The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
I'm not too happy about the automatic extension of these options, and I do not see how this in the shareholders interest. The directors are renumerated with a salary and the options are the added incentive to drive the share price. Every time these are automatically extended, you are removing a good deal of incentive from the CEO to be mindful of the share price.
I really think the interview seriously damaged sentiment, when Prof Durrant casually said money may need to be raised again at the end of 2024. I get that she needs to be honest, but there is certainly a way to say it.
"Obviously as a result of the decision to focus on the two core products, we have extended our cash runway to the end of 2024. This affords us more time to engage with the interested parties and hopefully conclude a deal with sufficient up-front payments to fund the business going forward. However, that is of course dependent on the third party being willing to complete a deal, so we can never say that a cash raise to the market won't happen, but I can assure out current shareholders that our aim is to be a self-sustaining business and we are working hard towards that end"
Its not that hard.
Https://www.liverpoolecho.co.uk/news/health/mum-news-never-expected-after-26852352
"Why are the little little ramp group not buying when they mocked me for doubting the trish stuff and warning others .
Its right there in the RNS you utter clown
"One head and neck patient achieved a partial response and remains on study at week 37"
Regarding isicb1
"If positive, data generated by iSCIB1+ could lead to the initiation of a potential, rapid clinical development programme in H2 2024. An adapted registration trial could yield Phase 2 data within 2 years and would provide the Company with a pathway to a potential deal. The Phase 3 data could be complete within the following 3 years."
Scancell have previously said they would be looking to partner this up at the end of this trial. Now they are talking about the two year data providing a pathway to a deal with a subsequent registration trial. Does anyone else think this whole paragraph above reads like a deal in principle is in place contingent on the iscib1 results?
Today's RNS seemed to have the new chairman's fingerprints all over it. Criticism of Scancell in the past is the failure to focus on the commercial side of the business, and instead wanting to progress anything and everything scientifically. Seems much more of a focus now on being realistic and pragmatic on the things they need to do to become a self sustaining biotech. If I was speculating, I would guess that one of the major shareholders are behind this drive.
"the Company believes that combination therapy with checkpoint inhibitors, which are not currently approved for the treatment of ovarian cancer, could further improve outcomes for this patient group. Evaluation of Modi-1 plus checkpoint inhibitors in other tumour types in the ongoing Phase 1/2 study, will provide supporting data for this proposed combination use."
If the results from the other studies support a combination trial in ovarian cancer, this could be a double gamechanger. Great for the patient's who cannot currently use CPIs, but also a gamechanger for the sales of CPIs if they can get approval for use in combination with moditope. Could be a very strong argument for the hem to buy up the modi platform.
My own view on this is that the web site is fully geared towards the combination study, and shouldn't be taken to mean that the monotherapy arm is necessarily fully recruited (although it probably is in ovarian).
The monotherapy arm are people without treatment options (CPIs not approved or ineffective) - in those cases it is very easy to convince someone to try an early stage experimental drug.
For people on the combination arm, they already have CPI as standard of care, which brings with it a range of possible serious side effects. I would guess it is significantly harder to recruit patient's to an experimental drug (which theoretically could bring unknown side-effects and no benefit, as well as additional tests and hospital visits) whilst you still have proven treatment options. That's where the additional recruitment materials could be used to encourage people to sign up.
It's for this reason that I think the omission of ovarian cancer from the website does not necessarily mean already fully recruited.
"This study has c138 participants and when my name was put forward by my oncologist there was only one place remaining and three standby places."
I found this particularly interesting. The target numbers are obviously correct (138)., but I wonder if the rest is a misunderstanding or miscommunication. This person obviously has to be in cohort 4, as they have just started treatment. We know that cohort 4 is to dose just 3 people, same as the other run in cohorts. So is this the 3 people on standby that she is referring to - 3 people waiting on standby to go once the safety committee approved the move into cohort 4?
The alternative, and if the statement is taken as fact, then to have fully recruited all 138 people to the trail, and now its just a case of dosing them, then wow! This trial will fly.
Feels a bit like Alan Partridge trying to get another series
https://www.youtube.com/watch?v=zgPF5xtppTs
Full eligibility and exclusion criteria are here:
https://www.clinicaltrials.gov/ct2/show/NCT05329532
https://www.scancell.co.uk/Data/Sites/1/media/publications/posters/aacr_modify-study-poster_march-2023_final-corrected.pdf
@TF Figure 3 on this poster explains it. Cohorts 1 and 2 had a variation in doses (80µg and 400µg) followed by a Dose Selection phase. The patient with partial regression was from cohort 2 (the higher dose). If you look at the "Results" section it says "20 pts (patients) have received Modi-1(v) (3 pts Modi-1v 80µg/peptide, 17 Modi-1 400 µg/peptide)". Cohort 1 was the 80, cohort 2 was the 400, so all the other patients have come from the expansion cohorts. This confirms that the dose selection for the monotherapy cohorts was the same as Cohort 2.
Interestingly, for Cohorts 3 and 4, figure 3 shows they had the option of dosing cohort 3 at either 80µg or 200µg. The table "Fully Recruited Cohorts" shows that Cohort 3 have all been given 200µg. This backs up the reported "no dose limiting toxicity" and they felt confident to go with the higher dose option alongside the CPI for the first time.
So with this context, the title ""Report after completion of monotherapy dose-finding" very very strongly indicates that the content to be discussed are the Cohorts 1 and 2, as they are the only monotherapy cohorts pre dose selection.
Personally I am more keen to see the CPI combination results to date for cohorts 3 and 4.
wtp you missed a word:
"Report after completion of monotherapy dose-FINDING"
Cohort 1 and 2 had variable doses to find the safe dose to expand out into the full monotherapy cohort. These were the "dose-finding" monotherapy cohorts. Hence why I said the other day that the clue is very much in the title. It is a report on cohorts 1 and 2.
If the expectation is "melting all tumours and 100% remission" then it will be very easy for investors to see anything less as a "failure"
The reality is that in order to be commercially viable, Moditope just have to offer benefits above current standard of care, that warrants the additional cost of prescribing Moditope. The fact that Moditope has already demonstrated it can halt disease progression in patients that had exhausted treatment options, then it could already have demonstrated the ability to meet that criteria. The question now becomes "by how much" does it exceed standard of care and "in how many indications". That will determine the value of the product.