SPL 3.06% 9.5¢ starpharma holdings limited

DEP phase 2 trials - patience required!

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    This forum lately has become a bit of an echo-chamber of discontent and negativity. I understand people’s disappointment about the rollout of Viraleze, especially when comparing the outcomes with statements that have been made in announcements.

    I share in that disappointment and believe management should be held to account. I also share the disappointment that many feel about Vivagel. A vote against the remuneration package may be appropriate and is something I will consider, depending on what happens between now and the AGM.

    On the positive side, however, I am very happy about the deal struck with Merck for development of ADCs. I believe this will lead to multiple new drug candidates. Dendrimer’s were made for ADCs!! a very hot area in oncology at the moment. I am very happy that the company has had approaches from other pharmaceutical companies interested in ADCs. I am happy that Starpharma has an ongoing relationship with Astrazenica. I am very happy about how AZD0466 is going.

    It is my opinion that civil criticism of management is fair regarding Viraleze and Vivagel but that some people on this forum are getting way too worked up about the so-called ‘delay’ in the release of results for the phase 2 DEP trials and making it out as some great failure by management.

    I appreciate it is frustrating having to wait for the DEP results but, when it comes to these trials, patience is required. The company has stated repeatedly that they will licence out the three candidates at a time that realises maximum value to shareholders. We just have to wait. The cake isn’t quite cooked yet! I believe the company is approaching this strategically, holding their cards close to their chest, planning the timing of the release of the results, to gain the maximum benefit as stated. It appears they may have changed their mind a couple of times about when they would release the data, but I am ok with that. It is their right to adjust their strategy over time as they consider the results, especially if it is in shareholder’s interests. Remember we are talking about likely (IMHO) multi-billion dollar deals here and things should not be rushed. Strategy is important.

    The company has been telling us consistently that the results of the three internal phase 2 trials are very good, in fact remarkable. They have released multiple EXTRAORDINARY case studies. Remember, these are open-label trials. The company knows how they are going and have given us some sneak-peek previews of some of the results. IMHO, the final results are going to be very, very good! Well worth the wait!

    Remember that, in the case of cancer trials, the longer the wait for outcomes (progression-free survival - PFS, median overall survival - mOS, etc) the better the results are! We currently have four DEP trials ongoing and I am happy that, with every one day that passes, four more ‘patient-days’ of testing and proving our DEP technology platform passes and that it likely means the phase 2 results are proving to be better and better!

    Whilst each of these first three individual DEP drugs needs to be licenced or sold, it is the DEP PLATFORM TECHNOLOGY that Starpharma ultimately is wishing to market to Big Pharma to bring in further interest and gain multiple further partnerships to develop many more DEP drugs in the future. I suspect that the company has a strategy to reveal all the phase 2 trial results close together, or at the same time, to make a big statement of proof of concept for DEP as a PLATFORM TECHNOLOGY, and that is when the excitement will begin and patience be rewarded! The bigger the statement is, the bigger the deals with big pharma will be!

    The DEP Docetaxel single agent trial results should already be ‘mature’ enough (demonstrating superior efficacy and safety compared with current standard-of-care, SOC) to be released any time now, if the company chooses to do so, but I suspect that they are holding off, waiting for the other two trials to mature further. In the meantime, they have repeatedly stated that they are value-adding with the Docetaxel combination trials (with gemcitabine and with nintedanib). I also suspect that the most recently recruited patients in all three trials have the most difficult to treat cancers (The combination of Docetaxel with gemcitabine will, no doubt, be testing against pancreatic cancer, which has a very, very poor prognosis with SOC treatment, following on after the strong preclinical results announced 16/11/2018). I don’t think the late recruitment of these patients will necessarily delay the release of phase 2 trial results significantly, it is just further value-adding. Demonstration of superior efficacy against these most difficult and deadly cancers, compared with current SOC treatments won’t take long and will add significant value to each of the drugs. Demonstration of superior efficacy can be achieved through imaging studies, tumour marker levels, or by measuring PFS without having to wait for mOS (eg. PFS is linearly, mathematically, related to mOS in pancreatic cancer and can act as an early ‘proxy’ indicator of mOS). For this reason, I am not concerned that the company is still recruiting into the phase 2 trials. I believe it is all just adding further value while waiting for the bulk of the patients’ data to mature enough to present to / negotiate with big pharma suitors. In fact, the company has stated recently that they are continuing with these trials in parallel with partnership discussions.

    (IMHO) when the first licencing deals get struck, DEP shareholders will be in for a very big payday and no-one will be complaining then! The demonstration of proof of concept should result in a barrage of interest from big pharma. The number of drugs that can be improved by DEP is very large and the pipeline of future DEP drugs is potentially very large. Big pharma will want to develop DEP versions of many existing and new drugs, once the benefits have been nicely demonstrated. I anticipate that Starpharma will need to then rapidly expand and will have the capital to go on to develop many, many DEP products, both internally and through partnerships. Unless, of course, we are bought out but this would have to be at a very attractive price.

    Just my thoughts

    Regards

    Gumnut
 
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