The opportunity exists for wholesale investors to express interest in an investment in InsituGen.

Pacific Channel, New Zealand’s first, most active and largest deep-tech venture capital firm is making a $500,000 investment as part of a $4m investment round of which $2m is committed at a pre money valuation of $14.7 million. As the lead investor, Pacific Channel has invested so far $2.825 million to date excluding the $500k (so total investment will be $3.325 million).

The problem: Steroid hormones (such as estrogens and androgens) are integral to animal and human health, playing major physiological roles in a range of systems (nervous, cardiovascular, immune etc.). Disorders in the activity of steroid hormones can lead to serious health conditions in humans and animals alike. Consequently, a multi-billion-dollar diagnostics market exists for steroid hormone testing, but existing solutions are complicated, expensive, time consuming, and in some cases inaccurate.  

The current approach to the detection and measurement of steroid hormones will fail to capture the full steroid hormone profile in a sample and will fail to detect any unknown synthetic steroid hormone.  

The solution: InsituGen’s technology provides rapid and accurate detection of all androgenic and estrogenic activity. InsituGen is developing (and has started commercializing) a multi-test diagnostics platform to test for steroid hormone activity. InsituGen’s unique, multi-patented (pending) technology-based bioassays rapidly detect the activation of androgen or estrogen receptors from any known or unknown compound (known and unknown steroid hormones, designer drugs, microplastics etc) interacting with the receptors and initiating a concerted signalling pathway inside cells.

One early use case in development by the company is hormone profiling in companion animals (dogs/cats) for general wellness. Estrogens and androgens play key physiological roles in the normal functioning of each body system. Abnormal levels of these sex hormones can be toxic, leading to hair loss, oily skin, weight fluctuations, osteoporosis, incontinence and increased aggression amongst other adverse symptoms and can indicate the development of tumours.  As sex hormone levels are vital to the longevity of the companion animal, as well as the quality of life as the pet ages, there is a demand for an ease-of-use, in-house test that can be incorporated into wellness check-ups.

InsituGen has conducted additional proof-of-concept studies in a range of indications, including but not limited to:, hormonal monitoring of human breast cancer patients to demonstrate treatment efficacy, detection of unwarranted steroid hormone activity in sports and wellness supplements, water quality testing for steroid hormone activity in fresh water rivers, investigating feminine hygiene products for unwarranted estrogen activity caused by inherent microplastics, as well as detecting anabolic androgenic steroid abuse (i.e. intentional sports doping) in the sporting arena of racehorses, racing camels and human athletes. Other markets will follow. 

Sales

Insitugen’s firstFlagX®, a bioassay kit allows the detection of total androgenic activity in samples from thoroughbred racehorses, racing camels, human athletes, and their associated feed or sports supplements. firstFlagX® augments existing testing systems and workflows in analytical laboratories, allowing non-targeted, rapid screening of a greater number of samples for the presence of androgens, including the hundreds of novel designer androgens that emerge every year.

firstFlagX® enjoys sales since last year including repeat customers in the horse antidoping.

Q1 of 2024 has seen the continued growth of InsituGen’s in-house testing with new and returning customers for the testing of freshwater, hygiene products, and supplements.

Six reasons why Pacific Channel is investing in InsituGen:

(1) Early commercial traction for 1st test: InsituGen is currently commercialising its first test kit, FirstFlagX, as a screening tool to detect designer androgen use in the racehorse and camel industries. After validating the technology in well over 1000 racehorses, and 400 racing camels, InsituGen has attracted significant interest from racing laboratories in Australia, New Zealand, and the UAE, and had first sales of FirstFlagX test kits in May 2023. The company recently signed a global exclusive distribution agreement with Berlinger Special AG – a global leader in the anti-doping industry, addressing over 95% of the analytical labs commissioned to perform racehorse and racing camel testing, with products sold in over 175 countries.

(2) Recognized by industry for detecting high-profile athletic drug scandals: Current methods for testing of designer steroids in athlete samples rely heavily on mass spectrometry that is exquisitely sensitive and can only detect chemical structures that are known to chemists. Underground chemists produce hundreds of new 'designer' steroids every year and existing processes can never be adequately kept up to date. Prof. Heather who famously helped detect drug cheating by decorated Olympian’s Marion Jones and Dwain Chambers, has since led the development of InsituGen’s synthetic biology designer androgen test, that can provide analytical laboratories with a screening tool to quickly detect unknown designer steroids.  

(3) 2nd use-case - COVID has created a multi-billion-dollar opportunity: Concurrently, InsituGen is expanding the platform to encompass hormone screening for companion animals, primarily pet dogs and cats (i.e. using abnormal hormone levels as a screening tool for cancers and other serious conditions). Pet ownership tripled during the COVID pandemic, and this trend is expected to continue. The global vet diagnostics market size is expected to reach $US 16.9 billion by 2030 with a compound annual growth rate (CAGR) of 11.2% from 2022 to 2030.  

(4) Activating veterinarians as distributors with new revenue streams: InsituGen is in the process of developing low-cost kits that would allow pets to be regularly screened for steroid hormones in the Vet clinic. Variation from normal hormone levels will quickly allow a veterinarian to perform follow-up testing for several hormone-related conditions. Such wellness testing will allow veterinarians to establish a new recurring revenue stream because currently steroid hormone testing is outsourced to much more expensive third-party labs. The test is being designed as a kit to be used at the veterinarian clinic. These three elements – low cost, recurring use, in-clinic test – create incentives for veterinarians to recommend these tests to their clients. The highly deregulated veterinarian market allows veterinarians to profit from in-house testing, something which is restricted in human diagnostics. Thus, veterinarians who see value in InsituGen can be activated as informal distributors to their clients.  

(5) Laying the foundations for future use-cases: InsituGen is setting the stage for several additional products – all based on the same steroid hormone platform technology.

Some examples:

Supplement testing: InsituGen has previously tested 112 over-the-counter sport supplements for designer androgen activity, six of which tested positive. On the back of these results, as well as other studies led by Prof. Heather, an Australian supplement company now uses InsituGen to test all batches of their product, “Plasmaide”.

Fresh water testing: The emerging evidence of xenoestrogens and xenoandrogens that leach from microplastics, the hormonal dominance from ingesting phytoestrogens and phytoandrogens, as well as synthetic hormones entering the environment through farming and industrial practices highlight a real need for constant monitoring of our water ways and other environmental sources. Because sex steroids affect almost every physiological system, environmental exposure through these pollutants can drastically impact animal welfare and human health.

Endocrine Disrupting Activity of Commercially Available Sanitary Products: Tampons, menstrual pads, and other menstrual products present a potential risk to women through the introduction of endocrine-disrupting hormones, given the direct contact with the permeable vaginal tract. Potential endocrine-disrupting chemicals have been found in in feminine hygiene products.

Blue sky markets will be in the human diagnostics space (hormone imbalances, cancer monitoring etc.).

(6) Syndicate of value-add investors: In this round there is a range of overseas investors such as Artemisia Equity GmbH (Germany). Marc Goldhammer (owner of Artemisia Equity) is a European Boarded Specialist in Veterinary Surgery and currently also CEO of ‘Small Animal Clinic Ludwigsburg-Ossweil. He strongly believes in the companion animal products and its markets. He is joined by several other Veterinarians personally investing and HNW individuals from Germany, Switzerland, and the Netherlands including the former head of Carlyle Europe.

Having a syndicate of deep-pocketed investors around the table also gives the company the best chance of continuing to secure its future financing needs as it grows. We are also joined in this round by a leading multinational player in the clean sports industry.  

Key milestones to be attained with this capital round:

• To further progress the environmental (water) test kit, with a target launch date in Mid 2024
• Expand in-house testing (supplements, water, hygiene products and pet food).
• Companion Animal first product: ‘Maturity Meter’ (timing of neutering) planned for launch in Q4 2024.
• Expansion into animal longevity monitoring (age-related health conditions).

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