Biotech Stock Mailbag: Aethlon Medical, Oxigene, Sarepta

 BOSTON (TheStreet) -- This week's Biotech Stock Mailbag is open for business.

Oke M. writes, "Is Aethlon Medical (AEMD) raising money in a similar way to the Lincoln Park Financial vulture financing scheme used by Galena Biopharma (GALE) ? Is the money coming from an institutional investor? And why are they buying the shares at a price way below the current market price and guaranteed this very price for five years? How would this affect the overall price of Aethlon shares on the open market?"

Someone on Twitter this week (I don't remember who) made a snarky but accurate observation about Aethlon: If a disease appears on the front page of a newspaper, Aethlon will claim to have a cure in short order. Ouch!

Aethlon's disease cure-all is called the Hemopurifier, which as the name suggests, purifies a patient's blood by sopping up viruses and other nasty disease particles. Supposedly, I've been referring to the experimental, unapproved medical device as the plastic miracle cylinder because there's hardly a disease it can't eradicate from the blood of treated patients, according to Aethlon's many stock-promoting press releases. Ebola. Gone. Hepatitis C. Vanished. HIV. Disappeared. Cancer. Eradicated.

Just think of the billions of dollars wasted each year by biotech and pharmaceutical companies on new drug research when the the solution, the cure, to so many of the world's deadliest diseases is as simple as dripping blood through a glorified, plastic-encased coffee filter. It's a wonder Aethlon is still a penny stock trading on the OTC.

On Wednesday morning, Nov. 26, while most of us were prepping for Thanksgiving, Aethlon issued a press release to announce the shipment of four Hemopurifier units to the Nebraska Medical Center (NMC) for use in the treatment of ebola patients. NMC is where Dr. Rick Sacra was treated successfully after he contracted Ebola while treating patients in West Africa.

Aethlon:

Aethlon disclosed that four Hemopurifiers have been shipped to the Biocontainment Unit at the Nebraska Medical Center (NMC) in Omaha as a therapeutic option to be stockpiled for Ebola patients that may be treated at the NMC. Aethlon further disclosed that it has provided onsite training to NMC clinical personnel related to the implementation of Hemopurifier therapy within the dialysis infrastructure already located at the center.

As you might expect from a penny stock issuing an ebola press release on the day before Thanksgiving, Aethlon's share pricing and trading volume exploded. At one point during the day, Aethlon shares were up 21%. The stock closed Nov. 26 at 52 cents, up 6%, on more than six times the average trading volume.

After last Wednesday's close, the company announced a quickie financing in which one unnamed investor bought $3.3 million in Aethlon stock priced at 30 cents per share, or a 42% discount to the stock's closing price that day. If the price discount wasn't enough, Aethlon also gave the investor 1.2 warrants for each share of stock purchased. The warrants, good for five years, were also priced at 30 cents.

To finally get around to answering Oke's question, yes, Aethlon's financing was vulture-esque in that the deep discount and warrant sweeteners suggest the buyer is merely flipping shares for a quick profit. Wouldn't you do the same if given the opportunity to buy stock for 42% below market price? Aethlon's balance sheet is already bloated with 295 million shares outstanding. The new financing diluted shareholders by another 8%, including the warrants.

The kicker here is that the press release issued by Aethlon about shipping Hemopurifiers to treat ebola patients at Nebraska Medical Center was a misleading piece of puffery.

I e-mailed Nebraska Medical Center spokesman Taylor Wilson to confirm Aethlon's claim about the Hemopurifier shipment. Here's his reply:

"They [the Hemopurifier units] may have been shipped, but we have not decided whether to use them or if they are effective. Essentially, they sent them to us, but we have had very little involvement beyond that," Wilson told me.

Not exactly a ringing endorsement for Aethlon from Nebraska Medical Center.

I reached out to Aethlon CEO Jim Joyce via email for his response. He insists Nebraska Medical Center requested shipment of a Hemopurifier for use during the emergency treatment of ebola patient Dr. Martin Salia on Nov. 16. Salia died the next day so the device was never used.

"We have since shipped Hemopurifiers as agreed in an effort to improve responsiveness should there be another opportunity to treat in the future... there is certainly no assurance that the NMC team will choose to deploy our investigation device in the future," Joyce told me.

Aethlon followed up its questionable ebola press release with another announcement on Tuesday in which the company claims its plastic miracle cylinder contributed to the cure of hepatitis C patients in a clinical trial. The study was conducted in India and involved just 12 patients, all of whom received the old, standard drug therapy for hepatitis C -- interferon and ribavirin -- in addition to having their blood filtered through a hemopurifier. None of the new, oral drugs for hepatitis C like Gilead Science's Sovaldi or Harvoni, were used. Without a control arm, there's no way to determine if blood filtering had any positive effect at all. Clinical trials conducted in India are notoriously unreliable.

Aethlon has been reporting on this hepatitis C trial from India for the past four years. Last May, the company issued a press release with almost identical results to what was announced on Tuesday.

Don't believe the hype.

Michael D. asks, "Any chance you would write an article describing the minimal side effects of Oxigene's (OXGN) non-chemo approach towards a patient's quality of life? Seems to be missed in your previous articles and of most importance."

No one knows if the combination of Oxigene's fosbretabulin and Roche's (RHHBY) Avastin will be safer or better tolerated than Avastin plus chemotherapy because the direct comparison hasn't been made in a clinical trial.

Oxigene and its supporters believe a non-chemo treatment option for recurrent ovarian cancer would be hailed as a breakthrough. Conceptually, I agree, but the non-chemo therapy can't be substantially less effective than a therapy with a chemo component. At this point, Oxigene's challenge remains proving fosbretabulin in any combination can be more effective in treating ovarian cancer than the recently approved Avastin-chemo combination. I have my doubts.


@adamfeuerstein your silence on sarepta lately speaks volume

— robert pomerantz (@asianjew222) December 1, 2014

@adamfeuerstein I was expecting a positive spin off the RNA buyout. Hopefully you haven't thrown in the towel

— robert pomerantz (@asianjew222) December 1, 2014

I haven't been silent on Sarepta Therapeutics (SRPT) , but even those with faith in its Duchenne muscular dystrophy drug eteplirsen can't ignore some painful truths. BioMarin's (BMRN) decision to acquire DMD drug rival Prosensa (RNA) is not a positive for Sarepta. At best, it's a neutral event because Sarepta has always planned for competition. But the folks at BioMarin are smart. They know how to develop orphan disease drugs and get them approved just about better than anyone. BioMarin went looking to acquire a DMD drug. There were two obvious options. BioMarin chose Prosensa over Sarepta. That's hard to spin positive.

Best I can say about the current situation: Sarepta's declining market value is baking-in at least some of the company's troubles.

SRPT Chart

If you're looking for the next opportunity for a significant Sarepta rebound, it might be the release of the week 168 analysis from the phase II study and/or results from the fourth muscle biopsies of phase II patients. When Sarepta intends to disclose these data isn't certain. At the Credit Suisse healthcare conference in November, CEO Chris Garabedian was non-committal on a timeline except to say the public data release would likely come before the delayed eteplirsen FDA approval filing in the middle of 2015.

The 168-week, six-minute walk test results and the dystrophin biopsy analysis need to be pristine to have any positive effect on Sarepta's stock price. Even if the data are positive, don't expect Sarepta bears to throw up their hands in surrender.

If you want to be entirely merciless in your support for Sarepta, you hope FDA rejects Prosensa/BioMarin's effort to get drisapersen approved on the messy phase II/III data. If that happens, Sarepta's outlook improves significantly.

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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