Cassiopea S p A : Half Year Report 2021

Half-Year Report 2021

Cassiopea at a Glance

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 Company's portfolio comprises four unencumbered clinical candidates, for which the Company owns the worldwide rights. These product candidates are based on three new chemical entities ("NCEs") that target unmet medical needs and address significant market opportunities in the medical dermatology market.

Cassiopea's management team has (directly and indirectly through the service agreement with Cosmo) extensive experience in product development and commercialization, having served in prominent roles at several leading pharma­ ceutical and medical dermatology companies.

The Company's strategy is to leverage this expertise to optimize the commercial potential for its products directly or with a partner in the US and partner the products in countries outside of the US.

Key events in H1 2021

During the first half of 2021, activities were focused on the preparations for the commercial launch of Winlevi® (clascoterone cream 1 %) and advancing the development of clascoterone solution for androgenetic alopecia (AGA).

Multiple transaction structures and opportunities were evaluated over the last twelve months in order to optimize the US commercial launch of Winlevi®.

Post period, on 26 July, Cassiopea and Sun Pharma announced the signing of License and Supply Agreements for Winlevi® (clascoterone cream 1%) in the United States and Canada. Sun Pharma will have the exclusive right to commercialize Winlevi® in the United States and Canada, and Cassiopea will be the exclusive supplier of the pro­ duct. Cassiopea will receive an upfront payment of US$ 45 million, potential commercial milestones totalling up to US$ 190 million and customary double digit royalties. The agreements will close upon the expiration of the HSR waiting period. Winlevi®

is expected to be available in the US in Q4 2021. Complete prescribing information is available on www.WINLEVI.com.1

2 Cassiopea Half-Year Report 2021 - Cassiopea at a Glance

Our development activity was primarily directed to advance the development of clascoterone solution for AGA. In Q2, we completed the Phase II trial of Clascoterone solution for androgenetic alopecia in females. The Phase II multicenter, prospective, randomized, double-blind, vehicle controlled, dose ranging study evaluated the efficacy and safety of clascoterone solution for the treatment of AGA in females. The six-month study enrolled 293 female subjects between 18-55 years of age with mild to moderate AGA in Germany. The four-arm study enrolled approximately 70 subjects per arm in each of four treatment groups: clascoterone solution 5 % BID (twice daily), clascoterone solution 7.5 % BID (twice daily), minoxidil solution 2 % BID (twice daily) and vehicle BID (twice daily). The co-primary endpoints are: (1) change from baseline in non-vellus Target Area Hair Count (TAHC) at month 6 in comparison to vehicle and

1. Hair Growth Assessment (HGA) score at month 6 in comparison to vehicle. Top line results will be available in 3Q 2021.

Additionally, progress was made in the development of a new Patient Reported Outcome (PRO) Questionnaire for AGA which has been requested by the US FDA to be used in the future Phase III trials of Clascoterone solution for AGA in males.

Concerning forward-looking statements

This report contains certain "forward-looking statements," which can be identified by the use of terminology such as "could," "might," "propose," "addressable," "outlook," "attractive" or similar wording. Such forward-looking statements reflect the current views of the Management and are not guarantees of future performance and involve risks and uncertainties. Readers are cautioned that actual results may differ materially from those in the forward-looking statements as a result of various factors. Cassiopea is providing the information in this report as of this date and does not under­- take any obligation to update any forward-looking statements contained in it as a result of new information, future events or otherwise.

3 Cassiopea Half-Year Report 2021 - Cassiopea at a Glance

Cassiopea Pipeline

PRODUCTPROPOSED INDICATION PRECLINICAL PHASE I PHASE II PHASE III APPROVAL

WINLEVI®	See full
(clascoterone	Prescribing
cream 1 %)	Information
Androgen receptor inhibitor
Clascoterone	Androgenetic
solution	alopecia in males
Androgen receptor inhibitor
Clascoterone	Androgenetic
solution	alopecia in females
Androgen receptor inhibitor
CB-06-01	Acne
Antibiotic
CB-06-02	Genital
Immune modulator	Warts

Key figures

EUR 1,000	30.06.2021	30.06.2020
Income statement
Revenue	-		-
Other income	-		-
Cost of sales	-		-
R&D costs	(3,753)	(2,510)
SG&A costs	(2,535)	(2,180)
Operating result	(6,288)	(4,690)
Profit (loss) before taxes	(6,165)	(5,322)
Profit (loss) for the period	(6,165)	(5,322)
Shares
Weighted average number shares	10,750,000	10,045,330
Basic earnings (loss) per share (in EUR)	(0.573)	(0.530)
EUR 1,000	30.06.2021	31.12.2020
Statement of financial position

Non-current assets

Inventories

Cash and cash equivalents Other current assets Non-current liabilities Current liabilities Equity

Equity ratio

12,498 12,797

1,817 761

1,796 2,646

2,291 2,423

• 66
  8,557 2,946
  9,845 15,615
  53.5% 83.8%

4 Cassiopea Half-Year Report 2021 - Cassiopea's Pipeline

Table of Contents

Cassiopea at a Glance ................................................................................................................................	2
Key events in H1 2021 ....................................................................................................................................	2
Cassiopea's Pipeline ......................................................................................................................................	4
Letter to Shareholders .................................................................................................................................	7
Business Strategy and Markets ...........................................................................................................	8
Research and Development .................................................................................................................	10
Patents and Trademarks .........................................................................................................................	16
COVID-19impact ...........................................................................................................................................	19
ESG policy ............................................................................................................................................................	20
Financial review .............................................................................................................................................	22
Condensed Consolidated Financial­	Statement (unaudited)..................................	26
Notes to the Condensed Consolidated Financial Statements (unaudited).....	30
Information for Investors ........................................................................................................................	50
Contacts and Addresses ........................................................................................................................	52

5 Cassiopea Half-Year Report 2021 - Table of Contents