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Quick summary of Helius Medical:
first and only solution indicated for mmTBI
pilot studies for MS, CP, stroke..all with similar results across all symptoms
350k Canadians with mmTBI
1.5MM Americans
120k new cases every year in USA
product stimulates trigeminal nerve via tongue
IP whitespace (tongue-based brain stimulation entirely unexplored before today)
60 patents covering method and utility
increases blood supply to brain
neuromodulation combined with phsy/cog therapy leads to brain rebuilding itself (neurplasticity)
shown efficacious on patients who have undergone every other available therapy, and are no longer improving, even after an average of 4 years since last treatment
study was patients who are all treatment resistant and min 1 year later (chronic symptoms set in, lifetime affliction virtual certainty)
120 person trial
50% of them regained normal balance after the trial
efficacy retained 3mo after last use of device, proving the remedy is permanent
Cleared in Canada, commercialization underway
cleared in Russia (partners in place)
EU clearance submission filed in Dec 2018
AU submitted in May 2019
expect AU verdict in summer 2019
FDA rejected "de novo" classification, so back to FDA around Sept to get detailed guidance
not waiting.. generating a random PT-only trial now
Canada alone is "multi-billion dollar business" just for mmTBI indication
device sales is focus, partners and clinic drive service
2 founding clinics in CA
3 more clinics in CA just signed (now over 50% of population have access)
*data due in summer about patient outcomes*, prelim is encouraging
PoNS is a platform tech
peer-reviewed studies on MS
AU publication on stroke
other neurological conditions likely
$19MM in cash at the end of Q1
$700k in revenue last year
2019 guidance: $1.6-2MM in revenue from the 2 initial CA clinics alone (though they already signed 3 more)
early Aug will report Q2 numbers and update guidance
JMP Conference webcast from June 2019: http://wsw.com/webcast/jmp39/hsdt/index.aspx
Latest Investor deck: https://heliusmedical.com/images/pdf/Presentation/2019/HSDT_Company_Public_Presentation_v_2.1_MLR_Approved_5232019.pdf
Video supposedly showing one child's result from PoNS treatment in Russia: https://vimeo.com/181665292
and to offer an alternative perspective, a bearish SA article from Jan: https://seekingalpha.com/article/4234256-helius-medical-failed-clinical-trial-redacted-data-questionable-leadership-points-ineffective
Anyone here heard of the CDMO called 53 Biologics, based in Spain? They have a new domain and a new Twitter account and mention being well-versed in C1. I don't believe I've come across their name before when researching Dyadic. It seems maybe a new company altogether? Is this one of the things they've been working on secretly?
https://twitter.com/53biologics
https://53biologics.com/
https://www.linkedin.com/company/53biologics/
DYAI on fire! How are the technicals looking? (Just curious, but I'm not stepping out of my position even if it looks way overbought.. I'm here through an acquisition or a C1-based CDMO spin-off, or a $2bn valuation at least.)
News: iBio Announces First Agreement for Fill-Finish Services
NEW YORK, June 19, 2019 (GLOBE NEWSWIRE) -- iBio, Inc. (IBIO) (“iBio” or the “Company”) today announced the activation of its new cGMP sterile fill-finish services operation via the signing of a supply agreement with a clinical-stage biopharmaceutical company developing breakthrough gene and cell therapies (the “Customer”).
Earlier in June, iBio introduced its new cGMP sterile fill-finish capabilities for pharmaceutical products, including monoclonal antibodies, viral vectors and other biologics. Focused initially on clients with preclinical and clinical stage programs, iBio’s fill-finish operation is housed in the Company’s 135,000 square foot CDMO facility located in Bryan, Texas.
Pursuant to the supply agreement, iBio will formulate and fill clinical research quantities of one of the Customer’s investigational therapies into sterile vials for use in a planned late-stage clinical trial. The Customer’s identity will be disclosed at the time and in the manner consistent with the Customer’s own disclosure practices.
“Shortly after our fill-finish services launch at BIO 2019, this first supply agreement with an emerging leader in the gene and cell therapy space was established. While we expect our new fill-finish capabilities will also be attractive to our end-to-end CDMO services clients, this first agreement was secured as a stand-alone project and helps validate our ability to work with a variety of cell-based and other biopharmaceutical products in different formats,” said Robert B. Kay, iBio’s Chairman and CEO.
src: https://seekingalpha.com/pr/17549103-ibio-announces-first-agreement-fill-finish-services
CEO yesterday: "In the industrial space we got over $110MM in cash between license fees and the Dupont transaction, and we expect multiple times that here in the pharmaceutical industry where we're bringing even more value..."
The CEO kept using the term "parabolic" when referring to the value inflection of the company, and how despite the significant share price appreciation over the past 3 months, he views this as just the beginning.
Can't wait for more news. Long DYAI.
Or grow CBD, or Stevia, or reservatrol.. like Cargil and other huge players do in yeast? I'm not sure.. I have asked the Q to IR in the past but not received any reply.
two part interview posted just now:
Part 1:
Here! With oversized position, and very eager to see events unfold over the next months: new deals, existing R&D deals turning into commercial contracts with upfront cash and royalties, progress on internal R&D programs, and of course hopefully positive news on their glyco-engineering efforts.
Their MST technology feels like the kind of thing that once one fab or chip manufacturer adopts it, they will almost all have to, no? Seems to me it would have significant impact of the efficiency of things like interference and battery life, which would give early adopters a leg-up on their competitors, but then the followers are free to license it also.
If the tech is simple to apply into existing manufacturing setups, and has such clear benefits.. a few big deal could create a cascade effect and turn into licensing deals with 75% of the players out there (which could eventually lead to royalties in the $billions).
I'll be keenly following their commercial traction over the next 3-9 months.. this could be an "all in" kinda stock if the share price doesn't surge too much ahead of progress. I already have a healthy starter position.
News release: MTD201 Development Plan
Midatech Pharma PLC (AIM: MTPH.L; Nasdaq: MTP), the R&D company focused on delivering innovative oncology and rare disease products to patients, is pleased to announce that it has finalised the development plan for its key MTD201 Q-Octreotide product, a treatment for acromegaly and neuroendocrine tumours (NET) based on the Company's unique polymer microsphere technology, Q-Sphera™ for sustained drug delivery.
Following consultations with key opinion leaders, regulators, and potential partners, the Company plans to develop MTD201 as a new differentiated product for the treatment of acromegaly and NETs. Midatech has determined that the product characteristics uniquely conferred by Q-Sphera support this positioning of MTD201 to provide the most valuable, de-risked development programme for the Company. A key factor underpinning this decision is the significant competitive advantage and value added as a result of Midatech's Q-Sphera sustained release technology. The technology has patent protection into the 2030's.
As previously reported, the pharmacokinetic and pharmacodynamic profile of MTD201 established in Midatech's 2018 Phase I exploratory study versus market leading Novartis' Sandostatin LAR (SLAR) delivered favourably on the target profile requirements needed compared to current marketed long-acting somatostatin analogues. Additional advantages demonstrated in the study include smaller, less painful needle size, simpler and error free reconstitution and injection, quicker bedside reconstitution (taking less than 10 minutes versus up to 40 minutes for SLAR), reduced wastage and significantly lower manufacturing costs.
Midatech expects further competitive advantages to be leveraged in a differentiated MTD201 product versus other players in the market, such as SLAR, to be:
- subcutaneous, rather than intramuscular, dosing. This is more convenient for patients, allows the potential for self-administration at home rather than having to come into the clinic, and is less painful to patients;
- longer dosing intervals up to 6 weeks, as opposed to 4 weeks for other products; and
- higher doses of up to 60mg compared to current 30mg doses. This means only a single injection is required for higher doses, compared to current octreotide products that require multiple doses that are both painful and very costly.
The next phase of clinical development for MTD201 as a differentiated product is scheduled to commence in H2 2019 to support a first indication in acromegaly. The pivotal registration study in acromegaly patients will seek to compare MTD201 versus placebo and is planned to commence early 2020 following receipt of approval by regulators. Prior to this, Midatech plans a short Phase I study to look to confirm the use of the sub-cutaneous route in the pivotal trial, which the Company believes will provide further significant advantages, as outlined above. The pivotal program, the costs of which are expected to be in-line with the previously stated budget expectations as outlined on 4 February 2019, is expected to conclude in 2021 and, subject to a successful outcome and expected completion on commercial scale-up of MTD201 production at the Company's manufacturing facility in Bilbao, Midatech plans to submit marketing authorisation applications the same year. Subject to funding, a pivotal registration programme to support a second indication in NET is expected to commence in H1 2020.
Commenting, Midatech's Chief Executive Officer, Dr Craig Cook, said: " We are delighted to be able to lay out our roadmap to bring MTD201 to market. Building on the exciting Phase I data and further leveraging the full potential of the Q-Sphera differentiating technology promises a compelling product opportunity for MTD201. The development path has been finalised in close collaboration with our distinguished advisory board, and we believe we have a clear path to potential commercialisation. We look forward to providing regular updates as the development programme progresses."
So was I but I'm not expecting we'll see them again. But it will likely depend on the news flow out of the company. Any commercial or scientific progress they report could have a strong impact on share price, but no news for another month.. and the price may sag. If the CEO's bullish tone and enthusiasm are anything to go by, I expect we'll hear more news before we see 4's again.. and then very likely never see them again.
The exciting long-term Q is what other conditions could benefit from PoNS treatment? If you consider how it works.. simply by stimulating the brain while it's learning something.. the applications could be super wide-ranging.
News out: they signed 3 more clinics in Canada. They'd originally set an objective of 3 more for the entire year, so they're significantly ahead of schedule. Recall that they expect about 90 devices per year per clinic, so that translates to $5,400,000 more revenue (annualized) from these 3 clinics, bringing their ARR projections to over $7MM.
If revenue does grow in-line with the parameters the provided, they would need 10 more clinics to be profitable (fewer for just EBITA + / CFP).
Their TAM for Canada alone is about 350,000 patients (about 4000 clinics worth).
When they get US FDA clearance, it's a game changer.
I'm not a buyer just yet.. but if they announce more clinics and next Q or two show predictable revenue progress, I likely will be.
Newly published write-up / interview on the company: https://www.proactiveinvestors.com/companies/news/221500/dyadic-s-red-hot-c1-gene-expression-technology-gets-biologic-vaccines-drugs-to-market-swiftly-at-lower-cost-221500.html
The future value of the platform to the pharma industry as a whole could be well over $10bn if things continue to unfold as they appear to be doing. The question may soon be what will it be worth to a single BP who wants to "take it out" (to use the CEO's words) and own the platform to gain an edge? $1bn? More? It seems to me that the most likely scenario is a buyout, but out-licensing to dozens of pharma and CDMOs (or even becoming a CDMO themselves) could be significantly more valuable to shareholders over the long term provided they have the patience to hold for a few more years.
Strong volume today. The company has been doing a lot of investor conferences lately.. maybe that's attracting some deep pockets?
Good article about LABS/MEDIF on SA: https://seekingalpha.com/article/4267077-medipharm-labs-now-working-cronos-undervalued
The company just lined its coffers with $75MM in cash at a price that is 25% from all-time highs, but 300% higher than the share price 6 months ago, higher even than the share price was just one month ago.
Not disappointing at all, for true shareholders, IMO. Especially when you read what they intend to use the funds for...
Management is executing beautifully.
Thanks. And there is this presentation from November which is worth a watch.
https://www.dropbox.com/s/m04d0wrj3vi983h/06%20-%201145%20-%20Matthew%20Jones.mov?dl=0&m
OK, I must have missed this. If they manage to announce this in the next 30 days, it's a really strong sign of them being able to meet or exceed on every milestone. CEO also hinted a potential large up-front cash deal being possible soon (don't recall if timeframes were implied) which would show further confidence from a customer in the value of the platform, since cash shows confidence more than royalty fees or equity in a JV.
Still shaking my head about this one.. so much potential with so little risk.
I'm not expecting this to be announced before the fourth quarter of 2019. If it comes sooner IMO it's a really great sign of how adaptable this platform really is and how adept the team is at engineering it.. which speaks volumes to its potential.
If they humanize C1 and demonstrate expressing nivolumab at higher rates and lower costs, then we'd have a true "back up the truck" situation on our hands.
I loved their last conf call and presentation. It's worth a listen for anyone considering taking a position here.
Today's market cap is just over $120MM (fully diluted). I think their C1 platform can be used to build a royalty monster over time, easily into the hundreds of millions $ annually. If they manage to humanize it, then it would easily be with $2bn to a big pharma, more if you include the NPV value of any royalty deals already locked-in.
The CEO is clearly not against playing the long game, and frequently mentions that he's already gifted equity to his children. He also seems to genuinely want C1 to be used to solve global human health problems. It seems to me that this would be best served by licensing one offs and waiting for royalties to ramp, rather than selling the IP to pad the bottom line of a single BP.
I'm kinda torn, as cherry-picking genes for one-off licensing deals could reap massive rewards long-term, but it could take 5-10 years or more to hit full speed. Whereas if BP just wrote them a check to lock out the competition, it could be very soon (within a couple of years?) and would be a big payday for shareholders.
My investment strategy right now:
Step 1: take core positions in LABS/MEDIF and DYAI (done)
Step 2: let LABS go parabolic (in-progress)
Step 3: move profits into DYAI
Step 4: wait...
Not sure I've ever seen an analyst report projecting revenue TEN years out. Is there a copy floating around somewhere?
The CEO did mention that the Alphazyme collaboration wouldn't see any commercialization of products until 2020 and that this was sooner than the other new deals (Serum 2021/2022, as they're all for new products, and Luina same timeframe).
Nevertheless, he hinted strongly at some major deals that would bring significant up-front cash, and even implied that the Serum deal was like a shot across the bow of Big Pharma that they have a killer platform and if BP doesn't start paying attention .. they'll lose out on the chance to license or even own the C1 tech.
Tremendous Q.
Do we know approximately what % of their current capacity (150k kg dried cannabis) they are operating at? Seems to me this is only about a quarter of what they could do at full tilt, and that's going to nearly double in Barrie alone.
Fantastic focus and pedigree at LABS. Congratulations to all shareholders.
I did, and I agree.
The CEO implies somebody could very much want to buy them outright, and soon, but what will his price be? $500MM? $2bn? It surely seems like it could be worth at least that, depending on the suitor.
Strong move up happening, but not on strong volume. Once revenue ramp starts and they're reporting it, this stock should see super strong gains.
Strong move today, but still really light volume. This company is still completely unknown. A few more deals with reputable pharmas and/or an increase in milestone revenue should help get them noticed.
Details (with redactions) of the agreement with Serum have been filed: https://www.sec.gov/Archives/edgar/data/1213809/000121380919000027/a101serumresearchandcommer.htm
Serum generates over $600MM in worldwide revenue, with GMP facilities across Europe.
Again Dyadic appears to have the partner foot the bill for the R&D and clinical trials, and pay out royalties if/when commercialized. Such a great business model. And they only signed away 12 specific compounds.. there are surely hundreds if not thousands they could have similar deals for.
Transcript available on SA: https://seekingalpha.com/article/4261757-resonant-inc-resn-ceo-george-holmes-q1-2019-results-earnings-call-transcript?part=single
Skip the prepared remarks and go to the "Question-and-Answer Session"
I've been long-term bullish on RESN for over 4 years, but I'm feel better today about the investment that at any point in the past. I think we're done languishing under $5 where we've been for most of the past 4 years.
Pre-market doesn't look kind, .. if it drops much more from here I'll be adding.
Whoa.. on the call just now.. they said customers shipped 800k units in Q1 (revenue was a paltry $134k), but they expect "millions" in Q2 and "tens of millions" in Q3. That would translate to $15-30MM in annualized revenue.
They also described their XBar as "the cat's meow" of the 5G chips, offering double the next best chip's bandwidth.
The management team has never sounded more bullish (and I've been listening to these calls for a few years now).
Has Resonant finally turned a corner? Are they really on the path to a $100MM++ revenue company that they always claimed they can be? Is this a $1bn company in the making, or a $5bn one a few years further out?
From Serum's own website:
65% of children in the world have had at least 1 vaccine manufactured by Serum
Serum vaccines are used in over 170 countries
India's #1 biotech company
World's largest vaccine manufacturer (by # doses)
More news: Dyadic and Serum Institute of India to Develop and Manufacture Globally Affordable and Accessible Antibody Products and Vaccines
(emphasis added by me)
PUNE, INDIA and JUPITER, FL / ACCESSWIRE / May 8, 2019 / Dyadic International, Inc. (''Dyadic'') (NASDAQ: DYAI), a global biotechnology company focused on further improving and applying its proprietary C1 gene expression platform to speed up the development, lower production costs and improve the performance of biologic vaccines, drugs and other biologic products, at flexible commercial scales, is pleased to announce a research and commercialization collaboration with Serum Institute of India Pvt., Ltd (''Serum''), one of the world's largest vaccine manufacturers, to develop and manufacture up to twelve antibodies and vaccines using Dyadic's C1 gene expression platform. This important collaboration is focused on making biologic vaccines & drugs accessible and more affordable to patients worldwide while lowering the financial burden on the global healthcare system.
Under the terms of this collaboration, Serum anticipates applying Dyadic's C1 technology to express up to twelve proteins - 8 MABs and 4 rVaccines and will undertake commercially best efforts to fully develop and commercialize the proteins expressed from Dyadic's C1 technology. Dyadic has agreed to grant Serum the option to obtain an exclusive commercial sublicense for each of the twelve (12) proteins in return for certain research funding, milestone payments and royalties for 15 years from the date of the first commercial sale.
''We are very excited to collaborate with Serum as our philosophies are directly aligned. Our goal is to offer our C1 gene expression platform to biotech and pharmaceutical companies as well as renowned institutes and governmental agencies that are committed to reducing the cost of healthcare and saving lives. Serum is a Worldwide leading vaccine and drug development institution and we are excited by the science and results we believe we can achieve together,'' said Mark Emalfarb, Dyadic's CEO.
''Serum has a proven track record of more than 50 years of developing and delivering affordable vaccines and drugs globally and we are eager to incorporate Dyadic's industrially proven C1 gene expression platform into our antibody and vaccine development and manufacturing programs,'' said Adar Poonawalla, CEO, Serum Institute of India. He further stated that ''In recent years, monoclonal antibodies have emerged as preferred therapeutic candidates for the treatment of a multitude of disorders and diseases. These include a broad range of cancers, auto-immune diseases, microbial infections. Traditionally, antibody treatment is extremely costly and not widely affordable in the developed and developing worlds. We at Serum are committed to finding ways to speed the development, lower the cost and improve the performance of high quality, affordable antibodies and vaccines which have the potential to treat and prevent various diseases in India and across the globe. Dyadic's C1 gene expression platform has the potential to help us deliver on our commitment to bring down the cost of biologics in order to make them more accessible and affordable to patients globally.''
''This collaboration will further demonstrate the potential of C1 to become a platform of choice for manufacturing protein-based biologics and vaccines because of its speed of development and low cost of goods,'' said Matthew Jones, Dyadic's CCO.
Alphazyme was founded only a few months ago, is based in the same town (Jupiter, FL) as Dyadic, and one of the founders is a former Dyadic employee. That said, their management team has an impressive background. Fishy, or a great way to use other people's money to swing for the fences?
This company is setting up very nicely. NDA submitted for a drug that soared through its clinical trials, has no tolerability issues, and is addressing a $1.4bn market (US only). Manufacturing plans (GMP soure in Europe) are done, stability tests proven, production capacity being increased in anticipation of a Q4 FDA approval. All that's left is to actually be successful at selling the drug. And from their answer on the call this morning about the challenges there, they are very confident the GI sector will welcome it.
Seems like a lot of ducks are now in a row for RedHill. The risks are largely behind them.. now it's just about approval and commercial traction and they seem to have a solid plan for marketing and sales. A partner ex-USA would be a nice thing to add in the run-up to approval later this year.
Key Highlights and Upcoming Milestones:
NDA submitted to the FDA for Talicia® for H. pylori infection, with potential U.S. commercial launch in Q4/2019, assuming FDA approval
FDA meeting planned for H2/2019 to discuss design of confirmatory Phase 3 study and path to potential approval for RHB-104 for Crohn’s disease
Initiation of pivotal Phase 3 study expected in H2/2019 with RHB-204 for first-line treatment of pulmonary nontuberculous mycobacteria (NTM) infections
Net revenues of $1.7 million, an increase of 28% over previous quarter
Debt-free balance sheet with $45.5 million in cash as of March 31, 2019, with quarterly cash burn at its lowest in two years
NEWS: Talicia NDA filed!
7 May, 2019
TEL-AVIV, Israel and RALEIGH, N.C., May 7, 2019 -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on gastrointestinal diseases, today announced that, following a positive pre-NDA meeting held recently with the U.S. Food and Drug Administration (FDA), it has submitted a New Drug Application (NDA) to the FDA for Talicia® (RHB-105)1 for the treatment of H. pylori infection.
The NDA was submitted under the 505(b)(2) regulatory pathway. Talicia was granted Qualified Infectious Disease Product (QIDP) designation by the FDA and is eligible for six-month priority review of the NDA. If approved, Talicia will receive an additional five years of U.S. market exclusivity on top of the standard exclusivity period, for a total of eight years of market exclusivity. Talicia is also covered by U.S. patents which extend patent protection until at least 2034, with additional patents and applications pending in various territories worldwide.
Gilead Raday, RedHill’s chief operating officer, stated: "The NDA submission for Talicia is a transformative milestone for RedHill and a critical step in our efforts to bring this much needed potential new therapy for H. pylori infection to the market. Assuming FDA approval, commercial launch is planned for the fourth quarter of 2019 with our established U.S. sales force, led by a highly experienced commercial management team.”
The NDA for Talicia is supported by a clinical package including two positive Phase 3 studies in the U.S., along with two pharmacokinetic studies evaluating food effects and the comparative bioavailability of Talicia. The first Phase 3 study with Talicia (ERADICATE Hp) successfully met its primary endpoint of superiority over historical standard-of-care eradication rate of 70%, demonstrating 89.4% efficacy in eradicating H. pylori infection with Talicia (p<0.001). The confirmatory Phase 3 study (ERADICATE Hp2) also met its primary endpoint, demonstrating 84% eradication of H. pylori infection with Talicia vs. 58% in the active comparator arm (p<0.0001). Moreover, 90% of subjects with confirmed blood levels of Talicia’s actives on day 13 of treatment (an indicator of compliance) achieved confirmed eradication of H. pylori. Importantly, low rates of eradication were obtained in patients treated with physician-directed standard-of-care therapies in the open-label parts of these studies (63% and 53%, respectively). These results are consistent with the literature describing the diminished efficacy of standard-of-care therapies. RedHill plans to share the ERADICATE Hp2 data in greater detail at upcoming scientific conferences and publications.
Ira Kalfus, M.D., RedHill’s medical director, said: “Talicia demonstrated robust results in its clinical studies for H. pylori infection, a common and increasingly resistant and difficult to treat pathogen. Importantly, in our clinical study, no H. pylori resistance to rifabutin, one of the key ingredients in Talicia, was identified pre and post treatment. We believe Talicia has the potential to become the new first-line, standard-of-care therapy for H. pylori infection and would like to thank the patients, investigators and clinical support staff who were involved in the clinical studies of this important potential new therapy.”
RedHill continues to implement its U.S. commercialization strategy in anticipation of the potential launch of Talicia with its dedicated sales force. As part of the ongoing preparations for the potential launch, RedHill continues to strengthen its commercial management team with additional senior industry executives. The Company’s sales and marketing teams currently promote several commercial GI products to gastroenterologists, other high-prescribing specialists and primary care physicians across select U.S. territories.
Talicia is a novel, patent-protected and proprietary fixed-dose, all-in-one oral capsule for the treatment of H. pylori infection. Talicia is addressing the increasing resistance of H. pylori bacteria to the antibiotics commonly used in current standard-of-care therapies and the imperative need for new treatments, as defined by the World Health Organization (WHO)2.
It is estimated that H. pylori infection affects over 50% of the population worldwide3 and approximately 35% of the U.S. population4, with an estimated 2.5 million patients treated annually in the U.S.5 H. pylori, classified as a group I carcinogen, is the strongest risk factor for the development of gastric cancer3 and a major risk factor for development of peptic ulcer disease6. The 2018 potential market for H. pylori eradication therapies was estimated at approximately $4.8 billion worldwide and $1.4 billion in the U.S.7
These last two deals fit the narrative the CEO has maintained for a while now.. planting grains of sand into many oysters. They don't need cash at all, so if the long-term value of an equity stake is better than an up-front cash payment, it makes sense to take equity. Hard to say when any of these deals may bear fruit, but I really like that this company looks so long-term. It fits my investment profile too.. which is buy & hold for multiple years.