1st I want to say thanks to Onebarkmill for the detailed summary.
Known coming milestones(based on dates given in CC):
- CardioPET clinical development report finished - ~2-3 weeks (early to mid July)
- Complete chemistry validation and open enrollment for BFPET P2 trial - "early Q3" (July?)
- Present CardioPET P2 comparative imaging data at ASNC - late Q3 (Sept 23)
- Present CardioPET P2 safety data at EANM in early Q4 (October)
- Meet with FDA regarding bringing CardioPET P2B into the US (2H '16)
(Hopefully) coming milestones (unknown timing):
- Merger/acquisition of Ground Flour Pharma - "coming months" - during CC, they said they likely have a lead investor to consummate the deal
- Money in the bank through a capital raise (or other) to get the financial overhang out of the way and fund the P3/P3 trials of PFPET and CardioPET through commercialization
- More licensing agreements - either with the new GFP tech, or licensing out 1 or both of the the homegrown products to other geographical areas.
If I missed anything, feel free to add.
We have been waiting for this company to get to the execution phase for a long time now. It looks like we just got there, and added a new technology that can provide some near term (albeit mild) revenue and allow us to make PFPET at a yield and scale that allows the commercialization to move forward and (more importantly) be profitable.
At the end of the CC, they said they now have enough $$$$ on hand to get the company through the merger and move the development of both CardioPET and BFPET forward as outlined above.
That is one hell of an improvement and speaks to the value proposition with the acquisition being acquired. The credentials of the members of GFP are impressive to say the least.
[18F]MFBG was prepared in almost 3-fold higher yield than previously reported (31% corrected to end of bombardment, n = 9) in a synthesis time of 56 min with 99.9% radiochemical purity. Other than pH adjustment and dilution of the final product, no reformulation was necessary after purification. This method permits the automated production of multidose batches of clinical grade [18F]MFBG. Moreover, if ongoing clinical imaging trials of [18F]MFBG are successful, this methodology is suitable for rapid commercialization and can be easily adapted for use on most commercial automated radiosynthesis equipment.
Been in here for a while now. Long term hold for me (2-3 year total). Betting on previous success of CEO and his ability to get low dilution funding.
Both working so far!
No. Absolutely not. Data is coming as said in the CC......BEFORE a public offering.
If you look at the 8k filed on the 25th of Jan, the notes related to the 2014 private placement were amended (extended and interest rate increased).
Thus they had to then amend the S1......which are the 26th and 28th filings.
Agree. No volume so its not very convincing, and therefore nothing to write about. Also agree with joncon though....the seller looks to be done.
"That certainly isn't setting the bar very high'
Thats a 5 bagger from here.
A 7 bagger from where the stock was at when that was filed.
Thanks for the summary. a VERY important addition:
1 thing I did not know from Thom Tulip's background: He was the "product champion" for flurpiridaz, CardioPET and BFPET's main competition (only F18 competition) from Lantheus. I think he did a great job highlighting the differences between especially CardioPET vs flurpiridaz. This was an area I was a little unsure about, but he cleared it up nicely.
In summary, (and as onebarkmill said) Tulip highlighted the fact that CardioPET can be used for both blood flow AND metabolism applications. This is HUGE. The metabolism piece is what opens the door to many more indications, and is the reason why the revenue projections for CardioPET are MUCH higher than previous projections.
I think we are in very very good hands here. It sounds like these two KNOW cardiac PET.
Boy, I sure hope so.
Not the HUGE volume Id like to see for a real capitulation, but high enough I hope.
We still have 2 weeks left in the year, lets hope those that take tax losses dont own anymore FPMI.
I think the 100 number must have come from filings. However, when this number is listed, it lists ETrade (for example) as 1 holder, when there are obviously many. Same goes with Fidelity, or TDAmeritrade, etc. There are many many more than 100, I am sure. I was just kiding around with the 10% of the total posting here.
Boy, the natives are getting restless. Management better start listening, there is already enough downward pressure on the stock.....we dont need the long and strongs losing faith and bailing.
If management is reading this message board.......I think a conference call before months end is an idea that needs to be heard. Tax selling is coming and every single person that owns this stock is sitting on a paper loss. This means any tax loss selling = more downward pressure and unless they want to see the pps at $0.10, they better speak up now.
"Does this mean they have to wait to officially sign a licensing deal until the P2 scans for BFPET come in? Or can they sign one for CardioPET and a separate for BFPET? Im not sure. That’s something I will ask management."
I asked for clarification on this and got it. I misunderstood the 8k. They are only looking at licensing out CardioPET in China, Australia and Singapore right now. The interested party asked for a right of first refusal for both compounds, meaning if someone comes along and offers FPMI a deal, this company has the right to match or beat it. So, they dont have to wait.....a licensing deal for CardioPET could happen anytime.
In addition, lets think about the market cap of this company. It currently sits at $7 million. Lets take a guess and say the deal brings in $5 million upfront cash plus future royalties for the rights to both compounds in China. This sets a price for both compounds IN CHINA (etc.) ONLY at $2.5mil each, or $5 mil total…....thats 70+% of the current value of the entire company......And only includes China, Australia and Singapore!!!!! (Think about the US market alone!!!). This is EXACTLY what we need……a way for investors to value this company. Because right now, we are the only pure play, public, cardiac molecular imaging agent company out there and no one really knows how to value the company outside of management and those deep in the industry. So, assuming this deal gets done with either 1 or both of the compounds, a value for the company can be set and the market will (hopefully) come to its senses with the valuation via the pps and adjust accordingly.
This is how I see it: they just announced that there is a VERY interested party wanting to do a licensing agreement specific to certain geographic areas (areas FPMI wouldn’t be able to get on their own anyway). This potential partner is obviously a VERY interested party.....interested enough to sign a BINDING term sheet. There is no money announced because they haven’t signed the licensing agreement yet. They signed a binding term sheet giving this company the 1st rights to license, pending due diligence.
If you read what is in the announcement, its pretty clear. Because they want to also license BFPET, they extended the DD period long enough for them to be able to see some of the phase 2 images that will be coming over the next couple of months. From someone in the biotech industry, trust me when I say, companies NEED to see phase2 data to sign deals (partnerships, buyouts, licensing agreements, etc).
What overall conclusion can be drawn from this?
In my opinion, this potential partner likes what they see with the CardioPET scans enough to want to license the product. However, they have also seen the P1 BFPET scans and want to license that product, but risk management says they need to see phase 2 data first. So, what does a company do in this situation? They sign a binding term sheet giving them first rights to both compounds with a DD period long enough for them to be able to see the P2 scans from both compounds…..which is exactly what we have here.
Does this mean they have to wait to officially sign a licensing deal until the P2 scans for BFPET come in? Or can they sign one for CardioPET and a separate for BFPET? Im not sure. That’s something I will ask management.
This is a nice turn of events IMO. I think it represents a change in attitude, re: more of a willingness to share information. I don’t think they had to share this. I think they CHOSE to share this. And as a long term investor, I find it refreshing.
A chance to buy in the teens was NOT what I had in mind when I wrote this post.
Just wanted to make that clear.
I think an important thing to note with respect partnership talks, is that these are unblinded data. Meaning FPMI has the scans, and can thus show anyone interested in a partnership.
I guess my point is.....in this case, they really dont have to wait for the final P2 results are out to consider the product derisked. It really could happen any time.
The most important piece of this PR is the fact that they are in partnership discussions and the level of interest in partnering is increasing.
As I have said previously, partners typically wait until the product is derisked to invest (whether via a partnership or a buyout). The "derisking phase" is considered by most in biotech/pharma land to be phase 2. If the data look good, the product is derisked. If the data are suspect, or major questions remain, the derisking occurs during a 2nd P2, in P3 or not at all. I have seen nothing to date that leaves me to believe that CardioPET wont be derisked once the full data are released. Thats when partnership interest turn into partnership offers.
My investment thesis continues to hold true.....i.e., that they partner out CardioPET in some way (e.g., license out the rights in Europe or Asia) to bring in enough cash to fund operations so we dont have to rely on these on-demand financings. Dont get me wrong, I think they were positive for us shareholders in the fact that the company was able to try to ensure the new shareholders were long-term and strong holders and to try to limit dilution. But, I think (hope) the company agrees, the time for those types of financing are over. The balance sheet has scared away many new potential investors.....and nothing shores up a balance sheet like up front cash through a partnership. Giving up some rights (the use of CardiopET in Europe and/or Asia, etc.) could bring in enough cash to make the balance sheet a reason to buy instead of reason not to. My belief is that the good folks at FPMI feel the same way and this is where we are headed.
Based on the letter, it looks like the scans/data, etc., are right now being prepared for the blind read by "qualified and experienced Nuclear Cardiology practitioners".
Also and importantly "The Phase II trial for BFPET is now open for patient recruitment, and "All of the key components are in place to recruit the first subjects"
Pretty good summary, IMO.
I posted a comment to the article correcting a couple of inaccuracies, but overall pretty good.
I like their comment on risk.....i.e., if there isnt news soon, the stock will slowly drip back down.