Member Info for NathanR999

Lost for words at that video. So awkward for those taking part and a massive contrast to NdF and PMG, one should never underestimate competitors and there will almost certainly be a third supplier that will seize the opportunity like Cipia and win decent business that maybe SEE themselves thought they would win, that's life but the gut from Smarteye looked defeated. Institutions invested there will be pushing for a lot of improvement to keep them invested. I bought more yesterday based on the videos, recent wins and my gut feel for trajectory coming through. Just hope no other world events come through as black swans to disrupt execution. GLA

Nice link ellish. I can see that orph might get quite a bit of ngo/who/barda/cepi funding to develop challenge models for ar3asnof concern or at least develop agents that might help test vaccines in the 100 day window. We will enter 2023 with alternate covid challenge agent based around omicron, malaria, maybe a pneumococcal agent based on areas, 'newer flu' strains and maybe another mosquito borne agent such as zika or dengue. There probably is a natural ceiling to numbers of challenge studies that can be done due to some virus/bacteria being very risky indeed to deliberately infect well humans. However the market is likely to want once the awareness of chims or the value of chims are seen for early stage pharma is maximised at least a doubling numbers of chimsnper year compared to 2022. This could equate to around 15 per year and at 10 Mill a study that would might value Orph at 300 to 450 mil on a rough revenue basis. If costs are managed sensibly and margins expand then I see a very attractive longer term business either independently or as a takeover for a larger CRO. I continue to be very bullish on this and my timescale for fullnvalue on core business is still 2 years away for me. Macroeconomic picture hopefully will improve or stabilise in that time too and further underpin a better valuation. The spin outs are still speculative for me, imutex and SEEK/conserv hold the keys here and unless we can sell our own share to.another player then it will be out of Orph control but in theory the asset should command a decent value if people realise flu is under-served currently vaccine wide. Prep is difficult to value, the data from previous work is dificult to interprete to value and needs a fair bit of work in p3 and if we get equivalent of 1 or 2p a share in cash or share equivalent in a listing then for my current holding it would be a nice amount to recycle into another holding. DIM could be great or a damp squib as I don't know enough on reliability of the biometric data for use in a smart watch format. If it works well and is accurate enough for FDA or similar rubber stamp then value and licence fees could be nice. FIRSTBEAT analytics was acquired for a quite a decent price for heartbeat analysis in in smart watch datasets for training monitoring. For me the original thesis for orph was rare disease data sets for use with pharma forndrug repositioning and if this is reinvigorated as well as biometrics from challenge then I can see good value for this spin out but lots of execution risks on that. It could be a portfolio maker, Polb for me will also be a portfolio maker but I think expectations of wild swings around price and sentiment will need to be set against a 3 to 5 year hold and for me that aligns with my plans for DIM(if it happens) and POLB. For context I have bought at 6p, 12p and at 22p ( post 47p peak) and average is around 17p so a little underwater but very confident I will exit this share at 2x multiple overall from my a

Government won't do these clinical studies by themselves, they will instruct clinical teams or corporations with experience. If they do choose to run themselves they will be likely shambolic, be delayed, suffer from such inertia from vested interests all chipping in they will be disastrous. They may sponsor some of the p3 trials for rapid action if future pandemic much like what we had in 2020 but we don't play in that space. We are much more focused on p1/p2. All completion is good as it drives awareness and acceptance but rocking up as a new player in CHIMS will be painful and need lots of work and capital. Moat is large for open orphan on this front. We have experience, expertise/staff and a portfolio advantage that would be better acquired for a large cro than to reinvent wheel. All adds to long term investment thesis.

They have already said that was likely in one of the many investor webinars. Once a few of these are on the books especially those targets discovered from the sequencing work for rsv then once.safety data is generated then a challenge would be appropriate. It could be that 1 challenge a year would be derived from poolbeg work. Based on 75mil projected annual revs of orph in maybe 2024 and a cost depending of size of trial of around 7mil per trial then poolbeg could be covering 10% of revs for orph. For instance for polb002 you would potentially to get best benefit of wide clin data do a challenge on flu to prove prevention and antiviral activity of compound and maybe do 2 further to get rsv and sarscov2 prevention data. If all indications showed improvement vs nontreatment arm then that 20mill or so spent would give real guidance to pivotal p2/3 to show wider activity. For a pan viral respiratory virus prevention drug would be a blockbuster if you applied to risk patients during winter. Asthmatics, COPD, cancer therapy patients, nursing home residents where respiratory virus cause significant morbidity and mortality. Would likely secure decent revenue upfront on initial onward license with royalties and milestones.
Always risks of clinical programme failure but that is pharma and my view gotta be in it to win it. Polb002 prob maybe 1 to 2 years away from the challenge study unless lots of safety data done by the Warwick team. You can see that any licensing of viral predictor platform or onward sale of polb001 if lps positive will be heavily contributory to downstream work we do to develop assets. Really nice.little set up I think for those with patience and stomach for.some swings. Some downside for sure if assets don't reach endpoints successfully which will mean other funding routes such as a placing and share issue but that's a while away unless a golden opportunity for a nice asset came about. The meliodosis vaccine could get reasonable initial funding from ngo due to significant need in low income countries and smaller market and that in itself shouldn't be sniffed at as getting into that area build prestige for the team. One to leave to grow for a few years I think but those that stick with it likely to get real decent return even if it looks grim currently for those investing at ipo.

Just to manage expectations here there are not 1200 hospitals that can do this kind of testing. Less than 200 as this is a professional diagnostic which will be run in a hospital Pathology lab by trained scientist. I am a holder here and approval is fantastic news and sales will flood in I am sure but we need to be careful not to.live in a fantasy world on numbers. Almost certainly they will be acquired by one of the large diagnostic corporations like Roche, Abbott, thermo or illumina. Maybe a raise in coming months at a decent premium to get commercial delivery humming. Market cap might look a bit high or based on future jam of it rise too much too soon but potential is definitely there in 3 to 5 years for real.wealth building.

Surely this is the rns from the 5th????

This isn't a human challenge study. This is a large scale monitored field study. Two cohorts. One vaccinated one not. Look over a period of time to see if more infections or evidence of infection in placebo vs vaccinated tonwork.out if vaccine works at scale.

Happy with in specie dividend and a lock-up should have covered 3 months only. POLB will be worth more than ORPH ultimately so very happy for my shares. I think Prep and Imutex will likely be as a cash distribution with a share spinout an outside chance for Prep if Nasdaq route rematerialises. IF orph sold prior to arrangements non core assets may get dumped in a listed shell holding company until further progress made, I think a lock up would be used until sale to protect value and prevent price manipulation and keep it stable, this may work better as no new money would be being raised at that point as just holding rather than trading concern. All in my very speculative humble opinion.

Agree, maybe semantics but I agree the 'significant' in this context I believe is not related to revenue although we will clearly get some revenue but is that is different to previous trial sales. If the people in recruitment process that maybe don't meet needs for challenge studies can be moved to non residential trial it goes a long way to recover waste screening costs if a candidate is screened but not used. People volunteering for trials maybe open to trials in unrelated drug fields and selling pre screened patients that are healthy but because of existing immunity to challenge agents can't be used in a CHIM we can drop the cost of trial participant acquisition. Effectively someone else pays for the screening and selection via onwardnselling of patients. Potentially a great move to increase overall margin on a trial.

*influenza A not S..... fat fingers doh!

As a microbiologist working in the clinical diagnostic space I was intrigued to know more about the challenge agent. I specifically asked IR at OO if the agent was SARS CoV2, an influenza S or B strain or RSV strain hoping this might shed some light on what might be going on in some of the pipeline and to satisfy my professional curiosity. However IR have said they are unable to share further details at request of the client. Make of that what you will. My take is maybe a more contemporary strain of Flu as historic strains have become less relevant post pandemic as they have nearly disappeared and replaced by others. It could of course be a completely new virus family not currently in our armoury which would certainly be a bonus. The interview with Mo did seem to mention a new model rather than explicitly saying an updated existing model which wouldn't necessarily be additive to the range although would keep the relevance of exisiting models fresh for client companies. Intriguing for sure. No doubt we will hear more once they have the virus manufactured under GMP and have approval for characterisation study.

Well Ashb23/Orc69 you dont speak for me - 45p sell out may suit your short term thinking - however I have just returned from ECCMID in Lisbon, the largest infectious diseases conference in the world as a delegate- I spoke to people on the booth at Pfizer, Novavax, Novartis, AZ, Moderna, MSD and two smaller biotechs in the vaccine space etc and nearly all were aware of the value of challenge studies and their role in their own vaccine programmes and antiviral/antiinfectives for the future and mentioned that they are likely to feature in their future roadmap as they move through phases. I would rather NOT sell out next week/month - I would prefer to watch this grow into something much larger. As a large holder buying at 6p, 12p and 22p to a total of 800,000 shares I am more than comfortable to watch this happen. But you do you. A sale at 45p will be a disappointment as a person with professional knowledge in this space as there is a lot of work and pharma candidates we will likely be involved with. Those that follow here with Poolbeg shares should also be encouraged that there is large demand for novel antiinfectives by the larger pharma and just one or two of our pool of candidates that we will have access to or in house develop meeting decent early results will really transform this freebie spin out investment - anyone jumping out once they get there shares may look back at an opportunity lost - everyone has to square their own financial requirements for sure but very encouraged at the health and vitality of this pharma space

should say 2022 is not 2020 - fat fingers

That would have been the case prior to vaccines - with vaccines the difference is negligible and weighted to Flu A 2022 is not 2022. I am a clinical microbiologist with 30yrs working in commercial diagnostics and UK clinical microbiology labs with heavy experience in Virology and personally worry about Flu more than Covid now. I am not down playing covid but one could make a decent argument that last two years have focused on more Covid therapies and vaccines than Flu in 30 yrs. There are minimal treatments for severe Flu and both are not great with resistance to one of them been seen for many years now.

Flu circulating currently at higher levels than last two years. A decent flu season with a divergent strain of Flu A it could be brutal.

With respect - I work in the diagnostic industry and FDA clearance or approval for a diagnostic test to be used for diagnostic screening will take at least a year from submission - no submission nor use in US for clinical reporting. No cancer marker test will be used in the UK without UK generated data that shows efficacy and value for money - not gonna waste time arguing here - considerable value her I dont deny but lets not get over egging timescales for this.

Looking at the timeline of RNS - roughly 1 or 2 per month since listing in July 2021. With negotiations for each of these as a rule of thumb being say 6 weeks and each news piece is deemed by NOMAD as material, where was the window to buy for JS - I dont see one that wouldnt lead to people claiming that JS had insider information and shafting PI. Damned if he does, damned if he doesnt.

The timescale for NHS is a few years away - Key Opinion Leader trials over maybe a year to feed into NICE guidelines etc
FDA approval at least 12 months to get through and longer if they seek clarifications or initial rejection because of t or i not being crossed or dotted as they are quite pedantic on approval. Other countries will have similar hoops to jump through so I think expectations need to be considered. As a reality check for future share price and company value. Biomerieux acquired a company with novel biomarkers for acute kidney injury in a more advanced position then Cizzle for 60million pounds rough 8x current value. Definite value her but I see this as a long term process and potential sales on this target could be 2x that of acute kidney injury with the added revenue for the respiratory asset royalty scheme and any other assay targets they can develop. Value will out here and at 2p its probably half fair value currently for me- this will increase no doubt over next year as news is released. Definitely a strong but at this price IMHO DYOR

Alanb, I think £100 per test is way too optimistic - I sell diagnostics tests for various biomarkers like infectious disease antigens and antibodies - Most likely this test will be presented either into an automated immunoassay machine or more manual immunoassay like an ELISA - either way max test cost in Uk likely sub £6 and in China less still. Lots to be optimistic about and licensing the target with royalties on test run to multiple manufacturers like Abbott, Roche, Beckman, Orto and Siemens plus many other smaller companies for use on their track based blood screening systems will still raise decent revenue imho - happy to hold for this point.

Decent strategy Trout and agree completely unknown how this plays out. Definitely more likelyhood of capital appreciating at a 5-10x level here than at Orph on current prices but orph holders will still do well even those that bought in the 30s.