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Proposed Placing and Open Offer

09th March 2016

THIS ANNOUNCEMENT 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 OR FROM THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, NEW ZEALAND, THE REPUBLIC OF IRELAND, THE RUSSIAN FEDERATION OR SOUTH AFRICA OR ANY OTHER JURISDICTION IN WHICH THE SAME WOULD BE UNLAWFUL.

FURTHER, THIS ANNOUNCEMENT IS FOR INFORMATION PURPOSES ONLY AND SHALL NOT CONSTITUTE AN OFFER TO SELL OR ISSUE OR THE SOLICITATION TO BUY, SUBSCRIBE FOR OR OTHERWISE ACQUIRE ANY ORDINARY SHARES OF SCANCELL IN ANY JURISDICTION IN WHICH ANY SUCH OFFER OR SOLICITATION WOULD BE UNLAWFUL. THIS ANNOUNCEMENT SHOULD BE READ IN ITS ENTIRETY. IN PARTICULAR, YOU SHOULD READ AND UNDERSTAND THE INFORMATION PROVIDED IN THE "IMPORTANT NOTICES" SECTION AND IN THE APPENDICES.

Scancell Holdings plc (LSE:AIM SCLP) ("Scancell" or the "Company"), the developer of novel immunotherapies for the treatment of cancer, is pleased to announce a proposed new issue to raise approximately £6.8 million, before expenses, at an issue price of 17 pence per New Ordinary Share by way of:

  • a firm placing of New Ordinary Shares to raise approximately £3 million, which will be conducted by accelerated bookbuild, and in respect of which the Company has received indicative demand for the entire amount; and
  • an open offer, for up to 22.4 million New Ordinary Shares, to raise up to £3.8 million, which will provide Qualifying Shareholders with the opportunity to subscribe for New Ordinary Shares on the basis of 1 New Ordinary Share for every 10 Existing Ordinary Shares held by Qualifying Shareholders on the Record Date.


The proposed placing and open offer are within the Company’s existing allotment authorities.

John Chiplin, Chairman of Scancell, commented:

"This placing and open offer will fund important next steps for the pipelines of both of our ImmunoBody® and Moditope® platform technologies as well as strengthening the Board and management as Scancell enters the next chapter in its growth.

“We recently announced that we had put in place a prestigious team of US investigators to lead a Phase 2 checkpoint inhibitor combination study with the ImmunoBody® lead cancer vaccine SCIB1 in melanoma. A proportion of funds raised will be used to accelerate the remaining preparatory work to allow such a trial to begin in a timely manner in 2017.

“We are also excited to be progressing the first pipeline product from our Moditope® platform, Modi-1, into the clinic. Part of the funds raised are earmarked for finishing the necessary work to allow Scancell to file a Clinical Trial Application in the UK for the planned Phase 1/2 clinical trial in triple negative breast cancer/ovarian cancer that we expect to begin next year.”

For further information please contact:

Scancell Holdings Plc
Dr Richard Goodfellow, Joint CEO
Professor Lindy Durrant, Joint CEO

+ 44 (0) 20 3727 1000

Panmure Gordon (Nominated Adviser and placing agent)
Robert Naylor/Paul Fincham, Corporate Finance
Maisie Atkinson, Sales

+44 (0) 20 7886 2500

Lesmoir-Gordon, Boyle & Co. Limited (Sub placing agent)
Angus Grierson

+44 (0) 20 7518 9892

FTI Consulting
Mo Noonan
Simon Conway

+ 44 (0) 20 3727 1000



The Placing is being conducted through an accelerated bookbuild which will be launched immediately following this announcement. Members of the public are not eligible to take part in the Placing.

The Company has received advance assurance from HM Revenue and Customs that it is a qualifying holding for the purposes of the Venture Capital Trust rules and a qualifying company for the purposes of the Enterprise Investment Scheme. Although the Company currently expects to satisfy the relevant conditions for EIS and VCT investment, neither the Directors nor the Company gives any warranty or undertaking that relief will be available in respect of any investment in the Company Shares, nor do they warrant or undertake that the Company will conduct its activities in a way that qualifies for or preserves its status.

A circular to shareholders, including further details of the Open Offer will be despatched to shareholders on or around 11 March 2016 and will also be available at this time on the Company's website at http://www.scancell.co.uk.

Panmure Gordon (UK) Limited is acting as Nominated Adviser and placing agent in respect of the Placing. Lesmoir-Gordon, Boyle & Co. Limited is acting as sub placing agent.

Description of Company

Scancell is developing immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms.
Immunotherapy is a form of treatment that may hold the key to keeping patients permanently disease-free. Unlike traditional therapies that attack cancer directly, immunotherapy uses the body’s own internal biological defences to ward off the disease, with the ultimate hope of building up longterm resistance to the cancer.

There is a strong rationale for the development of tumour-specific T cell stimulators to treat patients with cancer. Although some cancer vaccines in clinical development have been able to stimulate an immune response, few have yet been able to demonstrate an overall clinical benefit.
ImmunoBody® Scancell’s ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system: the helper cell system, where inflammation is stimulated at the tumour site, and
the cytotoxic T-lymphocyte or CTL response, where immune system cells are primed to recognise and kill specific cells.

Each ImmunoBody® vaccine can be designed to target a particular cancer in a highly specific manner.

Scancell’s first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma. The results of the Phase 1/2 clinical trial demonstrate that SCIB1, when used as monotherapy in stage III/IV (late stage) melanoma patients with resected disease, produced a melanoma-specific immune response; and a highly encouraging survival trend without serious side effects.

Pre-clinical data on a combination of SCIB1 and checkpoint inhibition (blockade of the PD-1 immune checkpoint pathway) has also shown enhanced tumour destruction and significantly longer survival times than when either treatment was used alone.

These data suggest that SCIB1 has the potential to become both the first stand-alone adjuvant treatment for early stage metastatic melanoma and an attractive partner with checkpoint inhibitors for later stage disease.

This has set the stage for an expanded clinical trial programme with a highly qualified group of US specialists. Dr Keith Flaherty, M.D., Director of the Termeer Center for Targeted Therapy at Massachusetts General Hospital and Associate Professor at Harvard Medical School has been named the principal investigator for a multicentre clinical trial, which aims to demonstrate an increase in the response rates when SCIB1 is added to checkpoint inhibitor monotherapy. The trial is expected
to commence in 2017.

Moditope®

Moditope® is a peptide-based vaccine platform that stimulates the production of killer CD4+ T cells that induce anti-tumour activity without toxicity. Although CD8+ T cell responses to tumourassociated antigens have been reported, it is difficult to induce tumour-specific CD4+ T cell
responses due to self‐tolerance against normal CD4+ T cell epitopes. The ability of Moditope®citrullinated peptides to induce CD4+ cytotoxic T cells against tumour-associated epitopes has therefore added a new dimension to the potential of anti‐tumour vaccines.

Publication of the scientific data supporting the Moditope® platform in Cancer Research in December 2015 provides further endorsement of the quality of Scancell’s innovative research and is a tribute to the strength of the Company’s research team.

Reasons for the Firm Placing and Open Offer

The latest survival data on patients treated with SCIB1 combined with the animal data showing the potential value of a SCIB1/checkpoint inhibitor combination, has set the stage for an expanded clinical trial programme in melanoma, starting in 2017.

Further progress has also been made with the Moditope® platform, and it is anticipated that the first product, Modi-1, will be ready for clinical trials for the treatment of triple negative breast cancer and ovarian cancer in 2017.

To support this process, the Board and management will be further strengthened to prepare the Company for its future as a later stage development Company.

This Capital Raising will allow the Company to prepare for further clinical studies on both SCIB1 and Moditope®, which the Board believes could add significant incremental value.

Proposed Use of proceeds

The Capital Raising is expected to raise gross proceeds of approximately £6.8 million (before commission and the costs of the Firm Placing and Open Offer), with the Firm Placing raising gross proceeds of approximately £3 million and the Open Offer expected to raise gross proceeds of up to
approximately £3.8 million, assuming full take up of the Open Offer.
It is expected that the net proceeds from the Firm Placing and Open Offer will be used as follows:

  • ImmunoBody®: approximately £1.9 million is expected to be used to secure approval of an Investigational New Drug application from the US Food and Drug Administration for the SCIB1 combination study and to complete all of the preparatory work for such a trial in the US, including the manufacture of SCIB1 and conducting suitable toxicology and stability studies;
  • Moditope®: approximately £1.4 million is expected to be used to prepare and file a Clinical Trial Application in the UK for the planned Phase 1/2 clinical trial with Modi-1 and to complete all of the preparatory work for such a trial in the UK, including the manufacture of Modi-1 and conducting suitable toxicology and stability studies;
  • approximately £0.6 million will be used to build an experienced US focused management team; and
  • the remaining balance of the net proceeds is expected to be used for the Company's working capital requirements.

Therapeutic drug development is a long process and the Directors believe that the Company will need additional funding in order to conduct the aforementioned clinical studies and as it moves from its current strong research base to a later stage development company.

This funding will need to be provided either by a development partner, such as a large pharmaceutical company, or by further equity issuance to existing and new shareholders. The Directors believe that delivering the milestones outlined above, enabling the Company to secure
approval to conduct clinical trials with SCIB1 in the US and the manufacture of SCIB1 and Modi-1 for both clinical trials, will enhance the value of the Company and prepare it for further later stage
fundraising. The Directors also believe that these milestones will ensure wider recognition of the Company both in the United States and Europe for the quality and value of both the ImmunoBody®and Moditope® platforms.

The expected use of proceeds set out above is illustrative of the Directors’ current intentions with regard to the proceeds from the Firm Placing and Open Offer and may be subject to change.

Expected Timetable of Principal Events

Announcement of the Firm Placing and Open Offer

9 March

Record Date for the Open Offer

9 March

Publication of the Open Offer document and the Application Form

11 March

Ex-entitlement Date

11 March

Open Offer Entitlements credited to CREST stock accounts of Qualifying CREST Holders

14 March

Recommended last time and date for requesting withdrawal of Open Offer Entitlements from CREST

4.30p.m. on 21 March

Latest time and date for depositing Open Offer Entitlements into CREST

3.00p.m. on 22 March

Latest time and date for splitting Application Forms
(to satisfy bona fide market claims only)

3.00p.m. on 23 March

Latest time and date for acceptance of the Open Offer and receipt of completed Application Forms

11.00 a.m. on 29 March

Announcement of result of Open Offer

31 March

Admission and commencement of dealings in the New Ordinary Shares

8.00 a.m. on 5 April

New Ordinary Shares credited to CREST members’ account

5 April

Despatch of definitive share certificates for New Ordinary Shares in certificated form

19 April


The above time and/or dates are subject to change and, in the vent of such change, the revised times and/or dates will be notified to Shareholders by an announcement through a Regulatory Information Service.

Definitions

The following definitions apply throughout this announcement, unless the context requires otherwise:

“Admission”

the admission of the Firm Placing Shares and the Offer Shares to trading on AIM

“AIM”

the AIM market operated by London Stock Exchange

“AIM Rules for Companies”

the AIM Rules for Companies and guidance notes as published by the London Stock Exchange from time to time governing the admission to, and operation of, AIM

“Application Form”

the personalised application form on which Qualifying Shareholders may apply for New Ordinary Shares under the open offer

“Board” or “Directors”

the directors of the Company

“Capital Raising”

the Firm Placing and the Open Offer, taken together

“Company” or “Scancell”

Scancell Holdings PLC

“CREST”

the computerized settlement system (as defined in the CREST Regulations) in respect of which Euroclear is the operator (as defined in the CREST Regulations), which facilitates the transfer of title to shares in uncertificated form

“CREST member”

a person who has been admitted to CREST as a system-member (as defined in the CREST Regulations)

“CREST Regulations”

the Uncertificated Securities Regulations 2001 (SI 2001/3755) (as amended)

“EIS”

Enterprise Investment Scheme

“EIS Qualifying Shares”

the Firm Placing Shares and the Offer Shares being the New Ordinary Shares that the Board have allocated to investors who are VCTs or wish to receive EIS relief

“Euroclear”

Euroclear UK & Ireland Limited

“Ex-entitlement Date”

the date on which the Existing Ordinary Shares are marked “ex” for entitlement under the Open Offer.

“Existing Ordinary Shares”

the Ordinary Shares in issue on the date of this announcement

“Firm Placees”

The persons who with whom the Firm Placing Shares will be placed pursuant to the Firm Placing

“Firm Placing”

the placing by the Company of the Firm Placing Shares with the Firm Placees, otherwise than on a pre-emptive basis, at the Offer Price

“Firm Placing Shares”

The Ordinary Shares which are the subject of the Firm Placing

“FCA”

the Financial Conduct Authority

“FSMA”

Financial Services and Market Act 2000 (as amended)

“HMRC”

Her Majesty’s Revenue and Customs

“London Stock Exchange”

London Stock Exchange plc

“LGB” or “Lesmoir-Gordon Boyle”

Lesmoir-Gordon, Boyle & Co Limited

“New Ordinary Shares”

the Firm Placing Shares and the Offer Shares

“Offer Price”

17 pence per New Ordinary Share

“Offer Shares”

the Ordinary Shares being made available to Qualifying Shareholders pursuant to the Open Offer

“Open Offer”

the conditional invitation made to Qualifying Shareholders to apply to subscribe for the Offer Shares at the Offer Price

“Open Offer Entitlement”

the entitlement of Qualifying Shareholders to subscribe for Offer Shares allocated to Qualifying Shareholders on the Record Date pursuant to the Open Offer

“Ordinary Shares”

ordinary shares in the capital of the Company

“Panmure Gordon”

Panmure Gordon (UK) Limited

“Overseas Shareholders”

a Shareholder with a registered address outside the United Kingdom

“Qualifying CREST Holders”

holders of Existing Ordinary Shares in uncertificated form on the register of members of the Company at the Record Date

“Qualifying Non-CREST Holders”

holders of Existing Ordinary Shares in certificated form on the register of members of the Company on the Record Date

“Qualifying Shareholders”

Qualifying Non-CREST Holders and Qualifying CREST Holders (other than certain Overseas Shareholders)

“Record Date”

5.00 p.m. on 9 March 2016 in respect of the entitlements of Qualifying Shareholders under the Open Offer

“Regulatory Information Service”

has the meaning given in the AIM Rules for Companies

“Restricted Jurisdiction”

the US, Canada, Australia, New Zealand, the Republic of South Africa, the Russian Federation, Japan or the Republic of Ireland and any jurisdiction where the extension or availability of the Open Offer (and any other transaction contemplated thereby) would breach any applicable laws or regulations and “Restricted Jurisdictions” shall mean any of them

“Scancell ” or “Group”

Scancell Holdings plc and its subsidiaries

“Securities Act”

US Securities Act of 1933 (as amended)

“Shareholders”

the holders of Existing Ordinary Shares

“United Kingdom” or “UK”

the United Kingdom of Great Britain and Northern Ireland

“United States”, “United States of America” or “US”

the United States of America, its territories and possessions, any state of the United States of America and the District of Columbia and all areas subject to its jurisdiction

“VCT”

Venture Capital Trust as defined by section 259 ITA

Webcasts, Interviews and Media Coverage

Scancell Holdings wins Japanese patent protection

It follows on from similar awards in key markets such as the US, Europe, South Africa and Australia

Mon, 08 Apr 2019 08:20:00

Scancell strengthens IP with two “important” patent grants in US and Europe

The US patent covers Modi-1, while the European patent relates to a monoclonal antibody called FG88

Wed, 20 Mar 2019 07:55:00

Scancell in vanguard of immuno-oncology advances, with two technologies that show early promise

The AIM-listed group is at the vanguard of advances in the emerging field of immuno-oncology and is working on two technologies that are showing early promise

Tue, 12 Feb 2019 15:07:00