Cordlife Group Limited: Regulatory Update on Licence Renewals and Implications for Shareholders

Summary of Key Developments

• Renewal of Singapore cord blood banking and human tissue banking licences, but with stringent new conditions.
• Ongoing suspension of new cord blood collection and processing activities in Singapore, with significant operational and financial implications.
• Continued full operations in other jurisdictions, including Malaysia, Hong Kong, India, Philippines, Indonesia, and Thailand.
• Uncertainty regarding the Group’s financial performance for FY2026 and its ability to continue as a going concern.
• Company under close regulatory scrutiny and subject to additional compliance requirements imposed by the Ministry of Health (MOH).

Background and Timeline of Regulatory Actions

Cordlife Group Limited has faced a series of regulatory actions from Singapore’s Ministry of Health (MOH) concerning its cord blood banking operations:

• On 14 January 2025, Cordlife’s cord blood banking service licence (CBBS Licence) and human tissue banking service licence were renewed for a year.
• On 1 October 2025, the company received a notice of intention from MOH to suspend its CBBS Licence for a year due to regulatory concerns.
• Following internal assessments and voluntary cessation of new CBU (cord blood unit) collection since 30 September 2025, Cordlife submitted written representations to the MOH.
• On 26 November 2025, MOH issued a press release mandating that Cordlife stop collecting, testing, processing, and storing new cord blood, effective immediately.
• By 1 December 2025, these restrictions were formalized, and new licencing conditions were imposed.

Current Licence Renewal Status and New Conditions

CBBS Licence Renewal: Cordlife’s CBBS Licence has been renewed for one year (14 January 2026 – 13 January 2027), while its human tissue banking service licence has been renewed for two years (till 13 January 2028). However, the CBBS Licence renewal comes with stringent new conditions, which are substantially similar to those imposed after the November 2025 MOH regulatory action, with some additional requirements.

Permitted Activities Under the New Licence

• Storing existing CBUs (cord blood units).
• Facilitating the transfer of existing CBUs to another local or accredited overseas provider, upon written client request.
• Retrieval of existing CBUs for clinical purposes (e.g., transplant), including specific pre-release post-thaw testing, some of which must be performed in accredited laboratories.
• Disposal of existing CBUs only with written client authorization.

Prohibited Activities: Cordlife is not allowed to collect, test, process, or store any new CBUs for the duration of the CBBS Licence, unless otherwise directed by the MOH.

Additional Compliance Requirements

• Appointment of a new, suitably qualified Clinical Governance Officer (CGO) in line with MOH regulations.
• Stored CBUs may only be released for clinical use after assessment by a qualified haematologist.
• Retrospective review of all CBUs stored since 14 January 2025, with any non-conformance requiring investigation and remedial action. All such CBUs must be reviewed by the new CGO for continued storage suitability.
• Disclosure of any non-conformance to the donor’s mother, with mandatory counselling on clinical implications. The mother’s decision on CBU disposition must be respected and executed.
• Retrospective review of all laboratory activities since 14 January 2025, with corrective and preventive measures for any non-conformance (including instrument maintenance, temperature monitoring, supplier management, and quality control).
• Mandatory re-training of all laboratory personnel and implementation of an effective supervisory and documentation framework.

Implications for Shareholders and Investors

Financial Performance and Operational Impact

Business Suspension in Singapore: Cordlife has voluntarily and now regulatory ceased all new CBU collection, testing, processing, and storage in Singapore since 30 September 2025. This suspension is expected to continue until the MOH lifts the restrictions.

Geographic Diversification: The restrictions apply only to Singapore. Cordlife’s operations and licences in Malaysia, Hong Kong, India, Philippines, Indonesia, and Thailand remain unaffected and fully operational.

Uncertain Financial Impact: The company is unable to assess the full financial impact for FY2026 due to ongoing investigations regarding additional tank test results and the uncertainty surrounding the timing and outcome of the regulatory process. This introduces significant earnings and revenue uncertainty.

Going Concern Risk: The Board has previously issued a statement on the company’s ability to continue as a going concern, considering various risk scenarios and tolerance levels. Shareholders are advised to review the Board’s detailed assessment for a fuller understanding of the risks and uncertainties facing the company.

Potential Price-Sensitive Factors

• Extended suspension of new business in Singapore may materially impact revenue and cash flow from the company’s core market.
• Additional compliance costs, operational reviews, staff retraining, and regulatory oversight may increase expenses.
• The inability to predict when (or if) the MOH will lift restrictions creates further risk for both operational recovery and investor confidence.
• Any material deviation in the Board’s assessment of going concern status or new adverse regulatory developments could trigger further share price volatility.

Caution to Shareholders and Investors

The company has emphasized that this announcement is based on currently available information and includes forward-looking statements that are inherently subject to risks, uncertainties, and change. Actual results may differ materially from those expressed or implied.

Shareholders and potential investors should exercise caution when dealing in Cordlife shares and consult their professional advisers if in doubt about their investment decisions.

Disclaimer: This article is for informational purposes only and does not constitute investment advice or a recommendation to buy or sell any securities. The information is based on publicly available documents and may be subject to change. Investors should consult their own professional advisers and perform their own due diligence before making any investment decisions.

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