Half Year Results

RNS Number : 4181W

Scancell Holdings Plc

31 January 2012

 



Scancell Holdings plc

Unaudited interim results for the six month period to 31^st October 2011

Scancell Holdings plc ("Scancell" or the "Company" or the "Group"), the developer of therapeutic cancer and infectious disease vaccines based on its patented Immunobody® platform, is pleased to announce the interim results for the six month period ended 31^st October 2011.

Highlights:

·    Sub-division of share capital and Placing to raise £1.73 million;

·    Development of new vaccine candidate for the treatment of lung cancer;

·    Phase 1 clinical trial of SCIB1 proceeded to highest dose level following safety review;

·     SCIB1 patent awarded; and

·    Change of board structure.

Post period highlights:

·    Receipt of second tranche payment of £2.85 million in November 2011 relating to the sale of a portfolio of antibodies to Arana Therapeutics.

For further information contact:

Scancell Holdings Plc Dr Richard Goodfellow / Professor Lindy Durrant	+ 44 (0)20 7653 9842*
Newgate Threadneedle (Financial PR) Guy McDougall/ Heather Armstrong	+ 44 (0)20 7653 9842
Zeus Capital - Nominated Adviser/Joint Broker Ross Andrews/Tom Rowley	+ 44 (0)161 831 1512
XCAP - Joint Broker Jon Belliss/ Adrian Kirk	[phone]

*calls to this number will reach Newgate Threadneedle, at Scancell's instruction.

About Scancell

Scancell is developing novel therapeutic vaccines for the treatment of cancer and infectious diseases based on its groundbreaking ImmunoBody® technology platform. Scancell's first cancer vaccine SCIB1 is being developed for the treatment of melanoma and is in Phase 1   clinical trials.

Treating cancer by vaccination allows small non-toxic doses of a vaccine to be administered to a patient, stimulating an immune response. Effective cancer vaccines need to target dendritic cells to 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.

A limitation of many cancer vaccines currently in development is that they cannot specifically target dendritic cells in vivo. Several groups have demonstrated successful vaccination by growing dendritic cells ex vivo, pulsing them with tumour antigens and re-infusing them. However, this procedure is patient specific, time consuming and expensive. Scancell has developed its breakthrough patent protected ImmunoBody® technology to overcome these limitations.

An ImmunoBody® is a human antibody or fusion protein engineered to express helper cell and CTL epitopes from tumour antigens over-expressed by cancer cells. Antibodies are ideal vectors for carrying T cell epitopes from tumour antigens as they have long half-lives and can effectively target dendritic cells via their Fc receptors, allowing efficient stimulation of both helper and CTL responses.

The Immunobody® technology can be adapted to provide the basis for treating any tumour type and may also be of potential utility in the development of vaccines against hepatitis, HIV and other chronic infectious diseases.

CHAIRMAN'S STATEMENT

In the six month period ended 31^st October 2011, Scancell raised £1.58 million, net of expenses, by way of a placing of new shares. Steady progress has been made with Scancell's vaccine SCIB1 with further patients being recruited into the Phase I clinical trials and new centres being opened.  Since the period end the Company has received £2.85 million (before any related tax or other costs are deducted) in respect of the second tranche payment from the sale of Scancell's antibody portfolio to Arana Therapeutics in 2006.

Financial

Profit and Loss Account

The Company made an overall operating loss for the six month period to 31^st October 2011 of £971,675 (2010: loss of £835,540). The increase in direct costs reflects the additional patient recruitment in the period and the opening of additional trial centres.

Overall the loss for the six month period was £923,405 (2010: loss £802,170)

Balance Sheet

The cash at bank at 31^st October 2011 was £1,915,276 (30^th April 2011: £1,110,630). The increase in cash during the period has arisen as a result of the net proceeds from the issue of shares of £1.58 million more than offsetting the loss for the period.

Subsequent to the period end, cash at bank was further augmented by the receipt of £2.85 million (before any deductions for tax and other costs) in respect of a second tranche payment from Arana Therapeutics. This payment arose as a result of a clinical mile-stone being achieved following the sale of Scancell's antibody portfolio in 2006.

Subdivision of share capital and placing

On 25^th July 2011 the shareholders of the Company approved resolutions for:

·      The proposed subdivision of each Existing Ordinary Share of 1p into 10 new Ordinary Shares of 0.1p each; and

·      A placing to raise £1.73 million, before costs, by means of the issue of 34,575,410 new Ordinary Shares at 5 pence per share to fund the working capital of the Company.

Following the approval of these resolutions the Company raised £1.58 million, net of costs

SCIB2

On 30^th June 2011, Scancell announced that a treatment utilising a DNA vaccine based on its Immunobody® technology, in combination with Homspera®, an adjuvant developed by ImmuneRegen Biosciences Inc, has produced encouraging anti-tumour responses in animal models.

This vaccine, known as SCIB2, stimulates immune responses to the lung cancer antigen NY-ESO-1 and may also have potential utility in oesophageal, liver, gastric, prostate, ovarian and bladder cancers. Unlike classical adjuvants, Homspera® did not enhance the SCIB2 systemic immune response but did make it more effective at the tumour site.  This successful application of Scancell's Immunobody® technology in conjunction with Homspera® provides further evidence that our Immunobody vaccine has the potential ground-breaking ability to augment the immune responses necessary to destroy cancer and could have profound implications for cancer vaccine therapy.

SCIB1 melanoma vaccine

Phase I Clinical Trial

The Phase I Clinical Trial commenced in June 2010 and is designed to evaluate the safety and tolerability of SCIB1 (Scancell's DNA Immunobody® vaccine being developed for the treatment of melanoma) in patients with late stage melanoma and also to gather data on the effects of SCIB1 on tumour growth and cellular immune response.

Whilst patient recruitment has been slower than originally anticipated good progress has been made and a second group of patients receiving the 2mg dose of SCIB1 in the Phase I clinical trial has been evaluated by the Cohort Review Committee.  Following the review of the safety data from this mid-dose level group of three patients the Cohort Review Committee approved further escalation of the dose to 4mg and the planned recruitment of the final group of patients

Patent Awarded

In a further important step in the development and commercialisation of SCIB1, a composition of matter patent (European Patent number: 2193803) has been granted for SCIB1.  This patent will protect the unique composition of the vaccine until March 2028

Board of Directors

Dr Richard Goodfellow was appointed Joint Chief Executive Officer on 30^th June 2011 as the Board recognised that Dr Goodfellow's position had evolved into a separate leadership role from that held by Professor Lindy Durrant, including management of Scancell's commercial activities, investor and City liaison.

On 18^th August 2011, Scancell announced the appointment of Kate Cornish-Bowden as a non-executive director. Kate is a Chartered Financial Analyst and has extensive experience of corporate governance as an institutional investor. She is currently a non-executive director of Investec Structured Products Calculus VCT plc. I am confident that she will make an invaluable contribution to the Scancell Board going forward.

.

Arana Therapeutics

On 1 December 2006, Scancell sold its portfolio of antibodies to Arana Therapeutics (then known as Peptech (UK) Limited and subsequently acquired by Cephalon, Inc, which itself is now owned by Teva Pharmaceutical Industries Limited). The consideration for the sale was a cash payment of £2 million, which was paid on completion of the sale, plus a possible further sum of £2.85 million gross which was payable when a milestone was achieved relating to the development of a drug derived from any of the antibodies which were the subject of the sale.

On 16^th November 2011, Scancell received payment of the further payment of £2.85 million from Cephalon Inc which, after the payment of bonuses and advisor costs, netted to £2.41 million before any charge for corporation tax that may arise.

Outlook

The broad utility and potential of the ImmunoBody platform continues to be supported by new research. This was exemplified in June 2011 by the discovery of a new candidate vaccine (SCIB2) which has potential for the treatment of lung and other epithelial cancers. The Board is confident that the research undertaken by Professor Durrant and her team will lead to the discovery of further vaccine candidates for other indications over the next 2 years. Such discoveries will provide further confirmation that the ImmunoBody platform can deliver multiple product candidates and underpin the value of the business as a product plus platform proposition.

Whilst the recruitment of patients for the SCIB1 phase clinical trial has been somewhat slower than originally anticipated, the Directors believe that recruitment for the Phase 1 trial will be completed during Q1 2012.  Phase 2, which is expected to commence in H1 2012, should be completed during 2013. The Directors believe that a successful outcome should present Scancell as an excellent potential acquisition opportunity for a larger biotechnology or pharmaceutical company operating in the oncology field.  

The clinical milestone that triggered the payment of £2.85 million gross from Cephalon Inc (Teva Pharmaceutical Industries Limited) provides further evidence to support the commercial viability of Scancell's research. Moreover the Directors believe that this money, together with other existing funds will be sufficient to complete the SCIB1 Phase I and Phase II clinical trials  without the need to raise further funds from Shareholders.

The Board is pleased with the Company's progress over the period, and would like to thank all those involved with Scancell for their dedication and support.

David Evans

Chairman

Scancell Holdings plc

Unaudited Consolidated Income Statement

for the six months to 31^st October 2011

                                                                                    Unaudited         Unaudited            Audited

                                                                                    six months        six months             Year to

                                                                                   31/10/2011        31/10/2010             30/04/2011

                                                                                          £                      £                          £

REVENUE                                                                                -                      -                           -

Cost of sales                                                                     526,077            377,655                 848,629

                                                                                 _________        ________           _________

GROSS LOSS                                                               (526,077)          (377,655)               (848,629)

Administrative Expenses                                                    445,598            457,885                 885,120                  

                                                                                 _________        ________           _________

OPERATING LOSS                                                    (971,675)          (835,540)            (1,733,749)

Interest receivable and similar income                                    6,240                  620                     9,613

                                                                                 _________          _______             ________

LOSS ON ORDINARY ACTIVITIES

BEFORE TAXATION                                                 (965,435)          (834,920)            (1,724,136)

Tax on loss on ordinary activities                                       (42,030)            (32,750)                 (74,911)

                                                                                 _________        ________           _________

LOSS FOR THE PERIOD ATTRIBUTABLE TO

EQUITY HOLDERS OF THE PARENT                    (923,405)          (802,170)            (1,649,225)

                                                                                 _________        ________             ________

BASIC EARNINGS PER SHARE (pence)(Note 2)            (0.9)                 (5.0)                    (10.4)

Scancell Holdings plc

Unaudited Consolidated interim statement of financial position

as at 31^st October 2011

                                                                                    Unaudited         Unaudited            Audited

                                                                                   31/10/2011        31/10/2010             30/04/2011

                                                                                           £                      £                          £

ASSETS

Non-current assets

Plant and equipment                                                          109,157            119,231                   98,933

Goodwill                                                                         3,415,120          3,415,120               3,415,120

                                                                     _______________ _______________ ______________

                                                                                      3,524,277          3,534,351               3,514,053

Current assets

Trade and other receivables                                               144,024            121,495                   58,626

Income tax assets                                                              116,250              97,567                   74,220

Cash and cash equivalents                                               1,915,276          1,740,925               1,110,630

                                                                     _______________ _______________ ______________

                                                                                      2,175,550          1,959,987               1,243,476

                                                                     _______________ _______________ ______________

TOTAL ASSETS                                                          5,699,827          5,494,338               4,757,529

                                                                     _______________ _______________ _______________

LIABILITIES

Current liabilities

Trade and other payables                                                   304,378            171,368                 121,787

                                                                     _______________ ______________ ______________

NET CURRENT ASSETS                                           1,871,172          1,788,619               1,121,689

                                                                     _______________ _______________ _______________

NET ASSETS                                                               5,395,449          5,322,970               4,635,742

                                                                     _______________ _______________ ______________

TOTAL EQUITY

Called up share capital                                                       194,093            159,266                 159,518

Share premium account                                                   9,911,110          8,345,275               8,369,023

Retained earnings                                                         (4,709,754)       (3,181,571)            (3,892,799)

                                                                     _______________ _______________ _______________

Attributable to equity holders of the parent                5,395,449          5,322,970               4,635,742

                                                                     _______________ _______________ ______________

Scancell Holdings plc

Unaudited consolidated interim cash flow statement

for the six month period to

31^st October 2011

                                                                                    Unaudited         Unaudited            Audited

                                                                                      6 months          6 months                Year

                                                                                   31/10/2011        31/10/2010             30/04/2011

                                                                                          £                      £                          £

Loss from operations                                                   (971,675)          (835,540)            (1,733,749)

Adjustments for:

Depreciation and amortisation                                              12,366              16,236                   33,250

Share based payment expense                                            106,450              53,263                 189,090

Operating cashflows before movements

in working capital                                                         (852,859)          (766,041)            (1,511,409)

Movement in receivables                                                   (85,398)            (63,676)                     (812)

Movement in payables                                                       182,591          (280,419)               (330,000)

Net cash outflow from operations                                (755,666)       (1,110,136)            (1,842,221)

Income taxes (paid)/ received                                                      -                      -                   65,510

Net cash used by operating activities                          (755,666)       (1,110,136)            (1,776,711)

Investing activities

Purchases of plant and equipment                                      (22,590)             (3,704)                     (417)

Interest received                                                                   6,240                  620                     9,613

Net cash used by investing activities                            (16,350)             (3,084)                     9,196

Financing activities

Proceeds from issue of shares for cash                            1,576,662              24,000                   48,000

Net cash from financing activities                                1,576,662              24,000                   48,000

Net increase/(decrease) in cash and cash equivalents  804,646       (1,089,220)            (1,719,515)

Cash and cash equivalents at beginning of period              1,110,630          2,830,145               2,830,145

Cash and cash equivalents at end of period                1,915,276          1,740,925               1,110,630

Scancell Holdings plc

Unaudited consolidated interim statement of changes in equity

                                                                                Share

                                                         Share              Premium         Retained

                                                         Capital            Account          Earnings            Total

                                                              £                        £                   £                        £

At 1^st May 2011                                 159,518               8,369,023     (3,892,799)            4,635,742

Loss for the period                                        -                           -        (923,405)            (923,405)

Share issue                                          34,575               1,694,195                    -            1,728,770

Share issue costs                                          -               (152,108)                    -            (152,108)

Share based payments                                  -                           -          106,450               106,450

                                                       _______          _________    _________          ________

At 31^st October 2011                         194,093               9,911,110     (4,709,754)            5,395,449

At 1^st May 2010                                 158,733               8,321,808     (2,432,664)            6,047,877

Loss for the period                                        -                           -        (802,170)            (802,170)

Share issue                                               533                   23,467                    -                24,000

Share based payments                                  -                           -            53,263                53,263

                                                       _______            ________    _________          ________

At 31^st October 2010                          159,266               8,345,275     (3,181,571)            5,322,970

At 1^st May 2010                                 158,733               8,321,808     (2,432,664)            6,047,877

Loss for the year                                          -                           -     (1,649,225)          (1,649,225)

Share issue                                               785                   47,215                    -                48,000

Share based payments                                  -                           -          189,090               189,090

                                                       _______            ________    _________          ________

At 30^th April 2011                               159,518               8,369,023     (3,892,799)            4,635,742

Scancell Holdings plc

Notes to the Interim Financial Statements

for the period to 31^st October 2011

1     Basis of preparation

This interim statement for the six month period to 31^st October 2011 is unaudited and was approved by the Directors on 30^th January 2012.  The financial information contained in the interim report has been prepared in accordance with the accounting policies set out in the annual report and accounts for the year ended 30^th April 2011.

The financial information contained in the interim report does not constitute statutory accounts as defined in section 434 of the Companies Act 2006. The financial information for the full preceding year is based on the statutory accounts for the year ended 30^th April 2011, upon which the auditors, Champion Accountants LLP, issued an unqualified audit opinion which did not contain any statement under section 498(2) or 498(3) of the Companies Act 2006. Without qualifying that opinion, the auditors drew attention to the fact that the Company's plan to raise additional funds by the placing of shares was subject to shareholder approval. The audited statutory accounts for the year ended 30 April 2011 have been lodged with the Registrar of Companies.

As permitted, this interim report has been prepared in accordance with AIM Rule 18 and not in accordance with IAS 34 "Interim Financial Reporting" therefore it is not fully in compliance with IFRS as adopted by the European Union.

2     Earnings per share

Basic earnings per share is calculated by dividing the earnings attributable to ordinary shareholders by the weighted average number of ordinary shares outstanding during the year.

The calculations of earnings per share are based on the following losses and numbers of shares.

                                                                  6 months to              6 months to         Year ended

                                                                  31/10/2011               31/10/2010          30/04/2011

Loss after taxation                                            (923,405)                 (802,170)          (1,649,225)

Weighted average number of shares               101,921,210               15,898,458           15,932,565

Basic earnings per share                                        (0.9)p                      (5.0)p                (10.4)p

On 25^th July 2011, the Company passed resolutions to subdivide the existing ordinary shares of 1p each into 10 new ordinary shares of 0.1p each and issue a further 34,575,410 shares to be placed at a price of 5p per share.

At 31^st October 2011 the Company had 194,093,310 Ordinary Shares of 0.1p in issue.

3     Taxation

Taxation for the six months ended 31^st October 2011 is based on the effective rates of taxation which are estimated to apply for the year ended 30^th April 2012.

 

4     Subsequent events

On 16^th November 2011 the company received £2.85m (before any related tax or other costs are deducted) in respect of the second tranche payment from the sale of Scancell's antibody portfolio to Arana Therapeutics in 2006.

On 13 December 2011 the company issued 376,175 new ordinary shares of 0.1 pence each at 6.38 pence per share in respect of annual advisory fees. 

5     Interim results

These results were approved by the Board of Directors on Monday 30^th January 2012.  Copies of the interim report are available to the public from the Group's registered office and the Group's website, www.scancell.co.uk.

 

END

 

 

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