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20 Nov 2009 07:00
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For immediate releaseΒ |
20Β November 2009 |
Β
MINSTER PHARMACEUTICALS PLC
("Minster" or "the Company")
Interim Results for the six months ended 30 September 2009
Minster Pharmaceuticals plcΒ (AIM: MPM), the drug development company specialising in neurological and psychiatric disorders, is pleased to announce its results for the six months ended 30 September 2009.
Highlights in the year to date:
H1 2009 pre-tax loss of Β£927,464 (H1 2008: Β£3,629,695)
SubstantialΒ reductionΒ during H1Β of Β£250,000Β inΒ annualΒ operatingΒ costΒ base
Cash andΒ cashΒ equivalents ofΒ Β£4,839,738Β (H1Β 2008:Β Β£9,009,917)
Decision to focus on sabcomeline for treatment of cognitiveΒ declineΒ in schizophrenia andΒ toΒ seekΒ aΒ partner to pursue tonabersat's further development
Currently finalisingΒ the development plan forΒ sabcomelineΒ
John Russell, Minster Pharmaceuticals'Β Chairman and Interim CEO, said:Β
"We have decided to seek a partner to pursue tonabersat's further development and to focusΒ our clinical workΒ on sabcomeline. WeΒ remain in a strong financial position, havingΒ substantiallyΒ reducedΒ operating expenditure toΒ achieve savings of Β£250,000 a year. At the completion of the half year, we had cash and cash equivalents of Β£4.8 million. We continue to explore all options to generate value for shareholders."
For further information:
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Minster Pharmaceuticals plc |
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|
John Russell, Chairman and Interim CEO |
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Karl Keegan, Chief Financial Officer |
Tel: +44 (0) 20 7936 9921 |
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Buchanan Communications |
Tel: +44 (0) 20 7466 5000 |
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Mark CourtΒ /Β Catherine Breen |
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Nomura Code Securities Limited |
Tel: +44 (0) 20 7776 1200 |
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Chris CollinsΒ / Richard PottsΒ |
Notes for editors:Β
About Minster Pharmaceuticals plc
Minster Pharmaceuticals is a drug development company focussed on neurological and psychiatric disorders. Its principal pipeline assets are tonabersatΒ and sabcomeline. Worldwide rights to both compounds were acquired from GlaxoSmithKline and the compounds benefit from comprehensive safety tolerance data as a result of investment by GSK.
Tonabersat is the leading compound in an exciting new class of selective drugs designated as neuronal gap junction blockers.Β Sabcomeline, a muscarinic partial agonist, has potential in the treatment ofΒ cognitive decline inΒ schizophrenia and the strategy for its further clinical development is currently under consideration.
Minster joined the AIM market in February 2005 and trades under the symbol MPM. For further information please visitΒ www.minsterpharma.com.Β
Β Β CHAIRMAN ANDΒ INTERIMΒ CEO'S REVIEWΒ
TheΒ half yearΒ to 30 September 2009 wasΒ a period during which we madeΒ goodΒ progressΒ in evolvingΒ our strategy for generating value for shareholders.Β During the period, weΒ also focused closely on our cost base, making substantial reductions in our operating expenditure toΒ achieve annualised savings of Β£250,000Β a year. At the completion of the half year,Β we had cash and cash equivalents of Β£4.8Β million.
We enter the current half with a compact and highly experienced operational team of three executives and a full-time consultant. This team isΒ examining the possibilities forΒ maximising the value of our pipeline assets, tonabersat and sabcomeline.
The result of the TEMPUS study of tonabersat in migraine prevention wasΒ disappointing,Β as we statedΒ in February this year. HoweverΒ weΒ remain confident aboutΒ the long term potential ofΒ tonabersatΒ in other indications.Β PreclinicalΒ data suggestsΒ strongly that tonabersat could be effective inΒ the treatment ofΒ epilepsy and neuropathic pain.Β We also announcedΒ very encouraging resultsΒ from theΒ Phase IIΒ trialΒ of tonabersat in migraine with auraΒ in October 2008.
The result of the TEMPUS studyΒ prompted the Board to look closely at the Company'sΒ assetsΒ in a strategic review focused particularly on the opportunities and costs associated with the development and commercialisationΒ of tonabersat and sabcomeline.Β
Tonabersat
The BoardΒ hasΒ concluded that the valueΒ of the tonabersat compoundΒ willΒ beΒ best exploitedΒ inΒ the areas of pain and epilepsyΒ as well as theΒ opportunity inΒ migraine with aura. Owing to the substantial furtherΒ clinicalΒ work required, we have decided to seek a partner toΒ pursueΒ the compound'sΒ further development.
We believe that tonabersat is a highly attractive asset to a company with the appropriate resources. It is the most advanced compound in a new class of drugs, known as gap junction blockers. ItΒ hasΒ alsoΒ been shown to be safe and well-tolerated in extensive human trials carried out by GlaxoSmithKline, prior to Minster's acquisition of the compound, and in Minster's own studies.Β
One of the key attractions of tonabersat is that it could have broad utility in a number of neurological conditions. TheΒ NINDS (part of theΒ National Institutes of Health in theΒ US)Β has been investigating tonabersat inΒ itsΒ preclinical models ofΒ epilepsy and neuropathic pain and is expected toΒ reportΒ itsΒ data on theΒ profileΒ of the compound in these indications in the near future.Β ReceiptΒ of this data should further the understanding of the compound and assist us in securing an appropriate development and commercialisation partner.
Sabcomeline
During the past few years, our clinical focus has been on tonabersat but we have also been evaluating sabcomeline for the treatment of cognitiveΒ decline inΒ schizophrenia.Β
We have now decided, given the exciting potential of this compound in this serious unmet medical need, to prioritise the development of sabcomeline. We are in the process of finalising a development plan and are considering the most appropriate development or co-development route. The development plan will allow the start of a Phase II proof of concept study in the first half of next year, which would report around nine months later.
Sabcomeline is a functionally selectiveΒ muscarinic partial agonist,Β whichΒ offersΒ potential in arresting cognitiveΒ decline inΒ schizophrenia. In common with tonabersat, sabcomeline benefits from extensive clinical data generated by GlaxoSmithKline indicating that the compound is safe and well-tolerated.Β
CognitiveΒ decline inΒ schizophreniaΒ has becomeΒ recognised asΒ an area ofΒ major unmet clinical needΒ in theΒ past few years. Atypical neuroleptics and other drugs have been successful in controlling theΒ positive symptomsΒ of schizophrenia but unfortunatelyΒ areΒ unable to treat cognitiveΒ decline,Β which often begins whilst a schizophrenic is in their 20s and renders them unable to work orΒ toΒ conduct a fulfilling lifestyle. We believe that sabcomeline could be given in combination withΒ currently available atypicalΒ neuroleptics to provide a significant improvement in the quality of life of schizophrenia sufferers. In theΒ USΒ there are 1.5 million schizophrenia sufferers,Β according to the US National Institute of Mental Health.Β
As an essential step towards the start of the Phase II proof of concept study,Β MinsterΒ hasΒ recently completedΒ an in-vitroΒ P-glycoprotein (P-gp) study of sabcomeline. TheΒ P-gpΒ study was seeking to identify any adverse effect of sabcomeline on theΒ P-gpΒ transporter enzyme system, which is involved in theΒ passageΒ of drugs through the gut wall and blood-brain barrier, to ensure that no detrimental drug interactionΒ is likely toΒ take place.
This study, which was carried out at a likely clinicalΒ plasmaΒ concentrationΒ and also at higher multiples of thatΒ concentration, was successful in that it showed that sabcomeline did not act as a substrate, inhibitor or inducer of theΒ P-gpΒ system.
During the half year,Β MinsterΒ sought to further developΒ itsΒ intellectual property around sabcomeline in cognitive declineΒ in schizophrenia and in July announced the successful filing of a divisional application in theΒ US.Β Based on an opinion obtained from Minster'sΒ USΒ attorney, the Company has confidence that the claims are patentable and should therefore be granted.
CostΒ baseΒ andΒ businessΒ development
As part ofΒ theΒ strategic review,Β theΒ BoardΒ looked very closely atΒ theΒ Company'sΒ cost base andΒ hasΒ made substantial reductions in operating costs. In addition to reducing the number of staff and consultants,Β MinsterΒ hasΒ closedΒ itsΒ Audley End officeΒ in EssexΒ and moved toΒ a small serviced office in centralΒ London.Β
As part of the review,Β theΒ BoardΒ also analysedΒ theΒ potentialΒ commercialΒ partnersΒ forΒ itsΒ compoundsΒ on a global basisΒ and determined thatΒ theΒ UKΒ andΒ mainlandΒ EuropeΒ should beΒ theΒ focusΒ ofΒ itsΒ efforts given the development stage ofΒ the Company'sΒ assets.Β MinsterΒ hasΒ thereforeΒ curtailedΒ itsΒ USΒ business development activitiesΒ but continuesΒ to work closely with US academics and clinicians.Β Minster'sΒ objective is to improve the understandingΒ amongst potential partnersΒ of the commercial opportunitiesΒ whichΒ the Company'sΒ compounds present and thereby attract the right partnering or collaborative opportunities.
Financial results
The unaudited loss after taxation for the six months ended 30 September 2009 was Β£927,464Β (H1 2008: Β£3,478,875) and is in line with management's expectations.Β Cash and cashΒ equivalents at 30 September 2009 wereΒ Β£4,839,738Β (H1 2008: Β£9,009,917).
The loss for the half year has reduced significantly comparedΒ withΒ the same period last year as a direct result of finishing the TEMPUS trial. Furthermore, given that the trial was not successful,Β we have been able to release accruals relating to this trial, resulting in a positive figure forΒ research expenses in the first half year.
Outlook
MinsterΒ isΒ making good progress in definingΒ itsΒ strategy to unlock the value inΒ itsΒ two compounds, tonabersat and sabcomeline.
The CompanyΒ hasΒ decided to find a partner for the further development of tonabersat,Β which has potential in multiple neurological indications, andΒ isΒ preparing sabcomeline for a Phase II proof of concept study in the treatment of cognitiveΒ declineΒ in schizophrenia, a condition ofΒ highΒ unmet medical need.Β
TheΒ Board of Minster isΒ focused onΒ exploring all options toΒ generateΒ value for shareholders.Β
John Russell
Chairman andΒ InterimΒ CEO
Β
20Β November 2009
Β Β UnauditedΒ CondensedΒ Consolidated StatementΒ of Comprehensive Income
For the sixΒ months ending 30 September 2009
|
6 months to |
6 months to |
12 months to |
|
|
30 September 2009 |
30 September 2008 |
31 March 2009 |
|
|
Β£ |
Β£ |
Β£ |
|
|
Revenue |
- |
- |
- |
|
Research expenses |
79,045 |
(3,078,550) |
(6,195,211) |
|
Administrative expenses |
(795,399) |
(1,238,688) |
(2,109,744) |
|
(Losses) / gains on foreign exchange |
(225,130) |
472,489 |
1,368,790 |
|
Operating loss |
(941,484) |
(3,844,749) |
(6,936,165) |
|
Interest receivable |
14,020 |
215,054 |
297,193 |
|
Loss before taxation |
(927,464) |
(3,629,695) |
(6,638,972) |
|
Taxation on the results for the period |
- |
150,820 |
326,641 |
|
LossΒ for the periodΒ after taxation |
(927,464) |
(3,478,875) |
(6,312,331) |
|
Total comprehensive income for the period |
(927,464) |
(3,478,875) |
(6,312,331) |
|
Loss per share |
|||
|
Basic per share |
Β£0.016 |
Β£0.059 |
Β£0.107 |
|
Fully diluted per share |
Β£0.013 |
Β£0.048 |
Β£0.088 |
Β Β Unaudited Consolidated Statement of Changes in Equity
For the sixΒ months ending 30 September 2009
|
6 months to |
6 months to |
12 months to |
|
|
30 September 2009 |
30 September 2008 |
31 March 2009 |
|
|
Β£ |
Β£ |
Β£ |
|
|
Equity shareholders' funds brought forward |
18,238,499 |
24,407,992 |
24,407,992 |
|
Total comprehensive income for the period |
(927,464) |
(3,478,875) |
(6,312,331) |
|
Effect of share-based payment charge |
74,169 |
70,761 |
142,838 |
|
Equity shareholders' funds carried forward |
17,385,204 |
20,999,878 |
18,238,499 |
Β Β
Unaudited ConsolidatedΒ Statement of Financial Position
At 30 September 2009
|
30 September 2009 |
30 September 2008 |
31 March 2009 |
|
|
Β£ |
Β£ |
Β£ |
|
|
Non-current assetsΒ |
|||
|
Intangible assets |
12,397,754 |
12,397,754 |
12,397,754 |
|
Property, plant and equipment |
7,310 |
8,276 |
6,999 |
|
12,405,064 |
12,406,030 |
12,404,753 |
|
|
Current assets |
|||
|
Trade and other receivables |
270,049 |
180,888 |
114,989 |
|
Current tax assets |
- |
150,820 |
326,641 |
|
Cash and cash equivalents |
4,839,738 |
9,009,917 |
6,341,650 |
|
5,109,787 |
9,341,625 |
6,783,280 |
|
|
Total assets |
17,514,851 |
21,747,655 |
19,188,033 |
|
Current liabilities |
|||
|
Trade and other payables |
(129,647) |
(747,284) |
(949,534) |
|
Non-currentΒ liabilitiesΒ |
|||
|
Provisions |
- |
(493) |
- |
|
TotalΒ liabilities |
(129,647) |
(747,777) |
(949,534) |
|
Net assets |
17,385,204 |
20,999,878 |
18,238,499 |
|
Shareholders' equity |
|||
|
Share capital |
2,945,066 |
2,945,066 |
2,945,066 |
|
Share premium |
26,071,249 |
26,071,249 |
26,071,249 |
|
Capital reserve |
4,837,500 |
4,837,500 |
4,837,500 |
|
RetainedΒ lossesΒ |
(16,468,611) |
(12,853,937) |
(15,615,316) |
|
Total shareholders' equity |
17,385,204 |
20,999,878 |
18,238,499 |
Β Β Unaudited ConsolidatedΒ Statement of Cash Flows
For the six months ending 30 September 2009
|
6 months to |
6 months to |
12 months to |
|
|
30 September 2009 |
30 September 2008 |
31 March 2009 |
|
|
Β£ |
Β£ |
Β£ |
|
|
Reconciliation of operating loss to net cash outflow from operating activities |
|||
|
Operating loss before taxation and interest |
(941,484) |
(3,844,749) |
(6,936,165) |
|
Depreciation charges |
1,906 |
1,613 |
3,300 |
|
Potential national insurance liability on unapproved warrants and share options |
- |
- |
(493) |
|
Loss on disposal of property, plant and equipment |
- |
70 |
70 |
|
Equity settled share options |
74,169 |
70,761 |
142,838 |
|
Change in receivables |
(155,060) |
(17,470) |
48,429 |
|
Change in payables |
(819,888) |
298,023 |
500,273 |
|
Cash outflow from operating activities |
(1,840,357) |
(3,491,752) |
(6,241,748) |
|
Cash flow statement |
|||
|
Cash flows from operating activities |
|||
|
Cash outflow from operating activities |
(1,840,357) |
(3,491,752) |
(6,241,748) |
|
Interest received |
14,020 |
215,054 |
297,193 |
|
Taxation received |
326,641 |
443,383 |
443,382 |
|
Net cash outflow from operating activities |
(1,499,696) |
(2,833,315) |
(5,501,173) |
|
Cash flows from investing activities |
|||
|
Purchase of plant and equipment |
(2,216) |
(1,490) |
(1,899) |
|
NetΒ (decrease)/increase in cashΒ andΒ cash equivalents |
(1,501,912) |
(2,834,805) |
(5,503,072) |
|
Cash and cash equivalents at beginning of period |
6,341,650 |
11,844,722 |
11,844,722 |
|
Cash and cash equivalents at end of period |
4,839,738 |
9,009,917 |
6,341,650 |
Β Β Notes to the Interim Report
|
1. |
Publication of non-statutory accounts |
|
i) |
The interim financial information for the six months ended 30 September 2009Β includes the results of Minster Pharmaceuticals plc and its subsidiary Minster Research Limited. |
|
ii) |
The unaudited income statement for the six month period to 30 September 2009Β and the unaudited balance sheet as at 30 September 2009Β do not amount to full accounts within the meaning of SectionΒ 435Β of the Companies ActΒ 2006Β and have not been deliveredΒ to the Registrar of Companies. The Interim Report is unaudited and does not constitute Statutory Accounts. |
|
The Group statutory accounts for the year ended 31 March 2009Β have been filed with the Registrar of Companies and are available on the Company's website at www.minsterpharma.comΒ and in printed form from the Company's Registered Office atΒ Salisbury House,Β Station Road,Β Cambridge,Β Cambridgeshire,Β CB1 2LA. The auditors' report on these financial statements was unqualified.Β |
|
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iii) |
The Interim Statement is available on the Company's website atΒ www.minsterpharma.comΒ and in printed form from the Company's Registered Office atΒ Salisbury House,Β Station Road,Β Cambridge,Β Cambridgeshire,Β CB1 2LA. |
|
2. |
Basis of preparation |
|
These consolidated interim financial statements are for the six months ended 30Β September 2009Β and are prepared in accordance withΒ IFRSΒ as adopted by the European UnionΒ on the historical cost basis. They do not include all the information required for full annual financial statements, and should be read in conjunction with the consolidated financial statements of the Group for the year ended 31Β March 2009Β which have been prepared in accordance with IFRS as adopted by the European Union. |
|
|
The unaudited interim financial statements have been prepared on the basis of the accounting policies adopted in the audited accounts for the year ended 31 March 2009. |
|
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3. |
Loss per share |
The calculation of loss per share is based on the following information:
|
6 months to |
6 months to |
12 months to |
|
|
30 September 2009 |
30 September 2008 |
31 March 2009 |
|
|
Loss attributable to shareholders |
Β£927,464 |
Β£3,478,875 |
Β£6,312,331 |
|
Weighted average number of shares (basic) |
58,901,312 |
58,901,312 |
58,901,312 |
|
Weighted average number of shares (diluted) |
71,801,312 |
71,801,312 |
71,801,312 |
The calculation of the basic and fully diluted lossΒ per shareΒ as set out in the condensed consolidated statement of comprehensive incomeΒ is based on the loss after taxation andΒ basic and diluted weighted average number ofΒ sharesΒ set out above.Β
The weighted average number of shares of 5p (diluted) is calculated to assume conversion of all shares to be issued as secondary consideration and those options and warrants where the exercise price is below the mid-market price of the Ordinary shares at the period end.Β
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