OptiBiotix Health Regulatory News (OPTI)

OptiBiotix Health plc

("OptiBiotix" or the "Company")

25 April 2017

Final Results

Notice of AGM

OptiBiotix Health plc (AIM: OPTI), a life sciences business developing compounds to tackle obesity, high cholesterol and diabetes, announces its audited results for the year ended 30 November 2016. 

The Company has made significant progress during this period, with early revenues and a promising development pipeline.

Highlights

· Successful fundraising of £1m from the placing of 1,282,051 new ordinary shares at 78p

· A substantive increase in IP portfolio which now covers 50 patents across 15 families, 8 strain registrations, and 16 trademarks 

· Joint venture agreement with the University of Manchester in skin health, creating a majority owned SkinBiotix Ltd (renamed SkinBiotherapeutics plc)

· Key commercial agreements signed with KSF Acquisition UK (Slimfast) and Royal DSM (leading supplier of nutritional ingredients)

· Successful launch and sales of Slimbiome® in GoFigure® shakes and bars; Creation of majority owned joint venture agreement with The Healthy Weight Loss Company  

· A significant scientific breakthrough in demonstrating the ability to change the microbiome in a very targeted way, and enhance a health benefit, in the case of our own cholesterol reducing strain LPLDL, leading to a threefold increase in the strains ability to lower cholesterol

Post-period end highlights

· Joint product agreement signed with Tata Chemicals Ltd

· Key Board positions made, with the appointments of a Commercial Director and a Sales & Marketing Director

· The successful admission of its majority owned subsidiary, SkinBiotherapeutics plc, to AIM in April 2017

· European manufacturing, supply and profit sharing agreement with Sacco S.r.l.

Stephen O'Hara, CEO of OptiBiotix, commented: "OptiBiotix has made significant progress in the last year in building the infrastructure and team to support the transition from a technology company, to a product company, with early revenues and a developing pipeline of products across all its platforms. We are delighted with the excellent reviews following the launch of GoFigure® products containing our SlimBiome® formulation. This has led to a growing customer base, early sales, and attracted interest from Tata Chemicals Ltd in developing products for the Asian market. We hope to build on this early success with the launch of our LPLDL® cholesterol reducing product in May of this year. Finally, we are pleased with the successful admission of SkinBiotherapeutics plc to AIM in April 2017, representing a substantial return on our initial investment. I would like to thank our investors for their support, and look forward to an exciting and rewarding 2017." 

This announcement contains information which, prior to its disclosure, was considered inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (MAR).

For further information, please contact:

About OptiBiotix - www.optibiotix.com

OptiBiotix was formed in March 2012 to develop compounds which modify the human microbiome - the collective genome of the microbes in the body - to prevent and manage human disease. 

The aim of OptiBiotix is to discover and develop microbial strains, compounds and formulations, which modulate the human microbiome and can be used as food ingredients and supplements or active compounds for the prevention and management of human metabolic diseases, examples of which include obesity, cholesterol and lipid distribution and diabetes. 

OptiBiotix has established a pipeline of microbiome modulators that can impact on lipid and cholesterol management, energy harvest and appetite suppression. The development pipeline is fuelled by its proprietary OptiScreen® and OptiBiotic® platform technologies designed to identify metabolic pathways and compounds that impact on human physiology and bring potential health benefits. These platforms are applicable across a wider range of other human diseases.

Chairman's and Chief Executive's Statement

We are pleased to present OptiBiotix Health plc's annual report and accounts for the year ended 30 November 2016.

OptiBiotix has made strong progress during this period in its strategy of developing compounds which modify the human microbiome, developing partnerships with industry, and broadening its position in the microbiome space by the acquisition of intellectual property in the skin microbiome. This period has also seen the start of the transition of OptiBiotix from a technology company, to a product company, with early revenues and a developing pipeline of products bringing the promise of the microbiome to human healthcare. This transition heralds a new phase in the Company's development as its science creates new products to prevent, manage, and treat many of today's chronic lifestyle diseases. As the promise of the microbiome materialises into products across an increasing number of OptiBiotix's technology platforms there is potential for significant enhancement in the value of the company.

Key Achievements

During the period to date we have achieved a number of key objectives which continue to build shareholder value, strengthen our position in the microbiome space, and put the necessary intellectual property protection and operational infrastructure in place to begin the next stage of development, the commercialisation of our products. These include: -

· A fundraising in February 2016 which raised £1m from the placing of 1,282,051 new ordinary shares at 78p to extend our position in the microbiome space and capitalise on opportunities arising in the skin microbiome

· Acquisition of the exclusive rights to intellectual property developed by The University of Manchester in skin health, creating a majority owned joint venture ('JV') called SkinBiotix Limited (subsequently renamed SkinBiotherapeutics plc)

· A substantive increase in our IP portfolio which now covers 50 patents across 15 families, 8 strain registrations, and 16 trademarks

· The completion of a number of partner agreements with major industry players including KSF Acquisition UK, owners of the Slimfast brand and Royal DSM, the world's leading supplier of nutritional ingredients

· The development of sweet calorie free natural healthy sugars (SweetBiotix®) with safety and sweetness confirmed by human taste studies

· Demonstration of our ability to change the microbiome in a very targeted way, and enhance a health benefit, in the case of our own cholesterol reducing strain LPLDL, leading to a threefold increase in the strains ability to lower cholesterol

· An investment to acquire 51% of The Healthy Weight Loss Company ("THWLC"), as a platform to incubate new technological solutions and develop wider product applications in weight management

· The launch of our first product, Slimbiome®, as an ingredient in GoFigure® meal replacement shakes and natural snack bars which are sold on line and through specialised retail outlets such as pharmacies and Whole Foods Market Inc (a $15bn American supermarket chain exclusively featuring healthy foods)

· The appointment of Luis Gosalbez as Director of Business Development to support the commercialisation and internationalisation of products.

Research and Development (R&D) strategy

OptiBiotix's R&D strategy has been designed to create technology platforms and intellectual property which provide multiple product and partnering opportunities both within each platform, and by combining platforms. For example, the different oligosaccharides produced by our OptiBiotix® platform can be used in our SlimBiome® formulation or in combination with the microbes identified in our Optiscreen® platform. This means that for a limited amount of extra cost we have the potential to create large amounts of additional value. Whilst this approach has complexity it has been designed to mitigate development risk in an evolving scientific field and provide a cost effective way to build overlapping IP and exploit the many opportunities offered by the microbiome. The other advantage of this approach is that as these platforms are structured under separate divisions, each containing its own technology platform, IP portfolio and partner agreements, they could in due course become separate legal entities with the potential for investment or a public listing. This strategy allows investors in OptiBiotix to build up a broad based investment portfolio across a number of areas in the microbiome space which diversifies risk, whilst offering shareholders ‎multiple opportunities in this exciting space.

OptiBiotix has made significant progress in the last 12 months as its development programmes have moved through the process of building the scientific and clinical evidence base for its products and reporting these for peer review in scientific journals and at international conferences, such as at the European Microbiome summit. These presentations and publications raise OptiBiotix's profile and reputation, attract commercial interest in our technology and products, and provide the scientific evidence for sales and marketing literature in support of product commercialisation.

As the Company transitions from a technology company, to a product company, the company anticipates future presentations and publications to support the launch of its pipeline of products.

SlimBiome, GoFigure, and the Health Weight Loss Company

OptiBiotix's weight management formulation, branded as SlimBiome® was developed as a low risk product by experts in the weight management field to give early market access. The constituent ingredients are established, with a substantial scientific evidence base, and the requisite regulatory approvals. The novelty is in the formulation and delivery allowing SlimBiome® to be used as a supplement or a food ingredient in cereal bars or dairy products.

In July 2016 OptiBiotix formed a partnership with THWLC to carry out a trial launch of Slimbiome® in GoFigure® snacks and shakes under a non-exclusive UK license agreement. The products received excellent reviews and most importantly, dieters reported losing an average of 2-3lbs with the products helping manage hunger and leading to a reduction in calorie intake. To gain more structured customer feedback OptiBiotix commissioned an independent consultant to carry out a small consumer survey by contacting customers who bought directly from the GoFigure website. These results provided further support of the science behind the Slimbiome® formulation with GoFigure® customers reporting reduced hunger, less snacking and easier weight loss. From launch to the end of this reporting period: - 

· THWLC has gained over 1,000 customers, retail listings in over 80 stores, and 4 distributorships in the UK and Iceland

· Sales have grown steadily and in line with seasonal trends

· GoFigure® was voted finalist in "Best New Health & Nutrition" at the 2016 European Natural & Organic Awards

THWLC provides an effective way to substantiate the commercial viability of early product concepts in the large but highly competitive weight management market. This market is driven by short-term fashions and trends which often lack scientific substantiation. Sales are driven by seasonality associated with targeted investment in product and brand marketing at key seasonal periods to attract motivated strugglers, whose weight typically fluctuates between diets. Products typically rely on customers' self-control to restrict calories and as a consequence have a high failure rate with only a small number of dieters maintaining their weight loss over the long term. The use of SlimBiome® in the GoFigure® range establishes a new approach to weight loss which uses innovations in science to help consumers manage their weight loss by reducing food intake without food cravings, leading to easier and more successful dieting.

OptiBiotix will continue to use THWLC to incubate new technological solutions and establish early consumer interest and product viability. It believes this is an effective way to attract interest from industry partners who want to use Slimbiome® as a food ingredient in other products in other product applications and international markets.

OPTISCREEN, CHOLESTEROL REDUCTION AND LPLDL®

OptiBiotix's first product developed using it's OptiScreen® platform, is a bacterial strain targeting cholesterol reduction. The strain, registered under international treaty's as Lactobacillus plantarum ECGC 13110402 and branded LPLDL®, was selected by OptiBiotix's proprietary OptiScreen® technology platform from over 4,000 candidate strains. The product, provided as a supplement containing 100mg of LPLDL®, successfully completed human studies in September 2015 with no safety, compliance, or tolerance issues and showing high levels of efficacy for both cholesterol and blood pressure reduction. The reduction of both blood pressure and cholesterol creates opportunities for a single product for both conditions (high cholesterol and high blood pressure), or two different products targeting separate conditions. Other possibilities under discussion with partners include combination products where additional ingredients provide performance or additional consumer benefits, such as reducing multiple cardiovascular risk factors, in a single presentation.

The results of the study created a greater number of opportunities than originally anticipated. This has led to OptiBiotix adding to its IP, developing novel formulations with key opinion leaders, and working with a wide range of partners who have the necessary supporting manufacturing, distribution, and sales infrastructure, to support a product launch in May 2017.

Presentation of our findings at international conferences has generated a lot of interest in this product as it has good clinical data, strong key opinion leader support, and uniquely reduces both cholesterol and blood pressure. This has an increased effect on reducing cardiovascular risk, and as such, provides a unique product differentiator. The key point to bring out to investors is that we don't see this as a single opportunity, but multiple opportunities with a range of partners with multiple products. Discussions have been on-going to ensure we have partners who have the necessary capability to fully exploit the opportunity across different formulations, presentations, and territories. We see our strain, which we have trademarked LPLDL®, as very much the 'Intel' inside a range of products for cardiovascular health across both consumer and pharmaceutical markets. This creates the opportunity for multiple revenue streams from sales of the strain, white label, and branded products - maximising shareholder return. Whilst time consuming multiple deals diversify investor risk and if successful will give a greater shareholder return.

The results from the independent human study have been submitted for publication in an international journal, and were presented at the European Microbiome summit. Further presentations are planned for ProBiotica (Berlin) in February 2017 and Microbiome Asia in March 2017, in preparation for a May 2017 launch of a range of formulations and presentations at Vitafoods in Geneva.

In the period covered by this report OptiBiotix has carried out further development to better understand the mechanisms of action and approaches to further optimise product efficacy. These include incorporating our own OptiBiotic® microbiome modulators with the LPLDL® strain, which has shown potential for a threefold enhancement in cholesterol reduction.

OPTIBIOTICS®, MICROBIOME MODULATION, AND SWEETBIOTICS®

Under the leadership of Dr. Sophia Kolida OptiBiotix has made significant progress in its programmes to develop sweet functional oligosaccharides which modify the human microbiome to prevent, manage and treat disease. The Company believes these developments have the potential to substantially increase the Company's value. This progress includes: -

Microbiome modulation/Precision microbiome engineering

Our R&D teams have used gut models to demonstrate the ability of our microbiome modulators to increase the growth rate, biological activity, and health effect, of specific microbial species in the human microbiome. This has now been demonstrated in multiple species, including OptiBiotix's cholesterol reducing strain (LPLDL®). To our knowledge, this is the first time this effect has been demonstrated and creates the opportunity for designer prebiotics which can modulate targeted elements of the microbiome. The ability to develop designer prebiotics, which can modify both the microbiome's composition and its function, creates the potential for designer ingredients or supplements which can modify an individual's current microbiome to improve health and the potential for precision microbiome medicine. This is an area of growing scientific and commercial interest with increasing evidence that the microbiome plays an important role in how the body metabolises pharmaceutical products, influencing their effectiveness and the potential for adverse reactions.

The ability to create designer ingredients which can modify an individual's microbiome to improve health places OptiBiotix at the forefront of global microbiome research and product development. This is a significant scientific breakthrough and has the potential to substantially increase the Company's value.

OptiBiotics®

Our R&D teams have made rapid progress with a new product concept called an OptiBiotic®. This is a combination of a targeted probiotic and prebiotic which selectively enhances the in vivo growth of the probiotic, accentuating its functional properties and health benefits. Our teams have demonstrated that by combining our cholesterol reducing strain, now trademarked LPLDL®, with galacto-oligosaccharides produced from it, we can selectively enhance its growth and increase cholesterol reduction threefold. To the best of our knowledge this is the first time that anyone has developed an optimised synbiotic, or OptiBiotic®, that increases the growth and health benefit of a specific bacterium in the microbiome.

This new research demonstrates the potential for the development of species or genera-specific probiotics to selectively enhance the growth and health benefits of existing probiotics. This concept is directed at companies in the probiotics functional food market who have benefited from the global trend for fortified and functional foods, a market that is expected to be worth in excess of $46.5bn by 2020 (Markets and Markets).

These galacto-oligosaccharides when used by themselves are heat resistant and stable during processing making them suitable as ingredients in a wide range of products. This finding extends the existing product opportunity offered by OptiBiotix's LPLDL® cholesterol reducing strain from supplements to ingredients, greatly increasing the market opportunity. The results of these studies have been submitted for publication and presentation in mainstream scientific journals and conferences throughout 2017.

SweetBiotix® 

Work to date has demonstrated our ability to synthesise sweet calorie free natural healthy sugars (SweetBiotix®) with safety and sweetness confirmed by human taste studies. These sweet natural healthy sugars are not digested in the human gut and hence calorie free. The SweetBiotix concept is an innovative concept with the potential to address a global requirement, addressing international concerns over the impact of sugar on obesity, with the prospect of replacing 'unhealthy' sugars in existing products with non-digestible, low calorie, healthy, SweetBiotix®. As the food and beverage industry responds to growing public and political concerns over traditional sugars and artificial sweeteners, we anticipate high levels of commercial interest in this product. In anticipation of growing industry interest, we have accelerated our development plans and hope to launch our first generation sugar product later this year, or at the start of 2018.

Further work is ongoing to develop other sugars and to modify existing structures to accentuate sweetness further. Having demonstrated the synthesis and purification of SweetBiotix® we are now actively engaging with commercial partners looking for safer, healthy alternatives to existing products.

RESULTS

OptiBiotix results for the 12 months ended 30 November 2016 are set out in the Consolidated Statement of Comprehensive Income. Administrative expenses were £1,765,736 (2015: £1,451,451) reflecting the costs of operating a public company. Cashflow remains tightly controlled with a focus on building shareholder value through investment in R&D, and adding to our in-house and out-house IP. The Groups cash position remains strong at £3,115,366 (2015: £2,040,888) which is sufficient to fund its existing research and development programmes, extend technology platforms into other product and application areas, and support the sales and marketing of our pipeline of products.

BOARD & MANAGEMENT

We believe that we have a well-balanced Board with a focus on the domain expertise in the founder and Chief Executive Stephen O'Hara, Non-Executive Directors Dr. Gareth Barker and Peter Wennström, who is one of the world's leading experts in functional food innovation and marketing. Dr. Sofia Kolida as Director of Research and Development brings specialised expertise in prebiotics. They are complemented by our Chief Financial Officer Mark Collingbourne and Adam Reynolds as Chairman.

We were pleased to announce the appointment of Dr Luis Gosalbez to our management team as Director of Business Development. Luis has worked at various times in Germany, Spain, and South Korea as a researcher, analyst, and as a director of strategic projects exploring opportunities in consumer healthcare, the microbiome, and biotherapeutics. His experience of the Asian market will help enhance our understanding and capability to support wider internationalisation of products and create new joint development opportunities.

We anticipate further changes to the management team and the Board as we evolve from a technology company to the commercialisation of our pipeline of products.

OUTLOOK

OptiBiotix is continuing its strategy of developing microbiome modulators for large markets (>£100m) where there are high growth opportunities (CAGR >10%), and a large unmet need. This will be achieved by developing our own IP, or acquiring new IP or technologies in areas of strategic interest in the microbiome space, when the opportunity arises.

As part of this strategy OptiBiotix acquired the rights to intellectual property developed by The University of Manchester in skin health in March 2016.

During 2016 it became clear to the Board that the opportunity offered by skin and its potential future value was not transparent to shareholders. Their interest tended to focus on more tangible near to market opportunities which were developed as low risk, relatively low return opportunities, to gain early market access. However, this meant that the value of some of OptiBiotix's more innovative technology, which was at an earlier stage of development, was not being realised.

The admission of SkinBiotherapeutics plc to AIM in April 2017 reflects a strategy to realise the value of each technology area, which the Board believes was not being fully realised when viewed as a whole. The listing of SkinBiotherapeutics plc materialises the value of a part of the business in which a 52% stake was acquired for £250K in March 2016 and 12 months later listed at a valuation of £11m, with OptiBiotix owning a 41.9% shareholding. This represents a substantial return on our original investment in just over 12 months. OptiBiotix believes that there is potential for substantive future value enhancement in SkinBiotherapeutics plc using the £4.1m raised at listing allowing it to fully exploit the potential of this exciting technology.

This strategy allows investors in OptiBiotix to build up a broad based investment portfolio across a number of areas in the microbiome space which diversifies risk, whilst offering shareholders ‎multiple opportunities in the exciting space. As a listed company grows in value OptiBiotix shareholders will benefit from the appreciation of each asset. This is an innovative business model which over time looks to give OptiBiotix shareholders a position in multiple companies, and with it the prospect of multiple returns.

The Board anticipates a future where microbiome products will make a significant contribution to the prevention, management, and treatment of disease. As the promise of the microbiome materialises into products across an increasing number of OptiBiotix's technology platforms there is potential for significant enhancement in the value of the Company. That future is unfolding with microbiome treatments using faecal microbial transplants (FMT's) now common place in over 500 US and 10 UK hospitals. Further evidence for the growing role of microbiome in healthcare came when US researchers and clinicians presenting at the 2016 Medical Innovation Summit identified the microbiome as the top innovation that they believe has the power to transform healthcare in 2017.

With a growing number of research publications showing the potential of the human microbiome in a broad range of health areas we anticipate microbiome therapies will be a large part of modern healthcare in the years to come. We believe OptiBiotix's broad range of technology platforms and our ability to modify an individual's current microbiome to improve health creates the potential for precision microbiome medicine, and places OptiBiotix at the forefront of this revolution in healthcare.

In the last 12 months commercial deals have focused on joint development, cost sharing, or option agreements with partners contributing funding in return for certain future rights. The next 12 months will see the Company transition from a technology company to a product company building revenues streams from a diverse range of products. This process started in August 2016 with the launch of GoFigure® products and continues with the launch of our LPLDL® cholesterol reducing strain in May 2017. We hope the launch of first generation SweetBiotix® later this year will complete the launch of innovative microbiome products across all our technology platforms.

The transition from a technology to product company requires a different skill set and the appointment of high calibre recruits who bring a track record of building sales, and a network of contacts across different geographies. This process commenced with the appointment of Luis Gosalbez in August 2016 and continued with the appointments of Per Rehne and Christina Woods in January 2017. Christina will take on responsibility for the commercialisation of SlimBiome® and its associated products (e.g. GoFigure®) whilst Per will lead commercialisation of the LPLDL® strain.

To support the commercialisation of our technology and protect our investment we have added significantly to our IP portfolio which now covers 50 patents across 15 families, 8 strain registrations, and 16 trademarks. We anticipate further patents filings and strain registrations where we feel there is commercial value. In addition to our own filings we will continue to explore opportunities to acquire new technologies or IP in areas of strategic interest to support our continued growth.

The Board believes OptiBiotix is at the leading edge of an emerging market, forecast to become one of the world's fastest growth areas. Over the last twelve months we have continued our progress of building a microbiome business with significant value for shareholders with a strategy which best maximises the value in each division and a diversity of IP and commercial relationships which provides shareholders with multiple opportunities. OptiBiotix now has a broad portfolio of IP, multiple technology platforms, and an increasing range of products entering the market, and believes it is well placed to build on this solid foundation to build a microbiome business with significant future value for shareholders.

On behalf of everyone at OptiBiotix Health plc we thank you for your support and look forward to an exciting future.

A Reynolds and S OHara24 April 2017

Consolidated Statement of Comprehensive Income

Consolidated Statement of Financial Position

Consolidated Statement of Changes in Equity

Share capital is the amount subscribed for shares at nominal value. Share premium represents amounts subscribed for share capital in excess of nominal value, net of expenses.

Merger relief reserve arises from the 100% acquisition of OptiBiotix Limited on 5 August 2014 whereby the excess of the fair value of the issued ordinary share capital issued over the nominal value of these shares is transferred to this reserve in accordance with section 612 of the Companies Act 2006.

Accumulated deficit represents the cumulative losses of the group attributable to the owners of the company.

Share based payment reserve represents the cumulative amounts charged in respect of unsettled warrants and options issued.

Consolidated Statement of Cash Flows

Earnings per Share

Basic earnings per share is calculated by dividing the earnings attributable shareholders by the weighted average number of ordinary shares outstanding during the period.

Reconciliations are set out below:

Basic and diluted earnings per share are the same, since where a loss is incurred the effect of outstanding share options and warrants is considered anti-dilutive and is ignored for the purpose of the loss per share calculation. As at 30 November 2016 there were 10,345,237 (2015: 10,345,237) outstanding share options and 1,983,709 (2015: 2,631,125) outstanding share warrants, both are potentially dilutive.

Notice of AGM

The Company's AGM will be held at the Walbrook PR, 4 Lombard St., London EC3V 9HD at 12pm on Thursday, 15 June 2017. A copy of the Notice of AGM may be downloaded from the Company's website.

Posting of Accounts

The Accounts have today been posted to shareholders and are available for download from the Company's website, www.optibiotix.com.