Gordon Stein, CFO of CleanTech Lithium, explains why CTL acquired the 23 Laguna Verde licenses. Watch the video here.
Thank you for sharing this link and content Energy.
One of the many q/a's supplied to Investor Meet by Avacta after the 13.12.23 presentation was:
Question 9:
This is a question for Fiona : You have mentioned a few times now that you are gaining new insights into FAP, potential active and non active forms for example. Can you elaborate on this and explain how, if at all, these findings affect the potential use of the platform? Thanks.
Fiona Answers - This is an important question.
We are exploring this but these insights potentially constitute new IP which we need to protect before we can discuss them publicly. We look forward to discussing this in the future.
Looks like your link supplies at least some of the IP Fiona refers to.
It's not unreasonable to suspect further IP to be registered.
Won't AS point to the recent appointments of Simon Bennett and Shaun Chilton and state that the business side of the company was bolstered by these appointments, and their tacit agreement was part of the decision making process that brought about the 50 p raise, (I can't see we announced a raise with these two saying 'over our dead body').
The above names don't feature here much when AS and the chairman are mentioned as requiring replacement.
Levicept Investors
https://www.levicept.com/investors
Medicxi
Pfizer Ventures
Advent Life Sciences
Gilde Healthcare
DTW - "... drop everything that isn't focussed on the P2 study, get it done, get it done well, and get it done as quickly as possible..."
Completely agree here.
My concern is CC's R&D team, and the FDA ODD team they are interfacing with as part of successful ODD application.
I wouldn't like to think that FDA project Optimus, ( https://www.fda.gov/about-fda/2023-oce-annual-report/ongoing-clinical-oncology-projects#Optimus ) and it's like, does not interfere greatly with AVA600 proceeding asap.
The massage has appeared in a previous RNS.
In the footer -
"With a balanced business and capital allocation model: a high-value oncology pipeline supported by a revenue generating, fast-growing diagnostics business, Avacta seeks to create long-term shareholder value alongside patient benefit."
Also appears in footer of the 22.01.2024 RNS.
In the footer -
"With a balanced business and capital allocation model: a high-value oncology pipeline supported by a revenue generating, fast-growing diagnostics business, Avacta seeks to create long-term shareholder value alongside patient benefit."
!
capital allocation model
supported by a revenue generating, fast-growing diagnostics business - it's for sale soon isn't it?
Ice -
RNS
Director Appointment
19 Jun 2023 07:01
Avacta appoints Shaun Chilton as Non-executive Director
Appointment brings additional, significant commercial and corporate development experience to the Board
Avacta Group plc (AIM: AVCT), a life sciences company developing innovative, targeted oncology drugs and powerful diagnostics, announces that Shaun Chilton has today joined the Board as a Non-executive Director.
Shaun Chilton was most recently Chief Executive Officer ("CEO") of the formerly London-listed Clinigen Group plc ("Clinigen"), a global pharmaceutical and pharmaceutical services platform business, which he led through a significant growth journey. During his tenure, the company expanded through both an organic and a buy-and-build strategy which included successfully completing several transformational acquisitions. The Company was eventually sold to Triton Partners for a total consideration of c.£1.3 billion in April 2022."
+++
How is AS and SB getting so much stick when Shaun is a management advisor with directly attributable experience.
How could he also not be in the firing line?
+++
"Alongside his role as the CEO of Clinigen, Shaun was Non-Executive Chairman of C7Health, a disruptive, venture capital-backed medical technology and services business which executed an acquisitive growth journey before successfully being acquired by a strategic buyer in 2022.
Shaun has held a number of senior and executive commercial positions over more than 30 years in companies in pharmaceutical and pharmaceutical services industries. These include at Pfizer, Sanofi, Wolters Kluwer Health and KnowledgePoint360 Group (now part of UDG Healthcare)."
+++
Shaun Chilton, Non-Executive Director of Avacta Group, commented:
"Avacta Group is building a high value, global business that is seeking to significantly improve people's health and well-being. I am excited to leverage my own broad experience of growing healthcare businesses and working with the other members of the Board to help guide Avacta to meet its very significant potential."
Current Directorships
Bellbrook Consulting Ltd.
Mustang Topco Ltd., (trading as MAP Patient Access)
Mustang Midco Ltd., (trading as MAP Patient Access)
Mustang Bidco Ltd. (trading as MAP Patient Access)
Shaun is spending too long on other projects outside Avacta,
and therefore we are getting insufficient bang for our buck.
Or is AS not taking his advice?
The following agents placed shares:
"Stifel Nicolaus Europe Limited ("Stifel"), Peel Hunt LLP ("Peel Hunt") and Turner Pope Investments (TPI) Limited ("Turner Pope" and, together with Stifel and Peel Hunt, the "Joint Bookrunners") acted as joint bookrunners in respect of the Placing. Beech Hill Securities, Inc. ("Beech Hill") acted as US placing agent."
Can anyone advise how the number of shares each of the above agents placed can be identified please?
Only interested in Beech Hill securities, to ascertain how many shares the US placing agent shifted.
Agree - "It is a term of the REX Offer that the aggregate total value of the REX Offer Shares allotted and issued pursuant to the REX Offer does not exceed £6.8 million." is in the Rex RNS.
Apologies Robin Hood, 11:00am is stated.
Invested the minimum £50.
Don't think I'll miss that if the investment bombs.
Nice LITTLE earner if it does OK.
"Applications are due to close at 9am on Monday 04 March.
Due to the nature of the fundraising, applications can close at any time and without prior warning."
Ice - "Looks like our new BD decided the deal wasn’t good enough after all or the data in cohort 7 was so conclusive, they could do it themselves and not need a partner for phase 2 STS. Bold strategy pivoting, however that would explain the reasons for the fundraiser..."
What might hinder that plan is that there is such a high %age of fickle PI's.
What might help that plan is considerably more II's.
That is a strong reason to drop the sp, which would encourage future II investment.
What would also help the plan and please II's would be to get Avacta trading on another exchange if possible.
Ref Pope Turner document - https://mcusercontent.com/d9ebd7c1aa0f3dbc5fab42eca/files/0131e630-3c92-ac71-831a-e2175441110a/AvactaGroupplc_29_2_2024_FINAL_BG.01.pdf
"To fulfil its ambition, the Group is expected to continue to explore all possible pathways to appropriately finance its clinical therapeutics programmes, including non-dilutive funding through business development, divestment of the Diagnostics division, attracting global specialist biotech investors and/or potentially a NASDAQ dual listing."
That was my initial reaction to your thought provoking post Ice, no idea of timescales.
Digging deeper as you say is always necessary, and what's not said is often as relevant as what is said.
Thanks for a thought provoking read.
AACR info a large inflection point? - Cohorts 5,6 and 7 results hold the key.
Crowfoot, I see the Turner Pope presentation as regurgitating past Avacta info, and summarising some RNS info since 28.02.24
1 Mar 2024 19:28
Morning,
- I was hoping to get some feedback from any with knowledge or experience of a trial being stopped for benefit from posters here, - but posted too late on a Friday.
This situation seems feasible to me, but haven't discussed it with others here before.
I would think the chances of it happening are reasonably high.
CTSFO - Thanks for sharing the link.
It contains the following passages
. Orphan drug trials are generally single arm (no placebo arm), nonrandomized, and open label. Safety Phase 1 trials are not usually required, and Phases 2 and 3 can be combined when the patient population is very low.
. Sponsors of an orphan drug can make use of expedited Food and Drug Administration (FDA) programs such as the Fast Track, Breakthrough Therapy, and Priority Review designations, as well as the Accelerated Approval pathway and unique grant funding opportunities, such as the Orphan Products Clinical Trials Grant program.
+++
So I stand to be corrected but I assume the first passage defines the phase 2 trial set for AVA6000?
How many patients are we expecting for a rare disease, and are those patients required to provide biopsies?
+++
https://www.trinitydelta.org/research-notes/building-on-therapeutic-and-diagnostic-foundations/
DOXORUBICIN EFFICACY (PFS, OS, ORR values)
"...Doxorubicin efficacy (progression-free survival, PFS, of four to six months;
overall survival, OS, of 12 to 15 months;
and a typical objective response rate, ORR, of 10-15%)
+++
If AVA6000 works well, and is comfortably beating the above Doxorubicin PFS, OS and ORR,
would we not be expecting the DMC to stop the trial early on grounds of benefit?
+++
Interested in any views on this, as stopping a trial (particularly a phase 2) for benefit has not been discussed much in recent threads at least.
This link good for the subject:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5024796/#:~:text=Ethically%2C%20clinical%20trials%20must%20sometimes,%2C%20benefit%2C%20and%20futility%20concerns.
Bbbbut...but
REX Offer
"The Company values its retail shareholder base and believes that it is appropriate to provide retail investors in the United Kingdom the opportunity to participate in the current fundraising.
Therefore, the Company is making the REX Offer open to eligible investors in the United Kingdom following release of this announcement through certain financial intermediaries."
REX offer - Retail Offer - The aggregate gross proceeds of the REX Offer shall not exceed £6.8 million -
The price of the REX Offer Shares is 50 pence per REX Offer Share, therefore 13.6 million shares are available.
There is a minimum subscription of £50 per investor.
Yeah, LTH's screwed.
13.6 Million - form an orderly queue there...
IMO, to meet AS's needs, interested parties needed to fall in love with the data from Arm 1 and any embryo Arm 2, and bid appropriately.
Would AS have allowed SB to show parts of AACR info?
What is shown at AACR may not be written yet if Arm 2 is progressing fast.
With Phase 2 not imminent, the project is probably too incomplete for those parties.
They are definitely interested in keeping abreast of progress of game changing tech, but what they offered (or didn't) means placings were ordered. (Many parties have already invested heavily in ADC's)
The different twists we see since Cohort 4, further Cohorts seeking to find MTD, larger 3W doses for a number of Cancers, then STS only. Arm 2 developed to intro further doses every 2W, all on an augmented phase 1a budget.
The FDA have been busy working with the Avacta team as part of Orphan Drug Designation, and evidence of their needs is probably in the above 1a development.
We can't proceed in ignorance ignoring all of their ideas, they sign the approvals.
It's a real bonus we now have CC in charge of R&D, someone who can be expected to understand FDA's thought processes, needs and way of doing things.
Perhaps there will be further interest in deals post AACR.
I suppose interested parties are still waiting for further risk reduction before decent bids flow, and meanwhile phase 2 needs successful completion, and I wonder how many times the FDA will introduce 'stuff' into that.
They cannot have any doubts about safety though.
Sievco - 4 "All of a sudden, the drug will need a Phase 3 trial (again, subject to funding)."
Perhaps the FDA have been clear to AS about this requirement now when it was not clear before.
Might CC know the answer, or knew someone who did.
If Accelerated Approval occurs after Arm 2 or after Phase 2, might AVA 6000 commence the Phase 3 after AA?
Sievco - For completeness,
CC had this to say about the patient with the 14% tumour reduction.
"Here we have a female with a highly Progressive tumour type, this is an Angio sarcoma it’s a soft tissue sarcoma of a blood vessel that developed in her spleen. This patient has achieved what we call a minor response at the first scan with a minus 14% shrinkage of metastatic lesions or metastatic tumours, and this deepened at the second scan to a minus 22% very similar to the prior patient that I described where we see this deepening, so the tumour continues to shrink over time. In parallel however this patient at that second scan developed bony metastasis which makes this a mixed response. The visceral or the organ type tumour lesions continue to shrink, but the tumour was able to escape to the bones, a place that has limited blood supply. This is a classic pattern of progression in a number of solid tumours but also including Angio sarcoma. What’s notable in this type of sarcoma that is highly refractory to therapy is that although this is not long lived the deepening tumour shrinkage so continuing to shrink over time is good evidence of an anti-tumour effect."