ACTINOGEN MEDICAL LIMITED ASX ANNOUNCEMENT
Actinogen March 2022 Quarterly Activity Report and Appendix 4C
Sydney, 28 April 2022. Actinogen Medical ASX: ACW ("ACW" or "the Company") announces the release of its quarterly activity report and Appendix 4C for the three-month period ended 31 March 2022.
Key Highlights
Advancing the Xanamem® clinical development pipeline:
o Completed final patient visit for the XanaMIA Part A trial in Mild Cognitive Impairment (MCI) due to Alzheimer's Disease (AD)
o Announced positive XanaMIA Part A trial topline results in post-quarter ASX release dated 27 April 2022
o Appointed leading clinical research organisation Worldwide Clinical Trials to manage the recruitment, conduct and general implementation of the XanaFX Phase 2 trial in adolescent boys and young adults with Fragile X Syndrome (FXS)
o Continued protocol development activities for the Phase 2 Major Depressive Disorder trial.
Appointed Professor Paul Rolan as Chief Medical Officer effective 15 February 2022
CEO Dr Steven Gourlay presented to major international healthcare conference events in January and March focused on updating potential pharmaceutical partner organisations on the expanded clinical development pipeline and multiple near- and medium-term milestones
Conducted a General Meeting in early April to approve resolutions in relation to share placements as part of capital-raising activities in November 2021
Cash balance of $19.0 million at 31 March 2022.1
Advancing the clinical development pipeline through multiple clinical trials
Actinogen continues to successfully progress its primary strategic priority focused on operational excellence in its clinical development program, which is designed to deliver timely and high-quality confirmation of clinical efficacy and safety in each of its disease programs. The Company is conducting its lead programs under US IND oversight to ensure it adheres to a global standard of regulatory compliance for clinical development, non-clinical studies and manufacturing.
® Xanamem is a registered trademark of Actinogen Medical Limited 1 Unless stated otherwise, all financial data is in Australian dollars
Dr Steven Gourlay, Actinogen CEO and MD, commented:
"This quarterly report is dominated by the positive XanaMIA trial results - a testament to the efforts of many volunteer participants, trial staff and our trial manager Avance Clinical to complete the trial in record time at five Australian clinics. This brings us a major step closer to realising Xanamem as a revolutionary therapy making a material difference to the lives of people living with serious neurological conditions.
The March quarter of 2022 marked further significant advances in Actinogen's clinical development pipeline including the appointment of the manager for our Phase 2 XanaFX trial for Fragile X Syndrome and the appointment of Professor Paul Rolan, a distinguished expert in neurology clinical trials and clinical pharmacology to the important post of Chief Medical Officer."
AD XanaMIA trial
On 11 February 2022, the Company announced that the final trial patient visit had been completed. The XanaMIA Part A trial was established to assess the efficacy of 5 mg and 10 mg Xanamem doses compared to placebo in older healthy patients (aged 50 to 80 years old), over six weeks, to confirm the minimum effective dose needed to improve cognition (ability to think and remember things). The target dose range was determined by the results of a dose-ranging positron emission tomography (PET) study of Xanamem's inhibition of its target in the brain.
The trial achieved its primary endpoints of safety, efficacy and pharmacodynamics. In particular, it achieved the prespecified endpoint of a clinically significant effect on cognition with a Cohen's d effect size of 0.32 (p <0.05).
For further information, please refer to the detailed XanaMIA trial results announcement along with the associated webcast slide presentation released to the ASX on 27 April 2022. Alternatively, please refer to the ASX announcements section in the Investor Centre on the Actinogen websitewww.actinogen.com.au.
FXS XanaFX trial
On 9 February 2022, Actinogen announced that it had appointed leading clinical research organisation Worldwide Clinical Trials ('Worldwide') to manage the recruitment, conduct and general implementation of its XanaFX Phase 2 trial in adolescent boys and young adults with Fragile X Syndrome (FXS).
Major Depressive Disorder Trial
Extensive consultations were held with international and Australian experts in cognition and depression to develop a proposed Phase 2 protocol to be implemented later in 2022. These discussions were led by Professor Rolan, newly appointed CMO, who has extensive experience in similar clinical trials.
Executive appointments including Chief Medical Officer (CMO)
The Company appointed Professor Paul Rolan as CMO effective 15 February 2022.
Professor Rolan is a clinical pharmacologist and neurology drug development consultant and one of Australia's most experienced clinical trial investigators and drug developers, having taken drugs from first human administration to market. He has extensive expertise in the development of medicines as principal investigator in more than 750 early phase proof-of-concept, clinical pharmacology, drug interaction and special patient groups studies.
The Company also recently made two further changes to its executive leadership team. The first is the promotion of Ms Tamara Miller to the position of Senior Vice President Product Development. Ms Miller has been a key driving force behind the Company's clinical development program in recent years.
Given the expansion of Actinogen's clinical program to include Major Depressive Disorder (MDD) as its third disease program, the Company has also created the new position of Vice President Clinical Operations andappointed Ms Cheryl Townsend to that role. Ms Townsend has extensive experience with clinical trial operations in the Asia-Pacific region across all phases of clinical development.
Further details on all Actinogen board, advisory board and senior executive personnel can be found on the Company's recently updated and improved corporate website,www.actinogen.com.au
Business development
In early January 2022, CEO Dr Steven Gourlay presented at the Biopartnering @JPM associated with the 40th annual JP Morgan HealthCare Conference in San Francisco and at the H.C. Wainwright BioConnect Virtual Conference that ran concurrently with the JP Morgan conference.
On 1 March, Dr Gourlay gave a virtual presentation to the Sachs 15th Annual European Life Sciences CEO Forum for Partnering & Investment conference.
Dr Gourlay used his time in San Francisco in January and virtually during the Sachs conference week in March to conduct multiple business development and other stakeholder meetings to update potential pharmaceutical industry partners on the Company's expanded clinical development pipeline and its near and medium-term milestones.
General Meeting
A General Meeting of the Company was held on 5 April 2022 to seek shareholder approval of two resolutions:
1. The issue of 797,222 shares to CEO Dr Steven Gourlay who subscribed for the shares at an issue price of $0.135 per share in conjunction with, and at the same price as, the placement of 88,091,659 shares to sophisticated investors
2. Ratification of the 88,091,659 shares issued to sophisticated investors on 30 November 2021 under the capital raising placement.
Both resolutions were approved as set out in an announcement dated 5 April 2022. Dr Gourlay has completed the $107,625 share subscription payment following shareholder approval of Resolution 1.
Cash position
Actinogen's cash balance as at 31 March 2022 was $19.04 million. Net operating cash outflow for the quarter was $3.17 million, primarily related to R&D spend of $2.62 million, staff costs of $0.39 million and administration and corporate costs of $0.15 million.
The Company remains well positioned to fund its current planned clinical trials and advance clinical development.
Consistent with ASX Listing Rule 4.7c.3, item 6 of the attached Appendix 4C of the cashflow report for the quarter included payments to Related Parties of approximately A$0.16 million, comprising the salary for the CEO/Managing Director, fees paid to Non-Executive Directors and superannuation.
ENDS
Investors | Media | |
Dr. Steven Gourlay | Michael Roberts | Randal Killip |
CEO & Managing Director | Investor Relations | Profile for Media |
P: +61 2 8964 7401 | M: +61 423 866 231 | M: +61 425 714 159 |
E.steven.gourlay@actinogen.com.au | E.michael.roberts@actinogen.com.au | E.randal@profileformedia.com.au |
3 | ||
Actinogen Medical Limited ACN 086 778 476 |
Suite 901, Level 9, 109 Pitt Street, Sydney NSW 2000 +61 2 8964 7401 | actinogen.com.au
Announcement authorised by the Board of Directors of Actinogen Medical
About Actinogen Medical
Actinogen Medical (ACW) is an ASX-listed, biotechnology company developing a novel therapy for neurological diseases associated with dysregulated brain cortisol. There is a strong association between cortisol and detrimental changes in the brain, affecting cognitive function, harm to brain cells and long-term cognitive health.
Cognitive function means how a person understands, remembers and thinks clearly. Cognitive functions include memory, attention, reasoning, awareness and decision-making.
We are currently developing our lead compound, Xanamem®, as a promising new therapy for Alzheimer's Disease, Fragile X Syndrome, Depression and other neurological diseases where reducing cortisol inside brain cells could have a positive impact. The cognitive dysfunction, behavioural abnormalities, and neuropsychological burden associated with these conditions is debilitating for patients, and there is a substantial unmet medical need for new and improved treatments.
About Xanamem®
Xanamem's novel mechanism of action works by blocking the production of intracellular cortisol through the inhibition of the 11β-HSD1 enzyme in the brain. Xanamem is designed to get into the brain after it is absorbed in the intestines upon swallowing its capsule.
Chronically elevated cortisol is associated with cognitive decline in Alzheimer's Disease, potentially linked to cognitive impairment and anxiety in Fragile X Syndrome, and cognitive impairment in Depression and other diseases.
The Company has studied 11β-HSD1 inhibition by Xanamem in more than 300 volunteers and patients, so far finding a statistically significant improvement in cognition over placebo in healthy, older volunteers. A series of Phase 2 studies in multiple diseases is being conducted to further confirm and characterise Xanamem's therapeutic potential.
Xanamem is an investigational product and is not approved for use outside of a clinical trial by the FDA or by any global regulatory authority. Xanamem® is a trademark of Actinogen Medical.
Disclaimer
This announcement and attachments may contain certain forward-looking statements that are based on subjective estimates and assumptions and relate to circumstances and events that have not taken place and may not take place. Such forward looking statements involve known and unknown risks, uncertainties, and other factors (such as significant business, economic and competitive uncertainties and contingencies, and regulatory and clinical development risks and uncertainties) which may cause the actual results or the performance of Actinogen Medical to be materially different from the results or performance expressed or implied by such forward looking statements. Past performance is not a reliable indicator of future performance. There can be no assurance that any forward-looking statements will be realised. Actinogen Medical does not make any representation or give any warranty as to the likelihood of achievement or reasonableness of any forward-looking statements.
ACTINOGEN MEDICAL ENCOURAGES ALL CURRENT INVESTORS TO GO PAPERLESS BY REGISTERING THEIR DETAILS WITH THE DESIGNATED REGISTRY SERVICE PROVIDER, AUTOMIC GROUP.
ASX Listing Rules Appendix 4C (17/07/20)
Rule 4.7B | |
(a) | entities |
(b) | businesses |
(c) | property, plant and equipment |
(d) | investments |
(e) | intellectual property |
(f) | other non-current assets |
Page 1 |
Name of entity
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
ACTINOGEN MEDICAL LIMITED
ABN
14 086 778 476
Consolidated statement of cash flows | Current quarter $A'000 | Year to date (9 months) $A'000 |
| (2,620) (386) (154) 10 (3) - (18) | (6,159) (1,202) (839) 25 (11) 1,435 (52) |
(3,171) | (6,803) |
2. 2.1
Cash flows from investing activities Payments to acquire or for:
+ See chapter 19 of the ASX Listing Rules for defined terms.
Quarter ended ("current quarter")
31 March 2022
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Disclaimer
Actinogen Medical Ltd. published this content on 27 April 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 28 April 2022 02:13:01 UTC.
