investor newsletter - dec 2018 · culmination of many years of hard work and planning. to have...

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Investor Newsletter - Dec 2018 As we near the end of 2018, we of course reflect upon our company’s accomplishments over the year. The key milestone was the enrolment of the final patient into the XanADu Alzheimer’s trial late last month, which initiates the countdown to results expected in Q2 2019. XanADu is a landmark trial in the treatment of Alzheimer’s disease, and the enrolment of the final patient is the culmination of many years of hard work and planning. To have reached this significant milestone within the original timelines, and to have exceeded our original patient target of 174 with a total of 186 patients enrolled, is testament to the quality of execution across multiple aspects of this trial. In addition to thanking our management team, Board and Xanamem Clinical Advisory members for their efforts, I would like to express my gratitude to all patients enrolled in the trial, their families and carers, and the participating trial sites involved with XanaADu. I also acknowledge the support of our shareholders as we work to develop this potential breakthrough treatment for Alzheimer’s. Another key accomplishment this year was the successful institutional placement and share purchase plan in July which together raised $16.5 million to fund further studies and drive the development of Xanamem. Continued on next page A Message from the CEO - Dr Bill Ketelbey Chief Executive Officer HIGHLIGHTS OF THIS NEWSLETTER Page 1 A Message from the CEO Page 2 A Message from the CEO (cont) Future investor and scientific conferences Page 3 Video featuring Xanamem Clinical Advisory Board Actinogen Medical in the media Page 4 Supportive research highlighting cortisol hypothesis Special Mention Updated investor presentation

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Page 1: Investor Newsletter - Dec 2018 · culmination of many years of hard work and planning. To have reached this significant milestone within the ... • Updated investor presentation

Investor Newsletter

- Dec 2018

As we near the end of 2018, we of course reflect upon our company’s accomplishments over the year. The key milestone was the enrolment of the final patient into the XanADu Alzheimer’s trial late last month, which initiates the countdown to results expected in Q2 2019.

XanADu is a landmark trial in the treatment of Alzheimer’s disease, and the enrolment of the final patient is the culmination of many years of hard work and planning. To have reached this significant milestone within the original timelines, and to have exceeded our original patient target of 174 with a total of 186 patients enrolled, is testament to the quality of execution across multiple aspects of this trial.

In addition to thanking our management team, Board and Xanamem Clinical Advisory members for their efforts, I would like to express my gratitude to all patients enrolled in the trial, their families and carers, and the participating trial sites involved with XanaADu.

I also acknowledge the support of our shareholders as we work to develop this potential breakthrough treatment for Alzheimer’s.

Another key accomplishment this year was the successful institutional placement and share purchase plan in July which together raised $16.5 million to fund further studies and drive the development of Xanamem.

Continued on next page

A Message from theCEO - Dr Bill Ketelbey

Chief Executive Officer

HIGHLIGHTS OF THIS NEWSLETTER

Page 1

• A Message from the CEO

Page 2

• A Message from the CEO (cont)

• Future investor and scientific conferences

Page 3

• Video featuring Xanamem Clinical Advisory Board

• Actinogen Medical in the media

Page 4

• Supportive research highlighting cortisol hypothesis

• Special Mention

• Updated investor presentation

Page 2: Investor Newsletter - Dec 2018 · culmination of many years of hard work and planning. To have reached this significant milestone within the ... • Updated investor presentation

Planned H1 CY2019 Partnering and Investment Conference AttendanceJP Morgan Healthcare Conference | January, San Francisco SACHS Neuroscience Innovation Forum | January, San Francisco BIO-Europe Spring 2019 | March, ViennaBIO 2019 | June, Philadelphia

The additional studies will support the next phase of development for Actinogen Medical, enhancing our data set for the treatment of Alzheimer’s disease and cognitive impairment associated with other neurological and metabolic diseases.

We were delighted to receive support in this placement from US specialist biotech investor Biotechnology Value Fund LP (BVF) and leading Australian institutional investors Australian Ethical Investment and Platinum Asset Management. The involvement of these groups has strengthened our financial position and added substantial value to our discussions with potential future commercial partners.

We have a pivotal few months ahead of us in the lead-up to results from XanADu, and we are making every effort to engage key stakeholders ahead of the read-out from this important global trial.

As you can see from this newsletter, our team will be attending a number of high-profile investor and scientific conferences over the next few months to present our work. Also, the team will be making a concerted effort to engage with the media and raise awareness of Actinogen Medical.

I hope you enjoy this newsletter, and wish you a restful time over the upcoming holiday season.

Sincerely, Dr Bill KetelbeyChief Executive Officer

A Message from the CEO (Cont)

Planned CY2019 Scientific Conference AttendanceAD/PD 2019 | March, Lisbon AAIC 2019 | July, Los AngelesCTAD 2019 | December, San Diego

Future investor and scientific conferences

With results from XanADu expected in Q2 2019, Actinogen Medical is attending a number of conferences in the New Year to engage with global investors, educate the scientific community and key opinion leaders, whilst progressing collaboration talks with prospective pharmaceutical partners.

Page 3: Investor Newsletter - Dec 2018 · culmination of many years of hard work and planning. To have reached this significant milestone within the ... • Updated investor presentation

January

The West Australian wrote a story about

Xanamem and a participating researcher

in the XanaADu trial, Professor Roger

Clarnette.

Click here to read the article.

February

The Daily Mail wrote a story about the search to find a treatment for

Alzheimer’s, mentioning Actinogen Medical’s work in the space.

Click here to read the article.

March

The Sydney Morning Herald ran a story

looking at international efforts to develop

Alzheimer’s treatments, including non-amyloid

approaches such as those being developed by Actinogen Medical.

Click here to read the article.

May

The Australian covered Actinogen Medical’s

successful institutional placement in May.

Click here to read the article.

July

Actinogen Medical CEO Bill Ketelbey spoke with

CommSec about the XanADu trial and the

growing need for new therapies to treat

Alzheimer’s.

Click here for the interview.

October

Melbourne’s Channel Nine featured a story

with Professor Michael Woodward, a

prominent Alzheimer’s expert involved with the

XanADu trial at Melbourne’s Austin

Health, where he talks about the potential of

Xanamem for Alzheimer’s disease.

Click here to view the story.

November

Actinogen Medical CEO Bill Ketelbey discussed Xanamem, the XanADu

trial and Alzheimer’s disease with Proactive

Investors.

Click here for the interview.

November

Biopharma Dealmakers in the journal Nature,featured a profile on Actinogen Medical, Xanamem, and the

Company’s XanaADutrial.

Click here to read the profile.

November

The Australian Financial Review featured a

comprehensive profile on Actinogen Medical,

summarising the Company’s recent

activities and its focus on developing a next-generation treatment

for Alzheimer’s.

Click here to read the profile.

November

BiotechDispatchcovered the

announcement of the final patient enrolment in Actinogen Medical’s

XanADu trial.

Click here to read the article.

Actinogen Medical has continued to generate media interest in its activities, with several stories featuring the Company, Xanamem and the XanADu trial throughout 2018. Outlined below is a selection of relevant coverage.

Actinogen Medical in the media

Video featuring Xanamem Clinical Advisory BoardIn October, members of the Actinogen Medical team met with the Company’s Xanamem Clinical Advisory Board prior to the CTAD conference in Barcelona, which is one of the leading international conferences focused on Alzheimer’s disease and the development of next-generation treatments.

In addition to the milestone of final patient enrollment in XanADu, the video touches on potential indications for Xanamem beyond Alzheimer’s, how the XanADu trial stands out in relation to other trials, and the growing interest in XanADu from other Alzheimer’s experts.

Click the image to view the video.

CEO Bill Ketelbey and Advisory Board members, including Professor Craig Ritchie, Professor Colin Masters AO and Professor Jeffrey Cummings, filmed a video covering a range of topics.

Page 4: Investor Newsletter - Dec 2018 · culmination of many years of hard work and planning. To have reached this significant milestone within the ... • Updated investor presentation

Special MentionIn July, a Member of the Xanamem Clinical Advisory Board, Professor Jeffrey Cummings M.D. Sc.D., was honoured with the prestigious industry Life-time Achievement Award by the Alzheimer’s Association.

The award recognises significant contributions to Alzheimer’s research and commitment to the fight against Alzheimer’s disease and dementia.

The award was presented at the Alzheimer’s Association International Conference 2018 (AAIC 2018).

Prof Cummings joined Actinogen’s Xanamem Advisory Board in early 2015 and has been an invaluable source of support and expertise in the clinical development of Xanamem.

Supportive research highlighting cortisol hypothesis

In November, Actinogen Medical released an announcement highlighting a study in the journal Neurology by Echouffo-Tcheugui et al., which found a link between higher serum (blood) cortisol, decreased cognitive performance and decreased brain volume.

These findings support the hypothesis underpinning development of Xanamem for the treatment of Alzheimer’s disease and cognitive impairment, and bode well for Actinogen in the lead-up to top-line results from the XanADu trial in Q2 2019.

Two other recent studies provide growing evidence to support the association between stress and age-related cognitive (learning and memory) decline. Both studies, performed in animal models of ageing and Alzheimer’s, demonstrate that an increase in stress hormones is associated with cognitive decline.

The research by Wheelan et al. (published in 2017) concluded that exposure to a period of stress in midlife results in cognitive decline in old age. These research findings were supported by another study by Stuart et al. (published in 2017) in the esteemed scientific journal, Nature.

These studies provide strong validation and support for the development of Xanamem, which is specifically designed to block the production of the stress hormone, cortisol, in the brain. If the XanADu study in Alzheimer’s disease is able to replicate the results of earlier studies in animal models, Xanamem could prove to be the most significant advance in decades in the management of this devastating disease.

Updated investor presentation

Last month, Actinogen Medical released an updated corporate presentation to support an investor roadshow across Australia and the Company’s recent AGM in Sydney.

The updated presentation effectively outlines key investment highlights and the progress and outlook for Actinogen Medical heading into 2019.

Key highlights include Xanamem’s novelty as a compound, the multiple additional studies initiated and planned, and Actinogen’s potential value upside in Alzheimer’s and other indications supported by significant interest from big pharmaceutical companies.

Click here to view the version of the presentation for the roadshow and here the version presented at the AGM.