Preliminary Results for the Year Ended 31 December 2014

Click here to download the full 2014 preliminary results statement

– Strong clinical progress; Cat-SPIRE phase III study fully recruited –
– Robust financial position; fully-funded to bring Cat-SPIRE to market –
– Commercialisation preparations underway; infrastructure build advancing –

Oxford, UK – 26 February 2015: Circassia Pharmaceuticals plc (“Circassia” or “the Company”) (LSE: CIR), a specialty biopharmaceutical company focused on allergy, today announces its preliminary results for the year ended 31 December 2014.

OPERATIONAL HIGHLIGHTS

Cat-SPIRE
• Completed recruitment for phase III registration study (CATALYST); on track to report results in H1 2016
• Initiated two-to-five year follow-on study (CP007A); 138 subjects from CATALYST enrolled to date
• On track to complete paediatric safety study (CP009) in H2 2015
• Paediatric study plan agreed with FDA

HDM-SPIRE (House Dust Mite)
• Positive results from two-year follow-up phase IIb study (TH002A)
• Excellent safety profile demonstrated in controlled asthmatic study (TH004)
• Completed observational study (TH003) to inform field study design
• Initiated large phase IIb field study (TH005)

Grass-SPIRE
• Highly encouraging results from third season follow-up phase IIb study (TG002B)
• Initiated phase II safety study in controlled asthmatics (TG004)
• Initiated observational study (TG003) to inform phase III design

Ragweed-SPIRE
• Symptoms reduced in phase IIb chamber study (TR006); results suggest optimal dose not tested
• Supportive subsequent field data from TR006; reduction in symptoms and rescue medication use
• Follow-up study (TR006A) planned to assess effect of allergen exposure during further ragweed season
• Positive results from safety study (TR007) support inclusion of controlled asthmatics in future studies
• Additional phase IIb dose ranging study planned

Commercialisation progress
• Appointed Chief Commercial Officer; US subsidiary established
• Building US and EU market access and medical affairs team to expand relationships with allergists
• Positive research with specialists, patients and payers in US and key EU markets
• US patent term extended for Cat-SPIRE, HDM-SPIRE and Grass-SPIRE; protection to at least 2030

FINANCIAL HIGHLIGHTS

• Successful flotation on the London Stock Exchange raised £202.0 million (£192.4 million net)
• Increased investment in research and development to £38.6 million (2013: £21.1 million)
• Loss for the year £35.1 million (2013: £20.0 million)
• Strong balance sheet with £186.6 million cash and deposits at 31 December 2014 (31 December 2013: £30.6 million)

Steve Harris, Circassia’s Chief Executive, said: “2014 has been transformational for Circassia.  In March, we raised over £200 million through a successful IPO, and now have the funds to accelerate our late-stage clinical portfolio and establish the infrastructure to independently commercialise our first next generation allergy treatment.  During the year, we made good progress towards meeting these goals.  We completed recruitment for our phase III Cat-SPIRE registration study, which remains on track to report in H1 2016, and completed five further clinical trials across our portfolio.  We are committed to bringing our innovative allergy products to market, and during the year we began to build our commercial organisation.  With the US allergy immunotherapy marketplace opening up to new treatment approaches, we are well positioned to exploit the growing interest in this poorly served field.”

– Ends –

An analyst meeting will take place today at 9.30am at Peel Hunt, Moor House, 120 London Wall, London, EC2Y 5ET.  A 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
Rob Budge, Corporate Communications
Tel: +44 (0)1865 405 560

J.P. Morgan Cazenove
James Mitford / Alex Bruce
Tel: +44 (0) 20 7742 4000

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

FTI Consulting
Ben Atwell / Simon Conway / Mo Noonan
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
Circassia Circassia is a specialty biopharmaceutical company focused on the development and commercialisation of a range of allergy immunotherapy product candidates.  Established in 2006, the Company has used its proprietary ToleroMune® technology to develop a new class of therapies, Synthetic Peptide Immuno-Regulatory Epitopes (SPIREs), which have the potential to revolutionise allergy treatment.

The Company’s portfolio of SPIREs is designed to treat a broad range of seasonal and perennial allergies.  The most advanced, Cat-SPIRE, targets cat allergy and is currently in phase III development.  Three other product candidates, targeting house dust mite, ragweed and grass allergies, have completed clinical proof-of-concept phase IIb studies.

Further information is available at: www.circassia.com.