Verona Pharma Share Discussion Threads

[meijiman] 08/9/2015 09:29

so the share price has reacted to increased losses and maybe a view that there will be a fundraising down the tracks?

[just_banter] 08/9/2015 08:16

From lse

Board Changes
I might be wrong but the board changes at this time suggests to me that they're streamlining for sale. As Claire and Stuart are both healthy shareholders, if they retain their shares then it very much strikes me that the Business is either already in discussions or preparing itself for the market. Typical takeovers on the Pharma sector would not take a whole board with them and the two Non-Exec appointments clears the way for them to keep the wheels on the track through the sale process with probably a healthy payout upon completion. Pure speculation on my part but if shares are not released by Stuart/Claire then it gains weight in my opinion. GLA

[vasilis] 08/9/2015 07:51

I see the appointment of the new non-execs as from 10 September as significant bearing in mind that results from the expected SAD/MAD study is early Q4 - ie almost certainly October taking into account when the study was completed in August. Whilst results have not yet been published it doesn't make sense to my mind for new non-execs to be joining unless the outlook for RPL554 is clearly positive since there is no other drug currently in development and the non-execs expertise is clearly focussed towards later stage development/partnering/licencing. It would of course be a further positive sign if they bought shares at the first available opportunity.

It's worth quoting what JAK says today - he's clearly quietly confident :-

Dr. Jan-Anders Karlsson, CEO of Verona Pharma commented: "In the first half of
2015 we have continued to make good progress with our lead drug candidate,
RPL554. In particular, initial results from studies in healthy volunteers using
our new more robust formulation of the drug have been extremely encouraging.
These data bode well for the outcome of our ongoing phase 2a multiple ascending
dose study with the drug in COPD patients, where we expect to announce results
in early Q4 2015. During the period we also initiated a phase 2a trial of
RPL554 in asthma patients to explore a dose-response relationship in this
setting and will report results early next year. Positive data in these studies
will encourage us to move into phase 2b studies. Further studies in cystic
fibrosis with RPL554 are planned for 2016. Additionally we continue to seek to
develop the Company by searching for suitable products to enhance our
pipeline."

Tim - I agree that fundraising will be required bearing in mind the scope of the outlined development programme and I wouldn't be surprised if they co-ordinated release of results with notification of raising new funds. The appointment of these new non-execs raises the profile - important for attracting new investors - particularly European ones!

[timbo003] 08/9/2015 07:48

On financials, they are burning through the cash (£3.4m in 6 months) as you would expect, but there's also a welcome £0.7M R&D tax credit.

I wonder when they will raise more money? Presumably after the MAD COPD results in Q4 or the RPL vs salbutamol asthma study in Q1.


FINANCIALS

The loss from operations after tax for the six month period ended 30 June 2015 (the “Period”) was £3.69 million (2014: £1.39 million) or 0.37 pence (2014: 0.19 pence) per ordinary share. The reported loss includes a non-cash share-based payment charge of £0.26 million (2014: £0.06 million) and receipt of a research and development tax credit of £0.74 million (2014: £Nil).

Research and development expenditure, which was expensed as incurred, amounted to £3.48 million (2014: £0.87 million). Development programme expenditures expensed during the period amounted to £3.37 million for RPL554 (2014: £0.57 million), and £0.11 million (2014: £0.30 million) for VRP700.

Expenditures in RPL554 increased by £2.80m as a result of accelerating the clinical trials for the SAD/MAD and asthma studies and advancing preparations for a commercially scaleable formulation of the compound.

Administrative expenses for the six month period were £0.98 million (2014: £0.53 million). The increase of £0.45 million over the prior period was due to an increase in the share-based payments and other administrative items including the strengthened Board and senior management team.

As at 30 June 2015, the Group had approximately £6.09 million (2014: £12.10 million) in cash and cash equivalents.

[timbo003] 08/9/2015 07:41

this is new....


Our initial focus to develop the nebulized formulation of RPL554 for hospital use is motivated in part by the increasing concern and intent to tackle the high rates of 30-day hospital re-admissions for COPD. This has recently gained impetus following the implementation by the US Government in Q4 2014 of a new policy which penalizes hospitals with high 30-day re-admission rates for select conditions, including COPD. Interestingly, such a policy has already been introduced by the NHS in the UK. In our clinical studies in hospitalised patients, we will explore the possibility that treatment with RPL554 will reduce such re-admission rates and so demonstrate a clear health-economic benefit of treatment with the drug.

[timbo003] 08/9/2015 07:19

No clinical results this time

It sounds like the next results (early Q4) will be for the MAD COPD study (where side effects will be in focus) and we have to wait for Q1 for the RPL vs Salbutamol results in asthma.

The appointment of the two new non-execs with their impressive CVs is encouraging.

[just_banter] 07/9/2015 21:45

So that 2 new trials starting fairly soon. Asthama & Copd. Both group of patients people aged over 40

[corbine] 07/9/2015 13:48

and note there is also an asthma copd overlap of course....



Specialists agree that a condition unofficially known as asthma-COPD overlap syndrome (ACOS) exists, according to a survey completed by Marc Miravitlles, MD, and colleagues.

The participants were 26 specialists in either asthma or chronic obstructive pulmonary disease (COPD practicing in Spain.

They first completed a structured questionnaire, and then attended an in-person work meeting that followed the Metaplan technique.

Both COPD and asthma are chronic inflammatory diseases that affect breathing, and both are characterized by bronchial obstruction, they are separate diseases with different causes, diagnostic procedures, and treatments.

Given the fact that they are separate conditions, it is possible for them to co-exist.

According to the researchers, “There are currently no universally accepted, validated criteria for the diagnosis of ACOS.” Yet, patients who have both diseases have more exacerbations, poorer health-related quality of life, worse symptoms, and greater comorbidity, and are usually excluded from clinical trials with medications.

The specialists who participated were evenly divided, with 13 specializing in COPD and 13 in asthma.

The results of the questionnaire showed that 84.6% of them recognize ACOS.

The majority, 80.8% of them also agreed that “the diagnostic criteria for ACOS were still not well defined.”

The second phase that participants completed was an in person, structured debate in which attendees wrote answers on cards, then a facilitator presented each card to the group and moderated the ensuing debate.

This technique promoted equal participation and facilitated an orderly debate, as compared to a conventional meeting.

Participants debated several issues, including the definition of ACOS, the diagnostic criteria, the treatment, and finally, what future investigations should be conducted. Of those topics, the participants were in most agreement about future studies.

Most agreed that longitudinal, populations studies and clinical trials would lead to a better definition of ACOS. -

See more at: hxxp://www.hcplive.com/medical-news/asthma-copd-sometimes-overlap-specialists-say#sthash.BtHeJmdi.6tSevy6T.dpuf

gldyoR etc

[corbine] 07/9/2015 13:41

thanks for all your in depth posts for such a long time, as we lead up to game changer news opportunties, lets not forget the importance of side effects as well as fev1 - dosing durations etc etc. we know breo one of the latest drugs to arrive has some dodgy sides but lets not forget when looking at ventolin (salbutomol?) etc and mixxed nebbed with ipratroprium bromide, the long standing nebbs currently in use, some fairly dodgy side effects there too as well as when used for long periods, and fairly limited how many times per day these can be used.
so far 554 when tested 16 times previous doses did not show up side effects. this bodes well for all? our future studies, but at what point might? we taper for sides? if not at all?
is this a unique feature of 554 as well as novel in design?
just asking out loud.
looking forward to the news, just like the rest of us here.
gl all :-)
corbs

[vasilis] 07/9/2015 13:06

Thanks for your thoughts Tim. I suppose until we get to see the results of the final part of the SAD/MAD study completed 12 August regarding the new formulation, we can only speculate on why this new study - a fairly comprehensive 'beauty contest' for RPL554 - has been submitted before those results have been published. Hopefully tomorrow will bring a little more clarity for us PIs and bring us up to speed with the current direction behind the BOD's strategy.

[timbo003] 07/9/2015 10:35

>>>>Vas

A couple of further thoughts.

If results tomorrow were to disappoint (i.e. only direction differences in favour of RPL554), then maybe they will concentrate resources on the COPD indication for now. I'm not sure which one offers the biggest opportunity, but one big factor for going for asthma, is FDA's hang-up against LABAs to treat asthma (especially in children).

I note that the primary end point the forthcoming COPD study is FEV1 over 8 hours and the secondary is FEV1 over 12 hours, that seems very prudent, but ideally we do really want to see an effect over 12 hours in order maximise the opportunity.

Good point about the 6mg dose!

[timbo003] 07/9/2015 10:08

>>>>meijiman, thanks for that. I would love to, but I think I will be double booked, but will investigate anyway

>>>>Vas, yes, that one is going to answer lots of outstanding questions. I see they haven't started recruiting yet, so maybe they were saving the news for tomorrow?

[meijiman] 07/9/2015 10:00

If anyone of you technical experts can attend the presentation this coming Wed you might be able to get some answers. There is always plenty of time for questions after the presentation -in this case I believe its the ceo. Starts 5-30pm in the City of london. Its hosted by an outfit called Hardman-you can google that and follow the info.

[timbo003] 07/9/2015 10:00

I wonder if we will get the clinical results tomorrow from the recently completed asthma study along with the 6 month interims?

It was a 7 way, placebo controlled, single dose crossover, so it shouldn't be too difficult to analyse:

4 different doses of RPL554, two different doses of Salbutamol and placebo.

Given that its just one dose, I don't think the anti inflammatory (PDE4)component of RPL554 will have time to kick in, so any effect will be down to the bronchodilatory action (PDE3), so if we see a greater treatment effect for RPL554 vs Salbutamol (either peak effect or duration of effect, or preferably both) then that advantage should if anything be more pronounced in a multiple dose setting.

[vasilis] 07/9/2015 09:26

That's an interesting new trial in kwizza's link - and not RNS'd (?).

A few questions spring to mind :-

1 The title refers to 'The effects of RPL554'. Are we to take these as the 'effects' as determined from the results of the current study though not yet published? The current COPD study was unblinded over 3 weeks ago.

2. Why would VRP compare combos with RPL554 alone IF current results were not statistically significant?

3. What would be the point of having both a placebo and RPL554 if current results were not significant?

4. The determined dose for RPL554 is 6mg. Where did that come from if not from the latest data from the newly completed trial?

What's your take on this trial Tim and how it has been designed bearing in mind the news we are currently expecting.

[bewise2] 06/9/2015 15:17

hxxps://clinicaltrials.gov/ct2/results?term=RPL554&Search=Search

[meijiman] 06/9/2015 10:53

Get real. I am over 50 and Ive been reading about cancer breakthrough stories/wonder drugs for the past 40 years. It fills up space in the newspaper.Can see where you're coming from though.I shall attend the Hardman presentation on Wed.

[thebossman] 06/9/2015 07:44

Its now 2015...How the years have past by since this news..

[thebossman] 03/9/2015 10:00

If more buys make the share price rise and sells have the opposite effect but that does not happen on the aim market can we assume that its what and who you know and nothing else.???????

I think 90% of the trades so far today have been buys.???

[thebossman] 28/8/2015 09:25

blade..mine cost me 8p some years ago so I'm holding,I suppose in a prefect world with results due one would expect a surge in SP,we have not seen that but I'm going to wait until after the results.hopefully I will get a few Bob back as we say..

[bomber13] 27/8/2015 18:48

haroldthegreat and Vasilis , heard VRP were presenting to Hardman clients after market close 9th Sept with three other companies , not sure who . Now that we know the interims are on the 8th , this meeting could just be part of the post results roadshow . N-1 Singers are the official brokers , and may also / definitely have post results meetings lined up .

[corbine] 27/8/2015 15:59

timing is everything- especially if theres some good news to release?
and maybe a slice of Lancet?
:-))

[vasilis] 27/8/2015 15:06

bomber13

I'm no doubt overlooking something but where did you get the info re VRP presenting on 9 September at a Hardman investor forum?

VRP are listed at the end of this Hardman link as having already presented in the past -

Are VRP presenting again on 9 September?