Jerry Randall, Chairman, said: "In very challenging markets, Silence Therapeutics has secured commitments from existing and new shareholders to raise at least £5.2 million. Over the next two years we expect to conclude multiple value-driving events including completion of a second clinical trial of Atu027. The proceeds from this fundraising will strengthen the balance sheet with a view to ensuring that Silence extracts the highest value from its products and RNAi technology platform."
Background to and Reasons for the Fundraising and Use of Proceeds
On 21 March 2012, the Company announced its unaudited preliminary results for the 12 months ended 31 December 2011. In this announcement, the Company disclosed that the Group had cash resources which, based on the current levels of cash expenditure, are expected to last into the second half of 2012. As a consequence, the Group stated that it would require additional finance at some point in the future to enable its strategy for creating Shareholder value to be implemented in an optimal manner.
It is the intention of the Directors that the amount of £5.2 million (before costs) being raised from the Subscription and the Convertible Loan Note will be used to support the development of the RNAi platform as outlined below.
The proceeds of the Fundraising will enhance the Group's financial position and provide it with sufficient cash resources to fund the business until 2014. This injection of funding would extend the existing window of opportunity for exploitation of the RNAi platform and the Company's lead development candidate Atu027. In particular, it would enable the Company to conduct a small Phase Ib trial and a subsequent small Phase IIa trial of Atu027, as described below. It would also enable the Company, and its Shareholders, to benefit from potential milestone payments which may arise from existing licensing agreements and licences which may arise from recently announced research collaborations including those with InteRNA Technologies BV and miRagen Inc.
If the Resolutions are not passed by Shareholders at the General Meeting, the Fundraising would be unable to proceed. In this situation, the Company would not have cash resources to maintain current operations beyond the second half of 2012 and would need to consider alternative strategic options that the Directors believe would not be in the best interests of Shareholders. These actions could include the sale of the business at a price which Directors believe would not recognise the potential long-term value of the business or possible insolvency.
It is the view of the Board that sale of the business in this circumstance would not enable Shareholders to benefit from the significant investment already made in developing the RNAi platform and Atu027 or the potentially significant value creation opportunity in RNAi therapeutics and in particular in Atu027 that would be afforded if sufficient finances were available.
Share Capital Reorganisation
Subject to the passing of Resolution 1 at the General Meeting, the Directors propose to sub-divide each Existing Ordinary Share of 1 pence in nominal value into one Sub-divided Share of 0.1 pence in nominal value and one Deferred Share of 0.9 pence in nominal value. The Sub-divided Shares of 0.1 pence each so created will continue to carry the same rights as attach to the Existing Ordinary Shares of 1 pence each (save for the reduction in nominal value). The Deferred Shares will be transferable only with the consent of the Company and will not be admitted to trading on AIM and will have the rights set out in the New Articles. The Directors consider the Deferred Shares so created to be of no economic value. The Deferred Shares will, subject to Shareholder approval pursuant to Resolution 9 of the Resolutions, be repurchased by the Company in accordance with the New Articles for one pence in aggregate and, following such repurchase, shall be cancelled. The repurchase of the Deferred Shares will be financed out of the proceeds of the issue of the New Ordinary Shares.
The Share Capital Reorganisation will enable the Company to issue and allot shares at a price below the former nominal value of the Ordinary Shares.
No certificates will be sent to Shareholders in respect of the Share Capital Reorganisation, as Shareholder holdings will not change.
During the last 12 months Silence has made progress in advancing its pipeline, capitalising on its RNAi drug delivery capabilities through research collaborations with third parties and in strengthening its intellectual property. In addition, Silence' licensee Quark Pharmaceuticals Inc. has continued to make progress with its clinical programmes which are based on Silence' AtuRNAi technology. The Company is now focused on creating value by making further advances in all aspects of the business.
Atu027, for the treatment of solid tumours, is Silence' most advanced internal drug candidate. Atu027 combines Silence' proprietary drug delivery system AtuPLEX with AtuRNAi, the Company's proprietary RNAi chemistry. Atu027 specifically targets PKN3, a protein implicated in cancer growth and metastases. Pre-clinical studies have indicated that Atu027 works by inhibiting blood supply to solid tumours and has a particular profound impact on the prevention and growth of metastases. Combination with other currently marketed anti-cancer drugs has demonstrated additive effects in pre-clinical studies.
Silence is currently conducting a Phase I trial of Atu027 in patients with solid tumours. Interim results from the trial were announced at the annual meeting of the American Society of Clinical Oncology ('ASCO') in June 2012. The results demonstrated that 10 of the 33 patients treated with Atu027 achieved stable disease at study end (three months after treatment initiation). Patient recruitment into this trial is now complete. A total of 34 patients have been recruited into the trial which is expected to finish in July 2012 with results available shortly thereafter. To date, Atu027 has been shown to be safe and well tolerated. The Company plans to use proceeds from this Fundraising to conduct a small Phase Ib trial using Atu027 in combination with a chemotherapy regimen, and subject to the results of this study and any necessary preclinical work, conduct a small Phase IIa trial.
Atu111, for the treatment of acute lung injury, is the Company's most advanced drug development candidate
outside oncology. Unlike Silence oncology drug candidates, Atu111 combines Silence' DACC drug delivery system with AtuRNAi. The target for this RNAi therapeutic is undisclosed. However, pre-clinical models using the DACC delivery system have shown sustained knockdown of up to three weeks in the lung endothelium. Silence recently completed proof-of-concept studies in a pre-clinical model of acute lung injury demonstrating encouraging results using Atu111. Based on these results, Silence plans to conduct further studies in different pre-clinical models of acute lung injury.
Diseases including liver fibrosis and liver cancer continue to be areas of high unmet medical need and their high prevalence in Asia mean they are of increasing interest to pharmaceutical companies. Silence has developed a novel delivery system known as DBTC that enables highly specific delivery of siRNA molecules to cells of the liver including hepatocytes. Silence therefore recently initiated several programmes looking at liver fibrosis and liver cancer in collaboration with Professor Schuppan and Professor Pinzani, two key opinion leaders in the field of liver disease. These collaborators are facilitating target selection and providing proof-of-concept experimental systems.
In addition to its Atu111 programme, Silence is looking to exploit DACC, its lung endothelium specific RNAi delivery system in other areas of lung disease and is therefore exploring several drug candidates in a variety of lung cancer models.
New delivery systems
Silence continues to work to both improve its existing, and develop, new RNAi delivery systems that target new cell types and organs.
Zamore Design Rules
Through its acquisition of Intradigm Corporation, Silence obtained exclusive licences to three Zamore patent families from the University of Massachusetts Medical School, where Philip D. Zamore, PhD is the co-director of the RNA Therapeutics Institute. Following a review of these licences, Silence has now decided that their high cost of maintenance is not warranted and has entered into discussion with the University of Massachusetts with a view to returning these rights.
Terms of the Subscription
The Company has today conditionally placed 840,000,000 Subscription Shares at 0.5 pence per share with existing and new investors to raise £4.2 million before expenses. The Subscription is conditional, inter alia, upon the passing of the Resolutions 1 to 3 and 8 and 9 (as set out in the Notice of General Meeting), the Share Capital Reorganisation occurring and Admission.
Details of the Open Offer
Silence is proposing to raise up to £0.5 million (before expenses) pursuant to the Open Offer. The proposed Issue Price of 0.5 pence per Open Offer Share is the same price as the price at which the Subscription Shares are being issued.
The Open Offer is being made on a pre-emptive basis, allowing all Qualifying Shareholders the opportunity to participate. The Open Offer is not underwritten. The Fundraising is not conditional upon the level of applications made to subscribe under the Open Offer. Accordingly, if no applications to subscribe under the Open Offer are received, the total amount that the Company would raise via the Fundraising would be £5.2 million (before expenses).
The Open Offer provides Qualifying Shareholders with the opportunity to apply to acquire Open Offer Shares at the Issue Price pro rata to their holdings of Existing Ordinary Shares as at the Record Date (subject to the effect of the Share Capital Reorganisation) on the following basis:
1 Open Offer Shares for every 5.77 Existing Ordinary Shares
and so on in proportion for any other number of Existing Ordinary Shares then held. Shareholders holding less than 5 Ordinary Shares will have no entitlements under the Open Offer. Entitlements to apply to acquire Open Offer Shares will be rounded down to the nearest whole number and any fractional entitlement to Open Offer Shares will be disregarded in calculating the Qualifying Shareholder's entitlement.
The Open Offer Shares will be issued in the form of Sub-divided Shares following the Share Capital Reorganisation and, when issued and fully paid, will rank pari passu in all respects with the Existing Ordinary Shares, including the right to receive all dividends or other distributions made, paid or declared after the date of their issue.
The Open Offer is subject to the satisfaction, amongst other matters, of the following conditions on or before 1 August 2012 (or such later date as agreed by the Company):
the passing of the Resolutions 1 to 3 and 8 and 9 (as set out in the Notice of General Meeting), including the Share Capital Reorganisation occurring;
Admission becoming effective by 8.00 a.m. on 1 August 2012, (or such later date as agreed by the Company).
Convertible Loan Note
The Company also announces today the conditional issue of a £1 million Convertible Loan Note to Robert Keith. The principal terms of the Convertible Loan Note are:
repayment on 1 August 2019, seven years after issue, if not previously converted into Ordinary Shares;
convertible into newly issued Ordinary Shares at the Issue Price;
convertible at any time from issue to maturity.
The price at which the Convertible Loan Note will convert into Ordinary Shares is subject to adjustment in certain circumstances. The Convertible Loan Note is secured by way of a pledge by the Company over the entire issued share capital of Silence AG and by a pledge by Silence AG of certain intellectual property rights owned by Silence AG.
In addition to the Convertible Loan Note, the Company has conditionally granted warrants over 7,500,000 Ordinary Shares, to ISM Capital pursuant to the CL Warrant. The warrants will be exercisable at a price of 1 pence at any time prior to the expiry of 36 months from the date of the CL Warrant.
The Convertible Loan Note and the CL Warrant are conditional, inter alia, upon the passing of Resolutions 1 to 3 and 8 and 9 (as set out in the Notice of General Meeting), the Share Capital Reorganisation occurring and Admission of the New Ordinary Shares.
Establishment of an Equity Finance Facility
The EFF provides Silence with a £10 million facility which (subject to certain limited restrictions) can be drawn down at any time over the next three years. The timing and value of any draw down is at the sole discretion of the Company.
Silence is under no obligation to make a draw down. The Company may make draw downs up to the total value of the EFF by way of issuing subscription notices to Darwin. Following delivery of a subscription notice, Darwin will subscribe and the Company will allot to Darwin new Ordinary Shares in Silence.
The subscription price for any Ordinary Shares to be subscribed by Darwin under a subscription notice will be at a 5 per cent. discount to the average of the three lowest reference prices where the reference prices will be the volume weighted average price of Ordinary Shares for each of 15 trading days following delivery of a subscription notice (the "Pricing Period"). Silence is also obliged to specify in each subscription notice a minimum price (the "Floor Price") below which Ordinary Shares will not be issued to Darwin. The Company will have the right to modify that Floor Price at any time with the consent of Darwin during the relevant Pricing Period. The number of Ordinary Shares issued on each draw down may not exceed 25 per cent. of the issued Ordinary Shares as enlarged by the issue.
The maximum number of Ordinary Shares which may be issued under any individual subscription notice will be 400 per cent. of the average daily trading volume of Silence's Ordinary Shares over the 15 trading days preceding the issue of the relevant subscription notice. The number of shares to be issued may be reduced in certain circumstances, including where the Floor Price is not maintained, the Company's shares not being traded or the Company having suffered a material adverse effect during the Pricing Period. There is an over-allotment facility available to the Company under which the Company may authorise Darwin at Darwin's discretion to increase the amount of draw down by up to the aggregate undrawn amount under the Equity Finance Facility.
The issuance of a subscription notice is conditional upon the satisfaction of certain subscription notice conditions (the "Subscription Notice Conditions") which have been agreed between Darwin and the Company. Any subscription notice which Silence may issue will only be valid to the extent that it has the requisite shareholder authority to issue the maximum number of Ordinary Shares that Darwin may be required to subscribe under the relevant subscription notice.
The Equity Finance Facility is conditional on the Company granting to Darwin a warrant to subscribe for up to 3,330,000 New Ordinary Shares at 1.5 pence per share at anytime within 36 months.of grant.
Irrevocable commitments from certain Directors and major Shareholders
The Directors who in aggregate hold 3,911,256 Existing Ordinary Shares, representing approximately 0.68 per cent. of the existing issued ordinary share capital of the Company, have irrevocably undertaken to vote in favour of the Resolutions at the General Meeting.
Certain major Shareholders, namely Robert Keith, and ACP IV LP who in aggregate hold 92,682,266 Existing Ordinary Shares representing approximately 16.06 per cent. of the existing issued ordinary share capital of the Company, have irrevocably undertaken not to take up their entitlements under the Open Offer and to vote in favour of the Resolutions at the General Meeting.
Current Trading and Prospects
Silence is a global leader in RNAi Therapeutics. The Company is nearing the completion of an open-label, dose escalation Phase I trial of its lead drug candidate Atu027 in patients with solid tumours. As at 30 June 2012, 34 patients have been treated with drug, which has been found to be safe and well tolerated. The trial is now expected to be completed in July 2012 with results available shortly thereafter.
In addition to Silence' own programmes, the Company has licensed its RNAi technology to several pharmaceutical companies including AstraZeneca, Dainippon Sumitomo, Pfizer and Quark. Silence has licensed its AtuRNAi technology to both Quark and Pfizer, which are collaborating on the development of PF-04523655 (PF-'655). In February 2012, Quark initiated a 264 patient Phase IIb trial of PF-'655 in patients with diabetic macular oedema. The trial is designed to compare the efficacy of PF-'655 when used alone or in combination with Lucentis (Novartis/Roche) against Lucentis in patients with diabetic macular oedema. The trial is expected to complete in the middle of 2014. In May 2012, Quark also announced it had amended its agreement with Pfizer to enable it to initiate a 108 patient Phase IIa trial of PF-'655 in patients with open-angle glaucoma (the most common type of glaucoma). Quark and Pfizer have also conducted a Phase II trial of PF-'655 in age-related macular degeneration, the leading cause of blindness in the elderly. In addition to royalties on product sales, milestones from these programmes could now total up to $120 million of which $6 million has been received to date. A further milestone of almost $4 million is due to Silence on initiation of a Phase III trial.
In addition to PF-'655, Quark is also developing QPI-1002 for the prevention of delayed graft function in kidney transplant patients and for the prevention of acute kidney injury. QPI-1002 is based on Silence AtuRNAi technology. In August 2010, Quark signed an option and licence agreement for QPI-1002 with Novartis for an upfront payment of $10 million. Quark is currently conducting a 366 patient Phase II trial of QPI-1002 in prevention of delayed graft function in kidney transplant patients. The trial is due to be completed before the end of 2012. Based on the results of this study, Novartis may decide to exercise its option to license QPI-1002. Quark also plans to initiate a Phase II trial of QPI-1002 in acute kidney injury. In addition to royalties on product sales, milestones to Silence from these programmes could total up to $100 million.
During the last 12 months, Silence has signed a number of delivery collaborations to evaluate the Company's three RNAi delivery systems including agreements with InteRNA Technologies BV, miRagen Inc. and Mirna Inc. Discussions with several other parties regarding similar collaborations are ongoing. If successful, these collaborations could lead to these parties taking a licence to Silence delivery technologies.
Potential News Flow Events 2012-2014
In the near and medium term, the Directors believe there is the possibility of multiple potential news flow events from the existing product portfolio of programme deals, and opportunities within the RNAi technology platform, that could, dependent on success, act as value creation points for the business. The indicative dates are the Company's estimates, however no assurance can be given that the various events will be achieved by those dates, or indeed at all.
Internal Product Portfolio
Atu027 (treatment of solid tumours)
Completion of Phase I trial of Atu027 (July 2012)
Final Phase I results of Atu027 (third quarter of 2012)
Initiation of Phase Ib trial (end of 2012/early 2013)
Completion of Phase Ib trial (2014)
Atu111 (treatment of acute lung injury)
Completion of further proof-of-concept pre-clinical models (end 2012)
Partnered Product Portfolio
PF-'655 (diabetic macular oedema, glaucoma and age-related macular degeneration)
Completion of Phase IIb MATISSE study (2014)
Initiation of Phase IIa trial in glaucoma (trial start date not yet disclosed by Quark)
QPI-1002 (acute kidney injury 'AKI' and prevention of delayed graft function 'DGF')
Completion of Phase II trial in prevention of delayed graft function (second half of 2012)
Potential milestone payment upon Novartis' exercise of a license (2013)
Related Party Transaction
As part of the Fundraising, the Directors propose to issue 200,000,000 Subscription Shares to Robert Keith which will represent approximately 13.18 per cent. of the Company's Enlarged Share Capital. In addition, the Directors propose to issue a £1 million Convertible Loan Note to Robert Keith which can be converted at any time into a further 200,000,000 Ordinary Shares at an issue price of 0.5 pence.
The proposed issue of the 200,000,000 Subscription Shares and the Convertible Loan Note will constitute a Related Party Transaction for the purpose of AIM Rule 13 as a result of Robert Keith being a "substantial shareholder" as defined by the AIM Rules for Companies. As at the date of this announcement, Robert Keith holds 11.67 per cent. of the Company's issued share capital.
As part of the Fundraising, Jerry Randall has agreed to increase his roles and responsibilities from Non-executive Chairman to become Executive Chairman. The transition to Executive Chairman will occur at Admission. At Admission, and subject to the transition to Executive Chairman, the Board intends to grant Mr Randall share options over 3 per cent. of the issued share capital.
In addition, the Board has decided to appoint Ali Mortazavi as Director of Corporate Strategy for the Company. Mr Mortazavi's appointment as an Executive Director will commence from Admission. At Admission, and subject to his appointment as a Director, the Board intends to grant Mr Mortazavi share options over 5 per cent. of the issued share capital of the Company.
In addition, Dr Tony Sedgwick and Max Herrmann have agreed to step down from the Company at Admission. In order to enable a smooth and orderly transition, Mr Herrmann has agreed to provide consultancy services to the Company for 6 months during which time, the Company will look for an appropriate replacement. Dr Sedgwick has also agreed to provide consultancy services and act as an adviser to the Company for a period of eight and a half months following the completion of the Fundraising.
In addition, Annette Clancy has decided to step down as Non-executive Director at Admission.
Intentions of the Directors and the Proposed Director in relation to the Subscription
Several of the Directors and the Proposed Director have agreed to subscribe for Subscription Shares as follows:
Director Number of Subscription Shares
Anthony Sedgwick 2,000,000
Max Herrmann 2,000,000
Ali Mortazavi 20,000,000
The Directors do not intend to acquire Open Offer Shares pursuant to their respective Open Offer Entitlements.
EXPECTED TIMETABLE OF PRINCIPAL EVENTS
Record Date and time for entitlements under the Open Offer 5.00 p.m. on 10 July
Existing Ordinary Shares marked 'ex' by the London Stock Exchange 8.00 a.m. on 12 July
Announcement of the Fundraising and posting of Circular, Application Forms
and Form of Proxy 12 July
Open Offer Entitlements credited to
stock accounts in CREST of Qualifying CREST Shareholders 8.00 a.m. on 13 July
Recommended latest time for requesting withdrawal of Open
Offer Entitlements from CREST 4.30 p.m. on 19 July
Latest time for depositing Open Offer Entitlements
into CREST 3.00 p.m. on 20 July
Latest time and date for splitting of Application Forms
(to satisfy bona fide market claims only) 3.00 p.m. on 25 July
Latest time and date for receipt of Forms of Proxy and electronic proxy
appointments via the CREST system 10.00 a.m. on 29 July
Latest time and date for receipt of completed Application
Forms and payment in full under the Open Offer or settlement
of relevant CREST instruction (as appropriate) 11.00 a.m. on 27 July
Latest time and date for receipt of Forms of Proxy and electronic proxy
appointments via the CREST system 10.00 a.m. on 29 July
Results of the Fundraising announced through the RIS 31 July
General Meeting 10.00 a.m. on 31 July
Record date for Share Capital Reorganisation 5.00 p.m. on 31 July
Sub-division of Existing Ordinary Shares 5.00 p.m. on 31 July
Admission and commencement of dealings of the New Ordinary Shares 1 August
New Ordinary Shares credited to CREST stock accounts 1 August
Despatch of definitive share certificates for New Ordinary Shares within 14 days of Admission
(1) References to times in this Announcement are to London time (unless otherwise stated).
(2) If any of the above times or dates should change, the revised times and/or dates will be notified by an announcement to an RIS.
(3) The dates and timing of the events in the above timetable and in the rest of this Announcement is indicative only and may be subject to change.
Defined terms in this announcement take the same meaning as set out in the Circular.
For further information please contact:
Silence plc Tel: +44-(0)20-7491-6520
Jerry Randall, Chairman
Anthony Sedgwick, CEO
Max Herrmann, CFO
Singer Capital Markets Ltd Tel: +44-(0)20-3205-7500
M: Communications Tel: +44-(0)20-7920-2345
Darwin Strategic Tel: +44-(0)20-7938-5754
Anand Sambasivan / Jamie Vickers