Interim Results for the Six Months Ended 30 June 2014

Click here to download the full 2014 interim results statement

— Successfully raised over £200 million in landmark IPO —
— Fully-funded to bring to market the first of a new generation of allergy immunotherapies —
— Strong operational momentum and Cat-SPIRE phase III study >85% recruited —

Oxford, UK – 29 July 2014: Circassia Pharmaceuticals plc (“Circassia” or “the Company”) (LSE: CIR), a clinical-stage specialty biopharmaceutical company, today announces its interim results for the six months ended 30 June 2014.

OPERATIONAL HIGHLIGHTS

Cat-SPIRE
– Phase III registration field study (CP007) >85% recruited: 1,037 subjects randomised, full recruitment on track to complete by year-end with headline data expected H1 2016
– Follow-on 2-5 year study (CP007A) initiated following regulatory approval
– Pilot phase II paediatric safety study (CP009) ongoing

HDM-SPIRE (house dust mite)
– FDA approval received for HDM-SPIRE phase IIb field study (TH005)
– Positive results from phase IIb two-year follow-up study (TH002A)
– Observational field study (TH003) successfully completed
– Phase II controlled asthmatic safety study (TH004) initiated and fully-recruited

Ragweed-SPIRE
– Confirmatory phase IIb chamber study (TR006) initiated and fully-recruited
– Phase II controlled asthmatic safety study (TR007) initiated and fully-recruited

Grass-SPIRE
– Phase IIb third season follow-up study (TG002B) initiated
– Phase II controlled asthmatic safety study (TG004) initiated
– Observational study (TG003) initiated

FINANCIAL HIGHLIGHTS (unaudited)

– Raised gross proceeds of £202.0 million (£192.4 million net of expenses) following successful initial public offering (IPO) on the Main Market of the London Stock Exchange
– Research and development investment of £16.4 million (H1 2013: £9.1 million)
– Loss for the financial period of £16.2 million (H1 2013: £7.3 million)
– Net cash used in operating activities of £21.3 million (H1 2013: £9.2 million)
– Cash balances1 at 30 June 2014 of £201.9 million (31 December 2013: £30.6 million)

1. Cash, cash equivalents and short-term bank deposits

Steve Harris, Circassia’s Chief Executive, said: “Circassia has made extraordinary progress over the past seven years which has resulted in a transformational start to 2014.  Building on impressive proof-of-concept clinical data across multiple programmes, we raised over £200 million through an IPO and are fully-funded to bring our lead product candidate Cat-SPIRE to market.  Our phase III registration trial in cat allergy is on track and we expect to report headline data in H1 2016.  Furthermore, we have initiated seven new clinical trials this year, six of which are expected to report over the next 12 months.

“Our short-course SPIRE product candidates represent a major step change to a new generation of allergy treatments.  The US immunotherapy market is gathering momentum, and with manufacturing already at commercial scale for the launch of Cat-SPIRE we remain resolutely focused on delivering our key clinical milestones, developing our commercial operations and pursuing options to accelerate growth.”  

-Ends-

An analyst meeting will take place today at 9.30am BST at the offices of FTI Consulting, 200 Aldersgate, Aldersgate Street, London EC1A 4HD, with registration and coffee from 9.15am BST.  Simultaneously, a live webcast of the event will be available in the Media section of the Company’s website at www.circassia.com.

For further information, please contact:

Circassia
Steve Harris, Chief Executive Officer
Julien Cotta, Chief Financial Officer
Lara Flynn, Vice President Corporate Affairs
Tel: +44 (0)1865 405 560

J.P. Morgan Cazenove
Gina Gibson / Siddharth Natarajan
Tel: +44 (0) 20 7742 4000

Peel Hunt
James Steel / Clare Terlouw
Tel: +44 (0) 20 7418 8900

FTI Consulting
Ben Atwell / John Dineen
Tel: +44 (0) 20 3727 1000

Forward-looking statements
This press release contains certain projections and other forward-looking statements with respect to the financial condition, results of operations, businesses and prospects of Circassia.  The use of terms such as “may”, “will”, “should”, “expect”, “anticipate”, “project”, “estimate”, “intend”, “continue”, “target” or “believe” and similar expressions (or the negatives thereof) are generally intended to identify forward-looking statements.  These statements are based on current expectations and involve risk and uncertainty because they relate to events and depend upon circumstances that may or may not occur in the future.  There are a number of factors that could cause actual results or developments to differ materially from those expressed or implied by these forward-looking statements.  Any of the assumptions underlying these forward-looking statements could prove inaccurate or incorrect and therefore any results contemplated in the forward-looking statements may not actually be achieved.  Nothing contained in this press release should be construed as a profit forecast or profit estimate. Investors or other recipients are cautioned not to place undue reliance on any forward-looking statements contained herein.  Circassia undertakes no obligation to update or revise (publicly or otherwise) any forward-looking statement, whether as a result of new information, future events or other circumstances.

Notes to editors

1. Circassia
Circassia is a specialty biopharmaceutical company focused on the development and commercialisation of a range of immunotherapy product candidates for the treatment of allergy.  Established in 2006, the Company has used its innovative proprietary technology, the ToleroMune® platform, to develop a new class of allergy therapies; Synthetic Peptide Immuno-Regulatory Epitopes (SPIREs) which Circassia believes represents a step change to a new generation of allergy treatments.  The Company’s portfolio of product candidates is designed to treat a broad range of seasonal and perennial allergies.  The lead product candidate Cat-SPIRE, a new treatment for cat allergy, is currently in phase III development and three other product candidates have completed phase IIb clinical studies.  As Circassia continues to grow, the Company remains focused on its founding principle – a commitment to improving patients’ lives by controlling immune responses.  Further information is available at: www.circassia.com.