is all in $AAPL $TSLA and $PMCB
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Austrianova owns the tech. It was greatly improved in 2015 and new patent applications were filed.
https://register.epo.org/application?number=EP15789170
https://register.epo.org/application?number=EP14744005
https://register.epo.org/application?number=EP12704722
This article provides a great explanation of the trial design as of January 2017. Bear in mind that some things have likely changed by now.
https://finance.yahoo.com/news/pharmacyte-going-head-head-eli-141000857.html
J&J has a market cap of over $350 Billion dollars. Honestly, I can't see them caring if PMCB was worth $50 or $70 Million.
Now, if you want me to put on a tin foil hat I can. I'd say any shenanigans would be from (a) any biotech that wanted to bankrupt PMCB to acquire its exclusive rights to CiaB on the cheap or (b) any biotech that has a competing encapsulation technology.
Based on the charting I've seen, I think IND submission will take us to the 25 cent range. How long it stays there is another issue for this ticker as it sure seems to lack staying power with such a large OS pool.
So, what I know could take us higher than 25 cents is a partnership. Pre-IND for diabetes could also take us higher. But I think a partnership, with multi-million dollar milestone payments, would push us up and keep us there.
Positive top line data, followed by request for accelerated approval would do wonders.
Anyway, I don't have a crystal ball but I understand what CiaB could be to the right big pharma partner. Hopefully that BIO award got us the attention we deserve.
$PMCB has FOUR institutional holders, which can be verified on the Nasdaq site:
http://www.nasdaq.com/symbol/pmcb/institutional-holdings
Yes, it's a small holding. However, it is very, very rare to see any institutional holdings in a 5-6 cent stock. Period.
Go lookup institutional holdings of the tickers on Hot! breakout boards. First two tickers have 0%. Next two have no data available (likely they are currently not reporting). Fifth has 1 institutional holder.
I disagree. When news of $PMCB's pre-IND meeting hit the wires, the price spiked.
For some reason people thought the IND would be filed immediately afterwards, completely oblivious to the cold hard fact that making a master cell line takes 6 weeks alone. I heard about the ticker via this website, and my first 10K share purchase was at 15 cents. Am I happy it's at 5-6 cents now? Yes and no. Yes, because I have averaged down my cost and no, because the MMs have been holding this down. How many days did we see 400K purchase with no price change, followed by 10K sold and a price drop?
The company, with KW at the helm and with KW being a lawyer, has been IMO overly cautious with PR. I've been invested in several pennies that I now believe were pure pumps, but I see PMCB as a very real company with the chance of a bright future.
The pancreatic cancer that PMCB can address is, thankfully, a small market. Diabetes is much larger. But what I think will be huge is any big pharma company with dozens of chemotherapy drugs going generic. By simply putting those chemo drugs into CiaB you get renewed exclusivity and that is truly mind numbing dollar values with slam-dunk, accelerated FDA approvals.
Seriously, you are taking already FDA approved chemotherapy drugs and putting them in CiaB. It is the biggest no brainer.
Fisher Asset Management has a $500K minimum for personal accounts and those accounts are actively managed. Hardly the type of trader that uses iHub.
Anyway, SEC Form 13F is for the institutions account, not customer accounts.
Otherwise Fidelity, ETrade, Robinhood, etc etc would show up at 20% owners of all equities.
Shorting $PMCB seems very silly to me. The range is very tight and there isn't a lot of volume.
IND could be filed at any time. Seems like a silly trade to me when there are so many obvious pump and dumps all over the "Hot!" tab.
Anyway, $PMCB longs will have their day. KW has done a masterful job getting us to this pivotal point.
FDA is different today. Janet Woodcock has implemented a lot of positive changes in my opinion.
For example, Accelerated Approval may very well be in $PMCB's future.
So I think that FB post just highlights that KW and PMCB are well aware of trends at the FDA.
Eurofins Lancaster Laboratories, Inc.
I said Boston earlier. My mistake, Eurofins is in PA.
We paid for a seat at the table and things are about to get very interesting and profitable, so of course Austrianova is going to re-negotiate. What choice does KW have, really, to only keep pancreatic cancer and let all other uses for CiaB get bought up by a European big pharma co? Do you want 90% of a small pie or 50% of a giant pie?
What I believe happened is PMCB got the attention of a US big pharma co at BIO. Austrianova was then approached by a European big pharma. Global big pharma is a small club and rumors spread very quickly.
I have no inside info. All I have is the text in the revised term sheet. Now, when negotiating, everything that ends up in the agreement is there for a specific reason. We can sort of reverse engineer the agreement by thinking about it in this way. You are too focused on %. Instead, focus on the material changes.
The non-disclosure clause added to the term sheet. Why was it added? So PMCB's US big pharma partner can be assured nothing is leaked to any European big pharm cos.
The right of first refusal clause added to the term sheet. Why was it added? So Austrianova can't sell everything when PMCB's Phase 2b returns some great top-line data.
Again, do you want 90% of a small pie or 50% of a massive pie?
I'm with KW here and my millions of shares have his full support.
I really feel the IND will be submitted soon! KW is in Boston now meeting with Dr. Hidalgo:
Very valid point. You can imagine a situation where Austrianova, knowing of pending PMCB news, goes to shop CiaB to european big pharma and gets some nibbles, and then comes to PMCB to re-negotiate.
Austrianova wants top dollar for CiaB tech and PMCB has gotten us to the verge of a Phase 2b trial. Both have positions of strength and both want to maximize profits in the long run.
It's hard to say who got the better deal. To me the deal looks fair and it very much looks like the term sheet changes were made to facilitate future PMCB partnerships.
In my opinion a potential partner wanted to make sure a rival company could not approach Austrianova and buy CiaB. PMCB is doing whatever it's potential partner wants to get the deal done.
I think the deal is fair. CiaB is Austrianova tech after all.
Someone can correct me if I'm wrong, but the $900K is for Austrianova Singapore because Singapore was supposed to produce the master cell line. It is now being produced in the US. Again, it seems to me that our potential partner wanted to have better control over the production of the master cell line.
You are being very dishonest in NOT including the word sublicensing. You are talking about SALES and we are a long way from sales. What KW did is stop the milestone payments that were happening NOW. KW stopped more capital from heading out the door in exchange for an increase in sales down the road. Seems smart to me.
People should read pages 6-7 for themselves.
http://www.otcmarkets.com/edgar/GetFilingPdf?FilingID=12268239
Right of first refusal for five years is huge and should be taken as a major indication of what the term sheet change does. It means that PMCB can confidently move to develop CiaB for pancreatic cancer without worrying Austrianova will sell CiaB in the meantime. It's a five year period, which is more than enough time for the biologic to be proven in the upcoming phase 2b trial. In five years they come back to the negotiating table and craft a new term sheet.
The fact that the term sheet was changed at all tells me more is happening behind the scenes that we don't know about.
Facebook was updated, 8-K filed, micro-cap article and press release. Finally seeing some coordinated PR here!
Catalysts in the near term: IND filing, diabetes pre-IND meeting request, and partnership announcements.
Term sheet was amended so that neither PMCB nor Austrianova can mention any pending partnerships.
The writing is on the wall if you care to read it: a carefully crafted and designed IND will be filed, the FDA will green light a pivotal Phase 2b, enrollment will start at Beth Israel Deaconess Medical Center in Boston, and partnership information will be announced.
Go $PMCB!!!
The increase is for sublicensing fees.
Milestone payments, which were huge, are eliminated. Sublicensing fees get passed through, 50/50, to Astronova.
What does that mean? PMCB has financial incentive to do as much in-house as possible.
In my opinion, these changes were made at the request of a future partner and provide guarantees that the underlying technology can't be bought from Astronova while we are in clinical trials.
It also expands the use of CiaB with any and all cell lines, including TCells.
Interesting, positive development.
The Road to the Biologic IND
JLABS @ Toronto
Tuesday, September 19, 2017 from 12:00 PM to 5:00 PM (EDT)
Toronto, ON
Anyone planning to attend?
https://www.eventbrite.com/e/the-road-to-the-biologic-ind-tickets-34717748721?aff=weekly
The shorts on $PMCB really have no clue how big pharma operates,
We are waiting on IND for CiaB and ifosfamide for pancreatic cancer. That's just one biologic. CiaB with a single proven chemotherapy drug for a specific type of cancer.
But CiaB can be used with any chemo drugs on any solid tumors. The potential is limitless.
Imagine you are a big pharma with dozens of chemotherapy drugs that are going off or have gone off exclusivity. The billions spent on R&D for those drugs was largely recouped, but now you stand to regain exclusivity by working with $PMCB.
So, do you just let your chemo drug go generic or do you turn it into a new, exclusive biologic by putting it inside CiaB?
Janssen has nearly 30 chemotherapy drugs.
http://www.janssen.com/products/Oncology
Chemotherapy is like carpet bombing a person's body. CiaB turns that very same medicine into a laser-guided missle.
Am I reading the quarterly wrong or does it say no gum sales in Q2? If no sales, why?
Richard Carter, PhD
Scientist at The Janssen Pharmaceutical Companies of Johnson & Johnson
February 2015 – Present (2 years 7 months)
Serve as a cell biologist in immunological assay group within Lead Optimization, a fast-paced R&D environment supporting Oncology and Infectious Disease large molecule and biologics programs.
Design and develop methods to establish proof-of-concept and mechanism of action for candidate lead molecules throughout phases of early discovery. Perform primary immune cell based assays. Considered resident expert in imaging flow cytometry analysis and immunological assays.
Leverage comprehensive knowledge and diverse skill set to originate research strategy and support critical path decisions. Interact cross functionally with internal and external collaborators, and communicate relevant data and conclusions to department-wide audiences.
bump:
CNBC showed EARS on the ticker around 6:15 EST at $.81...
Saw this on the JLabs Toronto calendar of events:
The Road to the Biologic IND
JLABS @ Toronto
Tuesday, September 19, 2017 from 12:00 PM to 5:00 PM (EDT)
Toronto, ON
JLABS, the Johnson & Johnson Innovation Centers and Janssen BioTherapeutics invite you to an in-depth look into the process of filing a biologic Investigational New Drug (IND) application and the procedures necessary for advancing your company's early-stage drug development program. Whether your goal is to develop a pipeline through commercial launch, or partner as early as possible, submitting an IND is a critical early milestone for every biotech company. With big Pharma and VC firms competing for the most promising compounds, startups are expected to demonstrate a solid plan for achieving IND acceptance.
Join us for a series of short presentations exploring the basic requirements and considerations necessary to achieve a successful biologic IND submission. The presentation will highlight the following:
Janssen BioTherapeutics - overview of biologics
Key CMC strategies to balance cost, time and comparability risks
Non-Clinical safety assessment strategies for biologics
Determining and understanding PK/PD and immunogenicity
Regulatory strategy, IND and CTA requirements, and Pre-IND meetings
https://www.eventbrite.com/e/the-road-to-the-biologic-ind-tickets-34717748721
Cool Technologies to Complete Production of MG System
BY GlobeNewswire
— 10:38 AM ET 08/15/2017
TAMPA, Fla., Aug. 15, 2017 (GLOBE NEWSWIRE) -- A surge of interest from a number of diverse industries caused Cool Technologies, Inc. ( WARM ) to accelerate the planned upgrade of its Mobile Power Generation (MG) system’s controller code to ensure maximum adaptability and sell-through. The software was rewritten to accommodate new applications, vehicles and vehicle manufacturers.
On Monday, Tim Hassett, Cool Tech’s CEO, announced “The software upgrade to our 80 kVA MG system will be finished within weeks. The Company is now taking pre-orders with deposits.” He added, “We’ll follow the same accelerated strategy and sales plan with our MG 125 system which will be completed this year.”
The catalyst for the upgrade was the company’s April demonstration at Craftsmen Industries before a live audience and online via video streaming as well as subsequent demonstrations at events in Louisville, Chicago and Pittsburgh.
Originally, Cool Tech ( WARM ) had planned to commercialize its technology by starting with the line of Ford Trucks it had successfully converted and expanding to other manufacturers and applications in a sequential process. All that remained to make the system production-ready were a few minor tweaks to the software.
Audience interest changed that. Disaster relief providers, buyers for the US Military and other truck manufacturers and distributors present wanted private demos for those who didn’t attend.
Viewers who watched on-line contacted the company and requested meetings. The company heard from a global battery manufacturer interested in the no-idle option, a truck up-fitter heavily invested in natural gas conversions and a developer of hydrogen fuel cells who flew in to meet with the CEO. Their interest: alternative energy (the MG System is fuel agnostic. It runs on whatever the vehicle runs on). Each saw a natural tie-in. Each offered a new revenue stream. And each had different software or vehicle requirements.
About Cool Technologies, Inc. ( WARM )
Cool Technologies ( WARM ) is an intellectual property and product development company commercializing patented thermal dispersion technology across multiple platforms. The Company has additional patents-pending for various OEM applications of its proprietary heat removal technologies. Tested and validated by two third parties, ESSCO Pumps and Nidec Corporation, the Company’s cooling system eliminates the need for costly modifications while increasing power output of pumps, fans, compressors, batteries, motors, generators and bearings.
Transcript of Q2 earnings call
https://finance.yahoo.com/news/edited-transcript-ears-earnings-conference-133824723.html
As of 10:53:
321,611 shares BOUGHT
257,510 shares SOLD
$PMCB down 5%. Riiiiiiight.
This along with Dr. Sher being tapped as the new Chief Medical Officer speaks volumes. Dr. Sher has experience and expertise managing multiple clinical trials. Really seems to me $PMCB will be filing multiple INDs in the very near future.
Normally Janssen will give around $30-50 Million for equity in good faith and set milestone payments in the $100s of millions as development progresses. Royalty agreements of course when all goes well. The possibility of an outright buyout is always there when the clinical trials do very well.
Overall I think we are in a fantastic place!
Bump!
Timeline of interesting events:
July 7: J&J announces the end of it's stem cell partnership with Capricor.
http://www.fiercebiotech.com/biotech/capricor-yo-yos-as-j-j-dumps-stem-cell-partnership
~July 20: $PMCB's Ken Waggoner posts to his FB page (now set to private) "Canadians will soon outnumber Americans at PharmaCyte" i.e., more Canadians than Americans i.e., Canadians will be in control. KW post pics from the Fairmont Hotel in Toronto, which is 5 minutes away from J&J's JLabs Toronto incubator site and 15 minutes away from Janssen's office.
July 27: Bavarian Nordic signs a "license and collaboration agreement" with Janssen under which J&J made an equity investment of $33 Million in Bavarian Nordic and Janssen will "conduct all clinical development and, subject to regulatory approval, be responsible for registration, distribution and commercialization of any potential new vaccine regimens worldwide. Bavarian Nordic will receive an upfront payment and be eligible to receive milestone payments based upon the achievement of specified development, regulatory and sales milestones and tiered royalties on future worldwide sales." Bavarian Nordic releases public information about the partnership on August 9.
https://finance.yahoo.com/news/bavarian-nordic-announces-subscription-price-182601887.html
August 8: Austrianova's FB page states: "Exciting new opportunities and partner for encapsulated stem cell applications - watch this space!"
https://www.facebook.com/austrianova/posts/1616942591670942
If I were a betting man, I'd wager Austrianova's stem cell biologics have replaced Capricor's in Janssen's massive pharma pipeline.
I'd also wager that $PMCB has signed a deal with Janssen because PharmaCyte holds exclusive rights to the CiaB pancreatic and diabetes treatments. If such a deal is a typical Janssen deal we should expect an equity investment into $PMCB along with license and collaboration agreements under which development of the pancreatic cancer CiaB and diabetes CiaB's biologics are Controlled and conducted by Janssen in return for generous milestone and generous royalty payments.
Excellent, valid points. MM behaviour is equally suspect. Millions of share purchased and the price stays the same, 10K sold and it drops 5%. Manipulation on so many levels.
But once partnership is announced none of that will matter.
Any day now
Great post! Fair and informative. If I may ask, what dollar value would you place on $WARM's patents?
July 7: J&J announces the end of it's stem cell partnership with Capricor.
http://www.fiercebiotech.com/biotech/capricor-yo-yos-as-j-j-dumps-stem-cell-partnership
~July 20: $PMCB's Ken Waggoner posts to his FB page (now set to private) "Canadians will soon outnumber Americans at PharmaCyte" i.e., more Canadians than Americans i.e., Canadians will be in control. KW post pics from the Fairmont Hotel in Toronto, which is 5 minutes away from J&J's JLabs Toronto incubator site and 15 minutes away from Janssen's office.
July 27: Bavarian Nordic signs a "license and collaboration agreement" with Janssen under which J&J made an equity investment of $33 Million in Bavarian Nordic and Janssen will "conduct all clinical development and, subject to regulatory approval, be responsible for registration, distribution and commercialization of any potential new vaccine regimens worldwide. Bavarian Nordic will receive an upfront payment and be eligible to receive milestone payments based upon the achievement of specified development, regulatory and sales milestones and tiered royalties on future worldwide sales." Bavarian Nordic releases public information about the partnership on August 9.
https://finance.yahoo.com/news/bavarian-nordic-announces-subscription-price-182601887.html
August 8: Austrianova's FB page states: "Exciting new opportunities and partner for encapsulated stem cell applications - watch this space!"
https://www.facebook.com/austrianova/posts/1616942591670942
If I were a betting man, I'd wager Austrianova's stem cell biologics have replaced Capricor's in Janssen's massive pharma pipeline.
I'd also wager that $PMCB has signed a deal with Janssen because PharmaCyte holds exclusive rights to the CiaB pancreatic and diabetes treatments. If such a deal is a typical Janssen deal we should expect an equity investment into $PMCB along with license and collaboration agreements under which development of the pancreatic cancer CiaB and diabetes CiaB's biologics are Controlled and conducted by Janssen in return for generous milestone and generous royalty payments.
Here's an article with background info on $PMCB:
http://www.marketwired.com/press-release/pharmacyte-biotechs-cancer-treatment-shows-complete-tumor-remission-published-preclinical-otcqb-pmcb-2026105.htm
Umm, Bavarian Nordic is the forerunner to Austrianova.
Look at the date. KW was in Toronto the week before. IMHO all signs are pointing to a partnership with Janssen for $PMCB.