Silence Therapeutics Plc (AIM: SLN), a leading international RNAi therapeutics company, today provides a corporate update and announces its interim results for the six months ended 30 June 2011.
- New German-based CEO appointed
- Business development operations strengthened, including the appointment of a Chief Business Officer, highlighting an increased commercial focus for the Group to monetise its strong portfolio of clinical and pre-clinical assets.
- US location closed and operations centralised in Berlin.
- Rationalisation and reorganisation of the Group has reduced burn rate.
- Non-executive Board membership reduced.
- Atu027 Phase I ascending dose trial continues with excellent safety at doses beyond those showing biological activity in preclinical studies.
- Continued progress with our three proprietary delivery systems enabling specific, targeted organ delivery.
- Collaboration deal signed with micro-RNAi partner, InteRNA.
- Fundraising in May 2011 increases cash runway to H2 2012.
In more detail
- Thomas Christély has been appointed the new Chief Executive Officer of Silence. Thomas was previously COO of Silence and has been with the Group for 10 years. Thomas brings to his new role considerable expertise in negotiating pharmaceutical deals and in people leadership. His appointment ensures the continuity of relationships with our collaboration partners and our staff, as well as making important use of his long-term familiarity with the science and IP.
- As separately announced today, Tony Sedgwick has been appointed as Chief Business Officer of Silence. Tony is a highly experienced executive in the life sciences arena and has a strong track record in licensing agreements in the biotechnology space. Tony will build a larger team in business development to significantly increase our activity to generate non-dilutive funding from deals.
- The US operations of Silence, based in Redwood City, California have been closed. The US-based business development and legal functions will be absorbed elsewhere in the Group. The operations of the Group will now be based in Berlin, where our research and development facilities have always been located, with the exception of a small management presence in London.
- The cost base and operations have been streamlined by reducing some non-critical staff, closing of the US operation and reducing the non-executive Board. This has helped to increase our cash runway.
- We have seen encouraging interim results from the Phase I ascending dose clinical trial of the cancer treatment, Atu027. These results were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting and the data presented showed disease stabilisation and other indications of potential efficacy, as well as demonstrating that the AtuPLEX™ delivery system is safe in humans at dose levels which has showed biological activity in pre-clinical species. As of August 2011, 27 patients have been treated. The trial is approaching the top of the dose range and enrolment is expected to be completed in early 2012 with results announced in mid-2012.
- Post-period end, we announced a new collaboration with InteRNA to investigate the potential of Silence's proprietary AtuPLEX™ delivery system in the development of novel microRNAi therapeutics targeting cancer. microRNA intervention is an exciting new therapeutic area for which the Silence technology platform is well suited.
- Silence's partner, Quark Pharmaceuticals ('Quark'), announced the completion of the DEGAS study, a Phase II trial of PF-04523655 ('PF-'655') in diabetic macular oedema. This compound was sublicensed by Quark to Pfizer and is based on Silence's AtuRNAi technology. It was shown to be more effective than laser therapy. Quark is also initiating a Phase IIb study of this compound in this indication.
- Issuance of a Japanese patent that provides protection for the Company's novel AtuRNAi molecules in Japan. This patent represents another critical asset to support our efforts to establish valuable partnerships with leading Japanese pharmaceutical companies.
- Issuance of a new US patent that broadens the Company's existing protection of optimised RNAi molecules, including its proprietary AtuRNAi platform.
- Revenue for the six months ended 30 June 2011 was £354,078 (six months ended 30 June 2010: £716,090).
- Research and Development costs decreased to £1.82m (six months ended 30 June 2010: £4.40m) reflecting the reorganisation of R&D in April 2010 following the acquisition of Intradigm Corporation ("Intradigm").
- Administrative expenses decreased to £2.00m (six months ended 30 June 2010: £3.23m) again reflecting the reorganisation of R&D in April 2010 following the acquisition of Intradigm. Excluding the restructuring cost of £0.44m with respect to closing the Redwood City facility in the US, Administrative expenses were £1.56m.
- In May 2011, Silence raised £5.51m (net of expenses. The cash position as of 30 June 2011 was £6.49m (at 31 December 2010: £3.57m). Cash usage in operating and investing activities in the half year amounted to £2.59m (six months ended 30 June 2010: £6.65m).
Board and Management Changes - Post-Period
- In August 2011, Silence announced a company reorganisation to consolidate and streamline the Company's operations. Related to this reorganisation:
- Silence closed its facility in Redwood City, California and reduced headcount in its Berlin, Germany, facility from 32 to 27. As the decision to close the Redwood City facility was taken prior to the period-end, a restructuring charge of £0.44m was recorded in the first half of 2011.
- Thomas Christély, former Chief Operating Officer of Silence, was appointed Chief Executive Officer effective 19 September 2011 following the resignation of Dr Philip Haworth.
- Dr James Topper resigned from the Board of Directors effective 29 July 2011 and Dr David U'Prichard will leave the Board at the end of 2011.
- Announced today, Tony Sedgwick appointed as Chief Business Officer strengthening the business development function. Tony will enlarge Silence's business development team with further members as Silence seeks to obtain further collaborations and partnerships that will generate non-dilutive funds for the Company.
Other Post-Period Events
- Received a notice of allowance of a new US patent covering novel siRNA delivery technologies. This patent provides protection for a core component of the Company's proprietary AtuPLEX™ delivery platform, which is incorporated in Silence's lead internal compound, Atu027, and in other RNAi therapeutic candidates.
- Issuance of a Japanese patent covering certain methods for screening a therapeutic agent for the treatment and/or prevention of any disease that involves elevated activity within the PI3-kinase pathway. This new intellectual property includes coverage for the use of protein kinase N 3 ("PKN3") for screening of therapeutic agents, thus preventing others from using PKN3 for screening purposes.
Thomas Christély, CEO of Silence Therapeutics, commented: "The restructuring, re-organisation and refocus of Silence Therapeutics is now complete. It has positioned Silence to be a leaner, more efficient organisation, poised to further develop its world leading RNAi asset portfolio. As a new and strengthened management team, we will have a sharper focus on identifying partners to help progress the development and partnering of our assets, thereby generating non-dilutive cash and/or funding to extend our cash runway. Technically, as we escalate through higher doses in our internal Atu027 oncology program, the interim data consolidate our belief that Atu027 is a safe and effective drug in patients. Our partner Quark also reported encouraging Phase II data in diabetic macular oedema in collaboration with Pfizer. We have strengthened our patent portfolio, streamlined our organisation and secured sufficient funding to continue this successful development. Although this progress has yet to be reflected in Silence's share price, we are convinced that siRNA therapeutics will become a major drug class similar in importance to monoclonal antibodies, due to the various advantages of siRNA therapeutics. In order to overcome the known challenges of delivering siRNA into cells, Silence has also expanded its proprietary delivery technologies from AtuPLEX™, to now include DACC and DBTC. This comprehensive delivery platform allows our RNAi therapeutics to reach and affect many different cell types. The breakthroughs have arisen from Silence's decade or more of investigating the actions and disposition of different oliogonucleotides in collaboration with several large pharmaceutical companies. Thus Silence offers today the most comprehensive RNAi therapeutic platform, founded on a portfolio of advanced delivery technologies."
SOURCE Silence Therapeutics Plc