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Silence Therapeutics plc: Unaudited Preliminary Results for the Year Ended 31 December 2011


3/21/2012 10:27:17 AM

LONDON, March 21, 2012 /PRNewswire/ --

Silence Therapeutics Plc (AIM: SLN), a leading international RNAi therapeutics company, today announces its unaudited preliminary results for the year ended 31 December 2011.

HIGHLIGHTS

  • Impressive interim data from Phase I trials of Atu027 (lead programme in metastatic cancer) presented at the American Society of Clinical Oncology conference in June 2011. The data showed disease stabilisation and other indications of potential efficacy. Atu027 remains one of the most advanced RNAi therapeutic candidates in cancer.
  • Silence's leadership position in RNAi delivery validated by three new partnerships including deals with a top 10 Pharma company, InteRNA Technologies and miRNA Therapeutics. These agreements covered all three of Silence's proprietary delivery technologies and two were for the delivery of a new form of RNA therapeutic (microRNA), showing the versatility of our portfolio.
  • Positive clinical data from Silence's partners Quark Pharmaceuticals and Pfizer - the Phase II trial of PF-04523655 in diabetic macular oedema showed it to be more effective than laser therapy. Quark has now initiated a phase IIb trial. This compound is based on Silence's AtuRNAi technology.
  • Silence streamlined and reorganised its operations to increase efficiency and reduce cash spend. As part of this, the facility in Redwood City, California was closed; headcount in some non-critical roles was reduced in Berlin; and the non-executive Board membership was also reduced.
  • Enhanced commercial focus and strengthened business development team with the appointment of Georg Buchner as VP Business Development, focused on partnering Silence's assets and accessing non-dilutive sources of finance.
  • Silence possesses one of the world's most comprehensiveRNAi technology intellectual property portfolios which was further strengthened in 2011 with the issuance of patents in Japan and the US.
  • In May 2011, Silence raised £5.51m net of expenses to fund development of the pipeline and investment in the RNAi technology platform. Combined with the impact of the restructuring, the cash runway extends to the end of Q3 2012.

POST YEAR-END EVENTS

  • Dr Tony Sedgwick was promoted to Chief Executive Officer in February 2012.
  • Deal announced with miRagenTherapeutics in January 2012 for the delivery of microRNAs using the DBTC liver delivery system - Silence's second deal on DBTC and third for microRNAs.
  • Creation of a Scientific Advisory Board with two Key Opinion Leaders in the area of liver disease - see separate announcement issued today.

Tony Sedgwick, Chief Executive Officer of Silence Therapeutics, commented: "In 2011 Silence Therapeutics has built a significantly stronger and more commercially-driven business. The quality of our RNAi therapeutic platform is high and our pipeline is strong. We expect clinical data from our lead programme, Atu027, in 2012 and look to generating income from our partnering activities. I am particularly excited by the Company's growth prospects from here and am focused on achieving shareholder value uplift in 2012 and beyond."

Analyst briefing and conference call

There will be a meeting for analysts today at 09:30am at M:Communications (1 Ropemaker Street, 11th Floor CityPoint Building, London EC2). There will also be a live call for analysts at 09:30 GMT. The conference call can be accessed by dialling:

Dial-in: +44-(0)1452-546-750

Participant PIN code: 64342375

A replay will be made available on Silence Therapeutics' website shortly after the call for a period of one month.

Company website

http://www.silence-therapeutics.com

Forward-Looking Statements

This press release includes forward-looking statements that are subject to risks, uncertainties and other factors. These risks and uncertainties could cause actual results to differ materially from those referred to in the forward-looking statements. All forward looking statements are based on information currently available to Silence Therapeutics and Silence Therapeutics assumes no obligation to update any such forward-looking statements.

CHAIRMAN'S STATEMENT

Silence Therapeutics is a leading RNAi therapeutics product and technology platform company with proprietary delivery systems. We have created two powerful platforms and a strong pipeline to exploit our impressive technological know how and IP.

Despite the difficult economic times, and capital market turmoil, with the support of our shareholders, in 2011 we were able to announce positive progress in our internal clinical programme, refinance and streamline the business, as well as sign further collaborative agreements covering our RNAi delivery technologies.

We believe that our achievements throughout the year validate the Board's decision to focus on building an independent and high value RNAi therapeutics company. Indeed, industry commentators believe that the field of oligonucleotide therapeutics, of which RNAi is a part, may be the third major drug development platform after small molecules and monoclonal antibodies.

When we reported to shareholders in our 2010 Annual Report, we predicted that '2011 would be a year rich in data from RNAi clinical trials', both from Silence Therapeutics and other companies in this therapeutic area. This has proved to be the case, with encouraging interim Phase I data from our lead product, Atu027 for metastatic cancer, which we were pleased to be able to present at the prestigious annual American Society of Clinical Oncology ('ASCO') meeting in June 2011 and we also plan to present further data for Atu027 at the upcoming ASCO meeting in June 2012. We believe it to be one of the most interesting and potentially promising RNAi therapeutics in clinical development. During the year, our partner Quark Pharmaceuticals also presented positive Phase II data with PF-04523655, which incorporates our AtuRNAi technology, in the area of diabetic macular oedema.

Silence Therapeutics' RNAi therapeutic platform, comprising our delivery technologies, siRNA sequences and structural features, has been validated by nine partnerships (some of these via our licensee Quark Pharmaceuticals). In 2011 alone, we were pleased to add three new deals including delivery deals with InteRNA Technologies, miRNA Therapeutics and a top 10 Pharmaceutical company. As a result, we now have links to four of the world's leading pharmaceutical firms.

Assuming these collaborations continue to proceed successfully, we believe that associated milestone payments represent a significant potential revenue stream to Silence Therapeutics in the coming years.

Other achievements for Silence Therapeutics in 2011 included a fundraising, which has extended existing funding until the end of the third quarter of 2012 and we are thankful to our shareholders for their valuable support towards this transaction. During 2011, Silence also focused on the streamlining of the business and the significant strengthening of the business development and management team. The latter two, we believe, represent an appropriate response to our developing pipeline, expanding portfolio of high-quality delivery technologies, and re-focused business approach. Assuming that our pipeline continues to progress, Silence will be seeking deals with partners to further its development. In addition, we believe that our strong portfolio of intellectual property and delivery technologies makes us a partner of choice for companies active in RNA therapeutics, and we will continue to build this important non-dilutive source of income. As with many other approaches in the medical field, delivery of the active RNAi therapeutic is the rate-limiting step and so we consider our suite of delivery technologies an important asset for us and our partners.

The evolution of the Company since the beginning of 2011 has resulted in some personnel changes, with Dr Tony Sedgwick recently appointed Chief Executive Officer, and Dr Georg Buchner joining as Vice-President of Business Development. On behalf of the Board, I would like to thank Dr Phil Haworth, Dr David U'Prichard and Dr James Topper, all of whom stood down during or at the end of 2011, for their contributions to the Company as Chief Executive Officer and Non-Executive Directors respectively. David U'Prichard, in particular, has been with the business for almost eight years, and has been instrumental in the development of our assets. Our thanks are also due to Thomas Christély who initially replaced Dr Phil Haworth and has recently left the Company, to be succeded by our new and commercially driven Chief Executive Officer, Dr Tony Sedgwick. Tony comes with a strong background in the commercial biotech environment, and has been successfully involved in developing biotech businesses and delivering value to shareholders.

Clinical data emphasises potential of RNAi therapeutics

With five of the estimated 13 clinical programmes ongoing worldwide using Silence Therapeutics' AtuRNAi technology, and having treated in excess of 300 patients, we believe we have the industry's broadest siRNA clinical pipeline. Looking elsewhere in the RNAi sector in 2011, we were pleased to observe encouraging clinical data from other players, which underlines the potential of the approach. Many of those working in this field share our view that the range of clinical results announced in 2011 represent a significant derisking of RNAi technology, and we look forward to further clinical advances in 2012.

The significant progress that Silence Therapeutics made in 2011 was achieved against a backdrop of a restructing and consolidating pharmaceutical sector, restricted access to capital for small and innovative companies, and turbulent-risk averse financial markets. That we were able to raise £5.51m (net of costs) under these conditions is a testament to the potential of the Company and the confidence placed in us by our shareholders, and many thanks are due to shareholders for this. I am as disappointed as our shareholders are that our increasing maturity is not yet reflected in Silence Therapeutics' share price, and believe that our new focused approach, coupled with the newsflow and advances we expect to announce in 2012, will go a considerable way to building shareholder value and enhancing our share price.

Silence Therapeutics is proud of its RNAi therapeutic platform, comprising proprietary delivery technologies, potent siRNA sequences, and innovative RNAi structural features. We believe that our progress in 2011 shows the synergistic value of these assets, and we look forward to updating shareholders on further advances in the clinic and other areas delivered via our new and focused management team throughout 2012.

We would like to thank all our shareholders for their continued support of Silence Therapeutics.

Jerry Randall ACA

Chairman


CHIEF EXECUTIVE'S REVIEW

OVERVIEW

Since joining Silence Therapeutics in September 2011, I have been excited by the Company and the opportunities that lie ahead. As a consequence, I was pleased to take over as Chief Executive Officer in February 2012, as I believe we have a unique proprietary position in RNAi therapeutics and their delivery. Over the next few years, I intend to increase the commercial focus of the Company, harness the RNAi therapeutics opportunity and, as a result, create substantial shareholder value.

2011 has been an exciting year for Silence Therapeutics, with progress across all areas of the business. We started this year looking forward to clinical data to validate both the therapeutic benefit to be obtained by RNA interference ('RNAi' or 'siRNA'), as well as our proprietary delivery technologies. I am pleased to report that the Company has delivered on this expectation, in both our proprietary and partnered programmes.

We have also worked hard on building the financial future of the business, improving its efficiency and strengthening its commercial activities, all of which is discussed below. Silence Therapeutics is proud of its RNAi therapeutic platform, comprising proprietary delivery technologies, potent siRNA sequences, and innovative RNAi structural features. We believe that our progress in 2011 shows the synergistic value of these propositions.

Encouraging clinical data

Silence Therapeutics is prominent in an exciting new sector in the drug development arena, the translation of RNA blocking (RNAi) technology into therapies. Since we, and others active in this area, believe that the technology has potential in a broad range of clinical indications - including oncology, vascular, metabolic and ophthalmic diseases - it brings the potential for better patient outcomes in these major therapeutics areas. One of the first steps in demonstrating this potential is the generation of data from clinical studies conducted with RNAi therapeutics.

In June 2011, Silence presented encouraging interim data from its ongoing Phase I trial of proprietary product Atu027 in patients with solid tumours at the prestigious annual meeting of the American Society of Clinical Oncology ('ASCO'). We believe that these important findings serve as valuable validation for Silence's RNAi technology platform, as well as its AtuPLEX delivery technology. This should stand the Company, with its increased business development focus, in good stead as we work on partnering our programmes and exploiting our valuable RNAi delivery intellectual property estate.

To summarise, Silence Therapeutics made progress in several key areas in 2011, which we discuss in more detail below. These include:

  • Clinical trial progress for both our proprietary and partnered programmes;

  • Three new delivery deals, with further progress in established programmes;

  • Sharpening of our business development focus with important new top-level hires;

  • Refinancing and restructuring of the organisation; and

  • Further development and recognition of Silence's intellectual property portfolio, particularly in the area of RNAi delivery

OPERATIONAL

Clinical trial progress for both our proprietary and partnered programmes

Clinical trial data is key to establishing the potential of RNAi therapeutics, and we are pleased that it generated significant excitement this year both for Silence and its partners.

Proprietary programmes

Atu027, Silence Therapeutics'lead programme for cancer

In 2011 we were able to report impressive interim results from the Phase I ascending dose clinical trial of our lead programme, cancer treatment Atu027 for solid tumours. Atu027 incorporates our AtuPLEX delivery system with AtuRNAi, our proprietary RNAi chemistry and specifically targets PKN3, a protein implicated in cancer growth and metastases.

These results were presented at ASCO, and showed stabilisation of the disease in 38% of the cases (9 of 24 patients), as well as other indications of potential efficacy. Importantly on the safety side, the trial data obtained so far have indicated that AtuPLEX is safe in humans at dose levels above those which have shown effectiveness in preclinical studies. Among the patients who achieved stable disease, one individual with neuroendocrine cancer achieved disease stabilisation for nine months with a second neuroendocrine cancer patient showing partial regression of pulmonary metastases. An additional patient with breast cancer experienced some regression in liver metastases.

32 patients have been treated so far, and enrolment of all 33-36 patients is expected to be completed in the first half of 2012 with results announced in the middle of the year.

The Company believes that the encouraging data received to date represents an important step along the path towards realising value for shareholders. Assuming successful completion of the Phase I study, we expect to initiate a Phase Ib/IIa clinical study of Atu027 in the second half of 2012. The Company will also continue licensing discussions regarding Atu027 with potential pharmaceutical partners.

Atu111, our most advanced product outside oncology

Atu111, for the treatment of acute lung injury, is our most advanced drug development candidate outside oncology. It combines our DACC drug delivery system with AtuRNAi, and its target is undisclosed. We have recently completed proof of concept studies in a preclinical model of acute lung injury demonstrating very impressive results using Atu111. Further studies are ongoing in a variety of other preclinical models of the disease.

Earlier preclinical work using Atu111 have shown sustained gene knockdown of up to three weeks in the lung endothelium suggesting the drug could be used with a single dose.

Atu134

Following the encouraging data generated from the ongoing Phase I trial of Atu027 and additional data from preclinical models of Atu134, Silence has concluded that the potential clinical profiles of these two products are too similar to warrant further development of both programmes. We therefore decided in November to divert the resources for Atu134 to other areas, specifically potential targets in the liver that could be inhibited by using Silence's novel liver-focused DBTC delivery system.

Partnered programmes

Silence Therapeutics has two licence agreements with partner Quark Pharmaceuticals, for products PF-04523655 and QPI-1002, both of which are in development in two different therapeutic indications. Quark has licensed these to Pfizer and Novartis respectively. The positive data received from the programmes in 2011 further highlights both the potential of RNAi therapeutics and of Silence's AtuRNAi technology which is incorporated into these products.

Quark/Pfizer programmes

In March 2011, Quark announced the completion of the DEGAS study, a Phase II clinical trial of PF-04523655 for the treatment of the ophthalmic indication of diabetic macular oedema. The product, which incorporates Silence's AtuRNAi technology, was shown to be more effective than laser therapy. Quark has now initiated a Phase IIb study comparing PF-04523655 to Lucentis (Roche/Novartis), the new standard of care in the treatment of diabetic macular oedema.

In addition, PF-04523655 recently completed a Phase II trial in the second ophthalmic indication of age-related macular degeneration. The trial demonstrated a dose-dependent increase in benefit of PF-04523655. Quark is now awaiting results from the Phase IIb trial in diabetic macular oedema before deciding on plans for the drug in age-related macular degeneration.

Quark/Novartis programmes

In August 2010, Quark signed an option and license agreement with Novartis for QPI-1002 as mentioned previously. In September of that year, Quark initiated a Phase II study in prevention of delayed graft function in patients undergoing kidney transplantation. Recruitment into this trial has progressed well and we expect the trial to be completed in the middle of 2012. A Phase I study has been successfully completed in the second indication of acute kidney injury. Quark plans to initiate a Phase II trial depending on the results of the ongoing trial in the prevention of delayed graft function.

Progress in research collaborations

Silence is pleased to have been working with AstraZeneca in the area of RNAi since 2007, in the form of two collaborations, both of which were extended in 2010. AstraZeneca has now completed the research phase of the first of these collaborations, a research and development collaboration focused on five respiratory and oncology targets, and nominated three of the five targets as 'Accepted Programmes'.

The second collaboration, for the development of novel approaches for the delivery of siRNA molecules, was entered into in March 2008. The research phase of this collaboration has also been completed and AstraZeneca retains the right to use the DACC delivery system developed for their 'Accepted Programmes'.

Valuable portfolio of delivery technologies

Efficient and safe delivery of RNAi therapeutics is key to the success of the field and Silence Therapeutics' programmes, as well as those of other companies active in this area. The Company possesses three proprietary siRNA delivery technology platforms, AtuPLEX, DACC (lung) and DBTC (liver), two of which are already being used in the programmes of partners. This comprehensive delivery platform allows our RNAi therapeutics to reach many different organs, with the liver and lungs increasingly becoming targets of interest in the RNAi field and the pharmaceutical industry generally.

Because of the importance of appropriate delivery in this therapeutic area, we believe our delivery platform will deliver significant value to the Company via non-exclusive partnership deals.

  • AtuPLEX enables the delivery of siRNA molecules to targeted diseased tissues and cells in the vascular endothelium (blood vessels), while increasing their bioavailability and intracellular uptake. It incorporates Silence's proprietary lipid AtuFect and is used to embed siRNAs into a multiple lipid bi-layer structure. It is incorporated in Atu027.

  • The DACC novel lipid delivery system enables functional, highly specific and efficient delivery of siRNA molecules selectively to the lung endothelium with a long duration of action (over three weeks). Like AtuPLEX, it also incorporates Silence's proprietary lipid AtuFect and is used to embed siRNAs into a multiple lipid bi-layer structure. The DACC delivery system is incorporated in Atu111, Silence's preclinical development candidate for the treatment of acute lung injury.

  • The DBTC delivery system is lipid-based and targets the liver. Studies have shown it to be well tolerated and have a significant duration of action. It therefore has therapeutic potential in areas such as heptatocellular carcinoma, liver fibrosis and acute liver failure.

Three new delivery deals

The value of this portfolio of delivery technologies was underlined in 2011 with the signature of three agreements with new partners, InteRNA Technologies B.V, miRNA Therapeutics Inc. and a top 10 Pharmaceutical company. Interestingly, two of these three agreements were for a different form of RNA therapeutic to the siRNA approach being used by Silence Therapeutics, i.e. microRNA. This emphasises the value of our delivery platform.

In September, we established an agreement with InteRNA Technologies B.V., which is developing microRNA ('miRNA')-based therapeutics for cancer. MicroRNA intervention is an exciting new therapeutic area for which the Silence technology platform is well suited, and the deal was our first in this area. We are looking forward to the results from this collaboration, which we believe will demonstrate the potential of AtuPLEX for the delivery of RNA-based therapeutics outside of the RNAi arena.

Under the agreement, we will combine Silence's proprietary AtuPLEX delivery system with InteRNA's novel microRNAs to develop multiple novel candidate drugs. The two companies will then undertake in vitro and in vivo studies of the candidate drugs and select lead candidates for further evaluation. Silence is eligible to receive upfront fees as well as staged research payments if the collaboration progresses.

The potential of Silence Therapeutics' delivery technologies in this new area was further underlined in October 2011 with our second miRNA deal. The collaboration, with miRNA Therapeutics, is to investigate the potential of both AtuPLEX and our DBTC delivery system with our partner's novel microRNAs for the treatment of cancer. We are pleased that our first deal on DBTC is in this exciting new therapeutic area. Silence Therapeutics will formulate selected miRNA sequences into AtuPLEX and DBTC in order to generate candidate drugs, which will then undergo in vitro and in vivo testing at miRNA in order to select those to take forward for further evaluation.

In October 2011 we also signed an siRNA delivery collaboration for DACC with top 10 Pharmaceutical company - our first deal covering this technology for delivery to the lung. Under the terms of the agreement, our partner will provide us with specific siRNAs, which we will formulate into the DACC delivery system. Silence and its partner will undertake in vitro and in vivo studies of the DACC-formulated siRNAs developed under the agreement and select lead candidates for further evaluation.

Ongoing delivery collaborations progress

In addition to these exciting new deals, we have an ongoing siRNA delivery collaboration with Dainippon Sumitomo signed in 2008. Under this collaboration, we are jointly leveraging Silence's proprietary siRNA molecules and delivery technologies to demonstrate delivery of RNAi therapeutics to specific disease targets. This agreement, which originally included two drug targets, was expanded in 2010 to include two more.

Securing our financial position

Silence Therapeutics ended 2010 with cash reserves of £3.57m and we indicated in the first quarter of 2011 that we would be seeking additional funding to drive continued development of the Company. Accordingly, in May 2011, Silence successfully raised £5.51m net of expenses through a placing and open offer.

Given the substantial financial and economic volatility experienced globally over the last few years, particularly in the biotechnology sector, we were extremely pleased with this result, which gave us a substantially improved financial footing, and extended the cash runway to the end of the third quarter of 2012 from existing cash resources alone. The fundraising was supported by both existing and new shareholders, whom we thank for their support, and welcome to Silence Therapeutics.

Part of the proceeds are to be used to, among other things, complete the ongoing Phase I trial and initiate a Phase Ib trial of Atu027, and advance preclinical development of the Atu111 programme for lung disease. As shareholders can see, we have made progress in these areas and expect to continue to do so.

A streamlined business focused on business development

Increased financial efficiency

As 2011 progressed it became clear to Silence Therapeutics that, in order to create a more streamlined and efficient business, some streamlining and consolidation of operating sites was needed. Following the 2010 acquisition of Intradigm Inc., managing and working across our three sites in the UK, Germany and the US had generated considerable operational difficulties as well as increased costs.

In April 2011, we announced plans to close our Redwood City office in California. This was completed in August. As a consequence of this, our US-based CEO, Dr Phil Haworth, stepped down. I joined the business in September initially as Chief Business Officer, but was delighted to be able to accept the appointment as Chief Executive Officer in February 2012 following the departure of Thomas Christely, who took on the role of CEO briefly after the departure of Dr Haworth.

With the US-based business development and legal functions absorbed elsewhere in the Group, its operations are now based in Berlin, where our R&D facilities have always been located. In addition there is a small management presence in London.

In addition to the closure of the US facility, we were able to further streamline the business by reducing headcount in Berlin from 32 to 27, via the loss of some non-critical roles, and reducing the size of our Board. The latter had become too large following the acquisition of Intradigm Corporation, and as a consequence, Dr James Topper and Dr David U'Prichard resigned from the Board of Directors effective 29 July 2011 and 31 December 2011, respectively. We thank both Dr Topper and Dr U'Prichard for their valuable contribution to Silence Therapeutics.

These measures helped us to increase our cash runway and, combined with our fundraising, mean that we have sufficient funding to last us until the end of the third quarter of 2012.

Significantly strengthened business development focus

With encouraging data so far from the Phase I trial of Atu027, and the level of interest in Silence Therapeutics' RNAi delivery technologies, in 2011, it was clearly time to invest more significantly in our business development activities. An important part of this will be the partnering of and generation of value from these assets. In addition, with the availability of finance significantly reduced in the current economic crisis, the global biotechnology sector has increasingly accessed non-dilutive financing from sources such as public sector organisations (for example, research councils and leading charities). We consider this to be a major objective in our enhanced business development activity.


Read at BioSpace.com


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