Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
Day 2 of the LSX World Congress in London - I hope Vlad is attending this.
https://informaconnect.com/lsx-world-congress/
Keep it up folks; must be getting close to a new world record on here today.
https://www.youtube.com/watch?v=USh-hM_Nq4Q
And the Auditor's Assessment of the Board's views on going concern and teh next 18+ months:
P42: "Key Audit Matter: Going concern (Group and parent company – Note 2)
As part of our audit, we have performed the following procedures:
• Reviewed management’s assessment of going concern to 31 December 2025 and assessed the reasonableness of key assumptions and inputs used by management;
• Evaluated and corroborated the key assumptions and inputs underlying the budgets and cash flow forecasts, including sensitivity analysis against the base case scenario;
• Discussed with management how they intend to fund the clinical trials and other clinical programs, including an assessment of the funding options currently under negotiation;
• Compared management’s forecasts to actual results through the subsequent events period and performed inquiries to the date of this report;
• Assessed the probability of obtaining additional sources of funds when required, together with the ability to defer research and development expenditure; and
• Assessed the disclosures made regarding going concern in the financial statements for consistency with management’s assessment.
The group intends to progress its key development project to clinical trials together with the performance of other clinical programs. Significant additional funds will be required in order to progress as planned, which are not yet agreed and unconditional. As disclosed in Note 2, the group has a high proportion of discretionary expenditure which it is able to defer, if sufficient funding is not available. "
And just to emphasise some key words above:
"including an assessment of the funding options currently under negotiation."
Funding matters are being 'negotiated'. This to me still suggests Prevail led PIPE funding round.
From the Annual Report - the Company's view of the next 12 - 18 months:
"The Company successfully raised £5.25 million (before expenses) through the allotment and issue of new ordinary shares during the year ended 31 December 2023, and a further £3.25 million in early 2024. These proceeds were raised in order to facilitate the progression of the Company's HEMO- CAR-T product candidate into clinical trials and to enable the Company to continue development of product candidates for the treatment of viral infections and cancers based on its CBR platform.
Funding will be required by the Company to complete Phase I clinical development.
The Company cannot be certain that such additional funding will be available on acceptable terms, or at all. To the extent that the Company raises additional funds by issuing equity securities, the Company’s stockholders may experience dilution. Any debt financing, if available, may involve restrictive covenants. If the Company is unable to raise additional capital when required or on acceptable terms, it may have to (i) significantly delay, scale back or discontinue the development and/or commercialisation of one or more product candidates; (ii) seek collaborators for product candidates at an earlier stage than otherwise would be desirable and on terms that are less favourable than might otherwise be available; or (iii) relinquish or otherwise dispose of rights to technologies, product candidates or products that it would otherwise seek to develop or commercialise on unfavourable terms.
However, the Directors are of the opinion that the Company has adequate working capital to execute its operations for the present time and is confident in its ability to access additional financing over the next 12 months. The Directors, therefore, have made an informed judgement, at the time of approving these financial statements, that there is a reasonable expectation that the Company has adequate resources to continue in operational existence for the foreseeable future. As a result, the Directors have continued to adopt the going concern basis of accounting in preparing the annual financial statements. "
And on P27: Carrying value of investment in Hemogenyx Pharmaceuticals LLC
"The Committee reviewed the impairment assessment report prepared by management and agreed that given the reasonable expectation that the Group will achieve its milestone targets over the next 18 months no impairment to the value of the investment in Hemogenyx Pharmaceuticals LLC was required as at 31 December 2023."
(i) to set current context and focus to the report, which is otherwise bias to 2023 and the 31/12/23 position and required disclosures; and
(ii) it's a continuation of the much improved and welcome engagement with shareholders (as a whole) that we started to see in 2023, and this is re-emphasised on page 31 of the Annual Report (but to save people reading teh report to find it):
"The Company is committed to a continuous dialogue with shareholders as it believes that this is essential to ensure a greater understanding of and confidence amongst its shareholders in the medium- and longer- term strategy of the Group and in the Board’s ability to oversee its implementation. It is the responsibility of the Board as a whole to ensure that a satisfactory dialogue takes place."
That said, (as many others have stated they have found previously) I also didn't get 'Proof of Concept' for the statement promulgated on p32 of the Annual Report:
"The Board’s primary shareholder contact is through Peter Redmond, the Non-Executive Director responsible for shareholder relations." - as I too didn't get any response or acknowledgement to my emailed request. But I see that he was in attendance at 12/12 board meetings in 2023 - though I'm not sure that's going to get my vote for re-election at this year's AGM - more needed.
An extract from Note 23 of the Financial Statements under Service Agreements:
"In September 2023, Hemogenyx Pharmaceuticals entered into a Master Services and Contract Agreement for a third party to provide clinical services and technologies for the forthcoming Phase I clinical trials for an initial term of 38 months, paying an aggregate of 2,530,057. This includes an upfront payment of 986,713 and monthly instalments over 38 months of 41,712 commencing in April 2024. No sums other than an upfront fee were paid during the year ended 31 December 2023."
- the monthly instalments payments 'commencing April 24' suggests to me that the commencement of the first trial is not that far away now, as Prevail are starting or about to start to undertake the regular work/services to be provided under the contract.
Have to agree with this title, and early release suggests Vlad at the LSX conference in London next week (29th/30th) or more news to come, that they wanted to keep separate (if anything worthy of announcement had happened pre-results release then would have to be lost in the PBSE note to the financials?
Going concern - seemingly not too much of an issue to prove for next 12 months (from signing date)
Perhaps coordinating attendance at this event in London with the board meeting and approval of year end report
https://informaconnect.com/lsx-world-congress/
in any case, looking forward to a more comprehensive update on progress - several CBRs are ready for next stage testing.
Chris, that's very interesting and I hope you are right. There has been a notable absence of Prevail either in the CH lift RNS nor any of the interviews or other media reports published since. Neither did Prevail issued anything of a congratulatory nature to promote Hemo on the CH lift on their media outlets.
Maybe Hemo board didn't like the way things seem to have gone over at BriaCell Therapeutics since Prevail's invested $4m as lead investor in its funding round. The subsequent spin out of one third of that company's pre-clinical assets, which was proposed prior to the funding round but only approved after, to a new company BriaPro, has seen BriaCell Therapeutics' share price drop from $6 at the time of the funding round (May 23), $7 just prior to the spin-out (Aug 23) down to around $2.15 (today); though the investors would seem to have received shares in BriaPro - but that's an unlisted reporting issuer in Canada.
Awaiting the Annual Report with interest.
Two weeks until the annual report update.
Last year they advised that IND enabling studies had been initiated on CDX. Nothing further since then on CDX but a brief comment in video output to suggest work was ongoing and Vlad's comment that he was not expecting HEMO CAR-T to be the company's only IND submission - but was he referring to CDX or one or more CBR constructs (several of which were reported, last September, as having already been developed and ready for next stage testing)?
We are now in the Spring 2024 window for the announcement of New York Biofense Commercialization Fund Grants.
Did HEMO make a short submission; was it then invited to make a full submission - we don't know? But HEMO does seem to fit the application parameters - with its innovative CBR technology?
2022 Award Winners - announced 11 April 2022
2023 Award Winners - announced 4 May 2023
https://www.governor.ny.gov/news/governor-hochul-launches-applications-third-round-new-yorks-40-million-biodefense
Https://www.proactiveinvestors.co.uk/companies/news/1044876/hemogenyx-pharmaceuticals-important-fund-raise-and-car-t-potential-makes-it-one-to-watch-1044876.html
per the Proactive report and UPenn's continued interest/involvement - "all along it has been data driven"
And remember that Hemo had developed a safety switch for SAFE-HEMO-CAR-T but in the end they determined (presumably in the work with UPenn) that due to other scientific advances it was not necessary to have the esafety switch for HEMO CAR-T.
Back to the science:
CD123 CAR-T was previously reported as UPenn's gold standard; here's what happened
https://ashpublications.org/blood/article/142/Supplement%201/217/503095/Cytokine-Release-Syndrome-Results-in-Reduced-AML
Note - one of the authors is Noelle Frey - who will now be the Principal Investigator for HEMO CAR-T Phase I at UPenn.
So - HEMO CAR-T now on pole position for the race to AML solution?