Keys for AEZSPediatric growth hormone deficiency test:
- Pediatric growth hormone deficiency data. Clinical trial expected to be fully enrolled at the end of 2023 so data could be very near. It can take 1-4 months for a subject to clear evaluation I believe.
- Regulatory approval to sell the test to children. That could happen this year.
- Licensing deal(s).
- Continued progress selling the test.
The test is already approved for adults in the US and Europe and there is previous data for children and adults. Gilles should know the terms of a new North American deal being discussed as a member of AEZS's Board of Directors. In July AEZS announced that based on discussions a new deal was expected. A key catalyst for a deal could be the pediatric data from the clinical trial expected to be fully enrolled by the end of last year. Given the adult and childhood data, and approval for adults in the US and Europe you have to like the odds of closing a deal; especially with Gilles inside the company and expectations of a deal. The product is already being sold today in the adult market and rolled out in Europe so Gilles has been able to watch progress in the market. New deal partners will be able to look at the commercial sales. The ramp-up appears to be accelerating in Europe. Multiple parties have licensed the test in the past validating the capabilities of the test in general. It is an established market with a need and AEZS's test appears to be a material improvement.
The pediatric market is the most important for the test; but adults can benefit too as growth hormone deficiency can result in changes in body composition, and muscle tone as well as changes in cardiovascular parameters. It can affect quality of life and lifespan. Adults lack awareness about the need to test. A new diagnostic such as that of AEZS's and being able to launch a full marketing program across all age groups as well as being able to sell into the childhood market could accelerate sales for adults.
Beyond the diagnostic test the declaration that preclinical testing has been completed for the AIM Biologicals program on the lead program and that a candidate for human trials has been selected it an important milestone. The clinical trial path and what it will be able to prove and when is also a potential key catalyst. AEZS's lead program is expected to have excellent tolerability so that risk may already be well addressed. It has put together a robust proof in more than one disease and model as well as with human blood. The technology appears to work. The market can judge the risk rewards with a clinical path and given the science. It is based on a natural process approved by the human body already, in a sense. Mother's immune systems don't reject the fetus despite a fetus being half foreign protein from the father. The market for the lead indication is US$2.5 billion and the platform is extendable to other diseases. The market could get really excited as trials get underway and key data approches given the robust proof and the US$2.5 billion market and that it is a platform technology expandable to other diseases.
Gilles, "...the exciting projects Aeterna has been developing."