Lainate, Italy – 29 July 2020 – Cassiopea S.p.A. (SIX: SKIN), a specialty pharmaceutical company developing and preparing to commercialize prescription drugs with novel mechanisms of action (MOA) to address long-standing and essential dermatological conditions, today announced its half-year 2020 results for the period ended 30 June 2020.
- Fluid interaction with U.S. FDA in conjunction with filed NDA for Clascoterone Cream 1%, where the PDUFA date is 27 August 2020.
- Submission of special protocol assessment to U.S. FDA for Phase III trial of Clascoterone Solution 7.5% in males with androgenetic alopecia (AGA).
- COVID-19 caused a brief interruption of recruitment in the Phase II trial of Clascoterone Solution in females with AGA. The trial is targeting 280 subjects in four study arms; it restarted in June and currently has recruited 165 subjects.
- Publication of Clascoterone Cream 1% Phase III data in the Journal of the American Medical Association Dermatology and the Journal of the American Academy of Dermatology, two prestigious peer reviewed medical journals in the USA.
- Successful capital increase reserved to existing shareholders issuing 750’000 new shares at a price of EUR 31 each.
- All costs within the approved/foreseen budget.
Diana Harbort, CEO of Cassiopea S.p.A., commented: “The first half of 2020 was marked by constructive interaction with the FDA for the NDA of Clascoterone Cream 1%. We also have made substantial progress in medical affairs, market access, commercial launch planning and product supply in anticipation of the 27 August 2020 PDUFA date for our first product. If approved, Clascoterone Cream 1% would be the first new mechanism of action for acne in nearly 40 years”.
Key financial figures
|In EUR thousands
(with the exception of the share data in EUR)
|H1 2020||H1 2019|
|Cost of sales||–||–|
|Research and development expenses||(2,510)||(4,689)|
|Selling, general and administrative expenses||(2,180)||(1,596)|
|Net operating expenses||(4,690)||(6,285)|
|Profit (Loss) before taxes||(5,322)||(6,458)|
|Profit (Loss) after taxes for the period||(5,322)||(6,458)|
|Profit (Loss) per share||(0.530)||(0.646)|
|In EUR thousands||30.06.2020||31.12.2019|
|Other current assets||2,954||2,829|
|Cash and cash equivalents||8,451||696|
|Total Equity & Liabilities||23,759||16,061|
- No revenues were generated in H1 2020 since all products are still under development.
- No goods were manufactured for sale so there were no Cost of Goods Sold (COGS).
- R&D costs declined primarily because the outsourced pre-clinical and clinical trial costs declined from EUR 2,502 thousand of EUR 640 thousand – because the Phase III for Clascoterone Solution 7.5% in males had not yet started and because of a COVID-19 induced interruption in recruitment for the Phase II proof of concept dose ranging trial of Clascoterone Solution in females.
- SG&A increase of EUR 584 thousand to EUR 2,180 thousand due to the increase of the U.S. operations.
- Cash and cash equivalents increased from EUR 696 thousand to EUR 8.451 thousand due to a cash net inflow from the capital increase.
- Non-current liabilities declined to EUR 8 thousand because the loans outstanding under the credit facility from Cosmo Pharmaceuticals N.V. were set off with the proceeds from the capital increase.
- Total equity increased from EUR 3,727 thousand to EUR 21,363 thousand because of the issuance of 750,000 new shares at a price of EUR 31 per share, for a capital contribution of EUR 23,250 thousand.
Half-year 2020 results conference call at 16:00 CEST on 29 July 2020
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 2020 at a conference call to be held today at 16:00 CEST.
|Switzerland / Europe:||+41 (0) 58 310 50 00|
|From UK:||+44 (0) 207 107 06 13|
|From USA:||+1 (1) 631 570 56 13|
The Half-Year Report 2020 and the presentation with further information were published today, 29 July 2020, at 7:00 am CEST, and are available for download at:
www.cassiopea.com/wp-content/uploads/2020/07/Cassiopea_Half_Year_Report _2020.pdf and https://www.cassiopea.com/investor-relations/#publicationsAndCalendar
Cassiopea is a specialty pharmaceutical company developing and preparing to commercialize prescription drugs with novel mechanisms of action to address long-standing and essential dermatological conditions, particularly acne, androgenetic alopecia and genital warts. Cassiopea is investing in innovation that is driving scientific advancement in areas that have been largely ignored for decades. The portfolio comprises four unencumbered clinical candidates, for which Cassiopea owns the worldwide rights. Cassiopea plans to determine the most efficient way to effectively commercialize the products in the U.S. after the planned approval of Clascoterone Cream 1% and to partner the products for countries outside of the US. For further information on Cassiopea, please visit www.cassiopea.com.
Clascoterone, a new chemical entity, is a proposed first-in-class topical androgen receptor inhibitor under U.S. Food and Drug Administration (FDA) review for the treatment of acne (in a 1% cream) and in late stage development for the treatment of androgenetic alopecia (in a higher strength solution) in males. Although Clascoterone’s exact mechanism of action is unknown, laboratory studies suggest Clascoterone competes with androgens, specifically dihydrotestosterone (DHT), for binding to the androgen receptors within the sebaceous gland and hair follicles. Because of Clascoterone’s likely local effect at the site of application, the risk of off-target, or systemic side effects, is minimized.
|HC Wainwright Annual Global Investors Conference||14-15 September, virtual|
|Investora||23 September 2020, Zurich|
|Jefferies Global Health Care Conference||17-19 November 2020, London|
|Credit Suisse Small & Mid Cap Conference||18-20 November 2020, Zurich|
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.