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These couple paragraphs from EA get me real excited about our future!
This agreement with the NRC is a significant milestone on our path to biosynthesize cannabinoids on a commercial scale. Beyond InMed's internal needs for a supply of cannabinoids, we believe that our technology will benefit other pharmaceutical companies that are looking for a commercial partnership or licensing of pharmaceutical grade cannabinoids for their specific R&D purposes as well as other non-pharmaceutical companies with the need for high quality cannabinoids for their products intended for other markets. This could provide InMed with incremental revenue opportunities ahead of our clinical development candidates.
Finally, during the quarter, we signed a master service agreement with an unnamed contract development and manufacturing organization that will be working on the downstream processing and purification processes for our biosynthesis production platform. So with the biosynthesis program, over the next several months, we will be focusing on first completing the technology transfer and fermentation optimization with the National Research Council; and secondly, the anticipated filing of additional provisional patent applications to further protect the commercial potential for this technology
That's awesome Dawgs post made the sticky board! He is very well informed and passionate about InMed! I will tell him! Thanks guys!
You are correct Matilda1! He is very knowledgeable and he really puts into light what Inmed is trying to accomplish!
This post below was posted by a Inmed FB member! Good stuff!
Pour a mug or a glass of your preferred bevvie cause this will take a while to plow through.
My takeaways from the call today is all very positive and a tonne to unpack here and I mean a metric sh**-tonne to unpack.
Lots of blue sky on the horizon and there are a few minor "Whoomps!" and one "Whoomp! There it is!" in there to take notice of.
Biosynthesis:
Started off with the hire of Mike Woudenberg. I think we can thoughtfully consider his background and how the CEO laid it out. 20+ years of experience in biologics manufacturing; has led a team of 50 staff covering manufacturing, R&D and business development for a generic biologics company. This is the resume of someone who has been conducting commercial biosynthesis operations as a general manager. This means that InMed looks to have a strong leader who can take over the whole biosynthesis portfolio and grow it into a revenue-generating asset.
The CEO noted that biosynthesis will supply their own needs as well as represent incremental revenues. That is, enough production of pharmaceutical grade cannabinoids for their own purposes and will have capacity left over to produce cannabinoids for other pharmaceutical companies' research projects, and revenue is expected. Also, sales or licensing deals to a pharmaceutical or OTHER companies are part of the strategy.
The questions on biosynthesis were enlightening.
First, the gist of the question was pretty pointed, but the answer was great. In short, why do we have to do this with NRC and TBA partner when you said you could already do it? The solution was clear but let me summarize with the bigger picture. InMed is confident that they can do this and they already know the methodology for scale-up. However, saying you can do it and proving you have done it are different things. If you are going to do a licensing deal, you will get better terms if there is no more experimentation and when you are following a well-documented process. Also, when you are filing a Clinical Trial Application (CTA for Canada) or Investigative New Drug (IND for FDA), they require a highly detailed report on how the IND compound is manufactured and this is a good segway to INM-750 and clinical trials.
The three steps for biosynthesis scale-up and partners are also more transparent. InMed already has figured out the genetic engineering of the e-coli bug with UBC and no partner needed for scale-up. NRC is focusing on the stage 2 hot tub. I have described this before as an engineering process and not really a science experiment. They know how to do it, but now it's time to prove it at scale and tweak the process to create an exact, documented process for partners to follow.
The unnamed downstream partner is only working on extracting the cannabinoids at volume, and this answered a couple of my own questions on the specifics of what downstream purification actually meant. First, the CEO stated that the manufacture of the cannabinoids is completed in the fermentation stage (NRC) and no more assembly is required.
LET ME REPEAT THAT! No more assembly of the cannabinoids is required after fermentation! For anyone who is still carrying a yeast infection worry, there is another necessary step in the yeast process to put the cannabinoid building block components together before the purification process can start.
Whoomp! There it is! The yeast process is inferior.
Downstream purification is understood, and the unnamed partner is demonstrating or perfecting the documentation on how to do it at scale. The process is known, and we just need to show we can do it at large scale and provide the documentation for future licensing partners.
Why unnamed? The downstream partner is purifying a controlled substance. It may or may not be legal in jurisdictions that the company currently operates so no need to poke the bear before you have to. Considering the current state of sentiment to cannabis, better to just wait for the legalization legislation ... n'est pas?
Clinical Plan.
Everyone's question should be, "Why does this take so long?" The documentation is mountainous, and the attention to detail is a top priority. Also, planning out a clinical experiment requires a lot of experience and insight into describing a good outcome and how you measure it. It's not enough to say it works; you have to quantify how much it works. Also, as noted above, they need to state where the drug comes from, who makes it and how it meets the minimum requirements for quality and GMP certification. In other words, they are writing a really thick book where the whole plot is understood and planned, but the details need to be filled in. Some parts are still under the verification processes but meeting the timeline to get everything done on time.
The CEO noted that they are screening CRO's to choose a company to conduct the clinical trials. In this context, a CRO is a Clinical Research Organization that specializes in doing clinical trials. Almost all small biotech or specialty pharma companies use CRO's because they have the infrastructure in place and employees in every relevant city around the globe to oversee the trials. In other words, InMed doesn't need to hire more people or pay for expensive IT systems.
Long Awaited Question Answered:
In between the lines, we got the answer to what's going on with the French 3D Skin Company ATERA. A lot of people who've been here a while wanted to know about the ATERA experiments. I think we got the answer. They have been testing to see which formulations could safely and effectively penetrate the skin and deliver the right payload of cannabinoids. It sounds like the results are still being tabulated but are as expected and are positive. Even though they know what the outcome will be for these additional invivo experiments, they need to be completed to bolster their CTA/IND applications. It's best to have more facts are supporting the theory.
INM-750 is on course to get to clinical trials, and preclinical experiments are ongoing.
Still Unpacking!
The CEO gave some positive insight into the valuation of the clinical program and the strategies.
INM-750 is on pace, but there is no intention to partner it at this point for a couple of reasons. Firstly, and this is my interpretation, the designated target market for EB is small, accessible and known. As a result, there isn't a need to have a significant distribution partner. This is a very high-value market, but the distribution channel is small enough that a courier or the postal service could handle the complete distribution more effectively than a pharma partner. Also, the product doesn't need to be sold like other therapies so no need for a large sales team. Secondly, a more accurate valuation of INM-750 would become evident in Clinical Phase II. This is where they have completed safety trials and are seeing how well the therapy will work. Careful planning of the clinical trials is vital to ensure you can measure how well it works and the better the accuracy can result in a faster approval process and therefore a better the valuation.
Currently, the company should have enough cash to get INM-750 to phase II and possibly beyond so there is no need to rush to find a partner. For our valuation purposes, doing this alone would mean keeping all the proceeds from sales if they manufacture the cannabinoids themselves.
Also, covered was how INM-750 works. I mentioned this in a post before and to summarize, EB sufferers lack the naturally occurring glue (faulty or inadequate keratins) that keeps the two layers of skin attached, and INM-750 helps to stimulate the keratins to establish the missing bonds normal skin has. New in the description was that one cannabinoid speeds healing, reduces pain, itch and inflammation while the other cannabinoid stimulates the keratin regrowth.
INM-085 and INM-045 for glaucoma and pain are earlier-stage, and the current focus of the cash is to prioritize biosynthesis and INM-750. As a result, they are open to doing a co-development licensing deal for both. Since there is no timeline on a partner for either, it is possible that this could be done soon ... or not ... but there is a reasonable likelihood it will happen.
Last thing to unpack!
The analysts had more questions about the clinical program which means an evolving investment thesis. Esther from Oppenheimer was more interested in the clinical program and the regulatory process. Great news for us because now we can start to get more exposure as to how to evaluate the current INM-750 and the pipeline. Also, it sounds like Esther represents a biotech audience of investors.
During this update, you needed to listen carefully to what is going on. Very little in the way of hype and a lot of substance. This is the type of update that gives more comfort than adrenaline unless you know what you are looking for.
On the whoompiness-scale, I rate this a 7.5 out of 10 because we can transparently argue where we are in the process of commercialization with a high degree of certainty InMed will hit their stated milestones. Overall, I think InMed made a big step in reducing the perceived risk of this investment. Biosynthesis is going to happen. They know what they are doing. Also, they have set out a timeline that can meet our February 20, 2020 party: we could see the completion of phase I and an announcement of the phase II clinical plan. And THAT is when the party begins both figuratively and perhaps literally!
#STMF
Bu by Jeff Sessions!
That would be awesome but I'd be happy if we can just get to $1! And stay there.
I'm feeling really exciting times ahead for Inmed!
Yes definitely, sometimes we have to be reminded about the big picture! Not the daily SP movement. This is going to be very special, I know it's hard but we just need some patience!
A gentleman just posted this on the FB group! It's great!
The Entourage Effect & Levi Strauss
The Entourage Effect is a concept originally presented in the European Journal of Pharmacology by Israeli researchers Shimon Ben-Shabat and Ester Fride in 1998. Their paper discusses that the combination of compounds in cannabis are effective together but not individually. They observed significantly enhanced outcomes caused using multiple cannabinoids and terpenes. Putting this in simple terms, your computer, electricity and internet connection work a lot better if you use them together but separately, not so much.
The most common references discuss the feeling derived by different the concentrations of THC and CBD. In addition to these and over 100 other cannabinoids contained in the various strains, there are concentrations of over 100 terpenes. The terpenes are most noted for their flavour and fragrance but they also seem to have physiological effect as well. Research continues in this area but it appears that they may modulate the interaction between cannabinoids and receptors.
An analogy that everyone can relate to is dinner. Salt, pepper, rosemary and some fresh ground coriander added to your main dish will stimulate multiple receptors in your mouth and nose. In the right dosages, this will create a culinary experience that can be especially pleasing or in the wrong measures, god-awful.
In a real-world example, we all know about GW Pharma and specifically their Sativex spray. But perhaps, what we didn’t know is that it is based on the entourage effect. The chairman Dr. Geoffrey Guy noted that in more than a decade of experiments, they discovered that whole-plant extracts were more effective than trying to isolate the single active components.
Although the entourage effect specifically refers to cannabis extracts, another example of a similar effect is the combination of acetaminophen and ibuprofen. In a National Institute of Health (NIH) study, Maxigesic tablets were more effective in pain relief after oral surgery than taking acetaminophen or ibuprofen alone. In a personal experience, a pharmacist explained to me that they work to reduce inflammation and pain in different ways so they don’t interfere with each other. Cool!
There is a significant amount of research on the medical benefits of the full spectrum use of cannabis understanding the matrix of over 100 cannabinoids and 100 terpenes in various concentrations is impractical. Access to each of these extracts has been limited due to cost but if there is a new technology that can unlock access to them, we could see a whole new industry emerge.
…. you had to know where this discussion was going.
Developing new strains of cannabis plants with different concentrations of cannabinoids and terpenes is a traditional time-honoured and time-consuming process of genetic selection and replanting. Imagine you are the Chief Science Officer for Canopy or Aurora and if you knew that your current strain THC/CBD cannabis would have an amplified efficacy with higher concentrations of specific minor cannabinoids or terpenes. It could take years (if ever) to genetically modify your strain to achieve the desired concentrations. Or you could just add them artificially by purchasing them from on of InMed’s biosynthesis partner.
Likewise, Big Pharma’s profits are teetering on the edge of drugs with expiring patents. Access to new compounds to develop new therapies or enhance current ones is of major importance to future profits. Inevitably, they will invest resources into studying the entourage effect and seek to commercialize new drugs.
The position of power in this new industry will be the companies that can provide access to this vast array of cannabinoids and terpenes. Like Levi Strauss, you don’t have to mine for gold to make huge profits, you can do it by outfitting the gold miners with everything they need to find their gold.
May I propose that denim is the dress code for #02/02/2020?
#STMF
I wonder if this is where deborah of America can help. I'm sure that organization is in contact with a lot of children affected with EB, they can help get children into human trials once we begin!
I was wondering, I thought you were trying to send us some hidden message! Lol.
Right on Matilda1! I seriously think there will be big news coming our way in the near future. IMO there will be one or more partnerships announced! Fingers crossed!
It was a replay, you were totally right Matilda. The guy that posted saw EA was being interviewed last night but didn't check if it was live. Sorry.
You could be right, someone posted it on FB that it was a live interview.
I guess EA had an interview on BNN tonight! I'm pretty sure it's nothing new and exciting but if someone heard it and caught anything he said interesting, please share!
So you're saying at the end of the day, the shareholders will be the ones to get screwed??
I was hoping Harrison would mention Inmed but he didn't. I know he's interested in Inmed because I've seen a few of his tweets! Thanks for the share.
I'm with you Matilda1! The pushback of 750 was very frustrating! I keep telling myself they did it to make sure it is 100% safe for the children that will be in these Clinical Trials. Also waiting for partnership news seems like is taking forever. That said as frustrating the wait is, I couldn't ever forgive myself if I sold this now. (I never would this low) Then a year down the road Inmed delivers massive news that skyrockets this! That would really suck!
Thanks Matilda for explaining !
Matilda, can you please educate me a little? What do you mean by offers being pulled? Thanks!
Nice close today! Maybe some news coming soon!
It means something else is up! I honestly think this is a sector wide correction. It will rebound! Especially once we get that other CMO partner announcement!!! Any time now Inmed???
The potential of this science is mind boggling! Then you throw in their pipeline? If Inmed succeeds with this, we all will be very rich! That alone I give this company a lot more slack! That said 2019 is a very big year! Like Eric Adam's said "Transformational year" I seriously expect huge steps forward next year!
You do the same GW!
Please share 👇 with every doctor / neurologist / patient / politician / person who wants to better understand the efficacious agility of cannabinoid wellness.
— Todd Harrison (@todd_harrison) October 18, 2018
IMO #cannabis biotech about to lead phase two of this secular 🐂 market. @CB1Caphttps://t.co/5tW74MIMZr
I still think we're going to get the other CMO partner announcement sooner than later! IMHO.
I know right? I keep believing but this definitely is testing my patience!
Let's keep our fingers crossed!
Ya, today didn't do much for the confidence but I still believe in this company 100%. Our time will come!
We can speculate all day but I just get a gut feeling something big is on the way!
You're guess is as good as mine. Maybe if it is Lilly, IF? MJ still illegal in Indiana! They want to be unnamed at this time. This all could be wishful thinking but why would Eric come out and say we're working with a 3rd company and not announce it?
I know! In his interview yesterday Eric stated "We are working with another company on the Downstream process!" But you can't name the company? I wonder why? Hmm.
Bring on the news! Longs been waiting Longs enough!!
Eli Lilly (Cough cough)
For all who heard the presentation, what's your thoughts? Maybe downstream CMO announcement with different company coming soon.
Thanks for sharing!!!
Les, can you please clarify Chow's involvement with Inmed? If you happen to know, thanks!
Maybe I misunderstood him and just botched the explanation! If you find something out, please share.
There is a gentleman on the FB page that's knows a ton about inmed, he said that chow had a big part financially that helped Inmed when they were trying to get this business moving. I'm talking when they dropped to like .07 a share. So I think this is a gift. He has nothing to do with Inmed now.