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Tell that to otcmarkets.com
Mymetics had nothing to do with whether or not otcmarkets.com correctly dropped them from OTCQB into the Pinks or not. That's out of Mymetics' hands.
not that it matters what I think, but I think you are right -- it closed under .001 only FOUR consecutive days:
https://www.nasdaq.com/market-activity/stocks/mymx/historical
extrinsic55 if you have a lawyer will it be a class action or are you doing it privately ?
In their 8-k they said the stock closed below .001 5 days in a row but that's not true. I was watching it. On the 5th day it closed at .001 or just above. It shouldn't have gone to the pinks.
8K today. Goodbye OTCQB, Hello Pinksheets!
https://www.otcmarkets.com/filing/html?id=17002435&guid=nM5-k6M9NMlPB3h
It's Pink now. I suppose it's been pink all day since they were notified yesterday according to the 8K. I didn't bother checking.
If you have proof, and you have an attorney, then God Speed!
I'll watch for your Class Action. I am a member of the Class so I would join of course, as would anyone who is a member of the Class, unless they want to sue on their own.
You will be able to post on this board forever, basically. Delisting, Expert Market, Caveat Emptor, WHATEVER -- you can still post in ihub. They only close a MB when it's replaced, like by a ticker symbol change.
I can give you dozens of examples but here's two really good ones -- my two favorite biotech scams of all time:
RXPC
KKUR
GetSeriousOK (1) I stand by my claim and have proof. They had inquires. (2) I have an attorney and have had 1 other Class Action Case in my life and Won that action and the Company international(Corporation) ended paying up big. Attorneys take cases as you well no on merit and with no pay other then what they receive from the settlement. There a dime a dozen. But a good attorney is the most important aspect. Seems to me there are 113 possible class action partners or possible more. Will see.
You say "I know for a fact that they have had inquires to buy the company and have not responded to the inquires..." you know this how?
Of course we don't know whether they have a secret buyer and are illegally withholding this information from shareholders. That wasn't my point. My point in responding specifically to YOUR post is that Toys 'R' Us was bought out and THEN taken private, which means those common shareholders got their money before the company went private. MYMX is going private without common shareholders getting paid off first. BIG DIFFERENCE.
If one believes that the company currently has a secret undisclosed buyer, it seems contradictive to also believe that Unregistered Shareholders and non-insiders will be treated fairly after the company goes private. I believe that anyone who is NOT an insider and NOT a Registered Shareholder is going to get ghosted, IMO, and would have a very difficult time getting company information and/or selling their private stock.
And good luck finding a lawyer to take this case. Where would you sue -- in Switzerland? In the USA? And you'd have to produce a smoking gun -- proof that they had a buyer before they went private -- which seems unlikely.
But, you obviously know more than I. Again, you stated "I know for a fact that they have had inquires to buy the company and have not responded to the inquires..." how do you know this?
They changed https://www.mymetics.com/about/.
There is no "COMPANY OVERVIEW" anymore and Fleury, Stegmann, Plotkin and Ruprecht were removed.
Phosphene I also have tried to contact management and kempers on several occasions in the past 8 months with no response.
I don't know how these jokers sleep at night.
I'm not sure why Gerry Gensler and The SEC hasn't stepped in and shut this turd down.
Lawsuits will expose them for what they are.
In addition to recent long time BOD member jumping ship while the company's in financial duress. SEC frowns upon that also.
Company sale is all fugazi.
Where's ANY of the work results from Sanofi, eTheRNA, IO Biotech, Baylor etc.?
These opossum taint's suffocated news for years while dirty NIH money continued to pay their salaries as they enriched themselves from the insiders.
I've never even received a simple email reply from them EVER.
Commons thrown under the bus while parasites feed off carcass remains.
No winner's is an understatement.
GetSeriousOK how do we know they don't have a buyer. First off I know for a fact that they have had inquires to buy the company and have not responded to the inquires. So sounds to me like they may have a buyer and are not coming forth with the information. Good reason for a lawsuit right from the start. Kemper could be held accountable as well. The point is unless you have some insider info you don't know if they have a buyer.
Thanks again. I will post temporarily on CTLT if this site goes down in the next week - using cast55 alias. Encourage others
to do so until we have a private site organized.
I'm not sure myself of how to set up a chat room using an alias name. Perhaps someone else on this board will know. If it trades below .001 today it would make it the 5th day in a row. If MYMX gets delisted will investorshub still let you post temporarily? I don't want to lose contact overnight. If it trades above .001 today and doesn't get delisted it's still temporary. According to their filing the reverse spit/going private is supposed to happen 20 days after the notice has been mailed to shareholders. If I read that incorrectly let me know.
In the case of waking up tomorrow and we're not able to post here, I would suggest posting on another board temporarily such as Catalent. It would be just so we don't lose contact. I don't like posting on other boards, but it would only be temporary.
Maybe this is why they put in their filings about a shareholder lawsuit slowing down their process. I think after they couldn't find a buyer, they changed their plan and decided to go private. Who knows, could have been their plan all along. Now they've left us with little time to coordinate.
Maybe we could have our own shareholder meeting since they never invited us to theirs.
Here's the sec website if any shareholders want to file a complaint directly with them.
https://www.sec.gov/contact-information/sec-directory
Thanks again for your thoughts, that clearly reflect what many shareholders are feeling right now. I do not know how to setup a chat room, but that seems what we will need to pursue a response to these MYMX decisions after the site is removed from the OTC. I agree that many of us may want to consider options to challenge this situation. We will sign up if you, or another concerned public shareholder, posts a link to enable our discussion to proceed in private once the stock is delisted.
If the stock price stays below .001 tomorrow MYMX will be delisted from the OTC. I mentioned a few weeks ago about getting a lawyer and holding their feet to the fire. I'm tired of being treated like a mushroom. If they go private, we'll know absolutely nothing about what their up to. At least we had some filings to pick through. It wouldn't surprise me if they have something on the back burner and their friends are buying the stock. I would like to see a list of who's buying millions of shares under these circumstances.
I've already been searching for a lawyer. I can post a couple links but if anyone else has a firm in mind please post it. I think it's time we tie them up in court for a while.
https://chapmanalbin.com/cases-investigations/
https://wattsguerra.com/commercial-litigation/as-a-shareholder-can-i-sue-an-officer-or-the-board-of-directions-of-a-corporation/
Toys 'R' Us got bought out and THEN went private. Mymetics is going private without first finding a buyer. BIG difference.
Owning stock in a Private Company when you're not a Registered Shareholder is a challenge. Anyone who thought it was difficult getting information from Kempers BEFORE is going to long for the days when they at least had to file. Factor in the difficulty of taking your MYMX tax loss, and I agree with siar -- WHY?
Pretty simple solution. If you feel shafted and most investors here I assume do. Hire an Attorney and go after Kempers and the company. Lock up the stock. i would almost wager a class action suit you would find plenty of people who were shafted and an Attorney willing to take it on for a percentage. Could teach them a lesson. Maybe even go after there patents. Anything is possible in court. Could be fun..
It's not fair to us to reverse split and going private without giving all information to us. The few holders of 51% just decide while - I have to suspect that - ignoring us.
In the last few days tenth of millions of shares were traded. I don't know about the buyers (perhaps they know more), but probably most of the sellers sold with a lack of information. Therefore it has to be assumed that some possibly suffered damage.
I have several options in mind, in short a few points:
- They keep open the cancellation of going private, perhaps they just want to put some pressure on potential buyers.
- They think about going private, while selling an exchange listed and reporting company with debt could bring in a substantial amount of money (for write-offs).
- That should mean they think the patents have more value.
- But how long would they keep alive the private company holding the patents; it could be better to keep the company listed for selling it, if the patents can not be sold. That's a question of the time horizons.
Nor do any of us shareholders appear to have access to the real story behind any of that. But there are hints…
* MYMX hired 2 companies for 7 months to look into the value of MYMX. No findings were reported in SEC documents. What did they do?
* Their financial advisors, Rock Creek Advisors, never even posted the MYMX purchase opportunity on their own company website. How did they earn their keep?
* MYMX is clawing back 2 BH patents, awaiting release of Ruth Ruprecht’s delayed NIH HIV trial results, silent about their covid and other research. These are timely factors in any potential business transaction, but useless to the longterm shareholders who will see their investment into this research agenda diluted…by 2000%.
* Twice in recent SEC filings MYMX warned that a shareholder class action lawsuit would divert their attention from selling the company and thus harm their business. But their “business” instead appears to have been structuring a way to go private and shaft the public shareholders.
* MYMX repeatedly notes that they are “winding down” their company. Given the huge number of shares purchased in recent weeks for this sub-penny stock, that does not appear to reflect their real intent. It seems more like a “going private” path that will remove public shareholders and escape public (SEC) reporting requirements.
Thanks for clarification, extrinsic55!
Yes, it's for sure a lottery ticket.
I think the circumstances for Mymetics are very different. In the filing I read, they stated that they contacted more than 500 companies and no one was interested.
I still don't fully understand their procedure.
The Bottom Line--- Toys R Us 2004-2005
From Investopedia:
"Shareholders can make out well financially when a public company goes private. In 2005, Toys "R" Us famously went private when private equity groups paid $26.75 per share to the company's shareholders.
5
U.S. Securities and Exchange Commission. "Toys "R" Us, Inc. Announces Agreement to Be Acquired by KKR, Bain Capital and Vornado for $26.75 per Share in $6.6 Billion Transaction."
This price was more than double the stock's $12.02 closing price on the New York Stock Exchange in January 2004."
The Bottom Line there no guarantee of what the result will be. I think somebody said it. Buying a few million is a lottery ticket for some of us who like gambling.
Unfortunately I don't see a similarity. What's your point?
Siar in response to your Why Buying ( Toy R US 2005) Public to Private
Great to hear from you, Llama! Am glad you exited prior to this, and really appreciate your support as remaining shareholders try to parse what is happening and how to respond.
Over the past months there have been days (like today) when multiple millions of shares changed hands in a now sub-penny stock. I wondered at the many identical purchases (ending in 1,999,999)…now it seems clear those were insiders privy to the split vote, and getting their hands on the shares that will be taken from us in just a few weeks.
Another oddity is the stall in publication of the HIV research results. What do those findings reveal? What are implications for the value of the MYMX-patented virosomes used? How might that play into this sudden desire to “go private”?
And finally, why did MYMX management advise shareholders in a public filing not to initiate legal action against the company while they were “trying to sell the company”, when in reality they were focused on a plan to go private and eliminate most of us. What will the SEC have to say about that ?
Again, glad you are out of the fray, and truly appreciate your knowledge and commentary on what is transpiring.
Question to those on the bid (5.6 million shares): Why do you want to buy now?
In the last three days 20.5 million shares were traded. And "traded" means, these shares were not only sold - what a surprise - but also bought by someone...
They will only have 133 Shareholders of Record after the R/S. That's a lot of cushion.
170 common shareholders would have to become Registered Shareholders. It won't happen.
The company stated in their SEC filings that they are going private, not going dark.
So make a decision
Long gone, just stopped by for my friends
Best of life for everyone
Fabulous Igm, you know why state of Louisiana stepped in
Sf screwed it up
Ruth is the big winner here & there is no winner b/c
Oxford has non cold storage 10 years out
:}
Do you know why I'm here ?
I'm out, big difference in 01 & 001 & 0001
Who changed the filling ?
I'm done here but I could care less about you......!!!!!!!!!!!!
Much less Fort Dietrich
Good luck, you are going to need it w/ a 2000 to one
What makes you think it's going private ? Don't ok....!!!! Tell your wife I said hi.... The difference in Chit Creek & you is nothing more that Dr S......!!!!!!
I see, my bad, I didn't realize they say they already filed the 13e-3. It SHOULD be on EDGAR. That's odd. It'll probably show up soon.
Both posts from p38 of 14C
I agree it should be on EDGAR.
Other Maters
Available Information
"Because the Reverse Stock Split will constitute a “going private” transaction, the Company has filed a Rule 13e-3 Transaction Statement on Schedule 13E-3 with respect to the Reverse Stock Split. The Schedule 13E-3 contains additional information about the Company and the Reverse Stock Split. Copies of the 13e-3..."
They will have to file the Schedule 13e-3 with the SEC, at which time we can all read it on the SEC website (or on otcmarkets.com). I doubt the company would make it available before they file it with the SEC.
Copies of the Schedule 13E-3 are available for inspection and copying at the Company’s principal executive offices during regular business hours by any stockholder of the Company, or representative of a stockholder who has been so designated in writing, or by request directed to Ronald Kempers, Chief Executive Officer and Chief Financial Officer, at Mymetics Corporation c/o Mymetics SA, Biopole, Route de la Corniche 4, CH-1066 Epalinges (Switzerland).
And my understanding of THAT is that when they pay off the shareholders with less than 2000 shares, the Shareholders of Record will number under 300, allowing them to terminate registration under Section 12(g).
If every shareholder with under 2000 shares buys another couple thousand shares, the Shareholders of Record will exceed 300 after the R/S, and they won't be able to terminate registration under Section 12(g).
LOL, I sold out months ago, but I will buy 2000 shares tomorrow just to be a jerk.
If you have a brokerage firm that will let you trade pinks.
They will get delisted from the OTCQB but they will still be listed on the OTC Pinksheets. There is no PPS requirement on the Pinks. They are current on quarterly reports so they will trade as Pink Current.... for a while.
They then intend to file a Form 15 to stop reporting to the SEC. They STILL will trade on the Pinksheets, but THEN they intend to file a Schedule 13E-3 to take it private, at which point it will no longer trade on an exchange.
Hard to believe they had 2 different firms for 7 months looking into the value of this company before they put themselves up for sale. You would think when they started the bid process, they would already have perspective buyers. I read through the filing and as was posted they said they contacted 500 different companies and no interest.
The problem now is after their last 2 filings the stock has dropped below the .001 range. If it stays there for 5 consecutive days, which I don't know how it won't, it will automatically be delisted from the OTC. I think some are taking a tax loss before they're not able to trade it anymore.
I find it ironic that they said there wasn't enough trading activity to do something else with the stock as far as a buy back or whatever. They certainly know how to get more shares being traded. Maybe if they had put out some PR'S in the last 3 years the stock price wouldn't have been where it was. In reading requirements on the OTC site, it said that companies were required to post any relevant info or results. Well,' that didn't happen.
This management has not been responsible to its shareholders. I thought owning a company with so much insider ownership was good. It didn't turn out that way. They did whatever they wanted with no regard for the other shareholders. I would like to see the minutes of their shareholder meetings.
Q:
Will I continue to receive information about the Company if I remain a stockholder?
A.
Stockholders may under certain circumstances obtain information from the Company in accordance with the requirements of the DGCL upon submitting a written request to the Company which specifies the information sought and the purpose of the request. Under Delaware law, the Company may withhold information from a stockholder who does not have a “proper purpose” or otherwise fails to comply with statutory requirements.
Interesting reading...
During these discussions, the following strategic alternatives in addition to the reverse stock split were considered:
1.
Sale of the Company or substantially all of its assets. Under this alternative, Mymetics would attempt to sell (subject to the stockholders’ approval) the Company or substantially all of the assets of the Company. However, even with the engagement of several business brokers to evaluate strategic alternatives for the Company or its assets, sale efforts were ineffective in attracting potential buyers. Between May 2022 and March 2023, the Company approached close to 500 companies globally and attempted, but was unsuccessful, in selling itself or substantially all of its assets. The Board concluded that, under the current conditions, the interest in the market to purchase the shares or assets of the Company is extremely low or absent.
2.
Dissolution of the Company and liquidation of its assets. Under this alternative, Mymetics would (subject to the stockholders’ approval) dissolve the Company in accordance with the DGCL and wind up and liquidate the Company’s assets. However, even after filing a Certificate of Dissolution, the Company may still be deemed to have such number of record stockholders in excess of the Exchange Act Rule 12g-4 thresholds. Accordingly, the Company would likely be required to continue its reporting under the Exchange Act until the time all assets and liabilities of the Company are wound up and sorted out pursuant to state law, which would continue to be costly for the Company.
3.
Other transactions. The Board also considered other possible transactions, such as purchases of shares on the open market or an issuer tender offer. However, the Board concluded that these and similar transactions would be more costly, including due to higher legal costs and other transactional expenses, lack certainty in reducing the number of stockholders of record to fewer than 300 and/or take a longer time to effectuate.
During these discussions, the Board also considered the benefits and disadvantages of:
1.
forming a special committee of the Board to consider and review the Reverse Stock Split and to make a recommendation to the full board as to the approval of the Reverse Stock Split. The Board discussed the fact that the Reverse Stock Split applies equally to all stockholders, including the directors and officers, and that no director, executive officer or affiliate of the Company would receive any benefit not received by any other stockholder. Based on these factors, the Board determined not to appoint a special committee.
2.
requiring the approval of the Reverse Stock Split by the holders of a majority of the shares of Common Stock held by our unaffiliated stockholders. In considering whether to require the approval of our unaffiliated stockholders, the Board discussed the fact that stockholders would have the option to remain stockholders of the Company if they purchase sufficient shares to bring their holdings to at least 2,000 shares immediately prior to the Effective Date, the fact that the Reverse Stock Split applies equally to all stockholders, the fact that the Company’s affiliate stockholders’ percentage ownership would likely not significantly change after the Reverse Stock Split and the likely inability to have a majority of the non-affiliate stockholders participate in such a vote. Based on these factors, the Board determined not to require the approval of the Reverse Stock Split by the holders of a majority of the shares of Common Stock held by unaffiliated stockholders of the Company.
The Board also discussed in detail other aspects of the going private transaction, including the price to be paid to stockholders in lieu of fractional shares. In that regard, the Company noted that historically its volume of trading was low and, as a result, neither might accurately reflect the value of the Company’s Common Stock, which price was higher than the book value per share reflected in the Company’s public filings with the SEC.
The Board also identified and undertook discussions of the disadvantages of the Reverse Stock Split, namely, the fact that stockholders of record owning fewer than 2,000 shares would not be able to participate in any future growth of the Company. The Board noted that this disadvantage is minimized by the fact that any stockholder who so chooses can remain a stockholder by purchasing a sufficient number of shares in order to increase the number of shares in such stockholder’s record account to at least 2,000. Another disadvantage discussed by the Board is the fact that stockholders who remain after the Reverse Stock Split will no longer have access to information concerning the Company’s operations and financial results that is currently available in its SEC filings.
On October 3, 2023, the Board concluded that a valuation of $0.0023 per share would be fair to the stockholders who would receive fractional shares as a result of the Reverse Stock Split, representing a 30% premium on the 25-day volume weighted average price of Mymetics common share during the period August 26, 2023 to September 29, 2023.
Based on these considerations, the Board determined that the results of a Reverse Stock Split are more predictable and automatic, and determined that the Reverse Stock Split is the most expeditious and economical way of reducing the number of holders of record to fewer than 300 and effecting the termination of its registration and periodic reporting obligations. The Board then unanimously approved by written consent a 1-for-2,000 Reverse Stock Split of the Company’s Common Stock on October 5, 2023.
In October, 2023, as the Company and the Board continued to have discussions on a going private transaction through the Reverse Stock Split, management of the Company had informal discussions with the Consenting Stockholders, and the Company asked the Consenting Stockholders if this might be something they would support, in order to determine the feasibility and advisability, as the Company did not wish to devote Company time and resources to such actions unless there was significant shareholder interest. The Consenting Stockholders indicated that they would consider supporting a Reverse Stock Split, and asked that the Company provide them with all available information when they were ready to move forward, in order to fully evaluate whether they would provide consent. Other than engaging in discussions initiated by the Company, the Consenting Stockholders were not involved in the planning or structuring of the Reverse Stock Split.
So my understanding is that if you have more than 2000 shares pre split, you are still a shareholder in the company without reporting. If you have less than 2,000 shares, you will be paid out .0023 per share per-split. It says in the filing it estimates $2k total expense for payments.
"In July and August, 2023, Company management held telephone discussions with representatives of McDermott Will & Emery LLP, the Company’s outside legal counsel. Various methods to accomplish a going private transaction were reviewed, including an examination of a cash out merger, a tender offer, a sale of the Company to, or merger of the Company with, another organization, a reverse stock split, and purchases of the Company’s common stock on the open market."
So they picked a reverse split over the others. It seems they felt the company value was worth more than sale or merger?
How is it possible that, with the patents and intellectual property they possess, the company is worth .0004 right now? Even with the pending but not approved R/S the market is saying the company is worth 125K? If true, what have they been doing all these years? What about Baylor, etc? It makes no sense. Ugly.
Thanks Fort Uitous. I believe we have a right to the minutes to shareholder meetings as well. I'm not sure how to go about that since they don't even answer an email.
cc:
Thank you for your work over the years and our present IP portfolio.
Just a reminder to all shareholders and as reaffirmed by a recent Delaware Supreme Court ruling, all Delaware Corporations have a duty by law to provide financial statements to a shareholder upon enquiry. Delaware Corporations are not entitled to enforce an NDA.
Regulation FD does not apply to Delaware Corporations when they de-register from the SEC.
https://courts.delaware.gov/Opinions/Download.aspx?id=337340
I agree with these sentiments, and suggest that the remaining shareholders create a private online chat room for those who wish to explore our options.
We were asked by MYMX management months ago not to take any legal action, as they were focused on selling the company. However, that clearly was not full disclosure…they were also planning this option. If what they are doing is illegal, we have every right to respond.
What this company and management is doing is criminal. They don't have to delist from the OTC but they're choosing to do so. They have until the end of December to get the share price over .01 and are choosing not to wait. All they had to do was a 2 to 1 reverse stock split to meet the requirement. They're doing a 2,000 to 1 reverse stock split. The price of .0023 per share they talked about in the filing was for any leftover shares you held under 2,000. They weren't giving partial shares. There were over 600 shareholders just this summer. According to their last filing they will now be under 300. How is that possible. Were there 300 shareholders with less than 2,000 shares? Something doesn't seem right. Somehow being under 300 it allows the company to terminate the registration of its common stock and suspend its reporting obligations. That's why they're doing a 2,000 to 1 split. It must be their magic number. The management has kept us in the dark for the last 3 years but at least we've had the filings to gain some info. Now we'll be totally in the dark. How many times has the management responded to any of your emails. I know I've emailed them multiple times and not once have they responded.
The fact that the company is choosing to be delisted during a period of time in which they have announce the sale of the company should be terms for a shareholder lawsuit on its own. I believe this is what the insiders wanted. If they orchestrated the price to fall to get the number of shareholders down below 300 that's criminal. If they can do that to the smaller shareholder, what confidence do you have they will treat the rest of us fairly when they sell the company. After going private they'll probably structure some deal to benefit the insiders only.
It doesn't matter if we think their patents are worth something and the company will sell eventually. I believe a shareholder lawsuit should be looked into. before it's too late. Like it's been said, after they go private how will any of the shareholders be able to communicate.
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http://www.mymetics.com/
COMPANY OVERVIEW
https://www.mymetics.com/files/8116/2081/0445/May21-Mymetics_Overview.pdf
Mymetics Corporation is US registered biotechnology company with its main offices in Switzerland and the Netherlands.
Focused on developing next generation preventative vaccines for infectious diseases.
Mymetics core technology and expertise are in the use of virosomes,
lipid-based carriers containing functional fusion viral proteins in combination with rationally designed antigens and membrane proteins.
Objective: "Build small / medium size innovative R&D virosome vaccine company with strong
partnerships, Phase II – III clinical vaccine pipeline and have optionality for M&A or sale."
Current Share Structure:
Outstanding Shares: 303.7 million (as of 01/18/2019 unchanged since 2014)
Floating Shares: 79.8 million* (a/o 01/18/19)
(https://www.otcmarkets.com/stock/MYMX/profile)
Rationale and Impact of MACIVIVA
With few exceptions, commercialized vaccines are generally delivered by injection through the intramuscular or subcutaneous route.
Vaccines contain immunogens classically found within a large variety of biological compounds such as peptides, proteins, glycoproteins and sometimes carbohydrates and lipids.
These immunogens may trigger the immune system for producing antibodies and/or cytotoxic T cells for preventing the pathogen transmission or blocking and/or slowing down the disease progression.
However, these vaccines generally exist as liquid formulation that are inherently prone to physical and/or chemical modifications. The cold chain storage is still fundamental for preserving the
bioactivity of most liquid and freeze-dried vaccines. For reconstituted freeze dried vaccines, they harbor important instability and must be used within hours and kept refrigerated. Vaccine degradation generally takes place
during shipment and/or storage of liquid or lyophilized products, which may affect the immunological properties of the immunogens, with unwanted immune responses or insufficient immune protection.
There is growing evidence that solid dosage formats (e.g. powder form) for vaccines may offer several advantages over the liquid formulations, such as the prevention of molecular motion and shear-induced degradation,
and slowing down modifications and degradation reactions involving water and oxygen radicals, resulting in improved stability, enhanced shelf-life of vaccines and greatly simplified logistics.
MYMETICS BV
Expertise: R&D on virosome formulations
Project responsability: Investigating and compiling the results about the physical and biochemical properties of the virosome-based vaccines obtained by spray-drying and lyophilization.
MYMETICS SA
Expertise : Non-GMP and GMP virosome production, clinical development
Project responsability: Excipient selection for liquid virosomes, supervising the non-GMP and GMP manufacturing of the liquid virosomes and development of analytical methods.
UPPERTON LIMITED
Expertise: Non-GMP and GMP Spray drying
Project responsability: Identification of excipients and experimental conditions suitable for virosome spray drying, production of non-GMP and GMP powder forms for nasal and oral delivery.
CATALENT U.K. SWINDON ZYDIS LIMITED
Expertise: Zydis technology for fast-dissolving tablet, world leader in drug formulation and distribution
Project responsability: Identification of excipients and experimental conditions suitable for virosome lyophylization, according to the Zydis technology, non-GMP and GMP tablets for sublingual delivery.
CHIMERA BIOTEC GMBH
Expertise: Ultra sensitive immunoassays development and bioanalysis based on Imperacer® (Immuno-PCR) technology.
Project responsability: Immunogenicity study in animals with spray-dried and lyophilized virosomes. Imperacer® immunoassay development and evaluation of the vaccine-induced antibody response.
BACHEM AG
Expertise: R&D, non-GMP and GMP manufacturing of API, world supplier
Project responsability: Process Development and manufacture of peptide P1, GMP-grade, including development and validation of analytical methods.
Vaccines are poorly accessible in developing countries
Vaccines require cold-chain storage and are often delivered by injection, which is undesirable, less safe and more expensive to administer.
Developing thermostable solid form vaccines through non-invasive routes may represent a long-term global solution to the vaccination challenge (Amorij, 2008).
Virosomes are an efficient vaccine delivery system
Virosomes are spherical, unilamellar lipid-based carriers, intercalated with functional glycoproteins to reflect the natural virus, however the lack of viral RNA means there is no risk of infection
(Figure 1). Virosomes can be tagged with different antigens and adjuvants, meaning they can be tailored to target different viruses, and offer increased immunogenicity over inactivated viruses.
Currently, virosomal influenza vaccines are only available in liquid form (Amorij, 2008).
Spray drying can produce dry powders for a range of dosage forms, including inhaled or nasal drug delivery.
A dry powder is formed when a liquid feed solution or suspension is atomised using a spray nozzle, and rapidly dried using hot air. However, while the drying process is gentle due to evaporative cooling,
there is still the potential to stress and inactivate vaccine components. It has been found that subunit and live-attenuated vaccines (and other delicate molecules such as proteins)
can be protected during processing b by incorporating them in an amorphous sugar matrix, which also offers longer term stability during storage (Kanojia, 2016).
A method has been developed to produce a powder form of virosome based influenza vaccine using spray-drying.
Formulations have been optimised for oral and nasal delivery.
Virosomal technology is approved by the FDA for use in humans, and has a high safety profile
Virosomes are biodegradable, biocompatible, and non-toxic12
No disease-transmission risk
No autoimmunogenity or anaphylaxis10
Broadly applicable with almost all important drugs (anticancer drugs, proteins, peptides, nucleic acids, antibiotics, fungicides)
Enables drug delivery into the cytoplasm of target cell
Promotes fusion activity in the endolysosomal pathway
Protects drugs against degradation
Intellectual Property
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