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Small Cap Network Blog

9/22/2009

Is it Time to Take a Little CEL-SCI (CVM) Off the Table?

Filed under: — SmallCapNetwork Editor @ 9:11 am

It’s hard to believe that CEL-SCI (CVM), which was only trading at $0.27 when we suggested it in January, has rallied more than 600%, and is currently priced around $1.85. THAT is the reason we focus on small and micro cap stocks… big winners are uncommon, but when you do latch onto one, wow!

That being said, I have two business items to take care of before we go any further.

  1. Just for the sake of smart trading, I think it’s time to at least take partial profits on CEL-SCI, even if temporarily.
  2. Just for the sake of disclosure, I want to make sure there’s no misunderstanding that this site has an indirect compensatory relationship with CEL-SCI.

First things first.

Not only have CVM shares rocketed past resistance around $0.80 recently, today’s peak of $2.10 also matches multi-year highs for the stock… not that it wasn’t deserved. The company’s swine flu technology (LEAPS) may indeed be a game-changer not just for the fight against H1N1, but also a game-changer for the company’s stature in the biotech community. (The U.S. government is interested, for cryin’ out loud.)

Still, a triple-digit rally is a tough thing to hold onto no matter what the cause. So, between the potential brush with long-term resistance and just the sheer size of the recent pop, it may be a smart move to take some profits on CEL-SCI here. (continued below)

Just to be clear, I’m a long-term bull on CEL-SCI. I would be even if we hadn’t picked it in January. I’m also interested in preserving gains though, and my defensive senses are just telling me to shrug of the swine flu euphoria and be smart.

If it’s the wrong move, you can always buy it back later. In fact, the company’s Multikine cancer treatment alone (I think) makes the per-share price worth more than $2.00. That’s a long-term proposition though.

That being said - and not that it matters at this point - you should know that in January, this site received shares from CEL-SCI to present the opportunity to our readers. Since then the entire format for this site has changed; we’re now ad-supported and sponsor-supported, and those shares were transferred to a sister site. So, we still have a vested indirect interest in CVM shares… albeit very indirect

So what? Well, there’s really no ’so what’ to it. We’re clearly not pumping the stock - we’re telling you to lock in profits while you can before a pullback. We’re not even ‘covering’ the stock anymore. We’re just answering any potential questions that may pop up from this follow up discussion. (Normally we’d just drop the coverage and topic altogether, but this is important enough to discuss.)

In any case, that’s what we see right now - simply a chance to lock in a near-term gain, if not for your whole trade, then at least part of it. Just something to think about.

By the way, if you missed out on the bulk of the CEL-SCI (CVM) gain because you didn’t get our initial recommendation, don’t miss out again - subscribe to our newsletter today.

6/9/2009

CEL-SCI (CVM) Fans the Flames With Adaptive Swine Flu Treatment Work

Filed under: — SmallCapNetwork Editor @ 6:49 am

How do you make a biotech stock gain 77% in one day? Have the company unveil a potential treatment for swine flu that (1) works, and (2) doesn’t cause a host of side effects in a swine flu patient that could actually make their illness worse rather than better. Take CEL-SCI Corp. (CVM) as an example. This stock - which had been off the radar for a while - made some big waves on Friday when it gained 77% following an announcement that their L.E.A.P.S. technology could possibly be adapted and turned into a very effective swine flu vaccine.

Exciting? Yep, but a little background may be in order to fully grasp what CEL-SCI offers to investors…. it’s not just a potential swine flu drug.

We actually recommended CEL-SCI back in January, when shares were trading at 27 cents.  For those who stepped in then, you’re up about 50% now. But, the basis of our recommendation wasn’t a swine flu treatment (which wasn’t even needed then). It was Multikine - the company’s impressive head and neck cancer treatment that’s on the verge of entering Phase III testing.

Biotech stocks are funny creatures though. As I mentioned in a column yesterday evening, the group is either hot, or cold… there’s no in between.

Back in January, the biotech environment was fairly cold. No capital-raising deals were being done, lending (and therefore acquisitions and expansion) had dried up, and the stock market was retreating. That’s quite a headwind, so we weren’t surprised to see so many of these stocks struggle. All tings considered, CVM’s sideways movement during that time was a relative victory.

Then, like the flip of a switch, a combination of the swine flu outbreak and the acceptance of immune therapies by mainstream medicine (thanks to Dendreon’s success with its prostate cancer treatment Provenge - an immune therapy) turned the biotech sector’s stocks ‘on’ again. If history holds up, they’ll stay on for quite a while, offering investors a chance at superior gains.

Now recognizing the wind is at our back, let’s fast forward to today.

We knew last Friday that CEL-SCI’s L.E.A.P.S. technology could work as a swine flu treatment, and we saw the stock rally as a result.

As of just a few moments ago, CEL-SCI announced they would indeed be developing a swine flu-specific L.E.A.P.S. treatment. As they put it, “expanded testing”.

On the surface, today’s press release may just look like a repeat of Friday’s news, but it isn’t. The theme is the same… L.E.A.P.S. is adaptable into several treatments, such as a vaccine for avian flu, Spanish flu, and now swine flu. What’s different, however, is that the work CEL-SCI is beginning is designed to fight not just the current strain of swine flu, but any possible mutations that could occur between now and the thick of the next flu season.

The possibility of mutations wasn’t discussed much when swine flu hysteria was running rampant in late April. The rush was to get a treatment on the market fast…. any treatment. Whether it worked great or just barely worked at all was irrelevant - just get it made. And, Sinovac Biotech Ltd. (SVA) seems to have won the initial race….  they’re mass producing a vaccine already.

All well and good, but as I said last night, biotech can’t be rushed. The Sinovac vaccine may work great against a mutated form of H1N1. Or, it might not work at all. One thing I am relatively certain of though….H1N1 will eventually mutate, and could possibly render many vaccine candidates obsolete.

CEL-SCI’s answer to that possibility? Prepare for a mutation now by creating a vaccine that’s able to fight not just the current virus, but the virus strain we could be seeing when swine flu comes around again this winter.

I suspect we’re going to see the stock go wild again today on the news. I hope you were in a position. Our readers have been in since January, finally being rewarded for their patience.

By the way, as impressive as CEL-SCI’s L.E.A.P.S. platform is, that’s not even the highlight of their R&D. Given that biotech in general is back in favor, I’m going to put CEL-SCI front and center again for our readers, as I think it’s one of the best small cap opportunities out there right now. If you want to learn more about what I think’s going to put CEL-SCI up on the same pedestal as Dendreon, stay tuned.

By the way, here’s today’s press release.
Do you want to be informed when CEL-SCI makes its next big announcement? How about exclusive interviews and insights from the company’s management? Get the comments and information you won’t get anywhere else by subscribing to our free newsletter today.

1/12/2009

Take Control of Your Tax Dollars - Contact Your Congressman About Stimulus

Filed under: — SmallCapNetwork Editor @ 2:08 pm

Normally we don’t take activist stances, opting to play the hand we’re dealt rather than trying to predetermine the hand we get. Given the situation though (not just for a particular company, but for our tax money as well), maybe it’s not out of place for us to shake the chains a little, and let our Congressmen hear from us.

If you’ve got something to say to them - and you probably do - we’ll tell you how to do so below. And while you’re at it, you can specifically make a case for the stimulus idea we mentioned this past weekend… the one that would indirectly benefit CEL-SCI (CVM).

To be clear, we’re not ‘advocating’ you do this. We view this like voting… vote with your heart, gut, and mind. We support your decision to vote however you want to. However, we are making this information available to you - and presenting it as a choice - because we think it’s something the majority of you would want to do, if not as investors, than at least as supporters of ongoing healthcare R&D.

Or, if neither of those reasons apply to you, then you’re probably at least interested in how your tax dollars are going to be given to someone else.

The Congressional contact information is at the bottom of this blog entry.

Immediately below is the template letter that CEL-SCI’s CEO Geert Kersten provided to us. I recommend you read it and/or modify it to really say what you want to say, though the letter in itself is quite effective as-is. The point is the same either way though… if you agree with the idea, tell Congress you’d  rather see the stimulus plan support this kind of research and development, as opposed to something they might have a personal interest in.

Anyway, here’s the basic form letter you might want to start with…

Re: Economic stimulus act help for tax and capital formation policies designed to promote innovation and job creation for America’s cutting-edge and research-intensive small companies, particularly biotechnology companies.Dear:

I applaud your commitment to economic stimulus legislation early in the 111th Congress. As part of this recovery plan, we respectfully urge you to include tax and capital formation policies designed to promote innovation and job creation for America’s cutting-edge and research-intensive small companies, particularly biotechnology companies.

Our nation’s small biotechnology companies, for example, are involved in the development of next-generation technologies to treat and cure diseases, yet are struggling to raise the necessary capital to survive the current financial crisis. Compared with 2007, funding raised by small biotech companies, both private and publicly-traded, has decreased by nearly 60 percent. The market for raising capital for these companies is now closed. Roughly one-third of small public biotech companies are currently operating with less than 6 months of cash-on-hand and nearly half have less than 1 year of cash remaining. In 2008, funds raised from initial public offerings (IPOs) have fallen a staggering 97 percent. Further, more and more small biotech companies throughout the United States have been forced into bankruptcy due to the financial crisis. These companies cannot simply be mothballed and resurrected when times are better. If Congress does not help quickly, a whole generation of new medicines will be destroyed in just a few months.

Small life sciences companies are a key component of the intellectual infrastructure of America’s 21st century economy. We fear that if no action is taken by the Congress to address the capital crisis facing small biotech companies, additional bankruptcies will occur, the search for new treatments will be threatened, and current drug development trials might be canceled. Additionally, the industry’s high-wage, high-skill American jobs will be put at risk. If small R&D-intensive companies are allowed to fail due to the current capital crisis, America’s overwhelming competitive edge in a variety of cutting-edge industries, such as biotechnology, could be lost.

As such, we urge you to include in the economic stimulus bill a provision allowing small companies to accelerate the use of their tax assets, such as net operating losses (NOLs), in order to receive critical funding now in return for giving up these tax benefits in the future. To ensure a stimulative effect for the economy, under this proposal any new funds received by companies would be required to be used for R&D activities in the U.S. or else would be recaptured by the U.S. Treasury.

Please insist on inclusion of this program for small cutting-edge and research-intensive small companies before signing off on this bill. The US used to be leading in finance and biotechnology. Now it is only leading in biotechnology, and unless Congress helps, that lead will be destroyed as well. Both the Canadian and British governments are working on similar support for their biotechnology companies, and we cannot yield the leadership to those nations. Too many high-wage high skilled jobs depend on this industry and too many of us depend on the new medicines that come from biotechnology.

Sincerely,

Just to reiterate, if you don’t believe in your heart that this is the right thing to do, don’t do it. The greatest part about this country is that we all have a say. You don’t have to side with the majority, and you can still fight a battle you know you’re going to lose… no hard feelings.

On the other hand, the first wave of bailout money (the first $350 billion from October) provided funds for ridiculous crap such as wooden toy bows and arrows and a rum company. Given the choice of how this money is allocated - which it will be, somewhere - I’d rather see it do some real good for the larger good. If we don’t tell ‘em where to use it, somebody else will.

While we’re at it, please feel free to modify or append the letter. Or, write your own. Or, write a different one that has to do with something else regarding any stimulus plan. We’ve been unheard long enough - let’s at least be heard this time.

Here are the links you can use to contact your appropriate Senators and Representatives. It probably goes without saying, but I will just to be sure… please don’t use this information to send spam, pointless inflammatory remarks, needless profanity-laden prose, or anything like that. That’s just waste of their time, and yours. The more legitimate your letter is, the more effective it will be.

Senators
http://www.senate.gov/general/contact_information/senators_cfm.cfm

Representatives
https://writerep.house.gov/writerep/welcome.shtml

Did you know there are some thoughts and comments that only appear in the e-mail version of our newsletter? That’s right - if you’re just reading the blog or the online version of the newsletter, you’re not getting everything. Be sure to sign up for it today.

8/20/2008

CEL-SCI (CVM) Signs Teva as Licensee, Stock Goes Wild

Filed under: — SmallCapNetwork Editor @ 5:37 am

It had been a while since we heard anything from biotech company CEL-SCI (CVM), but that changed yesterday with a fat dose of encouraging news. Teva Pharmaceuticals (TEVA) has been signed as an exclusive licensee of CEL-SCI’s cancer treatment - Multikine - for Turkey and Israel. What’s interesting here is that Teva got on board even before Phase III testing for Multikine has started.

Of course, Phase III is mostly an FDA-mandated stage, so the same testing requirements may not apply in other countries before a drug is approved for public use. Even so, Multikine is not quite ready to be put on the shelf anywhere…at least not until some more efficacy and benefit data is gathered. So, for Teva to sign a contract at this juncture indicates a fair amount of faith that Multikine will indeed be approved in the two afore-mentioned countries. And, that ‘faith’ is also coming in the form of dollars - Teva is putting up some money for Phase III testing.

I don’t know how big the head-and-neck cancer market is in Turkey and Isreal. I’m sure it’s not the biggest market either company is eyeing. However, even a small market can get the revenue ball rolling.

The press release also mentioned something I think we should never forget about Multikine…all the work and regulatory hoop-jumping so far has focused on using the cancer treatment only for head-and-neck cancer. But, Multikine is also known to be effective for all types of tumors, regardless of location. It’s just particularly more effective than most alternative head-and-neck cancer drugs.

I think what the company is doing is taking the path of least resistance - a wise move. The drug has already been ‘fast tracked’ by the FDA, so the odds of getting it approved as a head-and-neck cancer treatment in most countries are very good. Once that happens, it’ll be much easier to win approval for its use against other tumors.

Good news? You bet. So what happens with the stock? It surges….for a few moments. Then it sank into the red and closed out with about a 10% loss.

If you’re asking how that can happen following the best news in months from CEL-SCI, you’re not alone. My answer is simple…when has the market ever been logical?

Specifically, I think what we saw as just a case where CVM had hit new 52-week highs, and impatient owners just started taking profits. That profit-taking, however, started an avalanche that tripped a lot more owners up along the way; I’m guessing there were a lot of stops around - and slightly above - 60 cents.

Here’s my take on the matter….eventually, all stock prices are justified. In the short run, they may or may not be. Personally I think CEL-SCI is a long-term holding anyway, since Phase III won’t be over for at least a couple of years. That’s why I don’t really care what happens in the meantime, good or bad.

On the other hand, other traders clearly don’t have the same point of view. They ended up being net sellers yesterday. Maybe it was a case of ‘buy the rumor, sell the news’ (though it was the fastest case of it I’ve seen in a while).

Either way, whether you’re an investor or a trader, I don’t think Tuesday is the day to worry about. I think today (Wednesday) and the next few days will really tell the tale. Hyper-volatility can skew the true picture.

cvm

Are you a subscriber to the Small Cap Network newsletter? If not, you’re missing out on some great trading ideas and exclusive market commentary. To sign up, just go to the top right corner of any page of our website. You’ll be joining thousands of other subscribers who have already benefited from our news and views.

6/19/2008

CEL-SCI (CVM) Pops on Rheumatoid Arthritis Treatment News

Filed under: — SmallCapNetwork Editor @ 8:10 am

I really thought this week’s news would get biotech stock CEL-SCI (CVM) moving again. And it did…..for a while. We saw little follow-through on the chart though. Even so, CEL-SCI is still one of our favorite longer-term ideas.

If you didn’t hear, CEL-SCI announced they’ve discovered an effective treatment for rheumatoid arthritis. They’re calling it CEL-2000 for now; it’s a vaccine/peptide that so far seems to be as effective - if not more effective - than the leading RA treatment. That’s not to say CEL-2000 is ready for the market. It’s got a lot more R&D to go, not to mention it has to pass the FDA’s requirements as well. But still, it’s something they feel confident enough about to keep working on. The rheumatoid arthritis market is no minor market either - it’s worth $13 billion per year.

Now, if the CEL-SCI news is only a little bit familiar to you, it may be because we’ve primarily focused on their cancer treatment Multikine. It’s also a vaccine, but obviously one with a much bigger impact on a market with much stronger demand. We haven’t been able to tell you much about Multikine’s progress lately because, well, there’s not much to report. The wrapped up Phase II testing last year, and will start Phase III testing later this year. Once this last round of trials gets underway, we’ll certainly have more to talk about.

The CEL-2000 announcement is equally good news…just different. Keep in mind, however, that Multikine is closer to the end of its developmental cycle, while CEL-2000 is practically at the beginning of its creation.

As for the stock, the last time I looked I was looking mostly at its range-boundedness (which I know is not a word, but you know what I’m saying). Here it is more than two months later, and the story is still the same despite a brief glimpse of bullishness on Tuesday…stuck between 65 and 70 cents. That’s still the key to getting this one going again - a break past 70 cents. Give it time.

Are you a subscriber to the Small Cap Network newsletter? If not, you’re missing out on some great trading ideas and exclusive market commentary. To sign up, just go to the top right corner of any page of our website. You’ll be joining thousands of other subscribers who have already benefited from our news and views.

 

4/10/2008

Telemig (TMB) Too Hot to Handle? Biotech in Focus: CEL-SCI (CVM) & BioCurex (BOCX)

Filed under: — SmallCapNetwork Editor @ 6:49 am

Not surprisingly, March’s retail numbers were soft…for most. Discounters like Wal-Mart (WMT) and Costco (COST) did fine, while discretionary goods saw dampened demand. The futures dropped (pre-market) on the news, though that means little to me any more. Why? I’m still mostly in a ‘bet against the open’ mode. That’s why I’m actually glad stocks ‘opened’ a little higher at 9:30 am EST today.

That said, I’m still sitting on my QQQQ April 47 puts, which I bought at $1.85. They’re now worth about $2.00 - a meager 8% gain, though I guess that’s better than getting poked with a sharp stick.

I’m still in the trade for reasons that become a little more clear with the nearby chart. I’m looking for at least a retest of the 20 day moving average line near $43.15. That will give me a little cushion (and perhaps inspire the bears) for what I really want to happen, which is a move all the way back down to the lower Bollinger band (20 day) at $41.62. At that point my puts would be worth about $5.00…a nice 150%+ win. It ain’t happened yet though.

Other things you need to know about….

I love for my stock picks to go higher; I hate for them to surge to the point where anybody else is scared to step in. We should all be used to that by now, but somehow it’s still frustrating to deal with this fire-and-ice mentality.

I say that to preface you for the chart of Telemig Celular Participacoes (TMB), which we recommended back on February 24th when it was trading at $60.75. The current price of $66.20 represents a 9% gain. The problem is, the stock pick gained 13.5% in the last week and a half. That’s just a pace I don’t see being sustained. (If a candle somehow had three ends, it would be the equivalent to all three burning.) Such a move is just likely to invite a wave of profit-taking.

Plus, the quick move puts the stock just a tad under a long-term resistance line. A slower move would have let that line extend further up and out before it was intercepted.

That’s not to say I’m getting out; it’s still a good pick. I’d just rather get to our target price of $79.20 in a straight line (which is usually faster) than by bobbing up and down. Unfortunately, nobody who’s buying or selling the stock asked me what I want. Be patient and tolerant with TMB.

We recently had a reader ask about our coverage of BioCurex (BOCX). Yes, we’re still following the company, though they’re not at the top of our watchlist.

We mentioned a while back that we knew their project was going to take time, so we were going to give them plenty of it. Since then, Abbott (ABT) has indefinitely backed out of their deal with BioCurex…something of a game-changer. BioCurex is still going to proceed with the development of RECAF, but considering Abbott was such a big deal when they teamed up, I can only wonder what kind of blow this is to the company. They’ve been fairly quiet on the topic, which I don’t interpret as a good sign.

On the other hand, they signed Inverness (IMA) as a licensee not too long ago, so maybe the Abbott news doesn’t matter.

The European Patent Office has given them a patent on RECAF, which gives the company much more negotiation power than a ‘pending’ patent would.

Bottom line…we’re still following BioCurex, for the long haul. We don’t/can’t worry about the day to day stuff, as our interest primarily lies in the strength of their RECAF technology. Licensees and patents won’t change that.

Speaking of biotech, I want to point out CEL-SCI’s (CVM) chart again. We previously looked at its higher lows and persistent attack on the ceiling at 70 cents. Since then, the lows have continued to move higher, and the stock is still knocking on the door at 70 cents. Accumulation has picked up as well.

I don’t quite know why the renewed interest. Phase III starts later in the year, and nothing has happened in the meantime that would spark a rally. However, I’ve also observed countless times how biotech stocks trade about two years into the future. As such, I think CEL-SCI is actually one of the best trading opportunities out there right now.

Are you a subscriber to the Small Cap Network newsletter? If not, you’re missing out on some great trading ideas and exclusive market commentary. To sign up, just go to the top right corner of any page of our website. You’ll be joining thousands of other subscribers who have already benefited from our news and views.

11/9/2007

Cel-Sci (CVM) Responds to Potential ‘Buyout’ Issue With Shareholder Rights Plan

Filed under: — SmallCapNetwork Editor @ 8:56 am

Back in October 20th edition of the newsletter (‘Big Pharma, Small Biotech - Who Needs Who?’) I spent a little time talking about the potential for a buyout of small cap biotech company CEL-SCI (CVM). Or more specifically, I gave my reason why I thought an acquisition by a big pharma company was very unlikely. Well, now you can add another reason to the list. Today CEL-SCI announced the adoption of a shareholder rights plan that would make it even tougher to facilitate a take-over.

Disclaimers and warnings first….the rights plan will not prevent an acquisition. In fact, it’s not even designed to stave one off. The only goal (and this is from the company) of the plan is to protect current shareholders’ interests in the event of one. If it’s going to happen, the plan will ensure that current owners get at least fair value for their stake.

Why bother? Because with some acquisitions, shareholders receive less that what they should. The term the company used was ‘coercive accumulation practices’, which can and do occur (especially when the company is of the ’small cap’ variety).

Anyway, the deal basically gives current owners the right to buy more shares at a ridiculously low price. Through two tranches of rights (the option to buy a stock), current owners will be able to buy more shares at 20% of their value at the time, and/or 50% less than the value at the time if further conditions are met.

Like I said, technically this won’t bar an acquisition. However, you do the math here. If current owners can get such a deep discount and dilute the takeover attempt, the prospect of a buyout is incredibly unattractive to any suitors. They’ll have to end up possibly paying more than the market value at the time, and they’ll need a lot more shares to actually gain control of the company.

The plan is in effect through 2015. That should be more than enough time for the company to get through Phase III testing of Multikine and start generating revenue with it. If and when that happens, we suspect CEL-SCI shares will be far too expensive to even consider a buyout.

Anyway, for the official release, click here.

Are you a subscriber to the Small Cap Network newsletter? If not, you’re missing out on some great trading ideas and exclusive market commentary. To sign up, just go to the top right corner of any page of our website. You’ll be joining thousands of other subscribers who have already benefited from our news and views.

10/30/2007

CEL-SCI’s (CVM) New Site Fully Explains Cancer Immunotherapy, Investment-Worthy Ideas

Filed under: — SmallCapNetwork Editor @ 11:53 am

The timing on last weekend’s edition “Big Pharma, Small Biotech - Who Needs Who?” couldn’t have been any better. Why? Because it was only a kickoff to what I hope will become a fruitful discussion of biotechnology investing. The second act came on Monday when small cap company CEL-SCI (CVM) unveiled a brand new website, aimed entirely at explaining the usually-under-explained science of immunotherapy.

I’ve been scouring the site for a while, and already I’ve found some things I would have liked to known a long time ago. I’m NOT going to even try and teach you the ins and outs of immunotherapy - I’ll let the site do that. I will, however, highlight enough things to hopefully whet your appetite.

For instance, I never really had a grasp on why most immunotherapy efforts had failed. The reason is, they’re too targeted. There are a variety of cancer antigens to which a vaccine or antibody is targeted, and cancerous tumor calls can mutate as they grow. But, immunotherapy treatments thus far have only been aimed at specific antigens or tumor types. Target the wrong antigen, and the treatment is pointless. (I also think this is why immunotherapy has a bit of a bad rap within the investment community.)

The solution is simple enough - make the treatment less targeted. All well and good, but a multi-faceted immunotherapy may also be ineffective. See the two-edged sword?

CEL-SCI’s response to the problem was Multikine(r). Multikine is a combination of two types of treatments - one type to solve each of the previous problems with immunotherapies. It directly attacks cancer the way an ingested antibody would (like when you can’t shake a cold or the sniffles). And, it also induces and enhances the body’s own immune response, making it able to fight cancer on its own, like a vaccine does.

The company’s website obviously goes into a lot more detail, so I encourage you to take a look for yourself. I think it may clarify for investors exactly what CEL-SCI’s strategic advantage is. Even if you’re not an investor though, I think the medical science is fascinating enough to merit a look.

Side note: CEL-SCI’s site is the first and only site I’ve found to really detail the good, bad, and obscure within the world of cancer vaccines. It is centered around Multikine, but I believe their in-depth immunotherapy explanation will become an industry-wide resource. In turn, I also believe it will attract more investors to the stock. In that light, I see today’s announcement as another long-term plus for shareholders.

Are you a subscriber to the Small Cap Network newsletter? If not, you’re missing out on some great trading ideas and exclusive market commentary. To sign up, just go to the top right corner of any page of our website. You’ll be joining thousands of other subscribers who have already benefited from our news and views.

10/22/2007

Follow-Up Questions on CEL-SCI (CVM), Biotech Editorial

Filed under: — SmallCapNetwork Editor @ 7:27 am

Thanks for all the great feedback on Saturday’s commentary about small-cap biotech’s critical role in large-cap pharma’s success. We really enjoyed putting the unspoken reality together for you, though we also want to let you know we only scratched the surface of the topic.

We also want to share some of the key questions and comments we’ve gotten since then. Most are about CEL-SCI (CVM), but there are a couple of general biotech comments as well. Let’s just list each them one at a time, and respond accordingly.

1) agree with everything your saying , and truely realize the companies potential,but it has a long history of taking forever to do things. just look at the time its taking from when the fda allowed them to enter into phase 3 to the time its gonna take to build the manufactureing facility and actually start enrolling patients. cvm will be lucky to start enrolling patients by the summer of 08, but i doubt it. till then and for the last year owning cvm has been dead money, in one of the mkts greatest bull runs.

Response: Yes, we’d never say CVM has been on fire lately…a frustration in comparison to most other stocks. I think that’s just the nature of biotech though - they have to be hyper-careful, and painfully precise (and not just for the FDA). However, just so you know, Phase III is planned to start in the first half of 2008. The facility will be done in early 2008. I don’t doubt that timeframe at all. One thing to note though…the FDA is going to be looking at three-year efficacy data. So, if you’re looking for 2009 to be the payoff year, you might be early. I think the stock will start to rise before the final decision is made, but I’m looking for the last hurrah to coincide with an FDA announcement.

2) Another question about anyone trying to “buy-out” Cel-Sci: Who actually owns the patents on Multikine & Cel-1000? Not Cel-Sci directly. Can you write about thet?

Response: Great question. There are a few patents out there for something called Multikine. I think they’re all somewhat similar, but CEL-SCI has actually been assigned the one designated as a cancer treatment with a specific cytokine mixture. Here’s the patent office link. I know that CEL-SCI had filed a suit against another maker of a ‘Multikine’, though I don’t know where that stands now. Anyway, CEL-SCI controls the patent they need to control. The CEL-1000 question I can’t answer. I don’t think it’s CEL-SCI, but I’ll see what I can find out.

3) Another example of this is Generex biotechnology. They are entering phase 3 clinical trials for their oral spray insulin and have avoided big pharma collaboration. It appears likely (particularly in view of Pfizers recent withdrawal of Exubera from the market) that it will pay off large for the shareholders. Thought you might find this of interest.

Response: Thanks for the mention. I’ve heard of it, but that’s about it. Maybe there’s something there - especially after the Pfizer (PFE) news.

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10/4/2007

Questions Answered About Small Cap Stock CEL-SCI (CVM) & Multikine Cancer Drug

Filed under: — SmallCapNetwork Editor @ 9:20 am

We haven’t heard much from small cap biotech company CEL-SCI (AMEX: CVM) lately, but that hasn’t prevented the stock from trading all the same. Since it’s my job to be nosy for the benefit of our newsletter readers (and certainly for our readers who trade our stock picks), I took your questions straight to the top - to Geert Kersten, CEO of CEL-SCI. He answered them all to my satisfaction.

Though I can’t give you his complete answers (due to lack of space and my inability to write that fast), these are pretty good paraphrases of his responses. Our explanatory comments are in brackets.

Q. When will Multikine’s Phase III start?

A. Sometime early in the coming year. The production facility will be completed around then, and it takes a few weeks to manufacture enough backlog of Multikine to have a constant supply for testing. In terms of actually using Multikine on patients, though, the prep wok has already started. The study is being conducted on four different continents, and will treat 800 patients. A study of that size and scope has a lot of planning involved while the facility is being completed. [Even if the facility and drug were ready, the extensive planning would still take weeks to finalize.]

Q. Will you need another round of financing to start Phase III?

A. Yes, but we foresee no problem getting it. Phase III has a much stronger element of risk abatement than phase II studies, as far as investors are concerned. Statistically speaking, about 2/3 of Phase III drug trials get ultimate approval, so the quality of interested parties is different than it was before [based on conference call participants and investment inquiries]. Even if it takes years to complete the study, institutional investors don’t entirely care - since there’s nowhere near as much risk involved as there is with a phase II drug.

Q. Could someone else step in in the meantime and bring a competing cancer drug to the market?

A. Based on the complexity of Multikine, it’s unlikely any competitor could even come close to copying the biotechnology behind it (which could take years in itself to do). As for a comparable cancer drug already in the works, there is nothing out there. Also, remember that the FDA has specifically given Multikine an ‘orphan’ status, meaning this is a treatment that is much needed, but the demand is not currently adequately met. [If there was something else even close, it would be getting similar attention.]

————————-

There were some other things that came up, but those are best left for a follow-up newsletter. Overall, I got the impression that things are proceeding as they should be for CEL-SCI and Multikine. We just haven’t heard anything from the company because there’s nothing earth-shattering or game-changing to say during this mundane stage of the process. The thing is - and as I’ve now said about 90 million times - the time to step into a stock position is when nobody else is even thinking about it. CVM shares are at the low end of a multi-year range, yet real future revenue has never been closer. I guess the market isn’t all that efficient after all. 

Are you a subscriber to the Small Cap Network newsletter? If not, you’re missing out on some great trading ideas and exclusive market commentary. To sign up, just go to the top right corner of any page of our website. You’ll be joining thousands of other subscribers who have already benefited from our news and views.

9/20/2007

CEL-SCI (CVM) Announces Progress of Multi-Purpose Vaccine Adjuvant

Filed under: — SmallCapNetwork Editor @ 7:36 am

With all the talk about CEL-SCI’s (CVM) Multikine cancer treatment, it’s easy to forget they’re also working on a vaccine adjuvant platform that could ultimately be effective against several types of infections….including hepatitis B, malaria, herpes, and encephalitis, just to name a few. The name of the adjuvant is CEL-1000. If it rings a bell, it may be because this small cap biotech company’s CEL-1000 technology really came to light in early 2006 when it was realized it could be an effective tool in the war against the bird flu.

On Monday, CEL-SCI updated the market on CEL-1000’s status by releasing details about research done using the vaccine adjuvant against the hepatitis B virus. In a lab setting, it was found to increase the antibody signal in a mouse by 40% by the 28th day of observation. The study also determined what may be the ideal time of dosage, and degree of dosage.

The ‘bigger picture’ implication is simple enough…CEL-1000 continues to gain validity as a broad vaccine adjuvant. As more research refines how CEL-1000 can and should be used, the potential appeal to the market expands.

For the details of the news, click here.

As for CVM shares, the patient went into a critical status this summer, but appears to have stabilized over the last month.

It finally looked like CVM might get something going in April. Then between May and August, we saw shares slide from a peak of $1.08 to a low of $0.57. Since hitting $0.57 though, we’ve started to see the waters being tested again. Specifically, we’re not seeing a string of lower lows anymore. In fact, the 50 day line was tested as resistance three times over the last three weeks. So, clearly somebody is interested.

As for whether or not I think the worst is over, let’s just say I’m keeping a close eye on CVM for that possibility. The downtrend has stopped and a wedge has formed. The wedge will have to close up sometime, and force this chart out of its confines. That could be good or bad (bullish or bearish), but if it’s bullish I want to be ready. For me, the 50 day line may be the make-or-break point.

9/10/2007

CEL-SCI (CVM) Sends Shareholder Letter - Highlights Cancer Therapy Progress

Filed under: — SmallCapNetwork Editor @ 6:55 am

We finally got an update from CEL-SCI Corporation (AMEX: CVM) about its cancer therapy drug Multikine. The update came in the form of a letter to shareholders from CEO Geert Kersten, and serves as a nice recap of how they intend to develop a biotechnology known as immunotherapy and turn it into a one-of-a-kind treatment for head and neck cancer. Though scientific in nature, the letter looks at their work-to-date through the eyes of a biotech stock investor.

If you’ve been along for the CEL-SCI ride since the beginning - and have kept up with our coverage - we don’t think you’ll find anything new in the letter. But, if you’re not familiar with what the company is doing and want a full explanation of why this stock could make for a good longer-term biotech investment, it may do you some good to read it. Just click here. The premise and promise behind the biotechnology are pretty amazing.

Are you a subscriber to the Small Cap Network newsletter? If not, you’re missing out on some great trading ideas and exclusive market commentary. To sign up, just go to the top right corner of any page of our website. You’ll be joining thousands of other subscribers who have already benefited from our news and views. 

8/14/2007

CEL-SCI (CVM) Finds Long-Term Home To Manufacture Cancer Drug

Filed under: — SmallCapNetwork Editor @ 8:04 am

I think most everybody was aware of this plan a few months ago, but it’s always nice to get confirmation. CEL-SCI Inc. (AMEX: CVM) has entered into a long-term lease agreement for a Multikine manufacturing facility.

This is generally good news for an obvious reason….for Phase III testing to be completed, the drug has to be made somewhere. However, there’s a less obvious - and more important - reason for CEL-SCI to make longer-term plans.

The FDA prefers a fully-approved version of a biological drug to be made in the same setting as the Phase III version. Why? Even a minor difference in something as trivial as lighting or refrigeration can affect the drug’s effectiveness. 

From a bigger-picture perspective, this leaves little doubt that CEL-SCI is serious about Multikine, and fully expects to get an FDA approval. Based on our understanding, we expect it to as well.

As for the stock, today’s news probably ain’t gonna’ have much of an impact. There are no immediate benefits, and it wasn’t exactly news - this was an idea they talked about a few months ago. All the same, we consider it a minor victory. We just wish we could say the same for the stock price.

CVM shares have been in a slow slide, guided lower by resistance at the 20 day moving average. We’re not necessarily alarmed, as the overall market hasn’t helped either. It happens. The upside in all of this is how CEL-SCI’s stock tends to rebound well. We’ve seen support around 55 cents a couple of times on even longer-term charts. If past history is a guide, this dip to 61 cents may actually be flagging a great entry opportunity. You know we think highly of the company, and feel it’s only a matter of time before Multikine starts to reap rewards.

Here’s the release.

6/12/2007

CEL-SCI Getting A Little Help From The FDA

Filed under: — SmallCapNetwork Editor @ 8:06 am

I don’t think it’s any secret the Small Cap Network is an opinionated source of stock-related information. That’s by design - you can get ‘data’ anywhere, but meaningful opinions still seem to be a rarity.

It’s a point I wanted to stress today before I shared my personal take on some recent news from CEL-SCI Corporation (AMEX: CVM). They provided the facts; I’m just providing my opinion on what it ultimately means. In this case, I think the news may be a proverbial grand slam for the company. Whether you’re a full-blown CVM owner, or just mulling it over from a distance, trust me - you’ll want to keep reading.

First things first though, particularly if you’re new to the company.

Though it’s not the only drug CEL-SCI is working on, their primary focus has been on the development of a drug called Multikine as a treatment for head and neck cancer. Though Multikine is still being evaluated through the required FDA procedures, early testing indicates it’s very effective. In fact, the research so far shows a 33% improvement in survival of patients using the experimental treatment (which is quite a bit by medical standards). There’s really nothing else quite like it that’s tumor-specific in addition to being non-toxic.

OK - now with everybody on the same page….

Over the past few months, from my perspective, CEL-SCI has gone from being a question mark to being an exclamation point. You may recall in November we posted a blog entry asking our readers to write to the FDA and urge them to allow Multikine to proceed into Phase III testing (the final stage of the FDA approval process). At the time, the company had been waiting 22 months to hear from the FDA, with no explanation for the delay. Needless to say, everyone - the company, investors, even patients - was getting frustrated. It didn’t bode well for Multikine’s future.

Then on January 16th, things changed for the better - CEL-SCI got the greenlight from the FDA to take Multikine into the next stage of testing.

Though Phase III is obviously still not a final approval, we learned something after the news came out that we didn’t know before….approximately 2/3 of the drugs making it to Phase III testing are ultimately awarded FDA approval. I felt this was an outstanding sign of Multikine’s chances, especially considering Phase III was pretty much a large-scale version of Phase II, and was likely to yield the same results.

Well, I thought the story was pretty good as it was. I believe today’s news made it even better though…..far more encouraging than I ever imagined.

Multikine’s use as a head and neck cancer treatment has been designated as an ‘orphan drug’ by the FDA. What does it mean? The ‘orphan’ status is a good thing. To encourage the development of drug treatments for diseases that are very rare, the FDA sweetens the pot, so to speak.

Why would they do this? Let’s face it - big pharmaceutical companies are more interested in targeting common diseases and illnesses. If there’s not enough of a potential customer base for a treatment, it just doesn’t get developed. Needless to say, that’s far from fair for those affected with uncommon illnesses. 

As you may have guessed by now, head and neck cancer is considered a rare disease by the FDA. It’s estimated there are 500,000 (or more) new cases of head and neck cancer every year. Perhaps by GlaxoSmithKline (NYSE: GSK) standards that’s not a lot, but here’s where the power of being small is huge…….relative to CEL-SCI’s size, 500,000 potential patients each year is a massive number - plenty big enough to encourage them to develop a drug like Multikine. It may be a billion dollar opportunity, which is enormous for CEL-SCI.

Here are the main benefits of having an orphan-drug status:

1) Seven years or exclusive marketing rights after the drug is approved (regardless of the patent’s expiration)
2) Potentially, a faster approval time from the FDA
3) Potential grant money - up to $350,000 per year for three years, in CEL-SCI’s case
4) Tax breaks - up to 50% of the R&D costs

Now, I haven’t told you anything you can’t read (or infer) in the press release for yourself - yet. Here’s my perspective…..

There is one thing that strikes me about Multikine being granted this orphan status. Is it me, or is the FDA rolling out the red carpet for Multikine (to the largest degree that they can anyway)? I recall the company using the term ‘fast-track’ a few months ago to describe something they were hoping for Multikine to benefit from. I don’t know if this is what they were talking about or not, though I suspect it is. I do recall that the FDA fast-tracked drugs when they were desperately needed, and there were no alternatives quite as viable as the one in question.

The way I read between the lines, this makes the odds of Multikine getting final FDA approval even better - and they weren’t bad to begin with. Yeah, there’s always ‘a chance’ of something in the meantime, but the FDA is now doing what it can to support Multikine’s progress. Seems to me that’s a big deal. Yes, I see it as yet one more reason to own CEL-SCI. The dream seems to be making big progress towards becoming a reality.

Click here for the press release.

6/6/2007

CEL-SCI’s Chart Defines Support Line

Filed under: — SmallCapNetwork Editor @ 7:34 am

There’s no question the last several weeks have been a roller-coaster ride for CEL-SCI (AMEX: CVM) investors. Late last year shares were trading at 55 cents, and they peaked at $1.08 in late May. In between, there was plenty of ebb and flow….perhaps enough to make you wonder whether or not this thing was ever going to find a foothold.

After last week though, we believe we’re starting to get some clarity on the chart. The low of 80 cents we saw when May turned into June also tagged what is now a long-term support line (blue, on our chart). This same line was the bottom in December, in addition to being the bottom in March as well as April. In other words, there’s probably something to it. All things considered, this is a line we want to watch going forward. It’s currently at 81 cents. 

To a lesser degree, the 50 day moving average has also been support. It’s currently at 82 cents.

 

5/16/2007

CEL-SCI’s Like Rocky Balboa

Filed under: — SmallCapNetwork Editor @ 6:31 am

If you ever seen any of the ‘Rocky’ movies, then you know what I’m talking about. It doesn’t even matter which one you’ve seen, since the plot line is pretty much the same in all of them…an underdog becomes a contender. Just when things look like they’re taking a turn for the worst, Rocky gets off the mat and comes out slugging his way to the title.

For some reason I couldn’t get that goofy analogy out of my head while I’ve been watching CEL-SCI’s (AMEX: CVM) chart over the last few days. I was elated when CVM closed at 96 cents on the 8th, let down when shares fell back to 82 cents on the 10th, and then excited again to see the stock back up to 87 cents yesterday…..a rally made on pretty strong volume. You may have even noticed the stock was up as high as 98 cents in after-hours trading.

Exciting? You bet, but also encouraging. CEL-SCI refuses to go yield. Frankly, I don’t know what was going on over the last week. Maybe a big institution was trying to figure out what they thought of CEL-SCI. Or, maybe it’s just the result of tons of retail investors being pulled between extreme levels of fear and greed. Maybe it was neither.

Whatever it was, CEL-SCI is still slugging, and I like that. Let’s see if we can now get and stay above the 90 cent line.

5/7/2007

CEL-SCI - More of the Wall Crumblin’ Down

Filed under: — SmallCapNetwork Editor @ 1:29 pm

With the close of each recent trading day, I’m feeling better and better about CEL-SCI (AMEX: CVM)….not that I was ever particularly concerned following the news from a few weeks ago. Once they went into Phase III trials with Multikine, I just had a hunch the market would start to take notice.

The beneficiary of that reaction - for those who took the advice - was our readers. We renewed our bullish opinion back on January 16th, when shares were trading at 60 cents. Assuming you got a less-than-great fill of the close of 70 cents that day, you’re still up 35%.

Even if you were on the sidelines though, I still like the upside that may be in store. The resistance at 90 cents I’ve been eyeing for weeks finally looks to be broken. And better yet, the volume is getting stronger and stronger. The next milestone I see is 97 cents, though it’s only a minor one in my view. Yes, I think this might be the beginning of the payoff for those folks who stuck it out.

By the way, if we get a good start (and I think we will), we’re likely to yank that $1.48 target…it just doesn’t seem like enough in light of everything. We’ll look at that more closely when the time comes.

 

5/4/2007

CEL-SCI’s Getting Traction Now

Filed under: — SmallCapNetwork Editor @ 10:44 am

I think CEL-SCI (AMEX: CVM) could be a lot of fun real soon. Over the last couple of weeks we’ve been preaching the need to get and stay above 90 cents to really have a shot at a major upward move. But as of today, I really have to say I think it’s in the cards. Momentum is good, and there’s plenty of depth.

Though we haven’t broken past the 90 cent line as decisively as I’d like (we’re currently at 91 cents after reaching a high of 97 cents on Teusday), the higher lows and new highs are clear.

What I really like though, is the volume behind all this buying. This week’s volume was the most we’d seen in nearly a year…and it was almost all from the buying side of the table - CVM is probably going to close higher for the week, after gaining 12% last week, and 6.7% the week before that. The volume has been successively better each week.

I kind of think this thing could have a snowball effect, meaning each milestone passed is likely to incite more buying, and increase the pace. Things are getting real interesting now - in a good way.

 

 

5/1/2007

CEL-SCI Breaks Down The Wall

Filed under: — SmallCapNetwork Editor @ 6:14 am

I’m NOT surprised to see it happen. I’m a little surprised at the catalyst. For the past few days we’ve been watching CEL-SCI’s (AMEX: CVM) stock, anticipating a break past 90 cents could spark a much bigger rally. Why 90 cents? We topped out there in February. This time though, the market is choosing to get in rather than get out.

Today’s high (so far) has been 97 cents. We have to go all the way back to June of last year to find the last time we visited that level. Better yet, the volume behind the surge is enormous. For that matter, the volume behind the gains over the last two weeks has been very solid. We’d never say anything is ‘for sure’, but this certainly looks like a very good start on a major rally.

The news? I was surprised to read the news wasn’t prompted by CEL-SCI’s head and neck cancer treatment Multikine. Instead, the company put out a press release explaining another one of their drugs, CEL-1000, has been observed to improve some animal’s immune system’s response against Hepatitis B. CEL-1000 may already have practical applications in the vaccination against other diseases, but Hepatitis B is a big one the medical community would like to find a way to beat.

Now, here’s the interesting part - I don’t necessarily think the CEL-1000 news is the reason for the sudden interest in CVM. I think something like today has been brewing up for a while; today’s news is just an excuse (albeit a good one). Why do I feel that way? Because this isn’t exactly ‘news’. CEL-1000’s potential in the fight against Hepatitis B and other viral diseases was understood a long time ago. Some of CEL-SCI’s top researchers presented the Hepatitis B research at a conference in Maryland yesterday and today, but I think this move was likely to happen soon no matter what.

Regardless, the walls are starting to break down (and that’s a good thing). The next hurdle is 97 cents. A move past there, and the next stop may be $1.19. It’s getting real interesting.

For more on the CEL-1000 announcement, click here.

4/27/2007

CEL-SCI Gets AdapT Patent

Filed under: — SmallCapNetwork Editor @ 7:52 am

A bit of good news for CEL-SCI (AMEX: CVM) yesterday…..they were finally awarded a patent for their AdapT technology.

Don’t know what that is? It’s short for ‘Antigen Directed Apoptosis’ which is the process of using two proprietary molecular constructs to cause the death of immune T-cells that are the root of autoimmune conditions (and no, I didn’t understand that either).

In layman’s terms, CEL-SCI’s AdapT technology renders the undesired autoimmune T-cells harmless by preventing one of the two activations required to make the T-cell harmful. Without the second activating signal, these cells will automatically die, and therefore not cause autoimmune problems.

The cool part about CEL-SCI’s creation is that it doesn’t harm all T-cells….just the ones you don’t want.

In any case, the AdapT platform isn’t new - CEL-SCI has been working on it for a long time. However, the patent is new, and should afford the company many years of protection from copycat competition.

As far as any impact goes, we don’t expect this to be like a winning lottery ticket. Rather, it’s an asset that is now up to the company to fully monetize. Still, an asset is an asset.

By the way, the company’s flagship cancer treatment, Multikine, is not based on the AdaptT platform (not that it really matters).

For more, click here.

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