Member Info for Winter55

This will be in the 20p imo very soon. Dyor

Proactive investor interview back in April- available on YouTube. CDiff phase 3 expected to cost 50m Not looking to approach investors to fund phase 3 'looking to others to do the heavy lifting' It will either be a partnership or a major anti biotic programme from US or European governments or some combination. Market size expected to be around 2-3 billion pounds 'We want to find a partner soon, but there are alternative ways to fund this and we could look for a partner after phase 3.' When asked how many companies Glyn was speak to, he replied 'a number more than one. It will not be hard to find a partner given our data and the significant opportunity this market offers.' DYOR!

I see my previous post has been removed.

The Sarepta Finance BB's are finally discussing Summit's work. An interesting example here of how they view the PPMD Joint conference call (I quote verbatim without correction!): stocktrooth • 17 hours ago Flag Summary of PPMD conference call: Sarepta and Summit Summit will continue to execute the clinical trials. Phase 2 begins shortly in the US Made completely new utrophin modulator compound (S6) with work with Oxford. 10 boys will get S6 in the US in the PhaseOut study. The extension study will be of the compound that performs the best S3 vs. S6. Summit wanting a development program, with a single trial (carried out in US and Europe), that can satisfy both FDA and EMA approval. Not going to test combination therapy. Remain focused on single engine activity until both are proven. Sarepta to study 6 months to 4 years old group in Europe. Previously they've only looked at as low as 4 years old. Summit not interested in studying older patients (older than 18). Instead, they'd rather conduct trials on young homogenous groups and receive approval so all age groups can have access. Summit doesn't have a compassionate use policy but will need a level of efficacy and safety before it does so within the confines of clinical trials. Sarepta doesn't have compassionate use policy either to focus on meeting all the regulatory commitments with all their ongoing trials. Summit not worried about getting combination therapy in future in either EMA or FDA as other fields, such as cancer drugs, this is a common place. Sarepta and Summit partnership not brand new. Their research teams have collaborated with animal testing and biopsies to share lessons learned. Summit is looking for, and Sarepta offers, regulatory expertise. Utrophin produced during growth and in event of injury. "As muscle damage occurs then the utrophin turns off. When no dystrophin arrives then utrophin turns back on." They're finding high amounts of natural utrophin in DMD patients but it's patchy in biopsies. Sarepta has the sites that perform the biopsies to first process a piece of steak to prove they're capable of processing the biopsy exactly the same way before human biopsy is performed. Ed Kaye acknowledges MRI is a far distant surrogate marker

Q: Why would Sarepta, which already has a DMD drug, agree to pay so much for another one? A: EXONDYS 51, Sarepta’s DMD drug that recently received accelerated approval from the FDA, has been approved for the treatment of DMD patients who have a confirmed mutation in the DMD gene that is amenable to exon 51 skipping. This represents up to 13% of the DMD market. Trials of exon 45 and 53 are ongoing, which represents up to an additional 16% (8% for each) of the DMD market. Summit’s utrophin modulation programmes are a potential disease modifying approach that could potentially be used by 100% of DMD patients and in combination with other agents. By entering into a licence and collaboration agreement with Summit Therapeutics, Sarepta has created a presence in the entire DMD market in Europe and the additional regions of the deal. Q: At some point as Ezutromid completes clinical trials, would it not make more sense for Sarepta to acquire Summit? A: It is a theoretical possibility, particularly since the deal does not include the US. The structure of the deal enables Sarepta to benefit from the significant potential upside of Summit’s utrophin modulation programme without the substantial initial outflow of an acquisition. Q: Might there be a reset to the pace of clinical trials? A: Currently Summit’s development plans are still on track with the first muscle biopsy data from the ongoing PhaseOut DMD trial in Q2/Q3 2017. Q: Is Summit just a one-trick pony? A: Summit is certainly not just a one-trick pony as it currently has two very different programmes. One being utrophin modulation for DMD and the other a small novel antibiotic (ridinilazole) that is being developed to treat the infections caused by the hospital ‘superbug’ C. difficile. Summit announced positive data from its Phase II proof of concept trial of ridinilazole in November 2015. Q: Will this deal have any effect on the C-Diff programme? A: Summit has stated that it continues to evaluate all options for progressing ridinilazole (C-Diff) into Phase III trials with its preferred path forward to seek a partner. The deal with Sarepta provides Summit with an upfront milestone of US$40m, strengthening Summit’s balance sheet and enabling it to continue partnership discussions from a strong position.

Summit and Sarepta: The key questions answered 02:15 09 Oct 2016 We put some of your queries to life sciences research analyst Sheena Berry, of N+1 Singer, who has shed an analytical light on the licensing deal If you’ve even the faintest interest in the biotech space, we suspect you’ve heard about Summit Therapeutics PLC’s (LON:SUMM) recent licensing agreement with Sarepta Therapeutics (NASDAQ:SRPT). For those of you who aren’t aware, the pair inked a deal – which could be worth more than US$522mln – that will see them collaborate on Summit’s potentially breakthrough treatment for Duchenne Muscular Dystrophy (DMD). The science behind the treatment is, as you’d expect, quite complex. Essentially, what Summit’s discovery aims to do is to make up for a lack of dystrophin (which produces the protein essential for maintaining healthy muscle function) in DMD patients, by increasing the levels of another, similar protein called utrophin. The bulletin boards have been alight with questions about what the deal means and what the future of the discovery could be. Sheena has kindly agreed to share her expertise. Q: Can you put the licensing agreement into context? Is it a good deal on an international scale? A: Yes, on an international scale it is a very good deal. It covers Europe, Turkey and the Commonwealth of Independent States. Sarepta also has an option to license Latin America. Summit retains commercialisation rights to the rest of the world, including the US. Q: When are the next milestones? A: The first milestone following the US$40m upfront is US$22m upon the first dosing of the last patient in Summit’s ongoing Phase II clinical trial (referred to as PhaseOut DMD) of ezutromid. The US$22m milestone is payable on or after 1 April 2017. In relation to ezutromid, Summit is eligible to receive up to a further US$20m in specified development milestones, up to US$150m in specified regulatory milestones and up to US$330m in sales milestones. Details of what triggers the milestone and its quantum are undisclosed.Summit is also eligible to escalating royalties ranging from low to high teens percentage of net sales in the licensed territories as well as additional milestones on its next-generation utrophin modulators. If Sarepta elects to exercise its option for Latin American rights, Summit would be entitled to additional fees, milestones and royalties. Q: Do you think the Summit drug has blockbuster potential? A: Yes it does have blockbuster potential. Summit’s DMD programme involves developing small molecule utrophin modulators for the treatment of the genetic muscle wasting disease. Ezutromid is the group’s lead utrophin modulator. It has orphan drug designation in Europe and

Summit must be on the radar now. Not only do you get these great assets but also access to SRPT's data.

I'll top up if hits £2

Will we see some buying after investors learnt about Summit last night?

When should the variation payment of €6m been received?

Looks like PLE is down again!

Lse have said that the Ple board will change to RP after the takeover. It will take 48 hours to change after Ple delisted.