Investor Update June 2019

19-Jun-2019

Update on Sienna Cancer Diagnostics emailed to investors including our latest news & media coverage.

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Investor Update June 2019
Sienna Cancer Diagnostics Investor Update - June 2019
Matthew Hoskin Headshot

Dear Shareholder,

Your company has had an exciting and busy few months since the last update in early March. This edition highlights our most recent activities and achievements.

In line with Sienna’s technology expansion strategy, the company made its first acquisition, SIEN-NETTM, from US-based Sevident Inc. Thanks to our equity funding round last year, Sienna has entered the all-important global liquid biopsy market, estimated to be worth more than US$29 billion.

Dr Emily Stein and Dr Peter French joined the Sienna team from Sevident as part of the acquisition, and they are working hard on a range of new projects to create expanded revenue opportunities. Peter will play a strategic role at Sienna, helping us to build a portfolio of products over the next few years. Emily now heads the development of our new SIEN-NET product line, with a focus on getting product to market. We are expanding the intellectual property protection of this novel technology across global markets, and this month we received a new patent that was granted in China.

Following the acquisition of SIEN-NET, a new US-based subsidiary company, Sienna Cancer Diagnostics Inc. was incorporated. The new US company is 100% owned by Sienna, offering several advantages that will increase the group’s presence in the USA. Sienna will have greater ease and flexibility in financial transactions with US entities, potential access to US grant programs, and lower corporate tax rates.

We continue to identify and analyse potential in-license and acquisition targets using specific criteria to evaluate potential technology, including the validity of the science, IP protection, market opportunity, stage of development, and ability to leverage existing and future channels to market. We expect to continue to acquire technologies, creating an enhanced pipeline of products to generate additional revenue and long term growth for Sienna.

I would like to thank Wayne Rigler, Executive Vice President of Sales and Marketing at StatLab, our exclusive distributor for hTERT in the USA, for providing an update on StatLab’s sales and marketing efforts. His encouraging interview provided confidence that we’ll see growth for hTERT sales in the US.

Inside Diagnósticos was appointed as our exclusive hTERT distribution partner for Brazil. It’s exciting to see our hTERT test preparing to enter the large Brazilian market with a capable and enthusiastic distribution partner. The appointment of further distribution partners is a key part of the growth strategy for global expansion of our hTERT test into new markets around the world.

We thank our shareholders for their continued support and look forward to updating you later in the year.

Kind regards,
Matthew Hoskin
Chief Executive Officer

SIEN-NETTM: First acquisition in Sienna’s technology expansion strategy

In April 2019, Sienna acquired a unique sample preparation technology from Sevident Inc., which marked the company’s first transaction in its technology expansion strategy, and a new opportunity for future revenue generation.

The acquisition will assist Sienna to build a pipeline of novel diagnostic technologies that meet unmet clinical needs in the pathology market. The sample preparation technology, which we now call SIEN-NET, can isolate and capture molecular and cellular biomarkers from small clinical sample volumes, with high sensitivity and specificity. Successful development of SIEN-NET will enable Sienna to enter the liquid biopsy market, which is estimated to be worth $28.6 billion.

SIEN-NET isolates cancer derived materials like exosomes from blood or plasma faster than traditional means such as ultracentrifugation and column chromatography. It is flexible, scalable and both highly sensitive and specific. It is ideally suited for enhancing and streamlining sample preparation for liquid biopsies for screening and diagnostic purposes. Liquid biopsies have the potential to revolutionise the cancer diagnostics field, replacing invasive methods such as tissue biopsy and enabling more rapid detection of cancer at all stages. Sienna is in the process of planning for further technology development to bring this technology to market.

It is intended that the technology will not only be used to prepare samples for use in future Sienna-developed tests, but we will also seek to generate additional revenue from SIEN-NET through its sale for use in other non-competitive tests and applications as a standalone sample preparation product.

Click here to read the full announcement.

Liquid biopsy: The future of cancer diagnostics

Liquid biopsy is a minimally invasive and less risky procedure compared to solid tumour biopsy. It eliminates the need for preservatives, which interrupt molecular analyses, because the biofluid is fresh and easily accessible. As liquid biopsy is less invasive, it allows for repeated and consistent assessment throughout a patient’s entire cancer journey.

Until now, liquid biopsy has shown great potential but has not progressed beyond the research laboratory, due to limitations in capturing and isolating tumour-derived materials in a way which is fast, accurate, scalable and cost-effective for laboratories. SIEN-NET technology has the potential to overcome this limitation and help make liquid biopsy a routine diagnostic procedure.

Welcoming Dr Emily Stein and Dr Peter French

Dr Emily Stein - Research & Development Manager

Emily is the inventor of SIEN-NETTMtechnology. Based in what is now Sienna’s USA headquarters in Mineapolis, Emily brings a unique scientific background to Sienna that spans molecular biology, microbiology and molecular & cellular immunology. She completed her postdoctoral fellowship in the Department of Immunology & Rheumatology at Stanford University; she holds a PhD in Microbiology from the University of California at Berkeley, and a B.S. in Microbiology and Immunology at the University of Iowa.

Dr. Emily Stein

Dr Peter French - Strategic Technology Advisor

Peter has over 40 years’ experience in cell and molecular biology and has published across a wide range of areas including oncology, immunology, microbiology and neuroscience. Dr French was a Director of several biotech companies in Australia and the US, including Cryosite, Probiomics Ltd., Benetic Biopharma, and most recently served as CEO of Sevident.

Dr. Peter French

KDFA submission in Korea

Sienna, through its Korean distribution partner Mirax, recently submitted a formal application for regulatory approval of its hTERT test with the Korean regulatory authority, the KFDA. Preparation of the documentation for the submission was a joint effort between Sienna and Mirax, and Sienna is awaiting review and feedback from the KFDA.

Once Sienna's hTERT test is approved for sales in Korea, Mirax will launch the product to the substantial Korean market.

StatLab implementing strategies to increase hTERT sales in the US

In May, Sienna released a video from the Executive Vice President of Sales and Marketing for StatLab, Wayne Rigler. StatLab is the exclusive US distributor of Sienna’s in-vitro diagnostic (IVD) hTERT test. In the video, Mr Rigler discusses StatLab’s strategy for hTERT, including its enhanced sales and marketing plan, the significant market opportunity for StatLab and Sienna, and hTERT’s positive reception and future path to success.

Click here to read the full announcement.

Training session at Sienna in preparation for Chinese market launch

In late May, Sienna conducted a week-long in-depth training session in Melbourne with Sienna’s Chinese distribution partner Gaoyuan. The sessions covered a wide variety of topics, including technical, scientific, sales, marketing, and customer support training for Gaoyuan’s staff. Sienna’s submission package for regulatory approval in China is close to completion.

The photo below shows Mr Su Wen from Gaoyuan being trained by Sienna scientists Natasha Dagher & Shannon Turnbull, with assistance from Dr Lin Zhang, Sienna’s consultant pathologist who is fluent in both Mandarin and English.

Training session at Sienna in preparation for Chinese market launch

Sienna at the 20th International Cytology Congress

Members from the Sienna team presented a poster at the 20th International Cytology Congress in Sydney. The industry conference included 35 symposia and 18 case studies, which included our hTERT test presented by the Sienna team. The conference was attended by cytopathologists from all over the world, including luminary cytopathologist, Professor Eva Wojcik, Chair of Pathology at Loyola University Medical Center, and co-author of the highly regarded book on urine cytology, “The Paris System for Reporting Urinary Cytology.” Professor Wojcik is pictured here with Sienna’s Business Development Manager, Minesh Lalla, who was a co-author of the poster.

Sienna’s poster highlighted case studies where the addition of hTERT testing to routine urine cytology could help improve the chances of an early diagnosis of bladder cancer.

Sienna at the 20th International Cytology Congress

Sienna’s distribution network now covers four continents

The signing of Brazillian distribution partner, Inside Diagnósticos, in March represents a significant opportunity for Sienna. Brazil is the ninth largest economy in the world and offers a foothold in South America. This marks Sienna’s third distributor added since the start of 2019, with South Korea and Singapore announced in January and February.

Inside Diagnósticos have a different business model to our other distribution partners in that they are a reference laboratory. They will offer the test themselves as a pathology service provider, marketing it to their own referral base of urologists. In regions outside of their own direct referral network, they will act as a distributor and supply the test to other labs.

In 2017, the Brazilian market for in vitro diagnostics grew by 22% from the previous year to US$4 billion. Prior to sales commencing, the product must first be approved and registered with the Brazilian regulatory agency, ANVISA. Sienna will assist Inside Diagnósticos in that process.

To learn more, see the announcement here.

Sienna in the news

Sienna has received significant media coverage since the last investor update. A selection of these is summarised below, while the full list is available on our website, here.

Knox Biz Logo

Milestones aplenty as Sienna's cancer test goes global

The success of Sienna's biomarker test hTERT saw Sienna achieving nomination status at the 2018 Governor of Victoria Export Awards.

Stockhead Logo

Dr Boreham’s Crucible: Sienna’s first acquisition opens up the field of play

Tim Boreham, one of Australia's most well-known business journalists, explores Sienna's first acquisition and the implications it has for the future success of the company.

Biotech Daily Logo

Dr Boreham's Crucible: Sienna Diagnostics

Dr Boreham's crucible for April 2019 focusses on Sienna Diagnostics, where he discusses company background and progress as of late.

@auManufacturing Logo

Company Shines Through on World Stage

A Scoresby company has developed a test that can help urologists detect bladder cancer earlier. Sienna Cancer Diagnostics is a medical technology company that develops and commercialises cancer-related in vitro diagnostic tests for the pathology laboratory market.

Stockhead Logo

Company Shines Through on World Stage

A Scoresby company has developed a test that can help urologists detect bladder cancer earlier. Sienna Cancer Diagnostics is a medical technology company that develops and commercialises cancer-related in vitro diagnostic tests for the pathology laboratory market.



 
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