Invex Therapeutics Quarterly Report and Clinical Trial Closure - July 2024
INVEX THERAPEUTICS LTD (IXC) Share Update July 2024 Tuesday 23rd
Invex Therapeutics Provides Quarterly Update and Clinical Trial Closure
Invex Therapeutics Ltd (ASX: IXC) has released its quarterly activities report for the period ending 30 June 2024, providing updates on its clinical trials, financial performance, and corporate developments.
Instant Summary:
- Completion of final payments for the IIH EVOLVE Phase III Clinical Trial.
- Renewal of Orphan Drug Designations in the US and Europe.
- Renewal of SME status with the European Medicines Agency.
- Exploration of Exenatide for Traumatic Brain Injury treatment.
- Receipt of £633k ($1.2 million) from UK R&D tax incentive.
- Retirement of Non-Executive Director Dr. Megan Baldwin.
Operational Update
Invex Therapeutics Ltd has completed the final close-out payments to the Contract Research Organisation (CRO) under the termination agreement for the IIH EVOLVE Phase III Clinical Trial. The company does not anticipate any further material costs associated with this trial moving forward.
During the quarter, Invex also completed the analysis of safety and efficacy data for 14 patients who commenced treatment with Presendin™ or placebo prior to the early termination of the trial. Due to the early termination, planned analyses were limited, focusing primarily on safety endpoints. The data has been published on clinicaltrials.org.
IIH Orphan Drug Designations Renewed
Invex successfully renewed its Orphan Drug Designations (ODDs) for Idiopathic Intracranial Hypertension (IIH) with both the US FDA and the European Medicines Agency (EMA). This renewal ensures market exclusivity for seven years in the US and ten years in Europe upon market approval.
SME Status Renewed in Europe
The company also renewed its micro, small, and medium-sized enterprise (SME) status with the EMA, which provides various regulatory and financial incentives.
Traumatic Brain Injury
Invex continues to explore the potential of Exenatide for treating moderate to severe Traumatic Brain Injury (TBI). The company has a strong intellectual property position in this area, including a granted US patent and an ODD in Europe. Discussions with potential collaborators are ongoing.
Corporate Development
Invex is assessing potential corporate partnerships to complement its existing intellectual property assets. Several potential assets were reviewed during the quarter, but none are sufficiently developed to warrant further comment.
Corporate Update
On 21 June 2024, Invex announced the receipt of £633k ($1.2 million) from the UK government for eligible R&D expenditures during the 2023 financial year. The company plans to make an additional claim for further R&D tax relief for costs incurred in FY24.
Retirement of Non-Executive Director
Dr. Megan Baldwin retired as a Non-Executive Director effective 30 June 2024. The company thanked her for her significant contributions, particularly her expertise in ophthalmology.
Financial Summary and Analysis
Invex continued to manage its cash reserves prudently, closing the quarter with $6.02 million in cash and cash equivalents. The company reported overall operating cash inflows of $0.57 million for the quarter, primarily due to the R&D tax rebate.
Research and development expenditure for the quarter was $0.44 million, reflecting outstanding invoices related to the IIH EVOLVE trial. Administration and corporate costs were $0.19 million.
The completion of final payments for the IIH EVOLVE trial and the renewal of Orphan Drug Designations are positive developments for Invex Therapeutics. These actions reduce financial uncertainty and extend market exclusivity, which could positively impact the company's stock. However, the early termination of the clinical trial and the limited efficacy data may raise concerns among investors.
Investor Reaction:
Analysts have noted the mixed implications of the update. While the financial prudence and regulatory renewals are seen as positives, the early termination of the clinical trial has raised some concerns. Investor sentiment appears cautiously optimistic, pending further developments.
Conclusion:
Investors should keep an eye on Invex Therapeutics' future announcements, particularly regarding new clinical trials and potential partnerships. The company's strategic moves in managing its financials and regulatory status are promising, but the early termination of the IIH EVOLVE trial warrants close monitoring.