Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Doog- Thanks! Here is the PODRAS statement in company operational update. Lets hope they get these tests done in 1H2018 like it says.
Intellectual Property Portfolio
PODRAS™ Technology
Intellipharmaceutics continues to make progress regarding its PODRAS™ delivery technology, recently obtaining three additional patents from the U.S. Patent and Trademark Office (U.S. Patent Nos. 9700515 and 9700516 in July 2017 and No. 9,801,939 in October 2017) also entitled "Compositions and Methods for Reducing Overdose" and covering aspects of the Company's PODRAS™ delivery technology. The Company is optimistic about the prospects of this technology, which deliberately regulates the bioavailability of active ingredients in both generic and non-generic medications in a way that reduces the opportunity for overdose and/or abuse. The Company is finalizing plans to initiate proof of concept trials in humans. The Company believes that the preclinical work on the technology to date has shown encouraging results, but human trials are required to show that the technology works as expected. The human studies for PODRAS™ are expected to take place in the first half of 2018. Based on the results of these studies, the Company will evaluate commercial opportunities for the technology including potential out-licensing as well as incorporation into products within our pipeline.
Doog- If they ever launched these PODRAS trials the results would be quick. I think it is something like 20-30 test subjects. How long does it take to have someone take an overdose and then monitor their blood and see what their blood levels look like? I am guessing each subject would be under tests for only a couple days. So those tests should take 1-2 months max. Actually, I now think the IPCI board of directors should be used as test subjects for PODRAS tests... LOL... That way if it doesn't work we also solved another problem... LOL!
Agreed Doog- These next 6 months will make or break IPCI and determine if Odidi stays on as CEO. I don't think Armistice and others try to remove him just yet. But I know he is feeling a lot of pressure from many shareholders. And I am guessing his ego is suffering at this point as well.
Blue - welcome to the world of odidi... They have been getting those anda files kicked back to them for years. Many people have been trapped by odidis incompetence over the years. That answers your other question... Most people that know about the company won't buy because of odidi and the games that are played. Except idiots like me...
Tilator- What are the cash value of selling of all the ANDAs? Then compare that to market cap. Because the only thing worth any thing for certain is the ANDAs.
Doog- If they are planning on a RS, would they have to bring that to vote at the annual meeting? Or at least cover the topic?
Fabius- 100% agreed. And lets all remember Odidi has greatly failed in terms of business decisions as well as product market decisions. I am convinced his biggest problem is he does not react to failures or challenges adequately. In regards to China, I am guessing he started to get the ball rolling... But when it comes to finishing the plan and capitalizing on return he just does not follow through... A contract manufacturing agreement with a Chinese company is as EASY AS IT GETS!
Company released document where they now feel they are in compliance with shareholder equity of $2.5M:
As of the date of this report, the Company believes that it has regained compliance for continued Nasdaq listing pursuant to the
alternative stockholders’ equity requirement as provided in Nasdaq Listing Rule 5550(b)(1) after giving effect to the proceeds from the
March Financings, and the associated increase in the Company’s stockholders’ equity. As of the date of this report, the Company believes
its stockholders’ equity is in excess of $2,500,000.
Well said Samsa
Angelo I have speculated the same thing in regards to partnering with a Chinese manufacturer for the generics. The problem I see is Dr odidi never follows through and gets the job done. Let's hope he can in 2018. Just like you my investment is way red and I want that to change.
Blue- Yeah it is kind of ridiculous what they burn when you look at the results. Like I said. Talk, empty promises and nothing but excuses. This is an interview with Odidi from February 2017. Notice how he says he is working on all these applications for PODRAS... But over a year and we have heard nothing of any relevant developments.
https://www.midasletter.com/2017/02/intellipharmaceutics-ceo-dr-issa-odidi-preventing-overdose-death-oxycodone-fentanyl/
And then there are several combination products that are coming for opiates, these are based on our PODRAS technology, the abuse deterrent technology and the overdose technology. And then we are looking at several other once-a-day products with regards to hydromorphone,oxymorphone and hydrocodone. And like I said earlier, there are several more we haven’t made public, and therefore I won’t be able to talk about them.
Life Sciences Membership-Basic Recommended
IntelliPharmaCeutics CEO Dr. Issa Odidi on preventing overdose death from Oxycodone, Fentanyl
— James West
February 23, 2017 27
James West: Dr. Odidi, thank you for joining us today.
Dr. Isa Odidi: Thank you very much for having me, and thanks to all the listeners out there, all those who are looking at this online or through whatever medium. Thanks.
James West: Let’s start with an overview of what is the value proposition for investors in Intellipharmaceutics?
Dr. Isa Odidi: Basically, the value proposition is that we are a company that is growing and we are at an inflection point at this current time; and (we)filed several ANDAs in the United States of which three have been approved, and we’re set to put one of them into the market soon, sometime around May. And I think the big thing happening now is the NDA that we filed for an abuse deterrent oxycodone medication for pain in the United States as a 505(b)(2) filing. I think we are currently awaiting FDA acceptance letter for that particular filing, and that is certainly a big milestone for this company. And of course, we have several other products in the pipeline.
James West: Are these products for pain management, are they opioid based?
Dr. Isa Odidi: Yes, they are opioid-based products and various combination products; particularly we’re looking at exploring the technology which are approved on the two new patents that we recently received. These are technologies to prevent overdose. I feel strongly that that will be a game-changer if we are able to prove that this technology actually works in real practice.
James West: I see. So this would have direct implications for the fentanyl overdose epidemic, I guess?
Dr. Isa Odidi: Most specifically for overdose from taking solid oral dosage opiates, for example, oxycodone, hydromorphone, hydrocodone, morphine, and the like, particularly in situations where you have a combination product of oxycodone and paracetamol, which is basically what’s in Tylenol. Typically, I don’t want to mention trade names, I don’t want to label other companies’ products, but typically there are products on the market that contain oxycodone, say, a low dose of 5 milligrams for example, and also contain paracetamol. People, in trying to get access to the oxycodone, only 5 milligrams, they tend to want to take many of those tablets at one time. The problem is that when they take multiple tablets of that product combination, they are basically taking too much of paracetamol, and this has very serious untoward effects on liver, and they really get hurt.
In such situations, if our technology, the PODRAS,what we call Paradoxical Overdose Resistance Activating System, it is incorporated in such a formulation or such a tablet combination, they won’t be able to feel that impact, because the large dose of paracetamol will not be released at all.
James West: Interesting. So what is the target market size, then, for this kind of a product?
Dr. Isa Odidi: I know people have looked at it including ourselves and with this sort of technology, basically, I wouldn’t even call it a product because it’s applicable to any solid oral dose form; it’s quite a huge market we’re looking at here, not just opiates, but in any situation where overdose becomes an issue, this technology could be used. We are talking in the billions, if the product works.
James West: Sure. Okay, and so for Intellipharmaceutics, how much money have you put into the company to get it to this point of evolution? How much has been invested in the company altogether?
Dr. Isa Odidi: That’s a very good question. I’ve not been doing any back-of-the-envelope math for this, but several millions have gone in. It could be close to $100 million gone into the company, but that is the way it is right now, and that’s little money compared to most other companies. And I think that’s one of the things we take pride in. We’re a very nimble operation, very effective with limited resources.
James West: Great. How did you start this company, and what’s your background?
Dr. Isa Odidi: My background is in pharmacy. I read pharmacy as a first degree, then I did a Masters in pharmaceutical technology at Kent College, University of London. And then I did a PhD in Pharmaceutics at School of Pharmacy, University of London. I have an MBA from Rotman School of Management, University of Toronto, and I’ve been to Harvard to do some other management programs as well.
I started this company after leaving Biovail together with my wife, Dr. Amina Odidi, who herself has similar qualifications. We came to Canada in 1995 to come and help Biovail, which was owned by Eugene Melnyk at the time, to help it become a very strong company. And we did a lot of products at Biovail, a lot of research was done. At the time, I was the Chief Scientific Officer and the Vice-President for Research and Development of New Technologies.
Around ’98, I left Biovail, and then my wife, who had earlier on set up Intellipharmaceutics in 1996 as a consulting company, and then we decided to vertically integrate the company, make it an R&D company and a manufacturing company. So it’s since 1998; it’s been a long time, but this is truly one of the true Canadian companies, it’s Canadian based, and although we are now public on NASDAQ and TSX, we can still lay claim to the fact that this is truly a Canadian company.
James West: Interesting, that’s a great story. Was Biovail the precursor to Valeant?
Dr. Isa Odidi: Yes, it is the precursor to Valeant. A successful company, Biovail. Very proud of the work we did there.
James West: Right. Okay, so what other products do you have in the pipeline at Intellipharmaceutics that might add to the future success?
Dr. Isa Odidi: Okay, we have several, and they have not been made public, so therefore I’m not going to speak about them. But the one that was made public is pregabalin. Pregabalin is used for fibromyalgia and neuropathy. Currently pregabalin is taken as a twice or three times a day product. We’ve come up with a technology platform that will allow you to take this product once a day. Not only that, it also gives better coverage with regards to the exposure of patients to the drug in the sense that, given the dosing regimen that we are applying for this product, if it becomes approved, that’s after doing our first clinical trials, is a product we are trying to dose just at night before going to bed. And we think this helps cover the problem that fibromyalgia patients are talking about, the drug they’re currently taking perhaps is not giving them enough coverage and exposure.
So I think that’s the next big thing, and here we’re targeting a market that is currently over $3 billion.
And then there are several combination products that are coming for opiates, these are based on our PODRAS technology, the abuse deterrent technology and the overdose technology. And then we are looking at several other once-a-day products with regards to hydromorphone,oxymorphone and hydrocodone. And like I said earlier, there are several more we haven’t made public, and therefore I won’t be able to talk about them.
James West: Lineup, I’m impressed. I’ve not heard of your company, but now that I have, we’re going to follow it with interest. I’d like to thank you for your time today.
Dr. Isa Odidi: Thank you very much for giving me the opportunity to speak to you, and your big audience.
James West: You bet. Thank you. Bye-bye.
Dr. Isa Odidi: Bye.
Fabius- Yes, that could be done as well. EASY! It really does beg the question- what have they been doing?
Blue- Exactly... WTF have they been doing. Pay me $500K and I will get all these done by year end. These are not difficult tasks and if Odidi can not do these, he should be fired for sure. Here are the three:
1. Get Rexista HAP studies completed by September 2018.
2. Get first clinical trials of POPDRAS completed by end of Q3 2018.
3. Sign agreement for Chinese contract manufacturing of Generics.
These are not impossible tasks. These are three easy things a good business person could accomplish by just putting in a dedicated 40 hour work week.
blue- Yes now some accountability. Either deliver or you are kicked to the curb. Just the same as everyone else that holds a job. I don't buy everyone saying that Dr. Odidi is the company. He can be replaced just like everyone else. Everyone can be replaced. The market cap of IPCI is lower than it was prior to Focalin approval in 2013. The pipeline is exactly the same as it was in 2013 except for Ranexa and PODRAS. so if they are a development company... How come pretty much no new products in 5 years?
Here is market cap plot that Fabius did:
https://d28lcup14p4e72.cloudfront.net/181487/3810553/image001.jpg
blue- Maybe, but I think it could have been worded differently. Yes, legal mumbo jumbo... But the tone definitely rubs me the wrong... Yeah could just be me but I don't think so. Oh and by the way, part of the problem with IPCI is Odidi needs to have his hands on everything. The man has never heard the word delegate.
And Angelo- I have somewhat changed my opinion on China... Smart Pharma Shanghai is nothing more than a contract manufacturing agreement between Smart Parma (Africa) and Shanghai Yunfeng Pharma... Just more of Odidi thumping his chest and saying see how great I am- when there are ABSOLUTELY NO ASSETS IN SMART PHARMA SHANGHAI. You just watch, at some point he will be selling shares of that nothing company.
Angelo- I will paste below the section I am referring to. With Odidi's track record he should be humbled and eagerly listening to shareholders feedback. The market cap is now lower than pre Focalin approval. which confirms poor management. I see this excerpt below Odidi saying with a disingenuous attitude- "THID IS MY COMPANY AND I WILL RUN IT THE WAY I WANT:
Risks Relating to this Offering
Our management will have broad discretion in allocating the net proceeds of this offering, and may use the proceeds in ways with which
you disagree.
Our management has significant flexibility in applying the net proceeds we expect to receive in this offering. Because the net
proceeds are not required to be allocated to any specific product, investment or transaction, and therefore you cannot determine at this time
the value or propriety of our application of those proceeds, you and other shareholders may not agree with our decisions. In addition, our
use of the proceeds from this offering may not yield a significant return or any return at all for our shareholders. The failure by our
management to apply these funds effectively could have a material adverse effect on our business, results of operations or financial
condition. See “Use of Proceeds” for a further description of how management intends to apply the proceeds from this offering.
Fabius- I agree... New sheriff in town... So Odidi can either produce results or I sense an emergency meeting of BOD willed be called later this year...
Doog, Fabius, Tilator and Others- I think this is how it will play out. I don't think Armistice/others will remove Odidi just yet. I think they will be clear that he has until later this year to produce results on HAP studies, refiling Rexista NDA, PODRAS first human studies, get generic partners/approvals, etc. But they won't allow him any more time than later this year... So it is up to Odidi to produce results in six months. If not, he will be likely removed as CEO.
Fabius - I was really hoping to see Boyd bought more. Lets hope Dr odidi now sees a sense of urgency in getting things done...
I did not care on how the prospectus released today said that management had total discretion on how funds would be allocated... With the current state of ipci affairs I think management should be humbled... But the tone they used showed animosity towards the feedback shareholders have given them.
SCHEDULE 13G
This Schedule 13G (this “Schedule 13G”) is being filed on behalf of Anson Funds Management LP (d/b/a Anson Group), a Texas
limited partnership, Anson Management GP LLC, a Texas limited liability company, Mr. Bruce R. Winson, the principal of Anson Funds
Management LP and Anson Management GP LLC, Anson Advisors Inc. (d/b/a Anson Funds), an Ontario, Canada corporation, Mr. Amin
Nathoo, a director of Anson Advisors Inc., and Mr. Moez Kassam, a director of Anson Advisors Inc., relating to Common shares, no par
value (the “Common Stock”), of Intellipharmaceutics International Inc., a Canadian corporation (the “Issuer”).
This Schedule 13G relates to Common Stock of the Issuer purchased by a private fund to which Anson Funds Management LP and
Anson Advisors Inc. serve as co-investment advisors (the “Fund”). Anson Funds Management LP and Anson Advisors Inc. serve as
co-investment advisors to the Fund and may direct the vote and disposition of the 2,916,666 shares of Common Stock held by the Fund. As
the general partner of Anson Funds Management LP, Anson Management GP LLC may direct the vote and disposition of the 2,916,666
shares of Common Stock held by the Fund. As the principal of Anson Fund Management LP and Anson Management GP LLC,
Mr. Winson may direct the vote and disposition of the 2,916,666 shares of Common Stock held by the Fund. As directors of Anson
Advisors Inc., Mr. Nathoo and Mr. Kassam may each direct the vote and disposition of the 2,916,666 shares of Common Stock held by the
Fund.
One more:
ODIDI + STOCK OFFERING $ = 0
So using algebraic laws:
ODIDI = -(STOCK OFFERING $)
Fabius- I like it... The Odidi Syndrome
A little math humor for you...
TALK + PROMISES + NO PROGRESS + FAILURE + EXCUSES = ODIDI
Chess- 1. They are not manufacturing 12 generics at their facility in Toronto 2. They will never get 6 generic approvals this year.
Thanks for sharing Mike. I am sure the money raised will partially go to pay for these studies.
One more item form Prospectus:
We currently intend to use the net proceeds from this offering for general corporate purposes, which may include working capital,
capital expenditures, research and development, accounts payable and other commercial expenditures. The amounts and timing of our use
of proceeds will vary depending on a number of factors, including the amount of cash generated or used by our operations, and the rate of
growth, if any, of our business. As a result, we will retain broad discretion in the allocation of the net proceeds of this offering.
From Prospectus of latest offering... At least good for a laugh
Risks Relating to this Offering
Our management will have broad discretion in allocating the net proceeds of this offering, and may use the proceeds in ways with which
you disagree.
Our management has significant flexibility in applying the net proceeds we expect to receive in this offering. Because the net
proceeds are not required to be allocated to any specific product, investment or transaction, and therefore you cannot determine at this time
the value or propriety of our application of those proceeds, you and other shareholders may not agree with our decisions. In addition, our
use of the proceeds from this offering may not yield a significant return or any return at all for our shareholders. The failure by our
management to apply these funds effectively could have a material adverse effect on our business, results of operations or financial
condition. See “Use of Proceeds” for a further description of how management intends to apply the proceeds from this offering.
I have identified one more of odidis management failures... He has no idea when to sell shares to the market... Just another failure to add to the already long list...
It is like wainwright called them today and said we got another buyer... And odidi said sell as much as you can... All I can say is Wow...
Tilator- I do not know. But others may have a better idea. I think that this info is published every couple of weeks.
Quote for the day: Intelligence is the ability to adapt to change. Stephen Hawking
tilator- Would the contract manufacturer need to be an FDA approved site? I am guessing yes, but I do not know. So would Shanghai Yunfeng need to be or are they an FDA approved site?
Tilator and all- Question for you. What types of FDA approvals, etc. would be required for IPCI to allow Shanghai Yunfeng to contract manufacture FDA approved generics at their facility?
Doog- Hopefully they will announce starting HAP studies. As I feel this is significant news showing progress.
Numbers- my guess is offering money will be used for :
1. Rexista hap studies - probably about $1-2m.
2. Podras initial human trials - may be $0.25-0.5m.
My guess is since they have fda approved hap protocol, those studies could commence immediately.
My take on the offering is it will be used to pay for Rexista HAP studies and day to day expenses for the next couple of months. My hope is it is enough to fund PODRAS first clinical human trials as well. I also believe Regabatin will not go anywhere until a partner is found. I think I heard at one point the PH3 trials on Regabatin would cost about $10-20M.
Amigo- How do you envision getting CEO out as CEO? Do you think this could happen at anytime soon?
Amigo- I am glad you see this as a positive. As you have been right about many things on this stock in the past. I do remember hearing way back when that some people were asking the company to remove ATM. Well lets hope that was them listening to what people said.
Blue- I really don't know when there will be positive news. Rexista is their #1 product candidate right now. That is why. IPCI feels like there is a big market for Rexista.
blue- exactly... Before they had $3M they could make it to June, now that they got additional $3M they can only make it to June... I guess $3M went pay for HAP studies and PODRAS human clinical trials. Yes, where is all the money going... Notice how they backed off on Regabatin trials starting by year end as well...