Member Info for JohnnyB1

We know that the monotherapy dose-finding was completed 21 February’23 because the RNS of that date tells us “Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer and infectious disease, today announces completion of the monotherapy dose finding arm of the multicentre Phase 1/2 ModiFY clinical trial”.

I find the wording in the ASCO heading “Report after completion of monotherapy dose-finding” ambiguous.

Is it a more in depth look at the data as at 21 February’23? The wording AFTER implies that it could include data more recent than 21 February’23? I honestly don’t know.

I sometimes find this with Scancell that wording isn't always totally clear and is open to different interpretations.

Hi Lofas,

It's all detailed in my 15.59 post at the start of this thread. ATB.

Hi Chester,

Maybe RG could do something along those lines. I don’t honestly know either. Maybe (if he hasn’t already) he could sell the shares he already owns and buy some of the shares under his option. He could in turn sell these at a profit to buy other remaining shares he has under option.

That said, I am not really concerned about how he funds the purchase so much as whether there is a performance criteria in place and what that is.

I personally hope that the performance criteria is still the same ie. 45p share price for 30 consecutive dealing days or a takeover. That way he would likely be selling when the share price is over 45 pence. Better that than getting the shares now and selling them at current levels (The share price is already spiralling down enough as it is).

Johnny

Hi Chester,

RG may have sold shares that day. However, take a look at page 20 the accounts for 30 April’22:-

https://www.scancell.co.uk/Data/Sites/1/media/fininfo/scancell-holdings-financial-statements-to-30-april-2022.pdf

You will see RG only held 258,823 shares; so even selling at 20 pence (The share price wasn’t this high it is just for example) this would only raise less than £52k.

He also had 6,343,840 shares owned jointly with the Trustees of the Scancell Employee Benefit Trust. But I think that we would have heard had he sold any of these. You will no doubt remember the RNS when Lindy sold some of her jointly owned ones (some were sold to Redmile).

When I saw the RNS 17 April’23, I incorrectly assumed that RG had exercised his option over 2,880,000 shares at 4.5p. Thank you Bermuda and others for advising that this does not mean that RG had exercised his option. However, from a learning perspective I decided to look into this further and this is what I have managed to establish.

Lindy and RG were originally granted the following Share Options in July 2010.

Lindy 385,000 shares (of One Pence each) @ 45p Expiry 31.12.15
RG 288,000 shares (of One Pence each) @ 45p Expiry 31.12.15

Note The vesting criteria states “Conditional on the Company being sold for more than £25 million”.
Note also, the current options are 3,850,000 and 2,880,000 shares respectively (i.e. 10 X number of shares because the shares are now one tenth of a penny and option price is 4.5p which is one tenth of 45p):-

https://www.scancell.co.uk/grant-of-options

I refer also to page 6 (Note 1) of financial accounts for year end 30 April 2016 referring to these same share options, this states “Performance hurdle of 45p share price for 30 consecutive dealing days. In addition sale of company for in excess of £25 million”. (These options had an expiry date of 14 July 2020):-

https://www.scancell.co.uk/Data/Sites/1/media/fininfo/scancell-holdings-annual-report-30-april-2016-.pdf

A RNS was issued 4 September 2020 stating that new share options were issued on 30 July 2020 (For the same numbers of shares at 4.5p). These share options will expire on 30 July 2023 and replace previously issued share options that expired on 14 July 2020.

https://www.lse.co.uk/rns/SCLP/director-award-of-share-options-v0qz3514veilabd.html

I cannot see any reference to performance criteria so I do not know if it is still the same i.e. “Performance hurdle of 45p share price for 30 consecutive dealing days. In addition sale of company for in excess of £25 million”.

Going back to the RNS 17 April’23, this states “The block listing is expected to become effective on 20 April 2023. The Company will make six-monthly announcements of the utilisation of the block admission, in line with its obligations under AIM Rule 29.”

If the performance criteria is still the same, the 2,880,000 shares RG has an option over are sitting in the block listing waiting for the performance criteria to be fulfilled (either 45p share price for 30 consecutive dealing days or a takeover) before he can exercise his options.

Hi Bojo, thanks for your comments. I’m not a lawyer but perhaps it would have been a more interesting career.

I must admit, it was the lack of news that prompted me to make my earlier post.

I had been hoping for an update on or around 18 April’23, but of course that never happened. The 14 patients assessed would all have had their second (16 week scan) by then and the other 9 (of the 23) patients would all have had their first (8 week scan) by that date. When we do get an update there should be a lot of data on the patients with high grade serous ovarian carcinoma (HGSOC).

Given what we have heard so far on the first patient dosed, it will also be interesting when, in due course, we get data on the 3 patients in Cohort 3 with head and neck squamous cell carcinoma (SCCHN). Interestingly, I see that the Poster conclusion states “Safety and early efficacy data are supportive of the current ongoing sub-studies with Modi-1 in combination with standard of care checkpoint inhibitors”.

(Also worth noting that on 20 March’23 Patient X advised that her next round of vaccines and scans were planned for early May).

However, I hear what Ivyspivey is saying and I guess that all we can do is wait.

I have been looking at the AACR Poster and the RNS dated 21 February’23 to try to have a better understanding of the breakdown of the initial clinical response data.

The RNS states “So far, initial clinical responses have been assessed in 14 patients reaching the first imaging evaluation timepoint at week 8. Of these patients, one has had a confirmed partial response and seven patients have stable disease, despite having progressive disease prior to enrolment in the study.”

The AACR Poster tells us:-

Cohort 1 Consists of:
3 patients with high grade serous ovarian carcinoma (HGSOC)
One has stable disease and two have progressive disease.

Cohort 2 Consists of:
2 patients with high grade serous ovarian carcinoma (HGSOC)
One has stable disease and one has progressive disease.
1 patient with head and neck squamous cell carcinoma (SCCHN)
This patient has had a partial response.

Monotherapy Expansion Cohorts
It can be deduced from the above that clinical responses have been assessed in 8 (i.e. 14 minus 6) of these patients and 5 of these patients have stable disease.

I calculate that 3 of these 5 patients are high grade serous ovarian carcinoma HGSOC and 1 is triple negative breast cancer (TNBC). The remaining patient is either HGSOC or TNBC.

To summarise we have:-

One patient with head and neck squamous cell carcinoma (SCCHN) has been assessed and this patient has had a partial response.

One (or possibly 2) patient with triple negative breast cancer (TNBC) has been assessed. This patient (or possibly 2 patients) has stable disease.

12 (or possibly 11) patients with high grade serous ovarian carcinoma (HGSOC) have been assessed. 6 (or possibly 5) of these patients have stable disease; it should be noted that one of these patients was in Cohort 1 on a lower dose.

(Note I have based the monotherapy calculation on the following: 1) The RNS states “To date, 23 patients have been vaccinated, 18 with HGSOC, two with TNBC, two with SCCHN and one with RCC”. The poster makes no reference to the patient with renal cell carcinoma (RCC). This patient must therefore have been dosed later and not have reached their first assessment at the time of the RNS. 2) The RNS states “Modi-1 cancer vaccine showed partial response and stable disease in patients with hard-to-treat head and neck, high grade serous ovarian or triple negative breast cancers” (A reference to responses in 3 of the cancers but no reference to renal cell carcinoma). 3) The second SCCHN patient could not have reached their first clinical assessment because Prof Christian Ottensmeier talks in the singular in the RNS when he says “………and the early clinical results, particularly in the patient with advanced SCCHN”).

Thank you Bermuda, Moonparty, Emptyend and Konar for your comments.

Bermuda, thank you for explaining that. I had just assumed that RG had exercised his option.

Lindy has an option over 3,850,000 shares @ 4.5 pence due to expire 30 July'23. She still has 3 months to exercise this option but I just wonder why she has not done so yet. (We know RG exercised his option over 2,880,000 shares @ 4.5 pence on 17 April'23).

Apologies Page 18 of Scancell's accounts.

If you look at page 20 of Scancell’s accounts for 30 April’22 RG has the following share options:-

Grant Price Number of Shares Expiry Date

4.5 pence 2,880,000 30 July’23
33.2 pence 3,500,000 31 December’23
8.15 pence 1,000,000 30 April’30

https://www.scancell.co.uk/Data/Sites/1/media/fininfo/scancell-holdings-financial-statements-to-30-april-2022.pdf

He is only exercising the 2,880,000 @ 4.5 share pence option that expires 30 July’23. (Who wouldn’t?).

The RNS makes reference to the other share options RG has “The Ordinary Shares will be issued from time to time pursuant to the Company's existing share options plan for Richard Goodfellow for outstanding options already issued but not yet exercised by Richard Goodfellow”.

The abstract for Lindy’s presentation states “A total of 21/138 patients have been treated to date”. This fits in the Chairman’s statement in Scancell’s interim results issued 25 January’23 which states “To date, 21 patients have been immunised in the ModiFY study and a further 16 have been recruited”. So this information is almost 3 months ago.

I think that surely Scancell will issue a RNS advising shareholders of the AACR presentation before Lindy gets up to speak. That RNS could be as late as the close of business Tuesday 18 April’23. I agree, hopefully that will also provide an update on the ModiFY trial.

The earliest the full text of the clinical trials can be posted is 12.00 pm U.S. ET on Friday April 14 2023. So here it will be 5.00 pm British Summer Time. (I understand that we are 5 hours ahead of US Eastern Time i.e. Greenwich mean time is 4 hours ahead and British Summer Time is an hour ahead of GMT).

As discussed previously on this BB, I feel that it is in our interest not to hear the full text of the abstract until Lindy gets up to speak at some time between 1.30 pm and 5.30 pm U.S. ET * on Tuesday April 18 (Here that will be between 6.30 pm and 10.30 pm).
( * or maybe at an official AACR press conference)

That would mean that Lindy’s presentation would be in the official AACR press program:-

https://www.aacr.org/meeting/aacr-annual-meeting-2023/spotlight-on-clinical-trials/

“The full text of the Clinical Trial and Late-Breaking Abstracts will be posted to the AACR Online Itinerary Planner and the Meeting App no earlier than 12:00 p.m. U.S. ET on Friday, April 14, 2023, except those abstracts that are selected for inclusion in the official AACR press program. Abstracts that are featured in the official AACR press program will be made publicly available at the date and time of presentation, either at the meeting or an official AACR press conference.”

A brilliant find Falsedown. I have not read it all yet but this bit concerning dilution is reassuring:-

“The availability of real options – with multiple platforms and multiple indications, Scancell’s management has real choices about which products or indications it wants to pursue further, and which assets it wants to sell or licence out or develop in partnership. This enables the company to raise cash (critical for development of future assets) as also avoid dilution at low valuation levels”.

An interesting article Ratcliffewriter. There was another item yesterday:-

https://www.news-medical.net/news/20230410/COVID-mRNA-vaccines-fall-short-in-eliciting-lung-resident-memory-T-cells-compared-to-natural-infection.aspx

"Conclusions
Overall, the results indicated that mRNA vaccines do not elicit comparable resident memory T cell responses or polyfunctional resident memory T cell responses against SARS-CoV-2 in the lungs as SARS-CoV-2 infections. Strategies for future vaccines could consider mucosal delivery routes and the incorporation of other SARS-CoV-2 proteins to ensure more effective memory T-cell responses".

It is worth watching this video:-

https://www.wkyt.com/2023/04/06/uk-looking-volunteers-covid-vaccine-study/

Different proteins, T cells, longer durability. It is a bit like Covidity Groundhog Day.

Sorry TG5040 should read TG4050

Hi TF, Violindog and Bermuda (I hope you don’t mind I have highlighted your 21.00 post from Saturday),

Looking at the AACR site I can see Professor Christian Ottensmeier is linked to 2 presentations Modi-1 and Transgene TG5040:-

https://www.abstractsonline.com/pp8/#!/10828/presentation/10452

https://www.abstractsonline.com/pp8/#!/10828/presentation/9989

Note that the abstract for each of these presentations is embargoed at this time.

Something I find confusing (if you click on the link in my 10.49 post) it states:-

“In addition, Transgene’s management team will provide a company update, highlighting new Phase I data presented at AACR on April 18, 2023, confirming the high immunogenicity and promising efficacy profile of TG4050, an individualized neoantigen cancer vaccine developed by Transgene in collaboration with NEC Corporation.”

“highlighting new Phase I data presented at AACR on April 18, 2023” seems confusing to me as this appears to contradict the rules on the AACR website. Perhaps, as Bermuda said (in his aforementioned post) this might be previously unpublished immunogenicity data? :-

“The final submission date for the AACR presentation was a while ago - haven't checked, but from memory it was back in February. So whilst the poster may feature data from the 14 previously evaluated patients, I think it's unlikely it will include any new patients. The title of the abstract suggests that the poster will focus on the trial protocol and I'm hoping that they may also include previously unpublished immunogenicity data, but that's pure speculation on my part.”

I see Transgene are doing a webinar on 19 April’23 (The day after their AACR Presentation):-

https://www.pharmiweb.com/press-release/2023-04-04/transgene-to-host-kol-webinar-on-tg4050-an-individualized-cancer-vaccine-for-the-treatment-of-hpv-n

“The KOL webinar will provide insights on TG4050 from expert medical oncologist Professor Christian Ottensmeier, MD, PhD, FRCP (University of Liverpool, La Jolla Institute for Immunology) who will also discuss the unmet medical need and outlook on treatment landscape for patients suffering from head and neck cancers. Prof. Ottensmeier’s presentation will be followed by a Q&A session”.

“Unmet medical need and outlook on treatment landscape” It could be worth listening to.

Hi Chester/Chelsae11,

Chester,

I am sure you are definitely right. I cannot imagine Lindy boarding the aeroplane to the US without knowing the data inside out. Though RG did state in his recent video that she likes to read scientific papers on the plane ;-)

Chelsea11,

I guess it is working on the principal that Scancell issued an RNS 21 February’23 detailing trial results, so they must have been confident at that time that the results were accurate. As Chester points out they must have had this data earlier to check and double check it.

Lindy’s presentation is exactly 8 weeks later than that RNS so again they would have had time to check and double check the trial data that would have been available ahead of the presentation.

ATB