It is no secret that I was an outspoken bull on Celsion for the last three years.
While I have quite a lot of sympathy for current shareholders, I personally am 100% out of the stock right now. I had a good exchange with a current bull, and thought it would make the basis for an interesting post.
---
Most important, first:
>>did you flip around and go short?
Nope - I never short.
At the absolute most if I am quite certain of a decline I'll buy puts. Don't *like* the idea or process of shorting - too many problems/games that can be played but I guess this is not the time or place for that. [TH - I have PLENTY of posts here over the years to illustrate my issues with shorting]
>>Did you ever consider that PFS in the control group as a whole was 14.4, BUT what if it is less in other subsets? Such as China's 200 patients? What if PFS in the China subset is only 12?
I considered it, and here's my take:
We had very convincing arguments that we'd be golden if PFS came in anywhere under 17 months or so. (Perhaps you'll recall that although I was extremely bullish my own continued mantra was we should expect around a 14:24 PFS. My control arm projection was almost spot on - but with "not even close" we obviously made some kind of dreadful miscalculation of the hazard ratio.)
So given that 14.4 wasn't close, I hold out very diminishing hopes that even a clear subset at 12 would have been stat-sig.
Add to that, that for a 200 patient subset to achieve 12 when the overall was 14.4, the ex-Chinese group would have been even worse than 14.4.
And the DMC at interim did not halt for failure, which if we weren't close at 14.4, with a subset of ~500 out of 600 at the time showing a 15+ PFS ... I propose that such a situation simply couldn't have happened.
And finally:
>>They will not go bankrupt. They have a lot of cash now, 2 ongoing trials, RCW is VERY promising, and probably what they should have focused on in the first place.....
You are right, BK is not going to happen. But massive dilution has happened, and that cash will disappear faster that you might think. ABLATE is only 80?? patients but they were slow to enroll to conserve cash for HEAT results. Gearing up now cost $. And that is ph2, which they were depending on good HEAT results to allow off-label. By itself ABLATE is not registrational. More money needed! And if you'll recall, even the BS BiotechSage admitted HCC ph1 looked decent and it was MLC and distant mets that posed the problem.
I agree that RCW may be the best shot. But they took ... so ... long ... to enroll even the ph1, I don't see the larger ph2 finishing with results anytime before 2016.
I put a HUGE amount of time, attention, and DD into the bull case. But I am always cogent about what might happen and once the "unthinkable" happened then I have to put credence in the bear case until proved wrong (again). The reward is definitely there, at this price, but the risk is, in my opinion, much worse.
GLTY
Trond
---
So there you go. I followed my principles and took my basis out in the $7s and $8s, but for three years, and the time and effort I put into this, I am not sure I "got my money's worth" here. Another lesson in the minefield called biotech.
Best,
Trond Hildahl
** This is presented for educational and informational purposes only, and should not be construed as personalized legal, tax, investment, or financial advice. My own resources, risk tolerance, and personal situation have been taken into consideration for any trades mentioned and should not be used as a basis for someone else's trades. Stocks may lose value and this is not recommendation to buy or sell this particular issue.
Showing posts with label Celsion. Show all posts
Showing posts with label Celsion. Show all posts
Friday, February 22, 2013
Wednesday, December 19, 2012
Celsion and Oncothyreon
Celsion still is a good investment thesis.
If you have not heard, Oncothyreon had a failed trial this morning and had the share price cut by more than 50%. As a disclosure, I had no position in ONTY but was in it a couple years ago for the continue at the first interim. I do have a lot of friends and colleagues who were in it, some quite heavily, and they are hurting quite a bit this morning.
Celsion has had a number of people who are bullish because of models showing the trial “is running longer than it should, thus it must be doing well.” ONTY, as numerous trials have before this, should serve as a wake-up call to these investors. Fortunately, Celsion’s Thermodox has a plethora of features that allow me to be “watchfully bullish.”
For one, the method of action (MOA) is pretty clear.
Reviewing the concept in extremely basic language, Thermodox is the chemo doxorubicin, covered by a fatty layer. That fatty layer is engineered to be attracted to the “leaky” blood vessels that are found most prominently in tumors. So after Thermodox is infused into the patient, these entities congregate around tumors. When radio-frequency ablation (RFA) occurs, burning away the cancerous tissues, that fatty layers cracks open (it has been compared to a hexagonal soccer ball) and releases the doxorubicin, bathing the tumor and surrounding tissue in the chemotherapeutic agent.
Doxorubicin does two extra things germane to this process:
Its cell-killing activity is heightened by heat. Thus it’s even more effective than normal.
It lowers the temperature of the surrounding tissue. This means heat-activated ablation is more effective, especially in the margin areas that otherwise would not be completely ablated.
Importantly, both RFA and doxorubicin are known processes and drugs, with a familiarity by doctors and the FDA.
I question the models that show the trial is “going long.” We are actually on the schedule put out by management in the prior year. Enrollment took a heck of a lot longer than anyone initially thought. And HCC is a wide-open kind of cancer, where many issues interact and no patient can be said to be “average.” The size and number of tumors, where they are located, and general health (otherwise to the cancer!) all have a lot to do with their prognosis. While generally speaking the median progression-free survival (PFS) should be around 12 months for the RFA-only group in the trial, the clinical sites are at some of the most skilled RFA-practitioners in the world. Patients who are in clinical trials tend to have better outcomes, due partially to the placebo effect, to the improved follow-up care and also simply by the desire to live as evidenced by being willing to enter a clinical trial. I will not be surprised to see PFS for the placebo arm come in higher than 12 months.
The Japanese firm Yakult partnered with Celsion a couple years ago, and before partnering you can be sure they got a peek at the preclinical and other available Thermodox data. At the beginning of 2011 Yakult elected to pay an extra couple million dollars upfront in order to receive a lower-than agreed royalty rate going forward. I cannot imagine how that can be spun as anything but positive. Philips Healthcare has partnered with us using their high-frequency ultrasound (HIFU) technology at the heating mechanism in lieu of RFA. They are paying trial costs, which is a reasonable (and bullish) commitment, also having seen private company data. I think it fair to propose that preclinical and ph1 data are reasonably strong.
The most “squishy” factor to consider is the insider buying. Several officers and directors have recently bought shares on the open market or exercised options or warrants. As a reminder, this takes real money, either straight up or as “income” defined by the IRS, and so it is coming out of these folks’ disposable income. As the old saw goes, insiders can sell for many reasons, but there is only one reason for them to buy.
Alongside that, we need to look at the company’s refusal to do a financing prior to data, and in fact their reiterated commitment NOT to do so very recently. This is pretty much unheard of, and very bullish. Let me be explicit here – the insider buying and no-raise factors are bullish but these people do NOT have much more insight into the trial than investors do. They do not have unblinded info from the interim look, they don’t get “winks and nudges” from the Data Monitoring Committee (DMC), and they cannot trade if they did know such things. But they are the closest to the data and such actions should at least be acknowledged.
In sum, I feel Celsion at a sub $300M market cap is undervalued and eminently tradable. I think the HEAT trial has a very reasonable chance of success and have a 2-month target price of $20.
Disclosure and disclaimer:
I own shares and option of Celsion at the time of this writing and while my positions may change, I have no intention of doing so within three days of this article. My own resources, risk tolerance, and personal situation have been taken into consideration for any trades mentioned and should not be used as a basis for someone else's trades. Stocks may lose value and this is not recommendation to buy or sell this particular issue.
This is presented for educational and informational purposes only, and should not be construed as personalized legal, tax, investment, or financial advice.
If you have not heard, Oncothyreon had a failed trial this morning and had the share price cut by more than 50%. As a disclosure, I had no position in ONTY but was in it a couple years ago for the continue at the first interim. I do have a lot of friends and colleagues who were in it, some quite heavily, and they are hurting quite a bit this morning.
Celsion has had a number of people who are bullish because of models showing the trial “is running longer than it should, thus it must be doing well.” ONTY, as numerous trials have before this, should serve as a wake-up call to these investors. Fortunately, Celsion’s Thermodox has a plethora of features that allow me to be “watchfully bullish.”
For one, the method of action (MOA) is pretty clear.
Reviewing the concept in extremely basic language, Thermodox is the chemo doxorubicin, covered by a fatty layer. That fatty layer is engineered to be attracted to the “leaky” blood vessels that are found most prominently in tumors. So after Thermodox is infused into the patient, these entities congregate around tumors. When radio-frequency ablation (RFA) occurs, burning away the cancerous tissues, that fatty layers cracks open (it has been compared to a hexagonal soccer ball) and releases the doxorubicin, bathing the tumor and surrounding tissue in the chemotherapeutic agent.
Doxorubicin does two extra things germane to this process:
Its cell-killing activity is heightened by heat. Thus it’s even more effective than normal.
It lowers the temperature of the surrounding tissue. This means heat-activated ablation is more effective, especially in the margin areas that otherwise would not be completely ablated.
Importantly, both RFA and doxorubicin are known processes and drugs, with a familiarity by doctors and the FDA.
I question the models that show the trial is “going long.” We are actually on the schedule put out by management in the prior year. Enrollment took a heck of a lot longer than anyone initially thought. And HCC is a wide-open kind of cancer, where many issues interact and no patient can be said to be “average.” The size and number of tumors, where they are located, and general health (otherwise to the cancer!) all have a lot to do with their prognosis. While generally speaking the median progression-free survival (PFS) should be around 12 months for the RFA-only group in the trial, the clinical sites are at some of the most skilled RFA-practitioners in the world. Patients who are in clinical trials tend to have better outcomes, due partially to the placebo effect, to the improved follow-up care and also simply by the desire to live as evidenced by being willing to enter a clinical trial. I will not be surprised to see PFS for the placebo arm come in higher than 12 months.
The Japanese firm Yakult partnered with Celsion a couple years ago, and before partnering you can be sure they got a peek at the preclinical and other available Thermodox data. At the beginning of 2011 Yakult elected to pay an extra couple million dollars upfront in order to receive a lower-than agreed royalty rate going forward. I cannot imagine how that can be spun as anything but positive. Philips Healthcare has partnered with us using their high-frequency ultrasound (HIFU) technology at the heating mechanism in lieu of RFA. They are paying trial costs, which is a reasonable (and bullish) commitment, also having seen private company data. I think it fair to propose that preclinical and ph1 data are reasonably strong.
The most “squishy” factor to consider is the insider buying. Several officers and directors have recently bought shares on the open market or exercised options or warrants. As a reminder, this takes real money, either straight up or as “income” defined by the IRS, and so it is coming out of these folks’ disposable income. As the old saw goes, insiders can sell for many reasons, but there is only one reason for them to buy.
Alongside that, we need to look at the company’s refusal to do a financing prior to data, and in fact their reiterated commitment NOT to do so very recently. This is pretty much unheard of, and very bullish. Let me be explicit here – the insider buying and no-raise factors are bullish but these people do NOT have much more insight into the trial than investors do. They do not have unblinded info from the interim look, they don’t get “winks and nudges” from the Data Monitoring Committee (DMC), and they cannot trade if they did know such things. But they are the closest to the data and such actions should at least be acknowledged.
In sum, I feel Celsion at a sub $300M market cap is undervalued and eminently tradable. I think the HEAT trial has a very reasonable chance of success and have a 2-month target price of $20.
Disclosure and disclaimer:
I own shares and option of Celsion at the time of this writing and while my positions may change, I have no intention of doing so within three days of this article. My own resources, risk tolerance, and personal situation have been taken into consideration for any trades mentioned and should not be used as a basis for someone else's trades. Stocks may lose value and this is not recommendation to buy or sell this particular issue.
This is presented for educational and informational purposes only, and should not be construed as personalized legal, tax, investment, or financial advice.
Saturday, March 10, 2012
Celsion thoughts
I was asked the following question about Celsion raising more money prior to getting results from their HEAT trial....
>>Do you have an opinion on whether they would hang ten on cash until after the HEAT readout?
I was blindsided by the raise immediately after the interim results. That one-two punch really killed us, and only the specter of the 2nd intermi look was what was keeping us above $1.75.
It kind of blows my mind that we're this low - even if we're 7-9 months out. But it is what it is.
I feel fairly confident that as the summer draws nigh, we'll pick up some analyst coverage - and while they may be positive or negative, we're almost sure to add some, "IF they get good results, then my target is $XX" statements. Keep in mind the three targets we have, ($6, 7, and 10 IIRC) all were assuming a continue at interim. So we are so far below those targets it's not even funny (or at least my accounts are not laughing). We do have target reiterations to look forward to, as well as China completing enrollment, DIGNITY/ph2 starting, more ABLATE news, the mysterious product #4, Yakult news in Japan, the ever-present chance of a partnership or buyout, and the clock is always winding down towards Q4 and the 380th event. Today may not be the lowest price we'll see, but odds are in our favor to start a climb upwards - you just need to be patient.
All that does not answer the question, "Do you have an opinion on whether they would hang ten on cash until after the HEAT readout?"
They have been both aggressive and safe at times. Last summer, they starved themselves of cash to see if they could make it through the interim, and then they also raised at the worst possible post-interim time. It would not surprise me to see a raise at any time, but my opinion is they will not do so in the next two months. Once we have a handle on DIGNITY andf ABLATE costs in the next quarters' numbers, I might change my mind! And of course, when the price does get some traction, that begs the company to raise a little.
It probably comes down to how close they really are in partnership talks. Right now, they are fine for cash. Projecting out for 5 quarters, after thinking about the trials going on, we'll definitely need some more. Does it change things that we should *know* HEAT results exactly one year from now? Uh, yeah. So final thought is again the partnership side of things. If they can sign one more regional agreement for Thermodox - only (China, or Europe) and grab a $4M up-front payment, then I think a further raise can wait until we're at the final (and the price should be above $3).
Best regards,
Trond
Disclaimer:
This is presented for educational and informational purposes only, and should
not be construed as personalized legal, tax, investment, or financial advice.
I am long shares of Celsion in my personal accounts, but my holdings are based on my own risk tolerances and situation.
>>Do you have an opinion on whether they would hang ten on cash until after the HEAT readout?
I was blindsided by the raise immediately after the interim results. That one-two punch really killed us, and only the specter of the 2nd intermi look was what was keeping us above $1.75.
It kind of blows my mind that we're this low - even if we're 7-9 months out. But it is what it is.
I feel fairly confident that as the summer draws nigh, we'll pick up some analyst coverage - and while they may be positive or negative, we're almost sure to add some, "IF they get good results, then my target is $XX" statements. Keep in mind the three targets we have, ($6, 7, and 10 IIRC) all were assuming a continue at interim. So we are so far below those targets it's not even funny (or at least my accounts are not laughing). We do have target reiterations to look forward to, as well as China completing enrollment, DIGNITY/ph2 starting, more ABLATE news, the mysterious product #4, Yakult news in Japan, the ever-present chance of a partnership or buyout, and the clock is always winding down towards Q4 and the 380th event. Today may not be the lowest price we'll see, but odds are in our favor to start a climb upwards - you just need to be patient.
All that does not answer the question, "Do you have an opinion on whether they would hang ten on cash until after the HEAT readout?"
They have been both aggressive and safe at times. Last summer, they starved themselves of cash to see if they could make it through the interim, and then they also raised at the worst possible post-interim time. It would not surprise me to see a raise at any time, but my opinion is they will not do so in the next two months. Once we have a handle on DIGNITY andf ABLATE costs in the next quarters' numbers, I might change my mind! And of course, when the price does get some traction, that begs the company to raise a little.
It probably comes down to how close they really are in partnership talks. Right now, they are fine for cash. Projecting out for 5 quarters, after thinking about the trials going on, we'll definitely need some more. Does it change things that we should *know* HEAT results exactly one year from now? Uh, yeah. So final thought is again the partnership side of things. If they can sign one more regional agreement for Thermodox - only (China, or Europe) and grab a $4M up-front payment, then I think a further raise can wait until we're at the final (and the price should be above $3).
Best regards,
Trond
Disclaimer:
This is presented for educational and informational purposes only, and should
not be construed as personalized legal, tax, investment, or financial advice.
I am long shares of Celsion in my personal accounts, but my holdings are based on my own risk tolerances and situation.
Monday, November 28, 2011
Celsion safely past interim look
CLSN released a PR today:
http://www.celsion.com/releasedetail.cfm?ReleaseID=627024
Of which the important parts are shown below:
"Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, announced today that the independent Data Monitoring Committee (DMC) for Celsion's Phase III HEAT Study, a multinational, double-blind, placebo-controlled, pivotal study of ThermoDox® in combination with radio frequency ablation (RFA) for hepatocellular carcinoma (HCC) or primary liver cancer, has completed a planned interim analysis for safety, efficacy and futility and unanimously recommended that the study continue to its final analysis as planned. The DMC evaluated data from 613 patients in its review, which was conducted following the realization of 219 progression-free survival (PFS) events within the study population. A total of 380 events of progression are required to reach the planned final analysis of the study.
Celsion also announced today that the DMC, in its review, followed a statistical boundary determined by the Company using the Lan DeMets implementation of the O'Brien-Fleming spending function. This approach allows for the Company to conduct additional interim efficacy analyses prior to final data read-out at 380 PFS events with no increased risk of statistical penalty. The additional analyses may allow for earlier stopping of the study. Additionally, based on its internally modeled estimates of PFS events, Celsion reconfirmed that 380 PFS events are projected to occur in late 2012.
"The DMC's unanimous recommendation is a significant achievement for Celsion based on the most comprehensive review of the HEAT Study to date, including the first-ever review of efficacy results," said Michael H. Tardugno, Celsion's President and Chief Executive Officer. "Critically, we have the potential to realize a successful outcome to the study prior to its planned completion. We are encouraged by what may be sufficient rationale for conducting an additional preplanned efficacy review prior to the 380 events called for in our protocol, and will seek to amend our Special Protocol Assessment Agreement with the FDA accordingly. We thank the DMC for their work and thorough review, and are grateful for the continued support and enthusiasm from the healthcare community, regulators, our investors and our employees."
The HEAT Study is being conducted under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment, has received FDA Fast Track Designation and has been designated as a Priority Trial for liver cancer by the National Institutes of Health. Target enrollment of 600 patients was reached in August 2011, after which the DMC conducted this interim efficacy analysis based on the realization of 219 progression-free survival events. Consistent with the Company's global regulatory strategy, Celsion is continuing to enroll patients in the HEAT Study in order to randomize at least 200 patients in China, a requirement for sFDA (State Food and Drug Administration) registrational filing in that country and to ensure timely readout of final data. In addition to meeting the U.S. FDA enrollment objective, the HEAT Study has also enrolled a sufficient number of patients to support, in Asia, registrational filings in S. Korea and Taiwan, two very important markets for ThermoDox®."
So - my thoughts are as follows:
Disappointed? Yes - I did think we had a great shot at interim. Funny thing is, we just don't know: was P-value there but OS not enough of a trend? ("totality of the data")
So what do we know?
Safety is not an issue.
Enrollment at 613 (mid/late Sept?) This worries me a little bit. If 600 was ~ 8/5 and enrollment was 613 on 9/19ish, enrollment in China is slow. However, I believe that only those treated and at least one follow up might qualify under the 613. In that case, true enrollment might be closer to 625ish... I will have to follow up with the company here.
219 evaluated as "events". Q was asked at cc about the # past 190 and MT said "not substantial." 29 over = ~15% surplus... in my book that is substantial, but whatever.
The biggie in my estimation is that DMC advised them to seek an amendment to the SPA, instead of "simply" reccing a continue to 380. There is NO reason for this unless they were awfully close to being close enough to stop the trial. There is no other reason - period.
We have enough cash for about 8-11 months, depending on how much burn changes from the mrq. HEAT costs are "over the hump" supposedly but then we're still enrolling to 700, plus ABLATE expenses start. I assume ~1.7-2M a month, yielding my 8-11 months. We've demonstrated that we're willing to scrape the barrel... In my opinion it depends 1) on the FDA chat re the SPA and how soon we decide to take another peek and 2) on how licensing talks with big pharma (BP) go. Now that we're "de-risked" past the interim, BP may be more willing to loosen the purse strings. I repeat: with the DMC rec to amend SPA, the cat is out of the bag.
Was it Rodman & Renshaw that said $6 if a continue? I'm disappointed today, but especially if the overall market rallies, we'll nudge out of the mid $2s soon enough.
-Trond
http://www.celsion.com/releasedetail.cfm?ReleaseID=627024
Of which the important parts are shown below:
"Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, announced today that the independent Data Monitoring Committee (DMC) for Celsion's Phase III HEAT Study, a multinational, double-blind, placebo-controlled, pivotal study of ThermoDox® in combination with radio frequency ablation (RFA) for hepatocellular carcinoma (HCC) or primary liver cancer, has completed a planned interim analysis for safety, efficacy and futility and unanimously recommended that the study continue to its final analysis as planned. The DMC evaluated data from 613 patients in its review, which was conducted following the realization of 219 progression-free survival (PFS) events within the study population. A total of 380 events of progression are required to reach the planned final analysis of the study.
Celsion also announced today that the DMC, in its review, followed a statistical boundary determined by the Company using the Lan DeMets implementation of the O'Brien-Fleming spending function. This approach allows for the Company to conduct additional interim efficacy analyses prior to final data read-out at 380 PFS events with no increased risk of statistical penalty. The additional analyses may allow for earlier stopping of the study. Additionally, based on its internally modeled estimates of PFS events, Celsion reconfirmed that 380 PFS events are projected to occur in late 2012.
"The DMC's unanimous recommendation is a significant achievement for Celsion based on the most comprehensive review of the HEAT Study to date, including the first-ever review of efficacy results," said Michael H. Tardugno, Celsion's President and Chief Executive Officer. "Critically, we have the potential to realize a successful outcome to the study prior to its planned completion. We are encouraged by what may be sufficient rationale for conducting an additional preplanned efficacy review prior to the 380 events called for in our protocol, and will seek to amend our Special Protocol Assessment Agreement with the FDA accordingly. We thank the DMC for their work and thorough review, and are grateful for the continued support and enthusiasm from the healthcare community, regulators, our investors and our employees."
The HEAT Study is being conducted under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment, has received FDA Fast Track Designation and has been designated as a Priority Trial for liver cancer by the National Institutes of Health. Target enrollment of 600 patients was reached in August 2011, after which the DMC conducted this interim efficacy analysis based on the realization of 219 progression-free survival events. Consistent with the Company's global regulatory strategy, Celsion is continuing to enroll patients in the HEAT Study in order to randomize at least 200 patients in China, a requirement for sFDA (State Food and Drug Administration) registrational filing in that country and to ensure timely readout of final data. In addition to meeting the U.S. FDA enrollment objective, the HEAT Study has also enrolled a sufficient number of patients to support, in Asia, registrational filings in S. Korea and Taiwan, two very important markets for ThermoDox®."
So - my thoughts are as follows:
Disappointed? Yes - I did think we had a great shot at interim. Funny thing is, we just don't know: was P-value there but OS not enough of a trend? ("totality of the data")
So what do we know?
Safety is not an issue.
Enrollment at 613 (mid/late Sept?) This worries me a little bit. If 600 was ~ 8/5 and enrollment was 613 on 9/19ish, enrollment in China is slow. However, I believe that only those treated and at least one follow up might qualify under the 613. In that case, true enrollment might be closer to 625ish... I will have to follow up with the company here.
219 evaluated as "events". Q was asked at cc about the # past 190 and MT said "not substantial." 29 over = ~15% surplus... in my book that is substantial, but whatever.
The biggie in my estimation is that DMC advised them to seek an amendment to the SPA, instead of "simply" reccing a continue to 380. There is NO reason for this unless they were awfully close to being close enough to stop the trial. There is no other reason - period.
We have enough cash for about 8-11 months, depending on how much burn changes from the mrq. HEAT costs are "over the hump" supposedly but then we're still enrolling to 700, plus ABLATE expenses start. I assume ~1.7-2M a month, yielding my 8-11 months. We've demonstrated that we're willing to scrape the barrel... In my opinion it depends 1) on the FDA chat re the SPA and how soon we decide to take another peek and 2) on how licensing talks with big pharma (BP) go. Now that we're "de-risked" past the interim, BP may be more willing to loosen the purse strings. I repeat: with the DMC rec to amend SPA, the cat is out of the bag.
Was it Rodman & Renshaw that said $6 if a continue? I'm disappointed today, but especially if the overall market rallies, we'll nudge out of the mid $2s soon enough.
-Trond
Thursday, November 10, 2011
Celsion quarterly call
Following are my notes, in very rough form.
I'm very excited still, but very conscious that an investment here assumes that company guidance for 12 month placebo median PFS is correct. More precisely, it appears that anything up to about 17 months placebo PFS would give great odds at interim, which is 40% worse than guidance! So I am comfortable with such risk, but others need to decide for themselves.
26.6M shares OS, $21.4M cash, Q burn was 6.9M (will slow down somewhat - Q3 was high for HEAT milestone payments)
Acknowledged that burn will decrease slightly simce "hump" of HEAT costs are over in Q3.
380 events "possibly as early as q412".
HEAT enrollment extended to 700.
[me - was 640-650 to allow China to be registrational.]
later in QA acknowledged that 700 will get them to 380 events quicker
No OS (overall survival) bar is set at interim - it is "totality of the data".
Cash should last through 2012 [me- although this would reduce us to scraping the barrel again - doubt they'd go past 2q12]
S Korea and Taiwan are registrational in size, China [believe he said Taiwan in the call, but misspoke] is "quickly approaching" 200.
Japan PMDA still reviewing but no action. Yakult in charge of details of new trial and approach.
ABLATE - data should "closely follow" the approval of TDox. [assuming company guidelines]
Gross margins should be 90%+
SPA says if interim hit FDA would need to be consulted. No specific process.
If only a continue, co guidance is that DMC will only relay that fact. NO EXTRA DATA.
Well placed in terms of competition on horizon.
Co. gets "standard set of data" after continue - but pooled, not broken out per arm - it is still blinded!
No saying when DMC meets or when 190 happened [except we know 190 in 3q11 from the 8k filing. my best guess still second week of Aug '11]
Will not disclose p-value needed at interim. Can figure lots of stat data from that - not fair to all shareholders.
Went to 8-10 weeks for processing data... [believe this incorporates taking "extra care" with data into account w/ the increase over prior 6-8 weeks given]
Not substantially more than 190 events, but included a "safety margin".
Licensing talks continue.
I'm very excited still, but very conscious that an investment here assumes that company guidance for 12 month placebo median PFS is correct. More precisely, it appears that anything up to about 17 months placebo PFS would give great odds at interim, which is 40% worse than guidance! So I am comfortable with such risk, but others need to decide for themselves.
26.6M shares OS, $21.4M cash, Q burn was 6.9M (will slow down somewhat - Q3 was high for HEAT milestone payments)
Acknowledged that burn will decrease slightly simce "hump" of HEAT costs are over in Q3.
380 events "possibly as early as q412".
HEAT enrollment extended to 700.
[me - was 640-650 to allow China to be registrational.]
later in QA acknowledged that 700 will get them to 380 events quicker
No OS (overall survival) bar is set at interim - it is "totality of the data".
Cash should last through 2012 [me- although this would reduce us to scraping the barrel again - doubt they'd go past 2q12]
S Korea and Taiwan are registrational in size, China [believe he said Taiwan in the call, but misspoke] is "quickly approaching" 200.
Japan PMDA still reviewing but no action. Yakult in charge of details of new trial and approach.
ABLATE - data should "closely follow" the approval of TDox. [assuming company guidelines]
Gross margins should be 90%+
SPA says if interim hit FDA would need to be consulted. No specific process.
If only a continue, co guidance is that DMC will only relay that fact. NO EXTRA DATA.
Well placed in terms of competition on horizon.
Co. gets "standard set of data" after continue - but pooled, not broken out per arm - it is still blinded!
No saying when DMC meets or when 190 happened [except we know 190 in 3q11 from the 8k filing. my best guess still second week of Aug '11]
Will not disclose p-value needed at interim. Can figure lots of stat data from that - not fair to all shareholders.
Went to 8-10 weeks for processing data... [believe this incorporates taking "extra care" with data into account w/ the increase over prior 6-8 weeks given]
Not substantially more than 190 events, but included a "safety margin".
Licensing talks continue.
Wednesday, November 2, 2011
Celsion - buy, sell, or hold?
We should be hearing from the DMC (data monitoring committee) regarding the interim results at nearly any moment.
While I am a raging bull as far as Thermodox goes, this is a clinical trial and "anything" can happen. I feel it a very slim-to-none kind of possibility that the trial be stopped for failure, but one has to keep it in mind. If the loss of your dollars here would cause you to lose sleep at night; then it may be time to sell, today.
As long as you can live with that chance, the remaining choices are a recommendation for continuing to the final look or a recommendation for filing for early approval, based on overwhelming statistically significant advantage.
Message boards have been frothy with the odds of success as high as 60% or more. And I have to say, there appears to be some good data backing up such assertations. Nevertheless, the most likely possibility, in my opinion, is simply a continue. So what does that spell, in terms of CLSN's price?
I believe this depends solely (short term) on what data is released with such a recommendation. It is important to note that the DMC does not have to release anything extra. That said, if there is a definite trend, regardless of meeting the higher bar at interim, it is conventionally believed that the committee will say something about the data.
A drop, short term, could easily happen, especially if there is not extra data released. Many stat experts have been saying, contrary to company assertations, that the final look at 380 PFS events will not occur until mid 2013 (company has been guiding for about Q3 2012). With such an extra amount of time in between interim and final, I think the price would drop again to the $2s.
However, with the release of some data, speaking to the improvement seen to date or at least the placebo arm's performance, would go a long way to being able to peg the actual performance of Thermodox. If we can see that at the final, it looks to be a success, we could even see some price appreciation.
A buy here would simply be a lottery ticket for interim success; with normal volatility I'd say a hold here is prudent, again as long as you can stand the possibility of a near 100% loss on an admittedly low chance of trial failure.
Regards,
Trond
While I am a raging bull as far as Thermodox goes, this is a clinical trial and "anything" can happen. I feel it a very slim-to-none kind of possibility that the trial be stopped for failure, but one has to keep it in mind. If the loss of your dollars here would cause you to lose sleep at night; then it may be time to sell, today.
As long as you can live with that chance, the remaining choices are a recommendation for continuing to the final look or a recommendation for filing for early approval, based on overwhelming statistically significant advantage.
Message boards have been frothy with the odds of success as high as 60% or more. And I have to say, there appears to be some good data backing up such assertations. Nevertheless, the most likely possibility, in my opinion, is simply a continue. So what does that spell, in terms of CLSN's price?
I believe this depends solely (short term) on what data is released with such a recommendation. It is important to note that the DMC does not have to release anything extra. That said, if there is a definite trend, regardless of meeting the higher bar at interim, it is conventionally believed that the committee will say something about the data.
A drop, short term, could easily happen, especially if there is not extra data released. Many stat experts have been saying, contrary to company assertations, that the final look at 380 PFS events will not occur until mid 2013 (company has been guiding for about Q3 2012). With such an extra amount of time in between interim and final, I think the price would drop again to the $2s.
However, with the release of some data, speaking to the improvement seen to date or at least the placebo arm's performance, would go a long way to being able to peg the actual performance of Thermodox. If we can see that at the final, it looks to be a success, we could even see some price appreciation.
A buy here would simply be a lottery ticket for interim success; with normal volatility I'd say a hold here is prudent, again as long as you can stand the possibility of a near 100% loss on an admittedly low chance of trial failure.
Regards,
Trond
Tuesday, October 18, 2011
Marketocracy results
Well, I am a big fan of full disclosure, but this is a hard post to write. The Marketocracy website allows anyone to participate in managing a mutual fund - fake of course. Nevertheless, you are bound by some rules; you can't bet it all on one stock, as no one stock can be more than a certain percent of the total. You can't be on margin, and you must be at least 65% invested. If you want to be a sector based fund, then a certain percentage of the holdings must be in that sector. They do all the calculations across months, quarters, and years to figure your returns and most importantly, compare those returns against the other marketocracy funds.
The best of the best are called the M100 - the 100 best performers, long term; culled from the 85,000+ managers and the 100,000+ funds being managed. Those 100 actually make a little money, too - the company uses the best managers' ideas to run an actual mutual fund and those managers are compensated. It is no secret that I firmly intend to be one of those manangers one day.
And that is why I am writing so sheepishly today. They update the quarterly returns quite late - Q2 was just posted about a month ago. And in my Heartstone Health fund (http://www.marketocracy.com/cgi-bin/WebObjects/Portfolio.woa/ps/FundPublicPage/source=CmOhHbFfEfOmLoNbMaKiAbDf), I was the 7th best fund (yes, 7th, not top 7%!!!) for the three month period. For the 3 year returns, for as long as I've HAD the fund for more than 3 years, I've been in the top 89%, and this quarter I came in at #67 overall.
I was ecstatic, of course, but now for the disclosure. Since they posted the results in September, I knew already that my 3rd quarter results were going to equal my second quarter results to the downside. Yes, I fear that I may well be the 7th WORST fund across the universe this coming quarter. Celsion dipped about 40%; VirnetX went from the $30s to about $20; and Dendreon crashed from the $30s to about $10! To be frank, I am not sure if any holding had a positive return in this quarter.
Since I am a sector fund (biotech/healthcare) my beta is quite a bit higher than the S&P 500. Beta is a measure of how volatile I am versus the market-as-a-whole. It is the long term that matters, of course, and I'm fully confident that I will come back and with a vengeance. Bring on the fourth quarter!
Regards,
Trond
The best of the best are called the M100 - the 100 best performers, long term; culled from the 85,000+ managers and the 100,000+ funds being managed. Those 100 actually make a little money, too - the company uses the best managers' ideas to run an actual mutual fund and those managers are compensated. It is no secret that I firmly intend to be one of those manangers one day.
And that is why I am writing so sheepishly today. They update the quarterly returns quite late - Q2 was just posted about a month ago. And in my Heartstone Health fund (http://www.marketocracy.com/cgi-bin/WebObjects/Portfolio.woa/ps/FundPublicPage/source=CmOhHbFfEfOmLoNbMaKiAbDf), I was the 7th best fund (yes, 7th, not top 7%!!!) for the three month period. For the 3 year returns, for as long as I've HAD the fund for more than 3 years, I've been in the top 89%, and this quarter I came in at #67 overall.
I was ecstatic, of course, but now for the disclosure. Since they posted the results in September, I knew already that my 3rd quarter results were going to equal my second quarter results to the downside. Yes, I fear that I may well be the 7th WORST fund across the universe this coming quarter. Celsion dipped about 40%; VirnetX went from the $30s to about $20; and Dendreon crashed from the $30s to about $10! To be frank, I am not sure if any holding had a positive return in this quarter.
Since I am a sector fund (biotech/healthcare) my beta is quite a bit higher than the S&P 500. Beta is a measure of how volatile I am versus the market-as-a-whole. It is the long term that matters, of course, and I'm fully confident that I will come back and with a vengeance. Bring on the fourth quarter!
Regards,
Trond
Sunday, October 16, 2011
Celsion info re: Mangrove
Hello all,
It has been quite awhile since I have updated the blog. I've been a busy beaver on multiple fronts, but I still have great expectation for Celsion. Below, please follow the link to a great interview with Nate August, whose Mangrove Partners, LLP recently took an 8% stake in Celsion, expecting a great result at the interim look of the HEAT trial.
http://celsion.blogspot.com/2011/10/exclusive-interview-with-mangrove.html
Regards,
Trond
It has been quite awhile since I have updated the blog. I've been a busy beaver on multiple fronts, but I still have great expectation for Celsion. Below, please follow the link to a great interview with Nate August, whose Mangrove Partners, LLP recently took an 8% stake in Celsion, expecting a great result at the interim look of the HEAT trial.
http://celsion.blogspot.com/2011/10/exclusive-interview-with-mangrove.html
Regards,
Trond
Thursday, September 8, 2011
More thoughts on Celsion's 190th event
So it looks like the company has probably hit the 190th event... recent PRs talk about "confirming" rather than "achieving" the 190th event.
A reputable poster (biopharmpr) on Yahoo, who also tweets a bit under Magicsia and has a blog with some great info about Celsion, says he spoke with IR and the company is now backing off saying they will PR when the 190 happens.
Supposedly, they are concerned about having more than 190 events by the time they confirm 190 for sure, and then having to explain THAT makes them not want to do so at all. So - it is getting more likely that the next PR about the HEAT trial will end up being the actual interim results!!
I don't like this for several reasons, and I will probably call Jeff Church tomorrow when I can get my thoughts down cogently. But the important things for CLSN investors today are:
Per the last filng, they expect the 190th event in the 3rd Q and results in the 4th Q.
Previous guidance is for 6-8 weeks between the two.
Absolute best case is results by 9/17 -- meaning the 190th occured quite a while ago, has already been confirmed, and the DMC is currently doing the scutwork of visiting sites and checking paperwork ad nauseam... leading to a postulation of the interim results at 8 weeks by 10/1, but being done in only 6 weeks: 9/17/11. I find this extremely unlikely and think Q4 means exactly that.
Worst case would be the end of December. This could happen if radiologic reviews truly take 2-4 months to accomplish, meaning the event probably happened already, the confirms are pending, and might still take a couple months from now. Adding in the 6-8 weeks to compile/check the trial site info, we could be looking at December before knowing results.
I am mostly in shares, but did dabble in Oct and Jan calls. I think Jan are definitely the safest but there could easily be an "October Surprise" by the third Friday of October. I still expect a runup through September to the $5-7 range. As Mr. Market gets wind of the potential of Thermodox (and who doesn't like a binary event thrown in?) there will be some speculators also riding this up.
Regards,
Trond
A reputable poster (biopharmpr) on Yahoo, who also tweets a bit under Magicsia and has a blog with some great info about Celsion, says he spoke with IR and the company is now backing off saying they will PR when the 190 happens.
Supposedly, they are concerned about having more than 190 events by the time they confirm 190 for sure, and then having to explain THAT makes them not want to do so at all. So - it is getting more likely that the next PR about the HEAT trial will end up being the actual interim results!!
I don't like this for several reasons, and I will probably call Jeff Church tomorrow when I can get my thoughts down cogently. But the important things for CLSN investors today are:
Per the last filng, they expect the 190th event in the 3rd Q and results in the 4th Q.
Previous guidance is for 6-8 weeks between the two.
Absolute best case is results by 9/17 -- meaning the 190th occured quite a while ago, has already been confirmed, and the DMC is currently doing the scutwork of visiting sites and checking paperwork ad nauseam... leading to a postulation of the interim results at 8 weeks by 10/1, but being done in only 6 weeks: 9/17/11. I find this extremely unlikely and think Q4 means exactly that.
Worst case would be the end of December. This could happen if radiologic reviews truly take 2-4 months to accomplish, meaning the event probably happened already, the confirms are pending, and might still take a couple months from now. Adding in the 6-8 weeks to compile/check the trial site info, we could be looking at December before knowing results.
I am mostly in shares, but did dabble in Oct and Jan calls. I think Jan are definitely the safest but there could easily be an "October Surprise" by the third Friday of October. I still expect a runup through September to the $5-7 range. As Mr. Market gets wind of the potential of Thermodox (and who doesn't like a binary event thrown in?) there will be some speculators also riding this up.
Regards,
Trond
Tuesday, September 6, 2011
Celsion - To PR (190) or not to PR
An online friend contacted CLSN's IR today regarding the 190th even in the HEAT trial. Instead of regurgitating the content, I am just going to direct you there.
I will note, however, that I am putting less credence on having results by the options expiration in October. I still firmly believe we'll see quite a runup through Sept and October, but anyone betting on the Oct strike timeframe will probably not see the actual results by then.
http://celsion.blogspot.com/2011/09/dont-bank-on-190-pfs-event-press.html
regards,
Trond
I will note, however, that I am putting less credence on having results by the options expiration in October. I still firmly believe we'll see quite a runup through Sept and October, but anyone betting on the Oct strike timeframe will probably not see the actual results by then.
http://celsion.blogspot.com/2011/09/dont-bank-on-190-pfs-event-press.html
regards,
Trond
Tuesday, August 9, 2011
Celsion Q2 conference call
I'm most disappointed that they again missed their guidance on the interim calc - most recently in July, they said they'd have results from the interim by the end of Sept. According to the 10Q (pg 20), they now expect the 190th event "in Q3" and the interim results "in Q4". With 6-8 weeks necessary for that calc, that means the results could be anywhere from 10/1 to 11/25. I thus sold my Oct calls today, perhaps a bit hasty but Jan is now the safest. Still expect a runup, just pushed back again by a month or so.
Everything else looked okay, CRLM trial being initiated, EMA guidance for trial approval by eoy, Japan will start a separate trial from HEAT so as to take different standard of care issues into account - Yakult still responsible for 100% of that new trial costs. RCW Phase 2 trial (Dignity study) will be extended to other indications than just RCW cancer in order to speed enrollment, but that kills the registrational ability.
Please note that pushing out the 190 event was blamed on the slower than expected enrollment, but there is some reason for optimism about how well Thermodox is doing. The trial was based on assuming the placebo (RFA only) would lead to a median PFS of about 12 months and Tdox extending that by 33%. It appears to me that both arms are doing better than assumed, but Tdox by at least the same proportion. I still intend on selling 1/2 to 2/3 on the runup, but I'm getting a bit more excited about interim success.
Regards,
Trond
Sunday, July 31, 2011
Celsion upgrade and expectations
JPMorgan Chase & Co. raised their target price on Celsion on Thursday, to $8.50.
http://www.americanbankingnews.com/2011/07/29/jpmorgan-chase-co-jpm-analysts-raise-price-target-on-celsion-co-clsn-to-8-50/
While typically I would hesitate to even point this out, since Needham is the only analyst thus far to cover the company, I view the addition of JPM to the coverage "stable" as a good thing. With enrollment in the HEAT trial expected to be completed at 600 either this coming week or next, and the 190th Progression Free Survival (PFS) event expected in a similar timeframe, the more eyeballs the better.
They raised another $18M in cash two weeks ago, appearing flush with cash for the first time in years, while maintaining an outstanding share count somewhere around 23M. While they typically have their Q2 earnings call in the first week or so of August, it would not surprise me in the least to see them await these two events before hosting that call - I'm sure the management has no desire to hear all the questions about the trial that they would simply need to be answering within another week!
I still expect a decent runup into August and September; with the price at a post-offering price of $3.83 I'd like to see it hit between $5 and $7 in the next 2-8 weeks. The interim calculation results, still explicitly guided for by the end of September, are expected to take 6-8 weeks after the 600 & 190 events. I'd hazard that the later of those two events will happen by August 12.
I know several readers have advised me they have purchased Celsion shares or options; I still think shares are "safer" but acknowledge the leverage options allow. For me, as a new trade and looking at the October or January calls, I would pay the little extra premium the January strikes demand, for the security of the extra three months.
I hold a pretty large position of CLSN and will be lightening the load in Aug and Sep prior to the interim results.
Regards,
Trond
http://www.americanbankingnews.com/2011/07/29/jpmorgan-chase-co-jpm-analysts-raise-price-target-on-celsion-co-clsn-to-8-50/
While typically I would hesitate to even point this out, since Needham is the only analyst thus far to cover the company, I view the addition of JPM to the coverage "stable" as a good thing. With enrollment in the HEAT trial expected to be completed at 600 either this coming week or next, and the 190th Progression Free Survival (PFS) event expected in a similar timeframe, the more eyeballs the better.
They raised another $18M in cash two weeks ago, appearing flush with cash for the first time in years, while maintaining an outstanding share count somewhere around 23M. While they typically have their Q2 earnings call in the first week or so of August, it would not surprise me in the least to see them await these two events before hosting that call - I'm sure the management has no desire to hear all the questions about the trial that they would simply need to be answering within another week!
I still expect a decent runup into August and September; with the price at a post-offering price of $3.83 I'd like to see it hit between $5 and $7 in the next 2-8 weeks. The interim calculation results, still explicitly guided for by the end of September, are expected to take 6-8 weeks after the 600 & 190 events. I'd hazard that the later of those two events will happen by August 12.
I know several readers have advised me they have purchased Celsion shares or options; I still think shares are "safer" but acknowledge the leverage options allow. For me, as a new trade and looking at the October or January calls, I would pay the little extra premium the January strikes demand, for the security of the extra three months.
I hold a pretty large position of CLSN and will be lightening the load in Aug and Sep prior to the interim results.
Regards,
Trond
Saturday, July 23, 2011
July options
Oops, neglected to update the options expiration on the Port24 last weekend!
I had four stocks with calls sold against them - DNDN, EXEL, NBIX, and PIP. Dendreon and Exelixis expired under the strike price, so I retain the shares. NBIX and PIP were called away (although I retain some extra PIP, as I did not sell calls against the entire position).
The Port positions are shown below; I have $35,397.31 in cash with a 20.5% annualized return as of 7/22/11.
I do expect Celsion to continue its run; HEAT enrollment and the 190th PFS event should occur within 3 weeks now. I intend (in the Port24) to start taking some profits around the $5 mark - I'd bought lots around $2.64 and $2.31.
Regards,
Trond
# / Ticker / (calls sold)
1500 ARQL (0)
1200 BTX (0)
2600 CLDX (0)
9000 CLSN (0)
1600 DCTH (0)
300 DNDN (0)
1100 EXEL (0)
2000 MITI (0)
7000 NNVC (0)
2500 PIP (0)
1600 SGMO (0)
I had four stocks with calls sold against them - DNDN, EXEL, NBIX, and PIP. Dendreon and Exelixis expired under the strike price, so I retain the shares. NBIX and PIP were called away (although I retain some extra PIP, as I did not sell calls against the entire position).
The Port positions are shown below; I have $35,397.31 in cash with a 20.5% annualized return as of 7/22/11.
I do expect Celsion to continue its run; HEAT enrollment and the 190th PFS event should occur within 3 weeks now. I intend (in the Port24) to start taking some profits around the $5 mark - I'd bought lots around $2.64 and $2.31.
Regards,
Trond
# / Ticker / (calls sold)
1500 ARQL (0)
1200 BTX (0)
2600 CLDX (0)
9000 CLSN (0)
1600 DCTH (0)
300 DNDN (0)
1100 EXEL (0)
2000 MITI (0)
7000 NNVC (0)
2500 PIP (0)
1600 SGMO (0)
Monday, July 18, 2011
Celsion HEATing up
Please excuse the title - I promise that is the last time I'll use that atrocious pun.
I spoke to Jeff Church from Celsion Friday morning. Mr Church was the CFO until last Tuesday, when he was promoted to Senior Vice President, Strategy and Investor Relations. I've copied some notes of that chat at the end. Much is not exactly "new" information, but this is the first I've seen of the specific number of patients needed to be considered "registrational" for various Asian countries. My thanks to Mr. Church for taking the time to speak with me!
Please understand that these are MY words, even the text in quotes are my recollection of his words as I took extremely abbreviated notes as we were talking.
Last week the DMC also did a review of the 535 patients already randomized in the HEAT trial and unanimously recommended the trial continue. This gives extra credence to the notion that the upcoming interim look will have no problem at all with a futility analysis. It's interesting to note that this look was not even "supposed" to happen - they had expected enrollment to be completed by now!
A report called "Biorunup" was released on Thursday that calculated a fair market share price of $5.67 to $7.16 at the interim look. I take pride in saying all the way last winter that I expected $5-7 right before the interim look. I still think that is a pretty fair assumption - although I expect several spikes that may take up to $9 or more for brief periods.
Here's to a good-to-great interim look. I am still holding an obscene amount of Celsion in my real money accounts, as well as my Port24 holdings at around 20% and a similar weighting in my Marketocracy mutual fund. I will begin slimming the holdings at around $5.
Regards,
Trond
----
Celsion notes 7/15/2011
Telephone chat w/ Jeff Church
Congrats on promotion.
Can only speak to cash as have publicly released - $2M at eoQ1, raised $18M since. Should have “enough” through calendar year but will need more before filing. [guidance was for ~$1.3M/mo, so should have used 5.2M through eom July = 14.8M at this point]
Addressed payables from Q1 filing as liabilities, have some room to do payments, should not be regarded as immediately gone from cash. Most are CRO payments. These will not go away after enrollment completes, as when patients progress and are followed for OS, still make payments. But they’ll “be over the hump of the bell curve”.
I suggested a direct stock purchase program, helps existing shareholders get new shares first as well as gives company a steady, though small, source of capital that remains under their control. Pretty much dismissed this.
600 enrolled by end of July, “maybe a week into Aug.” 190 PFS events “maybe another week”.
Reiterated interim results by end of September.
Japan needs 60 to be “registrational” – how many in other Asian countries? China = 200 (both control and drug arm), Korea 90, Taiwan 90. China “almost there”.
CRLM trial, timing? Been “lots of planning”, takes some time, his view is most important piece is getting sign off by the review. They have that. Expects trial to start “in Q3”.
NDA has three modules: preclinical, manufacturing, clinical trials. They can use Dox safety and equivalency data for preclinical. Manufacturing will take huge amount of work, registrational batches for drug and stability, facility inspection, etc.
Interim enough for approval, “Possible, not a lot of probability”.
HIFU trial – excited for different heating modalities, get to hard to treat areas. [imagine trying RFA inside a bone!]
Sunday, May 22, 2011
May options expiration
There were certainly some surprises this last month in the Port24. I had sold covered calls against CLDX, ONTY, NBIX, DCTH, and MITI.
All expired harmlessly except for ONTY - it has been rising sharply and were exercised a good 25% above my $4 strike. It hurts to lose the extra amount I might have made, except for two things:
1) would I have actually sold at this price, or would I have sold earlier, or waited and had it go down again?
2) I bought these about a year ago with an average price of $3.46, and sold $0.70 cents of premium along the way... so my net return here has been around 35%.
CLDX just did a secondary offering which knocked it down from exercisable range to the present price. I expect it to be nudging $4 again within a couple months.
NBIX has dropped recently but with Phase 3 trials starting late summer, it should be climbing nicely over the next few months.
Celsion (CLSN) enrollment in the HEAT trial continues to be something I look forward to, over the next two months. They should have hit the 190th PFS event easily by this time and so we'll get to know the results of an interim calculation by the end of Q3 at the latest.
The Port has an annualized return of 17.1% with just over three years. That compares nicely to the S&P being flat over the same period and the Nasdaq gain of 7%.
With ONTY being exercised, I have $28,913.35 in cash and the following holdings:
Shares (calls sold)
2600 CLDX (0)
1200 BTX (0)
2000 NBIX (0)
7000 NNVC (0)
1600 DCTH (0)
3600 PZG (0)
9000 CLSN (0)
2000 MITI (0)
800 SGEN (8)
1600 SGMO (0)
All expired harmlessly except for ONTY - it has been rising sharply and were exercised a good 25% above my $4 strike. It hurts to lose the extra amount I might have made, except for two things:
1) would I have actually sold at this price, or would I have sold earlier, or waited and had it go down again?
2) I bought these about a year ago with an average price of $3.46, and sold $0.70 cents of premium along the way... so my net return here has been around 35%.
CLDX just did a secondary offering which knocked it down from exercisable range to the present price. I expect it to be nudging $4 again within a couple months.
NBIX has dropped recently but with Phase 3 trials starting late summer, it should be climbing nicely over the next few months.
Celsion (CLSN) enrollment in the HEAT trial continues to be something I look forward to, over the next two months. They should have hit the 190th PFS event easily by this time and so we'll get to know the results of an interim calculation by the end of Q3 at the latest.
The Port has an annualized return of 17.1% with just over three years. That compares nicely to the S&P being flat over the same period and the Nasdaq gain of 7%.
With ONTY being exercised, I have $28,913.35 in cash and the following holdings:
Shares (calls sold)
2600 CLDX (0)
1200 BTX (0)
2000 NBIX (0)
7000 NNVC (0)
1600 DCTH (0)
3600 PZG (0)
9000 CLSN (0)
2000 MITI (0)
800 SGEN (8)
1600 SGMO (0)
Tuesday, May 17, 2011
CLSN news, VHC, and Port24 add (SGMO)
I bought 1600 SGMO for the Port at $6.14 this morning. No calls sold yet... this is the second time Sangamo has appeared in the Port24!
Celsion had their conference call for Q1 last Friday. The primary news is that they are about 37 patients away from full enrollment in the HEAT trial. That should be accomplished by mid July so now we have a pretty much fixed timeframe. I expect a runup to occur anywhere from a few days to a month; unfortunately this may coincide with a general market slump and so the effect may be slightly muted. Nevertheless, this is my best opportunity seen in the next couple months.
While I normally look at biotech, I have to mention VirnetX (VHC). I've held it in my real money accounts since $6.50 last June and it is now $23. While of course I wish I'd highlighted it here earlier, I am more confident in it now; while near term it may certainly go lower (high teens, perhaps?) if you hold through the end of the year I think we may see the $30s or $40s. I may explore this further in a future post, but there is some great info out there on the InvestorVillage.com website for VHC.
Regards,
Trond
Celsion had their conference call for Q1 last Friday. The primary news is that they are about 37 patients away from full enrollment in the HEAT trial. That should be accomplished by mid July so now we have a pretty much fixed timeframe. I expect a runup to occur anywhere from a few days to a month; unfortunately this may coincide with a general market slump and so the effect may be slightly muted. Nevertheless, this is my best opportunity seen in the next couple months.
While I normally look at biotech, I have to mention VirnetX (VHC). I've held it in my real money accounts since $6.50 last June and it is now $23. While of course I wish I'd highlighted it here earlier, I am more confident in it now; while near term it may certainly go lower (high teens, perhaps?) if you hold through the end of the year I think we may see the $30s or $40s. I may explore this further in a future post, but there is some great info out there on the InvestorVillage.com website for VHC.
Regards,
Trond
Tuesday, May 3, 2011
Celsion and Micromet
Celsion has had a great week or so. From my 4/20 post at $2.30 advising that it was close to "fish-or-cut-bait" time, we hit $3.50 and are trading around $3.10 today.
I sold 20 May11 $7.50 MITI calls today in the Port24 - only for $0.10 each but that is 1.4% return for two-and-a-half weeks. I have quite a few calls expiring in May so the composition of the Port could well change dramatically within a month or so.
Regards,
Trond
I sold 20 May11 $7.50 MITI calls today in the Port24 - only for $0.10 each but that is 1.4% return for two-and-a-half weeks. I have quite a few calls expiring in May so the composition of the Port could well change dramatically within a month or so.
Regards,
Trond
Wednesday, April 20, 2011
Celsion (CLSN)
It has been a long time coming, but Celsion should be taking the big step forward within the next couple weeks. I have been screaming from the rooftop for weeks now that if you want a position, you need to fish or cut bait pretty quickly.
Presently around $2.30, by the end of June I am forecasting a price in the $5s or $6s. As soon as they complete enrollment in the HEAT trial, several cool things occur.
First, and most importantly, HEAT then gets a "shot on goal" - an interim calculation of how the trial is going. While interim looks typically are very low likelihood of showing statistical significance (and thereby stopping the trial while they apply for approval) from various simulations I believe we may have as high as 25-30% chance of such happening! But even if this does not occur, the final calculation will then be 8-12 months away - locked into a for-real timeline for final results. Funds and institutions tend to shy away from companies depending on interim calcs, but with a less-than-one-year deadline they would be more willing to invest.
Secondly, once HEAT is enrolled, they will immediately start enrollment in the next trial. Combined with the joint venture with Royal Phillips (HIFU guided Thermodox) they will then have three trials up and running in 2011.
Companies with a trial under an SPA, in a huge, unmet medical need like later stage liver cancer, nearing an interim calc should be trading around a $150M to 450M market cap. With Celsion currently listed as around $33M market cap, we'll be looking at a 3x to 10x increase in the few months leading up to full enrollment in HEAT.
Finally, once Japan's PMDA (FDA-equivalent) agrees to allow enrollment to restart in Japan, a couple more events occur. (enrollment was halted at a pre-agreed 18 patients for an extensive safety review - which is not yet complete)
Obviously, having Japan involved in enrollment again gets us to enrollment of 600 more quickly.
Forgotten by some is the fact that our Japanese partner Yakult pays us $2M at this milestone.
While holding through the interim calculation certainly gives the chance for a 20 bagger or more, an investmnet now, holding only into the near-certain runup into the summer should repay us with a double or more.
Regards,
Trond
Presently around $2.30, by the end of June I am forecasting a price in the $5s or $6s. As soon as they complete enrollment in the HEAT trial, several cool things occur.
First, and most importantly, HEAT then gets a "shot on goal" - an interim calculation of how the trial is going. While interim looks typically are very low likelihood of showing statistical significance (and thereby stopping the trial while they apply for approval) from various simulations I believe we may have as high as 25-30% chance of such happening! But even if this does not occur, the final calculation will then be 8-12 months away - locked into a for-real timeline for final results. Funds and institutions tend to shy away from companies depending on interim calcs, but with a less-than-one-year deadline they would be more willing to invest.
Secondly, once HEAT is enrolled, they will immediately start enrollment in the next trial. Combined with the joint venture with Royal Phillips (HIFU guided Thermodox) they will then have three trials up and running in 2011.
Companies with a trial under an SPA, in a huge, unmet medical need like later stage liver cancer, nearing an interim calc should be trading around a $150M to 450M market cap. With Celsion currently listed as around $33M market cap, we'll be looking at a 3x to 10x increase in the few months leading up to full enrollment in HEAT.
Finally, once Japan's PMDA (FDA-equivalent) agrees to allow enrollment to restart in Japan, a couple more events occur. (enrollment was halted at a pre-agreed 18 patients for an extensive safety review - which is not yet complete)
Obviously, having Japan involved in enrollment again gets us to enrollment of 600 more quickly.
Forgotten by some is the fact that our Japanese partner Yakult pays us $2M at this milestone.
While holding through the interim calculation certainly gives the chance for a 20 bagger or more, an investmnet now, holding only into the near-certain runup into the summer should repay us with a double or more.
Regards,
Trond
Saturday, April 16, 2011
Port 24 update
April options expiration came Friday and for the first time in three years my Port24 is without some Dendreon.
DNDN had a great run in the last month - moving from $32 to $42 - and my gamble that it wouldn't break $40 was a bad one. I will probably hold on to the cash for a few days to assess what I want to do. I really am not comfortable with the overall market but there are always places to put money to work.
PZG had a bad week - the first resource report came out and I feel was badly prepared-for by the company. I still look forward to a very good year for Paramount but it may be a couple months of sitting and waiting.
The Port's return is about 18% annualized, as of 4/15. In one month, it turns 3 years old! So I am lagging my desired return of 24% a year quite badly - by 6%! In my defense, for newer readers, I have made two stupid mistakes: 1) with Elan in not taking enormous profits when I could have, and 2) in neglecting the Port for about 9 of the 35 months I've been running it. Those nine months of "lost" covered call returns very well could have made up that 6%.
Even with the mistakes, I will concede that 18% is pretty good. And better, in comparison to the S&P 500 (SPY) and the Nasdaq (QQQQ), I am handily beating the market in the same period. The SPY has returned -0.6% in the 35 month period while the QQQQ's are at 5.7% annualized. So I'm still beating the better of the two by 12.4% per year. That is respectable.
Cash $19,372.85 Position (calls against)
2600 CLDX (26)
2000 NBIX (20)
7000 NNVC (0)
7000 ONTY (70)
1600 DCTH (16)
3600 PZG (0)
9000 CLSN (0)
2000 MITI (0)
800 SGEN (8)
Regards,
Trond
DNDN had a great run in the last month - moving from $32 to $42 - and my gamble that it wouldn't break $40 was a bad one. I will probably hold on to the cash for a few days to assess what I want to do. I really am not comfortable with the overall market but there are always places to put money to work.
PZG had a bad week - the first resource report came out and I feel was badly prepared-for by the company. I still look forward to a very good year for Paramount but it may be a couple months of sitting and waiting.
The Port's return is about 18% annualized, as of 4/15. In one month, it turns 3 years old! So I am lagging my desired return of 24% a year quite badly - by 6%! In my defense, for newer readers, I have made two stupid mistakes: 1) with Elan in not taking enormous profits when I could have, and 2) in neglecting the Port for about 9 of the 35 months I've been running it. Those nine months of "lost" covered call returns very well could have made up that 6%.
Even with the mistakes, I will concede that 18% is pretty good. And better, in comparison to the S&P 500 (SPY) and the Nasdaq (QQQQ), I am handily beating the market in the same period. The SPY has returned -0.6% in the 35 month period while the QQQQ's are at 5.7% annualized. So I'm still beating the better of the two by 12.4% per year. That is respectable.
Cash $19,372.85 Position (calls against)
2600 CLDX (26)
2000 NBIX (20)
7000 NNVC (0)
7000 ONTY (70)
1600 DCTH (16)
3600 PZG (0)
9000 CLSN (0)
2000 MITI (0)
800 SGEN (8)
Regards,
Trond
Thursday, April 7, 2011
More covered calls & Port24 update
Seeing as how option expiration is next week, I decided to get some premium this morning. DNDN Apr $40s for $0.38, DCTH May $9s for $0.50, and SGEN Jun $17.50 for $0.85. Nanoviricides (NNVC) is having a good week, up the $1.50s on more FluCide news. I actually sold a little in my real money portfolios, as I try to trade this one more actively than I sometimes do (this is in an IRA so I don't have to worry about taxes). If you have a 2 to 5 year holding time, this is still not a bad time to buy but I suspect it will be 10 to 20 cents lower in a month or two. The Port24 is back over 20% annualized returns... Dendreon's return to the high $30s as well as Nanoviricide's pop contributed. Celsion has been lagging but I expect within three months it will be the star of the show. I am loaded in CLSN in my real money accounts as well. Cash = $3,390.35 2600 CLDX (26) 400 DNDN (4) 2000 NBIX (20) 7000 NNVC (0) 7000 ONTY (70) 1600 DCTH (16) 3600 PZG (0) 9000 CLSN (0) 2000 MITI (0) 800 SGEN (8) Regards, Trond
Subscribe to:
Posts (Atom)
