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Share Name Share Symbol Market Type Share ISIN Share Description
Summit Therapeutics Plc LSE:SUMM London Ordinary Share GB00BN40HZ01 ORD 1P
  Price Change % Change Share Price Shares Traded Last Trade
  0.00 0.0% 20.50 0.00 00:00:00
Bid Price Offer Price High Price Low Price Open Price
18.00 23.00
Industry Sector Turnover (m) Profit (m) EPS - Basic PE Ratio Market Cap (m)
Pharmaceuticals & Biotechnology 43.11 5.04 9.16 2.3 69
Last Trade Time Trade Type Trade Size Trade Price Currency
- O 0 20.50 GBX

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DateSubject
15/1/2021
08:20
Summit Therapeutics Daily Update: Summit Therapeutics Plc is listed in the Pharmaceuticals & Biotechnology sector of the London Stock Exchange with ticker SUMM. The last closing price for Summit Therapeutics was 20.50p.
Summit Therapeutics Plc has a 4 week average price of 0p and a 12 week average price of 0p.
The 1 year high share price is 24p while the 1 year low share price is currently 19p.
There are currently 335,873,208 shares in issue and the average daily traded volume is 0 shares. The market capitalisation of Summit Therapeutics Plc is £68,854,007.64.
29/9/2020
11:47
chrisatrdg: Results Out YE 30th June 2020 Summit Therapeutics Inc. (‘Summit’;, the ‘Company’; or the ‘Group’) Summit Therapeutics Reports Financial Results and Operational Progress for the Second Quarter and Six Months Ended June 30, 2020 Cambridge, MA, September 29, 2020 - Summit Therapeutics Inc. (NASDAQ: SMMT) today reports its financial results and provides an update on its operational progress for the second quarter and six months ended June 30, 2020. Ridinilazole for C. difficile Infection (‘CDI’) Summit published data from its Phase 2 clinical trial of ridinilazole evaluating the effects of a narrow-spectrum (ridinilazole) or broad-spectrum antibiotic (vancomycin) on intestinal bile acid profiles. This was the first study to demonstrate in humans the relationships between Clostridioides difficile antibiotic treatment choice and bile acid metabolism both during therapy and after treatment cessation. The results indicated that ridinilazole maintained an intestinal bile acid profile associated with a lowered risk of recurrence. The data were published in the American Journal of Physiology – Gastrointestinal and Liver Physiology. As of August 31, 2020, Summit had enrolled a total of 369 patients into its Phase 3 Ri-CoDIFy clinical trials of ridinilazole. Below is a table outlining the enrollment statistics by calendar quarter and for this past July and August since the opening of the trials in February 2019. Quarter Number of patients enrolled Cumulative Patients Enrolled Q1 2019 9 9 Q2 2019 21 30 Q3 2019 43 73 Q4 2019 78 151 Q1 2020 101 252 Q2 2020 73 325 July 2020 22 347 August 2020 22 369 Due to the uncertainties surrounding COVID-19, Summit is withdrawing public commentary on the timing of completion of the Phase 3 Ri-CoDIFy clinical trials. The Company plans to publicly update stakeholders quarterly as to enrollment status. The Ri-CoDIFy clinical trials aim to support application for marketing approval of the precision antibiotic ridinilazole in the United States and other territories and the goal of it being used as a first-line treatment for CDI by: testing for superiority over the current standard of care, vancomycin, in the primary endpoint of sustained clinical response at 30 days after treatment has ended; generating health economic data to support ridinilazole's commercial launch, when as and if approved by regulatory authorities; and undertaking microbiome and metabolome analysis that aims to show ridinilazole’s impact on the gut microbiome and bile acids composition BARDA is supporting the Phase 3 clinical trials and regulatory development of ridinilazole with a financial award of potential funding of up to $72.5 million. As of June 30, 2020, an aggregate of $46.6 million had been received. Discuva Platform Enterobacteriaceae DDS-04 compound series is a new class of precision antibiotics, with new mechanism of action, which is in lead optimization that acts via the novel bacterial target LolCDE with the potential to treat multidrug resistant infections caused by the Gram-negative bacteria Enterobacteriaceae. Gonorrhoea Based on results from recent preclinical studies, the DDS-01 series of antibiotics against Neisseria gonorrhoeae was determined not to have suitable qualities for further development as it had shown toxicity in animal studies and therefore, Summit is ceasing work on the gonorrhea program. The Company expects CARB-X will cover its remaining share of the work that has been funded under the award. Corporate Highlights Mr. Michael Donaldson was appointed as Chief Financial Officer in June 2020. Previously, Mr. Donaldson served as Vice President, Finance, and Corporate Controller for Goldfinch Bio, Inc. from 2018 to 2020 and Vice President, Finance, Corporate Controller and Assistant Treasurer at ARIAD Pharmaceuticals, Inc., which was acquired by Takeda, Inc. in 2017, from 2016 to 2017. Prior to that, he was the Corporate Controller for Hittite Microwave Corporation, which was acquired by Analog Devices in 2014. Mr. Donaldson spent the first 11 years of his career at PricewaterhouseCoopers Dr. Jos Houbiers was promoted to Chief Medical Officer in July 2020. Dr Houbiers brings to Summit over 20 years of experience in pharmaceutical clinical development, where he’s implemented clinical development strategies, creative trial design and comprehensive medical safety monitoring across therapeutic areas, including functional urology, immunology and transplantation. He was most recently at Astellas, where he served in roles of increasing responsibility in clinical development from the Global Development hub, where he ended as Executive Medical Director and Group Head for the Medical Science Urology department. Dr. Houbiers received his MD from Leiden University Medical Center and PhD (immunology) and MSc in medicine from Leiden University. Ms. Ujjwala Mahatme was appointed as a Director in July 2020. Mr. Robert W. Duggan was appointed as Chief Executive Officer and Dr. Ventzislav Stefanov was appointed Executive Vice President and President of Discuva, the Company's discovery engine employing 14 people, in April 2020. Mr. Glyn Edwards stepped down as Chief Executive Officer in April 2020 and from the Board of Directors in June 2020. Summit has redomiciled to the United States, effective September 18, 2020. COVID-19 In light of the ongoing COVID-19 pandemic, Summit's employees continue to work remotely, enabling the majority of day to day business operations to continue. Summit's own laboratory facilities have begun to reopen to resume work on key projects; site access by staff is being monitored closely and is limited to ensure the safety of Summit researchers. There continues to be a negative impact on patient enrollment into the Ri-CoDIFy clinical trials. We are working to implement a number of initiatives and considering alternative courses of action to mitigate the impact of the COVID-19 pandemic on our clinical trials, although there can be no assurance that such actions will be successful. Financial Highlights Cash and cash equivalents at June 30, 2020, of $36.4 million compared to $63.8 million at December 31, 2019. The Company's existing cash and cash equivalents and committed external funding are expected to be sufficient to enable the Company to fund its operating expenses and capital expenditure requirements through January 31, 2021. The Principal shareholder of the Company, Mr. Robert W. Duggan, has given his intention to the Board of Directors to participate in a future fundraise as required in order to support the Company with its clinical operations and planned research and development efforts. Loss for the six months ended June 30, 2020, of $21.6 million compared to a loss of $13.7 million for the six months ended June 30, 2019.
19/3/2020
20:30
sikhthetech: SMMT share price fell back after you sold... fact is 1gw trades long and short... with his mates with dozens of multiple ids.. RECENT the evidence is there to be seen company: STU From lse: Having the edge..others question your uncanny ability to buy/sell with perfect timing.. Skindle Posts: 756 Price: 224.00 No Opinion 1GW_Wed 19:07 Our esteemed co investor has an uncanny ability to judge the right moments to buy shares in STU and the right moments to sell. I take my hat off to you. Could you let me know please when we can next expect an uplift. Company: TRMR - Just today: says he buys TRMR @ 9.39am, after which the share price rises up to 20%... 1gw - 19 Mar 2020 - 09:39:20 - 3177 of 3210 TREMOR:Make a Mint - TRMR I didn't think I'd be buying more here, but 87p seems like a pretty good price considering the price I was selling at in January and even earlier this month. Still under 3% portfolio weight though (given the falls) so not pushing the boat out too far just yet. It is going to see a slowdown in advertising spend I think, but brand video advertising might be one of the better segments to be in over the next few months as large companies try to remind us they're still around for when the crisis is over. I also like the net cash position and would hope that has been added to since 31st December as the cash relating to calendar 4Q revenues came in. But I would imagine there might also be some debts to write off. Looking forward to seeing the results. Company BYOT - PUMP 1gw - 27 Feb 2020 - 22:18:09 - 4654 of 4706 BYOTROL-CAN DELIVER AMAZING RESULTS - BYOT Do you think this is a good time to be looking for an investment partner in the US who can put serious marketing resource into a road-tested new consumer product which "eliminates OVER 99.9% of germs and keeps surfaces sanitized for 24 HOURS with a revolutionary NON-TOXIC cleaning formula"? And if financial terms with a partner are already all but nailed down, and can't be reopened, do you think this would be a good time to launch such a product nationally? What about Solvay and Actizone? Do you think the current environment might push them into getting their finger out and doing a proper launch of a product based on that technology? It seems to me that the 24-hour claim might be particularly attractive in the current environment. 1gw - 27 Feb 2020 - 21:46:46 - 4651 of 4706 BYOTROL-CAN DELIVER AMAZING RESULTS - BYOT Not many places to hide in this market. Apart from investors throwing in the towel on individual stocks, I guess lots of money is being pulled, or is going to be pulled, from funds - which may then force institutional selling on a fairly indiscriminate basis. So byotrol potentially is a winning stock on two counts: products for which demand seems likely to grow as the coronavirus incidence becomes more widespread (so "a place to hide" in the market); and not much of an institutional base. And that's on top of the underlying investment case (the reason I and I suspect many of the longer-term holders have been buying over the last few years) built around turnaround of the business under David Traynor's leadership through tight control of costs, development of IP that is at the leading edge of regulatory change, getting regulatory approval for products based on that IP and now (through the Medimark acquisition) moving into sales and marketing, with major upside possible through licensing/partnership deals. Now where's that US deal? Obviously wouldn't sell given the huge potential sikhthetech - 28 Feb 2020 - 09:57:02 - 4678 of 4706 BYOTROL-CAN DELIVER AMAZING RESULTS - BYOT obviously your 'mate' 1gw won't be selling any today... ;-) Oh, he did DUMP some on Friday - funny that 1gw - 02 Mar 2020 - 08:56:56 - 4697 of 4706 BYOTROL-CAN DELIVER AMAZING RESULTS - BYOT That was you selling out, stt, was it? What do you want me to say? Congratulations on getting the first trade? I've sold 10% of my holding at an average of just under 4p, mainly today, but a small amount on Friday, when it was more difficult to sell any quantity on a quote & deal or even worked order basis. Much easier this morning and there seems to have been good demand, even just above 4p.
21/2/2020
12:52
sikhthetech: "Why would you not buy on the U.K. line at 19-20p" 1gw bought at around 21-22p for arb trading. 1gw's buy price is not much different from current price.. However, his mate 'football' id held when the share price was around 200p but has disappeared... Seems more like 1gw is trying to persuade others, with concerns about the conversion process, that it's not a problem. ;-) 1gw - 06 Feb 2020 - 08:09:33 - 25456 of 25501 Summit - Climbing to new heights - SUMM So having bought into the UK and Nasdaq versions at about the same time, and actually having paid slightly more for the Nasdaq one, my portfolio is now showing +5% on the Nasdaq holding and -10% on the UK holding. Where are the arb players? 1gw - 23 Jan 2020 - 15:24:03 - 25412 of 25501 Summit - Climbing to new heights - SUMM And bought some ADRs as well. Ended up paying 24p/share equivalent for the ADRs ($1.54 per ADR plus dealing/xrate), so above the price I bought the UK shares at, but don't have a 24th Feb deadline to get rid of them if I don't like the exchange process.
10/2/2020
17:06
waterloo01: Just out. So easy to convert. No charges or stamp duty if done before 21st Feb. Also confirms can't be held in ISA (with HL anyhow) . Chris, not sure why you bothered with paper? There is no conversion fee up until the delisting of the Shares from AIM. After close of business on 21 February 2020, conversion into ADRs may incur UK stamp duty or stamp duty reserve tax (currently 1.5% of the market value of the Shares converted) and fees of up to USD0.05 per ADR may be levied by Bank of New York Mellon upon conversion. What action do I need to take? If you wish to sell your holding before the proposed listing cancellation you must do so before 4.30pm on Friday 21 February 2020. The trade will be placed in accordance with our terms and conditions and subject to the standard Stockbrokers commission rates. To sell these shares please phone us on 0117 980 9800 or you can place a trade online. Please note that if the cash consideration of a sale does not exceed the commission payable then the sale will not be executed. Please note that although Hargreaves Lansdown will endeavor to sell your shares it may not be possible to sell all, or even any, of your shares if a market for the shares no longer exists. If you wish to maintain your holding you need take no action. You should note that following the cancellation you may have difficulty selling this investment at a reasonable price and, in some circumstances, it may be impossible to sell it at any price. Can I convert my Ordinary Shares to ADRs? Shareholders have the option to convert their Ordinary Shares to ADRs (American Depository Receipts) that will continue to trade on NASDAQ in the US. They are currently trading at USD1.65 Each ADR represents 5 Summit Therapeutics plc Ordinary Shares, as such the conversion has to take place in multiples of 5 and it is not possible to receive a fraction of an ADR. Any holdings not in multiples of 5 will receive a fractional cash payment. Trades in ADRS will be settled in US Dollars in accordance with our Overseas Stockbroking terms and conditions. If you wish to convert your Ordinary Shares into ADRs you will need to give an instruction before our deadline of noon on Wednesday 19 February 2020. There is no conversion fee up until the delisting of the Shares from AIM. After close of business on 21 February 2020, conversion into ADRs may incur UK stamp duty or stamp duty reserve tax (currently 1.5% of the market value of the Shares converted) and fees of up to USD0.05 per ADR may be levied by Bank of New York Mellon upon conversion. You can give an instruction to convert your Shares online by clicking on your Fund & Share Account in the ‘My Accounts’ section of our website. Please select the dark blue Corporate Actions Icon alongside Summit Therapeutics plc Shares and follow the instructions provided. Please note, under HMRC rules the ADRs and Ordinary Shares will be unable to be held within a Stocks & Shares ISA as the underlying holding will not be listed on a recognised stock exchange. As a result any holding of Summit Therapeutics plc ADRs within a Stocks & Shares ISA will need to be removed within 30 days of the conversion.
28/1/2020
10:36
waterloo01: From HL What is happening? The Board of Summit Therapeutics plc has announced proposals to cancel the Company’s ordinary shares from trading on AIM (Alternative Investment Market). It is expected that the Company’s shares will be delisted with effect from the 7am on 24 February 2020. If the Delisting is approved at the shareholder Meeting Summit Therapeutics will be offering shareholders the opportunity to convert their ordinary shares into American depositary receipts (ADRs). ADRs are a form of stock traded in the US that represent a number of shares in a foreign Company. If approved we will write to you after the shareholder Meeting to inform you of the terms of the conversion. Why is this happening? “The AIM Delisting reflects the increasing focus of the Company’s business operations on the United States.” (Source: shareholder announcement, 6 December 2019) What action do I need to take? For the delisting to become effective, it must be approved at a General Meeting to be held on Monday 23 December 2019. Under AIM Rules, such a withdrawal resolution requires the consent of not less than 75% of votes cast by shareholders voting on the resolutions at the General Meeting. If you would like to submit a vote for or against the resolution to delist the shares, please provide us with your voting instruction by noon on Wednesday 18 December 2019 by clicking on your Fund & Share Account in the ‘My Accounts’ section of our website. Please then select the dark blue Corporate Actions Icon alongside your Summit Therapeutics plc shares and follow the online instructions provided. If you wish to sell your holding before the proposed listing cancellation you must do so before 4.30pm on Friday 21 February 2020. The trade will be placed in accordance with our terms and conditions and subject to the standard Stockbrokers commission rates. To sell these shares please phone us on 0117 980 9800 or you can place a trade online. Please note that if the cash consideration of a sale does not exceed the commission payable then the sale will not be executed. Please note that although Hargreaves Lansdown will endeavor to sell your shares it may not be possible to sell all, or even any, of your shares if a market for the shares no longer exists. If you dispose of your holding before shareholder approval has been granted you do so at your own risk. If you wish to maintain your holding you need take no action. You should note that following the cancellation you may have difficulty selling this investment at a reasonable price and, in some circumstances, it may be impossible to sell it at any price. Important information for holders of Summit Therapeutics plc shares within a Stocks & shares ISA Please note under HMRC rules unlisted shares and ADS’ are not eligible to be held within a Stocks & shares ISA. As a result, if the delisting become effective, any holding of Summit Therapeutics plc shares within a Stocks & shares ISA will need to be removed within 30 days of the effective date of the delisting.
07/10/2019
12:06
someuwin: Summit Therapeutics plc Summit Therapeutics Reports New Data From Phase 2 Clinical Trial Connecting Ridinilazole's Microbiome... 07/10/2019 12:00pm UK Regulatory (RNS & others) TIDMSUMM Summit Therapeutics plc ('Summit' or the 'Company') Summit Therapeutics Reports New Data from Phase 2 Clinical Trial Connecting Ridinilazole's Microbiome Preservation to Improved Clinical Outcomes for Patients with C. difficile Infection -- Data Presented at ID Week 2019 Oxford, UK, and Cambridge, MA, US, 7 October 2019 -- Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM) today announced the presentation of new data that explain the link between two key findings in the Company's Phase 2 clinical trial of ridinilazole for C. difficile infection ('CDI'): -- Ridinilazole demonstrated superior efficacy compared to vancomycin, driven by a 60% lower recurrence rate. -- Ridinilazole preserved the diversity of the gut microbiome. Researchers at Tufts University, collaborating with Summit, showed that these findings are connected mechanistically by bile acids, part of the 'metabolome' of active chemicals made or modified by gut bacteria. Bile acids exist in different forms that can either favour or block the regrowth of C. difficile after treatment. Vancomycin kills bacteria that turn pro-C. difficile bile acids into anti-C. difficile bile acids -- leaving an adverse ratio of pro- and anti-growth chemicals that favours the regrowth of C. difficile and the recurrence of C. difficile infection. By contrast, ridinilazole leaves these bacteria unharmed, allowing them to keep converting pro-C. difficile bile acids into anti-C. difficile bile acids, maintaining a positive chemical balance that prevents C. difficile recurrence. "The damaging effect of broad-spectrum antibiotics in the treatment of CDI is far-reaching from the make-up and function of the gut microbiome through the poor clinical outcomes seen in one third of patients, driven by a high rate of disease recurrence," said Dr David Roblin, President of R&D of Summit. "Ridinilazole has the potential to be a targeted CDI treatment that could result in significantly better patient outcomes for the over half million US patients per year who have an episode of CDI. These latest data help to put the science behind the function of a healthy microbiome into context and highlight its importance in sustaining CDI cures." The Phase 2 clinical trial enrolled 100 patients, half of whom received ridinilazole and the other half vancomycin. For both groups, there was a higher ratio of pro-C. difficile to anti C.-difficile bile acids at the start of treatment. This was expected, as patients who get CDI have perturbed microbiomes. However, during treatment, the proportion of anti-C. difficile bile acids increased in patients treated with ridinilazole, whereas patients treated with vancomycin initially showed decreases in anti-C. difficile bile acids and had stools dominated by pro-C. difficile bile acids. By the end of treatment, ridinilazole-treated patients' bile acid ratios returned towards a healthy, non-CDI state. These results support the data from the Phase 2 clinical trial, in which patients receiving ridinilazole showed a statistically significant improvement in sustained clinical responses. Copies of the two poster presentations are available in the Publications section of Summit's website, https://www.globenewswire.com/Tracker?data=1-ujmlz_AfYU4dN0w3FcC7e8IKaED85-OxxxSmLpKkNWooHrRFd6rqws_l_j44u8VtP_pSU8N2-L-OtrCWlv6_afyg9SR0MHxj4QOmKUgjY= www.summitplc.com.
17/7/2019
11:09
kirk 6: Summit Therapeutics plc Summit Highlighted Potential Of Smt-571 To Combat The Rising Global Health Threat Of Gonorrhoea At St...Source: UK Regulatory (RNS & others) TIDMSUMM Summit Therapeutics plc ('Summit' or the 'Company') Summit Highlighted Potential of SMT-571 to Combat the Rising Global Health Threat of Gonorrhoea at STI & HIV World Congress Oxford, UK, and Cambridge, MA, US, 17 July 2019 -- Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM) today announced that it highlighted the potential of its preclinical new class antibiotic, SMT-571, to treat all gonorrhoea, including multi-drug and extensively-drug resistant strains, in a poster presentation at the STI & HIV World Congress in Vancouver, Canada. "The problem of gonorrhoea resistance is very concerning, and if nothing is done, physicians could see more and more cases of untreatable disease, " said Dr David Roblin, President of R&D of Summit. "As shown by the preclinical data presented, our gonorrhoea-targeted new class antibiotic, SMT-571, has the potential to overcome known resistance mechanisms across global isolates, including multi- and extensively-drug resistant strains. Further, there is a clear need for new gonorrhoea treatment options that would allow ceftriaxone to be reserved for the multitude of other serious infections that rely on its potency." Infections caused by the bacteria Neisseria gonorrhoeae are a growing global healthcare problem, with an estimated 78 million new cases globally per year. Infection rates continue to rise sharply as highlighted by the Centers for Disease Control and Prevention ('CDC'), which reported a 19% increase in US gonorrhoea cases in 2017, and Public Health England, which reported a 26% increase in the UK in 2018. Of great concern is the increase in resistance towards the current standard of care treatment for gonorrhoea, a combination of the broad-spectrum antibiotics, azithromycin and ceftriaxone. N. gonorrhoeae resistance rates to azithromycin are 4.4% and rising, and there is an emergence of resistance to ceftriaxone in these same strains, which are referred to as cases of 'super gonorrhoea.' Summit's poster featured preclinical data showing SMT-571 to be highly potent against 262 clinical strains of N. gonorrhoeae. This comprehensive panel of gonorrhoea strains, obtained from 1991 to 2018, was selected to be geographically and genetically diverse and include strains that are multi- and extensively-drug resistant. SMT-571 had a minimum inhibitory concentration range of 0.064 mg/L to 0.125 mg/L against the strains, including those with reduced susceptibility to ceftriaxone. Significantly, SMT-571 did not show cross-resistance with any antibiotic currently or previously used to treat gonorrhoea infections. A copy of the poster is available on the Company's website: https://www.globenewswire.com/Tracker?data=hOwNpcVnH5ygYcPnItIIj3teosjDaNu3IshgbQPXqvAjgI1b0GLRE8kvTumrR7L-4AKVAssBT22nbf_MLgKdjbs_Rglaa0doF0rBkCuQegs= www.summitplc.com. About Gonorrhoea It is estimated by the World Health Organization ('WHO') that there are approximately 78 million new cases of gonorrhoea globally per year. Neisseria gonorrhoeae has consistently developed resistance to each class of antibiotics recommended for treatment and there is now only one treatment recommended by the CDC and European evidence-based guidelines, a combination of two antibiotics. There are currently no other recommended antibiotics that can be effectively deployed to target the disease. The WHO ranks as "high" the priority of R&D investment into the search for antibiotics which are effective against N. gonorrhoeae and in August 2018, the CDC stated that in light of increased problems with resistance, additional treatment options were urgently required. About SMT-571 SMT-571 is a small molecule, new class antibiotic in preclinical development for the treatment of gonorrhoea. SMT-571 is designed to be an oral treatment with potential activity across the three sites of gonorrhoea infection: urogenital, rectal and pharyngeal. Preclinical studies have shown SMT-571 to have potent activity across a wide range of N. gonorrhoeae strains, including multi-drug and extensively-drug resistant isolates. SMT-571 was identified using Summit's Discuva Platform, which can identify novel targets, elucidate mechanisms of action and optimise against bacterial resistance. The development of SMT-571 is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by an award from Wellcome Trust, as administered by CARB-X. The content of this announcement is solely the responsibility of the authors and does not necessarily represent the official views of the Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response, other funders, or CARB-X. 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) +1 617 225 4455 Cairn Financial Advisers LLP (Nominated Adviser) Tel: +44 (0)20 7213 0880 Liam Murray / Tony Rawlinson N+1 Singer (Joint Broker) Tel: +44 (0)20 7496 3000 Aubrey Powell / Jen Boorer, Corporate Finance Tom Salvesen, Corporate Broking Bryan Garnier & Co Limited (Joint Broker) Tel: +44 (0)20 7332 2500 Phil Walker / Dominic Wilson MSL Group (US) Tel: +1 781 684 6557 mailto:summit@mslgroup.com Jon Siegal summit@mslgroup.com --------------------------------- Consilium Strategic Communications (UK) Tel: +44 (0)20 3709 5700 Mary-Jane Elliott / Sue Stuart / Sukaina mailto:summit@consilium-comms.com Virji summit@consilium-comms.com --------------------------------- 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 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 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 NewswiresJuly 17, 2019 07:00 ET (11:00 GMT)Copyright (c) 2019 Dow Jones & Company, Inc.
18/6/2019
11:08
kirk 6: 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) +1 617 225 4455 Cairn Financial Advisers LLP (Nominated Adviser) Tel: +44 (0)20 7213 0880 Liam Murray / Tony Rawlinson N+1 Singer (Joint Broker) Tel: +44 (0)20 7496 3000 Aubrey Powell / Jen Boorer, Corporate Finance Tom Salvesen, Corporate Broking Bryan Garnier & Co Limited (Joint Broker) Tel: +44 (0)20 7332 2500 Phil Walker / Dominic Wilson MSL Group (US) Tel: +1 781 684 6557 mailto:summit@mslgroup.com Jon Siegal summit@mslgroup.com ------------------------------ Consilium Strategic Communications (UK) Tel: +44 (0)20 3709 5700 Mary-Jane Elliott / Sue Stuart / mailto:summit@consilium-comms. com summit@consilium-comms.com ------------------------------ 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.
15/4/2019
06:20
kirk 6: Released .....Summit Therapeutics plc Summit Presents In Vivo Proof Of Concept Data For New Mechanism Antibiotics Targeting Enterobacteriac...Source: UK Regulatory (RNS & others) TIDMSUMM Summit Therapeutics plc ('Summit' or the 'Company') Summit Presented In Vivo Proof of Concept Data for New Mechanism Antibiotics Targeting Enterobacteriaceae in Oral Session at ECCMID 2019 -- DDS-04 Series Cures Enterobacteriaceae Infection in Animal Model -- Potential in Lung, Bloodstream and Urinary Tract Infections -- Activity Shown Against Resistant and Non-Resistant Strains -- Enterobacteriaceae are Gram-Negative Bacteria that Cause a Large Number of Serious Infections Oxford, UK, and Cambridge, MA, US, 15 April 2019 -- Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM), a leader in new mechanism antibiotic innovation, presented in vivo proof of concept data for the DDS-04 series of new mechanism antibiotics targeting Enterobacteriaceae in an oral session at the 29(th) European Congress of Clinical Microbiology & Infectious Diseases ('ECCMID') in Amsterdam. Enterobacteriaceae are a family of Gram-negative bacteria responsible for a large number of severe and often deadly infections. In the data presented, a DDS-04 series compound cured infection in a translationally-relevant animal model of urinary tract infection, one of the major sites for Enterobacteriaceae infection. Therapeutic concentrations of the DDS-04 compound were also observed in other major sites in the animal model where life-threatening Enterobacteriaceae infections occur, including the lungs and the bloodstream. "Patients with Enterobacteriaceae infections are increasingly at risk for poor outcomes due to the spread of antimicrobial resistance," said Dr David Roblin, President of R&D of Summit. "Mainstay treatments are losing their effectiveness, and patients do not have the luxury of time to fail antibiotic therapy. There is a pressing need for new, targeted Enterobacteriaceae antibiotics that can serve to improve patient outcomes." The DDS-04 series acts via LolCDE, a novel bacterial target. The LolCDE site of DDS-04 series activity is conserved in the majority of therapeutically important Enterobacteriaceae, resulting in targeted spectrum compounds. With its new mechanism of action, the DDS-04 series was rapidly bactericidal and highly potent across globally diverse Enterobacteriaceae strains in research studies, which included multi-drug resistant isolates. Importantly, the DDS-04 series also showed low propensity for resistance development and did not show cross-resistance with existing classes of antibiotics, suggesting that DDS-04 compounds have the potential to overcome known resistance mechanisms. This profile makes the DDS-04 series attractive for further development for the treatment of Enterobacteriaceae infections. "The DDS-04 series aligns with our antibiotic strategy. There is a clear opportunity to improve patient outcomes and a need for new mechanisms to deliver these improved outcomes and also to help address the spread of antimicrobial resistance," commented Mr Glyn Edwards, Chief Executive Officer of Summit. "We look forward to gathering further data to support the selection of a preclinical candidate from the DDS-04 series." A copy of the presentation is available in the Publications section of the Company's website: https://www.globenewswire.com/Tracker?data=zF4OB7j7d6pSYP5Hg971LbjESS33LaZG5ArPp_57zfxJy8rR-_zzVA-Fkbbkp1Nyg9i2Qyb3rtxtHtD-vGKTKHqK5XJl97UGupr75mg7wpY= www.summitplc.com. About Enterobacteriaceae Enterobacteriaceae are a family of Gram-negative bacteria responsible for severe and often deadly infections. They account for a significant fraction of cases across conditions, including complicated urinary tract infections, bloodstream infections and hospital-acquired pneumonias. Summit estimates there are more than 1 million infections in the US annually caused by Enterobacteriaceae across these three settings. Increasing resistance of Enterobacteriaceae has rendered many marketed antibiotics ineffective against these bacteria. Two of the most alarming antibiotic resistance trends are extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae and carbapenem-resistant Enterobacteriaceae (CRE). ESBL is an enzyme that allows bacteria to become resistant to a wide variety of penicillin and cephalosporin antibiotics. ESBL-producing Enterobacteriaceae account for an estimated 26,000 infections annually in the US with 1,700 deaths, according to the US Centers for Drug Control and Prevention ('CDC'). CRE are resistant to nearly all existing antibiotics, including carbapenems which are considered the antibiotics of last resort. CRE account for an estimated 9,000 infections per year in the US and 600 deaths, according to the CDC. 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 ESKAPE pathogens and are using our proprietary Discuva Platform to expand our pipeline. For more information, visit www.summitplc.com and follow us on Twitter @summitplc. This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014 (MAR). Contacts Summit Glyn Edwards / Richard Pye (UK office) Tel: 44 (0)1235 443 951 Michelle Avery (US office) +1 617 225 4455 Cairn Financial Advisers LLP (Nominated Adviser) Tel: +44 (0)20 7213 0880 Liam Murray / Tony Rawlinson N+1 Singer (Joint Broker) Tel: +44 (0)20 7496 3000 Aubrey Powell / Jen Boorer, Corporate Finance Tom Salvesen, Corporate Broking Bryan Garnier & Co Limited (Joint Broker) Tel: +44 (0)20 7332 2500 Phil Walker / Dominic Wilson MSL Group (US) Tel: +1 781 684 6557 mailto:summit@mslgroup.com Jon Siegal summit@mslgroup.com --------------------------------- Consilium Strategic Communications (UK) Tel: +44 (0)20 3709 5700 Mary-Jane Elliott / Sue Stuart / Jessica mailto:summit@consilium-comms.com Hodgson / summit@consilium-comms.com --------------------------------- 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 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 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 NewswiresApril 15, 2019 02:00 ET (06:00 GMT)Copyright (c) 2019 Dow Jones & Company, Inc.
14/4/2019
13:51
waterloo01: How unusual, a Sunday news release just in via email. Summit Presents In Vivo Proof of Concept Data for New Mechanism Antibiotics Targeting Enterobacteriaceae in Oral Session at ECCMID 2019 Summit Therapeutics plc (‘Summit’; or the ‘Company’;) Summit Presents In Vivo Proof of Concept Data for New Mechanism Antibiotics Targeting Enterobacteriaceae in Oral Session at ECCMID 2019 DDS-04 Series Cures Enterobacteriaceae Infection in Animal Model Potential in Lung, Bloodstream and Urinary Tract Infections Activity Shown Against Resistant and Non-Resistant Strains Enterobacteriaceae are Gram-Negative Bacteria that Cause a Large Number of Serious Infections Oxford, UK, and Cambridge, MA, US, 14 April 2019 – Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM), a leader in new mechanism antibiotic innovation, today presented in vivo proof of concept data for the DDS-04 series of new mechanism antibiotics targeting Enterobacteriaceae in an oral session at the 29th European Congress of Clinical Microbiology & Infectious Diseases (‘ECCMID’;) in Amsterdam. Enterobacteriaceae are a family of Gram-negative bacteria responsible for a large number of severe and often deadly infections. In the data presented, a DDS-04 series compound cured infection in a translationally-relevant animal model of urinary tract infection, one of the major sites for Enterobacteriaceae infection. Therapeutic concentrations of the DDS-04 compound were also observed in other major sites in the animal model where life-threatening Enterobacteriaceae infections occur, including the lungs and the bloodstream. “Patients with Enterobacteriaceae infections are increasingly at risk for poor outcomes due to the spread of antimicrobial resistance,” said Dr David Roblin, President of R&D of Summit. “Mainstay treatments are losing their effectiveness, and patients do not have the luxury of time to fail antibiotic therapy. There is a pressing need for new, targeted Enterobacteriaceae antibiotics that can serve to improve patient outcomes.” The DDS-04 series acts via LolCDE, a novel bacterial target. The LolCDE site of DDS-04 series activity is conserved in the majority of therapeutically important Enterobacteriaceae, resulting in targeted spectrum compounds. With its new mechanism of action, the DDS-04 series was rapidly bactericidal and highly potent across globally diverse Enterobacteriaceae strains in research studies, which included multi-drug resistant isolates. Importantly, the DDS-04 series also showed low propensity for resistance development and did not show cross-resistance with existing classes of antibiotics, suggesting that DDS-04 compounds have the potential to overcome known resistance mechanisms. This profile makes the DDS-04 series attractive for further development for the treatment of Enterobacteriaceae infections. “The DDS-04 series aligns with our antibiotic strategy. There is a clear opportunity to improve patient outcomes and a need for new mechanisms to deliver these improved outcomes and also to help address the spread of antimicrobial resistance,” commented Mr Glyn Edwards, Chief Executive Officer of Summit. “We look forward to gathering further data to support the selection of a preclinical candidate from the DDS-04 series.” A copy of the presentation is available in the Publications section of the Company’s website: www.summitplc.com. About Enterobacteriaceae Enterobacteriaceae are a family of Gram-negative bacteria responsible for severe and often deadly infections. They account for a significant fraction of cases across conditions, including complicated urinary tract infections, bloodstream infections and hospital-acquired pneumonias. Summit estimates there are more than 1 million infections in the US annually caused by Enterobacteriaceae across these three settings. Increasing resistance of Enterobacteriaceae has rendered many marketed antibiotics ineffective against these bacteria. Two of the most alarming antibiotic resistance trends are extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae and carbapenem-resistant Enterobacteriaceae (CRE). ESBL is an enzyme that allows bacteria to become resistant to a wide variety of penicillin and cephalosporin antibiotics. ESBL-producing Enterobacteriaceae account for an estimated 26,000 infections annually in the US with 1,700 deaths, according to the US Centers for Drug Control and Prevention (‘CDC’). CRE are resistant to nearly all existing antibiotics, including carbapenems which are considered the antibiotics of last resort. CRE account for an estimated 9,000 infections per year in the US and 600 deaths, according to the CDC. 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 ESKAPE pathogens and are using our proprietary Discuva Platform to expand our pipeline. For more information, visit www.summitplc.com and follow us on Twitter @summitplc.
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