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Abliva AB (Nasdaq Stockholm: ABLI) today announced that it intends to raise a financing round of SEK 200 million to provide the company with the capital necessary to run the Phase 2/3 study with KL1333 to a key interim analysis, progress NV354 to be clinic-ready, and provide the company with 24 months of cash runway. The financing round will be comprised of a SEK 150 million directed issue, including participation by new specialist investor IP Group and existing venture capital investor, Hadean Ventures, as well as a fully underwritten SEK 50 million rights issue. The subscription price will be the same in both the directed issue and the rights issue, with an ambition to have a discount of no more than 10 percent compared to closing price per today, May 31, 2022. Abliva’s largest shareholder, Hadean Ventures, intend to convert all their convertibles, at an aggregated nominal value of SEK 26 million, together with accrued interest, to shares in connection to the financing round.
The majority of the proceeds from the SEK 200 million raise will be used to initiate a registrational, Phase 2/3 clinical trial evaluating KL1333 for the treatment of adults suffering from primary mitochondrial disease. This global study is expected to start screening patients in the second half of 2022. The financing procured will support recruitment of the first 40 patients in the study and progression of these patients to a key interim analysis in late 2023/early 2024. The interim analysis will provide important safety and efficacy information (through a conditional power analysis) followed by progression into the second stage of the seamless platform design, with either continuation at the planned study size or expansion up to a pre-defined cap. The interim analysis will also include a standard futility analysis. The full study readout from the Phase 2/3 study is anticipated in early 2026. The robust nature of the interim analysis, which, as noted, will provide important information in late 2023/early 2024, has been well received by investors and potential strategic partners as providing an early inflection point for Abliva’s lead programme.
The rest of the proceeds will be used to progress NV354 to be ready for the clinic as well as support the company. In particular, the proceeds will fund the manufacturing of clinical trial material and submission of the appropriate regulatory documentation to support a Phase 1 start for NV354. The company will continue to be run in lean manner with limited overhead and fiscal conservatism. The financing will provide the company with twenty-four months of runway through mid-2024.
Commenting on the intended financing, Ellen Donnelly, CEO, commented: “We are delighted that this intended raise will support progressing our lead asset into a Phase 2/3 registrational study bringing it one step closer to helping patients all over the world with this serious disease. Over the next months we will finalize the study design with regulators and look forward to screening the first patients in the second half of this year. We can now look forward with confidence to a major inflection point as we get our interim data, planned for late 2023/early 2024.”