SPL starpharma holdings limited

My position and why I have been an activist

  1. 13,198 Posts.
    lightbulb Created with Sketch. 1622
    I have owned shares in Starpharma for many years.........electing to stay and not sell.

    The company has a technology platform of enormous potential

    My main issue with the organisation is

    *it's inability to find the right partners to promote ground breaking products
    *keeping us in the loop

    For those that are unaware I was the instigator that contacted holders last year and lobbied with them to vote against the remuneration and option packages for management

    This year I nominated John Wise for a board position. This nomination was seconded by another top 20 shareholder.

    The purpose of this was to shake the board up and for them to start to take notice of it's retail shareholders. Hopefully this is a wake up call that won't be ignored

    There will be many questions asked of management this year, mostly received in emails in advance of the AGM. These should all be covered in the CEO presentation. For those that are not, I am sure many hands will be going up in the question and answer period.

    Some have asked why there was only one question asked at the 2019 AGM. It was because most of the questions were answered in the presentation made by the CEO  

    Below is an email that I sent to the investor relations in regard to questions with notice for the upcoming AGM.




    Hi Investor Relations



    It has definitely been a stressful year for stakeholders

    One of the main issues is........shareholders have lost faith with the board of directors

    Lack of credibility seems to be the common denominator

    I have attempted on many occasions (over the last 2 years) to contact the chief executive officer without success.

    I have asked several questions repeatedly, without even the courtesy of a reply

    Below are some of the questions that I hope will be answered in CEO presentation and/or during the dedicated question time.


    FDA NDA for Vivagel BV
    47 months have passed and Starpharma has nothing concrete to tell us……  For the last year there has been a standard phrase of "FDA review process ongoing" in updates or announcements regarding this.

    What exactly are we waiting on from the FDA. What is the hold up. The company indicated a two pathway approach. One of those pathways has been put on hold……..however, really, after all this time…..without any formal news from Starpharma, it seems to me the only pathway is the one that has been put on hold…..We are almost 4 years down the track from initial rejection of NDA, (and I understand around $100 million plus spent commercialisation of SPL7013 products thus far). I think a little bit of transparency being needed is certainly an understatement.


    Dep version of undisclosed AZ blockbuster

    The company indicated in the later part of calendar year 2021 we would have completion of pre clinical study of undisclosed DEP version of AZ blockbuster. It is now more than 12 months past this timeline. What has happened in this space?


    Mundipharma and Vivagel BV

    In regards to Mundipharma not promoting or selling Vivagel BV in brick and mortar stores, let alone in an almost negligible amount online, one could assume that they are not performing to contracted obligations. Why are they still our partners?


    Condoms

    I also understand it is the responsibility of our partners to market and sell condoms in approved jurisdictions ………however nothing has ever been sold in NZ, and we have not had supplies in Canada or Australia for at least 3 years. Based on the above it seems Starpharma does not care and simply don’t consider this a priority. Would I be correct in this assumption?


    Lilly

    Whatever happened to the Lilly relationship in animal health and preclinical drug collaboration for cancer drugs on humans. It just disappeared without a trace from any announcements over the last 5 years


    ADC Partners
    This timeline below presents a summary of what has occurred in the ADC space.
    There were 2 undisclosed partners working with Starpharma in the ADC field (2016)
    By 2018 both undisclosed partners had progressed pre - clinical studies 50% based on the graphics
    By 2020 there was no mention of these 2 undisclosed partners in annual report.


    What ever happened to the undisclosed ADC partners.

    The pre - clinicals must have been completed (or not if they walked away).

    If they were completed are any of the current disclosed partners these former undisclosed partners.

    If the pre - clinicals were completed did the partners walk away.

    If they were completed, are these partners still around and undisclosed to us


    Below is the timeline of events leading up to these questions


    29th August 2016

    Two new Targeted DEP™ partnerships signed with world leading antibody-drug conjugate companies

    In the DEP™ drug delivery portfolio, Starpharma signed and initiated two new partnered programs for Targeted-DEP™ with two global leaders in the antibody-drug conjugate (ADC) market

    So this was the first time a mention of two undisclosed partners in ADC's was announced


    28th August 2017

    UNDISCLOSED ADC PARTNER TARGETED DEP® CANDIDATE Oncology
    Status pre-clinical 40% complete








    One year later in the annual report there was a graphic of both of these partners having progressed (my estimation) 40% of the pre - clinical trials



    21st August 2018
    UNDISCLOSED ADC PARTNER TARGETED DEP ® CANDIDATE Oncology
    Status pre-clinical 50% complete
    ANTIBODY DRUG CONJUGATES






    One year later in the annual report there was a graphic of both of these partners having progressed (my estimation) 50% of the pre - clinical trials



    21st August 2019

    Antibody Drug Conjugates
    AGREEMENTS WITH UNDISCLOSED PHARMACEUTICAL PARTNERS

    A further year later no graphics and just the above mentioned in annual report


    27th August 2020

    Advanced arrangements with potential partners of new Targeted (ADC) ® programs

    A further year later no mention of these undisclosed partners at all (my interpretation). Just the above. Does this mean the pre-clinicals were completed and now a new agreement with the undisclosed partners were being discussed. Or does it mean there was a new pharma on the scene

    12th February 2021
    Starpharma signs DEP® ADC Research Agreement with MSD Melbourne, Australia; 12 February 2021: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that is has signed a Research Agreement with MSD, the tradename of Merck & Co., Inc., Kenilworth NJ USA. Under the agreement, MSD will conduct a preclinical research evaluation of dendrimer based Antibody Drug Conjugates (ADCs) utilising Starpharma’s proprietary DEP® technology. Dr Jackie Fairley, CEO of Starpharma commented: “MSD is a recognised leader in oncology, and we are delighted to have signed this new Research Agreement in such an innovative and valuable area.” DEP® ADCs exploit the unique potential of Starpharma’s DEP® technology to provide enhanced characteristics to ADCs including greater homogeneity, site specific attachment, and higher drug antibody ratio (DAR), than conventional ADC approaches. DEP® ADCs are the subject of internal and partnered programs.

    It is a bit confusing to me. Why. Because in the earlier agreements (undisclosed) there was an indication of pre - clinical work in progress. I can only surmise this to be a completely new agreement with a new partner



    26th August 2021
    Signed a Research Agreement with Merck & Co., Inc., (MSD) to conduct a preclinical research evaluation of dendrimer-based Antibody Drug Conjugates (ADCs) utilising Starpharma’s DEP® technology.
    This agreement and Starpharma’s impressive ADC data triggered a number of new ADC discussions with other commercial parties, and we look forward to progressing those opportunities.

    The use of ADCs is an innovative and cutting-edge area in cancer therapy that continues to grow. Targeted DEP® conjugates (DEP® ADC’s) are an exciting and valuable application of Starpharma’s DEP® platform and the basis of internal development activities and a number of partner programs in the area
    Following the MSD partnership for DEP® ADCs, Starpharma has initiated a number of new discussions for other DEP® ADC partnerships

    In particular, our team has seen growing international interest in commercial discussions in the area for DEP® Antibody Drug Conjugates (ADCs) and DEP® radiopharmaceuticals, and we look forward to progressing these arrangements in the future.

    7th December 2021
    Starpharma also has a number of existing DEP® partnerships with leading international pharmaceutical companies, including AstraZeneca, Merck & Co., Inc., Chase Sun, as well as several undisclosed partnerships.

    16th December 2021
    DEP® partnerships In addition to its programs with AstraZeneca, Starpharma is progressing its other partnered programs, including its Antibody Drug Conjugate (ADC) program with Merck & Co Inc., DEP® anti-infective program with Chase Sun, and other named and unnamed partners. Additionally, further partnered DEP® programs, including in the area of radiopharmaceuticals, are at an advanced stage of negotiation

    29th July 2022
    A further new DEP® agreement with a leading pharmaceutical company is well advanced.





    Finally.......$93,000 + fine from the TGA. As this occurred after financial year 2021, I conclude the amount was applied to FY2022. As it has been buried in the annual report, can you please advice of how much of this fine was paid


    There are many other questions that need answering..........however I am sure stakeholders have already made you aware of them

    I believe all my questions are reasonable and definitely need answering without hiding behind confidentiality agreement reasons for not responding to them


    Looking forward to an open and transparent AGM


    Kind Regards
    xxxxxxxxxx
 
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