The latest Investing Matters Podcast with Jean Roche, Co-Manager of Schroder UK Mid Cap Investment Trust has just been released. Listen here.
Made some notes on the IMC webinar just now. Most of the main presentation was information that’s been covered before so I didn’t note everything down there, and I missed a couple of questions so feel free to add them if you caught them (drinking a large, chewy IPA before trying to type quickly wasn’t my best decision).
Main presentation
- At the stage now where we are a really ‘grown up company, experienced CRO’
- CF now able to ‘make up for lost time’, ‘no excuses for not delivering spinouts after tonight’
- ORPH gets paid regardless of the success or failure of the product being trialled - ‘picks and shovels in a gold rush’
- Financials are in audit for another month or so, but on target to deliver full EBITA profitability for last year
- Now able to take on Phase II work which ORPH was previously turning down - existing demand for this additional service
- POLB - spinout completed, ‘pretty good job’, £25m dividend in specie handed back, tradeable from 19th April, ‘don’t rush’ to trade them, first six months may be volatile whereas 18 months may realise better value - take profits but don’t sell early at a loss
- PrepBio - deal had been done, SPAC now down 95% as it has no cash - the plan was to handover shares in a Nasdaq listed company as dividend in specie on 10th January but it fell through. ‘We will get another deal - give us a little more time’ - the ‘beauty of the deal’ is that we can hand the shares straight over when we have them
- Imutex - ‘very difficult’ majority shareholder - more time on CFs hands now to progress this, he will work very hard to divest Imutex, ConservBio doesn’t seem keen to monetise ‘two of the world’s most exciting’ vaccines
- DIM - very much CF’s focus, ‘that will happen in the months ahead’
- Core business is in fantastic shape - doubled the business in 18 months and this is just a ‘good start’, i.e. more to come
- ORPH is now able to conduct screening in and around Manchester. Quarantine during trials remains in London. When quarantine is finished, patients can return home for follow up appointments locally - convenience is important for expanding volunteer base
- Challenge studies have advantages over standard trial structures - potential for fast track / breakthrough designation which may speed up commercialisation by up to two years, rapid approval or rejection of pre-clinical data, dose ranging studies, reduce number of patients required for Phase III, ability to test against specific variants
- Number of P1/P2 clinical trials commencing is increasing strongly, especially for infectious/respiratory diseases
POLB is terrific but what about the other spinouts? Timeframes?
- PrepBio was sold to a Nasdaq SPAC, deal completed 2nd January, SPAC had 100% redemptions on 3rd January, SPAC had no cash, share price down 95% so now back to square one
- Imutex - only have 49% stake, very difficult to move forward if majority shareholder is ‘more interested in talking than walking’, Imutex has been difficult but CF has more time to pressure ConserV now
- DIM - a lot of work, ‘harder than POLB’ as being sold to existing customers with existing data, so have to move carefully
- ‘Bear with us, spinouts will happen’ now that CF has time
DIM - are major tech brands still in discussions? Will contracts be signed before spinout?
- Work in progress, that's all we can say currently, can’t name interested companies publicly at this stage. “A lot of focus on that” but highly confidential, ‘nowhere [for CF] to hide’ now that Mo is on board, progress will be made
Shareholders are angry and disappointed - comment on overpromises in the past?
- Nobody as disappointed as CF as the biggest shareholder, ‘we will get the share price back where it should be’, no one happy about the big sell off, CF paid 27p for £300k not long ago
Is business performance separate to sentiment?
- Nothing wrong with core business, we are expanding, global external factors are out of our control, we expect to continue with strong performance. CF is here tonight, now has more time as Mo has joined, two IPOs in 18 months is major undertaking for a small team, ‘spinouts will be done going forward from here’, unfortunate that PrepBio fell through
Will you buy shares Mo?
- Absolutely, when I have an open window, won’t be as much as CF but will purchase, would love to buy today if possible. Mo wants to align himself to shareholders
Are pharmas moving away from MRNA vaccines and towards antivirals?
- Mo doesn’t think so, disease is still transmissible after vaccination, combination will be needed between the two. Long term impact of MRNA vaccines still unknown
Summary - good team, has performed much better, CF has overpromised and underdelivered, but remaining parts of the ‘mission’ will be delivered, and ‘we are not talking in years’
Made some notes on the LSE webinar just now. Please add anything I missed, the presentation moved very quickly. I was very pleased to hear that Imutex hasn’t been completely abandoned after the comments on the POLB webinar last week, and that we will be ‘surprised and delighted’ by their plans for ORPH’s cash balance.
Main presentation
- Five of the Top Six pharmas are in contract negotiations with ORPH
- Mo joining as CEO to free up CF’s time - previously too ambitious with workload
- Spinouts are now CF’s focus; core business has ‘never been in better shape’
- ‘More important to look at what we’ve done rather than what we’re promising’
- £15.6m cash at end of December, currently a couple of million higher than that
- £50m non-Covid revenue FY 22, Covid work/revenue in addition to this
- ORPH now has 62 beds, up from 43 previously so a 50% increase, less than £500k has been spent on this
- Continuing to work on monetisation of non-core assets
- ORPH has ‘tons of cash’, no intention to fundraise, unlike many other small caps who are suffering more in the current tough market conditions
- ‘We’ll do something with excess cash that will surprise and delight’
- Key part of spinout process is getting Mo on board - Mo will run the core business, CF now has time to deliver what he has so far not delivered in terms of the spinouts
- Mo joined ORPH in October and was appointed CEO in February - 25+ years experience in biotech and CRO, has experience of buyouts, business development and project delivery
- Mo joined ORPH as it is truly the world-leader in its field of challenge trials
- 200k+ active subjects in existing database
Part of Mo’s remit is to scope areas where company can grow:
- quarantine/study capacity and offering (including Phase 2 field trials which are new for ORPH)
- increased number of challenge studies, more lab facilities (biomarkers and molecular testing, virus manufacturing, etc)
- cross selling services between Hvivo and Venn
- Workshops with ‘key sponsors’ in coming months regarding malaria challenge study, expecting first malaria contract this year
- 84k volunteers screened in 2021, will exceed that this year
- Typical study size £5m - £10m, can be completed quickly so revenue cycle repeats rapidly
- Current pipeline £75m; ‘future is really bright for ORPH’, ‘biggest it’s ever been’
Questions
Are you pleased to have joined the business Mo?
Yes, difficult to say no to CF! Mo is questioning why pharmas aren’t using challenge studies by default due to increased speed of results - expects interest to increase in near future, more clients are looking at bigger trials than they've ever carried out before
Are you struggling to recruit volunteers?
No, our Flucamp brand is ‘second to none’, we have so many excess volunteers we are selling them to other CROs. 15% utilised, remaining 85% can be passed to other CROs
When do you expect UCD licencing deal confirmed for meliovac?
- Awaiting toxicology results but nothing seems untoward - if it “comes back clean” we will progress but discussions are already underway. Discussions are at different stages for other products
What is POLB’s moat? What is to stop a bigger company with deeper pockets doing the same service?
- CF: We don’t provide a service, we provide IP to which we have acquired the rights. Couple of hundred thousand spent upfront on one product, we take forward with intention of out-licensing, much faster than traditional biotechs. “No one else doing what we’re doing, no competition”
- JS - pharma is always looking externally to smaller companies who’ve done the early derisking before they get interested. Everything is data driven from pharma standpoint
When will POLB receive first non-dilutive grants, size, source?
- Meeting tomorrow with a grant-funding organisation. US-based agencies such as DARPA etc may be a source of funding, interest in tropical and subtropical diseases. Funding could be “significant” but can’t be specific on amounts. One request already submitted, will be discussed tomorrow alongside other opportunities
How many people do POLB employ?
- Very few. JS is the only full time employee. POLB shares staff with ORPH, staff time is billed accordingly. More staff will be taken on as needed but don’t need a huge headcount. JS keen on outsourcing and using consultants/contractors rather than full time employees - cheaper and more flexible ‘semi virtual model’.
Meliovac - huge amount of work done, papers already published, GMP manufacturing process in place - this is a higher grade of manufacturing that is required for ‘in human’ products.
Any possibility of a combination trial for POLB-001 and Flu-V?
- Imutex are taking forever to do anything. We have 49% so don’t control Imutex or assets. “We have tried our best, it is breaking my heart, we are struggling to get a buyer when we have a minority stake”. To answer the original question, no. Imutex have extremely exciting products but “it doesn’t appear to be happening”, CF doubts whether he can “shift it” so unlikely to have any involvement with POLB or a dual-trial.
One program at a time or multiple?
- Can do multiple at the same time but will be staggered
Some brokers including II have said that POLB spin off shares are not ISA compatible and will have to be moved - can you clarify?
- We are going to get to the bottom of this in the next few days. Reason for ISA non-compatibility is that the shares don’t technically exist yet, so they are not in any ISAs at the moment. ISAs can’t hold restricted shares, but come 19th April they will not be restricted shares, they will be unrestricted and tradeable. They will go into your ISA at this point - we will get this confirmed in the next week or two. Confusion has come from details getting ‘lost in translation’
How are drugs like POLB001 valued by pharma when they make deals with companies like POLB?
- Drugs that are further along the dev pathway have greater value in the eyes of pharma. Human data is a big value inflection point. Upfront fee is the ‘reward for the work done thus far’ at a premium, but also for access to the data and intellectual property. Inflazone had P1 data in healthy volunteers, efficacy was shown in just one patient (i.e. not a statistically significant number of patients) and this was enough for Roche to purchase with the intention of designing their own P2 trial. Pharma take on the risk of P2/P3 trials, POLB gets paid as the drug progresses through the process - payment amounts still have to be negotiated but POLB-001 has potential for multiple diseases, so payments will come for every disease against which it is trialled
Any expected value from five different vaccine candidates?
- Meliovac just finishing up toxicology studies that will be trigger for licensing, currently everything is pointing in the right direction. When we see data we like we can step in to add to our pipeline, work out what’s worth bringing in and what’s not.
Results in 12 - 18 months per vaccine / therapeutic - how far down are we with POLB-001 and when did the clock start?
- 12 - 18 months is how long it takes to get human data, HCT’s starting in June and human data expected 3 - 4 months after that, will take time to carry out analysis. Once data is available and analysed, POLB can approach big pharma with the prospective drug. Human data is the key point in the process.
When is first sustained commercial income expected?
- First trial in June, will last 3 - 4 months, data to follow, as soon as we have data we should be negotiating for commercial income. As mentioned, we can sell country-specific rights easily if income required in the short term, but “we have tons of cash at the moment” so unlikely to need more
Which Schroder funds hold POLB?
- Not sure but can find out. There was some confusion early in the process, Schroders took 4.5% stake, someone accidentally bought more to take them above 5%, they sold back down to get to their original 4.5%
- POLB-002 has 20 years of research already behind it, ‘a terrific amount of work’ has taken place to move this forward, ‘planning to move rapidly into human testing’ - ‘University team have been excellent to work with’
- POLB-003 potentially of interest to the likes of the Bill & Melinda Gates Foundation, who focus on tropical diseases / medicines
- AI program with OneThree Biotech - preliminary data also expected in H2 2022, likely Q3
- Program is using drugs that are already proven safe, being repurposed for other diseases
- Won’t stop at first RSV project with OneThree - other targets already in mind, AI program has great potential
Questions
What is the estimated time that current funds will last?
- We try to conserve funds as long as possible, no plans to fundraise as stated at IPO, as we outlicence we rotate the cash back into the business/pipeline, similar to Evotec. ORPH/POLB’s Elaine Sullivan is also on the board of Evotec. If we needed cash we could sell non-core geographical product rights (non EU, non USA etc) but we don’t as we have £20m
Is a Nasdaq listing possible with a company the size of POLB?
- Aim is to grow big quickly, watch this space over the next few months, Nasdaq is definitely on the cards within 12 - 18 months of IPO. OTC listing coming in the next few weeks as interim step to full dual listing on Nasdaq. ‘Organic growth is a hard long road’ and CF is 57 so doesn't want to be on a hard long road, wants to make money in next couple of years
We’ve had positive news of portfolio expansion; why has there been substantial selling of shares presumably from IIs? No reason for six month lockup of POLB shares?
- Four different asset sets, three or four more being sought in the next few months, compared to one or two for conventional biotech. Selling - CF made a mistake in terms of lockup, if he was divesting POLB again he would have kept a proportion of shares on ORPH’s balance sheet, and would have shortened the lockup period to around three months. CF reiterated that he doesn’t expect a sell off, but we will have to wait and see what happens post-19th April. Some investors have sold shares having not fully understood POLB’s model; some early non-spin off investors expecting to be able to buy back cheaper when lockup ends. ‘Nine months gives people too long to think about it’.
I made some notes as CF and JS were presenting on the IMC webinar just now. A lot of JS's presentation about the product pipeline was covered in previous presentations so I didn't note everything down there. H2 this year sounds bright for POLB but I'm pretty disappointed by the comments on Imutex and baffled by ConserV Bio's apparent lack of interest. Feel free to add anything I missed.
Main presentation
- POLB ‘in very good shape financially’
- Two disclosable (3%+) shareholders are CF and Schroders
- CF and JS ‘specialise in exits and shareholder value’
- Significant upfront cash plus milestone payments for every partnership
- CF - as single largest shareholder, sees it as his duty to ensure SP starts performing again - no one is happy with share price at the moment, ‘we are not where we should be but we are working on that’
- ‘Market conditions remain extremely challenging but we are actively working on creating shareholder value’
- Major reason for dip is perceived overhang from forthcoming ending of lockup
- CF believes this perception is wrong, and that we won’t see a sell off when shares are tradeable
- Additional liquidity expected in next six to eight weeks from OTC listing some time in Q2, prior to the aim of full NASDAQ listing. ‘Well down the road’ to OTC listing
- Dividends in specie are tax free in the UK - only tax due is CGT when they are sold
- ‘In the months ahead, SP should and will continue to perform’
- POLB is unique publicly traded company, only company that is a close similarity is Evotec
- ‘Market doesn’t understand’ POLB’s model - the model is to pay very little upfront for assets, develop with low cost trials (£1m - £1.5m), data generated within 12 - 18 months of acquiring the asset before passing onto pharma for further development - proceeds are then reinvested into pipeline
- Enquiries received from major Asian markets, country specific rights can be sold off even before data is available
- POLB has no plans to fundraise any time soon, ‘money may be coming back sooner than people may think’
- “Couple of hundred thousands of euros” expended upfront for current assets
- One AI deal already signed, ‘more AI deals to come’
- POLB-001 has been ‘pushed forward quite rapidly’ since POLB’s demerger from ORPH, all milestones have been hit so far
- LPS human challenge trial for POLB-001 still on track for commencement this summer, ‘all pieces in place and ready to go’ in June this year
- ‘Relatively quick and efficient short term studies, data published H2 2022’ - when human data becomes available, discussions with pharma will progress and then potential for early revenue generation
Imutex gets a mention here in this article published yesterday:
https://www.technologynetworks.com/vaccines/articles/influenza-and-the-holy-grail-vaccine-359060
It's frustrating to read that Pfizer and Moderna seem to be catching up a little (CF was asked in a presentation last year whether Imutex/Flu-v are at risk of being superseded by newer vaccine technology) but the writer notes “the results were okay, but weren’t fantastic” so far for mRNA flu vaccine trials, and that "the pandemic has significantly slowed R&D on influenza vaccines".
The LFT has been a mess for sure, but my confidence in the company's progress of the therapeutics remains very high:
23rd December 2020 - Submission of CTA for AVA6000 Pro-doxorubixin (submitted before the end of 2020 as promised)
18th February 2021 - Phase I CTA for AVA6000 Approved by MHRA
11th August 2021 - First Patient Dosed in AVA6000 Phase 1 Trial
29th November 2021 - FDA Approval of IND Application for AVA6000
18th January 2022 - Second pre|CISION Pro-drug Candidate Selected
3rd February 2022 - Dose escalation in the phase I trial of AVA6000
7th February 2022, investor presentation - Regulators seem confident in safety profile - they recommend the escalated dose, having reviewed all the available data to date. Timescales on track apart from small delays due to covid staff shortages in hospitals and so on, "middle of the year, end of Q2" for P1a dose escalation - if all well, dose expansion (P1b) to follow later in 2022. "Not appropriate" to talk about data in the middle of the study but AVCT are very happy with progress so far. Significant pipeline will be unlocked if AVA6000 Phase 1 reveals positive data. Phase 1a will reveal some very significant data. "We are not looking to raise funds in the near future at all"
Questions
Where do you put your capex, allocated across various assets?
- Currently investing in manufacturing and getting clinical trials in place, key clinical trial data should be available in Q4 for POLB001 - discussion with pharma will happen by end of the year in terms of progressing further.
- Are you hiring a core team assigned to each asset?
Part of capital light approach involves external expertise, consultants can be brought on as and when required - more cost effective than full time employees in some cases. “Clever and well worn approach in the industry”
- What about internal team?
We are professional managers, we have project managers, CMO on contract who is monitoring development of programmes, “proof of the pudding” is that we are hitting our timeframes
- How much spend per asset?
£4m or £5m per asset - human challenge studies are major cost outlay but can’t be more specific in terms of cost, but £4m or £5m is the all-in ballpark. Attractive dataset can be generated for that amount of money before passing on to pharma
- 12 - 18 months sounds ambitious for a timeline - any thoughts?
There are certain essential processes in drug development which set the pace, but we plan ahead and are careful, “it’s doable”
- Would management consider more regular updates so the market remains excited about POLB?
Busy with new assets so this takes up a lot of time, “lots going on in the background”, don’t want to publish spurious RNSs but there are a lot more updates to come in the next few months. POLB001 is the lead asset, likely to be first bit of news
- Potential of oral vaccine delivery platform?
Mucosal immunity is a critical thing for illnesses such as E Coli. Pill makes worldwide distribution significantly easier. Very interesting technology, “if it works it can go anywhere, potential goldmine”
- Why don’t you buy some shares JS?
Part of challenge is that JS is an insider, “will be talking to lawyers and nomads” to address this, JS wants to purchase and resolve the issue as it “doesn’t look good”
- Nasdaq?
It’s on the cards, aiming to build the pipeline then "take Stateside to grow and expand"
Made some notes as JS was presenting on the LSE webinar just now. A good presentation I thought and a very upbeat view of POLB's prospects - sounds like lots of (good) news to come.
- “Capital light, rapid development” model that “pharma craves”; investment to be recouped with milestone payments etc.
- POLB doesn’t take drugs all the way to commercialisation - passes assets on to big pharma to take on the risk and cost of commercialising
- Pipeline described as “growing, burgeoning, promising”
- Significant progress since IPO:
POLB001
- progressing well, currently manufacturing, human trials this summer with HCT, Phase 1b LPS HCT expected in June 2022
- patent protected til 2038, POLB has worldwide rights in humans,
- “One drug with potential uses for multiple diseases” is very attractive to Pharma
POLB002
- broad spectrum RNA-based intranasal immunotherapy
- currently late preclinical stage, team being rapidly built around this asset, asset is “primed” for progress
- exclusive licence to dual action immunotherapy
- POLB002 has a very “unique approach, watch this space”
POLB003 Meliovac
- nothing else to compare this drug to so no competition, “jewel in the crown”
- conversations with pharma started already via the boards extensive network of contacts
- “great potential to move this forward” and five other vaccine candidates under investigation via the same licensing agreement
- Good contractual progress on AI programme, news to hopefully come soon, won’t cover in detail today as not enough time
- Oral vaccine delivery platform - triggers ‘mucosal immunity’ rather than systemic which has various benefits, interesting technology which prevents pathogens from infecting the body - platform covers many different diseases rather than targeting a single illness and is easier to distribute and administer than standard needle-administered vaccines
- New assets being sought
- £250bn market by 2025 reiterated, “Big Pharma seeking products” after being unprepared for Covid pandemic
- POLB to get products through Phase 1 before passing on to bigger pharmas for P2/P3 developments
- Aiming for cash generative status within 12 - 18 months (not specified whether this is from the point of IPO but I'd assume so)
- “Targeting 5 or 6 assets at the same cost and time that conventional biotech take for just one asset”
- Evotec comparison was repeated - aiming for similar share price progression for POLB, 339% increase in 5 years
- US trial - IND approved, looking for two initial trial sites in the US, part of the same P1 study currently ongoing, not a separate trial so will run alongside UK trials
- AVA3996 - Fiona is project lead for this - a number of 'derisking' studies over past 12 months, been working with CROs and external consultants throughout UK and mainland Europe looking at efficacy of molecule - "unanimous decision" to go with AVA3996 as no reason not to
- AVA3996 - used for multiple myeloma currently but also affect other parts of body, targeted approach would widen the possible uses of this drug type
- P1 study is not just to evaluate AVA6000, but also evaluating whether wider PreCISION platform works in humans as well as it did in preclinical stages - "potential value for the company is enormous" and is a "massive milestone"
- Significant pipeline will be unlocked if AVA6000 Phase 1 reveals positive data
- Phase 1a will reveal some very significant data - a lot of info to come in the middle of this year
- Funding for Phase 2 and further expansion of the platform could come from a variety of sources; if clinical data is good a licence deal is a possibility for AVA6000 and the wider platform - greater shareholder value from progressing ourselves so that is priority
- "We are not looking to raise funds in the near future at all"
- Prelims in late March / early April, exact date not yet fixed
- Oncology drug development big value inflection point in the middle of the year
- Market will be updated on 3996, IND filing next year
- More updates on partnerships to come
Key points I noted down from the Vox interview - well worth watching the whole thing, and thanks to benbenbenben for sharing the link.
- LFT - extremely unfortunate that Omicron affected test performance. Affimer works well, antibody was the issue. Searching for new affimer, "not necessarily a long process" to do this but unsure how regulators will view changes, so difficult to give an accurate timescale. Market to be updated when picture is clearer
- Huge number of mutations on spike protein and within the nucleocapsid protein - all antigen tests vulnerable to mutations, including future variants
- We now know a lot more about Covid so have learnt a lot about which part of the antigen is least vulnerable to mutation - gives us some guidance for future-proofing
- AS wants to focus investors' minds on oncology drugs as the main value drivers for Avacta, LFT is very much secondary but fortunately oncology side is performing well
- AVA6000 - molecule of Doxorubicin is very well understood, it is not a novel drug and the mechanism of action is very well understood - AVA6000 improves targeting and we now have first data
- Dose escalation up to 120mg is 50% increase from first dosing of 80mg
- Purpose of phase 1 is to determine safety rather than efficacy - what is important is the cumulative dose over time, which is what drives long term cardiotoxicity
- Cumulative toxicity of AVA6000 might be quite different to standard Dox, which is what they're trying to determine
- Biopsies will provide very important data, permission from patients required for this however
- Safety being measured using standard criteria that are used in all P1 oncology trials - white blood cell counts, biomarkers for cardiac output etc.
- Regulators seem confident in safety profile - they recommend the escalated dose, having reviewed all the available data to date
- Unable to say exactly how many patients have been dosed but "you can probably figure it out" from the structure of the 3+3 trial
- Timescales on track apart from small delays due to covid staff shortages in hospitals and so on, "middle of the year, end of Q2" for P1a dose escalation - if all well, dose expansion (P1b) to follow later in 2022
- Purpose of P1b is to find maximum tolerated dose or recommended dose for next phase
- PK data to be released at the end of the first phase of escalation, not able to confirm specific timeframe but won't be before the middle of 2022
- All patients are at terminal stage with different types of tumour, so expecting more variability in escalation phase data compared to expansion
- "Not appropriate" to talk about data in the middle of the study but AVCT are very happy with progress so far, but emphasise that they are still at early stages
Just published by the National Academy of Sciences in the US:
https://www.pnas.org/content/119/5/e2123477119
Unfortunately no specific mention of Imutex or Flu-v, but the article shows the size of the prize for whoever can get a universal vaccine developed and approved.
Thanks for sharing extrader, much appreciated.
An article published by the Telegraph just now. I've been in Avacta since April 2020 and having followed the company very closely ever since, it is infuriating to hear our politicians saying there is "no quick fix" to the shortage of LFTs when we have the very best available right in front of them but it isn't even currently able to be sold in the UK.
"Covid testing in tatters as Sajid Javid blames huge surge in demand
Health Secretary admits there is no quick fix as shortages raise fears of unintentional lockdown"
https://www.telegraph.co.uk/politics/2021/12/29/covid-testing-tatters-sajid-javid-blames-huge-surge-demand/
Sarah – perhaps you should go Cathal? In terms of corporate governane, maybe you need a different chairman?
– "We’ll see!" CF will be very ****ed off to be chairman beyond Easter, “does that give you an idea of where we’re going?”
What do we have to look forward to?
– a number of deals in the pipeline, 2022 with be “exhilarating and exhausting, looking forward to the journey”
- "All the fundamentals are in place" to make POLB a success
Questions
Nasdaq listing next year – surely you have to walk before you can run? Claims in the past were overegged – is Nasdaq next year really on the cards?
- CF claims he actually “underegged” – we should have had more newsflow, that’s where we messed up. CF and the board are not happy, JS knows that, CF wrote the biggest cheque so is unhappy with SP performance.
- Sarah – "why is it taking so long?”
- JS – we want to bring in good opportunities, a lot of bad ones out there, we are happy with the ones we have chosen but process is complex and negotiations drag on sometimes, another deal is pending and we are going to build on the momentum
JS – you've said you are excited about the future for POLB, are you excited enough to buy some shares to align yourself with holders?
- focus is to get going and develop the company but will likely purchase
AI programme - when will the AI dive be complete and who owns the information obtained from it? Is it Open Orphan, Poolbeg or DIM?
- very close to an agreement on this, POLB will own the outputs of the data analysis, initially looking at RSV as well as influenza, we have very exciting datasets, no one else has this data, we can do a “before and after” comparison of the immune system when a patient gets ill
Security - how safe are the 22 sample freezers, are they alarmed, what if there is a long term power outage, is there a backup generator? Parts of Scotland had been without power for over 5 days because of storms
- great question, JS has visited the site himself, they have “backups on top of backups on top of backups, there is no issue”, site is well protected
We are worried about 'jam tomorrow' – great RNS about Meliovac this week but it is still only an option - any comment?
- discussion with Meliovac team who are moving quickly, we are waiting on one key piece of data, we are assuming it’s positive but awaiting confirmation. Five other potential projects in the pipeline. We wanted the option for Meliovac to prevent a rival getting it
How can you convince investors that it’ll be more than just an option?
- licence will follow (missed the first part of the answer)
CF – you are becoming the ORPH dinosaur, JS is CEO of POLB whereas we look at you and see ORPH – should you not be chairman of POLB because we get confused? What happens when lock-in period is over and everyone sells POLB?
- CF has put a lot of money where his mouth is, no one else has put as much money into ORPH and POLB as CF. People forget that ORPH was at 5p not that long ago. “Lets see where ORPH goes between now and Xmas, that’s all I’m saying re: ORPH”. For POLB, there is more news to come, great synergy between POLB and ORPH, CF’s entire personal small cap investment portfolio is down so performance is not unique to POLB/ORPH. “Bear with us”, disappointed with lack of newsflow but it is coming
Made some notes as JS and CF were presenting just now. Both sounding very positive about the near term for both POLB and ORPH, with CF sticking to his pre-Christmas timeframe for some big ORPH news, and some very spicy questions from Sarah! A great interview in my opinion, it moved very quickly though so please add anything I didn't manage to note down.
- 15x IPO price is the target CF has set for JS, "in the next couple of years"
- CF has 7.3% of POLB, Schroders have 4.5%, "a good secure shareholder"
- POLB team have previous created c. $1bn in shareholder value
- Pandemic has done $17tn of damage to global economy, this is rising, govts. will spend big to prepare for future events
- ORPH will never again be raising money
- POLB focusing on earlier stages of clinical development, using HCS which won't be done by Hvivo as there are cheaper options
- Evotec-style journey is the aspiration for POLB, SP for Evotec has grown nearly 1800% since 2007
- Aim is to get POLB on Nasdaq
- Big pharma are continuing to in-licence, acquire or co-develop infectious disease products - great environment for POLB
- POLB aiming to generate own cash within 12 - 18 months
- Management not happy with share price but newsflow will come
- Share price will be "put right in the coming weeks and months"
- POLB's model is to get assets to Phase II with capital light approach
- "No better time to be in infectious diseases", big pharmas want assets for their pipelines
- Initial assets include POLB001, data and biobanks, PredictViral and vaccine discovery platform
- An asset that POLB is in-licencing is Meliovac, a Melioidosis vaccine candidate for which they have signed an option agreement (Meliodosis rare disease but more common in subtropical regions, 54% fatality rate)
- This vaccine candidate is currently at late pre-clinical stage, POLB aiming to progress this quickly
- Meliovac backed by Wellcome Trust, JS excited about the project and potential
- POLB 001 has already been through phase 1 so confirmed to be safe in humans, drug is a potential blockbuster, repurposed for flu
- POLB 001 can be expanded beyond flu, "going well from a development standpoint, very excited about this programme"
- POLB 001 trials to continue early next year
- Team in Netherlands carrying out bacterial protein study, part of process to prove that POLB001 works in humans
- Data readout will be very quick, Q3 2022 for data
- "If this works it could be enough for a partnership with a big pharma at that point"
- Eurofins Genomics chosen as partner to complete RNS sequencing of RSV samples as part of AI programme
- 300k samples available for data mining project with aim to select new drugs and drugs that can be repurposed
- "Pharma get interested" when "new targets" for drugs are identified
- "We are in perfect position" for AI project with renewed interest in infectious diseases and advances in AI technology
- "Al