The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
L2 - the reference to an 'Asset' is common place in Pharma and Biotech - unfortunately it does not imply any degree of value.
Having said that FLU -v certainly has a multi M$ value, given the published results. However, that value is being seriously eroded every day that it sits dormant, which it has been for the last 12 months. They really do need to move it into Ph3 or sell it!
Problem is that this statement, 'We continue to make progress regarding strategic discussions related to the assets in this JV, helping to maximise the strategic options available. We have had a number of positive discussions and we are continuing to explore a number of options to enable the continued development of the FLU-v vaccine.',
provides no new or additional information over that we got months ago.
The inflection point here will be when some concrete news comes re the development or sale of FLU-V.
Agreed Jimzi - but as per previous discussions, the major issue for me is that Hvivo will need to raise a considerable amount of capital to fund a Phase 3 program and without a 'strategic partner' I am not clear how they would achieve that.
Got to say that the radio silence is a bit disconcerting. As previous, you would expect some non specific updates along the lines of; 'in discussions with a potential partner or acquirer' etc, if it was indeed the case. No NDA would prevent or inhibit that sort of information being shared.
The clock is ticking and the top line Phase 2b results were released nearly one year ago, we need to see some movement!
mon - this is from the hVivo website:
'hVIVO is acquiring equity in PrEP for £14.0 million cash consideration and PrEP is contracting with hVIVO Services Limited to conduct a £10.0 million Phase IIa clinical programme of work in 2015 and 2016. hVIVO’s investment will be accounted for as an investment in associate in its balance sheet and, in the application of the equity method as an associate, the £10.0 million Phase IIa clinical programme of work will be recognised as revenue.'
Given that the total series 'a' raise was £21m and Jansen have taken equity for granting a global licence for -001 to Prep (likely to be around 10% ish) and the founders will have some equity (could be circa 20%), hVivo are likely to have circa 40-50% equity - please note the above is my best guestimate.
Re development of 001. My best guess is that Prep will not have a huge amount of that left after conducting the 2 clinical studies they were sponsors for. There are no active or recruiting studies registered in Clintrials.gov and therefore we are not likely to see any new data or results in the next year. As such they are in a similar position to hVivo - looking for partner/acquirer and/or another round of funding to move -001 forward.
As always adyor!
The competition is hotting up and moving forward:
https://www.fiercepharma.com/vaccines/flugen-plans-further-development-universal-flu-shot-after-phase-2-win?
Leas, Good call on IMM! Wrt potential 'breakthrough' designation, agreement on primary endpoint and overall requirement for filing and approval- those discussions occur with FDA during an end of Phase 2 meeting. Having agreed these things with FDA it makes the value proposition to potential partners/acquirers much clearer and hence their decision making easier. The EOP2 meeting with FDA costs peanuts in the grand scheme of things and IMO HVO/Imutex have the required skill set and knowledge to undertake such a meeting. Only sticking point at the moment is that FDA is not 'working' at the mo - thanks Donald!
Even with 'breakthrough therapy' designation, I seriously doubt that flu-v would be on the market by end of 2020. In addition if HVO/Imutex thought flu-v warranted breakthrough designation they should/would have already requested it from FDA. If they are in the process of requesting it at an end of Phase 2 meeting with FDA then not sure why they are not releasing updates stating that!
I would really like to see another RNS/press release giving an update on regulatory progress and any information re 'ongoing' discussions with big pharma.
Hi Jersey, Thanks. No they don't have sufficient data. They will have to conduct 2 x pivotal Phase 3 registration studies for regulatory filing and hopefully approval. So getting the nod from FDA that the NIAID endpoint is acceptable for inclusion in these studies as the primary endpoint would be very good news, given that we saw a positive outcome for this endpoint in the Ph2b study. This would also improve HVO's negotiating position with any potential acquirer.
ATB
Hi Jersey, no that's not quite it. What they are saying is that the additional endpoint analysed by NIAID has the 'potential' to be used as the primary endpoint in any future pivotal Phase 3 study. What this does imply is that, given the word 'potential', they have not yet got buy in from FDA that they will accept this as the 'primary endpoint' for the pivotal registration Phase 3 studies. When and if they do get FDA endorsement for this endpoint it would be good for HVO to release that information as it would then indicate that they have agreed a path to registration with FDA. This would make the situation much clearer for any potential partner/acquirer wrt what to do next.
Re-optimum time to do a deal and relative value - well the closer you get to regulatory submission and approval and therefore the market, the greater the value of the asset. The reason being, of course, is that the risk of failure reduces as you progress through the drug development process. The flip is that the further along you get in the development process the more expensive it gets to undertake that stage of development i.e as per previous post, HVO would need of the order of $50-100M to get to regulatory submission IMO. Hope this helps.
Jolanta, I have worked in the Pharm industry for 30+ years in very senior positions, so at least my opinion is informed.
Jersey, I absolutely agree, HVO is not able to progress this to market on its own. As I said previously, the next inflection point for HVO is when they announce a potential acquisition or co-development deal with a major pharma. They do need to get on with it though as any delays to the development of this asset start to erode its value.
Hi Jersey, we would certainly benefit from a bidding war, fingers crossed. Re the NDA/publication - any potential acquirer will make a deep dive into the data from the Ph2b and previous studies, pre-clinical data, manufacturing data etc etc and this is all done under NDA. The company can have several potential acquirers under NDA at any one time. When they have completed due diligence then the bidding can start! The publication does act as ratification of the validity of the results when published in a peer reviewed journal - so still a good thing.
ATB