There are multiple catalysts coming up in the next months (calendar year 2023)
WHAT WE DO KNOW
Starpharma has indicated the long awaited data from in-house Dep phase 2 trials will be available in the 3rd quarter of 2023. There has been ongoing discussions with potential licensee's for some time as continually stated by our CEO. One would expect these to be sown up concurrently once results has been made accessible. Hopefully a bidding war will materialise
AstraZeneca has AZD0466 in 2 trials with a total number of 43 locations recruiting and an additional 18 sites to open. Surely we must be approaching expansion to phase 2. (I have been stating this based on comments made by the CEO at 2022 AGM in late November). Our CEO publicly announced AstraZeneca are investigating more indications which could go into human trials (notably AZD0466 for small cell lung cancer)
A post-market clinical study of VIRALEZE™ in people with COVID-19 as of June 5th was more than 80% recruited. My estimation for completion was a couple of weeks into July. I believe we may have to wait till the end of August. No doubt we should have data readouts in time for Winter in the Northern Hemisphere 2023
The monotherapy trials for phase 2 of Dep Docetaxel and Dep Cabazitaxel are complete. I believe the monotherapy for Dep Irinotecan is also complete. We currently are investigating combinations of Dep Docetaxel with Gemcitabine and Dep Irinotecan with 5-FU/Leucovorin
A submission to the FDA for our Vivagel was flagged to be lodged in first quarter of calendar year 2023. It was then indicated the submission would be filed sometime in calendar year 2023 (being delayed due to precedents that needed to be attached to the application).
Dep Gemcitabine was scheduled to go into human trials in-house, but was at the last minute pulled (in order to conserve funds). I believe there is an option to license this out to the party that win the battle for our completed phase 2 monotherapy drugs
Dep Radiotheranostics portfolio in preclinical trials is impressive. Once again the company has informed the market it is in ongoing discussions with interested parties
We continue to progress preclinical Dep ADC molecules with a strategy of either licensing them out or developing in-house.
Starpharma's platform is quite remarkable with the ability of it's "plug and play scalable technology to be applied to hundreds if not thousands of life science situations
WHAT WE DON'T KNOW
Starpharma has a collaboration with Chase Sun to develop DEP nanoparticle formulations for an anti-infective drug. The deal was sign in August 2020. When will Chase Sun press the trigger and initiate human clinical trials
Starpharma has a alliance with Merck to develop Dep ADC's. A first agreement was implemented in February 2021. An additional agreement was launched in August 2022. When will Merck fire the gun and commence human clinical trials
Starpharma has a partnership with Genentech (parent company is Roche) to develop Dep Drug Conjugates. It's first research collaboration was instigated in December 2021. An additional program was initiated in June 2022. When will Genentech advance the preclinicals to first in human trials.
Starpharma has had a long association with AstraZeneca. In addition to the drug currently undergoing 2 human trials, there is an unnamed out of patent blockbuster drug which was "borrowed" by Starpharma in June 2019 to create a new improved formulation. The preclinical work has been completed. AstraZeneca has the option to licence the DEP® oncology drug candidate for an option exercise fee of US$5M, plus industry standard development and commercialisation milestones and escalating royalties on sales.
If AstraZeneca does not exercise the option to license the drug candidate, Starpharma has the option to license the rights to develop and commercialise the drug candidate itself or through a sub-licensee with milestones and royalties paid to AstraZeneca upon commercialisation of the product
There is an existing multiproduct licence for use of Starpharma’s DEP® drug delivery platform in the development and commercialisation of several AstraZeneca oncology drug candidates.
When will AstraZeneca decide to go forward with any of the above.
QUESTION OF TIMING OF CEO'S RETIREMENT
Had the board discussed succession plans of CEO over the last few years
Upon reflection I believe it had. Certain milestones had to be coming to a head. These being completion and licensing out of the in-house phase 2 drugs. This could take 6-12 months to bed down
What was the catalyst for the CEO's decision to retire
I would like to think it was on her own terms...........and these will happen over the next 12 months
With all the news (hopefully good), coming this calendar year, was it time to begin to start the end of her long tenure at the company.
After such a long tenure (16 years), one might think about other things in life. The Chairman indicated Jackie will be looking at non executive positions going forward.
BOARD AND MANAGEMENT RENEWAL
Over the last 3 plus years, the entire board has been replaced
We have a new Company Secretary and Financial Officer
Jackie is intending to step down once a suitable replacement is found and consult for up to an additional 12 months Our Chairman is coming up for re-election this year. I do not think he will step down until successful succession and transition are completed .
DISCLOSURE
I am not a financial advisor. The comments posted above are my opinion unless stated as fact. DYOR
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