Half-year Report

Have not updated for a while but off the back of the Half Year report an update was due. The report was significant and gives a good insight into the operations of Hemogenyx, I have extracted what I believe to be some key points:

Finances

The report goes into detail about the CLN facility which caused a technical crash of the SP, it also makes clear the facility and attached risk is now gone. The company holds approx £10m cash at hand with an approximate burn down of £3m per year and have confirmed they believe they have enough capital for at least 12 months.

CDX Antibodies

Detailed negotiations are ongoing with GlobalCo as to the exact terms of the licencing and Global Co’s involvement in progressing CDX towards clinical trials. The report makes a point to highlight work with Global Co continued at pace AFTER the initial development work completed. What is significant is that both parties are currently working “naked” as the existing development contract has expired, either side could walk away leaving the other high and dry having wasted considerable time and money. This co-operation and continuation of effort whilst negotiations take place is a demonstration of both sides commitment to get the deal done and a very positive indication.

HEMO-CAR-T

This is a significant update: “the Company has engaged a contract development and manufacturing organisation that will manufacture DNA plasmids and viral vectors for the production of HEMO-CAR-T for clinical trials.” There are 3 manufacturers required, what is outstanding is an organisation to produce the CAR if my understanding is correct. This is a necessary step in taking CAR-T to clinical trials and a strong and positive indicator of progress. Is it likely Hemogenyx would have secured 2 of the 3 suppliers to produce HEMO-CAR-T if they were not imminently prepared to file IND application and begin clinical trials?

The half year report also goes to pains to call out the significance that despite this advanced stage of HEMO-CAR-T and the Master Translational Research Services Agreement with the University of Penn the company retains 100% of the IP associated with this product. As highlighted elsewhere on this site CAR-T is an explosive and valuable sector worth billions, proof of clinical concept of HEMO-CAR-T would be game changing to the company.

CBR

The company has acknowledged a failure to update the market regularly and committed to update more as time progresses. This is due to a gradual consistent development rather than specific key milestones, however taken as a whole CBR has hit key milestones. First they have identified 2 key product candidates although more available, one for Covid-19 and one for an undisclosed type of cancer. In Vitro experiments have been successful and testing continues. Given the ability of Covid-19 to beat vaccines and mutate it is possible CBR may actually have a role at some point in the future. Early days but certainly a promising pipeline to watch.

Autoimmune Diseases

As reported in June 2020, the Company entered into an agreement with Eli Lilly and Company (“Lilly”) …. In recent months this work has significantly accelerated. Lilly and the Company are now progressing with the initial selection of potential drug candidates. This is a significant progression from our last update where we knew nothing, the next stages after selection of candidates will either be further testing or licencing, either indicates strong progress.

Patents

The unique properties of the patented monoclonal antibodies were the primary driver in bringing GlobalCo to enter into an agreement to develop CDX. The Company has made further patent applications in relation both to HEMO-CAR-T and to the CDX bi-specific antibodies, the latter entailing a joint application with GlobalCo. – The patents secured by hemogenyx provide key connectors to bind to multiple cells in the body including cancer cells and Bone Marrow stem cells. With a limited number of targets and patents granted the patents granted give Hemogenyx a massive presence in the Bone Marrow Transplant market and AML treatments. I will do a more detailed article on the Patents and the significance when time permits, suffice to say in my opinion they are worth as they stand many multiples of the current companies mCap even without CDX or CAR-T.

Growth

The company has taken on more staff, more scientists and are moving to a new larger premises in the near future, all key signs of growth.

Summary

As a shareholder in this company having read all previous updates I read the recent Half Year report with the expectation of nothing new. I expected no surprises or NEW information, I was plesently surprised. The Report does several things, it reassures us that the company is financially secure and well funded, dilution is unlikely and risk is mitigated, in terms of value the Patents secured + assets easily underpin the mCap. There are 4 key active pipelines, Lupus is the big surprise appearing to be close to a key milestone of selecting a candidate for progression. CAR-T is also primed for clinical trials requiring only IND application and CAR manufacturer, CBR is progressing nicely and will hopefully update soon. CDX is the primary focus of all investors however and whats clear is both Hemogenyx and Global Co are operating as if the licencing agreement is a done deal. The failure to halt progress pending a successful agreement shows both parties are committed to getting it done. At an mCap of 19mil the upside here is massive, there is always risk and the report highlights these risks.

None of this article should be taken as investment advice, do your own research, what is presented here is MY opinion only with no guarantee of accuracy. Please read the official RNS which can be found HERE.

CDX Licence Agreement

Hemogenyx Pharmaceuticals #HEMO, announces that it has signed a licence agreement (the “Agreement”) with Eli Lilly and Company (“Lilly”). Under this Agreement, Lilly grants the Company an exclusive worldwide licence to certain intellectual property developed by Lilly (“IP”) related to a CDX bispecific antibody for all uses, including the treatment of acute myeloid leukemia (“AML”) and other blood cancers.

A lead CDX antibody candidate has been successfully created and the Company is initiating investigational new drug (“IND”)-enabling studies that include manufacturing of the antibody for animal toxicology studies and subsequent clinical trials. The work done to date fully validates the Company’s original expectations and shows wider potential applications for CDX than originally envisaged. It is now being developed for conditioning for bone marrow transplantation and also for the treatment of several blood cancers, as further described below in the section headed ‘About CDX’ below.

Confirmation at long last that Global Co is Eli Lilly, confirmation that CDX works against a whole range of targets and not just AML. With a small upfront payment but Eli expecting substantial royalties and payments down the line instead just demonstrates they know what Hemo have is worth the big bucks. In my opinion today’s announcement unlocks Hemogenyx from the bureaucracy of big business so they can get to clinical trials faster but its clear Eli Lilly are behind this project. Zero risk for Eli at this point with the ability to just buy Hemo when CDX is proven in clinical trials.