Posts in Category: Regulatory News

Amendment to Options

Scancell Holdings Plc (‘Scancell’ LSE:AIM SCLP), the developer of novel immunotherapies for the treatment of cancer, announces the grant of a share option to Dr John Chiplin. Further to the announcement of his
appointment as non-executive Chairman of the Company in January 2016, Dr John Chiplin has been granted an option over 3,000,000 ordinary shares, under a one-off option grant.

The option vests over a period of three years in three equal tranches, subject to the achievement of performance criteria as specified by the Remuneration Committee. The exercise price payable in respect of the option is 17p per share; being the price paid by shareholders in the recent Placing and Open Offer.

For Further Information:

Dr Richard Goodfellow, Joint CEO Scancell Holdings Plc + 44 (0) 20 3727 1000
Professor Lindy Durrant, Joint CEO    
Robert Naylor (Corporate Finance) Panmure Gordon & Co +44 (0) 20 7886 2714
Maisie Atkinson (Sales)   +44 (0) 20 7886 2905
Mo Noonan/Simon Conway FTI Consulting + 44 (0) 20 3727 1000

About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms.

Scancell’s first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma and is being evaluated in a Phase 1/2 clinical trial.

Data from the trial demonstrate that SCIB1, when used as monotherapy, has a marked effect on tumour load, produces a melanoma-specific immune response and highly encouraging survival trend without serious side effects. In patients with resected disease there is increasing evidence to suggest that SCIB1 may delay or prevent disease recurrence.

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 Tlymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

Pre-clinical data on a combination of SCIB1 or SCIB2 and checkpoint inhibition (blockade of the PD-1 or CTLA-4 immune checkpoint pathways) have shown enhanced tumour destruction and significantly longer survival times than when either treatment was used alone.

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4+ T cells that destroy tumours without toxicity. The Directors believe that the Moditope® platform could play a major role in the development of safe and effective cancer immunotherapies in the future.

Result of the Open Offer (2)

On 1 April 2016 the Board of Scancell announced that it had received subscriptions in respect of 16,048,593 new Ordinary Shares of the 22,495,068 new Ordinary Shares available under the Open Offer.

The Company has now received applications for an additional 558,823 new Ordinary Shares, available but not subscribed for by Qualifying Shareholders in the Open Offer, therefore the revised total subscription under the Open Offer is 16,607,416 new Ordinary Shares, representing 73.8 per cent. the new Ordinary Shares available under the Open Offer. The Company has therefore raised gross proceeds of approximately £2.8 million through the Open Offer and £3.4 million through the Placing being approximately £6.2 million in total.

Application will be made to the London Stock Exchange for the admission to trading on AIM of the 36,607,416 new Ordinary Shares to be issued under the Placing and Open Offer. It is expected that Admission will occur and that dealings will commence at 08:00 a.m. on 5 April 2016. The total number of Ordinary Shares following Admission will be 261,558,099 with each share carrying the right to one vote. The above figure may be used by shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in Scancell under the FCA's Disclosure and Transparency Rules.

This announcement should be read in conjunction with the full text of the Circular posted to Shareholders on 11 March 2016, copies of which are available on the Company's website at www.scancell.co.uk. Capitalised terms not otherwise defined in this announcement have the meanings given in the Circular.

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

 

Result of the Open Offer

On 9 March 2016 the Board of Scancell announced details of a Placing in which it had conditionally raised gross proceeds of £3.4 million by means of a Placing of 20,000,000 Placing shares at 17 pence per share.

In addition, the Company announced that it was providing Qualifying Shareholders with an opportunity to subscribe, at 17 pence per share, for 22,495,068 new Ordinary Shares to raise gross proceeds of up to approximately £3.8 million by way of the Open Offer.

The Company has received subscriptions in respect of 16,048,593 new Ordinary Shares, representing 71.3 per cent. of the new Ordinary Shares available under the Open Offer. All applications made pursuant to the Open Offer including the Excess Shares applied for under the Excess Application Facility have been met in full. The Company has therefore raised gross proceeds of approximately £2.7 million through the Open Offer.

John Chiplin, Non-Executive Chairman of Scancell, said: "We are delighted that, through our Placing and Open Offer, the Company has successfully raised £6.1 million. We would like to thank our existing shareholders for their continued support, as well as welcoming new investors, at this important time in the Company’s evolution. As a result of this fundraising we are now able to accelerate the development of both our ImmunoBody® and Moditope® platform technologies. We will use the money raised to prepare for our SCIB1 ImmunoBody® / checkpoint inhibitor combination study in melanoma, including applying for a US IND later this year, enabling the study to begin in 2017 and also to take our first Moditope® product, Modi-1, into the clinic next year. We will continue to strengthen our Board and management team and increase our focus on the US with the goal of becoming one of the leading cancer immunotherapy companies.”

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

 

Application will be made to the London Stock Exchange for the admission to trading on AIM of the 36,048,593 new Ordinary Shares to be issued under the Placing and Open Offer. It is expected that Admission will occur and that dealings will commence at 08:00 a.m. on 5 April 2015. The total number of Ordinary Shares following Admission will be 260,999,276 with each share carrying the right to one vote. The above figure may be used by shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in Scancell under the FCA's Disclosure and Transparency Rules.

This announcement should be read in conjunction with the full text of the Circular posted to Shareholders on 11 March 2016, copies of which are available on the Company's website at www.scancell.co.uk. Capitalised terms not otherwise defined in this announcement have the meanings given in the Circular.

Scancell’s SCIB1 ImmunoBody® cancer vaccine being presented at the World Vaccine Congress

Scancell’s SCIB1 ImmunoBody® cancer vaccine being presented at the World Vaccine Congress Scancell Holdings plc, (‘Scancell’ or the 'Company’) the developer of novel immunotherapies for the treatment of cancer, announces that Dr Peter Brown, Clinical and Scientific Consultant, Immunotherapeutics, at Scancell, will be presenting an update on the Company’s SCIB1 ImmunoBody® cancer vaccine at the World Vaccine Congress US 2016, 29-31 March 2016, in Washington D.C., US.

The presentation entitled: “SCIB1 ImmunoBody® stimulates a potent T cell response that eradicates tumours and prevents recurrence” will be presented on Wednesday 30 March 2016 at 11:40am EDT.

Scancell’s first ImmunoBody®, SCIB1, is currently being evaluated in a Phase 1/2 clinical trial in patients with Stage III/IV melanoma. The latest data suggests that SCIB1 may have the potential to significantly extend survival times in patients, especially in those with resected disease. The Company is in the process of preparing a final clinical study report. A Phase 2 checkpoint inhibitor combination study of SCIB1 in melanoma is due to commence in 2017.

Richard Goodfellow, Joint CEO of Scancell, commented:

“We are delighted to be presenting an update on SCIB1 at the World Vaccine Congress, alongside some of the most distinguished companies in the immunotherapy field. Funds from the recently announced placing
and the pending open offer will be used to further progress our ImmunoBody® and Moditope® platforms, including helping to fund our expanded SCIB1 clinical trial programme, which will be led by a team of leading US specialists.”


For Further Information:

Dr Richard Goodfellow, Joint CEO

Professor Lindy Durrant, Joint CEO

Scancell Holdings Plc + 44 (0) 20 3727 1000

Robert Naylor (Corporate Finance)

Maisie Atkinson (Sales)

Panmure Gordon & Co

+44 (0) 20 7886 2714

+44 (0) 20 7886 2905

Mo Noonan/Simon Conway FTI Consulting

+ 44 (0) 20 3727 1000

 

SCIB1 mechanism of action

SCIB1 is a DNA ImmunoBody® immunotherapy encoding a human IgG1 antibody, with three epitopes from gp100 and one from TRP-2 engineered into its CDR regions. This immuno-stimulatory antibody targets dendritic cells in vivo via the high affinity Fc receptor, CD64, and stimulates high avidity T cells. Extensive research studies suggest SCIB1 ImmunoBody® has a dual mechanism of action that combines crosspresentation
with direct-presentation. This results in amplification of the immune response to induce high frequency, high avidity T cells which translates into a potent anti-tumour response.

About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms.
Scancell’s first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma and is being evaluated in a Phase 1/2 clinical trial. Data from the trial demonstrate that SCIB1, when used as monotherapy, has a marked effect on tumour load, produces a melanoma-specific immune response and highly encouraging survival trend without serious side effects. In patients with resected disease there is increasing evidence to suggest that SCIB1 may delay or prevent disease recurrence.

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 Tlymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

Pre-clinical data on a combination of SCIB1 or SCIB2 and checkpoint inhibition (blockade of the PD-1 or CTLA-4 immune checkpoint pathways) have shown enhanced tumour destruction and significantly longer
survival times than when either treatment was used alone.

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4+ T cells that destroy tumours without toxicity. The Directors believe that the Moditope® platform could
play a major role in the development of safe and effective cancer immunotherapies in the future.

Collaboration with Karolinska

Scancell embarks on strategic collaboration with world-leading research team at Karolinska Institutet

Collaboration to further explore the role of citrullination in cancer, a key mechanism underpinning the Moditope® platform

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, announces that it has embarked on a strategic research collaboration with scientists at the Rheumatology Unit at Karolinska Institutet, Sweden, led by Professors Lars Klareskog and Vivianne Malmström. The collaboration will further explore the scientific and clinical role of citrullinated proteins in the treatment of cancer.

Scancell’s Moditope® platform technology overcomes the immune suppression induced by tumours themselves, allowing activated T cells to seek out and kill tumour cells that would otherwise be hidden from the immune system. This is achieved by stimulating the production of CD4+ T cells using citrullinated tumour-associated peptide epitopes, which overcome self-tolerance and destroy tumour cells.

The teams of Professors Klareskog and Malmström have uncovered a central role for citrullinated proteins in the pathogenesis of the autoimmune disease rheumatoid arthritis. Conversely, Scancell has discovered that citrullinated proteins are also targets on cancer cells and this underpins the use of citrullinated peptides in the Company’s Moditope® cancer immunotherapy platform.

The groups of Professors Klareskog and Malmström perform world-leading research in the area of rheumatology and their work has been published in a number of leading academic journals, including Nature, Lancet, Arthritis & Rheumatism, Nature Medicine, Nature Genetics and Annual Review of Immunology.

Professor Lindy Durrant, Joint CEO of Scancell and Professor of Cancer Immunotherapy at Nottingham University, commented:

“Our research has previously shown that citrullinated proteins are involved in the control of tumour growth, which led us to the development of the Moditope® platform. The teams of professors Klareskog and Malmström have developed an understanding of the role of citrullinated proteins in the pathogenesis of the autoimmune disease, rheumatoid arthritis. We believe that this strategic collaboration with Karolinska will enhance our joint understanding of the role that citrullination plays in both cancer and rheumatoid arthritis, and will help us develop the Moditope® platform to its full potential.”

Professor Lars Klareskog, MD, PhD, at Karolinska Institutet, added:

“Citrullinated proteins have been implicated in the pathogenesis of rheumatoid arthritis. Collaborating with Scancell will allow us to further explore the role of immunity to citrullinated proteins in the control of tumour growth, and we are delighted to be working with Scancell on this exciting project.”

For Further Information:

Dr Richard Goodfellow, Joint CEO

Professor Lindy Durrant, Joint CEO

Scancell Holdings Plc + 44 (0) 20 3727 1000

Robert Naylor (Corporate Finance)

Maisie Atkinson (Sales)

Panmure Gordon & Co

+44 (0) 20 7886 2714

+44 (0) 20 7886 2905

Mo Noonan/Simon Conway FTI Consulting

+ 44 (0) 20 3727 1000

 

About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms.
Scancell’s first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma and is being evaluated in a Phase 1/2 clinical trial. Data from the trial demonstrate that SCIB1, when used as monotherapy, has a marked effect on tumour load, produces a melanoma-specific immune response and highly encouraging survival trend without serious side effects. In patients with resected disease there is increasing evidence to suggest that SCIB1 may delay or prevent disease recurrence.

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 Tlymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

Pre-clinical data on a combination of SCIB1 or SCIB2 and checkpoint inhibition (blockade of the PD-1 or CTLA-4 immune checkpoint pathways) have shown enhanced tumour destruction and significantly longer
survival times than when either treatment was used alone.

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4+ T cells that destroy tumours without toxicity. The Directors believe that the Moditope® platform could
play a major role in the development of safe and effective cancer immunotherapies in the future.

About Karolinska Institutet

Karolinska Institutet is one of the world's leading medical universities. Its vision is to significantly contribute to the improvement of human health. Karolinska Institutet accounts for over 40 per cent of the medical
academic research conducted in Sweden and offers the country´s broadest range of education in medicine and health sciences. The Nobel Assembly at Karolinska Institutet selects the Nobel laureates in Physiology
or Medicine.

Posting of Circular

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, further to the announcement on 9 March of the successful Firm Placing to raise £3.4 million, will today publish a circular setting out, amongst other things, details of the Open Offer.

The Open Offer is for up to approximately 22.5 million New Ordinary Shares at 17 pence per New Ordinary Share 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

The Firm Placing and Open Offer are within the Company’s existing allotment authorities. The Circular to shareholders will be available shortly on the Company's website at www.scancell.co.uk.

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

 

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.

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 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 4.30 p.m. on 21 March
Latest time and date for depositing Open Offer Entitlements into CREST 3.00 p.m. on 22 March
Latest time and date for splitting Application Forms
(to satisfy bona fide market claims only)
3.00 p.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 event of such change, the revised times and/or dates will be notified to Shareholders by an announcement through a Regulatory Information Service.

Dealing codes

The ISIN of the Open Offer Entitlement is GB00BDGSNM16
The ISIN of the Excess Application Facility is GB00BDGSNP47
All defined terms used in this announcement are defined, unless otherwise defined here, in the Proposed Placing and Open Offer announcement made on 9 March 2016.

 

Firm Placing Raises £3.4 million

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 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 SEAL 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 the successful completion of the Firm Placing announced earlier today.

The Company has conditionally raised, in aggregate, £3.4 million (before expenses) by way of the placing of 20,000,000 new ordinary shares at the placing price of 17 pence per share. The Placing Price represents a
discount of 16 per cent. to the mid-market closing price on 8 March 2016, being the last practicable date prior to the date of this announcement.
The new ordinary shares will be issued credited as fully paid and will be identical to, and rank pari passu in all respects with, the Existing Ordinary Shares following the date of Admission.

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 on the Company's website, www.scancell.co.uk., at this
time.

Director Dealings
All of the Directors of the Company have participated in the Firm Placing, as set out in the table below:

    As at the date of this announcement   Following Admission*  
   Ordinary shares percentage of issued Ordinary Share capital Firm Placing Shares Ordinary Shares percentage of issued Ordinary Share capital
Lindy Durrant # 10,480,920 4.66% 58,823 10,539,743 3.94%
Richard Goodfellow # 6,643,840   58,823 6,702,663 2.51%
John Chiplin Nil Nil 58,823 58,823 0.02%
Matthew Frohn Nil Nil 58,823 58,823 0.02%
Kate Cornish-Bowden 45,000 0.02% 58,823 103,823 0.04%
Sally Adams Nil Nil 58,823 58,823 0.02%

# In the table above, the number of Ordinary Shares held by two of the Directors includes their interests in joint ownership shares. Professor Lindy Durrant has an interest in 8,873,960 joint ownership shares and Dr. Richard Goodfellow in 6,443,840 joint ownership shares.

* These numbers and percentages are calculated assuming that the Firm Placing completes and the Offer Shares are fully taken up by Shareholders other than the Directors and that none of the outstanding share options are exercised. It is possible that Directors will take up some or all of their basic and excess entitlements pursuant to the Open Offer and, if this occurs, the Company will make an announcement via a Regulatory Information Service at the appropriate time.

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

All defined terms used in this announcement are defined, unless otherwise defined here, in the appendix to the Proposed Placing and Open Offer announcement made earlier today.

Proposed Placing and Open Offer

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 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 4.30 p.m. on 21 March
Latest time and date for depositing Open Offer Entitlements into CREST 3.00 p.m. on 22 March
Latest time and date for splitting Application Forms
(to satisfy bona fide market claims only)
3.00 p.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 event 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