Motif Bio Share Discussion Threads

[dstorey1] 14/7/2016 10:09

timbo003 have taken opportunity to post on LSE. Great article, thanks.

[timbo003] 14/7/2016 10:01

From today's Beaufort morning note (14th July):

Our view: This is the important news we have been waiting for. Not a total surprise, but still very comforting to know the Company has sufficient support and buy-in from US investors to ensure it will achieve a NASDAQ quotation. While a raise in the range US$35 to US$55 million will not be enough to fully fund the INSPIRE Phase III clinical trials as well, a variety of options should become available in due course. With its exceptional safety and efficacy characteristics, iclaprim is set to achieve first commercialisation (ABSSSI) during 2018, following which a range of further indications (starting with HABP) will be delivered from this platform molecule. Given the urgent and global need for new antibiotic treatment, total annual sales potential can realistically be expected to run into several billions of US$. This might seem to be a dramatic claim, but elementary analysis of the existing North American market bears it out. If one were to consider, for example, just the 3m US patients suffering from skin cancer, while recognising that around 25% of these also suffer from kidney or diabetes-related conditions for which obvious peer drug, Vancomycin, has required renal impairment dose adjustment, the immediate opportunity for iclaprim (being a bactericide) is in excess of US$2bn (based on expected treatment cost of US$3000/day). The potential is truly enormous. More immediately, however, what of today's proposal for a NASDAQ listing? Not only will it provide the next, all important, source of development funding, but also introduce a new realm of specialist US investors who are prepared to much more realistically value such early stage biotech. Take Paratek Pharmaceuticals , for example. It is a near-identical stage antibiotic development company, yet presently sustains a valuation over four-times that of Motif. Realistically, this alone should power quite a dramatic re-rating on achieving the North American listing, which might be expected to take place during September or October. Beyond this, considering the obvious global sales potential for icalprim, given that Motif management are already undertaking drug positioning assessments of US hospitals while also discussing non-US distribution partnerships with Big Pharma, a valuation in excess of US$1bn being achieved within 24 months is by no means unrealistic. Motif Bio remains on Beaufort's Speculative Buy list and remains one of our key stock picks for 2016.

[a1samu] 13/7/2016 08:17

There are no dogs involved, except confetti and except an opportunistic and greedy bunch of people, who are very focused on taking advantage of the gullibility of people, for the aspirations of this company may or may not work out yet!

It will be lucky if this share does not finish the day in minus, after perkiness in the morning!

[timbo003] 13/7/2016 08:12

They are intending to issue 100m shares, and there are currently 108m shares in issue, so there will be slightly more shares on AIM than on Nasdaq. I wonder if the tail will wag the dog or will the dog wag the tail?

[a1samu] 13/7/2016 07:53

I see Invesco, a UK shareholder is accommodated and will be allocated shares, but no UK punter. Neither is there any guarantee that motif shares will receive a boost from this financial shenanigans. After all, this still continues to be an all hope share.

Neither has the recent HCM experience offered any hope of fast capital appreciation.

[timbo003] 13/7/2016 07:39

>>>a1samu

I'm not sure about that, it guess it depends what you mean by nothing. I suspect the news will be well received by UK investors and if that is the case, they should see the shares looking a bit perky this morning.

The offer document is worth a read


The General meeting is at 14.00 on August 1st so I may go along to that one.

[a1samu] 13/7/2016 07:34

Big numbers this morning, but nothing for the UK punter!

[fightfear] 26/6/2016 08:12

A BIG thank you Timbo for taking your time to post your very informative (as usual) summary. I am sure that there many more people grateful for your posts than just us three. It's a shame I couldn't make it to the meeting myself.

[typhoon] 25/6/2016 23:10

Thank you Timbo for the information and evaluation...very enlightening

[scott1000] 24/6/2016 18:49

Great post from the event! Cheers for the feedback. I'm trying to grasp the general consensus of when and if they will list in the NASDAQ? we know that could be a significance catalyst. I've heard rumours of August/September.. did you get any vibes about this issue regarding timing? Cheers

[timbo003] 24/6/2016 00:58

There were around 30 people at Tuesday's meeting at the Rocket Bar which was hosted by Walbrook (Motif’s recently appointed PR agency).

Attedeees included representatives from the Motif BOD, the recently appointed US financiers Fulford group, healthcare analysts from Shard Capital and Northland Capital, two chaps from Canaccord (what were they doing there?) and representatives from Zeus Capital. The audience seemed somewhat more informed than those who usually attend the Share Mag and Proactive events and there were some really good Q&As at the end. The presentation and Q&As went on for around 60 minutes (until 18:00) and then it was an open bar with several plates of canapes doing the rounds, I stayed until around 20:30, but I was not the last to leave.

GL used a slide deck comprising 27 slides for his presentation, many of which were familiar as they had been used at previous meetings. Needless to say there was no new information disclosed, but he did mention (twice I think) that the recruitment on both of the current ongoing skin infection clinicals was running ahead of schedule which was good to hear.

There was quite a bit of time spent on the rational for the design of the clinical program both during GLs presentation and during the Q&As afterwards. I certainly got the impression that a lot of careful thought and planning went into the trial designs to de-risk the project and to identify the fastest speed to market. For example GL gave a detailed rationale for picking ABSSSI as the first indication and going for two essentially similar trials in that indication, before branching out into HABP.

There were numerous useful insights which has since prompted me to get up to date with the current iclaprim entries in the clintrials.gov data base. There are five Iclaprim studies listed, brief details are as follows:


1)……… Arpida’s phase II study Iclaprim vs Vanomycin to treat pneumonia
2)……… Motif’s phase III Iclaprim vs Vanomycin to treat ABSSSI (REVIVE 1)
3)……… Motif’s phase III Iclaprim vs Vanomycin to treat ABSSSI (REVIVE 2)
4)……… Arpida’s phase III Iclaprim vs Linezolid to treat cSSSI (ASSIST 1)
5)……… Arpida’s phase III Iclaprim vs Linezolid to treat cSSSI (ASSIST 2)

From a regulatory perspective there are several important differences in the study designs between Motif’s two REVIVE studies and Arpida’s two ASSIST studies, these were succinctly summarised by one of GL’s slides (see below):









The target indications for ASSIST and REVIVE studies are similar (skin infections) but the primary endpoints are different (FDA introduced new guidelines for primary endpoints in the period between the ASSIST and REVIVE clinical studies).

The comparator for ASSIST was Linezolid whereas for REVIVE it is Vanomycin (note: the successful Arpida phase II study used Vancomycin as comparator)

ASSIST used 500 patients (not enough; the studies ended up underpowered to meet the primary endpoints after FDA moved the goal posts half way through the studies). The REVIVE studies are using 600 patients and they are adequately powered to meet the primary end points (approved by FDA)

Importantly the dosing for both drugs used in the ASSIST study was based on mg/kg (body weight). For the REVIVE studies Iclaprim is being given as a fixed 80mg dose every 12 hours (irrespective of patient weight). GL stressed the importance of this point several times and inferred that their might even be some proprietary protection to be acquired from administering Iclaprim as a fixed dose. Opting for a fixed dose every 12 hours apparently overcomes problems previously encountered with dosing based on patient weight, in particular it avoids under dosing patients with lower body mass index, lowers mean Cmax (by 7%) thus reducing the potential for side effects and it improves certain efficacy parameters (presumably Cmin?) by 30%.

There were a few other notable insights (most of which came out of the Q&As) which are worth a mention now, or they risk getting lost and forgotten:

* GL was particularly effusive over the importance of QIDP designation and stressed on more than one occasion that it was considerably more valuable than having a 10 year patent extension. It was totally impossible for generics to compete against QIDP designated products as FDA would not grant regulatory approval to a generic copy under any circumstances during the 10 year QIDP period.

* Nuprim (who acquired the rights to Iclaprim and transferred them to Motif) was set up and owned by former Arpida executives (I didn’t appreciate this before, but it seems perfectly logical now and quite reassuring).

* Iclaprim will be positioned for hospital use only as an alternative to Vancomycin for patients with Renal impairment (Vanomycin is currently the standard of Care for a number of Hospital based infections). There is not an oral formulation for Vancomycin available and this potentially opens up further opportunities for an oral formulation of iclaprim, for example to treat osteomyelitis (a type of bone infection).

* There are no hidden or outstanding royalties or pay aways to be made for iclaprim, apart from one $500k outstanding payment (purpose not discussed)

* Oral delivery of iclaprim presents a challenge due to extensive first pass metabolism of iclaprim in the liver. Motif are looking at several (three ?) different approaches to overcome this problem, this includes orally administered sub lingual tablets. A successful outcome could result in additional IP protection for the oral formulation.

* The pharmacokinetics of Iclaprim suggests that dosing for an oral form might be just one or two tablets daily (much more preferable than 3 or 4 times daily).

* If a Nasdaq listing were to go ahead, the company would intend to maintain an AIM listing, Motif will require up to $25M to get to data read out on the clinical trial program, this could be raised with a Nasdaq listing.


The company haven’t yet made an electronic copy of the slide set available (although I do have a hard copy), so I have asked the agency if they can arrange for a copy to go up on the Motif web site, I will chase this up if nothing has appeared by early next week.

[hazl] 23/6/2016 09:51

Thank you for your reply metis.
I was concerned about some of the adverse effects that were directly related to the drug.
I am a mere layman in these matters but is it to do with a compromised system through diabetes or ill-health generally that these people succumbed or the need to balance the drug's efficacy I wonder?
I guess this is still to be addressed?

[timbo003] 21/6/2016 23:26

It was worthwhile meeting this evening, around 30 attendees at a guess, probably only 3 or 4 ordinary PIs, mainly city types. No new news but several new insights (at least for me), I will write up some notes at the earliest opportunity, but I'm away in Loughborough all day tomorrow at the Haydale investor day, so it might not be until Thursday.

[hazl] 21/6/2016 13:07

SOME OF THE QUESTIONS AT THE END OF THE VIDEO ABOVE were interesting when answered I found.

[hazl] 21/6/2016 12:38

Can any of you particularly informed posters who are aware of the company's day to day movements reassure about the reasons why Iclaprim may be more successful than it was back in 2008 under Arpida?
I would like to think that I am not just making money here but also saving lives rather than putting them at risk.
The following was posted on a different bb and I was concerned.


separately.

[timberwolf3] 21/6/2016 11:15

Thanks timbo003.

[timbo003] 21/6/2016 10:52

Motif are guests of honour at The Rocket Bar (just off Old Broad Street) tonight:


The event has been organised by Walbrook (Motif's PR company), I will go along and report back in due course.

[hazl] 20/6/2016 21:54

Absolutely adorling and I noticed there were only 29 views of the video when I initially posted it.
So hopefully the news is getting out there!
These small firms can go unnoticed outside of the industry,unless they have a bit of marketing.

IMO

[adorling] 20/6/2016 20:40

Hazl - good to see our CEO saying creating awareness of the Company is important for investors both current and future new investors.

[timberwolf3] 08/6/2016 12:57

There were some big players from Pharma in the audience.

[hazl] 08/6/2016 11:33

Presentation must be doing its magic..........

[hazl] 08/6/2016 09:10

What an excellent header and thread you have produced timbo very impressive thanks.
The ease with which I clicked on notes for the AGM made me comment on it generally!