Update on Launch of Lung Cancer Test in USA

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15 October 2026

Cizzle Biotechnology Holdings plc

("Cizzle", "Cizzle Biotechnology", or the "Company")

Update on Launch of Lung Cancer Biomarker Test in USA

New Milestone Payment and Revised Advance Royalty Payments Schedule

Cizzle Biotechnology, the UK based diagnostics developer of early cancer tests, is pleased to provide an update on progress in the USA towards early adoption of its proprietary test for the CIZ1B biomarker (the “Test”), which is highly associated with early-stage lung cancer.

Highlights

•          The Company and BIO have successfully achieved the Test’s validation in a CLIA accredited laboratory in the USA and BIO is rolling out the Test to larger, more centralised CLIA laboratories as part of a strategy to achieve national coverage.

•          As part of the exclusive licensing agreement between the Company and BIO, the Company has received upfront and advance royalties.

•          The Company and BIO have now agreed to recognise all advance royalty payments as upfront or milestone payments, enabling the Company to benefit from immediate royalties based on early sales adoption.

•          The Company has agreed to realign its guaranteed future royalty payments over the period ending December 2027 instead of December 2026, and has an option to convert these payments into capital stock in BIO, at the Company’s election.

Following validation of the Test in a Clinical Laboratory Improvement Amendments (“CLIA”) accredited laboratory, the Company’s North American licensing partner Cizzle Bio Inc (“BIO”) entered into an agreement with a second CLIA-accredited laboratory, BioBridge Global (“BBG”), to offer the Test to licensed healthcare providers, as announced on 3 August 2026.

BIO is investing in PR, sales and marketing and has identified key opinion leaders, clinicians and select targeted private pay opportunities to deliver early sales. In addition, BIO is in discussions with further CLIA-accredited laboratories regarding offering the Test. The Company believes that this diversification, part of BIO’s phased strategy to build a network of high-quality laboratory partners across the United States, reduces risk associated with a single delivery facility.

On 23 February 2026, the Company announced that it had received US$590,000 from BIO, comprising US$100,000 of initial exclusivity fees and US$490,000 of advance royalties, as part of guaranteed advance payments totalling US$2.4 million due by 31 December 2026. The remaining US$1.81 million was due to be paid by that date. BIO has not made the remaining payments and is not expected to pay the full US$1.81 million to the Company by 31 December 2026 under that schedule.

Therefore, the Company and BIO have agreed a variation to the payment schedule (the “Variation”). Under the Variation, the remaining US$1.81 million of guaranteed advance payments will be paid by 31 December 2027, rather than by 31 December 2026, in accordance with a revised schedule aligned with BIO’s sales and marketing plans. In addition, the US$490,000 of advance royalties already received and future payments of advance royalties will be treated as non-refundable upfront or milestone payments rather than as advances against future royalties, so that the Company will receive royalties from initial sales of the Test. As part of the Variation, the Company may elect to convert the deferred payments into capital stock of BIO at the price achieved by BIO in its next fundraising or, if no such fundraising takes place, at fair market value at the date of a conversion notice. The further minimum guaranteed payments of US$3.5 million on extension of the agreement in 2031, announced on 23 February 2026, are unaffected by the Variation.

Background to and reasons for the Variation

On 16 June 2026, the Company announced that the Test had successfully completed laboratory validation and had been approved for use under CLIA at OmniHealth Diagnostics (“OmniHealth”).  The Test was then made available to selected clinicians on 22 July 2026 and for general release to licensed healthcare providers.

On 23 February 2026, the Company announced that it had secured guaranteed advance payments of US$2.4m over the period to 31 December 2026, and a further minimum of US$3.5m of guaranteed payments over the seven years following an extension of the current agreement to 2031, guaranteeing payments beyond the initial seven-year period of the licence. Minimum royalties to be paid as part of the Company’s licensing agreement with BIO are based on a 10% royalty on gross sales over the term of the agreement which commenced on 18 October 2024.

BIO’s go to market strategy to secure early adoption is to target the private pay market which includes key opinion leaders, clinical concierge services, occupational health schemes and insurance groups. To achieve national coverage, BIO plans to partner with selected clinical laboratory groups, especially large, centralised facilities that can deliver resilience, testing at scale and have established routes to clinical partners. The agreement between BIO and BBG, a healthcare services organisation with expertise in laboratory medicine, biomanufacturing, blood banking and translational science, that was announced on 3 August 2026, is a further step towards commercialisation of the Company’s minimally invasive blood test in regions facing a significant lung cancer burden and health disparities. BBG is one of the largest biological testing laboratories in the United States, testing over 50 million samples annually, operating in state-of-the-art facilities with extensive high volume automation capability in San Antonio, Texas.

The Company will continue to support BIO in its roll out programme, including support for BBG to achieve validation for the Test in the near term, while also focusing on completing its validation programme with European laboratory partners and in the UK with the NHS.

Because the Test is a laboratory-developed test (“LDT”), each CLIA-certified laboratory performing the assay must complete independent validation to verify analytical performance and meet rigorous quality standards. CLIA approval is regulated by the Centers for Medicare & Medicaid Services and signifies that a laboratory's testing processes and assays meet US federal standards for clinical accuracy, reliability, and patient safety. CLIA compliance is also mandatory for a laboratory to receive Medicare and Medicaid reimbursements.

On 25 February 2026, the US Government announced several actions to strengthen oversight of Medicare and Medicaid programmes. This included the launch of the CRUSH Initiative (Comprehensive Regulations to Uncover Suspicious Healthcare) Request for Information (RFI); a 6-month nationwide moratorium on new Medicare enrolment for certain medical product suppliers, and deferral of US$259.5 million in federal Medicaid funds to Minnesota pending review of questionable claims. The CRUSH initiative signals a more aggressive federal strategy to combat healthcare fraud through expanded oversight. While these efforts may strengthen programme integrity, implementation is impacting clinical laboratory supply chains, leading to reimbursement restrictions, delays in payments and potential suspension of laboratory operations.

In this climate, the clinical laboratory market in the USA can create uncertainty and financial pressure, especially for companies reliant on reimbursement from federal government budgets. This may affect the ability of the Company’s partners to meet their obligations to the Company and has resulted in disruption to operational capabilities at BIO’s initial laboratory partner. BIO’s additional laboratory partner, BBG, is not directly dependent on federal budget reimbursements because it operates a non-profit and B2B revenue model through commercial partnerships, biotech contracts, contract development and manufacturing organization services, and private licensing agreements and the provision of advanced specialty services. If additional guaranteed royalties and advance royalty payments were delayed or not received, the Company may need to seek alternative funding.

BIO is initially focused on the private pay market, concierge clinical practices, occupational health and insurance companies, which are not affected by federal budgets. BIO is also adding large clinical laboratories which are significantly more resilient to federal funding restrictions.

Commenting, Allan Syms, Executive Chairman of Cizzle Biotechnology, said:

“The Company has now moved from its R&D phase to commercialisation of its proprietary CIZ1B biomarker test for early-stage lung cancer. The focus is now on securing early adoption in the USA private pay market, including among doctors, concierge groups, occupational health and insurance groups. We continue to work closely with our licensing partner, Cizzle Bio, and its laboratory partners. We have now secured a new revenue-sharing model under which all advance royalties are recognised as upfront and milestone payments, enabling the Company to immediately earn royalties on all sales going forward.”

Enquiries:

About Cizzle Biotechnology

The CIZ1B biomarker is a naturally occurring variant of the cell nuclear protein CIZ1, which is linked with the preservation of epigenetic integrity. CIZ1B is highly associated with the presence of early-stage lung cancer and can be measured in small quantities of blood. The Company has developed CIZ1B into a non-invasive, cost-effective blood test to help in the early detection of lung cancer. In June 2026, the test was successfully accredited for use in the United States under the Clinical Laboratory Improvement Amendments (CLIA) at OmniHealth Diagnostics, providing a regulated laboratory route to market that enables licensed US healthcare providers to order the test.

Cizzle has entered into commercial royalty-bearing licensing arrangements covering North America and the Caribbean and continues to work with commercial partners and centres of excellence in cancer care to support the adoption of its proprietary diagnostic technologies in the UK and elsewhere.

Cizzle was admitted to the Official List and Main Market of the London Stock Exchange in May 2021. 

For more information, please see https://cizzlebiotechnology.com

You can also follow the Company through its twitter account @CizzlePlc and on LinkedIn.

About Cizzle Bio Inc.

Cizzle Bio, Inc. is a pioneering biotechnology company focused on developing innovative solutions for early lung cancer detection. With a commitment to advancing cancer diagnostics, Cizzle Bio, Inc. collaborates with leading research institutions and healthcare professionals to bring groundbreaking biomarker blood tests to market, aiming to improve patient outcomes and save lives.

For more information, please see: cizzlebio.com