I have done the same in anticipation of good results from the Opaganib Phase 2/3 results due in Q1. Today's news of yet another clinical benefit in the treatment of Covid-19 is very encouraging, and increases the likelihood of good results in early 2021 leading to EUA.

Call yesterday was the same broken record as the past few years. Management is utterly incapable of capitalizing on their B-TRAN tech.. they have fumbled for too long (and outright failed with PPSA in the past, forced to sell it in a fire-sale to keep the lights on and try again with B-TRAN. They are back to getting funding from government projects, just as they did in the beginning. They all come to nothing.

I still hold shares, but only a token amount. Will continue to follow them but at this point I have expect they'll only realize a small fraction of the potential.

Anyone here still bullish, or have any insight to share?

Meet the new boss. Same as the old boss. WTF? This is the last company I invest in with amazing tech but clowns running the company. I see the patterns so easily now (and I saw it here too), but I was seduced by the amazing IP, the size of market, and the potential, but without a strong management team, good tech goes nowhere. Always.

They utterly failed to commercialize their innovative PPSA technology, worth hundreds of millions in the right hands, and with BTRAN seem to be clinging to the government/military relationships they had when they started the business. The have the next transistor. If positioned correctly, shipped units of this device should number in the billions over the next decade. Management lacks the experience, connections, or resolve to market properly and sell it. Brdar was CEO before Bell, now back at the helm why? Only because Lon is getting old. How about some fresh blood? Bring in some pedigree and make something out of this could-be-amazing-but-never-seems-to-progress company.

I'm so far in the red on my position that I won't bother selling at all... this is either gonna be a $bn company in 5 years, or bankrupt with the IP sold for a song.

Talicia launch today.

We're excited to announce that #Talicia is now available in the U.S. – for details about the prescribing information, full ISI and availability check here: https://t.co/xyPzR5aLSW #RDHL $RDHL #GI pic.twitter.com/UiZVtc7TGG

— RedHill Biopharma (@RedHillBio) March 9, 2020

The company just released prelim numbers for 2019. Revenue was $1.5MM (the low end of their already once downgraded range), and this was with 6 clinics in Canada, many which only came on-board late in the year.

They have since added 7 more clinics covering 9 more locations (no details on where), and will be requesting clearance in Canada for Multiple Sclerosis indication, in addition to mmTBI (the only official indication today).

They also said they will submit FDA de-novo for MS later this year based on an existing body of evidence. Hopefully their discussions with FDA are well informed enough that they don't expect the same rejection they got for mmTBI.

Still, encouraging progress out of Canada. I would still love to see more official statements from the PT community or patients about their results. My last post about the MS patient was very encouraging. There should be dozens more like it if the results are real.

Still largely sitting on the sidelines here, ready to jump in if things look very positive.

A recent article about PoNS use to aid a man with MS:

https://calgary.ctvnews.ca/calgary-man-with-multiple-sclerosis-sold-on-tongue-tingler-neural-therapy-1.4730971

Hard to say how big an impact Coronavirus will have, but unless it substantially reduces the planet's headcount I don't see it affecting RedHill's future prospects. Personally, I doubled my position yesterday as I feel it's significantly oversold given how far they've come and how close they appear to generating revenue. The investment by HRP boosted my confidence that they will ultimately be successful.

So we now have:
* well funded (non-dilutive) for a big commercial push
* a new and very complementary product in their portfolio that already has annual sales of $96 million (expected close by end March)
* an additional 80+ sales people from AZ
* prior consultations/panels/focus groups with so many physicians that has given them the confidence that Talicia will be the first-line defense against H.Pylori and thus eventually become the new SOC
* Talicia pricing + insurance coverage they are happy with (term sheets with 13 payers representing 200 million Americans)
* launch in 2 weeks

Are we ready yet? Can we see some double digits or will the market need to see proof of sales traction first? Been in RDHL for years now, patient as a [underwater] rock.

Encouraging progress, and so soon after the G0 achievement, which bodes well for the remaining work. Does anyone here have enough knowledge of the glyco-engineering benefits to be able to help us understand at what point it's a "game changer"? Mark has lauded the human glycan structure objectives as such in the past, but I'm not entirely clear if it is "binary" in terms of being beneficial beyond 98% for example, or if it's a sliding scale in terms of the benefits (potentially improved efficacy, reduced chance of AE's, etc.) and thus anything north of 75% is good and 100% is simply "as good as possible".

My understanding is rather than it's not binary.. and even 100% doesn't guarantee anything specific, but it does mean that in-vivo trials stand a better chance of success with 100% human glycan structures.

Is that incorrect or incomplete as a perspective? Could something more binary (scientifically, or commercially) be lurking should they hit a specific % in the glyco progress?

The company seems quite confident in their preparedness to start & ramp sales of Talicia, and I'm seeing more social media messaging coming out lately. They mentioned they have their own internal sales targets for Q3/Q4 and beyond, but didn't disclose them. I'm hoping for the best, but expecting to be underwhelmed. I don't think they'll take the market by storm.. it will be a slow and hard slog, but I still like their odds and expect they will chisel away at the marketshare enough to bolster the share price in 2020/2021. Unless sales entirely bomb, I would not expect much share price erosion from these levels. Talicia, even with modest success, could help the share price establish a stronger floor for the future. Hopefully in the $10-11 range. Also, they have a robust pipeline and have been fairly consistent & successful moving the trials forward thus far.

The company recently announced another clinic that will offer PoNS treatment, bringing the total to 8 in Canada, slightly ahead of the number they anticipated to have by the end of 2019. However, the latest clinic is a one-physician outfit, 40 miles from the largest city on Vancouver island, with a population of under 100,000 people, so it's hardly a "material event" worthy of an 8K.

If the patient outcomes from the initial larger clinics are as good as the company has been touting, the PT community will surely pick up on it and more clinics will sign-on. If they fail to get the word out and build momentum by the end of summer 2020, then I'm inclined to think it's not going happen. And if there is no commercial traction in Canada, then a US FDA approval would be a non-event.

If, on the other hand, we do get strong testimonials from patients and physicians, and the company can get their devices into more Canadian clinics, it would bode well for the stock (finally) and FDA approval would be an inflection point.

For now, I'm watching this space with a speculative position (well into the red), and ready to invest more should we see encouraging progress.

I'm assuming increased mention on Sanofi and pandemics in the latest run of interviews is just Mark being bullish and opportunistic. Getting the word out. I'm not holding my breath that there is anything formal in the works with any partner as a result of Coronavirus. I just hope it's working and they attract more investor attention and/or convince existing pharmas to invest more in C1. Otherwise I expect we will just trade sideways or downward until and unless there is a significant commercial announcement. Still long and overweight.

Strong recovery from December lows here.. solid volume and slow steps up. I'm finally back over my average price too which is nice Good things coming here for those who are patient, IMO. Commercial success sure feels more than ever like a "when" than an "if".

Notable differences from the last deck (other than highlighting their G0 success) from slide 17:
* Fc-Fusion expression rates are up 8%
* mAbs expression rates are 13% higher than before
* Virus-Like Particles rates are almost 800% greater

NEWS: more licenses from existing customer. If it weren't for the lack of revenues I'd say the company is doing an outstanding job! LOL Nevertheless, this is undeniably more encouraging news for longs. https://www.resonant.com/news-awards/press-releases/detail/364/resonant-inc-expands-relationship-with-existing-customer

White Diamond has written another bearish article about HSDT on SA. I have provided an alternative viewpoint. https://seekingalpha.com/article/4314666-helius-medicals-new-report-provides-evidence-device-is-ineffective#comments

That's right.. FDA wanted assurance (that even this latest independent study did not provide) that physical therapy alone was not yielding the same improvement in balance than PT together with the PoNS.

I find it a little far-fetched to suggest PT alone may have been the main factor in the improvements given that all patients had already been undergoing PT in the past and were no longer seeing any improvements. Perhaps the PT regime was very different when done together with PoNS?

Either way, the company is all over this, and unless the new trials that they've agreed with FDA do not yield the same results, I would expect FDA clearance is in the bag. I just won't be very soon. But in the meantime, Canadian market is their litmus test.. if results are strong there, then they really have something unique. More indications and larger markets (US, EU) would be outstanding.

The third-party study is definitely helping IMO, though that particular study did also have a statement in the conclusion that they could not rule out that the improvements were not related to the PT alone. This was FDA's main gripe, but given that all these patients had been doing PT before and were no longer improving, I find it hard to imagine PT (or placebo effect) was the sole reason for the dramatic improvements.

With the existing Canadian clinics alone, by their own estimates, they should achieve annual revenues of $7MM. If traction continues and they get more clinics and actual results yield the same outcomes as the studies, then an FDA approval would be huge. But Canada alone can easily make this a profitable business. Time will tell .. so far not much press out of the Canadian clinics...

Third party validation is crucial IMO, and this study echoes the findings of previous studies. But it does not draw a comparison between PoNS with PT and PT alone. However I find this requirement (imposed by FDA for before granting 510k for PoNS) to be superfluous given that both this and prior studies clearly stated that all participants "had seen little progress or had plateaued in their recovery with PT", implying that PT alone will not benefit the patients further.

Here is the partial PR, with emphasis added.

Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (the “Company”), a neurotech company focused on neurological wellness, announced today that the results from independent research conducted at the University of Wisconsin-Madison on translingual neurostimulation for the treatment of chronic symptoms due to mild-to moderate traumatic brain injury (“mmTBI”) have been published in the December 2019 issue of the Archives of Rehabilitation Research and Clinical Translation. For more information on the trial and its results, see the published journal article.
The newly published results from the double-blind randomized clinical trial which paired translingual neurostimulation using the Portable Neuromodulation Stimulator (PoNS™) device with therapeutic activities, showed significantly improved balance and gait scores over the 14-week treatment period and the outcomes were sustained for 12 weeks after discontinuing the treatment.

“Traumatic brain injuries are rising steadily in North America and whether these injuries are mild or moderate, the effects can last a lifetime,” said Philippe Deschamps, Chief Executive Officer of Helius Medical Technologies. “The results from this independent clinical trial provide clinical support for the PoNS Treatment™ as an effective treatment option for patients suffering from the effects of mmTBI and we are excited to have the validation of the data in a peer reviewed publication.”

The trial evaluated 43 participants who had experienced an mmTBI at least one year prior to receiving the PoNS Treatment and had seen little progress or had plateaued in their recovery with physical therapy. Researchers found that approximately 74 percent of the participants who completed the 14 weeks of PoNS Treatment experienced significant improvements in their balance. Patients also showed meaningful improvements in their gait and walking endurance.

Exploratory endpoints, such as headache burden and sleep quality, were also observed as part of the trial. While further analysis and research is needed, there was an indication of improvement in these exploratory endpoints. The demonstrated improvements in balance and gait, coupled with potential improvements in the exploratory endpoints may allow treated individuals to experience a better quality of life.

I hesitated to move some of my DYAI into PFNX, but never pulled the trigger. At just twice the valuation they have considerable commercial traction and are seeing strong milestone payments already. I can see both Dyadic and Pfenex as attractive acquisitions. Dyadic's C1 platform should ultimately be more valuable, but is likely a longer hold IMO.

Does anyone have a sense of what the milestone and royalty potential is from the already signed deals? If Serum were to use C1 for just 1 or 2 of the 12 antibodies they are targeting, what might that mean to Dyadic? We only have the past industrial deals to compare yet Mark has hinted that the pharma space would command higher milestones and royalties.

yup

but totally worth it IMO .. LOL.

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Wow, great read. They sound very enthusiastic about this scientific milestone and it's importance to the commercial prospects of C1.

"We forecast $123 million, $262 million and $416 million of sales in F2023, F2024 and F2025, respectively." -- given their expected high margin, if they hit those revenues numbers the share price should easily top $150 in 2025. Aggressive, but feasible.

Best write up I've seen on "glyco-engineering" and its importance : https://scr.zacks.com/News/Press-Releases/Press-Release-Details/2018/DYAI-Dyadic-Supplementary-Information/default.aspx

Anyone else listen to the call earlier? I found it to be very well run -- they sounded confident they're totally ready for this launch and that the groundwork is laid for sales to start swiftly. They acknowledged how difficult/impossible it is for a small young pharma co like they are to successfully commercialize their first approved drug, but insisted that their team knows how to do this and what obstacles they'll encounter, and are prepared. Exciting!

G0 glycan levels of up to 95% have been reached with this strategy. In addition to G0, only Man3and GlcNAcMan3 remain in the glycan pattern.

The glycan pattern remained good with 93-95% G0 glycans.

Summary from VTT:

? Myceliophthora thermophila C1 is an industrialized protein production host that is now developed for therapeutic protein manufacture - with several large biopharma companies entering into collaborations.

? We have identified critical proteases to deal with for therapeutic protein production enhancement and enabled a very significant reduction of the protease load in the production strains.

? Our glycoengineering program aims at high proportions of human glycoforms G0, G2, FG0 and FG2. Excellent G0 levels have been reached through alg3-alg11 deletion strategy.

Any summary of the glyco results from the VTT presentation this morning at PEGS in Lisbon? Mark used some big words to describe the progress that would be presented. Hopefully it wasn't just posturing.

Yep, very amateur. They surely won't keep their short position for long of they really do have one. And so much upside in comparison longer term.

I'm not expecting dramatic news from glyco program tomorrow, as I have to believe they would PR anything newsworthy, but I do hope progress is significant and that BP will soon begin courting our Lady Dyadic in droves. Bidding war in 2021??

Just found it posted on Stocktwits : https://www.floridatrend.com/print/article/5136

I don't see Dyadic listed as a speaker or keynote at PEGS, do you know if their presentation will be recorded or broadcast?

good interview, terrible CGI background overlay :)

Great call just now. Nothing new revealed but some gushing by an analyst, and strong hints of hidden progress as encouraging glyco-engineering efforts.

Vanguard Group Inc. acquired a new position in Dyadic International, Inc (NASDAQ:DYAI) during the second quarter, according to the company in its most recent 13F filing with the Securities and Exchange Commission (SEC). The institutional investor acquired 709,698 shares of the biotechnology company’s stock, valued at approximately $4,443,000. Vanguard Group Inc. owned about 2.65% of Dyadic International as of its most recent filing with the Securities and Exchange Commission (SEC).

Other hedge funds also recently made changes to their positions in the company. Bandera Partners LLC bought a new position in Dyadic International in the second quarter worth $9,534,000. Northeast Financial Consultants Inc bought a new position in shares of Dyadic International during the second quarter valued at $1,565,000. Pekin Hardy Strauss Inc. bought a new position in shares of Dyadic International during the second quarter valued at $384,000. BlackRock Inc. bought a new position in shares of Dyadic International during the second quarter valued at $337,000. Finally, Cedar Brook Financial Partners LLC bought a new position in shares of Dyadic International during the second quarter valued at $314,000. Institutional investors own 12.92% of the company’s stock.

from: https://technewsobserver.com/news/2019/11/12/vanguard-group-inc-makes-new-investment-in-dyadic-international-inc-nasdaqdyai-updated-updated.html

See https://stocktwits.com/TenFolds/message/182619199 for some musings on that. Nobody can say when profitable, but share price should definitely improve as revenue ramp begins.. long before profits are in sight.

Way oversold here IMO. I bought a few more today...

As much as any long here, I'm frustrated by the absence of material royalties this company has delivered. They have relentlessly failed to deliver in the time frames they set out themselves, over and over.

However stepping back and looking at the company today, their IP, the space they're in, the partnerships and clients they have (quality and quantity), I would argue they've never been in a better situation and that the downside risk here is very low now, versus the incredible upside potential.

If I weren't so jaded, and discovered this company and stock today and was comfortable with a 2-3 year minimum investment horizon, I'd say the exhausted retail long has given me an opportunity to buy in at a bargain price. And I'd likely take a position.

As it stands, I am a little jaded, and slightly below my average price. But taking the emotions out, the company has clearly made significant commercial inroads, and the valuation doesn't reflect the risk/potential here.

I'll be buying more in the coming weeks if the price stays in today's range.
I

We've never seen anything close to this volume before, so despite the modest post-open gains, it bodes very well for the near term IMO. Today's FDA approval significantly de-risks this stock. I cannot see how, given the phenominal clinical results, this drug doesn't start to see commercial traction and start to generate material revenues for RedHill in 2020. And they have a few more blockbuster candidates in their quiver.

Can anyone clarify the following statement by the CEO in the latest presentation: "we have the rights to use C1 and sub-license it exclusively until 2029 for animal and human health"? Does this imply that they lose their exclusivity on C1 uses in pharma at that time, and if so.. to whom? TIA

While "fingers crossed" is not a good investment strategy, with biotech its all too common. So I'm crossing mine anyway. I'm a big fan of the long term prospects of this stock, but it sure would be nice to get to some all time highs quickly, post clearance.

News. Well, not really. This sums it up: "our customers shipped more devices in the three months of the third quarter of 2019 than shipped in total during the first six months of 2019. Royalty revenues in the quarter were also higher than in Q2, although they remain immaterial".

If 1.5MM units leads to immaterial revenue, then even the "tens of millions of units" they expected in Q4 may not be enough to turn the share price around just yet.

Still holding, but still frustrated.

I registered no problem, and listened to the interview with Mark (and a few others they had with companies I follow). I didn't notice anything new in there however, just the same fiercely optimistic founder I've heard on many prior presentations.