CLINUVEL Annual Report 2022 and Appendix 4E

On August 30, 2022 CLINUVEL reported its sixth consecutive annual net profit, driven by revenues of $66.987 million, a 38% increase. For the year ending 30 June 2022 (FY2022), the Group has reported profit after income tax expense (NPAT) of $20.876 million and profit before income tax expense (PBIT) of $34.321 million, as disclosed in its Appendix 4E and Annual Report (Press release, Clinuvel, AUG 30, 2022, View Source;mc_eid=a3338e0afe [SID1234618781]). The Group also reported a non-IFRS measure of adjusted net profit before tax of $39.837 million, which adjusts for certain material non-cash items that do not impact the Group’s cash position.

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"CLINUVEL’s commercial operations are scaling up to meet treatment demand worldwide, while the Group is pursuing R&D projects which aim to add value over the long-term," CLINUVEL’s Chief Financial Officer, Mr Darren Keamy said. "Our FY2022 results show a fundamentally strong business to date, allowing us to invest for future growth.

"Improved cash inflows this year have further bolstered the Company’s cash reserves enabling us to continue the implementation of a growth strategy in the face of difficult economic headwinds. The strong cash position has also allowed the Board to declare an increase in dividend this year, most of all recognising the loyalty and patience of long-term shareholders. We remain focused to translate our technology to the benefit of patients and specialised populations, particularly those at highest risk of light-induced damage and skin cancer," Mr Keamy said.

SIX YEARS OF REVENUE GROWTH AND PROFIT
CLINUVEL remains one of the few ASX-listed bio-pharmaceutical sciences companies to generate a profit. In FY2022 the Company delivered its sixth consecutive year of positive cashflow, revenues and profit, while maintaining control of operating expenses to facilitate growth and expansion.

The Group has outlined a clear long-term growth strategy reinvesting a large percentage of proceeds into new development. The expansion strategy is enabled by the ongoing increase of cash inflows from commercial operations. The accumulated cash reserves increased by $38.818 million (47%) during FY2022 to stand at $121.509 million as of 30 June 2022. CLINUVEL has committed to expenditures of $175 million over the five years to 30 June 2025 to achieve its growth and expansion objectives and, based on expenses in FY2021 and FY2022, is on track to achieve this projection.

INCREASE IN ANNUAL DIVIDEND
Following the financial results for the year ending 30 June 2022, the CLINUVEL Board has declared an increase to its full-year dividend distribution to $0.04 per ordinary share fully franked, up from 2.5 cents per share unfranked for the full year to 30 June 2021. This is the fifth consecutive dividend declared by the Group. Subject to sufficient cash reserves, the key dates for the dividend are:

Ex-dividend date: 06 September 2022;
Record date: 07 September 2022; and
Payment date: 21 September 2022.

Dividends are available to Australian and overseas registered shareholders, including holders of CLINUVEL’s Level 1, American Depository Receipts. Prior to the record date, shareholders are encouraged to confirm their personal shareholder information, including payment election information, with the share registrar.

Alpine Immune Sciences Announces R&D Day to Provide Clinical Updates on Wholly-Owned Programs ALPN-303 and Davoceticept

On August 30, 2022 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune and inflammatory diseases, reported that it will host an R&D Day featuring clinical data presentations on ALPN-303, a potentially best-in-class dual B cell cytokine antagonist being developed for the treatment of B cell mediated inflammatory and autoimmune diseases, and davoceticept (ALPN-202), a conditional CD28 costimulator and dual checkpoint inhibitor in development for the treatment of cancer (Press release, Alpine Immune Sciences, AUG 30, 2022, View Source [SID1234618765]).

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The event will also feature presentations by two leading experts, Vibeke Strand, MD, Biopharmaceutical Consultant and Adjunct Clinical Professor, Division of Immunology/Rheumatology, Stanford University School of Medicine, and Katy E. Beckermann, MD, PhD, Assistant Professor of Medicine, Division of Hematology/Oncology, Vanderbilt University Medical Center, who will review the current treatment landscape as well as the potential role for new treatment options in lupus and renal cell carcinoma, respectively.

R&D Day Event Information:

Date and Time: Monday, September 12, 5:00 pm to 6:30 pm ET

Event registration will be available through the Alpine Immune Sciences website at View Source An archive of the presentation will be accessible after the event through the Alpine Immune Sciences website.

Novartis presents new data in breast and prostate cancer at ESMO

On August 30, 2022 Novartis reported that it will showcase new data from across its oncology portfolio at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022 with over 35 accepted abstracts from Novartis-sponsored and investigator-initiated trials including new data in advanced breast cancer and metastatic castration-resistant prostate cancer (Press release, Novartis, AUG 30, 2022, View Source [SID1234618782]).

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"We are excited to share the data being presented across our portfolio of cancer therapies, which reinforce our commitment to pursuing every possible approach to address the urgent and significant unmet medical needs of people living with cancer," said Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development, Novartis. "Our presentations at ESMO (Free ESMO Whitepaper) will highlight our continued dedication to advancing innovative treatment options for these critical diseases."

Key highlights of data accepted by ESMO (Free ESMO Whitepaper):

Medicine Abstract Title Abstract Number/ Presentation Details
Kisqali (ribociclib)*

Pooled exploratory analysis of survival in patients (pts) with HR+/HER2− advanced breast cancer (ABC) and visceral metastases (mets) treated with ribociclib (RIB) + endocrine therapy (ET) in the MONALEESA (ML) trials
​ Abstract #205P
Poster Session
Saturday, September 10

Kisqali (ribociclib)*

HARMONIA SOLTI-2101 / AFT-58: A head-to-head phase III study comparing ribociclib (RIB) and palbociclib (PAL) in patients with hormone receptor-positive/HER2-negative/HER2-Enriched (HR+/HER2-/HER2-E) advanced breast cancer (ABC)†

Abstract # 272TiP
Poster Session
Saturday, September 10
Piqray (alpelisib) BYLieve trial (alpelisib [ALP] + endocrine therapy [ET]) versus real-world (RW) standard of care (SOC) in patients (pts) with PIK3CA-mutated (mut), hormone receptor-2 positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced 3 breast cancer (ABC) who progressed on cyclin-dependent kinase 4/6 inhibitor (CDKi) 4 therapy (tx)

Abstract #222P
Poster Session
Saturday, September 10

Tislelizumab​

Final Analysis of RATIONALE-301: Randomized, Phase 3 study of tislelizumab versus sorafenib as first-line treatment for unresectable hepatocellular carcinoma

Abstract #LBA36
Proffered Paper Session
Saturday, September 10
09:15 – 09:25 AM CEST

Tislelizumab​ Tislelizumab (TIS) versus docetaxel (TAX) as second- or third-line therapy in previously treated patients (pts) with locally advanced non-small cell lung cancer (NSCLC): Asian versus non-Asian subgroup analysis of the RATIONALE-303 study

Abstract #1031P
Poster Session
Monday, September 12

Pluvicto (lutetium 177Lu vipivotide tetraxetan) (formerly referred to as 177Lu-PSMA-617) Association between prostate-specific antigen decline and clinical outcomes in patients with metastatic castration-resistant prostate cancer in the VISION trial Abstract #1372P
Poster Session
Sunday, September 11

Pluvicto (lutetium 177Lu vipivotide tetraxetan) Radiographic progression-free survival correlation with patient-relevant outcomes: a post hoc analysis of time-to-event endpoints of the VISION trial

Abstract #1374P
Poster Session
Sunday, September 11,

Prostate Cancer Quality of life across three countries using a large-scale, fully digital survey of patients with prostate cancer

Abstract #1401P
Poster Session
Sunday, September 11

Canakinumab
(ACZ885) CANOPY-A: phase III study of canakinumab (CAN) as adjuvant therapy in patients (pts) with completely resected non-small cell lung cancer (NSCLC)

Abstract #LBA49
Proffered Paper Session
Sunday, September 11
09:20 – 09:30 AM CEST

Vijoice (alpelisib) Clinical benefit of alpelisib in pediatric patients with PIK3CA-related overgrowth spectrum (PROS): an EPIK-P1 analysis

Abstract #468P
Poster Session
Monday, September 12

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aTen Therapeutics awarded £282k to develop new breast cancer treatment

On August 30, 2022 Scottish biotech company, aTen Therapeutics, reported a £282,733 Innovate UK grant to advance a promising new therapy for breast cancer (Press release, aTen Therapeutics, AUG 30, 2022, View Source [SID1234625372]). The award will allow the company, in collaboration with scientists at ARU (Cambridge), to accelerate the development of its novel human monoclonal antibody ATN-E11.

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ATN-E11 has already been shown to prolong survival in experimental models of cancer. It targets the angiotensin-II type I receptor (AT1R), which is overexpressed in a range of different cancers. This overexpression stimulates tumour growth and increases the ability of malignant cancer cells to invade and migrate. By blocking the receptor, ATN-E11 could become a powerful new cancer treatment.

Breast cancer is the most commonly diagnosed cancer globally. With an estimated 2.3 million new cases in 2020, it accounts for 1 in 4 female cancer diagnoses and 685,000 deaths annually. There are several subtypes of breast cancer with different molecular and clinical features (including drug resistance) that dictate and limit treatment options, so demand for novel therapies remains very high.

Dr Karen Spink, Head of Medicines at Innovate UK, said: ‘This exciting project, funded through our Biomedical Catalyst Programme, addresses a critical unmet need for better targeted and more effective cancer treatments. Access to a diverse armoury of precision therapies is at the heart of our mission on cancer, that promises to radically improve patient outcomes.’

aTen Therapeutics’ CEO, Ian Abercrombie, said: ‘We’re excited by the potential of our technology to extend and improve lives. The Innovate UK grant is a great endorsement of this potential and the hard work of our team in Edinburgh. We look forward to progressing ATN-E11 towards clinical trials, and ultimately providing a new treatment option for people living with breast cancer.’

Prof Chris Parris, Head of School of Life Sciences at ARU, said: ‘We’re delighted to be working with the aTen Therapeutics team to explore this exciting new approach to cancer treatment and we look forward to generating key data in the coming months. Our first target is breast cancer but the therapy could also be effective in many other cancer types.’

PAT-DX1 Engineering Run Update

On August 30, 2022 Patrys’ appointed Contract Development Manufacturing Organisation (CDMO) reported that has successfully completed specification testing of PAT-DX1 drug substance produced in the recently-completed engineering run, laying strong foundations for the Company’s planned phase 1 clinical trial next year (Press release, Patrys, AUG 30, 2022, View Source [SID1234618730]).

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Specification, or batch release, testing is a necessary requirement to ensure high quality pharmaceuticals are used in GMP and clinical studies.