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just to be clear
I think Nemus has a monopoly when thinking about cannabinoid drug development. They stop doing pumps a Long time ago and they possess is the Real deal
It takes Courage but I like the jockeys and will get all my questions answered,.
I took a quick look and didn't see anything either, so I guess they were paid. Atypical, but doesn't surprise me.
No advisors have equity AFAIK
Never announced in PR or SEC filing
What costs? Advisers usually are paid in equity that vests, not cash.
NB1222 isn't technically the lead candidate.
Maybe they couldn't afford the costs involved on retaining their services. Both of these hires were done when Hollister was there.
Also doesn't make sense with them transitioning to NB1222 lead
Robert Weinreb was removed from Nemus' site sometime between July 2016 and February 2017. Judy Gordon was also removed from Nemus' site in February/March 2017.
JUDY GORDON, D.V.M.
SCIENTIFIC ADVISOR OPHTHALMOLOGY REGULATORY SPECIALIST
Pre-eminent regulatory specialist with internationally recognized expertise in regulatory filings at FDA/EMA for NCE’s for use in the ophthalmology space.
from her own company ClinReg Consulting Services' website:
"Judy F. Gordon, DVM, founder and president of ClinReg Consulting Services, has over 20 years progressive clinical, regulatory, quality and R&D experience in the pharmaceutical and medical device industry. She has worked to gain FDA approval for multiple PMAs for Class III devices, and has made many presentations to Advisory Committees. She has also directed clinical trials of biologics, pharmaceuticals, and Class I, II and III medical devices, from protocol development through clinical reporting to FDA.
Furthermore, Dr. Gordon has served as the industry representative to Medical Devices Dispute Resolution Advisory Panel to FDA and the Ophthalmic Devices Advisory Panel to FDA."
They don't do fake news
Or news for the sake of news
Last time they went this long without a PR, it was announcing the raise
They are working on it I would imagine
Those are questions only Nemus could answer.
Why did Dr. Weinreb leave Nemus?
He appears in the PR until late 2015. Was supposed to head up a 'opthamology' board...
PR in 2016 said they had planned FDA pre-NDA meetings about NB1111. Did those happen? How often has Nemus met with the FDA?
With this low pps and share count, in time this will do well.
It is new.
Because it discusses ZYNE recent failed read outs of ZYN002. Murphy takes the high road as well, considering what Vinpat had said about the company believing ZYNE would run into trouble with transdermal patches.
“Despite the failure, Zynerba should be commended for advancing the synthetic manufacturing of cannabinoids and also coming up with a novel way of getting the drug into the body, bypassing the liver, attempting to do it transdermally,” he added. “They will probably have to go back and reengineer the product. So we’ll have to wait and see what happens. But I think Zynerba should be commended anyways.”
It will be an interesting finish to the year for sure for NMUS regarding the financing and whether they file an IND (or two) before the page turns on 2017....
NEW ARTICLE:
https://www.benzinga.com/analyst-ratings/analyst-color/17/09/10002943/nemus-bioscience-ceo-talks-waves-of-dominance-in-the-ca
I dont see anything relatively new or exciting here, nor does it really say if this interview is new with Murphy or just re-hashed from the previous Benzinga interview. Maybe the pot will start to stir.
Nemus Bioscience CEO Talks 'Waves Of Dominance' In The Cannabis Therapeutics Industry
https://www.benzinga.com/analyst-ratings/analyst-color/17/09/10002943/nemus-bioscience-ceo-talks-waves-of-dominance-in-the-ca
Can always count it on the crooks to bring it down. Theyve been working extra hard the last couple of weeks!
You too. Thank you.
Thank you! Have a good weekend, I guess we will find out soon.
Regards
I have no clue why unless there's some article we don't know about,
I came to say the same thing. The volume today is great. Looks like someone is loading up!!
Some serious interest today???
Regards
My understanding is the agreements were similar to other deals in the sector. Skibinski's background is in biotech and he helped structure it. The relationship is solid and the agreements have flexibility. The university had been repeatedly approached for partnerships and they chose this group which should tell you something.
They're very tight lipped and by the book so information on financing or other developments are never disclosed. But, I haven't heard they are trying to raise money from other sources so I think the deal will get done.
Vinpat, while your here
The licensing agreements. The 60/40 split on revenue from potential sublicense fees, and the 5.5% Net fees royalty to UM, how does that compare to other deals between private/public entities? I have nothing to reference it to.
If a company just wanted to pay a bunch of cash, and no royalty, would UM be flexible if the money was right? Basically, and the agreements there to just protect both parties IP/investment or are they Strict agreements
Any financing rumours....?
Hope all is well
Man you're good. Skibinski is brilliant and has more intergrity than any man I've ever known. He was an assistant coach to Bobby Knight 40 years ago and wrote a book with him a few years back. Skibinski and Lapham were instrumental in getting the licensing agreements with the university. He would have stayed on with Nemus but SnapMD is his baby. He's raised much more than $3 million for it and I think they have the best model and technology in telemedicine. He'll end up selling it for a lot of money in the next year or two and his investors, who shall remain nameless, will be very happy.
Both of them picked the current executive team and stepped into the background to do other things.
I finnaly found some info about one of Nemus founder(s)
Skibinski, who has just under 5% of the common stock, is running SnapMD (cloud based telemedicine technology allows for more efficient interaction between healthcare providers and patients) They just raised a few million and seem Not scam like.
Lapham, who is the biggest individual holder (and has never sold a share)...well....I found more than I bargained for
From-DollarsOnPennies - 08/29/17 01:39:39 AM
$NMUS - NEMUS Bioscience, Inc. is a biopharmaceutical company focused on the discovery, development, and commercialization of cannabis-based therapeutics for global markets with significant unmet medical needs. Utilizing certain proprietary technology licensed from the University of Mississippi, NEMUS is working to develop novel ways to deliver cannabis-based drugs for specific indications, with the aim of optimizing the clinical effects of such drugs, while limiting the potential adverse events. NEMUS's strategy is not limited to the sole use of either natural or synthetic inputs. (Chart)-http://investorshub.advfn.com/boards/read_msg.aspx?message_id=134209118&utm_source=dlvr.it&utm_medium=twitter
The financing was set to close July 10th.
Schneider (financier) was given a 90 day extension. So were about halfway to the deadline, the company has not provided any guidance either way.
A few days after the 10th, Nemus also exercised the guaranty from entity tied to Schneider for the 20m.
Late September- early October we will know whether the deal is dead or not.
Regardless, should be able to complete a raise to file the INDs and start clinical trials in one of their candidates during first half of 2018
Thanks. Any guesses to when that will be?
The series e financing delay
Is what has caused the downward pressure of the SP. And that it is tough to be a unknown and trading on the OTC
Once the Money has been figured out, a timeline should start to become firm for a IND for NB1222 and/or NB1111. Also, whether or not FDA will grant 502b pathway to NB1222 or not.
FDA saying they are going to remove red tape and become more open minded should help too.
Been holding for a year. This is my first time checking the stock in about four months. Can anyone give me a quick updated on what's happening?
Why is this so low?
Anything coming on the horizon?
Well the good thing about August ending is that we're 2/3 through 3Q and 48 days through the financing 90 day extension. Which means we're as close as we've ever been and the IND for NB1222 is hopefully 60 days away. Murphys "3Q or 4Q" timeline will defintiely now be 4Q but we can almost taste it!
$5 is unrealistic, but I would love to be proved wrong.
I dont think anybody expects the $20 mill injection to get to approval stage, nor should it even be discussed. All it needs to do is get us to higher valuations for another moderate raise that brings us to Phase 3 trials.
The 502(b) filing for NB1222 is infinitely less costly than a normal NDA process, and they've directed much of their focus to this. Once they get past the first Phase 2 trials, the market cap will undoubtedly allow for a another large raise that doesnt dilute to heavy.
In a perfect world, share price gets to 5+ in 2018 then, raise another 100 million for 20,000,000 shares, giving us capital for other indications and completion of Phase 3 for CINV. At that point we'll have enough champagne to pass around from the share price increase : )
Trial of Cannabidiol for Drug-Resistant Seizures in the Dravet Syndrome
http://www.nejm.org/doi/full/10.1056/NEJMc1708349#t=article
$20mm isn't that much. G&A costs are $2mm ytd, and those will increase as they move forward. Filing an NDA is around $2mm as well. It won't be enough to approve NB1222, enough to get started on two indications though.
"How can you say that there is no data showing the improved pharmacokinetics of the THC-VHS prodrug (NB1222)?
http://www.sciencedirect.com/science/article/pii/009130579390194X
http://europepmc.org/abstract/med/8897084 "
Those links are 20+ years old. Where on their website?
So the current patent is already ~9 years old?
"I'm not sure what the formulation would be with a transmucosal patch. I guess it would depend on what indication it is. But seems like down the list of things considering NB1222 (suppository) and NB1111 (eye drops-->contact lense) "
They've already said the transmucosal patch would be for CINV/CIPN. For those indications, a transmucosal patch is really all I care about.
"'wouldn't the absorption as a suppository be too quick?' No, see the above research. I think NMUS is in the proccess of answering your question. NMUS will prove it on the field anyway. You can say whatever you want, but the scoreboard doesn't lie."
I said if they used the prodrug that Elsohly developed for the transmucosal patch, which could be THC-VHS. If Elsohly said the previous prodrug's (from the suppository) absorption was too slow in a buccal patch, then it's perfectly reasonable to question whether the buccal compound would be too quick if used in a suppository. If it's a different prodrug altogether then that means a lot more time and money.
Nemus can prove it now, they would have already conducted in vivo studies. So why haven't they?
Aug. 18 issue of BioWorld.--- Can cannabinoids earn respect? New candidates not just blowing smoke! Companies such as GW Pharmaceuticals plc and Insys Therapeutics Inc. continue to use the native tetrahydrocannabinol (THC) molecule formulated for oral administration, observed Brian Murphy, CEO and chief medical officer of Nemus Bioscience Inc., of Costa Mesa, Calif. In contrast, "companies like Zynerba [Pharmaceuticals] and Nemus are developing bioengineered cannabinoids for a more optimized route of administration in a more effective manner, so that blood levels associated with that administration stay more reliably within the therapeutic window."
Oral administration also requires developers of cannabinoid therapies to contend with a drug's metabolism in the liver, where miscalculation in dosing or in drug-drug or food-drug interactions could lead to inter- and/or intra-patient variation, he added. Using synthetic manufacturing, Nemus is addressing those issues to ensure reliable pharmacokinetics and bioavailability. http://www.bioworld.com/content/can-cannabinoids-earn-respect-new-candidates-not-just-blowing-smoke
Is Marijuana’s “Entourage Effect” Scientifically Valid?
https://www.scientificamerican.com/article/some-of-the-parts-is-marijuana-rsquo-s-ldquo-entourage-effect-rdquo-scientifically-valid/
I saw someone bragging in a SeekingAlpha comments section about GW and the 'entourage effect'.
Let me tell you that is very Fake news! Believe me.
Also some interesting comments about Syndros and Sativex.
I like Where I am at on the racetrack
Are you one of those Ban the Fed guys?
I'm not a macro guy. But 20 million is still 20 million. NMUS has been spending about a one million on research and licenses, so 20 would go a long way. [t][/t]
With that 20m, they could do different things. All of those involve one of their candidates completing a Phase 2 trial in 2018.
Before Zynerba's readouts, the Street was giving them a 250m market cap with 60ish million cash. Imagine what they would of been valued at with Positive results!
I don't know where along the development path Nemus will find a partner for one of their indications, if at all. However, the further Nemus goes down the road of approval with a drug(s), the market will price in a % of potential revenues from the drug(s). If required, I think future financings will be done at a higher valuation and be less dilutive than in the past than the most recent one.
If the most recent financing was to fall though and not complete, I think NMUS will be able to raise capital to continue operations and research. Since the company has completed previous raises diligently, and I would assume do the same in the future. One of the many advantages of owning shares in a company run by Good operators. 5-10m gets them into Phase 2 with something IMO.
Even though People got burned with ZYNE, the interest is there for the space and the Scoreboard won't lie.
You are right that ElSohly and UM were involved with another pharma about something that sounds similar to NB1222 and it didn't go through. I remember an article was posted awhile back. I don't think enough information is available to be able to form a strong opinion about why things never moved forward. It was a long time ago too. Post anything you have about it.
How can you say that there is no data showing the improved pharmacokinetics of the THC-VHS prodrug (NB1222)?
http://www.sciencedirect.com/science/article/pii/009130579390194X
http://europepmc.org/abstract/med/8897084
There is some on the NMUS website too.
The current patent is here: https://www.google.com/patents/US8809261
I'm not sure what the formulation would be with a transmucosal patch. I guess it would depend on what indication it is. But seems like down the list of things considering NB1222 (suppository) and NB1111 (eye drops-->contact lense)
'wouldn't the absorption as a suppository be too quick?' No, see the above research. I think NMUS is in the proccess of answering your question. NMUS will prove it on the field anyway. You can say whatever you want, but the scoreboard doesn't lie.
Generally true, though NB1222 will still be expensive even using the 505b2 pathway. $20mm won't go that far, and there are also g&a/research costs. The earlier they license the less it will cost Nemus, the tradeoff is a lower royalty. My concerns are efficacy and marketability. We know Elsohly developed a prodrug suppository years ago that was never successfully licensed. That patent expired, and we still don't know the pharmacokinetics of the THC-VHS prodrug, it may or may not be better. Elsohly mentioned that the transmucosal patch he developed (to treat glaucoma as well as cinv) initially used the suppository prodrug, but the absorption was too slow so it had to be reformulated. Will the transmucosal patch use THC-VHS? If so, wouldn't the absorption as a suppository be too quick? There are questions Nemus needs to address.
NB1222 won't add value if they can't find a partner, which is why dilution is important to consider.
Thanks, Anton.
Wouldn't get beat up about it. Partnerships for early trials are less likely and less important because theyre smaller sample sizes and are testing for safety primarily, and they cost a fraction of the price.
Broad Phase 3 trials (and can be multiple phase 3 designed differently) are where you start to hit the 100-200+ million mark for completion, which is where a partnership would be critical.
Nauseating at the moment, yes, but this is biotech to the T.
-----------
Take a gander at the 5-year chart for Aurinia Pharma. Totally different market with Lupus but you have a dead "downtrend" for 3 years while conducting trials and then a 5-bagger in 2 months on succesful Phase 2. Now they are the crown jewel of clinical-stage biotech.
You saw the hype with $ZYNE. They blew through a $350 mill market cap on hype leading up to Phase 2 trial results. It'll come.
You ask tough questions CJ
I have always enjoyed that, you have made me Sharper
You're right, biotech is a capital intensive industry which is one reason many don't make it. Unfortunately Nemus' efforts to attain non-dilutive finacing through partnerships hasn't been successful.
I've debated this stock ad nauseum.
GLTA.
the 'downtrend'
However, what they do realize is a lot of dumb money does use this newest nitch charting or TA (Technical Analysis) to run a stock either up or down. To the MMs this is like taking candy from a baby. Simply they will paint the tape and use whatever tactic to affect the charting bands. Thus the public and dumb money they will have eating out of their hands. Effectively the MMs can show a strong stock growing weak by manipulating the close price in order to generate selling volume, delaying trading time to manipulate trading activities, or even stalling the ask without honoring orders to hold a stock price.
Confessions of an OTC MM
https://www.reddit.com/r/weedstocks/comments/1xydch/market_maker_speaks_out_ways_of_a_market_maker/
Reading charts is beyond my paygrade
GLTFA
Its par for the course in biotech. This raise is neccessary and will propel shares to higher valuations. If Murphy & Co wanted less money for less dilution, they wouldve raised less. This isn't their first rodeo.
In theory, and Vinpat has touched base on this, the team believes there is incredible value behind the science and IP, and therefore its only a matter of time before the market catches fire.
Progressing through Phase 2 trials for both CINP & Glaucoma sucessfully with the 20 million (key word SUCCESSFULLY), would blow the share price over $5 even with 100mill fully diluted, and then they can do another moderate raise to finish trials, or partner (which Murphy has said they prefer do to, cough cough, Allergan + Doug Ingram)
Either way, downtrend is a product of bio company tendencies, not anything that Nemus is doing wrong.
I said basic shares, which right now is around 33.5mm. Series D would add nearly 67mm shares.
My point was that the long term downtrend is important - it's not a result of low liquidity, and as a consequence the dilution is significant.
the Series C guys
have fully converted, no? Maybe they are selling, 100k block today at .253....
Were at 40M fully diluted
and if the financing goes through (Series D) it will mean another 60m shares of common stock if fully converted.
So, not triple. And while that is significant dilution, the EV of the company doesn't change immediately (market cap - cash) and given the position Nemus has worked to get itself in, that Cash will be used to show the efficacy of Two of their drugs in clinical trials. These trials will go Well because Nemus has done their homework.
If your a Long, that means a significant re-rate of the stock price (which is a metric for how much the market values the pipeline) Even with the dilution.
Look at Zynerba, swing and a Miss on their lead candidate but Market Cap - Cash still values the Pipeline at around 20m. That is with a candidate apparently entering Phase 3 after failing Phase 2 trials, and a pre-clinical drug.
I think the score will be much different in a year.
PS = even with the Series D financing, Nemus will have = or less shares outstanding than $CNBX $IMLFF $OWCP which all have bigger market caps than Nemus right now. They have done all their financing's diligently thus far.
Unfortunately the stock has basically been bearish since the beginning. Liquidity is a problem, but the downward pressure can't be ignored. It has lead to a relatively large financing that will triple the number of basic shares.
There's no volume because there are only about 4 million shares in the market that came from the shell company officers who sold in 2015. All the other shares are either controlled by insiders or PIPE investors and they're not going to sell anything until it hits.
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Our lead candidate, THCVHS, a proprietary prodrug of tetrahydrocannabinol (THC), is a topical formulation under development for the treatment of glaucoma and ocular hypertension (OHT).
Previous US government studies in humans discovered that THC was able to reduce intraocular pressure (IOP), which is in part responsible for the crush-like injury to the cells of the optic nerve that can eventually result in blindness. Additional preclinical studies have shown the potential for THC to also provide neuroprotective benefit, which may be especially important to patients with glaucoma who are experiencing disease progression with normal IOP levels.
One of the major drawbacks of previous studies of the use of THC for glaucoma was that they relied on inhalation or ingestion of THC. These systemic routes of drug administration cause negative side effects like psychotropic effects and potentially decreasing blood pressure , which resulted in the American Academy of Opthamology determining that the adverse effects of systemic cannabis administration/consumption outweighed its therapeutic benefit.
At Skye Bioscience, we chemically modify THC to create a unique synthetic molecule with the intent to safely realize the known positive effects of THC. Our molecule enables enhanced local delivery in the eye, reduced systemic side effects, and the potential for neuroprotection for the treatment of ocular diseases.
Glaucoma is a group of eye diseases that can cause vision loss and blindness by damaging a nerve in the back of the eye called the optic nerve. Damage to the optic nerve is caused by increased intraocular pressure (IOP) due to improper drainage and/or overproduction of fluid in the eye.
According to the American Academy of Ophthalmology, glaucoma affects over 75million people worldwide and is the leading cause of blindness in adults aged 60 and older.
Current therapies can lower IOP but progressive tolerance requires switching or combining drugs. They do NOT provide neuroprotective capabilities.
In preclinical studies, Skye’s THCVHS demonstrated the potential to significantly reduce intraocular pressure (IOP) – exceeding the capabilities of leading commercialized drugs in the current glaucoma market.
Additionally, it has been demonstrated:
We develop novel and proprietary classes of synthetic molecules through the modification of naturally derived systems.
Shifting the solutions paradigm on a effective treatment of diseases through the development of novel neuroprotective solutions.
Science First
The foundation of Skye Bioscience.
Revolutionary Solutions
Solving unmet needs of diseases with limited treatment offerings.
Product-led
Commercial differentiated applications to provide therapeutic benefits.
Impact driven
Change makers. Platform solutions that can extend beyond a single disease.
Mr. Dhillon was the co-founder, CEO, and director of OncoSec Medical Inc., a leading biopharmaceutical company developing cancer immunotherapies for the treatment of solid tumors.
Mr. Diep brings more than 15 years of scientific and clinical research experience to Skye Bioscience. Prior to joining Skye, Mr. Diep was at Protox Therapeutics Inc.
Richard has more than 30 years of business experience and served as a Vice President to CFO on multiple companies in a wide range of industries both public and private, domestic and international.
Mr. Kim serves as the General Counsel and Director of IP at Emerald Bioscience. He is an experienced biotech executive and corporate attorney, and a registered patent attorney.
Karam Takhar serves as Vice President, Corporate Development & Investor Relations at Skye Bioscience Inc. Prior to joining Skye, Mr. Takhar was at Emerald Health Sciences.
Mr. Dhillon was the co-founder, CEO, and director of OncoSec Medical Inc., a leading biopharmaceutical company developing cancer immunotherapies for the treatment of solid tumors.
Mr. Heppell is the co-founder, President and Director of BC Advantage Funds (VCC) Ltd., a venture fund that invests in and builds technology, life science and clean technology companies.
Dr. Dalesandro is the President of Brecon Pharma Consulting, a full-service biotech consultancy firm focused on identifying and obtaining critical information early in product development.
Dr. Muñoz is a Professor of Immunology in the Department of Cell Biology, Physiology, and Immunology of the University of Córdoba, Spain.
Dr. Pasquale is a Professor of Organic Chemistry, Department of Pharmaceutical Sciences at the University of Eastern Piedmont, Novara, Italy, where his research activities focus on isolation ..
Dr. Goldberg is the Professor and Chair of Ophthalmology and Director of the Spencer Center for Vision Research at the Byers Eye Institute at Stanford University.
Dr. Pasquale is the Professor of Ophthalmology at the Icahn School of Medicine at Mount Sinai in New York City.
Dr. Ritch holds the Shelley and Steven Einhorn Distinguished Chair in Ophthalmology and is Clinical Professor of Ophthalmology at the Mt. Sinai Medical School and Surgeon Director Emeritus.
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