Israel's BiondVax To Take 'More Global View' With NASDAQ-Only Listing
Executive Summary
BiondVax's CEO tells Scrip why the Israel-based vaccine maker wants to delist there and only have a US-based NASDAQ listing and re-make its executive board in to one that's more internationally experienced.
BiondVax Pharmaceuticals Ltd. wants to "spread its wings" now that it is adequately funded to progress its lead flu vaccine candidate – but to do that BiondVax feels it must delist from the Tel Aviv Stock Exchange while maintaining a continued listing on NASDAQ, and rebuild its executive board into one that is more commercially minded.
NASDAQ-Centered
"We are now ready to concentrate our attention on just one exchange as we move forward," Ron Babecoff, BiondVax's CEO told Scrip in a telephone interview from Ness Ziona, Israel.
BiondVax Pharma CEO Ron Babecoff
BiondVax Pharmaceuticals Ltd
BiondVax listed first on the Tel Aviv Stock Exchange in 2007. It established a NASDAQ listing in 2015. Half of the company's investors are already US-based.
Its listing decision was taken after the release in July of positive data from a Phase IIb clinical trial in which BiondVax's universal influenza vaccine, M-001, hit both of the primary endpoints in safety and influenza-specific cellular immune responses. BiondVax now aims to initiate Phase III trialing and invest in a new manufacturing facility in Israel to secure supplies of M-001 for the remaining development and commercial launch.
Candidate Vaccine
M-001 was designed to induce T-cells that target common and conserved regions of flu viruses and to produce anti-viral cytokines such as INF-gamma and IL-2, as well as extending a T-cell priming effect for enhanced B-cell (HAI) responses. Thus, M-001’s dual mode of action potentially can offer multi-season and multi-strain protection.
The completed Phase IIb trial using the therapy was funded through a grant from the European Union and was conducted in conjunction with the European UNISEC Consortium and enrolled 219 participants aged 18 to 60 years. Each participant received two injections of either 0.5 mg M-001, 1.0 mg M-001, or placebo prior to a partial dose of avian H5N1 pandemic vaccine.
BiondVax's CEO says the vaccine maker is now looking for a new chairman and board members who have successful track records in M&A and the commercializing of assets internationally. The current chair, Professor Avner Rotman, will continue in that role until a suitable replacement is found.
Has Adequate Phase III Funding
Babecoff said the company was adequately funded with the equivalent of $12m on its books at the end of the second quarter of this year.
In June, it signed an agreement with the European Investment Bank to support commercial scale production and Phase III testing of M-001. Under the agreement signed with the EIB, BiondVax over the next three years will be able to draw down all the money, presuming the development milestones related to the lead universal flu vaccine candidate M-001 are met.
Analysts at Edison said the €20m loan agreement with the EIB represented "a game changing event" for BiondVax in that it provided financial visibility for the medium term and represents a de facto external validation of BiondVax’s technology. The new funds are available via Horizon 2020, the EU Research and Innovation Framework Programme for 2014-20, managed by the European Commission and the EIB.
Partnering Likely
Babecoff told Scrip he will would like to land a partnering deal while M-001 is in Phase III studies, which will start during the flu season of 2018. He said no partnering discussions have started yet.
The delisting process of BiondVax's shares from trading on the Tel Aviv Stock Exchange will take place by the end of 2017. During the interim period, BiondVax's shares will continue to be traded on the Tel Aviv Stock Exchange. All shareholders will retain their pro-rated holdings, as trading will migrate to the NASDAQ.