Excerpts from the 1998 Annual report. 1999 not issued yet. Sorry about the formatting. Can't seem to get it lined up cleanly. (The occaisonal ? is an artifact fomr my word processor.)
Cambridge Antibody Technology Annual Report 1998 Highlights
? Impressive Phase I/IIa clinical data with D2E7, CAT/BASF human anti-TNFa antibody in rheumatoid arthritis. ? Human anti-TGFb2 Phase I/IIa clinical trials in glaucoma surgery initiated and on schedule but PVR clinical trial programme delayed. ? Two drug candidates entered pre-clinical development with clinical trials in fibrosis (anti-TGFb1 ) and autoimmunity /inflammation (anti-IL-12) due to commence in 1999. ? Powerful extension to platform technology and intellectual property through the purchase of Aptein Inc. ? CAT libraries now contain 100 billion human antibodies. ? Increased breadth of potential drug target base through significant collaborations with ICOS and Progenitor. Using its world-leading platform technologies, CAT is exploiting the unique characteristics of antibodies both to discover new disease targets through functional genomics and to engineer fully human antibodies as treatments for human diseases. CAT?s aim is to secure short term and long term revenues through technology access and product development respectively, working in partnership with others at all stages of the discovery and development process.
Statement by the Chairman CAT?s progress in its first full year, since becoming a listed company in March 1997, can be assessed against the plans given at that time. I am pleased to report a year of solid progress towards the delivery of those plans.CAT?s strategy continues to centre on a balance of collaboration, in-house development, and technological advance. As part of the pharmaceutical/life sciences industry, we are well aware of the opportunities and challenges arising from massive sequencing of the human genome. This in turn is expected to generate a proliferation of proteins that are targets for pharmaceutical intervention. Rights to those new targets will clearly be of major commercial significance and competition for them will be intense. Identification of such targets would be greatly assisted by the development of high throughput screening methods for selecting those genes whose predicted products are most likely to be pharmacological targets. CAT?s ProAb TM and ProxiMol © technologies do exactly that. Both require combinatorial antibody libraries. CAT can therefore make major contributions, industry-wide, to unlocking the value of genomic databases.
That is our intent: we aim to enter major collaborations and to secure rights to novel targets for antibody therapy. In the last year we signed two such collaborations with ICOS and Progenitor. Our technology platforms were further strengthened during the year by the acquisition of the US company Aptein Inc. bringing sole rights to the controlling patents for polysome display. Together with phage display this new technology has the potential to enhance significantly CAT?s antibody libraries. Of particular note during the year has been the progress achieved in the drug development pipeline with the initiation of clinical trials with 6B1 in glaucoma drainage surgery, the recently reported clinical studies with D2E7 in rheumatoid arthritis and the pre-clinical development of the human antibodies SL15 (anti-TGFb1) and J695 (anti-IL-12) ahead of clinical trials during the next year in fibrosis and autoimmunity/inflammation respectively. The demonstration of clinically significant benefit in the early studies of D2E7, the first product developed by CAT to enter clinical trials, is particularly encouraging and a demonstration of the power of our platform technology to derive drug candidates.
Financial review Net cash outflow for the financial year ended 30 September 1998 was œ10.0 million (1997: œ7.2 million) a 39% increase on 1997 levels. Cash at the year end was œ34.8 million (1997: œ44.6 million). CAT made a loss for the financial year of œ7.0 million (1997: œ8.4 million, after intellectual property acquisition costs). Revenues in the year totalled œ1.4 million (1997: œ1.1 million).The profile of revenues is irregular due to the nature of CAT?s business with the exact timing of milestone payments and licence fees being uncertain.The major source of income during the financial year has been the second instalment of a licence fee from Eli Lilly. Operating costs were œ11.2 million (1997: œ8.3 million, excluding intellectual property acquisition).The rise over the previous financial year largely reflects the increased scale of our activities, staff numbers having risen over the year from 98 to 139. Over the next financial year it is anticipated that staff costs will show a more modest increase as staff numbers level out at around 160. Capital expenditure during the year was œ3.9 million (1997: œ1.4 million). A significant part of this expenditure represents the cost of refurbishment and fitting out of 23,000 sq.ft. of additional specialist laboratory and office space at Cambridge House in Melbourn. Cambridge House was occupied earlier this month. CAT originally acquired a short leasehold interest but since the year end has acquired the freehold for œ0.8 million. During the year CAT entered into an agreement to purchase a US company, Aptein Inc. The acquisition was completed in July and gives CAT a powerful extension to its existing antibody display platform technology. Under the terms of the agreement CAT purchased the issued share capital and outstanding share options and warrants of Aptein for a total consideration of up to $11 million satisfied by the issue of up to 2.366 million CAT shares (an implied CAT share price of 278p.) $6 million of the consideration was satisfied by the issue of 1.290 million CAT shares on closing.The balance of the consideration of up to $5 million will be satisfied by the issue of up to 1.076 million CAT shares after Aptein?s European patents have been sustained through opposition or appeal. In accordance with accounting standards the cost of acquiring this new technology has been capitalised and will be written off over the lives of the patents concerned. The œ10 million cash spend in the period was significantly less than that estimated in December 1997. This was primarily because of lower spending than anticipated on pre-clinical development and clinical programmes. It is anticipated that CAT?s cash burn rate will rise modestly over the coming year ? levels are expected to increase to an average of approximately œ1.5 million per month (excluding revenues). At this increased burn rate, and excluding any cash from future collaborative deals, CAT has sufficient funds to finance existing operations for approximately two further years. CAT expects to require additional financing for the further development of its business.
Substantial shareholdings On 23 November 1998 the Company had been notified, in accordance with section 198 to 208 of the Companies Act 1985, of the following interests in the ordinary share capital of the Company: Number of issued share Percentage
Oracle Group 1,627,030 6.9% Medical Research Council 1,120,000 4.8% Vector Fund Management L.P. 1,072,960 4.6% 3i Group plc 1,000,865 4.3% Peptech Limited 819,125 3.5%
Patents CAT?s policy is to seek patent protection for technology it develops in-house and in collaboration with its research partners and to defend patents forcefully during the formal opposition phase of the European patent process and against any challenge to validity. A number of patents arising from both families of patent applications (McCafferty et al and Winter et al) covering CAT?s basic antibody technology have been granted in Europe and are currently in the opposition phase. In the US CAT has filed broadly similar patent applications with the United States Patent Office. The McCafferty patent application is under examination in the US.The Winter et al patent application is the senior applicant in an interference action within the US Patent Office involving other US patent applications. Since the year end CAT?s bi-specific diabodies patent has been granted in the US. The acquisition of Aptein Inc. has provided CAT with the fundamental patents for polysome display which are granted in both the US and Europe. CAT has licensed certain rights to phage display patents held by Dyax Corporation. CAT continues to oppose Dyax?s patent in Europe. In September 1998 CAT commenced a patent infringement action in the Munich District Court against MorphoSys of Germany who it believes is currently infringing two of the Company?s key patents ? Winter et al and McCafferty et al. The action does not impact on CAT?s freedom to operate its technology.
Consolidated profit and loss account for the year ended 30 September 1998
1998 1997 œ?000 œ?000 Turnover 1,354 1,134 Direct costs (61) (51) Gross profit 1,293 1,083
Research and development expenses (9,125) (6,693) MRC intellectual property acquisition (non-cash) (2,967) General and administration expenses (2,078) (1,576)
Operating loss (9,910) (10,153) Amounts written off investments ? (1) Interest receivable (net) 6 2,959 1,799
Loss on ordinary activities before taxation (6,951) (8,355) Taxation on loss on ordinary activities (4) ?
Loss on ordinary activities before taxation (6,951) (8,355) Taxation on loss on ordinary activities (4) ?
Loss per share ? basic and fully diluted (pence) 31.0p 47.9p
Consolidated balance sheet 30 September 1998 1998 1997 œ?000 œ?000
Fixed assets Intangible assets 4,576 ? Tangible fixed assets 4,792 1,763 9,368 1,763
Current assets Debtors 1,449 1,111 Investment in liquid resources 34,824 44,182 Cash at bank and in hand 36,293 45,704
Creditors Amounts falling due within one year (2,194) (1,817) Net current assets 34,099 43,887 Total assets less current liabilities 43,467 45,650 Creditors Amounts falling due after more than one year (9) (13) Net assets 43,458 45,637
Capital and reserves Called-up share capital 2,349 2,215 Share premium account 45,820 42,785 Other reserve 13,339 13,383 Shares to be issued 1,650 ? Profit and loss account (19,700) (12,746) Shareholders? funds ? all equity 43,458 45,637 |