cash flow has been negative for four consecutive years, reflecting a business that has not yet generated cash internally. Recent financing has also come through convertible securities such as convertible preferred stock and convertible bonds, which could result in equity dilution upon conversion. Given a past history of capital impairment, the need for further fundraising could recur.

10

Risk factors

Clinical and regulatory risk

The strategy of moving TED-A9 directly into a US Phase 3 trial could change depending on further discussions with the FDA. If follow-up meetings, such as a Type C meeting, require additional Phase 2 data, the development timeline could be delayed.

Korea's regenerative medicine law amendment and Japan's conditional PMDA approval pathway also remain unconfirmed.

Financial risk

The company has posted operating and net losses for four consecutive years, with persistently negative operating cash flow. Costs are expected to increase further once US Phase 3 trials begin.

This raises the possibility of needing additional external financing, which depending on the method used could lead to equity dilution or changes in the financial structure.

Competitive and industry risk

Competitor BlueRock Therapeutics has a precedent of skipping Phase 2 and entering Phase 3, and is viewed by some as ahead in development speed.

The cell therapy industry overall remains in an early growth stage where commercialization capabilities such as stable production and manufacturing reproducibility are decisive. As a later entrant, it is difficult to secure competitive advantage based on clinical data superiority alone.

11

What to watch next

  1. Around October 2026

    Investors should check whether the company meets its stated target of submitting a Phase 3 IND for TED-A9 to the US FDA.

  2. 3Q26 earnings disclosure in Q4 2026

    Quarterly results should be checked to see whether the trend of widening operating losses continues and how the pace of cash burn evolves.

  3. During the National Assembly session in Q4 2026

    The progress of the regenerative medicine law amendment referred to the Health and Welfare Committee should be monitored, as its passage could change the availability of a domestic early-treatment pathway.

  4. Following IND submission, during FDA discussions

    It should be confirmed whether the FDA allows a direct path to Phase 3 without a Phase 2 trial; if not, the overall development timeline may need to be revised.

12

Overall view

S. Biomedics has accumulated 24-month long-term follow-up data for its Parkinson's disease cell therapy TED-A9, building the evidentiary basis for entering US commercial-stage trials.

At the same time, consolidated revenue has grown for four straight years, driven mainly by subsidiary Esthepharm's filler business, while operating losses have clearly widened both annually and in recent quarters.

The large-scale, zero-interest, no-refixing financing completed in April 2026 secured near-term financial flexibility, but operating cash flow remains negative and further fundraising needs may persist.

The key variable going forward is whether the company meets its 2026 target of filing-and gaining approval for-a Phase 3 IND with the US FDA, alongside progress on Korea's regenerative medicine law amendment and Japan's conditional PMDA approval pathway.

DS Securities has issued a target price reflecting a positive view of the commercialization strategy, but this is a brokerage opinion that could be revised depending on future clinical and regulatory outcomes.

Overall, the stock sits at a juncture where expectations tied to clinical progress and a persistent widening of losses remain in tension.

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. mpharm.edaily.co.kr
  2. comp.fnguide.com
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  4. m.thinkpool.com
  5. etoday.co.kr
  6. etoday.co.kr
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  8. etoday.co.kr
  9. ds-sec.co.kr
  10. newsway.co.kr
  11. saramin.co.kr
  12. fetv.co.kr
  13. hitnews.co.kr
  14. m.irgo.co.kr
  15. kr.investing.com
  16. dealsite.co.kr
  17. newswell.co.kr
  18. pharm.edaily.co.kr

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.