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Good stuff. Bless you on this Sunday for your diligence. I feel you have identified the reason for PR silence about payments. Thanks again.
Got it. That would be our delight, although it is hard for me to envision anyone shorting this stock, even if an Exchange would permit it, an issue so illiquid.
Solar tech, l find your posts helpful and encouraging. Thanks for your energy and intelligence.
Yes, it is.
You do not know this improbable development is true and that now QMC will implode. That is speculation. Other possible outcomes exist. For example, there may have been a merger or sale of the company now awaiting shareholder approval. There may have been an assignment of QMC ‘s Assam interests for a large sum leaving QMC to carry on elsewhere. We simply do not know. I am confident Squires has good faith. Yes, he has made mistakes but I have not seen the actions of a dishonest man. Have faith in him please.
I have had four similar experiences despite having a significant number of shares.
You are probably correct about the pps dropping below
$.020 if there is no announcement confirming a $1 million deposit. But still bad faith on Squires’
part has not been proven, only his reluctance to keep us timely informed. It is hard to dismiss all the work outlined in the 10 Q as being fraudulent. A positive resolution is likely IMO.
These hyper-efficient solar panels could actually live on your roof soon
https://techcrunch.com/2019/02/19/these-hyper-efficient-solar-panels-could-actually-live-on-your-roof-soon/
This technology could be applied to QMC panels.
Points well made. Thanks
Thank you
Good point. Have no Idea what performance obligation may not have been met unless it might somehow relate to a resolution of litigation, and I doubt that would be a factor. This is another unexplained issue.
Yes, indeed, you are right vajus. The Effective Date of the Amtronics/QMC Agreement was November 19, 2018. $500,000 was due within 30 days and another $500,000 within 60 days of the agreement. Technical default seems to have occurred, but there may have been an extension (maybe a tacit understanding) of another month making the due date Feb. 20th. I don't know and QMC has not offered an explanation to the best of my knowledge. QMC needs to explain more. In the absence of more disclosure and $1 million not being received this month, the pps will almost certainly drop more. I intend to continue buying, however, because bad faith has not been proven yet. CEO Squires seems relatively indifferent to timely but unmandated disclosure.
https://www.sciencenews.org/article/water-purification-light-graphitic-carbon-nitride?utm_source=email&utm_medium=email&utm_campaign=latest-newsletter-v2
This technology offers a fascinating new revolutionary way to purify water. Could QDs of carbon nitride act the same way? The market would be humongous of course.
TedJ
I am apparently not making myself clear. IMO the warrants and options have little significant value as long as the exercise prices are out of the money. I have purposely ignored them as important current considerations.
The vast majority, my estimate is about 99%, have an exercise price $0.05 or higher. Why do you insist on including warrants and options that have little current conversion value in determining current ownership interests? As an example, how many holders in your opinion are going to convert their warrants at $.12 per share when the current price is around $.026 per share if meanwhile they are being paid interest? Warrant and option holders with few exceptions have little incentive to convert and when the exercise prices expire those holders will have presumably no residual value unless there can be recovery of the principals. At current pps forget about warrants and options please.
The point I am laboriously making is that insiders and individuals holding warrants and options are under tremendous stress. Unless the pps rises above $0.05 their warrants, options, convertible debentures will have lost most value unless there are options in the notes allowing them to recover the principals they loaned. Many tens of millions of these instruments expire on or before 2023.
Enough said, I do not want to have to make the same point over and over that at current pps warrants, convertible debentures, options and other convertible instruments have little conversion values. As a result, ownership percentage interests are not what they would seem to be if one included warrant, options and these financial instruments in making determinations.
If one included options and warrants, you are quite right the ownership percentages would change if those instruments were exercised. But very few options and warrants have been exercised because almost all are out of the money. Simply review a 10 K or Q to see that the exercise prices are well above $0.05 with few exceptions. Admittedly, the structure of options and warrants is convoluted and complex but it is clear there are almost none that are in the money. And you are right that options and warrants have no voting rights unless they are exercised.
Regarding the loans made by litigants, I reference 10 K's. For example, the 1o-K of June 30, 2018, page 13 states, "CAUSE NUMBER 17-2033; Hays County, Texas
Two lenders, SBI Investments LLC, 2014-1, and L2 Capital, LLC, asked the Company’ transfer agent, Empire Stock Transfer, Inc., to set aside fifty-million (50,000,000) shares of stock as collateral for four loan agreements the Company had entered into in late March 2017. This joint request occurred despite the fact that or about September 30, 2017 Quantum had repaid $339,000 (plus accrued interest of $10,170) on two of the loans. Subsequently, in November 2017, the Company also repaid $213,650 and $8,636 of accrued interest on two of the remaining loans on their due dates.
On page 14 of the same document it states clearly the four loans amounted to $1.5 million dollars.
"SBI and L2, with new counsel, and Cleveland Terrazas PLLC, brought suit against the Company on October 10, 2017 for $1.5 million on the four notes that had been repaid and were not in actual default, though SBI Investments LLC, 2014-1, and L2 Capital, LLC claimed technical defaults. The court in Hays County granted the Company’s temporary injunction and set the full case for trial. The next day, SBI Investments LLC, 2014-1, and L2 Capital, LLC dismissed their suit against the Company and refiled similar actions in Kansas and Florida on the notes claiming that one note was paid on a Monday when it was due on a Sunday, demanding late payment in stock (they refused cash), and another was paid on a Friday when it was due Saturday, claiming a pre-payment penalty. All three suits are related to the same transactions. The lenders claim 140% interest, attorney’s fees, 20 million shares of stock, and damages. The Company maintains all loans have been paid timely."
In an earlier Email I pointed out that time is running out for holders of Convertible Promissory Notes, Convertible Debentures and other financial arrangements. By 2023 tens of million warrants will expire if the pps is not above $0.05. The principal beneficiaries of expiring warrants will be Directors and Executive Officers as a group of 5 persons, Hoppel and the Carson Group holding altogether about 167 million shares or over 33% insider ownership. Their percentage control would increase as warrants expire. An irony is that the unusual amount of convertible notes expiring over the next three plus years will have provided free financing if the pps does not rise above $0.05 pps. CEO Squires will have been clever indeed.
Considering the average current volume represents about $40,000 or less a day, it would not take much selling to keep the pps below $.05 for a time until significant earnings materialize, and there would be some incentive possibly for one or more large shareholders to engage in selling despite warrants they hold expiring.
An additional incentive to keep pps low, is that two lenders, SBI Investments LLC, 2014-1, and L2 Capital, LLC, will have less incentive to claim up to 50 million shares at a price below $0.05 per share, and they may agree to a deeply discounted settlement that could presumably be paid out of anticipated cash payments this month. When the pps was around $0.10 the litigants were looking for a fast buck, up to $5 million in stock from loans of only $1.5 million.
The putative default according to SBI and L2 was the failure to properly and timely file a Form S-1 with the SEC. That claim and other claims relating to frivolous technical defaults are unlikely to persist with the pps being so low and cash becoming available to pay for a quick settlement for all parties.
QMC claims it has already paid $561,286 (339,000 + 213,650 + 8636) out of the $1.5 million originally loaned by SBI and L2. At a current price of $.025 per share, 50 million shares would be worth $1,250,000, and QMC could legitimately argue it only owes $689,714 equal to about 27.5 million shares at current prices. Assuming QMC receives about $7 million dollars as down payments for two mini Assam reactors this month, QMC will have the means to argue convincingly for a cash settlement of $689,714 or no more than 27 million shares and even fewer shares should the pps rise.. Even accounting for $1.5 million (the original loan amounts) QMC should arguably owe no more than $938,714 not accounting for legal fees and interest. What is not clear is whether or not there are conversion features with the original $1.5 million loans at an exercise price of more than $0.05 that are expiring in a year or two. If so, management would have additional leverage against the litigants, especially if the pps remain low.
Putting an end to this expensive and inane litigation should be a top priority for management. I predict a settlement with the litigants will be reached this year.
I intend to keep buying. At these prices per share stocks are deeply discounted permanent warrants. A DCF analysis should show this to be a fact.
Time is running out for holders of Convertible Promissory Notes, Convertible Debentures and other financial arrangements. By the end of 2020 tens of millions of warrants that can be exercised at $0.12 per share will no longer have value unless the pps rises to that level or higher. Equity compensation plans approved by security holders of warrants and financial rights for about 60 million shares at an average cost of around $0.08 per share will have no value unless the pps rises to that level or higher.
As of today 2/10/2019 the CEO Mr. Squires will lose value in 2,968,750 warrants at an exercise price of $.06 per share and on 6/62019 he will lose value in another 937,500 warrants at an exercise price of $.08 per share unless the pps is above $.08.
In February 2016, the Board of Directors authorized certain performance-based stock options to be earned upon the Company signing its first solitary sales contract worth in excess of $1,000,000 revenue. The option exercise price of the unexercised unearned options is the greater of (i) $0.30 and (ii) the market price when deemed earned by the Board. As of June 30, 2018, options to purchase 8,400,000 shares were outstanding under the 2009 Plan at an exercise price on average of $.05 pps.
The loss of conversion rights implies the rate of dilution will lessen even with $1,000,000 having been received before January 31, 2019 unless the pps will rise above at least $0.05. Upon the receipt of about $7 million presumably this month for the installation of two mini-reactors in Assam, the market value at a pps of around $0.25 is likely to double to above $.05 pps.
Employees, management and financial instrument holders are under stress. More loans for share conversion and services have become less appealing to note and warrant holders, and certainly more so if $1 million is not confirmed as being received in the forthcoming 10 K on February 14th. Then the pps will drop further -- and then I will buy more shares because I believe in the integrity of Mr. Squires despite never having met him.
What follows now will be interesting indeed, but I predict the price will rise above $0.05 within six months. I hope so because then my many shares largely purchased in the last six months at an average price below $0.05 pps will have gained value. On certain days I felt I was the only buyer. I doubt that loneliness will continue.
Morocco in the fast lane with world's largest concentrated solar farm
https://www.cnn.com/2019/02/06/motorsport/morocco-solar-farm-formula-e-spt-intl/
First thin-film solar power industrial park in Middle East | Printed Electronics World
https://www.printedelectronicsworld.com/articles/16481/first-thin-film-solar-power-industrial-park-in-middle-east
Solar panel revolution is in process. QTMM will emerge as one of the leaders.
Egypt is building one of the world’s largest solar parks. I wonder who is supplying the panels.
Https://www.weforum.org/agenda/2019/01/egypt-is-building-one-of-the-worlds-largest-solar-parks/
WAITING, WAITING AND MORE WAITING WHILE ALL IS QUIET ON THE NBS FRONT.
Should it really take until mid-November for the PreSERVE AMR-01 results to be known? I very much doubt that. Why is there this waiting? Is NBS shopping the results for a partnership? When will BAX announce the results of its P3 RENEW study using PCT cells? If BAX already knows the results of the RENEW study as seems likely is it currently in discussions with NBS?
Let’s not forget either the Belgian Federal Agency for Medicines and Health Products (FAMHP) Congestive Heart failure Cardiopoietic Regenerative Therapy (CHART-1) European Phase III trial for C3BS-CQR-1 being conducted by Cardio3 Biosciences in Belgium? Nor should we forget the VSEL studies for radiation exposure. What are their results?
Soon we can expect the filing of an IND following positive PreRESERVE results being published for the preservation of heart function following an AMI. Then there would be enrollment presumably for a P1b/2a study for CHF, the start of a P2 trial for Type I diabetes using Tregs, the start of a P1b/2a trial for steroid resistant asthma using Tregs, the start of a Meta-T P3 trial for melanoma, and God knows what other trials lingering in the minds of management. Any one of these studies would benefit from a partnership in order to fast track a start. Any partnership would probably mirror the CBMG guidelines wherein the partner would pay for study costs except for licensing fees. Meanwhile there will be further demand for PCT's contract development and manufacturing services.
The Aspire Capital financing of up to 30 million even with the 41 million cash probably less estimated to be on the books already will not be enough to finance all the trials that are planned. Nor will another secondary offering following the announcement of good news leading to a rise in pps probably fill the financing hunger impinging upon fertile management imaginations.
The more time that passes increases the likelihood of the announcement of a critical partnership. NBS simply has too much on its plate to continue doing its thing alone much longer. It is not a question of IF there will be a partnership announced but WHEN.
The Gamida Cell purchase by Novartis for 600 million put small cap stem cell companies like NBS in play and a buyout offer remains a definite possibility especially from BAX. The AEGIS projection of a pps of 21 is entirely possible within a year.
Less frustrating here
Finally there is a partnership that makes sense from the standpoint of being non-dilutive. CBMG will pay for the P2 hepatocellular study costs except for licensing fees. I would expect a similarly structured partnership to follow the PreSERVE results. It makes little sense for financially strapped NBS to initiate one study after another if it has to pay for the many studies now pending themselves.
Two P3 trials using PCT stem cells are nearing completion.
These are the Baxter RENEW and Cardio3 trials in the U.S. and Europe respectively.
The results of the RENEW trial are expected around June of this year. Positive RENEW results should have more clinical significance than positive results from the PreSERVE trial by NBS since they would be P3 results rather than P2 results.
The Mayo Clinic has conducted studies using Cardio3 technology that in turn employs PCT stem cells. "It's critical that this new process of cardiopoiesis was achieved in 100 percent of cases, with a very good safety profile," Dr. Terzic one Mayo researcher said. 100% of cases seems an outstanding result to me.
Even if the PreSERVE trial results are negative, the P3 RENEW results are likely to be positive.
Need for financing is obvious, BUT --
Although I suspect it would cost less than 50 million to complete an AMR P3 study, perhaps 25 - 30 million, there is still the meta-t P3 study costing an estimated 25 million and a host of other studies pending. Total financing needs could be approaching 75 million and more. The desperate need for financing is obvious.
Management is not suicidal. That is why a partnership or buyout is likely in the immediate future. Either could be with BAX that is finishing their P3 RESERVE study around June, coincidentally about the same time as the P2 AMR study. BAX could spend as much for COGs using the PCT stem cells in their study as it would cost to initiate a buyout or BAX may elect for a partnership.
Obviously, there are other possibilities including interest from other major pharmaceuticals emerging.
Keep in mind too that Cardio3 Biosciences is finishing a P3 study using PCT stem cells in Europe and CBMG is finishing a P2b study using California Stem Cell technology. More than a dozen studies of various sorts are being done with PCT or CSC technology.
Remember too the Gamida Cell precedent just a month ago of a buyout offer probably in the hundreds of millions of dollars. Many major pharmaceuticals want a stem cell presence.
MR. FEURSTEIN IS MISLEADING
OK, let’s assume what Adam Feuerstein wrote on his blog is correct. “Assuming all 42 patients could have been treated with mela-t, the manufacturing success rate in the phase II study was 22% and median manufacturing time was almost 7 months. Dismal. In fact, 20 patients died waiting for their mela-T to be manufactured.”
In effect, Mr. Feuerstein is predicting that PCT methodology will be just as dismal. Perhaps in any other lab than that of PCT this would be true. However, I am positive that Mr. Feuerstein is no expert in stem cell production.
Mr. Feurstein also adds, “You're right if you suspect making Mela-T isn't easy. Researchers in the study started with 188 melanoma samples, but only 78 adequate cell cultures were grown -- a 41.5% success rate. It took a median of 3.1 months to grow these cancer cells.”
Was median manufacturing time 7 months or 3.1 months? Mr. Feuerstein makes no attempt to explain the discrepancy.
OK, let’s accept that manufacturing these dendritic cancer influenced stem cells, a.k.a. mela-t cells as Mr. Feurstein calls them, is difficult, but not necessarily at PCT. When 42 patients were randomized and studied, using mela-t stem cells where median production time was 3.1 months, results were off the charts in effectiveness with a p=@.001. With a statistical significance of this order, one does not need a large patient pool as Mr. Feurstein complains was not the case.
So really the challenge comes down apparently to NBS being able to manufacture these cancer antigenic dendritic stem cells, i.e. mela-t cells, with a mean production time of 3.1 months or less. We know this is possible because in the P2 study that was the case. Can NBS do this? Of course, it can; it was already done in the P2 study. It would be folly otherwise of NBS to embark upon an estimated expenditure of 25 million dollars to conduct P3 studies using “meta-t” stem cells for Stage 3-4 metastatic melanoma unless PCT staff felt a shorter production time was feasible.
One thing I know for certain is that Mr. Feuerstein is not knowledgeable in stem cell manufacturing and furthermore his logic in presenting his arguments was largely illogical.
How many cures?
This was one of the questions Michael Yorba asked Robin Smith on the Clear Channel interview 4-15-2014 in Dallas. Robin's response was that after acute MI where we are using AMR-001, we plan treatments for brain injury, steroid resistant asthma, autoimmune disorders e.g. Lupus, MS,and wound healing. Where is the funding going to come from to study all these cures and the other studies already planned?
Is Financing a Problem?
How will NBS finance the extensive studies that are pending?
• “In 2014, NeoStem plans to initiate a Phase 3 study for Melapuldencel-T with a primary endpoint of overall survival.” Cost estimated to be 25 million by management.
• “Completion of enrollment in Dr. Bluestone’s Phase 1 trial for type 1 diabetes trial using Treg cells.” Estimated cost 2 million.
• P2 study of Tregs for Type 1 diabetes. Cost to completion in 2015 estimated to be 20 – 25 million.
• P3 study of AMR-001 assuming P2 results are positive. Estimated cost 25 – 30 million to completion in late 2015 early 2016.
• Initiate a Phase 2 chronic heart failure trial in CD34 Cell Program. Estimated initial cost 5 million in 2014. Cost to completion 20 -25 million in late 2015, early 2016.
Estimates are mine except for P3 study for Melapuldencel-T. From the FY 13 report, “Overall, there were ~50% more active clients compared to 2012. Year-end cash balance was $46.1 million.
Operating expenses were $38.5 million compared to $32.8 million in 2012.”
NBS does not have enough cash to conduct all these studies without the help of a major partner unless management was suicidal. A secondary offering in the immediate future at these depressed prices makes little sense. Therefore, a partnership with a major pharmaceutical has become absolutely necessary and will likely be made in the near future.
The announcement of a partnership will lead inevitably to a rise in pps as would positive AMR-001 P2 results, and then assuming a secondary offering follows there could be sufficient funds to carry out remaining studies.
A P3 SPA and fast track approved FDA study
for metastatic melanoma is a very, very big deal. An important question is how will NBS pay for this. A reasonable supposition is that the PreSERVE results due in about two months will be positive and that there will be a secondary offering afterwards. Maybe there will be another partnership (BAX for example) to fund this study. The P2 results for met. melanoma were almost unbelievable with more than a doubling in overall survival. Based upon faith that results that outstanding will get financed somehow or another, I believe that NBS will somehow come up with the estimated 25 million needed to fund the study. I still feel NBS is on its way to @15 later this year.
Dr. Nada represents another Baxter connection.
Douglas W. Losordo, MD, FACC, FAHA was also at Baxter. From the Neostem web site, “Prior to his appointment as the Company’s Chief Medical Officer, Dr. Losordo served as Vice President, New Therapies Development, Regenerative Medicine and Baxter Ventures at Baxter International from October 2011 through February 2013.” There is an excellent chance that Dr. Nada and Losordo will be working for Baxter again if there is a Baxter takeover as many expect.
Cat out of the Bag: Positive results highly likely.
NBS is conducting a PreSERVE P2 trial for acute myocardial infarction (AMI) using its proprietary stem cells AMR-001 (CD 34) administered via coronary arteries. A fourth data monitoring review recommended on March 17, 2014 that the trial continue. At this time BAX is also conducting a RENEW study for Chronic Myocardial Ischemia (CMI) using stem cells purchased from the NBS subsidiary Progenitor Cell Therapy (PCT) that are injected into the heart. Results for both studies are expected coincidentally around July 2014.
Optimism is based on a CADUCEUS (http://www.ncbi.nlm.nih.gov/pubmed/22336189) study using intracoronary cardiosphere derived stem cells and more convincingly a host of European studies using PCT stem cells (http://eurheartj.oxfordjournals.org/content/29/15/1807.full.pdf). Cardio3 BioSciences is partnering with the Mayo Clinic studies using NBS PCT stem cells injected into the heart for heart failure following MIs (http://www.upi.com/Health_News/2014/01/17/Mayo-Clinic-to-test-adult-stem-cells-to-treat-heart-failure/UPI-46731390019847/). Another Mayo researcher, Dr. Terzic, said regarding the use of NBS PCT cells, "It's critical that this new process of cardiopoiesis was achieved in 100 percent of cases, with a very good safety profile." (http://www.mayo.edu/research/discoverys-edge/regenerating-heart-tissue-stem-cell-therapy)
Although 100% cardiopoiesis does not necessarily correlate with 100% improvement in left ventricular function, Dr. Turiks’s assertion seems to let the cat out of the bag that the RENEW results will be positive.
Baxter will be the first out the door
with completion of a P3 study for cardiac disease this year using PCT cells. NBS will be a beneficiary of positive news.
Even if treating Dilated Cardiomegaly is not exactly the same as treating Acute MI (AMI)as Mesoblast or NBS hope to do or Chronic Myocardial Ischemia as BAX hopes to do, many aspects of current treatments are the same, and there will be cross-over usage eventually following approval of PCT stem cells for one or another form of cardiac disease.
Mathematically, there are two immediate outcomes,
these being the results of the RENEW and PreSERVE studies around July of this year. Although the two events are not completely independent of one another since PCT cells are being used in both studies, let us assume they are independent more or less since different routes of administration are being used (myocardial injections versus coronary artery infusions). Independence is also arguable because the RENEW study uses CD 34 stem cells whereas the PreSERVE study uses enhanced CD 34/CC4 stem cells. Admittedly, there would be some interdependence but it would be hard to estimate.
Let us be conservative and assume the probability of the RENEW study being positive is 60% although Dr. Turik affirmed cardiopoiesis was present in 100% of cases, and let us assume additionally that the percentage chance of the PreSERVE study being positive is 70% although the fourth monitoring committee ruled in March 2014 that the study should continue. The point is not whether or not these percentages are accurate but that when there are two future events occurring about the same time the chance of one or the other occurring is greater than the chance of just one isolated event occurring.
If events A and B are independent, the probability that either A or B occurs is: P(A or B) = P(A) + P(B) - P(A and B). Therefore, P (A or B) = .6 + .7 - (.6*.&) + 0.88 or 90% chance. Subjectively, this seems too high a probability and yet there is a very high probability that one or the other studies will be positive, and let us assume that one or the other events being positive would be strong catalysts for NBS.
What should we make of the drop in pps of NBS the last two weeks?
Today the pps of NBS reached a low of 6.23 and rebounded at the close to 7.24. This was a release indicating a bottom.
In the last week the pps of micro-cap ASTM has almost doubled in large part based upon a glowing article by Jason Napodono in Seeking Alpha projecting positive results for its ixCELL-DCM study followed by positive results in a partnered P3 study for DCM. Coincidentally, the pps of ASTM rose while the pps of NBS fell during this same time period. Did some investors initially leave NBS for what they thought were greener stem cell pastures of ASTM? I suspect so.
Mr. Napodono’s projections are based upon financing becoming available for a ASTM P3 study for DCM through a partnership that is yet to be announced. His projections are hugely speculative for this reason alone.
By coincidence the results of the P2b ixCELL-DCM study will be out about the same time as the PRESERVE P2 study of NBS for Acute MI (AMI) and RENEW P3 study of Baxter for Chronic Myocardial Ischemia (CMI).
Who will be first with the most impressive results? It certainly will not be ASTM even in the face of Mr. Napodono’s optimism that the P2b study of ASTM will be positive, a feeling that mirrors my confidence that the RENEW and PRESERVE results will be positive. Mr. Napodono affirmed, “It is clear to us based on the data Aastrom has generated to date that ixmyelocel-T has utility in ischemic DCM.” By implication Mr. Napodono might agree that NBS and BAX results should have utility in DCM. All three studies are using autologous stem cells although ASTM is not using a PCT product.
It is highly likely that ASTM approval for ixmyelocel-T whether for CLI or DCM, if it occurs at all, will follow approval of the Baxter PCT CD 34 product for cardiac disease after the RENEW study is completed. Baxter will be first out the door with P3 results enabling early market share dominance that could easily jeopardize the optimistic Napolono projections for ASTM, a company that remains marginally financed. Today in a follow-up article on ASTM by Michael Sacerdote, Mr. Napodono was far less sanguine than earlier assessments: “I’m saying there is a 20% chance ixmyelocel-T gets to market in either CLI or DCM. That’s pretty skeptical.”
Even if treating Dilated Cardiomegaly (DCM) is not exactly the same as treating Acute MI (AMI) or Chronic Myocardial Ischemia (CMI) many aspects of current treatments are the same, and there will be cross-over usage eventually following approval of PCT stem cells for one or another form of cardiac disease.
If investor confidence in ASTM is warranted because of the effusive Seeking Alpha article of Mr Napodono, more confidence should be directed towards the Baxter and NBS studies and the futures of those companies.
Although there is collaboration between NBS and BAX currently, NBS remains on a fast track for being bought out at my estimated pps of 15 - 20 by Baxter or another pharmaceutical wanting a presence in the stem cell arena. ASTM appears to be a passing fancy likely to implode financially.
Gamida Cell receives buyout offer
that could reach hundreds of millions of dollars
Sources say Swiss drugmaker Novartis made the bid for the Israeli startup that specializes in stem cell medical technology.
By Yoram Gabison | Mar. 19, 2014 | 2:44 AM
http://www.haaretz.com/business/.premium-1.580557
NBS will be next when the results of the Baxter RENEW and Neostem PRESERVE studies are completed around July of this year with excellent results. I expect the Baxter tender offer to be between $15 - 20 per share. In the long run it may be cheaper for Baxter to buy out NBS than pay NBS for the CD 34 stem cells it buys from the NBS subsidiary of PCT.
WOW! 20% of Type 1 Diabetic patients off insulin with Tregs
In the P1 study using Tregs for Type 1 diabetics, 20% of patients came off insulin after four months of therapy. UNBELIEVABLE! Now, this is truly a humongous result in a humongous market. It will be interesting to see how long lasting insulin independence lasts in those Type 1 diabetics who come off insulin after four months. If a second dose is given of Tregs would the percentage coming off insulin increase? A P2 study will start this year to answer questions like this. I’ll bet you there’s talk about a partnership even before the P2 starts with results like those in the P1 study.
At least 20 pps. I have told a close friend that my prediction is 50 or more within five years unless NBS is bought out this year or next. That pps would correspond to a market cap of about 1.5 billion. If the RENEW and PRESERVE trials are positive, the efficacy of PCT stem cells would be established. Partnerships would follow to explore other indications using PCT stem cells. Eventually there would be a study comparing cardiac injection of stem cells as was done in the Baxter RENEW study in contrast to coronary artery injection of stem cells as was done in the NBS PRESERVE study. I like the coronary artery approach available to cardiologists because it is technically more feasible than percutaneous or intrathoracic injections (10 intramyocardial injections into targeted areas of the heart tissue)that would require in most instances the expertise of a thoracic surgeon.
Anyway, my guess is that Baxter will make a tender offer for NBS after it has the results of its RENEW P3 study later this year. It would be speculation as to what pps Baxter might make a tender offer. My guess is it would be between 15 - 20.
There will be huge amounts of cash down the road
From NBS Investor Presentation Mar 2014
COMMERCIAL MANUFACTURING CONTRACT FOR PCT
Est. Peak Annual Sales
2,500 to 5,000 Units $38M to $75M / Yr.
10,000 to 25,000 Units $80M to $200M / Yr.
25,000 to 50,000 Units. $125 to $250M / Yr
Conservatively when Baxter commercializes the PCT CD34-Positive Cells for AMI following completion of the RESERVE study this year, at least 50,000 units will be sold in treating AMI. At that time enough cash could come into NBS coffers to equal the current capitalization. The COGS would then compel Baxter to make a tender offer.
By September of this year, results should be known in large part from two studies: the Baxter Reserve study for AMI using PCT CD34 cells and the PRESERVE P2 NBS study. Both should be positive because of earlier studies in Europe showing positive results for similar studies. The Baxter study uses injection of cells whereas the NBS study injected stem cells through the coronary artery, so there is a difference in administration.
When will there be another secondary offering?
At its current rate of spending, NBS will feel a need for more money within a year. Yes, another secondary offering is inevitable, but when? From the FY 13 report, “Overall, there were ~50% more active clients compared to 2012. Year-end cash balance was $46.1 million. Operating expenses were $38.5 million compared to $32.8 million in 2012.” Another secondary offering will occur a short time after the announcement of positive results from the Preserve study. It will be oversubscribed and the offering price will not be as low proportionately to market price as the last secondary offering.
Baxter P3 trial results will probably be positive
NBS could be a double winner.
On February 28, 2012 Baxter International Inc. (NYSE:BAX) announced it had “initiated a phase III pivotal clinical trial to evaluate the efficacy and safety of adult autologous (an individual's own) CD34+ stem cells to increase exercise capacity in patients with chronic myocardial ischemia (CMI). --- After stem cell mobilization, apheresis (collecting the cells from the body) and cell processing, participants received CD34+ stem cells or placebo in a single treatment via 10 intramyocardial injections into targeted areas of the heart tissue.” As many as 50 clinical sites enrolled 444 patients into this clinical trial. http://clinicaltrials.gov/ct2/show/NCT01508910
The Baxter stem cells were obtained from PCT, a subsidiary of NBS, in this RENEW study. Enrollment ended around December 2013 coincidentally about the same time that enrollment for the NBS PRESERVE P2 study ended. Some results are expected from both studies in about six months (around July 2014) from the end of enrollment around December 2013.
It is not just the announcement of PRESERVE P2 NBS results that could be a significant catalyst for NBS. If results of the RENEW study are positive milestones would probably be due to NBS and there would be future royalties and sales after the therapy is presumably approved.
When will there be a buyout offer?
In a few months the results of the NBS Preserve study will be known. It is likely results will be positive for showing increased cardiac function in patients receiving autologous NBS stem cells via a coronary artery following an MI.
Following the release of the Preserve study results, it is a reasonable bet that BAX will make a buyout offer. Even though BAX is using PCT cells in its P3 study, BAX will not want competition from NBS using a broader and probably more effective batch of stem cells than those BAX used.