Short interest at 4/30/13 (~1.29 million) decreased by ~34% over 3/15/13 (~1.96 million), since it was last reported on the blog, and increased ~69% since 12/13/12 (766K).
Showing posts with label $PVCT.OB. Show all posts
Showing posts with label $PVCT.OB. Show all posts
May 10, 2013
March 26, 2013
Get Shorty (update)
Short interest at 3/15/13 (~1.96 million) increased by ~15% over 2/28/13 (~1.70 million) and ~157% since 12/13/12 (964K).
It is quite possible short interest will increase again when the results of the 3/29/13 period are released on April 9th, barring any sharp increase in share price between now and the end of the month (quarter).
Some shareholders think management is unaware of the growing short interest, or that management believes it is fully or mostly due to preferred share conversions (recall my last short interest-related blog post here) or other reasons save for simple, direct, unabashed and understandable shorting of Provectus stock. It might be hard to fathom why anyone would short PVCT, especially given the cost of the borrow. Some very experienced and savvy capital markets folks who also are shareholders have held the view for sometime the stock indeed is being shorted and the short is accelerating/will accelerate (almost pegging today's number). I've been listening to them for a while.
Management has appeared loathe to overtly discuss such speculation. Until recently.
I think management has had a very quantitative sense short interest has been growing steadily over time. I think they understand, however, there is little or nothing they can do about it without news (e.g., SPA, China, Moffitt, etc.), and perhaps thus don't (won't) discuss it much or at all.
It is very easy to both short and not buy this stock.
That management is acknowledging the situation is good. Perhaps they are adding the short squeeze and cover to the list of news they hope to deliver in the coming weeks and months to propel the share price upwards.
It is quite possible short interest will increase again when the results of the 3/29/13 period are released on April 9th, barring any sharp increase in share price between now and the end of the month (quarter).
Some shareholders think management is unaware of the growing short interest, or that management believes it is fully or mostly due to preferred share conversions (recall my last short interest-related blog post here) or other reasons save for simple, direct, unabashed and understandable shorting of Provectus stock. It might be hard to fathom why anyone would short PVCT, especially given the cost of the borrow. Some very experienced and savvy capital markets folks who also are shareholders have held the view for sometime the stock indeed is being shorted and the short is accelerating/will accelerate (almost pegging today's number). I've been listening to them for a while.
Management has appeared loathe to overtly discuss such speculation. Until recently.
I think management has had a very quantitative sense short interest has been growing steadily over time. I think they understand, however, there is little or nothing they can do about it without news (e.g., SPA, China, Moffitt, etc.), and perhaps thus don't (won't) discuss it much or at all.
It is very easy to both short and not buy this stock.
That management is acknowledging the situation is good. Perhaps they are adding the short squeeze and cover to the list of news they hope to deliver in the coming weeks and months to propel the share price upwards.
March 11, 2013
$PVCT: Get Shorty (Update)
Did short interest drop from the February 15 reporting period? No. Short interest at 2/28/13 (~1.70 million) increased by ~8% over 2/15/13 (1.58 million). The closing share price, over the same period, increased ~27% from $0.62 to $0.79.
Volume has definitely ticked up of late. Regardless of which numbers you use for trading data, the trend line is upward sloping. Note the average monthly volume from Yahoo! Finance (and other monthly numbers) below since January 2012. The closing share price is approaching that last seen in June. Average daily volume is nearly to more than 3 times that of the last several months.
With very limited data, volume has picked up since the release of Moffitt's AACR abstract, which was released about midway through the trading day.
At 9/30/12, the last 10-Q identified 2,941,665 of convertible preferred stock. Revelation ended 2012 with 816,134 shares of such stock (I think the figure reported in the firm's Form 13G is unconverted preferred stock; thus, it must be converted into common stock before it can be sold).
In speaking with Peter last year, and also with equity traders, it seems an "artificial short" is created by the process of convertible preferred shareholders converting their holdings of this security into common stock (which they ultimately or immediately sell). Last year, short interest rose when Revelation was converting much of their preferred stock. Depending on the share certificate transfer process, the quality of the transfer agent, etc., the duration of the artificial short can be swift or lengthy.
One usually associates rising short interest with a falling share price. Short interest and share price are rising together. Is the increasing short interest artificially high because more of the convertible preferred stock issued in March 2010 was converted? The next short interest reporting period of 3/15/13 will be reported March 26. The 10-Q share balances for 1Q13 will be reported around mid-May. By then, all of this navel gazing may and probably will result simply in more fuzz.
Shouldn't the conversion and sale of preferred stock push the price down? For all that selling, there has been buying. And at some point, these preferred stock shareholders run out of stock to sell. Nevertheless, we sadly bid farewell to these preferred stock folks: "Alpha Mike Foxtrot."
Who's buying? Volume, of late, the last few days to be more specific, look more like institutional buying. I speculate a life sciences fund has stepped off the sideline and dipped a toe in the water; however, I cannot confirm such speculation with either Porter, Levay & Rose or Peter. Peter said understanding PV-10's clinical relevance was critical to life sciences investors. Let's see how the rest of this week turns out.
It sounds like progress is continuing to be made towards a China deal, with serious interest I think being drawn from between 5 and 10 partners; however, I think the earliest we can expect to learn about exactly where things stand should be the week of March 18.
Volume has definitely ticked up of late. Regardless of which numbers you use for trading data, the trend line is upward sloping. Note the average monthly volume from Yahoo! Finance (and other monthly numbers) below since January 2012. The closing share price is approaching that last seen in June. Average daily volume is nearly to more than 3 times that of the last several months.
With very limited data, volume has picked up since the release of Moffitt's AACR abstract, which was released about midway through the trading day.
At 9/30/12, the last 10-Q identified 2,941,665 of convertible preferred stock. Revelation ended 2012 with 816,134 shares of such stock (I think the figure reported in the firm's Form 13G is unconverted preferred stock; thus, it must be converted into common stock before it can be sold).
In speaking with Peter last year, and also with equity traders, it seems an "artificial short" is created by the process of convertible preferred shareholders converting their holdings of this security into common stock (which they ultimately or immediately sell). Last year, short interest rose when Revelation was converting much of their preferred stock. Depending on the share certificate transfer process, the quality of the transfer agent, etc., the duration of the artificial short can be swift or lengthy.
One usually associates rising short interest with a falling share price. Short interest and share price are rising together. Is the increasing short interest artificially high because more of the convertible preferred stock issued in March 2010 was converted? The next short interest reporting period of 3/15/13 will be reported March 26. The 10-Q share balances for 1Q13 will be reported around mid-May. By then, all of this navel gazing may and probably will result simply in more fuzz.
Shouldn't the conversion and sale of preferred stock push the price down? For all that selling, there has been buying. And at some point, these preferred stock shareholders run out of stock to sell. Nevertheless, we sadly bid farewell to these preferred stock folks: "Alpha Mike Foxtrot."
Who's buying? Volume, of late, the last few days to be more specific, look more like institutional buying. I speculate a life sciences fund has stepped off the sideline and dipped a toe in the water; however, I cannot confirm such speculation with either Porter, Levay & Rose or Peter. Peter said understanding PV-10's clinical relevance was critical to life sciences investors. Let's see how the rest of this week turns out.
It sounds like progress is continuing to be made towards a China deal, with serious interest I think being drawn from between 5 and 10 partners; however, I think the earliest we can expect to learn about exactly where things stand should be the week of March 18.
February 27, 2013
$PVCT: Get Shorty (Update)
Short interest at 2/15/13 (~1.58 million) increased by ~11% over 1/31/13 (1.42 million). Since January 14, 2011:
Since January 14, 2012:
Volume since the last reporting period (through today's market session) has been 1.8 million shares (assuming this OTC reporting from Yahoo! Finance indeed is accurate; as a reminder, I obtain the short interest figure from the OTC website):
Did short interest drop significantly this week? To the extent it may matter, we'll find out the result of the period ending February 28 on March 11.
The rumor mill has started churning. You would figure it was getting close enough to the likely event outcome that it had to start in ernest at some point. I heard several.
The first rumor purports Peter will return with an agreement (but no cash yet) with a Chinese pharmaceutical partner. The agreement -- call it what you wish (e.g., an MOU, an LOI, etc.) -- thus would allow Provectus to issue a PR (because the agreement would be a material event) revealing the name of the Chinese firm and key provisions of the anticipated license agreement that would form the basis for a definitive contract, which likely would be consummated and funded within 30 to 60 days.
The second, which I won't go into any detail, would lead one to think the Chinese partner is Hisun.
Maxim Group's Dr. Echo Yinghui He, MD PhD, a Senior Analyst who also covers Provectus, purportedly accompanied Peter on his China trip.
Finally, a large Hong Kong-based Provectus shareholder purportedly also joined Peter. From what I gathered, the shareholder's purpose was Reaganesque.
Peters returns Saturday. A PR next week? Maybe...
Since January 14, 2012:
Volume since the last reporting period (through today's market session) has been 1.8 million shares (assuming this OTC reporting from Yahoo! Finance indeed is accurate; as a reminder, I obtain the short interest figure from the OTC website):
Did short interest drop significantly this week? To the extent it may matter, we'll find out the result of the period ending February 28 on March 11.
The rumor mill has started churning. You would figure it was getting close enough to the likely event outcome that it had to start in ernest at some point. I heard several.
The first rumor purports Peter will return with an agreement (but no cash yet) with a Chinese pharmaceutical partner. The agreement -- call it what you wish (e.g., an MOU, an LOI, etc.) -- thus would allow Provectus to issue a PR (because the agreement would be a material event) revealing the name of the Chinese firm and key provisions of the anticipated license agreement that would form the basis for a definitive contract, which likely would be consummated and funded within 30 to 60 days.
The second, which I won't go into any detail, would lead one to think the Chinese partner is Hisun.
Maxim Group's Dr. Echo Yinghui He, MD PhD, a Senior Analyst who also covers Provectus, purportedly accompanied Peter on his China trip.
Finally, a large Hong Kong-based Provectus shareholder purportedly also joined Peter. From what I gathered, the shareholder's purpose was Reaganesque.
Peters returns Saturday. A PR next week? Maybe...
February 23, 2013
February 11, 2013
$PVCT: Get Shorty (Update)
Short interest at 1/31/13 (1.4MM) increased by ~47% over 1/15/13 (964K), the highest it's been in 2 years.
February 4, 2013
$PVCT: $CLSN, the @adamfeuerstein-Ratain Rule, and Provectus in China
Celsion's share price was obliterated last Thursday, down more than 81% and lower than price levels in 2012 before the stock made a dramatic run-up later in the year. On Friday, the stock dropped nearly 13% more. This morning it is down another 10%. Celsion “...announced what appeared to be an absolutely catastrophic failure from their
Phase III heat trial for ThermoDox,” and succumbed to the Feurstein-Rattain rule.
![]() |
| Adam Feuerstein's column here. |
The Celsion deal essentially was a license transaction call option owned by
Hisun. Positive ThermoDox results were necessary for Hisun to exercise its
option to further negotiate an eventual license transaction for China, Hong
Kong and Macau. While Hisun is not one of the top pharmaceutical
companies in mainland China (according to 2011 market caps), based on the table (below) I previously published, I must acknowledge I previously was incorrect about suggesting or implying the no name-ness of Hisun, which launched a joint venture with Pfizer in September 2012, Hisun-Pfizer Pharmaceuticals Co.
I am a big fan, proponent and practitioner of process. Good process doesn’t make a bad deal good, but can make a good deal great. In the case of Provectus, management’s good process could make a good China deal a great one.
Success in China for
Western companies appears based on working with that country's federal government as
a partner, rather than acting antagonistic, ignoring it or not involving it in
one's process.
Engaging in business in China as a foreign entity can be a very challenging endeavor for the largest of multinational corporations, let alone a small biotechnology company like Provectus. Two issues usually arise, the positive resolution of which typically bode well for success: the presence or lack of government support and, depending on the industry sector and business application, sufficient or insufficient intellectual property protection.
Many companies have enjoyed success because of a fruitful and “eyes wide-open” relationship with the Chinese state. When I traveled there a few years ago, that was the message of the CFO of Intel’s Dalian-based organization: see and seek the government as your partner, not your opponent. Just ask how successful Google and Paypal, among others, have been in trying to thwart or circumvent the Chinese government.
A nanotechnology company in which I am a very active shareholder spent a good amount of time, money and resources as it struggled to gain sufficient protection for its products, technologies and intellectual property as it hammered out a relationship with Foxconn to provide certain hand held electronics parts, componentry and coatings to several smartphone OEMs. The end consumer market was not China, but rather the company had to utilize China for manufacturing of products that ultimately would be sold in the U.S. and Europe. In the end, with the necessary support and promises of enforcement of its larger partners, the small nanotechnology company felt sufficiently comfortable and compelled to move forward in China. As a small company, time, money and resources are scarce and have to be adjudicated wisely, sometimes leading to nothing in the end.
Engaging in business in China as a foreign entity can be a very challenging endeavor for the largest of multinational corporations, let alone a small biotechnology company like Provectus. Two issues usually arise, the positive resolution of which typically bode well for success: the presence or lack of government support and, depending on the industry sector and business application, sufficient or insufficient intellectual property protection.
Many companies have enjoyed success because of a fruitful and “eyes wide-open” relationship with the Chinese state. When I traveled there a few years ago, that was the message of the CFO of Intel’s Dalian-based organization: see and seek the government as your partner, not your opponent. Just ask how successful Google and Paypal, among others, have been in trying to thwart or circumvent the Chinese government.
A nanotechnology company in which I am a very active shareholder spent a good amount of time, money and resources as it struggled to gain sufficient protection for its products, technologies and intellectual property as it hammered out a relationship with Foxconn to provide certain hand held electronics parts, componentry and coatings to several smartphone OEMs. The end consumer market was not China, but rather the company had to utilize China for manufacturing of products that ultimately would be sold in the U.S. and Europe. In the end, with the necessary support and promises of enforcement of its larger partners, the small nanotechnology company felt sufficiently comfortable and compelled to move forward in China. As a small company, time, money and resources are scarce and have to be adjudicated wisely, sometimes leading to nothing in the end.
A regional oncology deal in China between Provectus and a Chinese Big Pharma company has been in the works for several calendar quarters. The making of a deal emerged earlier this year in the spring. The company has worked through a process of due diligence, evaluation and negotiation to arrive where it is today.
In late-November, after a good amount of groundwork was laid, Peter traveled to China to meet with potential strategic partners and a bevy of government officials. There are multiple prospective partners for now (all of whom apparently are on the list of the top local pharmaceutical companies according to market cap above), and Provectus still is assessing the optimal one. On the government side, Pete and his intermediaries met, differently, with senior leadership of the office of the Premier of the People’s Republic of China, the Ministry of Health, the Ministry of National Defense, and the State Food & Drug Administration.
In late-November, after a good amount of groundwork was laid, Peter traveled to China to meet with potential strategic partners and a bevy of government officials. There are multiple prospective partners for now (all of whom apparently are on the list of the top local pharmaceutical companies according to market cap above), and Provectus still is assessing the optimal one. On the government side, Pete and his intermediaries met, differently, with senior leadership of the office of the Premier of the People’s Republic of China, the Ministry of Health, the Ministry of National Defense, and the State Food & Drug Administration.
It appears he left China having established a good
working relationship with the government and government officials, a relationship that since has permitted Provectus and its advisors to now work with prospective strategic partners to finalize a license
transaction with a down-selected one on top-line terms and
conditions blessed by the government. Government support of Provectus, PV-10 and the business relationship between the company and the eventual strategic partner has been established, as I think has been the intellectual property protections afforded Provectus (with which I think management is mostly comfortable, or understanding or realistic of how the relationship might work in the context of their IP and its protection or lack thereof).
When Pete returns from his late-February trip to China (this assumes, of course, he does travel), he could bring home a signed deal and the contemplated upfront cash payment. These monies could fund the pivotal MM Phase 3 trial, to-be-finalized HCC (liver cancer) Phase 2/Phase 3 trial and, possibly, and one or two more Phase 1 trials, and contribute to other corporate use of funds.
An interesting situation arises, since the prospective partners all appear to be from the table above, with the China subsidiaries (WFOEs/WOFEs, which I think is unlikely, or acquired domestic subs) of key Western Big Pharma companies. I need to do more homework on this aspect or facet of a potential China deal.
Of course, Pete may not be successful. Deals break down or do not come to fruition for both substantive
and silly reasons. As cliched as the phrase is, only time will tell.
February 3, 2013
$PVCT: Fundraising? Haven't Seen It Yet.
As of the last 10-Q, as at 9/30/12, Provectus had cash and cash equivalents of $1.84MM. In October, per the Q, management raised about $2MM (in which both Eric and Peter participated). The company had just under $4MM going into 4Q12. We are some 4 months later from the end of 3Q12. The 10-K for 2012, with cash balance figures as 12/31/12, comes out in March.
Raising another "slug of money," like management did in October 2012, is a consideration depending on how deal discussions and activity go. Obviously management would prefer partnership agreements that provide cash for operations without punitive equity dilution; that is, raising money at current share price levels.
Right now, such fund raising appears secondary to China potential, other potential (license related) and/or, possibly, news flow (where management uses a piece of its shelf filing to raise money at higher share prices, and thus is less but stil dilutive).
If we can expect a China deal and its upfront payment of multiple tens of millions of dollars at the end of February or thereabouts, that is nearly 5 months later.
Management burned ~$745K per month in Q3. The burn rate has come down, but to what (for us to explore this thought exercise, until it becomes reality once we have the actual data)? $500K? More? Less? At $500K, or an expenditure of $2.5MM through the end of February, perhaps there's a cushion of under $1.5MM. Perhaps $2MM at the end of January.
If we learn of a company fundraising, China is going to take time or may not happen. From what I gather, Craig recently turned down one and maybe two unsolicited requests to invest money in the company, and purportedly told these folks to buy shares in the market.
As each week between now and the end of next month passess, if no money raise is announced or sussed out, a China deal could be a reality (in lieu of other potential or more immediate news flow) because management thinks there is greater certainty of that money arriving, via China, in Provectus' bank accounts.
Raising another "slug of money," like management did in October 2012, is a consideration depending on how deal discussions and activity go. Obviously management would prefer partnership agreements that provide cash for operations without punitive equity dilution; that is, raising money at current share price levels.
Right now, such fund raising appears secondary to China potential, other potential (license related) and/or, possibly, news flow (where management uses a piece of its shelf filing to raise money at higher share prices, and thus is less but stil dilutive).
If we can expect a China deal and its upfront payment of multiple tens of millions of dollars at the end of February or thereabouts, that is nearly 5 months later.
Management burned ~$745K per month in Q3. The burn rate has come down, but to what (for us to explore this thought exercise, until it becomes reality once we have the actual data)? $500K? More? Less? At $500K, or an expenditure of $2.5MM through the end of February, perhaps there's a cushion of under $1.5MM. Perhaps $2MM at the end of January.
If we learn of a company fundraising, China is going to take time or may not happen. From what I gather, Craig recently turned down one and maybe two unsolicited requests to invest money in the company, and purportedly told these folks to buy shares in the market.
As each week between now and the end of next month passess, if no money raise is announced or sussed out, a China deal could be a reality (in lieu of other potential or more immediate news flow) because management thinks there is greater certainty of that money arriving, via China, in Provectus' bank accounts.
January 31, 2013
$PVCT: Refractory scalp #Sarcoma
I wanted to dig deeper into Tan and Nehaus’ letter to the
editor about the “Novel use of
Rose Bengal (PV-10) in two cases of refractory scalp sarcoma.”
Refractory means “resistant to treatment or cure.” So,
refractory scalp sarcoma means a sarcoma
already shown to be resistant to other treatments. “A sarcoma is is
a cancer that arises from transformed cells of mesenchymal origin. Sarcomas
are quite rare. Common malignancies, such as breast, colon,
and lung cancer, are almost always carcinoma.”
The article in ANZ Journal of Surgery is just
another example of PV-10 have a positive effect on tumors.
The first patient previously underwent surgery, which was
followed by radiotherapy to combat his sarcoma. Nodules, however,
appeared afterwards in the area to which radiotherapy was applied. Rose Bengal
(PV-10) was used, and a complete clinical response was attained.
The second patient also underwent, first, surgery and,
second, radiotherapy. Rose Bengal was used with good clinical effect; however,
he subsequently developed pulmonary metastases, which is being combated with a systemic
chemotherapy. It does not appear from reading the letter that the pulmonary mets was challenged with PV-10.
Some would say, quickly: one success and one failure. More
substantively and intellectually honestly: one complete
success and one near success. After all, only two patients were treated, with limited frequency (once per patient) and amount of Rose Bengal treatment, with stunning success given sarcomas are rare. I doubt much successful clinical work has been done on
patients with fibrous histiocytoma. Yet, here Rose Bengal is with near complete success (both patientdespite limited application.
Both patients were treated with PV-10 after first being
treated with surgery and then with radiotherapy, an immunosuppressive therapy.
What happened with the second patient? Maybe surgery removed
a certain antigenic type, and the pulmonary mets are another type that does not
match. Tumor heterogeneity might be interfering (a topic of a blog entry that I
will post in a bit). Maybe all of the high-affinity monoclonal antibodies capable
of killing the tumor were killed by the radiotherapy treatment. How the patient
was first treated (i.e., surgery, radiotherapy) might precipitate the failure
of immune system to ultimately help in the removal of the tumor.
Maybe the patients’ parents didn’t give their now elderly son the proper genes for his immune system to respond. There are a number of these folks in any population, and saving them with any kind of treatment is a near impossibility.
As Craig has long said, and I expect Moffitt to confirm, using PV-10 first, followed if necessary by other treatments is the way to go. In the two cases highlighted by the authors, the approach was backwards. Yet, the “backwards” approach yielded good results on refractory sarcoma. Why backwards? Recall Foote et al.’s past and current work: PV-10 first, followed by radiotherapy. That appears to be the right treatment order.
Maybe the patients’ parents didn’t give their now elderly son the proper genes for his immune system to respond. There are a number of these folks in any population, and saving them with any kind of treatment is a near impossibility.
As Craig has long said, and I expect Moffitt to confirm, using PV-10 first, followed if necessary by other treatments is the way to go. In the two cases highlighted by the authors, the approach was backwards. Yet, the “backwards” approach yielded good results on refractory sarcoma. Why backwards? Recall Foote et al.’s past and current work: PV-10 first, followed by radiotherapy. That appears to be the right treatment order.
Still, and to be intellectually honest, we’re talking about
only two patients. There is much more to do and much more to learn.
January 30, 2013
$PVCT: The @adamfeuerstein-Ratain Rule
A good read is Oncology Micro-Cap Stocks: Caveat Emptor!, a September 2011 article in the Journal of the National Cancer Institute authored and researched by Adam Feuerstein, Senior Columnist at TheStreet, and Dr. Mark J. Ratain, MD, Leon O. Jacobson Professor of Medicine at the University of Chicago Medicine.
The "Feuerstein-Ratain Rule:" If a publicly traded company has a market capitalization under $300MM 120 days before the issuance of public announcements (e.g., press releases, etc.) of its oncology Phase 3 clinical trials results, the trial will fail.
A key paragraph in the authors' article summarizes the essence of their rule:
The rule was tested, for the first time, in 2012 on Keryx Biopharmaceuticals (NASDAQ:KERX) and its drug Perifosine. On April 2, shares of Keryx fell by more than 60%.
0-for-22 (micro-cap).
Up next, in 2013, is Celsion (NASDAQ:CLSN) and ThermoDox. The company has scheduled a conference call tomorrow to present the top-line results from its pivotal Phase III HEAT Study with ThermoDox in combination with radiofrequency ablation (RFA) in patients with intermediate hepatocellular carcinoma versus those patients receiving RFA alone. Celsion had a sub-$200MM market cap about 4 months (120 days) ago. Last week, Celsion announced a development deal with China's Zhejiang Hisun Pharmaceutical.
0-for-23 (micro-cap), or 1-for-23?
It is too early to apply the rule to Provectus because the company is not close to the commencement of its pivotal MM Phase 3 trial and, thus, not close to the public release or announcement of trial data (i.e., interim, preliminary or final).
Nevertheless, it is informative to explore the Feuerstein-Ratain Rule, and keep it in mind as Provectus and its market capitalization approaches public pronouncement time.
For the MM Phase 3 trial, management thinks the company can make at least an April 1 start date should the SPA arrive on or around March 15. Further, management thinks interim data could be available in Q3 or Q4. Enrollment will take some time. The Dacarbazine control arm is expected to collapse within 1 to 2 months or less.
Assuming there is a public announcement of interim results by Provectus in late-Q3 (late-August to September) or Q4 (October to December) 2013 because, for this thought exercise, I assume results are available to announce, where would the company's share price have to be 4 months earlier in regards to the Feuerstein-Ratain Rule?
4 months earlier is early-May to early-September. At least a $300MM market cap is about $2.65 per share.
Between now, essentially the end of January, and early-May to early-September (illustratively), several events are needed or necessary to get Provectus' market cap safely above $300MM, and not have it become fodder for potentially another statistic for the lack of success of oncology micro-cap stocks and their Phase 3 trials:
The "Feuerstein-Ratain Rule:" If a publicly traded company has a market capitalization under $300MM 120 days before the issuance of public announcements (e.g., press releases, etc.) of its oncology Phase 3 clinical trials results, the trial will fail.
A key paragraph in the authors' article summarizes the essence of their rule:
The difference in the market capitalization at day −120 most likely reflects publically available information regarding the phase I and II clinical trials (as well as other factors, including competition and management), which has been incorporated into the market value of a stock. The stock market is known to anticipate future events, as opposed to reacting to the past. Thus, it is not surprising that sophisticated investors are able to judge the probability of success, which is reflected in the share price.The results of their analysis are stark:
...there were no positive trials among the 21 micro-cap companies (ie, companies with less than $300 million market capitalization..., whereas 21 of 27 studies reported by the larger companies analyzed (greater than $1 billion capitalization) were positive.0% (micro-cap) vs. 78% (larger cap).
The rule was tested, for the first time, in 2012 on Keryx Biopharmaceuticals (NASDAQ:KERX) and its drug Perifosine. On April 2, shares of Keryx fell by more than 60%.
0-for-22 (micro-cap).
Up next, in 2013, is Celsion (NASDAQ:CLSN) and ThermoDox. The company has scheduled a conference call tomorrow to present the top-line results from its pivotal Phase III HEAT Study with ThermoDox in combination with radiofrequency ablation (RFA) in patients with intermediate hepatocellular carcinoma versus those patients receiving RFA alone. Celsion had a sub-$200MM market cap about 4 months (120 days) ago. Last week, Celsion announced a development deal with China's Zhejiang Hisun Pharmaceutical.
0-for-23 (micro-cap), or 1-for-23?
It is too early to apply the rule to Provectus because the company is not close to the commencement of its pivotal MM Phase 3 trial and, thus, not close to the public release or announcement of trial data (i.e., interim, preliminary or final).
Nevertheless, it is informative to explore the Feuerstein-Ratain Rule, and keep it in mind as Provectus and its market capitalization approaches public pronouncement time.
For the MM Phase 3 trial, management thinks the company can make at least an April 1 start date should the SPA arrive on or around March 15. Further, management thinks interim data could be available in Q3 or Q4. Enrollment will take some time. The Dacarbazine control arm is expected to collapse within 1 to 2 months or less.
Assuming there is a public announcement of interim results by Provectus in late-Q3 (late-August to September) or Q4 (October to December) 2013 because, for this thought exercise, I assume results are available to announce, where would the company's share price have to be 4 months earlier in regards to the Feuerstein-Ratain Rule?
4 months earlier is early-May to early-September. At least a $300MM market cap is about $2.65 per share.
Between now, essentially the end of January, and early-May to early-September (illustratively), several events are needed or necessary to get Provectus' market cap safely above $300MM, and not have it become fodder for potentially another statistic for the lack of success of oncology micro-cap stocks and their Phase 3 trials:
- The receipt of the SPA around mid-March,
- The closing of the currently contemplated China deal (which should be much larger than Celsion's, assuming the Chinese pharma company exercises its option to do its Celsion deal) in late-February, and
- The release of highly anticipated Moffitt mouse and human data in early-April (e.g., "the closest thing we've seen to a cure for cancer," etc.).
January 29, 2013
January 27, 2013
$PVCT: March Madness 2013

March Madness 2013 begins on Tuesday, March 19 and ends on Monday, April 8. The Final Four will be played in the Georgia Dome in Atlanta, Georgia. I contend this period (including leading into it) will be an important time for the company, its more mainstream awareness, and the share price.
There is a lot of information to digest, from Craig's presentation at the Noble Financial Capital Markets Ninth Annual Equity Conference to Peter's trip to New York City.
PV-10
Most of Pete’s time lately, probably more than anything else it seems (save for another effort), is focused on communicating PV-10's unique immunotherapeutic characteristics in the context of global oncology. You see this manifested in discussions with Big Pharma (as Craig commented at Noble: "interactions with potential global license partners," and by that he does not include just Pfizer) and continued visiting with life sciences investors (trying to get them off the sidelines and into the stock).
PV-10 + “other stuff”
I think Craig et al.’s SITC work (PV-10 + systemic chemotherapy), their upcoming AACR work (PV-10 + systemic immunotherapy), Foote et al.’s expanded work (PV-10 + radiotherapy), and Craig’s skunk works work on more combinatory explorations (e.g., intra-tumoral GM-CSF, systemic interleukin, anti-PD-1 antibodies/agents, etc.) is opening a lot of eyes at Big Pharma and the FDA very wide.
Management is contemplating an MM Phase 1 trial combining PV-10 and ipilimumab (while Craig mentioned this in his Noble presentation, I also followed up). Perhaps the protocol might include the assessment of safety and efficacy in a number of patients with metastatic melanoma (Cohort 1 receives PV-10) and in a number of patients who are taking ipilimumab, an approved treatment for MM (Cohort 2).
As I wrote earlier this week, this combination work of PV-10 + ipi clearly targets and is in response to serious interest from Big Pharma: Bristol-Myers Squibb & ipilimumab/Yervoy and Pfizer/MedImmune-AstraZeneca & tremelimumab (MedImmune in-licensed tremi from Pfizer in 2011 for global development rights to the drug while Pfizer retained rights to specified types of combination therapies).
The liver trials
Let's segue from combination therapies to the expanded liver P1 trial, and what the likely results will mean for the design and very likely outcome of the liver P2/P3 trial. I think there is enough information to speculate (of course, the foundation of the speculation merely is a framework, and not overly substantial) or project success of PV-10 + sorafenib (a systemic drug, so see PV-10 + other stuff above) over the sorafenib-alone treatment arm. Interference studies and other work confirm PV-10 is orthogonal to sorafenib (and lots of other drugs, too): PV-10 does not interact negatively with sorafenib, and appears to enhance sorafenib's benefit by PV-10 first boosting the immune system.
When Provectus announces -- via an upcoming PR -- that patients have begun to be enrolled and treated in the expanded liver P1 trial, the timeline of results making their way to the FDA should not be lengthy. The same FDA group of folks reviewing Provectus’ pivotal MM Phase 3 trial design suitable for an SPA, Division of Oncology Products 2 (DOP2), are the same folks (i.e., DOP2) who will review the company’s liver Phase 2/Phase 3 trial design suitable for accelerated approval.
The hard work, time, energy, resources, expense, etc. exerted to get the SPA for MM should pay-off when it comes time for management to request AA for liver.
The SPA
Barring another eleventh hour request or issue, it appears the SPA should arrive around March 15.
While it certainly is possible that the SPA arrives earlier, I am setting my own expectations for the Ides.
Shelf filings
The pulling of the two $50MM common stock filings still are in process with Provectus’ attorneys. Management believes the act of pulling them is form over substance, since the company will not be using them. I think communicating their intended action to pull them and/or the actual act and notification to the market of pulling them is substantive.
Work continues, and the process of arriving at and consummating a deal progresses. Should Pete travel to China again (he visited there in late-November 2012), it would be to close the deal, the announcement of which should follow via PR and 8-K filing.
In terms of setting my own expectations for this item, a deal could get done by or around late-February. If Celsion's China deal is worth several hundreds of millions of dollars (per the analysts and others commenting on valuation), by comparison I think you're looking at a Provectus China worth at least $1 billion (perhaps as much as $2 billion) with higher upfront, milestone and royalty payments.
India & Japan
As a result of a completed China deal, Provectus’ visibility should be much more pronounced. Deals in India and Japan could follow thereafter, but more of the deal process must progress before I would speculate about timing. India could be accelerate given the level of interest of the top Bio-Pharma players in the country. For now, I’m not setting any expectations.
Moffitt & Reproducibility
Craig expanded in some detail about Moffitt's work in his Noble presentation: their reproduction of his work, his reproduction of their work, their upcoming data release and presentation(s), etc. According to Craig, Moffitt's immunological MOA characterization work results (mouse and human) will be revealed imminently. I think Craig's comments related to reproducibility, particularly in the context of creating and making a product (i.e., PV-10, PH-10), were very important and very true.
I think it is easy, at this point, to connect the dots so as to speculate (identify) about which conference Moffitt will present their highly anticipated results. I still expect forthcoming visibility about these Moffitt results in late-January, and some data released in stages in March, prior to the full dataset being released at the expected conference in early-April.
More valuation-raising work to be done
When I wrote my blog post entitled $PVCT: Immunologic Potential, and thus Value, I set a very lofty valuation for the company, particularly as it related to the expectation of management for an upfront payment ($3 billion at last check) at the end-game. You don't get from $67.65 million (Google Finance's market capitalization for the company as at 1/25/13) to $3 billion in one leap.
Rather, Provectus arrives there in several leaps and bounds, together with perhaps some end-game auctioning momentum and exuberance: China, India, Dermatology, momentum share buying, etc.
Peer-based management compensation proposal coming
As management noted in a previous filing, a peer company-based bonus compensation structure should be part of a new compensation plan that management should introduce with Provectus' next proxy filing likely in late-April.
PH-10
From a review of history, it appeared Provectus was on the cusp of securing a deal to license its dermatology business (i.e., inflammatory skin disorders) in early-2011. Up to that point, management's valuation expectations, on a net present value (NPV) basis, were about $500 million.
No term sheet materialized from the most serious prospective partner, which would have triggered the official hiring of the financial adviser (Bank of America Merrill Lynch) and an auction process involving the other prospective partners. I think the lack of certain desired information at the time, since fulfilled by the Psoriasis Phase 2c trial, created a valuation gap between the prospective lead and Provectus that prevented the parties from coming together on suitable top-line term sheet parameters. Hence, the prospective lead declined to extend a term sheet it knew would be turned down management.
As time progressed (i.e., as the psoriasis Phase 2c trial was completed), a process appears to have been established that paralleled Moffitt's work on PV-10. Namely, a world renowned cancer research center engaged in work, initially at their own expense, to explore and characterize the immunological mechanism of action of Provectus' oncology drug.
In addition to better understanding PH-10 immunologic MOA, and on a related note, more insight into the drug's distinct lack of toxicity is necessary to better inform the FDA and assist in the design of the eventual Phase 3 trial.
It is not unreasonable to analogize PV-10's path to PH-10's, and thus potentially explain the delay in getting to a dermatology license or sale transaction. Immunologic mechanism of action characterization work is being done on PH-10 by a world-class institution to complete the understanding of certain prospective dermatology licensees before they fully commit to jumping into the pool. I think management's NPV figure for the dermatology business has increased significantly to at least $750 million (perhaps as much as $1 billion).
As for expectations, Craig did note in his Noble Presentation that we should look for the company to request a end-of-Phase-II (EOP2) meeting with the FDA. Presumably this announcement, if one is made by the company, or step precedes or signals the extension of a term sheet for dermatology is imminent, inbound or at least very close at hand.
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January 25, 2013
$PVCT: Get Shorty (Update)
Short interest at 1/15/13 (964K) increased by ~26% over
12/31/12 (766K), and was last seen two months ago at 11/15/13 (966K), the
aftermath of the now terminated PVCTP “IPO,” and three-and-half months ago at
9/28/12 (959K), the beginning of the “IPO” chaos.
I am a little surprised, yet perhaps not surprised, by the
uptick in short interest. I can understand why it is happening. There
probably is some modest shorting of the stock (why one would short a penny
stock mystifies me at a very low level; it's like rubber necking in some regard), say a couple of hundred
thousand shares, because of the share price run-up through January 11. It also
could be the balance of the short interest, above the historically
innocuous 400-500K level, is related to the continued conversion of
the preferred shares (hundreds of thousands of shares?) by funds like
Revelation and others.
These funds probably have sold more of their
since-converted-into-common shares earlier in the month and late last month (as
they look to complete their departure from the stock) when buyers from two
locales (one domestic, one international) bought shares. They probably also further
knocked the share price down to current levels, which were of course last seen
before the late-December/early-January share price run-up.
Despite management’s efforts to bring so-called “serious”
life sciences investors into the stock, these folks remain firmly on the
sidelines. I appreciate Peter’s tenacity and persistence.
What will it take to bring the life sciences folks in and
the generalist funds in and/or back? A
little more time: say, a month or two.
For the former, it is looking more and more like what is necessary is the revelation
of the highly anticipated Moffitt data (combined with profound statements like
“…the nearest thing to a cure for cancer we’ve seen.”) A China regional
oncology deal and the SPA will of course help a lot, too. Ironically, both of
these should arrive [very] roughly around the same time as Moffitt’s data, conclusions
and declarative statements begin to be and are fully unveiled.
For the latter, it will take more mass awareness and an
upward moving share price whose momentum-based vortex subsequently draws these
investor types into and back into the stock.
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