January 10, 2023, Vancouver, British Columbia: Gemina Laboratories Ltd. (CSE: GLAB) (FRA:8I7) (the “Company” or “Gemina”) is pleased to provide the following strategic overview and share an outlook for 2023 and beyond. The Company enters 2023 at a significant inflection point in its growth, maturing from its primary focus on R&D and proof of concept work, to the development of large-scale commercial partnerships and opportunities. The Company has narrowed its core development focus to the area of respiratory diagnostics, while committing to partner and license its technology platform in high-value diagnostic areas outside of Gemina’s current scope. 2022 was a transformational year at the executive level. The Company welcomed Brian Firth as CEO, a proven diagnostics executive formerly with Swiss Precision Diagnostics GmbH, who brings decades of proven experience in the global diagnostic sector. Mr. Firth and the Gemina team have also established and continue to augment a world-class advisory board and management team to help guide the Company through these next chapters of accelerated growth.
Initially announced in October of 2022, December saw Gemina complete the transfer to manufacture of its first product – the Legio XTM COVID-19 Rapid Antigen Test (“Legio XTM”). The product is now available for sale as we enter 2023. We expect to be announcing more about the distribution plan for Legio XTM in the near future.
2022 saw the Company commit to developing a pipeline of products for the diagnosis of infectious respiratory diseases. The completion of Gemina’s prototype Flu A/B test this month sees this project move into full development. With this advance in the Flu A/B test programme, we are now able to commence feasibility studies for a Respiratory Syncytial Virus (“RSV”) test, the next target in our respiratory panel.
To date, Gemina’s focus has been on developing tests using the lateral flow assay (“LFA’s”) platform, but the Company recognised that lateral flow technology would not be suitable for diagnosing all respiratory disorders. In addressing this, the Company is delighted to announce that it has established a master services and license agreement (the “Agreement”) with ReadyGo Diagnostics of the United Kingdom. Under this Agreement the two companies will work together using the ReadyGo Geo and Gemina chemistries to develop and launch a tuberculosis (“TB”) test for primary care screening. This programme is designed to deliver Gemina’s first molecular assay (i.e. DNA based test). The Agreement provides Gemina the rights to market and sell the resulting TB diagnostic test globally, on an exclusive basis.
Commenting on this latest Agreement Rob Greene, CTO of Gemina stated, “This is a significant move towards becoming a diagnostics company of significance, one that is able to tackle a variety of challenges across respiratory diagnostics. It will further our goal of democratising diagnostics by creating a crucially important molecular test for TB that is not only highly effective, but affordable for all healthcare systems globally.”
During 2023, the company will continue to strategically explore its Wellness testing concepts in targeted areas (for instance, in applications such as sports and fitness). Unlike the conventional pointof-care diagnostics market, the market for wellness monitoring is nascent. As such, Gemina’s approach is to work with significant customers and research counterparties to help define strong productmarket matches. The Company plans to make further announcement in this regard in the first quarter of 2023.
From Product Strategy to Licensing
The Company is increasingly confident that its surface chemistry platform is able to power a wide range of medical and consumer point-of-care tests across a variety of devices, including lateral flow tests and beyond. In 2022, the Company was able to demonstrate the viability of its chemistry platform through independent laboratory testing and patient trials which culminated in the achievement of CE Marking for the Legio XTM test (see news releases on May 5th and May 17th).
On the back of the chemistry and product performance achievements, the Company is focusing its product and market development activities on the Infectious Respiratory Disease Diagnostic space. Gemina believes there is a significant market opportunity, and a specific opportunity for the Company to establish a differentiated and highly effective commercial solution set while building a significant market share in this growing sector. The Company recognizes the Gemina chemistry platform can be applied to many unserviced or underserviced areas of diagnostics where the Company has no immediate product development plans. To address these opportunities, Gemina has established a commercial strategy to exploit non-competitive diagnostic product development opportunities. During the second half of 2022, the Company began to nurture a number of relationships with parallel non-competitive global diagnostic market participants to explore mutually beneficial opportunities to deploy Gemina’s platform chemistry. As a result of this outreach, we expect to have announcements regarding strategic licensing agreements in 2023.
Research & Development
The Gemina research team continues to innovate and further develop our chemistry platform, and during 2022 the Company filed important extensions to existing patents. These filings include the application of the chemistry to enable the use of novel materials, such as cellulose, in LFA’s that are far more environmentally friendly than the current materials used worldwide. Such innovations open the prospect of developing fully bio-degradable lateral flow devices. Gemina foresees a major evolution in test design that includes the use of sustainable materials which, as far as the Company is aware, are only made possible by the versatility and strength of Gemina’s chemistry platform.
The patent filings also cover Gemina’s “Universal Test Platform” which allows for the creation of an extremely versatile lateral flow test, which is not only more stable, but much more responsive and adaptive to changing needs and diagnostic requirements around the world. More on these developments will be shared throughout 2023.
As a result of the Company’s growth and progress, 2022 saw a number of hirings and appointments to better position the business for its next phase of growth. The focus has been and continues to be on strengthening the team with highly experienced diagnostic, clinical and strategy professionals who have proven track records of scaling companies to commercial success. Most notably:
- The hiring of Brian Firth, a veteran diagnostics executive, who joined Gemina as Chief Executive Officer in September 2022.
- The appointment of Dr. Mike Shannon in December 2022, as Chair of the Company’s Clinical Advisory Board as the Company focuses on respiratory infections.
- The appointment of Dr. Rob Porter as Company President in December 2022. Dr. Porter’s appointment was contemporaneous with a transaction where the Company took a stake in British rapid test optimizer, RAPIvD, (founded by Dr Porter) with the option, subject to certain conditions, to acquire all remaining issued and outstanding shares of RAPIvD. Securing this strategic stake in RAPIvD was the first step in a process that aligns the Gemina chemistry platform with accelerated product development competencies. The acquisition helps facilitate the development of next generation, high feature diagnostic device designs, which Gemina plans to bring to market in the future.
- The Company will be making further announcements in the coming weeks and months as appointments are made to further strengthen the organisation.
Commenting on the progress made in 2022, and the year ahead, Brian Firth, Gemina’s CEO stated, “Gemina’s chemistry platform removes traditional barriers for Point of Care tests, opening the possibility of producing higher quality, lower cost, and more environmentally friendly tests at the point of need. 2022 was a milestone year for the Company with the CE mark for Legio XTM, representing a major validation event. Our focus in 2023 will be on converting this developmental success into revenues, an expanding product panel, and our first licensing transaction. I believe the potential is enormous, and for Gemina, our focus is the key: the right products with the right team with the right access to market, will allow us to maximise the benefits from this chemistry, and secure long-term success.”
The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 virus.
About Gemina Laboratories Ltd.
Gemina Labs is a biosensor and diagnostic company with a transformative, patented, proprietary chemistry that powers next-generation testing platforms for a wide range of pathogens that affect human health and wellness. Our technology drives testing platforms that are fast, affordable and accurate, and easily self-administered. Our development pipeline includes platforms for the rapid testing of COVID-19, influenza and other viruses. Additional information on the Company can be found at www.geminalabs.com.
About Syniad Innovations
Syniad Innovations is a company focused on building breakthrough deep tech companies around cutting-edge advances in science & engineering, like quantum networking.
Syniad addresses some of the world’s most pressing challenges by collaborating with exceptional researchers and provides the expertise, capital, and networks to help accelerate their ideas into important new products and services. Founded in 2015 in Vancouver, Syniad possesses a unique pedigree in research commercialization.
Our experience includes projects with various stakeholders, from Fortune 500 companies to governments and universities that want a step change in impact.