Actinogen Medical receives final consent to continue XanADu Phase II trial without change

The Sydney-based Actinogen Medical Limited (ASX: ACW), is engaged in developing and commercialising new treatments for Alzheimer’s disease and the cognitive deficiency associated with other metabolic and neurological disorders. On March 26th, 2019, the company announced that the Data Safety Monitoring Board (DSMB) has yet again reaffirmed its recommendation to continue the Phase II Alzheimer’s trial XanADu without modification after reviewing unblinded safety data from 162 patients who have completed the trial. This positive recommendation from the DSMB is the third and final in the row.

XanADu is a Phase II placebo-controlled, double-blind, randomised, study to evaluate the tolerability, safety and effectiveness of Xanamem in subjects with mild dementia due to Alzheimer’s disease over 12 weeks. So far, the study has enrolled 186 patients from 25 research sites across the United Kingdom, the United States as well as Australia. The final results are expected to be out during the second quarter of 2019.

The progress of XanADu is in line with the significant advancement of the Xanamem clinical development program launched back in July 2018. Around nine new studies have been initiated since then, including a target occupancy study, a higher dose safety study (XanaHES) and multiple safety toxicology studies.

The first patient for the Phase I XanaHES dose escalation study was randomized in early February 2019 to examine the safety and tolerability of a single daily dose of Xanamem™ 20 mg and 30 mg in healthy elderly volunteers. A total of 84 participants in two cohorts are expected to be randomised, and the results from the first cohort of 42 are scheduled to be out in Q2 2019 tentatively.

On March 21st, the company released its Investor Presentation highlighting Actinogen’s key investment highlights, clinical progress and outlook. According to the information revealed, the market for Alzheimer’s disease presents a compelling commercial opportunity to target initially. The addressable market is worth more than USD 7.5 billion with unmet needs and potential upsides.

As per the financial report for the six months from July 1st, 2018 to December 31st, 2018, Actinogen Medical reported a reduction in the revenue from ordinary activities by 64%. Besides, the loss from ordinary activities after tax attributable to members amounted to $ 7.13 million, significantly up by 97% as compared to $ 3.62 million recorded in the previous corresponding period ended December 31st, 2018. The net cash outflows from operating activities amounted to ~ $ 2.55 million resulting from interest paid, payments to suppliers & employees and payments for research & development. On the contrary, the investing activities contributed to net cash inflows of $ 71.7k received as proceeds from the expiration of bank guarantee.

Furthermore, the financing activities were at a high and generated net cash inflow of ~ $ 8.05 million primarily due to proceeds from the issue of shares, the exercise of options as well as repayment of LTI Rights by former Directors. In October 2018, the Company received an R&D tax incentive rebate of around $ 3.16 million for the 2017-2018 financial year, strengthening its cash position. The net cash at hand as of December 31st, 2018, stood at $ 15.46 million.

With the end of the trading session on March 26th, 2019, the ACW stock closed at the price of AUD 0.054, down 1.82% by AUD 0.001.


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