Summit Therapeutics Share Discussion Threads

[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.

[kirk 6] 17/6/2019 21:23

Nice rally over on the Nasdaq about time too

[chrisatrdg] 17/6/2019 12:11

Agronomics Ltd
Half-year Report

It includes a good piece on Summit so he is still holding Summit shares.

[chrisatrdg] 17/6/2019 10:57

The next RNS

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.

[waterloo01] 16/6/2019 17:50

I continue to wonder about the effect on the rest of the microbiome.

FDA In Brief: FDA warns about potential risk of serious infections caused by multi-drug resistant organisms related to the investigational use of Fecal Microbiota for Transplantation

[waterloo01] 15/6/2019 09:31

Wonder if Port Erin (Mellon's vehicle) now called Argonomics will increase stake or are sellers?

[waterloo01] 15/6/2019 07:09

good finds.

[chrisatrdg] 14/6/2019 23:16

FDA issues warning after patient dies from fecal transplant containing drug-resistant bacteria

[chrisatrdg] 14/6/2019 23:01

Fighting antimicrobial resistance & making the EU a best practice region remains top priority in the area of health, agree EU ministers on day 2 of the #EPSCO.

[chrisatrdg] 13/6/2019 15:47

Summit Therapeutics 'taking leadership role' in development of new antibiotics

investors.co.uk/companies/stocktube/13726/summit-therapeutics--taking-leadership-role--in-development-of-new-antibiotics-13726.html

[chrisatrdg] 12/6/2019 21:19

A Critical Juncture for Antibiotic R&D
Jun 11, 2019
By David Roblin
Pharmaceutical Executive
Volume 39, Issue 6

[kirk 6] 12/6/2019 19:24

Got big stakes in quite a few stocks so haven't got the time soo busy trading

[waterloo01] 12/6/2019 18:52

Well you are going to have to be patient to see a return (or an exit). You should attend the AGM and get to know your investment

[kirk 6] 12/6/2019 18:21

Hold well over 1mI'm sure there has recently been a £1.50 price target (will take a look later)Also the 25p equivalent funder will want a return and all the options at 29.5p will want to be exercised

[waterloo01] 12/6/2019 17:54

kirk6, how many shares do you own? Who's £1.50 price target?

No the phase 3's are expensive and while they have up to $62m from Barda, there is a funding gap. The C.diff trial won't report till 2021. Might find partner, but seems unlikely unless the whole antimicrobial s space improves, or other sources of funding for other targets or get grants etc.

I just expected it to be well into 2020 before funds needed and time to 'mine' the options. Maybe they are being super cautious?

[kirk 6] 12/6/2019 17:46

Less spend tho and just under 28m in cash surely if the trials are successful Summ can partner?!?What about the recent £1.50 share price target ?

[waterloo01] 12/6/2019 16:43

I'm not that pessimistic and have few worries that the company can get the funding needed, so not concerned about it's 'existence' just the cost in dilution, unless ANO Barda type options? Not past them to pull that off.

[chrisatrdg] 12/6/2019 16:29

I agree with waterloo01 the principal matter of note is the delay to SMT 751 but also they have said that there is now also added the following under the Notes to the Accounts - Note 1 Basis of Accounting

'Should the Group be unable to raise additional funding, management has the ability to take mitigating action to fund its operating expenses and capital expenditure requirements in relation to its clinical development activities for only a short period beyond 12 months from the date of issuance of these financial statements.'

The above says there are contingency plans to extend the ability of the Company to trade beyond 31st January 2020 & may tie in to another reason for delaying on SMT751.The date becomes 12 months from the 12th June 2019 as the final date they could go to then its good night Vienna.

[waterloo01] 12/6/2019 15:15

Well a mixed bag I guess. SMT 751 trial date delayed but they hope as a result will be a quicker trial once it starts. I suspect it's as much to do with cash preservation as only have cash till end January 2020, despite having £28m in cash end April and money due from carbX and Barda.

Let's hope there are enough grants etc out there to fund going forward as not sure an equity raise is particularly welcome, although last time they raised at a premium, but the dilution was chunky.

Still Nasdaq don't like it!

Edit: and now it does!

[kirk 6] 12/6/2019 13:48

Reduced loss and exciting future ?

[chrisatrdg] 10/6/2019 20:01

AGM

I will see you there waterloo01 & I am looking forward to some of your questions.Regards

PS INFA starting to move up again I hope to be in a better place by next week.

[waterloo01] 10/6/2019 19:18

Haven't decided yet, but a few other posters know who I am. I usually like to ask questions!

[algernon2] 10/6/2019 19:05

It'll be good to meet you Waterloo, how will I know you? Will you be suited or carrying a rolled up umbrella or have a giant Moustache?

[waterloo01] 10/6/2019 18:24

I'm going.