Thoughts7 Aug 2022 10:23
Time to join the dots on this company and for those who are reticent to do research allow me to outline the following: Hemogenyx are currently an R&D preclinical company with a Mcap of around £13m and it’s worth noting that peer level clinical (phase 1) companies have an average MCap of £70m+. So how likely are Hemogenyx to get a product candidate into the clinic (human trials) and to achieve the same sort of valuation? Well, firstly they have at least 4 viable candidates product candidates at this point in time, Hu-PHEC, CDX (developed in a multi year collaboration with Eli Lilly), HEMO CAR-T (in collaboration with Penn University) and their CBR platform. All candidates are fully patent protected. As it’s the most advanced I’ll focus on HEMO CAR-T in this post. So, the positives I see is that with over £7m in the bank, Hemogenyx are fully funded to achieve clinical proof of concept. They have already had very PIND discussions with the FDA who have outlined the steps required for IND application, clinical trials and commercialisation for the treatment for AML. (CAR-T therapy is around $450k per patient so not cheap). So how confident are Hemogenyx? Well, they have allocated a multi million pound budget to achieve clinical proof of concept. They have moved to a new purpose built 10,000 foot laboratory with clean rooms and commercial manufacturing capability ( manufacturing their own CAR as opposed to outsourcing leads to savings of over £3m in the process). They have already employed an additional 2 scientists with CAR manufacturing experience and in 2 weeks employ a highly respected scientist as Manufacturing Director to oversee all aspects of the laboratory. His main area of expertise, CAR-T. In parallel with this Hemogenyx have already outlined the roadmap to IND application, with first trial manufacturing run scheduled for September, second in October and the third and final run in November, followed by IND application in December, then clinical trials can commence (I understand for an initial 12 patients). My personal thoughts are why set up a full infrastructure complete with staff if you weren’t extremely confident this therapy works? Additional positives if you needed them, HEMO CAR-T has been developed in collaboration with UPenn arguably the world leaders in CAR-T and responsible for assisting in getting the first CAR-T therapy FDA approved and commercially manufactured and remember this stage alone should (based upon peer level valuations) takes the SP up to 7p+. Throw in their other product candidates who will have their own updates issued in parallel and who knows what Hemogenyx could be valued at in 3-6 months time. Throw in the expertise that Vlad has at his disposal of Sir Marc Feldmann, Chairman and David Shepard, Chief Scientific Advisor, both winners of the equivalent of the Noble prize in America who are responsible for 2 of the top 5 best selling drugs in the world, and I find it difficult to find a more compelling investment