On May 15, 2024 Amplia Therapeutics reported the successful completion of its $4.27 million fully underwritten, non-renounceable entitlement offer which was well supported by existing eligible shareholders and new institutional and sophisticated investors (Entitlement Offer) (Press release, Amplia Therapeutics, MAY 15, 2024, View Source [SID1234643366]).

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Under the Entitlement Offer eligible shareholders were entitled to apply for two (2) fully paid ordinary shares (New Shares) for every five (5) shares held on Friday 19 April 2024 (Record Date) at the offer price of $0.055. The Entitlement Offer will issue 77,602,838 New Shares raising a total of $4.27 million (before costs).

In total, Amplia received valid applications from eligible shareholders for 36,049,966 New Shares ($1.983 million). The resultant shortfall of 41,552,872 New Shares ($2.285 million) (Shortfall) was placed by the Lead Manager and Underwriter, Taylor Collison Limited (Lead Manager), to new and existing institutional and sophisticated investors.

Amplia’s CEO and Managing Director Dr Chris Burns commented "Amplia’s Board and Management are extremely grateful for the ongoing support of our shareholders and advisors and we welcome new shareholders to the Company. Our successful Entitlement Offer permits the Company to continue to actively progress development of our best-in-class FAK inhibitor narmafotinib, with specific focus on delivering critical interim data in our ongoing Phase 2 ACCENT trial in pancreatic cancer."

Director Participation
As previously announced, US based Company Director, Dr Robert Peach, committed to sub-underwrite A$150,000 in the Entitlement Offer and was proportionally allocated A$105,000 in the Shortfall. In addition, Managing Director and CEO, Chris Burns, and Company Director, Jane Bell, cumulatively took up $78,000 of their rights under the Entitlement Offer.

Use of funds
The proceeds from the Entitlement Offer will be used to fund the ongoing Phase 2 ACCENT trial in pancreatic cancer to an Interim Analysis (expected in Q3 2024), as well as undertake production of additional narmafotinib capsules and support a pilot Investigator Initiated trial in ovarian cancer currently in planning.

ACCENT Trial Update
The Company is pleased to announce that the ongoing Phase 2a ACCENT trial in advanced pancreatic cancer patients is progressing to plan. In this stage of the trial, newly diagnosed advanced (metastatic) pancreatic cancer patients receive orally-dosed narmafotinib (at the optimal 400 mg dose identified from the Phase 1b trial) combined with the standard-of-care chemotherapy gemcitabine and Abraxane. At present, nineteen (19) patients of a total of 26 are enrolled in trial sites in Australia and South Korea. An interim analysis will be conducted to determine whether six (6) or more patients on the trial record a partial response, and if so, a further 24 patients will be enrolled, bringing the patient cohort to 50 patients in total. The Company previously disclosed that six (6) patients out of fourteen (14) recorded a partial response in the Phase 1b stage of the trial. Dr Burns commented: "The excellent recruitment progress and support from clinicians seen to date in the ACCENT trial is extremely encouraging and we expect it to allow us to report Interim Data in Q3 this year."

About the ACCENT Trial
The protocol for the ACCENT trial is entitled ‘A Phase 1b/2a, Multicentre, Open Label Study of the Pharmacokinetics, Safety and Efficacy of AMP945 in Combination with Nab-paclitaxel and Gemcitabine in Pancreatic Cancer Patients’.

The trial is a single-arm open label study conducted in two stages. The first stage (Phase 1b) determined an optimal dose of narmafotinib (AMP945) by assessing the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of narmafotinib when dosed in combination with gemcitabine and Abraxane in first-line patients with advanced pancreatic cancer.

This second stage (Phase 2a) of the trial currently underway will assess efficacy of narmafotinib in combination with gemcitabine and Abraxane, along with continued assessment of safety and tolerability. The primary endpoints are Objective Response Rate (ORR) and Duration on Trial (DOT) with secondary endpoints being Progression Free Survival (PFS) and Overall Survival (OS).

More information about the ACCENT trial, including a list of participating sites, can be found via the Amplia Therapeutics website and at ClinicalTrials.gov under the identifier NCT05355298.

The Company will provide further updates on the trial as recruitment proceeds.

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.