Member Info for Hulver

From the link in the RNS:

"Bispecific antibodies generated using Lonza's bYlok technology display >95% HC-LC pairing giving you access to a close-to-nature solution for an IgG-like bispecific antibody."

that's what I like about all of Hemo's science - it seems to be working in line with how nature intended.

Last week's news.

https://www.lse.co.uk/rns/HEMO/presentation-at-cbd-st-conference-0vctnptwlillvvy.html

Yea, though I walk through the valley of the shadow of death, I fear not Stu, for I am with Hemo; its mice, its staff and their fountain, all comfort me.

I have been keeping an eye on staffing - there seems to have been a couple of staff changes this year; but all the key scientists would appear to still be working at Hemogenyx. One of last year's summer interns is back.Tells me all I need to know.

So hopefully the scientists have been afforded a break to recharge batteries and are now working towards the next stage of CBR and CDX. Good news on CBR last week - first publicised indication that the testing in the BSL3 level lab at the government controlled organisation have showed something worth reporting (at least) in testing.

The HEMO story seems to be evolving nicely.

Evolution takes time - "the one most adaptable to change is the one that survives".

Don't forget the below forthcoming presentation on the 'cancer' strands of CBR (eg glioblastoma). That was announced through Reach in July (and so does not appear in the announcements section on Hemo's website); today's was announced through RNS.

LONDON, UNITED KINGDOM / ACCESSWIRE / July 29, 2024 / Hemogenyx Pharmaceuticals plc ("Hemogenyx Pharmaceuticals" or the "Company")(LSE:HEMO), the clinical-stage biopharmaceutical group developing treatments for cancers and viral diseases, is pleased to announce its participation in the 6th Macrophage-Directed Therapies Summit ("Summit"), which will be held on October 1-3, 2024, in Boston, MA. The Company will present its work on its proprietary Chimeric Bait Receptor ("CBR") platform.

The Company's CBR platform is an advanced immunotherapy designed to program or redirect innate immune cells, such as macrophages, to eliminate specific types of cancer as well as combat infections from both existing and emerging viral threats. The Company's presentation at the Summit will focus on the use of the CBR platform for the treatment of rare cancers.

Dr. Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented: "Our presentation at the Summit will provide the Company with an opportunity to further establish its unique position in the emerging field of myeloid cell therapies. It will also allow us to exchange ideas with like-minded cell therapy developers, potential collaborators, and investors."

Swazers - did you get to the bottom of that spurious October 24 announcement that was appearing in your Trifusin AI report for HEMO yesterday?

It's very difficult to predict the future, that seems to be why so many of these trading algorithms eventually fail.

I'm just interested to try to understand - was it an error in attribution of a different companies announcement, and why when captured in the AI model did it not seem to have that much of an effect on the SP?

The 'latest news and analysis' section of your Trifusion Report states:

"Strategic Developments (August 2024): Hemogenyx announced a new collaboration with a

major pharmaceutical company to accelerate the development of its leading drug

candidate. This partnership is expected to bring additional resources and expertise,

potentially speeding up the path to commercialization."

What announcement in August 2024 are you referring to? Or are you privy to/prophesying unreleased information?

And the Auditor's assessment (at sign off date at end of April), is given below:

Note bullet point 1: to 31/12/2025

Note bullet point 3: "including and assessment of the funding options currently under negotiation"

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.

{Part of the clinical trials sites' (and any other service provider's due diligence) will be to ensure that Hemo has funding in place before they permit trials to begin. Not sure they would permit commencement unless a reasonable point could be reached (and maybe that's just the completion and evaluation of the first three candidates, maybe that is an appropriate step to evaluate the findings, before incurring further expense).}

The following was the reported position at end April, just over three months ago; though I know his track record of what will happen in the next three months is not great, there's no need to panic just yet:

P56 Annual Report: Going Concern

The Company has not experienced and does not anticipate that there will be any impact, including on its personnel or supply chain, as a result of the on-going war in Ukraine or the situation in the Middle East save for a general increase in inflation such as of the cost of energy.

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.

Https://www.bbc.co.uk/news/articles/c4gzldll44lo

"The next stage is unpleasant. It takes a course of chemotherapy to kill off the old stem cells that were producing broken haemoglobin, before the new ones can be put in."

This sounds very similar to the 'bone marrow conditioning' application of CDX (or CAR-T) which HEMO were intending to be a replacement for chemotherapy prior to BMT.

With the forthcoming CBR presentation, does anyone consider that we might be getting closer to the spin-off of BAIT Biotechnology for CBR?

Might such spin-off (with new US investors) help to unlock BARDA funding for BAIT, as a US company; whereas HEMO is not?

Any thoughts?

Just perhaps they (and others) would be happy to let us to think they are a binary play!

Solzhenitsyn wrote that: it is a mistake that people make; to look at a single branch and think that they are looking at the whole tree!

Daz, I think Vlad said that, once P1 is agreed and signed up to trial, cell harvesting to reintroduction as HEMO CAR-T to P1 would take 14 days; which, from your post, would appear to be in line with the current best standard.

And the good news from Hemo's perspective....

The second site has indicated to Vlad that it could process 18 Phase 1 trial patients in the next six months; but the FDA will not allow that, it has to be one patient at a time in series (each patient taking approximately 1 month); what this does indicate is that once/if the second site's review team approves the trial going ahead at their site, and teh trial starts then there should be little delay in patients or processing. The fact that Prevail are already in place should also be a mitigating factor to some of the other potential delays.

Coincidence?

https://worldbiohaztec.com/us/portfolio-item/fortdetrick/

https://x.com/HemogenyxPharma/status/1474261737427898370

Https://globalbiodefense.com/2024/06/06/usammda-team-at-bio-2024/

Vlad was also an attendee.

Digitt,

In my view either of those requirements could well be the case; given recent RNS's I'm sure there have not been a multitude of new investors buying, but with 10% of the company changing hands at the IND lift announcement and then whatever has been picked top subsequently with the crashed price at the fund raise (and who knows who those went too!) - but potentially I think someone(s) have been accumulating - ready for what - I wouldn't think it's for a delisting ?

But strangely there's never been any TR1s from externals here ?

I won't be swapping HEMO shares for GDR.

Apologies, I doubled up the final link.

https://en.wikipedia.org/wiki/Sidney_Farber

I suppose this could apply to any of these sites, but I liked the bullet point on the AML page:

"Access to new therapies through clinical trials, some of which may not be available elsewhere"

HT - that seems a very good fit on several levels, Vlad did some research work there pre-HEMO.

Read the 'why choose us' at the bottom of this page.

https://www.dana-farber.org/cancer-care/types/acute-myeloid-leukemia

and also has a focus on glioblastoma (a target for CBR!)

https://www.dana-farber.org/newsroom/news-releases/2023/dana-farber-leads-adaptive-efficient-multi-arm-phase-2-clinical-trial-for-glioblastoma

and the history:

https://en.wikipedia.org/wiki/Sidney_Farberhttps://en.wikipedia.org/wiki/Sidney_Farber

Funded by the 'Jimmy Fund'

This share is such a learning experience.