Clinuvel Pharmaceuticals : Quarterly Activities/Appendix 4C Cash Flow Report

COMPANY ANNOUNCEMENT

Appendix 4C & Activity Report

Record March Quarter Caps Strong Rise in Annual Cash Inflows

Melbourne, Australia, 28 April 2022

ASX: XETRA-DAX: ADR Level 1:

CUV UR9 CLVLY

CLINUVEL PHARMACEUTICALS LTD today released its Appendix 4C - Quarterly Cashflow Report and Activity Report for the period 01January to 31 March 2022.

HIGHLIGHTS CASH FLOW
Q3 FY2022¹	Last 12 Months
Cash receipts4	$11,442,000	$57,266,000
Operating Cash expenditures	$7,445,000	$28,256,000
Net operating cash flow2	+$4,087,000	+$29,496,000
Cash reserves3	+2.9%	+36.0%
Debt-free

The table provides context of the quarterly result ending 31 March 2022.

• 1. Period 01 January to 31 March 2022. All dollar figures in this release are rounded and reported in Australian dollars.

• 2. Operating cash flow excludes non-cash items.

• 3. % increase in cash reserves compared to previous quarter/same time last year.

• 4. Excludes interest income

RECORD MARCH QUARTER

Further efficiencies in product distribution, increase in the number of prescribing centres, and rising patient demand for SCENESSE® (afamelanotide 16mg) were the main factors contributing to positive receipts for the March quarter for the Group. The further strength in performance enabled the Company to reinvest in research and development, and attract additional staff talent. In parallel, and according to projections, expenditures remained higher than average across the business units to provide for long-term growth. Overall, the Group recorded - for the first-time - cash and cash equivalents exceeding $100 million, serving as a buffer to respond to unforeseen adverse events and enabling further investments.

"After years of treatment, we see a gradual shift in a pattern of filling prescriptions by physicians providing all-year-round photoprotection to a growing number of erythropoietic protoporphyria (EPP) patients," CLINUVEL's Chief Financial Officer, Darren Keamy said. "According to our projections, weare in the position to actively invest in new product development, capital equipment, clinical programs, infrastructure and - most importantly - specialised staff to build the company we envision."

CLINUVEL's cash receipts, coupled with prudent control of expenditures, are enabling the progress of a multi-pronged strategy to:

• • grow commercial operations based on SCENESSE®;

• • develop innovative melanocortin products to treat a range of indications with unmet medical need;

• • provide non-prescription healthcare solutions to wider populations at highest risk of exposure to ultraviolet (UV) and high energy visible light (HEV); and

• • further integrate critical parts of its supply chain.

CASH RECEIPTS FROM CUSTOMERS

Annual Cash Receipts and Operating Expenditures

(A$m, on rolling quarterly basis)

Cash ReceiptsOperating Expenditures

60.0

50.0

40.0

30.0

20.0

10.0

0.0

Mar-18

Sep-18

Mar-19

Sep-19

Mar-20

Sep-20

Mar-21

Sep-21

Mar-22

CLINUVEL recorded cash receipts of $11,442,000 and net operating cash flows of $4,087,000 for the March quarter of 2022. The results in cash receipts exceed the next highest comparative result by 75%.

"Our teams on the ground directly assist the centres in streamlining insurance claims for reimbursement, in managing administrative obstacles and coding queries for the medical treatment provided," Mr Keamy said. "In setting up the systems and processes, patients ultimately benefit from easier and faster access to treatment, and payment cycles reduce over time, as we see in these results."

CASH OUTFLOWS

Operating expenditures totalled $7,445,000 for the quarter, whereby much went towards optimising the supply chain to meet clinical demand. Supply and manufacturing costs were impacted by rising inflationary pressure. Further increases in research and development expenditure were made. The cash outflows saw an impact since some annual administration and corporate expenditures were incurred at the start of the calendar year.

DNA Repair Program: assessing the ability of afamelanotide to assist the repair of DNA of skin damaged by UV radiation and HEV (visible light). The clinical focus is relevant to over two billion people worldwide who show some inefficiency in their biological DNA reparative processes (nucleotide excision repair and basic excision repair).
Study	Status
CUV156 adult xeroderma pigmentosum C (XP-C) patients	Study ongoing. Results expected in 2022.
CUV151 disease free adult subjects	First subject dosed in February 2022. Results expected in 2022.
CUV152 adult xeroderma pigmentosum V & C (XP-V/XP-C) patients	First XP-V patient dosed in March. Results expected in 2022.
Arterial Ischaemic Stroke Program: assessing the ability of afamelanotide to improve blood flow and increase the delivery of oxygen and nutrients to deprived brain tissue in acute stroke patients. An estimated 15 million strokes are suffered each year.
Study	Status
CUV801 adult stroke patients	Study complete. Preliminary results announced in March 2022: afamelanotide well tolerated, Five of six patients

"Overall, we remain mindful of the growing pressures on costs worldwide. The inflation seen in the pharma industry also impacts CLINUVEL, as we absorb cost increases passed on by some of our key suppliers and service providers. More than ever, we emphasise our long-standing and consistent approach to managing a variable cost base in a controlled and deliberate manner. It is clear that we need to balance successful execution of operations with expected reinvestments to secure growth. The cash generated allows us to seize opportunities as they are presented," Mr Keamy said.

KEY ACTIVITIES - MARCH QUARTER 2022

Commercial Operations

CLINUVEL continued the commercial distribution of SCENESSE® for EPP in Europe, the USA, and Israel during the March quarter 2022 to meet ongoing and growing patient demand for treatment.

In January 2022, the Company announced a second agreement with the German National Association of Statutory Health Insurance Funds (GKV-SV). Negotiated over 18 months, the agreement ensures ongoing access to SCENESSE® treatment for German EPP patients. The extensive negotiation process and the significance of the outcome for the ongoing treatment of EPP patients was discussed in detail inNewsCommuniqué I.

Progress of Clinical Programs

CLINUVEL is actively conducting clinical trials to evaluate the safety and efficacy of melanocortins - including afamelanotide - for a range of patients with genetic, metabolic, systemic, and life-threatening, acute disorders. The expanded clinical program progressed during the quarter with key developments in individual programs is reported below.

showing improved neurological functions, as measured using the National Institute of Health Stroke Scale (NIHSS). Final results expected in 2022.
Vitiligo Program: assess the ability of afamelanotide to repigment skin in pigment loss disorder affecting up to 45 million individuals worldwide.
Study	Status
CUV104 adult vitiligo patients with darker skin complexion (Fitzpatrick IV-VI)	Study design agreed with the US Food and Drug Administration (FDA). First patient dosing expected in 2022.

Melanocortin Drug Portfolio

In March 2022, CLINUVEL provided an update on the scaled manufacture of adrenocorticotropic hormone (ACTH) for the novel NEURACTHEL® product formulations. The drug substance is being manufactured under current Good Manufacturing Practices by a strategic partner and is undergoing development and validation work. NEURACTHEL® will be evaluated for patients with neurological, endocrinological and degenerative disorders, who lack alternative therapy.

Healthcare Solutions

TheOperations Update I - 2022 Webcast in February 2022 provided an update on the Group's planned launch of its first product line of dermatocosmetics range. CLINUVEL is preparing its distribution processes, implementing necessary knowhow and putting together digital teams to engage with specific audiences at highest risk from exposure to ultraviolet and high energy visible light. The identified audiences are underserved in current markets.

Other Activities and Announcements

All of the Company's announcements in the March quarter 2022 are available on theCLINUVEL website, with other updates available on theCLINUVEL Newswebsite.

Although the Company is no longer obligated under ASX Listing Rules to publish quarterly cash flow results, it elects to continue to do so to keep its global investors updated regularly. A copy of the Appendix 4C - Quarterly Cash Flow Report for the second quarter of FY2022 is attached.

Pursuant to Listing Rule 4.7C and as disclosed in Item 6.1 to the attached Appendix 4C, $1,046,000 were recorded in respect to Non-Executive Directors' fees, Managing Director's fees and non-monetary benefits (inclusive of non-monetary and non-cash benefits and unused and long accrued annual leave entitlement to Managing Director).

- End -

1 SCENESSE® (afamelanotide 16mg) is approved in the European Union and Australia as an orphan medicinal product for the prevention of prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). SCENESSE® is approved in the USA to increase "pain-free" light exposure in adult EPP patients with a history of phototoxicity. Information on the product can be found on CLINUVEL's website atwww.clinuvel.com.

About CLINUVEL PHARMACEUTICALS LIMITED

CLINUVEL (ASX: CUV; ADR LEVEL 1: CLVLY; XETRA-DAX: UR9) is a global specialty pharmaceutical group focused on developing and commercialising treatments for patients with genetic, metabolic, systemic, and life-threatening, acute disorders, as well as healthcare solutions for the general population. As pioneers in photomedicine and the family of melanocortin peptides, CLINUVEL's research and development has led to innovative treatments for patient populations with a clinical need for systemic photoprotection, DNA repair, repigmentation and acute or life-threatening conditions who lack alternatives.

CLINUVEL's lead therapy, SCENESSE® (afamelanotide 16mg), is approved for commercial distribution in Europe, the USA, Israel and Australia as the world's first systemic photoprotective drug for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria (EPP). Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Singapore and the USA. For more information, please go tohttps://www.clinuvel.com.

SCENESSE®, PRÉNUMBRA®, and NEURACTHEL® are registered trademarks of CLINUVEL.

Authorised for ASX release by the Board of Directors of CLINUVEL PHARMACEUTICALS LTD

Media Enquiries

Monsoon Communications

Mr Rudi Michelson, 61 411 402 737,[e-mail]

Head of Investor Relations

Mr Malcolm Bull, CLINUVEL PHARMACEUTICALS LTD

Investor Enquirieshttps://www.clinuvel.com/investors/contact-us

Forward-Looking Statements

This release contains forward-looking statements, which reflect the current beliefs and expectations of CLINUVEL's management. Statements may involve a number of known and unknown risks that could cause our future results, performance or achievements to differ significantly from those expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialise pharmaceutical products; the COVID-19 pandemic and/or other world, regional or national events affecting the supply chain for a protracted period of time, including our ability to develop, manufacture, market and sell biopharmaceutical products; competition for our products, especially SCENESSE® (afamelanotide 16mg), PRÉNUMBRA® or NEURACTHEL®; our ability to achieve expected safety and efficacy results in a timely manner through our innovative R&D efforts; the effectiveness of our patents and other protections for innovative products, particularly in view of national and regional variations in patent laws; our potential exposure to product liability claims to the extent not covered by insurance; increased government scrutiny in either Australia, the U.S., Europe, Israel, China and Japan of our agreements with third parties and suppliers; our exposure to currency fluctuations and restrictions as well as credit risks; the effects of reforms in healthcare regulation and pharmaceutical pricing and reimbursement; that the Company may incur unexpected delays in the outsourced manufacturing of SCENESSE®, PRÉNUMBRA® or NEURACTHEL® which may lead to it being unable to supply its commercial markets and/or clinical trial programs; any failures to comply with any government payment system (i.e. Medicare) reporting and payment obligations; uncertainties surrounding the legislative and regulatory pathways for the registration and approval of biotechnology and consumer based products; decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; our ability to retain or attract key personnel and managerial talent; the impact of broader change within the pharmaceutical industry and related industries; potential changes to tax liabilities or legislation; environmental risks; and other factors that have been discussed in our 2021 Annual Report. Forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation, outside of those required under applicable laws or relevant listing rules of the Australian Securities Exchange, to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. More information on preliminary and uncertain forecasts and estimates is available on request, whereby it is stated that past performance is not an indicator of future performance.

www.clinuvel.com

Level 11, 535 Bourke Street, Melbourne, Victoria, Australia, 3000, T [phone], F [phone]