Summit Therapeutics Share Discussion Threads

[chrisatrdg] 21/6/2019 22:36

Summit Therapeutics
Summit Therapeutics
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We'll be presenting at ASM Microbe on our pipeline and strategy for our new classes of #antibiotics. Friday, June 21 from 2:52-3:03pm PDT, Dr. Clive Mason will present on our pipeline and strategy, and on Sunday, June 23 from 10:30am-4:00pm PDT, Dr Paul Meo will present on SMT-571, our new class antibiotic in preclinical development for the treatment of #gonorrhea.

[waterloo01] 20/6/2019 16:52

The more I read the more I think the DISARM act, currently going through Congress might well make all the difference. Just waiting on Trumps signature, so hopefully won't have to wait till 2022.

If the bill gets signed, raising the extra cash will be a great deal easier

[bermudashorts] 20/6/2019 16:38

Thanks gooosed - Ridinilazole trial results seem a long way off but that may be no bad thing! Just have to hope that by 2022 one or some of these incentives have been put into place.

[gooosed] 20/6/2019 16:12

"Existing incentives to entice antibiotic R&D in the United States are too feeble to fix this ‘broken system’ critics have argued. Other parts of the world, such as the UK, are considering different approaches to reinvigorate antibiotic R&D. A UK government report published earlier this year outlined a plan to de-couple price from demand and shift to a more value-based approach that would compel institutions to pay fees based on their need for new antibiotics, akin to a licensing approach that former FDA commissioner Scott Gottlieb threw his support behind."

[kirk 6] 19/6/2019 21:33

Well got my quid in the game with this one ! Hope to see you at next agm

[chrisatrdg] 19/6/2019 21:26

True Kirk 6 That was my impression from today but we have a long wait.

[kirk 6] 19/6/2019 21:07

If the commercialisation of these antibiotics actually happens this could be worth 100's if millions if not more!

[bermudashorts] 19/6/2019 19:49

Thanks both for taking the time and trouble to add your comments

[algernon2] 19/6/2019 19:27

Hi Waterloo and Chris, great to meet you both at last.
I only have a few minor items to add for those interested in the DMD side of things.
Dame Kay Davies is still involved in DMD research and the Utrophin up-regulation side of things.
Summit have no further interest in DMD seeing themselves as an Antibiotic focused Company now.
I did ask if Kay came up with something else in the DMD (utrophin) side of things whether Summit would still have either first refusal or be interested in pursuing it.
The answer unequivocally from Richard Pye was "NO".
So thats it lads the DMD dream is over for us at least.

[chrisatrdg] 19/6/2019 15:51

Hi Waterloo01 Thanks for your excellent posting & good to have met up again.

I am glad I went today & things look bright for the future but it will be a while before we see any further inflection points except where we are post the next funding particularly if it bridges the C-Diff funding gap.

I have no further points to add.

[gooosed] 19/6/2019 15:16

Many thanks Waterloo.

[bermudashorts] 19/6/2019 13:10

Good stuff, thanks Waterloo

[kirk 6] 19/6/2019 13:05

Thanks Waterloo interesting and exciting !

[waterloo01] 19/6/2019 12:56

Quick AGM update.

Lots of talk about the different approach to antibiotics, in going for both superiority and presenting the economic case. Many of the recent failures in the space have a lot to do with the fact most are going for equivalence/me too products.

There are only 8 antibiotics currently in phase 1-3 that are new mechanism if actions, RDZ being one of them

Are about 100 sites currently open (Clinical trials lists 2 but apparently is out of date). Results still planned mid 2021.

Barda relationship is good and possibility of some more from them but there is a funding gap which is estimated to be between $60m and $100m over 2 years.

Most likely this will be raised from equity and one has the feeling they have somethings lined up. Stressed point that last placing was at a premium, so hopefully that's repeated. Dungan continues to be supportive and likely to come in on any further raises.

Push and pull incentives are important, but because of their approach (superiority)they will build an economic case regardless. However the current bill going through US congress (Disarm) could make a massive difference as will pay hospital 102% of the cost of the drug (are other initiatives ongoing as well). Might this be the thing that will change the whole investment environment?

Still suggesting market could be worth $1bn US alone (they want to keep US rights but might other geographies be part of any funding?) and if adopted RDZ should save hospitals $3 bn a year.

Other antibiotics all going to plan.

So in short, an exciting future but further funding needed, but the end prize remains significant and ever more so as and when the investing community start to reinvest in the area (and Disarm act might be the thing that makes the difference here).

More if I remember. Good to meet the other investors.

[chrisatrdg] 18/6/2019 16:05

The Elephant in the room

I think todays RNS may have got rid of 'The Elephant in the room' i.e. future funding & for the first the share price continues to rise (no profit taking).I only wish I had the funds to top up.

[multiplural] 18/6/2019 15:24

BTIG issued a 14 page note on Summit on June 12th . They have a 12 month price target of 5 USD for the ADS or some 80p per share.

[waterloo01] 18/6/2019 15:08

I saw a broker note some time back and they had peak sales of $900m/$1bn, however it's hard to see that given current climate

[kirk 6] 18/6/2019 15:03

What is the likely upside if phase 3 trials are positive? The implications could be monumental with numerous offers of partnerships available to commercialisation!!!The confidence here now must be improving daily

[waterloo01] 18/6/2019 14:59

Nasdaq up nicely from a bottom of $1.20. Market obviously takes comfort that Barda are continuing to fund, with a little extra added on.

[chrisatrdg] 18/6/2019 13:59

Todays RNS

Well looks like my gut feeling Monday was right ( see below) todays RNS is great news & demonstrates that there is additional support for the Phase 3 C-Diff trials which should extend the cash runway.

Monday post:

'Could we be in for a surprise RNS soon in which it is announced that Summit will receive further funding for their C-Diff trials based on recent articles for the need to combat diseases like C-Diff there was a final realisation that their drug must succeed & so funds provided.Just a thought.'

[kirk 6] 18/6/2019 13:19

Sounds very positive!!

[gooosed] 18/6/2019 13:18

"Summit estimates the cost of managing CDI is upwards of US$6bn every year in the US alone."

as per Proactive Investors.

[chrisis33] 18/6/2019 13:07

sounds positive?

[kirk 6] 18/6/2019 12:08

Summit Therapeutics plc Increased Barda Award And Option ExerciseSource: UK Regulatory (RNS & others) TIDMSUMM Summit Therapeutics plc ('Summit' or the 'Company') Summit Announces BARDA Increases Award for Ridinilazole Clinical and Regulatory Development to up to $63.7 Million and Exercises Next Contract Option -- Summit Awarded $9.6M under Next Contract Option -- Total Committed BARDA Funding Now $53.6 Million Oxford, UK, and Cambridge, MA, US, 18 June 2019 -- Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM), a leader in new mechanism antibiotic innovation, today announces that the Biomedical Advanced Research and Development Authority ('BARDA') has increased the total value of its award for the clinical and regulatory development of Summit's precision antibiotic ridinilazole for the treatment of C. difficile infection ('CDI') to up to $63.7 million. Under this award, BARDA has opted to exercise the next contract option for $9.6 million, which will support patient enrolment and dosing in the ongoing Phase 3 clinical trials of ridinilazole. "The funding from BARDA is a testament to the promise of ridinilazole to address an important public health need in CDI. Through our ongoing landmark Phase 3 clinical programme, we aim to show that our microbiome preserving antibiotic is superior in sustaining cures compared to the current standard of care and so has the potential to be the front-line treatment option for patients with CDI," said Mr Glyn Edwards, Chief Executive Officer of Summit. "We are pleased with the excellent working relationship that has been formed between us over the last two years and thank BARDA for its continuing support of ridinilazole." The total committed funding from the BARDA award under Contract No. HHS0100201700014C is now $53.6 million, with one final option remaining. The final option provides funding support for potential applications for marketing approvals of ridinilazole. The BARDA contract provides for a cost-sharing arrangement with the committed funding drawn down over a specified development period. This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014 (MAR). About C. difficile Infection C. difficile infection is a serious healthcare threat in hospitals, long-term care homes and increasingly in the wider community with over one million estimated cases of CDI annually in the United States and Europe. CDI is caused by an infection of the colon by the bacterium C. difficile, which produces toxins that cause inflammation and severe diarrhoea, and in the most serious cases can be fatal. Patients typically develop CDI following the use of broad-spectrum antibiotics that can cause widespread damage to the natural gastrointestinal (gut) flora and allow overgrowth of C. difficile bacteria. The vast majority of patients are treated with broad-spectrum antibiotics, which cause further damage to the gut flora and are associated with high rates of recurrent disease. Reducing disease recurrence is the key clinical issue in CDI as repeat episodes are typically more severe and associated with an increase in mortality rates and healthcare costs. A study estimated that the total costs attributable to the management of CDI were approximately $6.3 billion per year in the United States. About Ridinilazole Ridinilazole is an oral small molecule new mechanism antibiotic that is designed to selectively kill C. difficile, thereby preserving patients' protective gut microbiome and leading to sustained CDI cures. In a Phase 2 proof of concept trial in CDI patients, ridinilazole showed statistical superiority in sustained clinical response ('SCR') rates compared to the standard of care, vancomycin. In that trial, SCR was defined as clinical cure at end of treatment and no recurrence of CDI within 30 days of the end of therapy. Ridinilazole was also shown to be highly preserving of the gut microbiome in the Phase 2 proof of concept trial, which was believed to be the reason for the improved clinical outcome for the ridinilazole-treated patients. In addition, ridinilazole preserved the gut microbiome to a greater extent than the marketed narrow-spectrum antibiotic fidaxomicin in an exploratory Phase 2 clinical trial. Ridinilazole has received Qualified Infectious Disease Product ('QIDP') designation and has been granted Fast Track designation by the US Food and Drug Administration. The QIDP incentives are provided through the US GAIN Act and include a potential extension of marketing exclusivity for an additional five years upon FDA approval. About the Contract with BARDA This project has been funded in whole or in part with federal funds from the Biomedical Advanced Research and Development Authority, a component of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, under contract number HHS0100201700014C. About Summit Therapeutics Summit Therapeutics is a leader in antibiotic innovation. Our new mechanism antibiotics are designed to become the new standards of care for the benefit of patients and create value for payors and healthcare providers. We are currently developing new mechanism antibiotics for infections caused by C. difficile, N. gonorrhoeae and Enterobacteriaceae and are using our proprietary Discuva Platform to expand our pipeline. For more information, visit www.summitplc.com and follow us on Twitter @summitplc. Contacts Summit Glyn Edwards / Richard Pye (UK office) Tel: 44 (0)1235 443 951 Michelle Avery (US office) [phone] Cairn Financial Advisers LLP (Nominated Adviser) Tel: [phone] Liam Murray / Tony Rawlinson N+1 Singer (Joint Broker) Tel: [phone] Aubrey Powell / Jen Boorer, Corporate Finance Tom Salvesen, Corporate Broking Bryan Garnier & Co Limited (Joint Broker) Tel: [phone] Phil Walker / Dominic Wilson MSL Group (US) Tel: [phone] mailto:[e-mail] Jon Siegal [e-mail] ------------------------------ Consilium Strategic Communications (UK) Tel: [phone] Mary-Jane Elliott / Sue Stuart / mailto:summit@consilium-comms. com [e-mail] ------------------------------ Lindsey Neville Summit Forward-looking Statements Any statements in this press release about the Company's future expectations, plans and prospects, including but not limited to, statements about the potential benefits and future operation of the BARDA contract, including any potential future payments thereunder, the clinical and preclinical development of the Company's product candidates, the therapeutic potential of the Company's product candidates, the potential commercialisation of the Company's product candidates, the sufficiency of the Company's cash resources, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the ability of BARDA to terminate our contract for convenience at any time, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the "Risk Factors" section of filings that the Company makes with the Securities and Exchange Commission, including the Company's Annual Report on Form 20-F for the fiscal year ended 31 January 2019. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent the Company's views only as of the date of this release and should not be relied upon as representing the Company's views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release. -END- (END) Dow Jones NewswiresJune 18, 2019 07:00 ET (11:00 GMT)Copyright (c) 2019 Dow Jones & Company, Inc.