Summit Therapeutics Share Discussion Threads

[football] 08/9/2016 14:58

Summit Therapeutics highlights clinical progress
Share

14:35 08 Sep 2016
Chief executive Glyn Edwards highlighted the recent progress through the group's clinical programmes for Duchenne muscular dystrophy (DMD) and C. difficile infection (CDI) .

Glyn Edwards, Summit Therapeutics PLC (LON:SUMM, NASDAQ:SMMT) chief executive, has highlighted the group’s progress through its ongoing clinical programmes.

Edwards, in the Duchenne muscular dystrophy (DMD) and C. difficile infection (CDI) drug developer’s quarterly results statement, told investors that a landmark DMD programme had continued to gain momentum.

“We initiated our Phase 2 proof of concept clinical trial, PhaseOut DMD, of ezutromid and are actively enrolling patients in the UK.

“This trial represents the first long-term clinical trial of a utrophin modulator, a potential disease-modifying therapy applicable to all patients with DMD. We look forward to receiving data from the first group of 24-week biopsies in Q2/Q3 2017.”

He also highlighted positive findings of a separate Phase 1 trial. The trial results showed that a new formulation had achieved over a six-fold increase in maximum plasma levels but with a reduced oral dose compared to the current formulation.

“With these results, we plan to incorporate the new formulation, subject to regulatory approval, into PhaseOut DMD alongside the current formulation. Including both formulations allows us to further explore the potential therapeutic effect of ezutromid with an expanded range of blood concentrations,̶1; Edwards said.

Separately, Edwards noted the progress with the company’s Phase 2 CDI trial and highlighted that the company continues to evaluate its options to advance into Phase 3.

He added: “In our CDI programme, additional results from our Phase 2 CoDIFy clinical trial support ridinilazole as a highly selective, microbiome-sparing antibiotic that has great promise in both the treatment of the initial infection and in reducing CDI recurrences, the key issue in the treatment of CDI.”

Summit finished the second quarter with £7mln of cash and equivalents. The pre-revenue drug developer reported a £11.5mln for the six months ended July 31.

hxxp://www.proactiveinvestors. co.uk/companies/news/163664/summit-therapeutics-highlights-clinical-progress

[chrisatrdg] 08/9/2016 13:23

Listening now but the best schedule is the cash flow and in particular it is the refund of the R&D tax credit of £3,005,000 which is received in arrears which has helped finance the 6 months ended 31st July 2016 hence a bank balance of £6,996,000.Looks ok to me & have myself worked as an accountant in Biotech dealing with such matters.They have to December 2016 to find funds which is only 16 weeks from today fingers crossed.

Edit:Today
Not sure if I missed anything but it seemed to me to be more of a holding call rather than that we learned anything new.Other views welcome.

I am still showing as a Strong Buy at these prices & as the science is still holding also cannot believe that Summit will not find funds albeit, at worse, at a high dilution.

[someuwin] 08/9/2016 12:45

Seem to me they've made a loss for the last 3 months (to end July) of GBP6.3m

But are claiming cash is only down from 10m to 7m - should be much lower surely (or is it the way they are counting cash and cash equivalents).

Either way, burning GBP2m per month makes this uninvestable until they raise cash. imo.

[clarkey26] 08/9/2016 12:35

My previous comment re going concern is highlighted in the accounts, need funding by end December at latest. Very little in the statement re progress of any partnering for c-diff, although appreciate not easy to include when could be uncertain and confidential etc. Will be interesting to see if better insight on any progress on conference call. I do fear a fund raise as feel will be deeply discounted. Hopefully deal or as referred to maybe non-profit organisation so shareholders not impacted. Given major shareholders vote re remuneration, at AGM, I think that will influence any ability to raise funds on market. Timing getting very tight! Fundamentals good re drugs but need management to deliver now

[theunluckyone] 08/9/2016 12:06

football - That just about sums it up

[football] 08/9/2016 12:04

Looks like same old stuff more jam tomorrow but tomorrow is getting closer and more cash burn

[football] 08/9/2016 10:31

gla 4 noon

[chrisatrdg] 07/9/2016 21:07

Back to Buy again following todays trading per link below:

[waterloo01] 07/9/2016 19:53

Fingers crossed for a well received update tomorrow. I'll try and log in at some point during the day.

[sorrento06] 07/9/2016 19:11

Or derampers

[sorrento06] 07/9/2016 17:08

I'm being conservative to please the de-tampers. I

[patviera] 07/9/2016 16:39

Wow sorrento Most of us are in at 200p!!

[sorrento06] 07/9/2016 13:41

In the Proactive investor interview, G confirm there have been offers but he was looking for a multi company distribution deal for C-Diff. I'm not worried! £100m upfront plus 10-20% royalties and we are looking at £1.70 a share! DYOR GLA

[patviera] 05/9/2016 22:10

I warned you all that our shares would fall if Glyn stayed as CEOThis has underperformed the general market and biotechnology sector by huge amountsWe need new mgmnt

[chrisatrdg] 05/9/2016 19:47

Hi waterloo01 - Concur with all your points and the reported cash balance will be of interest.I also now fear that a placement is on the cards certainly if they are not certain of a deal by the end of September even at current low prices.I am not able to invest more in order to average down & will therefore suffer if there is a placement with no chance of recovery until I suspect next year.The current position we are in is not where I and many others thought we would be a year ago but maybe 'one day' we will get our reward.

[waterloo01] 05/9/2016 18:43

I'll be travelling on Thursday when the results are out. The commentary and in particular the call will be most interesting. I would have thought they will have to make some comment on the state of play re Ridn'azole deal plus news on how dosing is going in DMD. If a deal isn't close, I'd expect it to be quickly followed by news of a placing. The share price seems to be reflecting that expectation, rather than a deal, so hopefully any 'good' news will see the appropriate share price response. Normally it's firmly in the damp squib territory but 'one day'.....

[clarkey26] 05/9/2016 16:08

Yes will be interesting, especially re funding as are they now able to satisfy 'going concern' element if need funding within next 12 months of account period end. Suspect will be a caveat to this in the accounts.

[chrisatrdg] 05/9/2016 12:10

At last Summit RNS re 1/2 year results will be interesting to listen in this Thursday.

[algernon2] 04/9/2016 18:59

Thanks Chris did you see the bit in the Richard Vickers lecture where he discussed the couple who researched and did their own DIY "fecal transplant" to cure their case of C-Diff.It apparently worked.
This was after she failed all other therapy.
Its worth watching just for this story of how desperate the illness can make you.

its at about point 31 minutes in:

[chrisatrdg] 04/9/2016 13:16

per gmcc last Friday from the other board:
SMT C1100 (Ezutromid )

'FYI Trial update : “This study is currently recruiting participants. (see Contacts and Locations)

Verified September 2016 by Summit Therapeutics “

--- additional sites added now 5 in UK



Edit: Thanks algernon2 for your posting.

[algernon2] 03/9/2016 18:20

"Richard Vickers | UK | Antibiotics 2015| Conference .."

This is Richard in late 2015 but I can't remember this being posted before.It only has 2 views so am guessing this may be new for some of us.
Tons of Info on hyper virulent strains of c-diff and our new antibiotic..

[chrisatrdg] 30/8/2016 16:59

Interim results announcement for 6 months 31st July 2016 when ?

Based on last years timetable the RNS for announcing that 6 months results to be issued was out by now.Maybe they are holding onto final version in order to include 'the C-Diff' deal under post balance sheet events or maybe that is wishful thinking.So no RNS this Friday - surprised.Maybe a deal is in progress which holding things up

Edit: I would start to worry if no C-Diff deal by end of September 2016.

Edit: Note that previous years results were early Sept so based on that not yet too late.

[chrisatrdg] 29/8/2016 19:46

Muscular Dystrophy News Weekly Digest - includes per below:

Muscular Dystrophy News reporting (per previous RNS)

Potential DMD Therapy, Ezutromid, Shows Effectiveness in New Formulation