Investor Update – September 2018

03-Sep-2018
Message From The CEO

Welcome to the September 2018 investor update.
The last few months was a busy and exciting time for Sienna, so we’d like to provide you with a summary of the many announcements made and milestones achieved.
On 20 July 2018 the company announced a $5.2 million capital raising via a placement with institutional and sophisticated investors and a rights issue to existing shareholders. This funding has now been received and provides Sienna with the resources to explore strategic opportunities for the acquisition of technologies which are complementary to our business and existing product.
Our hTERT test progressed on multiple fronts including:
  • an exclusive distribution agreement was executed for mainland China, and;
  • a proof-of-concept trial was initiated with the Royal Melbourne Hospital in Victoria to investigate the use of this technology for thyroid cancer.
We are pleased with the recent progress made in all four of our strategic growth areas. We thank you for your continued support and look forward to providing further progress updates.

Sincerely,

Matthew Hoskin
Chief Executive Officer
$5.2 million Share Placement and Rights Issue
In mid-July, Sienna announced two initiatives to raise $5.2 million of new capital:  
  • a $1.6 million share placement to institutional and sophisticated investors, and;
  • a $3.6 million non-renounceable rights issue offer open to existing shareholders.
Merchant Opportunities Fund and Mr David Williams took the majority of shares issued via the placement and the rights issue was well supported by existing shareholders who were offered one new share for every three shares held on the record date. The funding initiatives resulted in approximately 87.1 million new ordinary shares were issued. The new capital provides support for the company’s technology expansion strategy.

Read the closing announcement here
Clinical trial agreement with the Royal Melbourne Hospital
On 30 August 2018 Sienna announced the initiation of a proof-of-concept clinical study agreement with the Royal Melbourne Hospital to investigate the use of Sienna’s hTERT IVD Test on Fine Needle Aspirite (FNA) samples of the thyroid gland. The study forms part of the hTERT application expansion strategy.

Thyroid nodules are common, and usually harmless, though a needle biopsy is needed to confirm if the nodule is benign (safe to leave alone), or cancerous (needs to be removed or treated). Approximately 10% of thyroid needle biopsies are reported as indeterminate and carry a 20-30% chance of harbouring cancer. An indeterminate diagnosis typically requires surgery to remove half the thyroid to enable a more exhaustive analysis and subsequent diagnosis. Sienna’s hTERT test has the potential to assist doctors in making the determination of whether this surgery is necessary and therefore prevent unnecessary surgeries.

With over 1.5 million thyroid cytology tests conducted world-wide each year, there is a significant unmet medical need for an adjunct to needle biopsies to assist in diagnosing indeterminate biopsies.

The proof-of-concept study is being supported by an Innovation Connections Grant, administered through CSIRO.

Read the ASX announcement here
Sienna signs exclusive Chinese distribution partner – GaoYuan
Sienna has recently appointed Shaanxi GaoYuan In Vitro Diagnostic Reagents Co. as the Company’s exclusive distribution partner for mainland China. This partnership represents a significant milestone in Sienna’s geographical expansion strategy. China has a population of approximately 1.4 billion people and is one of the fastest growing consumers of IVD products globally. 

GaoYuan has significant reach across China through both direct sales and distribution networks, both of which are key sales channels for the market. The agreement gives GaoYuan the exclusive right to sell Sienna’s in-vitro diagnostic (IVD) test for hTERT to pathology labs where it will be used as an adjunct to urine cytology, assisting pathologists and urologists in the diagnosis of bladder cancer. 

For the full story, see here
Johns Hopkins Study Published in Peer Reviewed Journal

In June, the results of the largest independent study using Sienna’s IVD test were published in the leading cytopathology journal Acta Cytologica. The study, authored by researchers at the prestigious Johns Hopkins University School of Medicine in Baltimore, concluded that testing urine samples for hTERT using Sienna’s IVD test is a clinically useful adjunct to urine cytology.

Peer-reviewed data is often requested by labs evaluating the implementation of Sienna’s IVD test, it is expected this study will assist with adoption by new customers of the test. The study provides an additional level of confidence, assurance and validation to adopt the test for routine clinical use.

View the study publication online

Full year financials

Sienna announced revenue from operating activities for the last 12-months of $527k, and a loss for the year of $2.2 million. This result comes as the company continues to invest in the strategic objectives of US market penetration, geographic expansion, application expansion for hTERT, and technology pipeline expansion.

Find the full financials here
Sienna Executive and Board Members Actively Engaged in State Level Industry Bodies

Sienna CEO Matthew Hoskin has been appointed to AusBiotech’s VIC AusMedtech committee representing the medtech industry at a state level. The Committee is dedicated to promoting the interests of the Australian medical device and diagnostics (medical technology) industry in Victoria.
The advisory group is comprised of some of Victoria’s leading medtech CEOs, Managing Directors, Vice Presidents and Managers.

Sienna Non-Executive Directors Helen Fisher and Carl Stubbings also hold roles in state level biotechnology committees, with Ms Fisher holding the role of Chair of AusBiotech’s VIC State Committee, and Mr Stubbings a member of the AusBiotech NSW State Committee. These Committees are comprised of leading figures within the biotechnology industry, and is designed to promote the interests of the sector at both a state and national level.

Sienna in the news 

To view the list of media articles in which Sienna has appeared, see here


 
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