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Proposed Fundraise

15 Jun 2017 07:00

RNS Number : 1572I
Shield Therapeutics PLC
15 June 2017
 

Shield Therapeutics plc

Proposed Fundraise

 

Shield Therapeutics plc

15 June 2017

 

THIS ANNOUNCEMENT (INCLUDING THE APPENDIX) AND THE INFORMATION CONTAINED HEREIN IS RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, SOUTH AFRICA OR ANY OTHER STATE OR JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL. PLEASE SEE THE IMPORTANT NOTICE AT THE END OF THIS ANNOUNCEMENT.

 

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR IMMEDIATE RELEASE.

 

Shield Therapeutics plc

("Shield" or the "Company" or the "Group")

London, UK, 15 June 2017

Shield Therapeutics plc (LSE:STX), the specialty pharmaceutical company focused on the development and commercialisation of late-stage pharmaceuticals that address unmet medical needs in secondary care, today announces its intention to raise a total of approximately £12 million (before expenses) through (i) a co-ordinated exercise of existing warrants at an exercise price of 150p per share to raise approximately £10.3 million (the "Warrant Exercise"), and simultaneously with the Warrant Exercise (ii) a placing of new ordinary shares at 150p per share to raise approximately £1.5 million (the "Placing") and (iii) a subscription of new ordinary shares at 150p per share by certain directors and a senior manager of the Company to raise approximately £0.145 million (the "Subscription" and, together with the Placing and the Warrant Exercise, the "Fundraise").

Liberum Capital Limited ("Liberum") and Peel Hunt LLP ("Peel Hunt") are acting as joint bookrunners (together the "Joint Bookrunners") in respect of the Placing. Liberum is acting as Nominated Adviser to the Company.

Transaction Summary

· The Fundraise - the Company intends to raise approximately £12 million through the Fundraise via (i) a co-ordinated exercise of existing warrants to raise approximately £10.3 million, and simultaneously with the Warrant Exercise (ii) a placing of new ordinary shares to raise approximately £1.5 million, (iii) the subscription of new ordinary shares by each of the directors and a senior manager of the Company ("Subscription Shares") to raise approximately £0.145 million.

 

· Warrant Holder Irrevocable Undertakings - following this announcement the Company expects to receive irrevocable undertakings or firm commitments from warrant holders committing, subject to completion of the Placing, to exercise warrants with an expiry date of 30 June 2017 at an exercise price of 150p per new ordinary share, which is expected to result in the issue of 6,870,538 new ordinary shares to the relevant warrant holders (the "Warrant Exercise Shares").

 

· Proposed Placing - the Placing is being conducted via an accelerated bookbuild exercise, pursuant to which it is intended that a minimum of 1,000,000 new ordinary shares will be issued to investors (the "Placing Shares") at an issue price of 150p per new ordinary share.

 

· Fundraise Price - The Warrant Exercise price of 150p was set at the time of the Company's IPO and each of the Placing, the Warrant Exercise and the Subscription are being conducted at 150p per share, (the "Fundraise Price"), which represents a discount of 11.0 per cent. to the closing middle market share price of 168.5p per existing ordinary shares on 14 June 2017, being the last trading day prior to the publication of this announcement.

 

· Use of Proceeds - the net proceeds of the Fundraise of approximately £11.4 million, alongside the Company's existing cash resources of approximately £12 million (unaudited as at 31 May 2017) (together, the "Cash Resources"), will be used to:

o fund increased commercialisation activities for Feraccru in the UK and Germany;

o deliver primary endpoint data from the pivotal phase 3 AEGIS Chronic Kidney Disease ("CKD") study (anticipated Q4 2017); and

o provide further working capital until towards the end of Q1 2018.

 

In addition, the Cash Resources will be used to fund continued progress:

o of phase 3b AEGIS head to head ("H2H") trial to its 12-week primary endpoint (anticipated H1 2018); and

o towards a New Drug Application ("NDA") filing of Ferracru for US regulatory review (anticipated during H1 2018).

 

· Admission - admission of the Placing Shares, the Warrant Exercise Shares and the Subscription Shares is expected to occur concurrently at 8.00 a.m. on 28 June 2017 (or such later date as the Company, Liberum and Peel Hunt may agree, being no later than 30 June 2017) ("Admission").

 

· No general meeting of the Company will be required to complete the Fundraise.

Carl Sterritt, Chief Executive Officer and Co-Founder of Shield Therapeutics, commented: Since our IPO in 2016 Shield has transitioned into a commercially focused specialty pharma business that is now actively generating revenue in both Germany and the UK from its lead product, Feraccru. With key data and pipeline progress due in the coming months, which are expected to provide significant additional value creating opportunities for the Company, the Board and management team remain focused on execution of our plans. I am grateful for the support indicated for the Fundraise from our existing shareholders at this exciting time as these funds will enable us to reach and go beyond the upcoming key inflection points."

Enquiries

Shield Therapeutics plc

+44 (0)20 7186 8500

Carl Sterritt, Chief Executive Officer

Joanne Estell, Chief Financial Officer

Karl Keegan, Director Corporate Development

Nominated Adviser, Joint Bookrunner and Joint Broker

+44 (0)20 3100 2222

Liberum Capital Limited

Christopher Britton

Steve Pearce

Jonathan Wilkes-Green

Joint Bookrunner and Joint Broker

+44 (0)20 7418 8900

Peel Hunt LLP

James Steel

Alastair Rae

Oliver Jackson

Financial PR Advisor

Consilium Strategic Communications

+44 (0)203 709 5700

shieldtherapeutics@consilium-comms.com

Mary-Jane Elliott

Matthew Neal

Lindsey Neville

Hendrik Thys

 

Further information regarding the Fundraise

Information on the Company

Shield is a specialty pharmaceutical company focused on the commercialisation and development of late-stage, hospital-focused pharmaceuticals which address unmet medical needs in secondary care. The Company's clear purpose is to help its patients become people again, by enabling them to enjoy the things that make the difference in their everyday lives. The Group owns the marketed product, Feraccru, which has been approved initially for the treatment of iron deficiency anaemia ("IDA") in adult patients with inflammatory bowel disease ("IBD") and has exclusive IP rights until the mid-2030s. The Company is currently conducting a phase 3 pivotal study in approximately 170 pre-dialysis CKD patients with IDA in approximately 30 US-based expert nephrology centres. The AEGIS-CKD study is aiming to prove the effectiveness of Feraccru in the treatment of IDA in pre-dialysis CKD patients and is due to read out in Q4 2017 and a successful study is expected to significantly increase the commercial opportunity for Feraccru via a label expansion in Europe during 2018 as well as allowing for a filing of an NDA in the USA.

In addition, having taken PT20 - a development product for the treatment of systemic phosphate accumulation (hyperphosphatemia) in CKD patients - through to being phase 3 ready; the Group is seeking licensing/co-development partners for it and for PT40, a generic form of Venofer which could be used to treat IDA in renal dialysis patients.

Details of the Fundraise

Shield is proposing to raise approximately £12 million (before expenses) through the issue of, in aggregate, 7,967,207 new ordinary shares of 1.5p each in the capital of the Company at a price of 150p per share pursuant to the Warrant Exercise, the Placing and the Subscription (the "New Ordinary Shares"). The Directors in consultation with the Joint Bookrunners have the ability to increase the size of the Fundraise at their discretion. It is expected that 6,870,538 Warrant Exercise Shares will be issued pursuant to the Warrant Exercise, 1,000,000 Placing Shares will be issued pursuant to the Placing and 96,669 Subscription Shares will be issued pursuant to the Subscription, in each case at the Fundraise Price of 150p per share. The Fundraise Price represents a 11.0 per cent. discount to the closing middle market share price of 168.5p per existing ordinary share on 14 June 2017. The Fundraise, which is not underwritten, is not conditional on Shield shareholder approval and the Placing is being undertaken utilising a cash box structure.

Application will be made by the Company to the London Stock Exchange for the New Ordinary Shares to be admitted to trading on the AIM market. The New Ordinary Shares will be issued free of all liens, charges and encumbrances and will, when issued and fully paid, rank pari passu in all respects with the existing ordinary shares. It is expected that Admission of the New Ordinary Shares will become effective at 8.00 a.m. on 28 June 2017, and that dealings in the New Ordinary Shares will commence at that time.

The Warrant Exercise

The Warrant Exercise will be conducted in accordance with the instrument entered into by the Company by way of a deed poll dated 12 February 2016 ("Warrant Instrument") which granted to the holders of warrants the right to subscribe for ordinary shares of 1.5p each in the capital of the Company by 30 June 2017 at an exercise price of 150p per share.

Following this announcement, the Company expects to receive irrevocable undertakings and/or firm commitments from certain warrant holders (including the Company's largest shareholder W. Health L.P.) to exercise warrants in respect of in aggregate 6,870,538 New Ordinary Shares at the exercise price of 150p per share representing 58.9% of the available warrants that were issued at the IPO. Unless exercised by 30 June 2017, the remaining warrants will expire on that day. Pursuant to the terms of the irrevocable undertakings and firm commitments, warrant holders will undertake to exercise (or procure that their nominee exercises) the number of warrants specified in the irrevocable undertaking or firm commitment at the exercise price of 150p per share by way of a submission in the prescribed form in CREST ("CREST Instruction") by no later than 11:00am on 27 June 2017.

The irrevocable undertakings and firm commitments will lapse in the event the placing agreement between the Company, Liberum and Peel Hunt dated 15 June 2017 (the "Placing Agreement") is terminated or does not become unconditional in accordance with its terms by 28 June 2017 (or such later date as the Company, Liberum and Peel Hunt may agree being no later than 30 June 2017). In the event that the irrevocable undertakings and firm commitments lapse, the Company will (to the extent a CREST Instruction has been submitted) authorise the revocation of the CREST Instruction and procure that the funds and warrants are returned to the CREST exercising member as soon as practicable thereafter.

The Subscription

Each of the Company's directors (Carl Sterritt, Andrew Heath, James Karis, Peter Llewellyn Davies and Joanne Estell) and a senior manager have indicated that they intend to subscribe for, in aggregate, 96,669 Subscription Shares at a price of 150p per Subscription Share raising, in aggregate, approximately £0.145 million. Further details of any such participation will be set out in the announcement to be made on the closing of the Bookbuild, which is expected to be made later today.

The Placing

The Placing is being conducted through an accelerated bookbuild process (the "Bookbuild") which will commence immediately following this announcement. Liberum and Peel Hunt have been appointed as Joint Bookrunners in respect of the Placing.

Under the terms of the Placing, it is intended that a minimum of 1,000,000 Placing Shares will be placed on a non-pre-emptive basis at the Fundraise Price, which represents 0.92 per cent of the existing issued ordinary share capital of the Company as at 14 June 2017. The Directors in consultation with the Joint Bookrunners have the ability to increase the number of Placing Shares to be issued at their discretion. The timing of the closing of the Bookbuild, the number of ordinary shares to be issued and allocations are at the discretion of the Company and the Joint Bookrunners. Details of the outcome of the Bookbuild will be announced as soon as practicable after it is closed.

The Placing Shares are not subject to clawback in favour of shareholders, the Placing is not underwritten and is subject to the terms and conditions set out in the appendix (the "Appendix") to this announcement (which forms part of this announcement, such announcement and the Appendix together being, this "Announcement"). The Placing is conditional upon inter alia, the Placing Agreement becoming unconditional and not being terminated and Admission becoming effective prior to 28 June 2017 (or such later date as the Company, Liberum and Peel Hunt may agree being no later than 30 June 2017).

The issue of the Placing Shares to institutional investors is to be effected by way of a cash box placing. The Company will allot and issue the Placing Shares on a non-pre-emptive basis to placees in consideration for Liberum transferring its holdings of redeemable preference shares and ordinary shares in a Jersey special purpose vehicle ("JerseyCo") to the Company. Accordingly, instead of receiving cash as consideration for the allotment and issue of Placing Shares, at completion of the Placing, the Company will own all of the issued ordinary shares and redeemable preference shares of JerseyCo, whose only asset will be its cash reserves, which will represent an amount approximately equal to the net proceeds of the Placing (net of any agreed commissions and expenses).

Lock-up Arrangements

Each of Andrew Heath, James Karis, Peter Llewelyn Davies, Carl Sterritt, and Joanne Estell as directors of the Company has agreed to enter into new six-month lock-up arrangements, during which time, subject to certain exceptions, they may not issue, offer, sell or contract to sell, or otherwise dispose of any ordinary shares, or enter into any transaction with the same economic effect as the foregoing (each a ''Disposal''). In addition, they have also agreed that any Disposal in the subsequent six-month period will be undertaken by Liberum or Peel Hunt (for so long as either Liberum or Peel Hunt remain the Company's joint broker).

Pursuant to the terms of the Placing Agreement, the Company has also agreed that for a 90-day period from the date of the Placing Agreement, the Company will not issue, allot, offer, pledge, sell, contract to sell, grant any option or contract to purchase, purchase any option or contract, grant any option, right or warrant to purchase, lend or otherwise transfer or dispose of, directly or indirectly, any ordinary shares in the Company without the prior written consent of the Joint Bookrunners except under an existing employee share scheme of the Company and/or the allotment and issue of ordinary shares pursuant to the exercise of warrants outstanding after Admission.

Expected Timetable of Principal Events

Event

Date

Announcement of the Fundraise

 

7.00 a.m. on 15 June 2017

Commencement of the Bookbuild relating to the Placing

 

7.00 a.m. on 15 June 2017

Irrevocable undertakings from warrant holders to exercise their warrants pursuant to the Warrant Exercise received by the Company

Before the Placing closes on 15 June 2017

Results of the Fundraise announced

 

By close of business on 15 June 2017

Date by which warrant holders who are exercising their warrants pursuant to the Warrant Exercise must have submitted (either directly or via their nominee) the USE instruction into CREST

 

11.00 a.m. on 27 June 2017

Admission and commencement of dealings in New Ordinary Shares issued pursuant to the Fundraise

8.00 a.m. on 28 June 2017

New Ordinary Shares to be held in Uncertificated Form credited to CREST stock accounts

 

28 June 2017

 

Background to and reasons for the Fundraise

In February 2016, Shield successfully completed its IPO on the AIM market of the London Stock Exchange ("IPO"), raising £32.5 million (gross) of growth capital from a high quality group of new and existing investors. As part of the IPO, investors were issued with warrants to subscribe for new ordinary shares in Shield at 150p per share by the warrant expiry date of 30 June 2017, and these funds would be used to further fund the Company's existing business plan as set out at IPO.

The IPO has been a transformational event for Shield and provided the capital to set up a lean and focused sales force to commercialise Feraccru initially to specialist gastroenterologists in the major European pharmaceutical markets, as per the initial approval of Feraccru. Through the funds raised at IPO, Shield has continued to invest in a growing commercial team as well as necessary infrastructure, significantly adding resources and competencies through 2016 and into 2017. This has resulted in Shield transforming itself from a small, wholly development-focused and privately owned company with approximately 16 employees, into a publicly traded, significantly larger and increasingly commercially-focused, customer-facing organisation of approximately 70 employees, which is set up to sell innovative and value-added specialty pharmaceuticals, in particular Feraccru, that effectively treat otherwise unmet medical needs.

Since IPO, the Company has made significant progress in a number of key areas including:

· in February 2016, the Company received Pan-European Marketing Authorisation Approval of Feraccru for the treatment of IDA in adult patients with IBD;

· in May and October 2016, attractive price points of £1.70 and €2.29 per day were achieved for Feraccru in the UK and Germany, respectively;

· effective sales teams have been built in the UK and Germany with c. 20 customer-facing members of the team now interacting daily with customers across both geographies, with further expansion planned through 2017;

· sales of Feraccru commenced in the UK and Germany;

· first commercial product shipments have been completed to the Company's Central & East European commercialisation partner, AOP Orphan Pharmaceuticals ("AOP");

· grants have been received for a new Composition of Matter patent covering the crystalline forms of Feraccru. To date grants have been issued by the UK Patent Office (October 2016), Australian Patent Office (March 2017), Canadian Patent Office (April 2017) and the European Patent Office (May 2017). This patent considerably improves the protection surrounding Feraccru and, where granted, extends the main IP coverage from 2023 through to as long as 2035;

· a pre-approval notification for Feraccru was received from the Swiss regulatory authority in June 2017;

· the AEGIS-CKD pivotal Phase 3 study has progressed well with primary endpoint data readout anticipated towards the end of 2017. Positive data is expected to facilitate a broader label application in Europe and NDA filing in the US. With successful applications, the Company expects an increase in the available patient population from the current estimated 330,000 with IBD in the EU-5 (being UK, Germany, France, Italy and Spain), to approximately 2.6m patients with IBD-IDA and CKD-IDA in the EU-5 and the US;

· in May 2017 the Company signed an agreement with AOP that improved the commercial terms of the existing agreement for Central and Eastern Europe and also extended AOP's distribution agreement to include Scandinavia;

· Shield is also actively discussing licensing agreements for Feraccru across a number of non-core markets with further potential partners; and

· the Company is progressing opportunities to partner or out-licence its complementary pipeline assets, particularly PT20 and PT40.

As reported in the Company's full year 2016 results announcement issued on 4 April 2017, as at 31 December 2016 the Company had existing cash resources, of approximately £21 million, which had reduced, in line with the Company's expectations, to approximately £12 million as at 31 May 2017 (unaudited). As anticipated at IPO, and on the basis of the Company's anticipated future cash requirements, the Company requires further funding for the continued development and commercialisation of Feraccru and, in particular, to deliver pivotal phase 3 AEGIS-CKD data by the end of 2017, a potentially transformational milestone and value inflection point for Shield due to the significant increase in Feraccru's target populations and available markets such a positive result would facilitate.

The Board believes that raising equity finance using the flexibility provided by a non pre-emptive placing combined with a co-ordinated exercise of the Company's existing warrants is the most appropriate and optimal structure for the Company at this time. This allows both existing institutional warrant holders and new institutional investors the opportunity to participate in the Fundraise and avoids the requirement for a prospectus, which is a costly and time consuming process.

Use of Cash Resources

The net proceeds of the Fundraise of approximately £11.4 million, alongside the Company's existing cash resources of approximately £12 million (as at 31 May 2017 (unaudited)), will be used to:

· fund increased commercialisation activities for Feraccru in the UK and Germany;

· deliver primary endpoint data from the pivotal phase 3 AEGIS CKD study (anticipated Q4 2017); and

· provide further working capital until towards the end of Q1 2018.

 

In addition, the Cash Resources will be used to fund continued progress:

· of the phase 3b AEGIS H2H trial to its primary endpoint (anticipated H1 2018); and

· towards a NDA filing of Feraccru for US regulatory review (anticipated during H1 2018).

 

Should the Company raise funds in excess of approximately £12 million as part of the Fundraise or should any of the remaining warrants be exercised prior to their expiry, the net proceeds of the additional funds raised will be used to provide further working capital and to extend the cash runway of the business further into 2018; including to make further progress towards the completion of the phase 3b AEGIS H2H trial, as well as advancing the filing of the NDA for Feraccru in the US. In addition, the Company will continue to assess the range of options available to it to further extend its cash runway, in particular through its increased focus on outward business development activities in respect of partnering assets, which may result in upfront licence fees being received by the Company, before the end of the first quarter of 2018.

Business and Strategy Update

Feraccru - initial focus on targeting IDA patients with IBD in UK and Germany

Feraccru is the Company's lead product and is a novel therapy for the treatment of IDA that received an initial marketing authorisation across Europe in February 2016 for the treatment of adult IBD patients with IDA. Feraccru is the first oral iron therapy to be approved for the treatment of IDA in patients with IBD and Shield's initial target market for Feraccru for in-house commercialisation is the approximately 330,000 IBD patients in the EU-5 who have IDA and require pharmaceutical therapy. Commercially, Feraccru is not directly competing against or seeking to be compared with the wide range of mostly generic and low priced oral ferrous products ("OFPs") available in the market, rather Shield's positioning of Feraccru is focused on patients who are either currently on IV therapy, are treated ineffectively with OFPs or are unwilling to take them due to their well-documented adverse event profile. The Company's near-term commercial focus is to grow sales in Germany and the UK, creating a strong base from which to expand into new geographies and indications.

Pivotal research and development to support broader commercialisation of Feraccru

AEGIS-CKD Phase 3 study -primary endpoint data anticipated Q4 2017

In December 2016, the Company commenced recruitment into a randomised, placebo-controlled phase 3 pivotal study of approximately 170 pre-dialysis CKD patients with IDA in approximately 30 US-based expert nephrology centres. The AEGIS-CKD study is aiming to prove the effectiveness of Feraccru in the treatment of IDA in pre-dialysis CKD patients.

This study continues to recruit well and remains on track to deliver top-line primary efficacy data in the fourth quarter of 2017. A positive result from the AEGIS-CKD study is highly relevant to the Company's long-term commercial plans as it is expected to facilitate concurrent regulatory filings in Europe and the US in 2018, providing (a) a broad label for Feraccru in Europe, increasing the evidence-based target population for Feraccru in the EU-5 from an estimated 330,000 with IBD-IDA to c. 1.3 million by the addition of CKD-IDA patients suitable for therapy and (b) access to the more than c. 1.3 million US patients with IBD-IDA and CKD-IDA for whom Feraccru will then become a realistic treatment option following potential FDA approval as early as H1-2019, which will allow the start of commercial operations for Feraccru in the world's largest and most profitable pharmaceutical market. The attraction of the US opportunity in terms of enlarging the addressable patient population for Feraccru is further enhanced by the routinely higher pricing opportunity the US market typically affords prescription pharmaceuticals. Market research commissioned by the Company has suggested that Feraccru's price could be approximately 3x the premium achieved in the UK of £1.70 per day.

What is CKD and why is it an attractive second indication for Feraccru?

In CKD patients, IDA develops due to blood loss through frequent blood tests, decreased iron absorption from the gut, lower iron intake through eating less iron rich foods (renal diet) and increased iron sequestration by the major organs due to chronic inflammation caused by CKD. It is a chronic progressive disease manifested by patients losing kidney function over a prolonged period. It is estimated that 5-10% of the global population have CKD, driven primarily by an ageing population and diseases associated with a Western lifestyle such as high blood pressure, obesity, diabetes and high cholesterol levels.

Oral iron supplements are considered first line therapy and are the most common form of treatment for patients. However, oral iron therapy is suitable mainly for pre-dialysis CKD patients, typically stages 3 and 4 as patients in stages 1 and 2 often have asymptomatic disease, while patients in stage 5 are often already on dialysis and the intravenous mode of iron administration is currently considered more appropriate at that advanced stage. Unlike IBD which is characterised by episodic "flares" which are currently treated intermittently, CKD is a chronic progressive condition, which requires constant treatment. This potentially offers the prospect of a significantly more attractive commercial opportunity due to an initially larger and increasing patient pool combined with a longer treatment duration per patient. Furthermore Feraccru has the potential to demonstrate clinical differentiation to current treatments by (i) offering a form of oral iron that has been demonstrated to be well tolerated and (ii) has a distinctive mechanism of action, (iii) is efficiently absorbed, (iv) is used at much lower doses of iron and (v) potentially offers a lower pill burden, all adding to a strong rationale for its use.

Feraccru has the potential to demonstrate clinical differentiation to current treatments by offering a form of oral iron that is well tolerated and, due to its clearly distinctive mechanism of action, is efficiently absorbed so allowing the use of much lower doses of the active pharmaceutical ingredient and potentially a lower pill burden, all adding to the compelling rationale for the use of Feraccru.

AEGIS-H2H non-inferiority Phase 3b study - primary endpoint data anticipated H1 2018

The AEGIS-H2H Phase 3b study is designed as a non-inferiority trial comparing the efficacy and safety of Feraccru to the market-leading latest generation form of IV iron (Ferinject, ferric carboxymaltose). The study - which is a long term 52-week trial with a primary endpoint assessment to be delivered on 12-week data - is intended to generate a range of pharmaco-economic end points to support the Group's commercial activities and support pricing and reimbursement applications in markets such as Spain, France and Italy that routinely use health technology assessment protocols.

 

Despite investing in US centres and additional EU-based centres, the episodic nature of IBD-related IDA together with some of the protocol's specific inclusion and exclusion criteria has meant that patients have to be identified and screened for the study in a very narrow timeframe, which has resulted in a slower than anticipated rate of recruitment. Furthermore, in Germany - a country that has routinely recruited well into Feraccru clinical studies - the positive start to our initial commercial activity has at times resulted in patients being placed on commercial therapy, rather than clinical trial therapy. Consequently the primary endpoint data from the AEGIS-H2H study is now expected to be available during H1 2018; however, should the AEGIS-CKD study report a positive primary endpoint, Shield retains the option to analyse the data at an earlier point of time, albeit that would be on a reduced number of subjects enrolled. Based on current timelines for data availability from the AEGIS-H2H trial, the Company conservatively anticipates launch in the EU-3 (being France, Italy and Spain) in H1 2019.

Other trials and data collection efforts

With Feraccru now commercially available the Group is actively working to enable and facilitate other methods of data collection to support its marketing activities and pricing and reimbursement applications. This includes a patient registry in Germany and a real world evidence study across a small number of UK prescribing centres involving upwards of 100 patients receiving commercial Feraccru. As well as generating supportive data for the use of Feraccru, involvement in such programmes can more directly increase the prescriber's knowledge of the product being assessed.

The Group's first paediatric pharmaco-kinetic study of Feraccru has also now commenced recruitment of 36 subjects across up to 6 expert centres in the UK. Recruitment is going well and Shield is observing a high degree of interest and involvement from the participating centres. Data from this study will help the Group design the small phase 3b study that the European Medicines Agency requires to enable Feraccru to be marketed to the paediatric opportunity that has been identified.

Further strengthening the intellectual property protection of Feraccru

Shield continues to strengthen its IP position in regard to Feraccru. Following the UK grant notification in October 2016 for the composition of matter patent application covering "Crystalline Forms of Ferric Maltol", Australian and Canadian patent grants were received in March and April 2017, respectively. In May 2017 the European Patent Office also notified Shield that it intends to grant the patent across its jurisdiction. In addition, in the US and elsewhere, the Group is utilising an expedited examination under the Global Patent Prosecution Highway program (GPPH) based on the UK patent (UK Patent No. GB2531742) for "Polymorphs of Ferric Maltol". Where granted, the composition of matter patent protects the active substance of Feraccru through to as long as 2035.

Business development

Geographic expansion of Feraccru outside the Group's stated core markets is an important element of Shield's broader commercialisation strategy and good progress continues to be made in this respect. The Group recently concluded an update to and expansion of the existing agreement with AOP Pharmaceuticals which provides for improved commercial terms in existing territories and the addition of commercial rights to Feraccru in Scandinavia (as contemplated and disclosed at IPO). This improved agreement is expected to accelerate access to near-term revenues in this market region and allows Shield to focus its working capital on the clearly identified core markets. Discussions are also progressing well in other non-core markets including the likes of Australia, Canada and Switzerland.

With the AEGIS-CKD trial due to read out in Q4 2017, the Group is placing greater focus on proactively exploring the multiple options available to it to commercialise Feraccru in the US including self-launch, co-promotion or out-licencing. The Company has received preliminary interest from third parties with regard to out-licencing/partnering Feraccru in the US and the Board continues to evaluate all opportunities with a view to being able to determine the most appropriate strategy in a timely manner following reporting of the AEGIS-CKD trial results.

The Group has also increased activities aimed at delivering partnering opportunities for its additional assets. These include PT20, a phosphate binder for CKD patients with hyperphosphataemia which has already successfully completed 1 of 2 required pivotal trials; as well as PT40, a generic formulation of Venofer [1], which if approved, would currently be the first generic version of iron sucrose to come to market. Following the recent recruitment of a Business Development Executive our outward-focused business development activities now include more than 50 initial interactions across our portfolio, leading to around 10 due diligence exercises and detailed term discussions. We expect that such progress will in due course lead to signed terms sheets and ultimately executed licensing agreements, just like we have recently achieved for Feraccru in Scandinavia.

Corporate Development

Since the Company's IPO, it has grown rapidly from an operational perspective, so has also needed to evolve at a corporate level to support this enlarged and more complex business. The Board has maintained close contact with Executive Management to ensure identification and timely addition of required competencies to the senior levels of the business. To date, this has included a targeted appointment of a new CFO with significant FTSE 100 and M&A experience, as well as the addition of further senior level employees including new Directors of Corporate Development and Business Development. Furthermore, through a targeted search, the Board is seeking to add further competencies and experience related to commercial aspects of both European and US prescription pharmaceutical markets through the appointment of relevantly experienced non-executive directors.

Trading Update and Sales Outlook

In-market demand for the period from 1 January 2017 to 2 June 2017 was £0.13 million and the Board expects in-market demand and partner revenues in the first half of 2017 to be c.£0.18 million, slightly behind target. Demand for Feraccru in April was slightly softer than forecast, which the Board believes was caused by the Easter vacation period reducing new patient starts, as lower staffing levels at prescribing centres meant their focus was transiently more on management of existing patients. Save for some weakness in April, demand for Feraccru has been growing in the UK and Germany through the first five months of the year and is expected to continue to increase as Shield moves into H2 2017, particularly due to the impact of continued investment in strategically targeted, carefully aligned promotional strategies and activities, which are being further supported by significant increases in customer-facing headcount in Germany and the UK through 2017. In England, where reimbursement is achieved on an institution by institution basis, market access continues to expand and remains on track to meet expectations of access to c. 60% of the patient population by year end, with England representing c. 85% of the UK opportunity. These elements provide the Board with confidence in the sales prospects for the year to 31 December 2017 and of achieving in-market demand and partner revenue guidance of c. £1.1 million for the full year.

Short-term strategic goals

The Company is targeting the achievement of the following strategic goals by mid-2018, subject to available funding:

· continue to drive commercial traction in Germany and the UK to meet FY 2017 expectations;

· accelerate the Group's multiple out-licensing and partnering discussions;

· fortify the Board with additional non-executive commercial/US experience;

· deliver positive primary endpoint data in Q4 2017 on the pivotal phase 3 AEGIS CKD;

· following receipt of the phase 3 AEGIS CKD primary endpoint data, raise further funds to facilitate the continued growth of the Company in Europe and fund delivery of the chosen strategy for US commercialisation;

· progress and potentially deliver positive phase 3b AEGIS H2H primary endpoint data;

· drive discussions with and continue to engage key opinion leaders on changing the treatment algorithms in IDA for patients with IBD and CKD; and

· complete validation of second drug substance manufacturer.

 

IMPORTANT NOTICE

This announcement is released by Shield Therapeutics plc and contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) 596/2014 ("MAR"), encompassing information relating to the Fundraise as described above, and is disclosed in accordance with the Company's obligations under Article 17 of MAR.

For the purposes of MAR and Article 2 of Commission Implementing Regulation (EU) 2016/1055, this announcement is being made on behalf of the Company by Carl Sterritt, CEO.

No action has been taken by the Company or the Joint Bookrunners, or any of their respective affiliates, that would, or which is intended to, permit a public offer of the Placing Shares in any jurisdiction or the possession or distribution of this Announcement or any other offering or publicity material relating to the Placing Shares in any jurisdiction where action for that purpose is required. Any failure to comply with these restrictions may constitute a violation of the securities laws of such jurisdictions. Persons into whose possession this Announcement comes shall inform themselves about, and observe, such restrictions.

No prospectus will be made available in connection with the matters contained in this Announcement and no such prospectus is required (in accordance with the Prospectus Directive (as defined below)) to be published.

THIS ANNOUNCEMENT, INCLUDING THE APPENDIX AND THE INFORMATION CONTAINED HEREIN, IS FOR INFORMATION PURPOSES ONLY, IS NOT INTENDED TO AND DOES NOT CONSTITUTE OR FORM PART OF ANY OFFER OR INVITATION TO PURCHASE OR SUBSCRIBE FOR, UNDERWRITE, SELL OR ISSUE OR THE SOLICITATION OF AN OFFER TO PURCHASE OR SUBSCRIBE, SELL, ACQUIRE, DISPOSE OF THE PLACING SHARES OR ANY OTHER SECURITY IN THE UNITED STATES (INCLUDING ITS TERRITORIES AND POSSESSIONS, ANY STATE OF THE UNITED STATES AND THE DISTRICT OF COLUMBIA, COLLECTIVELY THE "UNITED STATES"), AUSTRALIA, CANADA, JAPAN OR SOUTH AFRICA OR IN ANY JURISDICTION IN WHICH, OR TO ANY PERSONS TO WHOM, SUCH OFFERING, SOLICITATION OR SALE WOULD BE UNLAWFUL.

The Placing Shares have not been and will not be registered under the United States Securities Act of 1933, as amended (the "Securities Act") or under the securities laws of any state or other jurisdiction of the United States, and may not be offered, sold or transferred, directly or indirectly, in or into the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in compliance with any applicable securities laws of any state or other jurisdiction of the United States. The Placing Shares are being offered and sold (i) outside the United States in reliance on Regulation S under the Securities Act and (ii) within the United States only to persons reasonably believed to be "qualified institutional buyers" pursuant to an exemption from, or in transactions not subject to, the registration requirements of the Securities Act. There will be no public offering of the Placing Shares in the United States, the United Kingdom or elsewhere. No representation is being made as to the availability of any exemption under the Securities Act for the reoffer, resale, pledge or transfer of the Placing Shares.

The Placing Shares have not been approved or disapproved by the United States Securities and Exchange Commission, any state securities commission or other regulatory authority in the United States, nor have any of the foregoing authorities passed upon or endorsed the merits of the Placing or the accuracy or adequacy of this Announcement. Any representation to the contrary is a criminal offence in the United States.

The relevant clearances have not been, and nor will they be, obtained from the securities commission of any province or territory of Canada; no prospectus has been lodged with, or registered by, the Australian Securities and Investments Commission or the Japanese Ministry of Finance; and the Placing Shares have not been, and nor will they be, registered under or offered in compliance with the securities laws of any state, province or territory of Canada, Australia, Japan or South Africa. Accordingly, the Placing Shares may not (unless an exemption under the relevant securities laws is applicable) be offered, sold, resold or delivered, directly or indirectly, in or into Canada, Australia, Japan or South Africa or any other jurisdiction outside the United Kingdom or to, or for the account or benefit of any national, resident or citizen of Australia, Japan or South Africa or to any investor located or resident in Canada.

This communication is directed only at: (a) persons in member states of the European Economic Area who are qualified investors within the meaning of article 2(1)(e) of EU Directive 2003/71/EC and amendments thereto and (b) if in the United Kingdom, persons who (i) have professional experience in matters relating to investments who fall within the definition of "investment professionals" in article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "Order"), or are high net worth companies, unincorporated associations or partnerships or trustees of high value trusts as described in article 49(2) of the Order and (ii) are "qualified investors" as defined in section 86 of the Financial Services and Markets Act 2000 (as amended) and (c) to persons to whom it may otherwise be lawful to communicate it. Any investment in connection with the Placing will only be available to, and will only be engaged with, relevant persons. Any person who is not a relevant person should not act or rely on this Announcement or any of its contents.

Each of Liberum and Peel Hunt is authorised and regulated in the United Kingdom by the Financial Conduct Authority and is acting exclusively for the Company in connection with the Placing and no one else and will not be responsible to anyone other than the Company for providing the protections afforded to its clients nor for providing advice to any other person in relation to the Placing and/or any other matter referred to in this Announcement.

This Announcement is being issued by and is the sole responsibility of the Company. No representation or warranty, express or implied, is or will be made as to, or in relation to, and no responsibility or liability is or will be accepted by the Joint Bookrunners (apart from the responsibilities or liabilities that may be imposed by the FSMA, as amended, or the regulatory regime established thereunder) or any of their respective affiliates or any of their respective directors, officers, employees, advisers, representatives or shareholders (collectively, "Representatives") for the contents of this Announcement, or any other written or oral information made available to or publicly available to any interested party or its advisers, or any other statement made or purported to be made by or on behalf of the Joint Bookrunners or any of their respective affiliates or by any of their respective Representatives in connection with the Company, the Placing Shares or the Placing and any responsibility and liability whether arising in tort, contract or otherwise therefore is expressly disclaimed. The Joint Bookrunners and each of their respective affiliates and each of their respective Representatives accordingly disclaim all and any liability, whether arising in tort, contract or otherwise (save as referred to above) in respect of any statements or other information contained in this Announcement and no representation or warranty, express or implied, is made by the Joint Bookrunners or any of their respective affiliates or any of their respective Representatives as to the accuracy, fairness, verification, completeness or sufficiency of the information contained in this Announcement and nothing in this Announcement is, or shall be relied upon as, a promise or representation in this respect, whether as to the past or future.

This Announcement does not identify or suggest, or purport to identify or suggest, the risks (direct or indirect) that may be associated with an investment in the Placing Shares. Any investment decision to buy Placing Shares in the Placing must be made solely on the basis of publicly available information, which has not been independently verified by the Joint Bookrunners.

This Announcement contains (or may contain) certain forward-looking statements, beliefs or opinions, with respect to certain of the Company's current expectations and projections about future prospects, developments, strategies, performance, anticipated events or trends and other matters that are not historical facts. These forward-looking statements, which sometimes use words such as "aim", "anticipate", "believe", "intend", "plan" "estimate", "expect" and words of similar meaning, include all matters that are not historical facts and reflect the directors' beliefs and expectations and involve a number of risks, uncertainties and assumptions that could cause actual results and performance to differ materially from any expected future results or performance expressed or implied by the forward-looking statement, including, but not limited to, those risks and uncertainties described in the risk factors included in the Company's 2016 Annual Report. These statements are subject to unknown risks, uncertainties and other factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Statements contained in this Announcement regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. The information contained in this Announcement is subject to change without notice and, except as required by applicable law, neither the Company nor the Joint Bookrunners nor any of their respective affiliates nor any of their respective Representatives assumes any responsibility or obligation to update, amend or revise publicly or review any of the forward-looking statements contained in this Announcement. You should not place undue reliance on forward-looking statements, which speak only as of the date of this Announcement. Any indication in this Announcement of the price at which Placing Shares have been bought or sold in the past cannot be relied upon as a guide to future performance. No statement in this Announcement is or is intended to be a profit forecast or profit estimate or to imply that the earnings of the Company for the current or future financial years will necessarily match or exceed the historical or published earnings of the Company. Past performance of the Company cannot be relied on as a guide to future performance and persons reading this Announcement are cautioned not to place undue reliance on such forward-looking statements.

In connection with the Placing, the Joint Bookrunners and any of their respective affiliates, acting as investors for their own account, may take up a portion of the shares in the Placing as a principal position and in that capacity may retain, purchase, sell, offer to sell for their own accounts such shares and other securities of the Company or related investments in connection with the Placing or otherwise. Accordingly, references to Placing Shares being offered, acquired, placed or otherwise dealt in should be read as including any issue or offer to, or acquisition, placing or dealing by, the Joint Bookrunners and any of their respective affiliates acting in such capacity. In addition, the Joint Bookrunners and any of their affiliates may enter into financing arrangements (including swaps) with investors in connection with which the Joint Bookrunners and any of their respective affiliates may from time to time acquire, hold or dispose of shares. The Joint Bookrunners do not intend to disclose the extent of any such investment or transactions otherwise than in accordance with any legal or regulatory obligations to do so.

The Placing Shares to be issued pursuant to the Placing will not be admitted to trading on any stock exchange other than the AIM market operated by the London Stock Exchange.

Neither the content of the Company's website nor any website accessible by hyperlinks on the Company's website is incorporated in, or forms part of, this Announcement.

This Announcement does not constitute a recommendation concerning any investor's options with respect to the Placing. Each investor or prospective investor should conduct his, her or its own investigation, analysis and evaluation of the business and data described in this Announcement. The price and value of securities can go down as well as up. Past performance is not a guide to future performance. The contents of this Announcement are not to be construed as legal, business, financial or tax advice. Each investor or prospective investor should consult his, her or its own legal adviser, business adviser, financial adviser or tax adviser for legal, financial, business or tax advice.

 

 

APPENDIX

TERMS AND CONDITIONS

 

 

THIS APPENDIX, AND THE INFORMATION CONTAINED IN IT, IS RESTRICTED AND IS NOT FOR PUBLIC RELEASE, PUBLICATION, OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, SOUTH AFRICA OR ANY OTHER STATE OR JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL.

IMPORTANT INFORMATION FOR INVITED PLACEES ONLY REGARDING THE PLACING

MEMBERS OF THE PUBLIC ARE NOT ELIGIBLE TO TAKE PART IN THE PLACING. THIS ANNOUNCEMENT AND THE TERMS AND CONDITIONS SET OUT IN THIS APPENDIX ARE FOR INFORMATION PURPOSES ONLY AND ARE DIRECTED ONLY AT PERSONS WHO ARE: (A) PERSONS IN MEMBER STATES OF THE EUROPEAN ECONOMIC AREA ("EEA") WHO ARE QUALIFIED INVESTORS WITHIN THE MEANING OF ARTICLE 2(1)(E) OF EU DIRECTIVE 2003/71/EC AND AMENDMENTS THERETO (THE "PROSPECTUS DIRECTIVE") ("QUALIFIED INVESTORS"), (B) IF IN THE UNITED KINGDOM, PERSONS WHO (I) HAVE PROFESSIONAL EXPERIENCE IN MATTERS RELATING TO INVESTMENTS WHO FALL WITHIN THE DEFINITION OF "INVESTMENT PROFESSIONALS" IN ARTICLE 19(5) OF THE FINANCIAL SERVICES AND MARKETS ACT 2000 (FINANCIAL PROMOTION) ORDER 2005, AS AMENDED (THE "ORDER"), OR ARE HIGH NET WORTH COMPANIES, UNINCORPORATED ASSOCIATIONS OR PARTNERSHIPS OR TRUSTEES OF HIGH VALUE TRUSTS AS DESCRIBED IN ARTICLE 49(2) OF THE ORDER AND (II) ARE "QUALIFIED INVESTORS" AS DEFINED IN SECTION 86 OF THE FINANCIAL SERVICES AND MARKETS ACT 2000, AS AMENDED ("FSMA"), AND (C) TO PERSONS TO WHOM IT MAY OTHERWISE BE LAWFUL TO COMMUNICATE IT TO (EACH A "RELEVANT PERSON"). NO OTHER PERSON SHOULD ACT OR RELY ON THIS ANNOUNCEMENT AND PERSONS DISTRIBUTING THIS ANNOUNCEMENT MUST SATISFY THEMSELVES THAT IT IS LAWFUL TO DO SO. BY ACCEPTING THE TERMS OF THIS ANNOUNCEMENT YOU REPRESENT AND AGREE THAT YOU ARE A RELEVANT PERSON. THIS APPENDIX AND THE TERMS AND CONDITIONS SET OUT HEREIN MUST NOT BE ACTED ON OR RELIED ON BY PERSONS WHO ARE NOT RELEVANT PERSONS. ANY INVESTMENT OR INVESTMENT ACTIVITY TO WHICH THIS ANNOUNCEMENT (INCLUDING THIS APPENDIX) AND THE TERMS AND CONDITIONS SET OUT HEREIN RELATE IS AVAILABLE ONLY TO RELEVANT PERSONS AND WILL BE ENGAGED IN ONLY WITH RELEVANT PERSONS. THIS ANNOUNCEMENT (INCLUDING THIS APPENDIX) DOES NOT ITSELF CONSTITUTE AN OFFER TO SELL OR ISSUE OR THE SOLICITATION OF AN OFFER TO BUY OR ACQUIRE ANY SECURITIES IN THE COMPANY.

THE INFORMATION CONTAINED HEREIN IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES (INCLUDING ITS TERRITORIES AND POSSESSIONS, ANY STATE OF THE UNITED STATES AND THE DISTRICT OF COLUMBIA) AUSTRALIA, CANADA, JAPAN, SOUTH AFRICA OR ANY JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL. THIS DOCUMENT (AND THE INFORMATION CONTAINED HEREIN) DOES NOT CONSTITUTE AN OFFER OF SECURITIES FOR SALE IN THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, SOUTH AFRICA OR IN ANY OTHER JURISDICTION IN WHICH THE SAME WOULD BE UNLAWFUL.

THE PLACING SHARES HAVE NOT BEEN AND WILL NOT BE REGISTERED UNDER THE US SECURITIES ACT OF 1933, AS AMENDED (THE "SECURITIES ACT"), OR UNDER THE APPLICABLE SECURITIES LAWS OF ANY STATE OR OTHER JURISDICTION OF THE UNITED STATES, AND MAY NOT BE OFFERED, SOLD, ACQUIRED, RESOLD, TRANSFERRED OR DELIVERED, DIRECTLY OR INDIRECTLY WITHIN, INTO OR IN THE UNITED STATES, EXCEPT PURSUANT TO AN APPLICABLE EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN COMPLIANCE WITH THE SECURITIES LAWS OF ANY RELEVANT STATE OR OTHER JURISDICTION OF THE UNITED STATES. THERE WILL BE NO PUBLIC OFFER OF THE PLACING SHARES IN THE UNITED STATES, THE UNITED KINGDOM OR ELSEWHERE.

EACH PLACEE SHOULD CONSULT ITS OWN ADVISERS AS TO LEGAL, TAX, BUSINESS, FINANCIAL AND RELATED ASPECTS OF ACQUIRING THE PLACING SHARES.

Persons who are invited to and who choose to participate in the Placing (and any person acting on such person's behalf) by making an oral or written offer to acquire Placing Shares, including any individuals, funds or others on whose behalf a commitment to acquire Placing Shares is given ("Placees"), will be deemed to have read and understood this Announcement including this Appendix, in its entirety and to be making such offer on the terms and conditions, and to be providing the representations, warranties, acknowledgements and undertakings, contained in this Appendix. In particular, each such Placee represents, warrants and acknowledges that:

1. it is a Relevant Person and undertakes that it will acquire, hold, manage or dispose of any Placing Shares that are allocated to it for the purposes of its business;

 

2. if it is in a member state of the EEA and/or if it is a financial intermediary, as that term is used in Article 3(2) of the Prospectus Directive, that any Placing Shares acquired by it in the Placing will not be acquired on a non-discretionary basis on behalf of, nor will they be acquired with a view to their offer or resale to, persons in any member state of the EEA in circumstances which may give rise to an offer of securities to the public, other than an offer or resale in a member state of the EEA which has implemented the Prospectus Directive to Qualified Investors, or in circumstances in which the prior consent of each of Liberum and Peel Hunt has been given to each such proposed offer or resale;

 

3. it is acquiring the Placing Shares for its own account or is acquiring the Placing Shares for an account with respect to which it exercises sole investment discretion and has the authority to make and does make the representations, warranties, indemnities, acknowledgements, undertakings and agreements contained in this Announcement;

 

4. it understands (or if acting for the account of another person, such person has confirmed that such person understands) the resale and transfer restrictions set out in this Appendix;

 

5. it acknowledges that the Placing Shares have not been and will not be registered under the Securities Act or with any securities regulatory authority of any state or other jurisdiction of the United States and may not be offered, sold or transferred, directly or indirectly, within the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in compliance with any applicable securities laws of any state or other jurisdiction of the United States;

 

6. except for a limited number of "qualified institutional buyers" ("QIBs") as defined in Rule 144A under the Securities Act ("Rule 144A"), (i) it and the person(s), if any, for whose account or benefit it is acquiring the Placing Shares are purchasing the Placing Shares in an "offshore transaction" as defined in Regulation S under the Securities Act; (ii) it is aware of the restrictions on the offer and sale of the Placing Shares pursuant to Regulation S; and (iii) the Placing Shares have not been offered to it by means of any "directed selling efforts" as defined in Regulation S;

 

7. The Company, Liberum and Peel Hunt will rely upon the truth and accuracy of the foregoing representations, acknowledgements and agreements.

Each of the Company and the Joint Bookrunners may require a Placee to agree to such further terms and conditions and/or give such additional warranties and/or representations as it (in its absolute discretion) sees fit and/or may require any such Placee to execute a separate placing letter. The terms of this announcement will, when applicable, be deemed to be incorporated into such placing letter.

The Placing Shares have not been approved or disapproved by the US Securities and Exchange Commission, any state securities commission or other regulatory authority in the United States, nor have any of the foregoing authorities passed upon or endorsed the merits of the Placing or the accuracy or adequacy of this Announcement. Any representation to the contrary is a criminal offence in the United States.

No prospectus has been lodged with, or registered by, the Australian Securities and Investments Commission or the Japanese Ministry of Finance; and the Placing Shares have not been, and nor will they be, registered or otherwise qualified for offer and sale under the securities laws of any state, province or territory of Australia, Canada, Japan or South Africa. Accordingly, the Placing Shares may not (unless an exemption under the relevant securities laws is applicable) be offered, sold, resold or delivered, directly or indirectly, in or into the United States, Australia, Canada, Japan or South Africa or any other jurisdiction outside the United Kingdom.

Persons (including, without limitation, nominees and trustees) who have a contractual or other legal obligation to forward a copy of this Appendix or the Announcement of which it forms part should seek appropriate advice before taking any action.

Neither Liberum nor Peel Hunt makes any representation to any Placees regarding an investment in the Placing Shares.

Details of the Placing Agreement and of the Placing Shares

The Company has today entered into an agreement (the "Placing Agreement") with Liberum and Peel Hunt, who are each acting as bookrunners (the "Joint Bookrunners"), under which, subject to the conditions set out therein, each of the Joint Bookrunners has agreed, as agent for and on behalf of the Company, to use its reasonable endeavours to procure Placees for the Placing Shares at a price of 150p per Placing Share (the "Placing Price"). The Placing is not underwritten.

The Placing Shares will, when issued, be credited as fully paid and will rank pari passu in all respects with the existing ordinary shares in the Company, including the right to receive all dividends and other distributions declared, made or paid in respect of such ordinary shares after the date of issue of the Placing Shares.

The issue of the Placing Shares is to be effected by way of a cash box placing. The Company will allot the Placing Shares to Placees in consideration for the transfer to the Company by Liberum of certain shares in a Jersey incorporated subsidiary of the Company, certain of which shares in the Jersey company Liberum shall be obliged to subscribe for using the proceeds of the Placing (net of any agreed commission and expenses).

At the same time as the Placing, additional ordinary shares in the Company will be issued to (i) certain holders of warrants which will be exercised at the Placing Price (the "Warrant Shares") and (ii) certain directors and senior management of the Company who subscribe for ordinary shares at the Placing Price (the "Subscription Shares").

Applications for admission to trading

Applications will be made to the London Stock Exchange for admission of the Placing Shares, the Subscription Shares and the Warrant Shares to trading on the AIM market ("Admission").

It is expected that Admission will become effective on or around 8.00 a.m. on 28 June 2017 and that dealings in the Placing Shares, Subscription Shares and Warrant Shares will commence at that time.

Bookbuild

The Joint Bookrunners will today commence the bookbuilding process in respect of the Placing (the "Bookbuild") to determine demand for participation in the Placing by Placees. This Appendix gives details of the terms and conditions of, and the mechanics of participation in, the Placing. No commissions will be paid to Placees or by Placees in respect of any Placing Shares.

The Joint Bookrunners and the Company shall be entitled to effect the Placing by such alternative method to the Bookbuild as they may, in their sole discretion, determine.

Participation in, and principal terms of, the Placing

1. Liberum and Peel Hunt are arranging the Placing as Joint Bookrunners and agents of the Company.

 

2. Participation in the Placing will only be available to persons who may lawfully be, and are, invited to participate by the Joint Bookrunners. The Joint Bookrunners' agents and their respective affiliates are each entitled to enter bids in the Bookbuild as principal.

 

3. The final number of Placing Shares will be agreed between the Joint Bookrunners and the Company following completion of the Bookbuild. The number of Placing Shares will be announced on an FCA-listed regulatory information service (a "Regulatory Information Service") following the completion of the Bookbuild (the "Pricing Announcement").

 

4. To bid in the Bookbuild, Placees should communicate their bid by telephone or in writing to their usual sales contact at either of the Joint Bookrunners. Each bid should state the number of Placing Shares which the prospective Placee wishes to acquire at the Placing Price. Bids may be scaled down by the Joint Bookrunners on the basis referred to in paragraph 9 below. Each of the Joint Bookrunners is arranging the Placing severally (and not jointly, or jointly and severally), each as agent of the Company.

 

5. The Bookbuild is expected to close no later than 5 p.m. (London time) today, 15 June 2017, but may be closed earlier or later at the absolute discretion of the Joint Bookrunners. The Joint Bookrunners may, in agreement with the Company, accept bids that are received after the Bookbuild has closed. The Company reserves the right (upon the agreement of the Joint Bookrunners) to reduce or seek to increase the amount to be raised pursuant to the Placing.

 

6. The Joint Bookrunners shall propose the basis of the allocation of the Placing Shares for final determination by the Company following consultation with the Joint Bookrunners. Each prospective Placee's allocation will be confirmed orally or by email by a Joint Bookrunner as agent of the Company following the close of the Bookbuild. That oral or email confirmation will constitute an irrevocable legally binding commitment upon that person (who will at that point become a Placee) to acquire the number of Placing Shares allocated to it at the Placing Price on the terms and conditions set out in this Appendix and in accordance with the Company's articles of association and each Placee will be deemed to have read and understood this Announcement (including this Appendix) in its entirety.

 

7. Each prospective Placee's allocation and commitment will be evidenced by a contract note or trade confirmation or (at the sole discretion of the Company or Joint Bookrunners) a placing letter issued to such Placee by one of the Joint Bookrunners. The terms of this Appendix will be deemed incorporated by reference therein.

 

8. Each Placee will also have an immediate, separate, irrevocable and binding obligation, owed to the relevant Joint Bookrunner, to pay as principal to the relevant Joint Bookrunner (or as it may direct) in cleared funds immediately on the settlement date an amount equal to the product of the Placing Price and the number of Placing Shares such Placee has agreed to acquire and the Company has agreed to allot and issue to that Placee.

 

9. Subject to paragraphs 4 and 5 above, the Joint Bookrunners may choose to accept bids, either in whole or in part, on the basis of allocations determined in agreement with the Company and may scale down any bids for this purpose on such basis as they may determine. The Joint Bookrunners may also, notwithstanding paragraphs 4 and 5 above, subject to the prior consent of the Company (i) allocate Placing Shares after the time of any initial allocation to any person submitting a bid after that time; and (ii) allocate Placing Shares after the Bookbuild has closed to any person submitting a bid after that time.

 

10. A bid in the Bookbuild will be made on the terms and subject to the conditions in this Announcement (including this Appendix) and will be legally binding on the Placee on behalf of which it is made and, except with the consent of the Joint Bookrunners, will not be capable of variation or revocation after the time at which it is submitted.

 

11. Except as required by law or regulation, no press release or other announcement will be made by the Joint Bookrunners or the Company using the name of any Placee (or its agent), in its capacity as Placee (or agent), other than with such Placee's prior written consent.

 

12. Irrespective of the time at which a Placee's allocation pursuant to the Placing is confirmed, settlement for all Placing Shares to be acquired pursuant to the Placing will be required to be made at the same time, on the basis explained below under "Registration and Settlement".

 

13. All obligations under the Bookbuild and Placing will be subject to fulfilment or (where applicable) waiver of the conditions referred to below under "Conditions of the Placing" and to the Placing not being terminated on the basis referred to below under "Right to terminate under the Placing Agreement".

 

14. By participating in the Bookbuild, each Placee will agree that its rights and obligations in respect of the Placing will terminate only in the circumstances described below and will not be capable of rescission or termination by the Placee.

 

15. To the fullest extent permissible by law, neither of the Joint Bookrunners nor any of their respective affiliates, agents, directors, officers or employees shall have any liability to Placees (or to any other person whether acting on behalf of a Placee or otherwise). In particular, neither of the Joint Bookrunners nor any of their respective affiliates, agents, directors, officers or employees shall have any liability (including to the extent permissible by law, any fiduciary duties) in respect of the Joint Bookrunners' conduct of the Bookbuild or of such alternative method of effecting the Placing as the Joint Bookrunners and the Company may agree.

Conditions of the Placing

The obligations of the Joint Bookrunners under the Placing Agreement in respect of the Placing Shares are conditional on, inter alia certain publication of announcement obligations; the warranties being true and accurate; fulfilment by the Company of its material obligations; Admission taking place; allotment of the Placing Shares, Subscription Shares and Warrant Shares; and the Company's registrar having received the requisite instructions from each participant in the Warrant Exercise to exercise its relevant warrants. The Joint Bookrunners have a discretion to waive compliance with the conditions (where capable of waiver) and/or agree an extension in time for their satisfaction.

If (i) any of the conditions contained in the Placing Agreement, including those described above, are not fulfilled (or, where permitted, waived or extended in writing by the Joint Bookrunners) or become incapable of fulfilment on or before the date or time specified for the fulfilment thereof (or such later date and/or time as the Joint Bookrunners may agree, which date shall not be later than 30 June 2017); or (ii) the Placing Agreement is terminated in the circumstances specified below, the Placing will not proceed and the Placees' rights and obligations hereunder in relation to the Placing Shares shall cease and terminate at such time and each Placee agrees that no claim can be made by the Placee in respect thereof. Any such extension or waiver will not affect Placees' commitments as set out in this Announcement (including this Appendix).

Lock-up

The Company will not, and will procure that none of its subsidiaries will, at any time between the date of this agreement and the date which is 90 calendar days from the date of Admission without the prior written consent of the Joint Bookrunners (i) issue, allot, offer, pledge, sell, contract to sell, grant any option or contract to purchase, purchase any option or contract to sell, grant, any option, right or warrant to purchase, lend or otherwise transfer or dispose of, directly or indirectly, any ordinary shares or other shares in the capital of the Company or any securities convertible into or exchangeable for ordinary shares or other shares in the capital of the Company; or (ii) enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of ordinary shares or other shares in the capital of the Company, whether any such transaction described in (i) or (ii) above is to be settled by delivery of ordinary shares or other shares in the capital of the Company or such other securities, in cash or otherwise, provided that the foregoing shall not prevent or restrict (i) the grant of options under, or the allotment and issue of shares pursuant to options under, any existing employee share schemes of the Company; and/or (ii) the allotment and issue of ordinary shares pursuant to the exercise of warrants outstanding after Admission.

Following Admission, assuming no further warrants are exercised between the date of this Announcement and Admission, there will be 4,796,120 warrants outstanding in respect of which 4,796,120 new ordinary shares may be issued at a price of 150 pence per share prior to 30 June 2017.

Right to terminate under the Placing Agreement

At any time before Admission, the Joint Bookrunners are each entitled to terminate the Placing Agreement in the following circumstances, amongst others: (i) if any of the Company's warranties or representations are not or cease to be true and accurate or have become misleading; or (ii) if any of the conditions have not been satisfied or waived by the Joint Bookrunners by the date specified therein; or (iii) if the Company's applications to AIM and Euroclear, respectively, in respect of Admission are withdrawn by the Company and/or refused by the London Stock Exchange or Euroclear (as appropriate); or (iv) there shall have occurred any Material Adverse Change (as defined therein); or (v) if there has occurred any material adverse change in any major financial market in the United States, the United Kingdom or any member of the European Union or in other international financial markets which are relevant to the Placing; or (vi) if trading in the ordinary shares of the Company is suspended or limited by the London Stock Exchange; or (vii) if a banking moratorium has been declared; or (viii) if there is a change or development in Tax materially affecting the Ordinary Shares or the transfer thereof or exchange controls having been imposed by the United States or the United Kingdom.

Upon such notice being given, the parties to the Placing Agreement shall be released and discharged (except for any liability arising before or in relation to such termination) from their respective obligations under or pursuant to the Placing Agreement, subject to certain exceptions.

By participating in the Placing, Placees agree that the exercise by the Joint Bookrunners of any right of termination or other discretion under the Placing Agreement shall be within the absolute discretion of the Joint Bookrunners, and that it need not make any reference to Placees and that the Joint Bookrunners shall have no liability to Placees whatsoever in connection with any such exercise or failure so to exercise.

No prospectus

No offering document or prospectus or admission document has been or will be published or submitted to be approved by the FCA or the London Stock Exchange in relation to the Placing and Placees' commitments will be made solely on the basis of their own assessment of the Company, the Placing Shares and the Placing based on the Company's publicly available information taken together with the information contained in this Announcement (including this Appendix) released by the Company today and any information publicly announced to a Regulatory Information Service by or on behalf of the Company on or prior to the date of this Announcement, and subject to the further terms set forth in the contract note or trade confirmation or placing letter (as applicable) to be provided to individual prospective Placees. Each Placee, by accepting a participation in the Placing, agrees that the content of this Announcement (including this Appendix) is exclusively the responsibility of the Company and confirms that it has neither received nor relied on any other information, representation, warranty or statement made by or on behalf of the Company, the Joint Bookrunners or any other person and neither of the Joint Bookrunners or the Company nor any of their respective affiliates will be liable for any Placee's decision to participate in the Placing based on any other information, representation, warranty or statement which the Placees may have obtained or received. Each Placee acknowledges and agrees that it has relied on its own investigation of the business, financial or other position of the Company in accepting a participation in the Placing. Each Placee should not consider any information in this Announcement to be legal, tax or business advice. Each Placee should consult its own attorney, tax advisor and business advisor for legal, tax and business advice regarding an investment in the Placing Shares. Nothing in this paragraph shall exclude the liability of any person for fraudulent misrepresentation by that person.

Registration and settlement

Settlement of transactions in the Placing Shares following Admission will take place within the CREST system, subject to certain exceptions. The Company and the Joint Bookrunners reserve the right to require settlement for and delivery of the Placing Shares (or a portion thereof) to Placees by such other means that they deem necessary, including in certificated form, if in the Joint Bookrunners' reasonable opinion delivery or settlement is not possible or practicable within the CREST system within the timetable set out in this Announcement or would not be consistent with the regulatory requirements in the Placee's jurisdiction.

Following the close of the Bookbuild for the Placing, each Placee allocated Placing Shares in the Placing will be sent a contract note or trade confirmation or placing letter (as applicable) in accordance with the standing arrangements in place with Liberum or Peel Hunt (as applicable) stating the number of Placing Shares to be allocated to it at the Placing Price, the aggregate amount owed by such Placee to Liberum or Peel Hunt (as applicable) and settlement instructions. Each Placee agrees that it will do all things necessary to ensure that delivery and payment is completed in accordance with the standing CREST or certificated settlement instructions that it has in place with the Joint Bookrunners.

The Company will deliver the Placing Shares to CREST accounts operated by Liberum and Peel Hunt as agent for and on behalf of the Company and will enter its delivery (DEL) instruction into the CREST system. The input to CREST by a Placee of a matching or acceptance instruction will then allow delivery of the relevant Placing Shares to that Placee against payment.

It is expected that settlement will be on 28 June 2017 on a T+9 basis in accordance with the instructions set out in the contract note or trade confirmation or placing letter.

Interest is chargeable daily on payments not received from Placees on the due date in accordance with the arrangements set out above at the rate of two percentage points above LIBOR as determined by the Joint Bookrunners.

Each Placee is deemed to agree that, if it does not comply with these obligations, the Joint Bookrunners may sell any or all of the Placing Shares allocated to that Placee on such Placee's behalf and retain from the proceeds, for the account and benefit of the Joint Bookrunners, an amount equal to the aggregate amount owed by the Placee plus any interest due. The relevant Placee will, however, remain liable for any shortfall below the aggregate amount owed by it and may be required to bear any stamp duty or stamp duty reserve tax or other stamp, securities, transfer, registration, execution, documentary or other similar impost, duty or tax (together with any interest or penalties thereon or other similar taxes imposed in any jurisdiction) which may arise upon the sale of such Placing Shares on such Placee's behalf. By communicating a bid for Placing Shares, each Placee confers on Liberum or Peel Hunt (as applicable) all such authorities and powers necessary to carry out any such transaction and agrees to ratify and confirm all actions which Liberum or Peel Hunt (as applicable) lawfully takes on such Placee's behalf.

If Placing Shares are to be delivered to a custodian or settlement agent, Placees should ensure that the contract note or trade confirmation or placing letter (as applicable) is copied and delivered immediately to the relevant person within that organisation.

Insofar as Placing Shares are registered in a Placee's name or that of its nominee or in the name of any person for whom a Placee is contracting as agent or that of a nominee for such person, such Placing Shares should, subject as provided below, be so registered free from any liability to UK stamp duty or stamp duty reserve tax. If there are any other circumstances in which any stamp duty or stamp duty reserve tax (including any interest and penalties relating thereto) is payable in respect of the allocation, allotment, issue or delivery of the Placing Shares (or for the avoidance of doubt if any stamp duty or stamp duty reserve tax is payable in connection with any subsequent transfer of or agreement to transfer Placing Shares), neither of the Joint Bookrunners nor the Company shall be responsible for the payment thereof. Placees (or any nominee or other agent acting on behalf of a Placee) will not be entitled to receive any fee or commission in connection with the Placing.

Representations and warranties

By submitting a bid and/or participating in the Placing, each prospective Placee (and any person acting on such Placee's behalf) irrevocably acknowledges, confirms, undertakes, represents, warrants and agrees (as the case may be) with each Joint Bookrunner (in its capacity as a bookrunner and agent of the Company, in each case as a fundamental term of its application for Placing Shares) that:

1. it has read and understood this Announcement (including this Appendix) in its entirety and that its participation in the Bookbuild and the Placing and its acquisition of Placing Shares is subject to and based upon all the terms, conditions, representations, warranties, indemnities, acknowledgements, agreements and undertakings and other information contained herein;

 

2. no offering document or prospectus or admission document has been prepared in connection with the Placing and it has not received a prospectus, admission document or other offering document in connection with the Bookbuild, the Placing or the Placing Shares;

 

3. it has neither received nor relied on any "inside information" as defined in the EU Market Abuse Regulation ("MAR") concerning the Company in accepting this invitation to participate in the Placing;

 

4. it has the power and authority to carry on the activities in which it is engaged, to acquire Placing Shares and to execute and deliver all documents necessary for such acquisition;

 

5. neither of the Joint Bookrunners nor the Company nor any of their respective affiliates, agents, directors, officers or employees nor any person acting on behalf of any of them has provided, and none of them will provide it, with any material regarding the Placing Shares or the Company other than information included in this Announcement (including this Appendix), nor has it requested either of the Joint Bookrunners, the Company or any of their respective affiliates or any person acting on behalf of any of them to provide it with any such information;

 

6. (i) it has made its own assessment of the Company, the Placing Shares and the terms of the Placing based on this Announcement (including this Appendix) and any information publicly announced to a Regulatory Information Service by or on behalf of the Company prior to the date of this Announcement (the "Publicly Available Information"); (ii) the Company's ordinary shares are listed on AIM and the Company is therefore required to publish certain business and financial information in accordance with the rules and practices of the London Stock Exchange and relevant regulatory authorities (the "Exchange Information"), which includes a description of the nature of the Company's business, most recent balance sheet and profit and loss account, and similar statements for preceding years, and it has reviewed such Exchange Information as it has deemed necessary or that it is able to obtain or access the Exchange Information without undue difficulty; and (iii) it has had access to such financial and other information (including the business, financial condition, prospects, creditworthiness, status and affairs of the Company, the Placing and the Placing Shares, as well as the opportunity to ask questions) concerning the Company, the Placing and the Placing Shares as it has deemed necessary in connection with its own investment decision to acquire any of the Placing Shares and has satisfied itself that the information is still current and relied on that investigation for the purposes of its decision to participate in the Placing;

 

7. (i) none of the Company, the Joint Bookrunners or any of their respective affiliates has made any representations to it, express or implied, with respect to the Company, the Placing and the Placing Shares or the accuracy, completeness or adequacy of the Publicly Available Information or the Exchange Information, and each of them expressly disclaims any liability in respect thereof; and (ii) it will not hold the Joint Bookrunners or any of their respective affiliates responsible for any misstatements in or omissions from any Publicly Available Information or any Exchange Information. Nothing in this paragraph or otherwise in this Announcement (including this Appendix) excludes the liability of any person for fraudulent misrepresentation made by that person;

 

8. the content of this Announcement (including this Appendix) is exclusively the responsibility of the Company and that neither of the Joint Bookrunners nor any of their respective affiliates, agents, directors, officers or employees nor any person acting on their behalf has or shall have any liability for any information, representation or statement contained in this Announcement (including this Appendix) or any information previously published by or on behalf of the Company and will not be liable for any Placee's decision to participate in the Placing based on any information, representation or statement contained in this Announcement or otherwise. Each Placee further represents, warrants and agrees that the only information on which it is entitled to rely and on which such Placee has relied in committing itself to acquire the Placing Shares is contained in this Announcement (including this Appendix) and any Publicly Available Information including (without limitation) the Exchange Information, such information being all that it deems necessary to make an investment decision in respect of the Placing Shares and that it has neither received nor relied on any other information given, investigation made or representations, warranties or statements made by either of the Joint Bookrunners or the Company nor any of their respective affiliates, agents, directors, officers or employees nor any person acting on its or their behalf and neither of the Joint Bookrunners nor the Company nor any of their respective affiliates, agents, directors, officers or employees will be liable for any Placee's decision to accept an invitation to participate in the Placing based on any other information, representation, warranty or statement;

 

9. in making any decision to acquire the Placing Shares, it has knowledge and experience in financial, business and international investment matters as is required to evaluate the merits and risks of taking up the Placing Shares. It further confirms that it is experienced in investing in securities of this nature in this sector and is aware that it may be required to bear, and is able to bear, the economic risk of participating in, and is able to sustain a complete loss in connection with, the Placing. It further confirms that it relied on its own examination and due diligence of the Company and its associates taken as a whole, and the terms of the Placing, including the merits and risks involved, and not upon any view expressed or information provided by or on behalf of either of the Joint Bookrunners;

 

10. (i) it and each account it represents is not and at the time the Placing Shares are acquired will not be a resident of Australia, Canada, Japan, South Africa or any other jurisdiction in which it is unlawful to make or accept an offer to acquire the Placing Shares, and it and each account it represents is either (1)(a) outside the United States and will be outside the United States at the time that any buy order for Placing Shares is originated by it and (b) acquiring the Placing Shares in an "offshore transaction" within the meaning of Regulation S under the Securities Act ("Regulation S") and (c) not acquiring any of the Placing Shares as a result of any form of "directed selling efforts" within the meaning of Regulation S; or (2)(a) a "QIB" and (b) not acquiring any of the Placing Shares as a result of any form of "general solicitation" or "general advertising" within the meaning of Rule 502(c) under the Securities Act; (ii) it is not acquiring the Placing Shares with a view to the offer, sale, resale, transfer, delivery or distribution, directly or indirectly of any such Placing Shares into the United States, Australia, Canada, Japan or South Africa or any other jurisdiction in which it is unlawful to do so; and (iii) that the Placing Shares have not been and will not be registered under the securities legislation of the United States, Australia, Canada, Japan or South Africa and, subject to certain exceptions, may not be offered, sold, acquired, renounced, distributed or delivered or transferred, directly or indirectly, within or into those jurisdictions;

 

11. it understands, and each account it represents has been advised that, (i) the Placing Shares have not been and will not be registered under the Securities Act or under the applicable securities laws of any state or other jurisdiction of the United States; (ii) the Placing Shares are being offered and sold only (a) to persons reasonably believed to be QIBs in transactions exempt from, the registration requirements of the Securities Act or (b) in "offshore transactions" within the meaning of and pursuant to Regulation S under the Securities Act; and (iii) no representation has been made as to the availability of any exemption under the Securities Act or any relevant state or other jurisdiction's securities laws for the reoffer, resale, pledge or transfer of the Placing Shares;

 

12. it will not distribute, forward, transfer or otherwise transmit this document or any other materials concerning the Placing (including any electronic copies thereof), in or into the United States;

 

13. if it is a pension fund or investment company, its acquisition of Placing Shares is in full compliance with applicable laws and regulations;

 

14. neither it, nor the person specified by it for registration as holder of Placing Shares is, or is acting as nominee or agent for, and the Placing Shares will not be allotted to, a person who is or may be liable to stamp duty or stamp duty reserve tax under any of sections 67, 70, 93 and 96 of the Finance Act of 1986 (depositary receipts and clearance services) and (ii) the Placing Shares are not being acquired in connection with arrangements to issue depositary receipts or to issue or transfer Placing Shares into a clearance system;

 

15. it has complied with its obligations under the Criminal Justice Act 1993, section 118 of FSMA, and in connection with money laundering and terrorist financing under the Proceeds of Crime Act 2002 (as amended), the Terrorism Act 2000, the Terrorism Act 2006, the Money Laundering Regulations 2007 (the "Regulations") and the Money Laundering Sourcebook of the FCA and, if making payment on behalf of a third party, that satisfactory evidence has been obtained and recorded by it to verify the identity of the third party as required by the Regulations;

 

16. if a financial intermediary, as that term is used in Article 3(2) of the Prospectus Directive, the Placing Shares acquired by it in the Placing will not be acquired on a non-discretionary basis on behalf of, nor will they be acquired with a view to their offer or resale to, persons in a member state of the EEA other than to Qualified Investors, or in circumstances in which the prior consent of the Joint Bookrunners has been given to the proposed offer or resale;

 

17. it and any person acting on its behalf falls within Article 19(5) and/or 49(2)(a) to (d) of the Order and undertakes that it will acquire, hold, manage and (if applicable) dispose of any Placing Shares that are allocated to it for the purposes of its business only;

 

18. it has not offered or sold and will not offer or sell any Placing Shares to the public in any member state of the EEA except in circumstances falling within Article 3(2) of the Prospectus Directive which do not result in any requirement for the publication of a prospectus pursuant to Article 3 of that Directive;

 

19. it has only communicated or caused to be communicated and will only communicate or cause to be communicated any invitation or inducement to engage in investment activity (within the meaning of section 21 of FSMA) relating to the Placing Shares in circumstances in which section 21(1) of FSMA does not require approval of the communication by an authorised person;

 

20. it has complied and will comply with all applicable provisions of FSMA with respect to anything done by it in relation to the Placing Shares in, from or otherwise involving, the United Kingdom;

 

21. if in a member state of the EEA, it is a "qualified investor" within the meaning of the Prospectus Directive;

 

22. if in the UK, that it is a person (i) who has professional experience in matters relating to investments falling within Article 19(5) of the Order, (ii) falling within Article 49(2)(A) to (D) ("High Net Worth Companies, Unincorporated Associations, etc") of the Order, or (iii) to whom this Announcement may otherwise be lawfully communicated;

 

23. that no action has been or will be taken by either the Company or either of the Joint Bookrunners or any person acting on behalf of the Company or either of the Joint Bookrunners that would, or is intended to, permit a public offer of the Placing Shares in any country or jurisdiction where any such action for that purpose is required;

 

24. it is acting as principal only in respect of the Placing or, if it is acting for any other person: (i) it is duly authorised to do so and has full power to make the acknowledgments, representations and agreements herein on behalf of each such person; and (ii) it is and will remain liable to the Company and/or the Joint Bookrunners for the performance of all its obligations as a Placee in respect of the Placing (regardless of the fact that it is acting for another person). Each Placee agrees that the provisions of this paragraph 24 shall survive the resale of the Placing Shares by or on behalf of any person for whom it is acting;

 

25. (i) it and any person acting on its behalf is entitled to acquire the Placing Shares under the laws of all relevant jurisdictions which apply to it, (ii) it has paid any issue, transfer or other taxes due in connection with its participation in any territory, (iii) it has not taken any action which will or may result in the Company, the Joint Bookrunners, any of their affiliates or any person acting on their behalf being in breach of the legal and/or regulatory requirements of any territory in connection with the Placing, (iv) that the acquisition of the Placing Shares by it or any person acting on its behalf will be in compliance with applicable laws and regulations in the jurisdiction of its residence, the residence of the Company, or otherwise, and (v) it has all necessary capacity and has obtained all necessary consents and authorities to enable it to commit to this participation in the Placing and to perform its obligations in relation thereto (including, without limitation, in the case of any person on whose behalf it is acting, all necessary consents and authorities to agree to the terms set out or referred to in this Announcement (including this Appendix)) and will honour such obligations;

 

26. it (and any person acting on its behalf) will make payment for the Placing Shares allocated to it in accordance with the terms and conditions of this Announcement (including this Appendix) on the due time and date set out herein, failing which the relevant Placing Shares may be placed with other persons or sold as the Joint Bookrunners may in their discretion determine and it will remain liable for any amount by which the net proceeds of such sale falls short of the product of the Placing Price and the number of Placing Shares allocated to it and may be required to bear any stamp duty for stamp duty reserve tax (together with any interest or penalties due pursuant to the terms set out or referred to in this Announcement) which may arise upon the sale of such Placee's Placing Shares on its behalf;

 

27. its allocation (if any) of Placing Shares will represent a maximum number of Placing Shares which it will be entitled, and required, to acquire, and that the Joint Bookrunners may call upon it to acquire a lower number of Placing Shares (if any), but in no event in aggregate more than the aforementioned maximum;

 

28. neither of the Joint Bookrunners, nor any of their respective affiliates, agents, directors, officers or employees, nor any person acting on behalf of any of them, is making any recommendations to it or advising it regarding the suitability of any transactions it may enter into in connection with the Placing and participation in the Placing is on the basis that it is not and will not be a client of either of the Joint Bookrunners and the Joint Bookrunners have no duties or responsibilities to it for providing the protections afforded to their respective clients or customers or for providing advice in relation to the Placing nor in respect of any representations, warranties, undertakings or indemnities contained in the Placing Agreement nor for the exercise or performance of any of their respective rights and obligations thereunder including any rights to waive or vary any conditions or exercise any termination right;

 

29. the person whom it specifies for registration as holder of the Placing Shares will be (i) itself; or (ii) its nominee, as the case may be. Neither of the Joint Bookrunners nor the Company will be responsible for any liability to stamp duty or stamp duty reserve tax or other similar taxes resulting from a failure to observe this requirement. Each Placee and any person acting on behalf of such Placee agrees to participate in the Placing and it agrees to indemnify on an after-tax basis and hold harmless the Company, each of the Joint Bookrunners and their respective affiliates, agents, directors, officers and employees in respect of the same on the basis that the Placing Shares will be allotted to the CREST stock accounts of Liberum and Peel Hunt who will hold them as nominee on behalf of such Placee until settlement in accordance with the standing settlement instructions;

 

30. it indemnifies and holds harmless the Company, the Joint Bookrunners and their respective affiliates, agents, directors, officers and employees from any and all costs, claims, liabilities and expenses (including legal fees and expenses) arising out of or in connection with any breach of the representations, warranties, acknowledgements, agreements and undertakings in this Appendix and further agrees that the provisions of this Appendix shall survive after completion of the Placing;

 

31. in connection with the Placing, a Joint Bookrunner and any of its affiliates acting as an investor for its own account may acquire Placing Shares in the Company and in that capacity may acquire, retain, purchase or sell for its own account such ordinary shares in the Company and any securities of the Company or related investments and may offer or sell such securities or other investments otherwise than in connection with the Placing. Neither of the Joint Bookrunners intends to disclose the extent of any such investment or transactions otherwise than in accordance with any legal or regulatory obligation to do so;

 

32. its commitment to acquire Placing Shares on the terms set out in this Announcement (including this Appendix) will continue notwithstanding any amendment that may or in the future be made to the terms and conditions of the Placing and that Placees will have no right to be consulted or require that their consent be obtained with respect to the Company's or the Joint Bookrunners' conduct of the Placing;

 

33. neither the Company nor either of the Joint Bookrunners owes any fiduciary or other duties to any Placee in respect of any representations, warranties, undertakings or indemnities in the Placing Agreement;

 

34. its commitment to acquire Placing Shares on the terms set out herein and in the contract note or trade confirmation or placing letter (as applicable) will continue notwithstanding any amendment that may in future be made to the terms of the Placing and Placees will have no right to be consulted or require that their consent be obtained with respect to the Company's or the Joint Bookrunners' conduct of the Placing;

 

35. these terms and conditions and any agreements entered into by it pursuant to these terms and conditions (including any non-contractual obligations arising out of or in connection with such agreements) shall be governed by and construed in accordance with the laws of England and it submits (on behalf of itself and on behalf of any person on whose behalf it is acting) to the exclusive jurisdiction of the English courts as regards any claim, dispute or matter arising out of any such contract, except that enforcement proceedings in respect of the obligation to make payment for the Placing Shares (together with any interest chargeable thereon) may be taken by the Joint Bookrunners in any jurisdiction in which the relevant Placee is incorporated or in which any of its securities have a quotation on a recognised stock exchange; and

 

36. the foregoing acknowledgements, agreements, undertakings, representations, warranties and confirmations are given for the benefit of each of the Company and the Joint Bookrunners (for their own benefit and, where relevant, the benefit of their respective affiliates and any person acting on their behalf) and are irrevocable. The Company, the Joint Bookrunners and their respective affiliates, agents, directors, officers and employees and others will rely upon the truth and accuracy of the foregoing acknowledgements, representations, warranties and agreements and it agrees that if any of the acknowledgements, representations, warranties and agreements made in connection with its acquiring of Placing Shares is no longer accurate, it shall promptly notify the Company and the Joint Bookrunners. It irrevocably authorises Liberum, Peel Hunt and the Company to produce this Announcement pursuant to, in connection with, or as may be required by any applicable law or regulation, administrative or legal proceeding or official inquiry with respect to the matters set out herein.

The agreement to allot and issue Placing Shares to Placees (or the persons for whom Placees are contracting as nominee or agent) free of stamp duty and stamp duty reserve tax relates only to their allotment and issue to Placees, or such persons as they nominate as their agents, direct from the Company for the Placing Shares in question. Such agreement is subject to the representations, warranties and further terms above and assumes, and is based on the warranty from each Placee, that the Placing Shares are not being acquired in connection with arrangements to issue depositary receipts or to issue or transfer the Placing Shares into a clearance service. If there are any such arrangements, or the settlement relates to any other dealing in the Placing Shares, stamp duty or stamp duty reserve tax or other similar taxes may be payable, for which neither the Company nor either of the Joint Bookrunners will be responsible and each Placee shall indemnify on an after-tax basis and hold harmless the Company, each of the Joint Bookrunners and their respective affiliates, agents, directors, officers and employees for any stamp duty or stamp duty reserve tax paid by them in respect of any such arrangements or dealings.

Neither the Company nor either of the Joint Bookrunners is liable to bear any capital duty, stamp duty and all other stamp, issue, securities, transfer, registration, documentary or other duties or taxes (including any interest, fines or penalties relating thereto) payable in or outside the United Kingdom by any Placee or any other person on a Placee's acquisition of any Placing Shares or the agreement by a Placee to acquire any Placing Shares. Each Placee agrees to indemnify on an after-tax basis and hold harmless the Company, each Joint Bookrunner and their respective affiliates, agents, directors, officers and employees from any and all interest, fines or penalties in relation to any such duties or taxes to the extent that such interest, fines or penalties arise from the unreasonable default or delay of that Placee or its agent.

Each Placee should seek its own advice as to whether any of the above tax liabilities arise and notify the Joint Bookrunners accordingly.

Each Placee, and any person acting on behalf of each Placee, acknowledges and agrees that the Joint Bookrunners and/or any of their respective affiliates may, at their absolute discretion, agree to become a Placee in respect of some or all of the Placing Shares.

When a Placee or person acting on behalf of the Placee is dealing with the Joint Bookrunners any money held in an account with either of the Joint Bookrunners on behalf of the Placee and/or any person acting on behalf of the Placee will not be treated as client money within the meaning of the rules and regulations of the FCA made under FSMA. The Placee acknowledges that the money will not be subject to the protections conferred by the client money rules; as a consequence, this money will not be segregated from the relevant Joint Bookrunners' money in accordance with the client money rules and will be used by the relevant Joint Bookrunner in the course of its own business; and the Placee will rank only as a general creditor of the Joint Bookrunners.

Past performance is no guide to future performance and persons needing advice should consult an independent financial adviser.

The rights and remedies of the Joint Bookrunners and the Company under these Terms and Conditions are in addition to any rights and remedies which would otherwise be available to each of them and the exercise or partial exercise of one will not prevent the exercise of others.

If a Placee is a discretionary fund manager, he may be asked to disclose, in writing or orally to the Joint Bookrunners the jurisdiction in which the funds are managed or owned.

All times and dates in this Announcement (including this Appendix) may be subject to amendment. The Joint Bookrunners shall notify the Placees and any person acting on behalf of the Placees of any changes.


[1] Venofer (iron sucrose) is the market leader in the treatment of IDA in dialysis patients in the USA. For FY2015 Daiichi Sankyo recorded Venofer sales of US$260m through its US subsidiary Luitpold Pharmaceuticals Inc.

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MSCZMGMVKKVGNZG
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