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BiondVax Pharmaceuticals

Termination of coverage

Update | Pharmaceuticals & healthcare | 16 Jan 2018

Since BiondVax shares are no longer traded on the Tel Aviv Stock Exchange (TASE), Edison Investment Research Ltd. has terminated coverage of the Company within the framework of the TASE analysis program.

BiondVax Pharmaceuticals

Phase III for universal flu vaccine starts in 2018

Update | Pharmaceuticals & healthcare | 15 Jan 2018

Over 2017 BiondVax crystallised its late-stage development plans for lead asset M-001, a potentially universal influenza vaccine. Following its discussions with the regulatory authorities and gaining access to new capital (European Investment Bank and share issues), the company confirmed on 27 December 2017 that it will initiate a pivotal Phase III trial on its own for a universal flu vaccine indication (likely to start in Q318). We have revised our assumptions substantially and increased our valuation to $200m (NIS689m) or $32.4/ADS (NIS2.80/share) from $165m previously.

BiondVax Pharmaceuticals

Positive Phase IIb, preparing for pivotal Phase III

Update | Pharmaceuticals & healthcare | 09 Oct 2017

Following the positive Phase IIb trial results with universal flu vaccine, M-001, BiondVax is now preparing to initiate a Phase III study, which will likely evaluate M-001 as a universal, standalone vaccine – another major strategic decision by BiondVax – as opposed to a stepwise approach to develop M-001 as a primer and then as a standalone vaccine. A universal, standalone flu vaccine indication is the most lucrative and the pivotal trial could start in 2018. We increase our valuation of BiondVax to $165m (NIS577m), $26.8/ADS (NIS2.34/share), from $111m previously.

BiondVax Pharmaceuticals

New funds to support M-001’s Phase III initiation

Update | Pharmaceuticals & healthcare | 17 Jul 2017

The EUR 20m loan agreement with the European Investment Bank (EIB) is a game changing event for BiondVax, we believe. The agreement was signed on 19 June 2017 and over the next three years the company will be able to drawdown all the money presuming the development milestones related to the lead universal flu vaccine candidate M-001 are met. BiondVax now aims to initiate Phase III activities and also invest in a new manufacturing facility securing the supply of M-001 for the remaining development and commercial launch. We have revised our model to reflect the changes and value BiondVax at $111m (NIS398m), up from $77m (NIS278m).

BiondVax Pharmaceuticals

Phase IIb with universal flu vaccine readout close

Update | Pharmaceuticals & healthcare | 15 May 2017

BiondVax's FY16 business update reiterated that the company and its partners are on track to deliver full results from the ongoing Phase IIb trial with multimeric vaccine candidate M-001 by end Q217. According to plans, the US National Institutes of Health (NIH) will initiate the last Phase II study with M-001 in 2017, which will pave the way for partnering and the Phase III programme. Currently BiondVax is a leader in the development of a universal influenza vaccine. Our valuation is increased to NIS278m ($77m); on a per share basis it is down slightly to NIS1.7/share ($18.2/ADR) after the recent fund-raising.

BiondVax Pharmaceuticals

Most advanced universal influenza vaccine

Initiation | Pharmaceuticals & healthcare | 08 Dec 2016

Biondvax with its epitope-based multimeric vaccine candidate M-001 is among the leaders in the development of the universal influenza vaccine worldwide. In previous clinical trials M-001 was shown to be consistently safe, immuno-genic and demonstrated synergy with conventional flu vaccines. The readout from the ongoing European Phase II study is imminent, while the initiation of the last Phase IIb study funded by the US National Institutes of Health (NIH), with results likely in H217/H118, will pave the way for partnering and the Phase III programme. We initiate coverage with a valuation of NIS269m ($71m).