The latest Investing Matters Podcast episode featuring financial educator and author Jared Dillian has been released. Listen here.
Bit depressing watching the share price sink back after the fantastic RNS a week ago, really did expect it to kick on with the level of value clearly now being baked into the various platforms.
Anyway, by means of a comparison, results were released by ProQR therapeutics the other day, see below.
https://www.proqr.com/press-releases/proqr-announces-positive-results-from-clinical-trial-of-qr-421a-in-usher-syndrome-and-plans-to-start-pivotal-trials
ProQR Therapeutics N.V. (Nasdaq: PRQR) (the “Company”), a company dedicated to changing lives through the creation of transformative RNA therapies for inherited retinal diseases (IRDs), today announced results from a planned analysis of its Phase 1/2 Stellar trial of QR-421a in adults with Usher syndrome and non-syndromic retinitis pigmentosa (nsRP) due to USH2A exon 13 mutations.
Across all treated patients (n=14), a mean benefit of 6.0 letters was observed at week 48 in the treated eyes compared to the untreated (contralateral) eyes after a single injection.
Share price up around 60% after releasing the results. MCAP of over $400m.
They have one study in phase 1, one study in phase 1/2, and another in phase 2/3.
I think it shows just how close Reneuron are to realising its true value at long last. Further positive data from the expanded phase 2a study and we will be moving in a pivotal phase 3 study. At which point the value disconnect from Reneuron and its peers will simply have to be acknowledged by the market. Upfront payments for any licencing deals for a phase 3 candidate will eclipse the current MCAP. The same is likely true for any exosomes deals that will be taken into clinical study.
https://www.bbc.co.uk/news/uk-56475807
Whilst I personally find the prospect quite unwelcome for any prolonged period in the future, this does perhaps outline what we may realistically have to expect moving forwards.
A market that will absolutely support a significant area of the Heiq business model in the near term, but not necessarily define the company over the longer term, given the breadth of technology and IP that has been developed over a number of years.
Think the next two quarters has first non US patient dose in phase 2a, then leading to all expanded trial cohort dosed by end of Q2?
Further POC data for exosomes is due Q2, then Q3 expecting readouts from hrpc trial at conferences. Not sure what will happen with that though, as all the main conferences have been pushed back later in the year due to covid. Not rene's fault for that though obviously, they'll probably just wait a do a 6 month read out instead I suspect.
Q3 onwards for potential commercial deals on exosomes. Potential hrpc licencing deals ones read out of expanded phase 2a is presented. Would be better if they can take hrpc to market themselves though, or maybe just do licencing deal for a smaller area and keep the rights for the US perhaps.
I might have missed something out, but not at a computer.
Stateside - I do hope they pursue a nasdaq listing, as I think that will be the pathway to the true value being understood and realised. MH has previously commented that as nasdaq listing is an objective, but they see the timing of any such listing as being important. I don't therefore think that would be linked in any way to his departure (in terms of a difference of opinion).
If the new CFO has experience from an equivalent role in a nasdaq listed company, then that would be a clear indication (in my eyes) of the intentions moving forward. Will be interesting to see.
I thought it might be useful to post a brief summary of what we have learnt in the last 3 months or so, as quite a lot has happened.
- A published timeline of events/inflection points that has so far been achieved
- Further exosome collaborations signed.
- POC data for CTX derived exosomes demonstrating functional payload delivery, both in vitro and in vivo, to the brain and peripheral tissues.
- Licencing deals expected within the next 6 months if exosome data continues to deliver as expected.
- New CFO incoming
- New joint broker appointed
- New IR/PR company appointed
- Approx £20m in the bank following Dec 2020 fundraise. 18 month+ runway of cash presuming no additional external sources of finance. Any licencing deals would however come with potentially significant upfront payments (reference Codiak, Evox, Jcyte etc).
- Expanded phase 2a study for hRPC underway, looking to expand on already industry leading efficacy signal data based on 1m cell dose. Expanded study exploring minor modification to delivery of cells and an increased 2m cell dose.
- 5 hRPC trial sites established across US, UK and Europe.
- A host of new institutional investors on board in the last 3 months, and certain ones subsequently increasing their holdings in the last week.
- Patents issued protecting IP.
- Fosun advancing CTX and hRPC studies in phase 2b in China with milestone payments on the horizon.
- Very bullish share options announced for directors, intrinsically linked with returning shareholder value.
Anything I've missed? Worth bearing in mind that none of the above are the actual catalysts for the true value being realised. The next 6 months is when we get to see the contents of Aladin's cave.
Enjoy your weekend.
Great update and delighted that the company has stuck to its published timeline. Thanks for the research paper and patent links, I shall review over coffee.
Thanks Donacropolis, I hadn't previously picked up that reference to the clause relating to rene, so it's useful you have pointed this out. The article linked below summarises it as follows:
'In addition, the Company and the Buyer have agreed to a potential adjustment to the acquisition price in the event of significant changes in value of the listed portfolio companies Mereo BioPharma and ReNeuron on an aggregated basis by the date of completion of the Transaction.'
https://newsnreleases.com/2021/01/27/schroder-to-sell-49-0-million-worth-of-assets-to-rosetta-capital/
Link below to a nugget of information that may be of interest; it's a circular from Fosun Pharma dated December 2020, outlining a share issue to fund the development of various drug programmes:
https://www.fosunpharma.com/uploads/2020120752938.pdf
If you open the link and press 'ctrl' and 'f', then search for 'rene', you will find some references to the CTX and hRPC trials, along with associated figures. Appendix 1, items 10 and 11 are of interest.
Item 10 relates to the CTX programme ( Phase IIb clinical trials for disability after ischemic stroke in mainland China and Taiwan region), with 113m RMB (Chinese Yuan) outlined for the purpose of; "Introduce stem cell therapy (CTX) ReNeuron Group Plc for the exclusive clinical R&D and commercialization license of disability after ischemic stroke, and pay the subsequent expenses such as R&D milestone payments".
From that figure, it appears that 26m RMB (approx. £2.9m) is for R&D milestone payments to Rene.
Item 11 relates to the hRPC programme (Phase IIb clinical trials for retinitis pigmentosa in mainland China and Taiwan region) with 110m RMB (Chinese Yuan) outlined for the purpose of; "Introduce stem cell therapy (hRPC) from ReNeuron Group Plc for the exclusive clinical R&D and commercialization license of retinitis pigmentosa, and pay the subsequent expenses such as R&D milestone payments."
From that figure, it appears that 53m RMB (approx. £5.9m) is for R&D milestone payments to Rene.
I think my interpretation of the figures is correct, but would be useful to get some other opinions. Clearly this isn't necessarily money in the bank for Rene (as we can presumably expect a large chunk of that money will relate to successful completion of those trials), however it is good to see everything is continuing to progress with regards to the Fosun arrangement, as frankly I don't think we've really had much further info on this since the deal was signed a couple of years ago.
Also worth noting that for hRPC it says 'Phase IIb' trial, whereas obviously it was (and still is for the in-house work) a Phase IIa trial when the deal was signed, so perhaps and indication of some further progress being made there.
FYI, this was updated yesterday by the looks of things.
https://clinicaltrials.gov/ct2/show/study/NCT02464436
Oregon and Barcelona have been added by the looks of it (based on comparison with Clive's post on Thursday). Arizona now saying active and not recruiting.
Locations
United States, Arizona
Retinal Research Institute Active, not recruiting
Phoenix, Arizona, United States, 85053
United States, Massachusetts
Massachusetts Eye and Ear Infirmary Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jason Comander, MD 617-573-6060 ophthalmologyclinicalresearch@meei.harvard.edu
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Mark Pennesi, MD
Contact: Sreesha Sreedhar, M.B.,B.S, M.S 503-494-9771 sreedhas@ohsu.edu
Spain
Institut de la Màcula Not yet recruiting
Barcelona, Spain
Contact: Jordi Monés, MD +34 935 95 01 55
United Kingdom
Oxford Eye Hospital Not yet recruiting
Oxford, United Kingdom, OX3 9DU
Contact: Robert MacLaren, Professor
Also, just noticed that you can do a side-by-side comparison of how the study has been changed since it was first published (hopefully this link works):
https://clinicaltrials.gov/ct2/history/NCT02464436?A=1&B=10&C=Side-by-Side#StudyPageTop
I'm still trying to piece together what this is telling us, as for me it really has come out of the blue. However, what is clear is that since Obotritia have become significant investors and Mark Evans has been put on the board, the company has sidelined the CBX trial for licencing, the company has engaged with shareholders significantly more (3 investor presentations in the last 2 weeks), a new joint broker has been appointed, a PR/IR company has been appointed, and now the CFO (who has been leading almost all of the investor presentations) has stepped down.
Change is most clearly taking place at this company and I think the clear intention is to finally begin generating shareholder value, or at least try.
Quite odd and unexpected. The strength of the successor, when announced, will undoubtedly tell us about the direction we can expect the company to be going in the future. Here's hoping this is part of some grand masterplan laying out the foundations for the roll out to commercialisation.
I wish MH the best for the future either way, he may have had his detractors (which CFO doesn't?, but he is a decent bloke and a good servant to the company.
Skip to around 1h37m onwards for the good stuff.
https://youtu.be/eyPksoILpxo
What a company, highly excited across all timescales for the potential on offer here.
Frustrating to see the share price drop back over the past few weeks again, however I think it's worth viewing this in the context of the wider sector. Biotechs had a good run last year, but since the turn of the year (and especially so in the last month) there are very few that are actually up - Rene being one of the exceptions, up around 20% since 31st Dec.
Once the tailwinds return to the sector, there will be plenty to look forward to. Picked up some more at 98p this morning and more than comfortable with my holding.
Maxcyte are close to the automatic entry value threshold for FTSE250, by looks of it:
http://www.stockchallenge.co.uk/ftse.php
Anyone aware of any commentary on this point? Would be good to get established in this index prior to NASDAQ listing. FTSE100 obviously being the long term aim here as well.
Decent mention for Heiq on this vox market share chat. Skip to around 31m if you don't want to watch the full thing.
https://youtu.be/HoTULGVSEvM
Amarti Global certainly seem bullish about the prospects for this company.