Lainate, Italy – 28 May 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, announced today its interim first quarter results for the period ended 31 March 2020.
- Ongoing fluid interaction with FDA in conjunction with the NDA for Clascoterone cream 1% for which the PDUFA date is 27 August 2020
- Filing of a Special Protocol Assessment with FDA for the phase III program for Clascoterone solution 7.5% in males
- Due to COVID-19, approximately three month interruption in the recruitment of subjects in phase II trial of Clascoterone solution in females
- All expenses within budget
Diana Harbort, CEO of Cassiopea S.p.A., commented: “We have been working closely with FDA during the review process of our NDA for Clascoterone cream 1% and we look forward to the PDUFA date of August 27, 2020. If approved, Clascoterone cream 1% will be the first new mechanism of action in the treatment of acne in nearly 40 years, offering dermatologists and patients a new therapeutic alternative.”
Key financial figures
|In EUR thousands
(with the exception of the share data in EUR)
|Q1 2020||Q1 2019|
|Cost of sales||–||–|
|Research and development expenses||(1,060)||(2,900)|
|Selling, general and administrative expenses||(828)||(647)|
|Net operating expenses||(1,888)||(3,547)|
|Profit (Loss) before taxes||(2,119)||(3,621)|
|Profit (Loss) after taxes for the period||(2,119)||(3,621)|
|Profit (Loss) per share||(0.212)||(0.362)|
|Other current assets||2,881||2,829|
|Cash and cash equivalents||915||696|
|Total equity & liabilities||16,231||16,061|
- No revenues were generated in Q1 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 consisted primarily of outsourced preclinical and clinical expenses of EUR 398 thousand of which EUR 337 thousand were for Clascoterone solution and EUR 59 thousand were for Clascoterone cream 1%
- Personnel expenses increased from EUR 396 thousand to EUR 731 thousand. There was an average of 12.00 employed persons in Q1 2020 vs 10.00 in Q1 2019.
- Cash and cash equivalents of EUR 915 thousand include availability on current Bank accounts.
- Non-current liabilities stood at EUR 13,476 thousand mainly comprising loan drawn under the credit facility that is being made available by Cosmo Pharmaceuticals
- Total equity declined to EUR 1,821 thousand; 11,2% of assets were financed by equity
The Interim Report as of and for the three months ended 31 March 2020 was published today, 28 May 2020, at 7:00 am CEST, and is available for download at:
Cassiopea is 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, particularly acne, androgenetic alopecia (or AGA) 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. The Company 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.
|Extraordinary Shareholders Meeting||28 May 2020, Lainate|
|Half Year Report 2020||July 2020|
|Investora||23-24 September 2020, Zurich|
|Credit Suisse Small & Mid Cap Conference||18-20 November 2020, Zurich|
|Jefferies Global Health Care Conference||19-21 November 2020, London|
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.