Lainate, Italy – 18 July 2018 – Cassiopea SpA (SIX: SKIN), Cassiopea SpA (SIX: SKIN), a clinical-stage specialty pharmaceutical company focused on developing and commercializing innovative and differentiated medical dermatology products, announced today its half-year results for the period ended 30 June 2018.
Highlights
- Very positive top line Phase III results for Winlevi® (Clascoterone) in treating acne; statistically significant improvements in all primary endpoints.
- Very positive six-month interim analysis Phase II Dose Ranging results for Breezula® (Clascoterone) in treating androgenetic alopecia in men; statistically significant improvement for Target Area Headcount (TAHC) and directional improvement for Hair Growth Assessment (HGA).
- CB-06-02 Proof of Concept trial in genital warts completed and results will be available later in July 2018.
- All costs within budget
Diana Harbort, CEO of Cassiopea SpA, commented: “It’s been an exciting and productive first half of the year. As promised, 2018 is a pivotal year for our Company as we complete major clinical studies for three of our products, move toward regulatory submission and pre-commercial activities for Winlevi®, further invest in the advancement of each of our programs, and begin to build out the infrastructure of Cassiopea. We are convinced that we have one of the most innovative pipelines in the dermatology industry and view the future with great optimism.
Key financial figures
| In EUR thousands (with the exception of the share data in EUR) | 1H 2018 | 1H 2017 |
| Revenue | – | – |
| Cost of sales | – | – |
| Research and development expenses | (6.423) | (6.452) |
| Selling, general and administrative expenses | (663) | (818) |
| Net operating expenses | (7.086) | (7.270) |
| Operating result | (7.086) | (7.270) |
| Profit (Loss) before taxes | (6.729) | (9.267) |
| Profit (Loss) after taxes for the period | (6.729) | (9.267) |
| Profit (Loss) per share | (0,673) | (0,927) |
| In EUR thousands | 30.06.2018 | 31.12.2017 |
| Non-current assets | 8.964 | 9.104 |
| Other current assets | 1.954 | 1.767 |
| Cash and cash equivalents | 11.361 | 17.598 |
| Total assets | 22.279 | 28.469 |
| Non-current liabilities | 0 | 0 |
| Current Liabilities | 2.233 | 2.115 |
| Total Equity | 20.046 | 26.354 |
| Total Equity & Liabilities | 22.279 | 28.469 |
- No revenues were generated in H1 2018 since all products are still under development
- No goods were manufactured for sale so there were no COGS
- R&D costs consisted primarily of outsourced preclinical and clinical expenses of EUR 5.169 thousand of which 71,1% were for the phase III trials for Winlevi®, 28,2% for the phase II dose ranging trial of Breezula® and 0,7% for the proof of concept trial of CB-06-02.
- Personnel expenses were increased 14,4% to EUR 717 thousand. There were 9 directly employed persons, no change from H1 2017.
- Cash and cash equivalents declined to EUR 11.361 thousand. These funds are held primarily in US$.
- Total equity declined to EUR 20.046 thousand; 90% of assets were financed by equity.
Half-year 2018 results conference call at 16:00 CEST on 18 July 2018
Diana Harbort, CEO; Luigi Moro, CSO; Alessandro Mazzetti, CMO; Chris Tanner, CFO and Head IR; and Marco Lecchi, Finance Director, will present the half-year results and discuss the outlook for 2018 at a conference call to be held today at 16:00 CEST.
Dial-in numbers:
Switzerland / Europe: +41 (0)58 310 50 00
From UK: +44 (0)203 059 58 62
From USA: +1 (1) 631 570 56 13
The Half-Year Report 2018 and the presentation with further information were published today, 18 July 2018, at 7:00 am CEST.
About Cassiopea
Cassiopea is a clinical-stage specialty pharmaceutical company focused on developing and commercializing innovative and differentiated medical dermatology products. Our focus is on the topical treatment of acne, androgenetic alopecia (or AGA) and genital warts. The portfolio comprises four unencumbered clinical candidates, for which Cassiopea owns the worldwide rights. The Company plans to commercialize the products directly in the US and partner the products outside of the US. For further information on Cassiopea, please visit www.cassiopea.com.
About Clascoterone
Clascoterone is a new chemical entity topical anti-androgen in late stage development for the treatment of acne (in a 1% cream) and androgenetic alopecia (in a higher strength solution). It is a topically delivered small molecule that penetrates the skin to reach the androgen receptors of the sebaceous gland and hair follicle. It aims to be the first effective and safe topical anti-androgen that does not have systemic effects.
Next Events
| Jefferies Health Care Conference, London | November 14-15, 2018 |
| CS Small & Mid Cap Conference, Zurich | November 16, 2018 |
| Full-year results 2018 reporting February | 2019 |
Cassiopea SpA
Dr. Chris Tanner, CFO & Head of Investor Relations
Tel: +39 02 868 91 124
Some of the information contained in this press release may contain forward-looking statements. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those in the forward-looking statements as a result of various factors. Cassiopea has no obligation to publicly update or revise any forward-looking statements.
