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Although the following article relates to rare earths, it is interesting to note the measures that governments may adopt to protect access to resources.
"Japanese Template
...... Back in 2010, China threatened to cut off supplies of rare earths to Japan, threatening the viability of Japanese companies producing advanced technical equipment and forcing Japan to mount a rescue bid for a financially stressed miner, Lynas Rare Earths, by offering capital to complete mine development and a contract to supply future rare earths.
That rescue of the Mt Weld mine of Lynas led to the creation of the biggest rare earth business outside China......."
Link to full article: https://www.forbes.com/sites/timtreadgold/2024/03/12/nickel-rescue-plan-risks-starting-a-new-trade-war/?sh=6777846832e5
Steve305 - I think we should avoid trying to guess the reasons for a resignation. Personally, I believe we should consider the overall situation: the developments re the NHS trials, the progress towards the FDA phase 3 trial and the ramping up of production capability are worthy of a positive outlook.
Proactive Investors interview:
"The company aims to develop a business case with York health economics group and Mid Yorkshire for broader NHS adoption, based on the successful outcomes and health economics work."
There are 195 NHS trusts, excluding Ambulance and Mental Health trusts, many with more than one site. If Steriwave is widely adopted after the preparation of the business case, the potential number of applications is considerable. There are also private hospitals to consider.
This extract is from the Ondine news update 25/03/24:
"SSIs are one of the most common healthcare-associated infections (HAIs) and affect one in every 20 patients who undergo a surgical procedure in the NHS. SSIs can cost up to £100,000 per patient, and the overall cost of HAIs to NHS England is over £2 billion a year. These costs are expected to rise as growing rates of antimicrobial resistance (AMR) make the current standard of care – the antibiotic mupirocin – less effective."
There is a massive opportunity for Ondine IMO.
The 3 sell trades at 10p just before the close were my buys. Can someone explain how I was offered a price so different to the other buys that occurred around the same time.
If you are wondering why I made 3 trades: after the first trade, I decided it was worth buying more and then just before the close, I wondered if I could repeat my good fortune and since I could, I bought some more.
RNS 13/12/23
"The Company has confirmed that it has more than doubled the number of Steriwave® deployments in 2023 and is in discussions with more than 75 hospitals in the UK, Mexico, Spain, and Canada. The growing global emphasis on preventing HAIs post-surgery, coupled with the escalating challenge of antimicrobial resistance, has spurred heightened interest in Ondine's photodisinfection technology."
Let's hope their discussions with all 75 hospitals are successful.
In terms of cash runway the RNS on 11/12/23 stated:
"The net proceeds from the Fundraising will provide further cash runway until at least mid Q2 2024. The Company continues to evaluate funding opportunities for its Phase 3 study in the US, subject to the finalisation of the trial design with the FDA, and for further commercial development internationally."
Question: will another fundraise be required?
The factsheet for the Act, which was referred to by Stefan, can be accessed via this website
https://ec.europa.eu/commission/presscorner/detail/en/fs_23_1663
I would be obliged if someone could explain the difference between the pilot at Pontefract Hospital and the YHEC evaluation.
Have the results of the Pontefract pilot been released?
1 Aug 2023 RNS
“Ondine commences first NHS Steriwave® pilot
Mid Yorkshire Teaching NHS Trust will be using Ondine's nasal photodisinfection therapy prior to orthopaedic surgeries at Pontefract Hospital over a six-month pilot”
5 Mar 2024 RNS
“Ondine starts first UK health economics study
The York Health Economic Consortium will undertake the first UK health economic analysis of Ondine's Steriwave light-activated antimicrobial to reduce Surgical Site Infections
Ondine Biomedical Inc. (LON:OBI), Mid Yorkshire Teaching NHS Trust, and Health Innovation Yorkshire and Humber are partnering with the York Health Economics Consortium (YHEC) to evaluate the use of Ondine's light-activated antimicrobial, Steriwave®, to reduce the incidence of surgical site infections (SSIs).”
CrustyPete
I note your reference to risk identified by Liberum - "Further testing may suggest uncommercial status".
When considering risk, one needs to consider the probability that the event may occur. Each investor needs to review the information currently available and make their investment decision accordingly. A simplistic approach to this risk is to consider it in terms of Low / Medium / High.
The 2023 results should be available in May. Whilst more trials provide valuable information regarding the efficacy of the product and the potential cost savings, revenue generation is important. In 2022, there was loss before tax $19.5 million.
All the studies reported on so far show significant cost benefits, as well as better patient outcomes. I hope progress towards improving revenues has been made (2022 Revenues were $0.6 million)
I will be interested to see what progress has been made re the Phase 3 trial.
An article posted in the Jakata Times talks about the establishment of a cartel, similar to OPEC, for nickel producing countries:
"It may also be good to strengthen partnerships with other countries with major nickel reserves such as Australia, Brazil, Russia and New Caledonia, so that these producing countries can have better bargaining positions amid increasing demand for the mineral.
The idea to establish an OPEC-style organization for nickel was once introduced by President Joko “Jokowi” Widodo and Investment Minister Bahlil Lahadalia. Such an organization could help producing countries better coordinate supply and prices. Perhaps it is a good time to carry on with the plan."
The establishment of a cartel may never happen, but talk of one could increase the importance of an independent source in Europe, assuming Finland would not be interested in joining.
Link to full article: https://www.thejakartapost.com/opinion/2024/03/05/nickel-rush-needs-a-rethink.html
Tillerman
Thank you for an excellent post providing information about the cost of a trial.
Your reference to Ondine prompted me to review their Half Year Report (25/09/23); the report includes:
"FDA approval
We are continuing to work with FDA as well as our partner HCA Healthcare on the planning and execution of the pivotal Phase 3 study. Following a recent review meeting held with FDA on September 22, 2023, we can confirm that FDA has agreed that Ondine's summary of the extensive safety data is sufficient to proceed into the Phase 3. We are now working closely with FDA on specifics of the Phase 3 protocol."
QUESTION: Does working with their partner HCA Healthcare mean that the cost of the trial per patient could be significantly reduced?
An interesting article. The intervention of the Japanese government in 2010 to save the Australian miner Lynas Rare Earths by offering capital to completE mine development means there could be a range of financing options available to HZM.
On 01/08/23, Ondine issued an RNS stating
"Ondine commences first NHS Steriwave® pilot
Mid Yorkshire Teaching NHS Trust will be using Ondine's nasal photodisinfection therapy prior to orthopaedic surgeries at Pontefract Hospital over a six-month pilot"
Does anyone know if this was undertaken and, if so, when the results are likely to be published?