Timelines3 Sep 2024 14:56
From RNS 17 Jun
Cizzle received an up-front payment of US$100,000 as a non-refundable fee to grant BIO an exclusive negotiating period of 120 days from the signing of the MoU on 1 April 2024.
• It is anticipated that the binding agreement, together with an initial royalty payment of US$300,000, will be completed within this 120 day period and will grant BIO an exclusive licence to develop and market clinical diagnostic assays based on the CIZ1B biomarker to facilitate the early detection of lung cancer in North America.
• Minimum advance royalty payments of US$2.3 million, as part of the 10% royalty to be paid on gross revenues minus taxes, are due over a period of 30 months following signing of a binding agreement.
• On completion of the binding agreement, Cizzle will own 10% of BIO for no cash consideration.
• Cizzle has been selected by a major cancer centre in the US to evaluate CIZ1B testing as part of an important clinical study, to confirm whether lung nodules identified by CT scanning are positive for the CIZ1B biomarker.
• BIO expects to register its first US CLIA (Clinical Laboratory Improvement Amendments) accredited lab with the FDA (US Food and Drug Administration) for the CIZ1B LDT test in September 2024
• BIO plan to achieve CLIA Certification for the LDT test in November 2024, with insurer reimbursement code achievement and full product launch April 2025.
From RNS 25 July
BIO has been successful with its initial investment round and has requested a 60-day extension to the completion of the binding legal agreement with Cizzle, as envisaged under the MoU, to enable BIO to complete on additional strategic investment that has been proposed. As Cizzle will be granted a 10% stake in BIO, for no cash consideration on closing, the Cizzle Directors believe that allowing for the extension will increase the value of the Company's stake in BIO and with access to greater funds BIO will be able to accelerate the deployment of its go to market strategy for the Company's CIZ1B biomarker test. Cizzle has therefore agreed to the 60-day extension. There are no other amendments to the terms of the MoU, detailed in the announcement on 2 April 2024, or amendments to BIO's planned timetable of key milestones for bringing the Company's CIZ1B biomarker test to market, as outlined in the Company's announcement on 17 June 2024.
So, expecting first lab accreditation, and closure of Ciz Bio deal this month....