Opexa Therapeutics, Inc. (NASDAQ: OPXA) is on fire this morning with investor interest. The company announced that it has successfully completed two End-of Phase 2 meetings with the FDA over its Tovaxin. This is the company’s lead-product candidate and is said to be the first ever personalized T-cell therapy aimed as multiple sclerosis.
The company believes that these FDA meetings put Opexa in position to move forward with a pivotal Phase 3 study of Tovaxin, which Opexa preparing for to being the Phase III study.
A Phase 2b study of Tovaxin demonstrated overall clinical and disability benefits over the placebo group, including a clinically relevant decrease in the Annualized Relapse Rate and improvement in disability score. Another benefit beyond the efficacy measures that the FDA will ultimately evaluate is the safety profile. Opexa notes an “excellent safety profile” with no serious adverse events related to the Tovaxin treatment.
There are MS drugs on the market. Biogen Idec Inc. (NASDAQ: BIIB), which we recently covered as having risen above analyst expected targets, has the great MS drug called TYSABRI. Unfortunately, the adverse effects that have greatly limited TYSABRI are rare instances of the potentially fatal brain infection PML.
It is probably too soon to call for a change of treatment regimens based upon already approved drugs against drug-candidates that still have to go through Phase III trials for broader data before the application process can even begin. That being said, what makes Tovaxin different from current MS treatments is that it is a personalized cellular immunotherapy treatment. It is derived from T-cells isolated from a patient’s peripheral blood, which is then expanded ex-vivo, and ultimately reintroduced into the patient by injection. This process then triggers an immune response against specific subsets of autoreactive T-cells known to attack myelin, which reduces the relapse risks through time.
Opexa noted, “The second meeting was a face-to-face End of Phase 2 clinical meeting in which Opexa presented its rationale and trial design for a Phase 3 pivotal study with Tovaxin in Relapsing Remitting-MS (RR-MS) patients. The FDA concurred with Opexa regarding its proposed clinical trial protocol including the patient population, end points, patient numbers and trial design. The FDA also offered several recommendations to further enhance a Phase 3 trial.”
Opexa is one we highlighted before on positive stem cell safety profiles. Opexa is also one that has not been without controversy and has not been without financial liquidity measures. Novartis (NYSE: NVS) put the company on the map on news in 2009 that it was acquiring the company’s stem cell technology.
The war against MS is a large one. The National Multiple Sclerosis Society lists on its site that there are approximately 400,000 people with multiple sclerosis in the United States alone, with 200 more new cases diagnosed every week. The Society also noted that MS is thought to affect more than 2.1 million people on the planet.
It is still too soon to know if Tovaxin will be the next big MS treatment. The FDA is a tricky institution and approvals have been more scrutinized of late. So you know the good news, and you have at least some of the caveats.
The market is voting this one as a success today. Opexa shares are up almost 60% at $2.49 on almost 6 million shares as of 11:30 AM EST. The high for the day is $2.90 and the 52-week trading range is $1.02 to $3.07.
Even after the big gain, Opexa has a micro-cap value of only $45.9 million. The company’s cash and equivalents was listed as only $4.73 million as of September 30, 2010. Another round of funding is probably a safe assumption for the near future. The company has noted funding and partner searches and the press release today noted: “Moving forward we are focused on implementing the necessary steps to advance toward a Phase 3 clinical trial, continuing discussions with potential development partners for Tovaxin and attempting to secure appropriate financing.”
If the company’s new MS treatment is as good as the investor reaction is signaling today, that funding should be easy enough to secure. The question to ask on funding is probably “how much and when?” over other issues.
JON C. OGG
StemCells, Inc. (NASDAQ: STEM) has created some interest in the stem cell sector again on some important safety news. While today’s news is best for StemCells, Inc. (NASDAQ: STEM) as a company, this will only act to highlight others involved in stem cell research. We are also seeing moves in Geron Corporation (NASDAQ: GERN), Neostem, Inc. (AMEX: NBS), and Opexa Therapeutics, Inc. (NASDAQ: OPXA).
The company (StemCells) announced that Nathan Selden (M.D., Ph.D., F.A.C.S., F.A.A.P.) is presenting a feature presentation today at the American Association of Neurological Surgeons 2010 Annual Meeting. This is said to be one of the leading forums for neurosurgeons from around the world to present and discuss cutting-edge research in the field.
Opexa Therapeutics (NASDAQ:OPXA) shares were battered as the company went to market to raise cash.
The firm said it entered into definitive agreements with institutional investors in a direct placement with gross proceeds of $5.1 million. The offering is made pursuant to the Form S-3 shelf registration statement that was filed by Opexa with the Securities and Exchange Commission (the “SEC”) and declared effective by the SEC on November 23, 2009. The offering is expected to close on or about December 14, 2009, subject to the satisfaction of customary closing conditions. Opexa intends to use the net proceeds from the offering for general corporate purposes, including activities related to further clinical development of Tovaxin® and for other working capital and operational purposes.
The securities in the offering include 2,550,000 shares of Opexa common stock and warrants to purchase up to 1,275,000 shares of Opexa common stock, which securities are being offered in “units” at a price of $2.00 per unit. Each unit consists of one share of Opexa common stock, a five year Series A warrant to purchase 0.35 of an additional share of Opexa common stock, and a one year Series B warrant to purchase 0.15 of an additional share of Opexa common stock. The warrants have an exercise price of $2.55 per share and are exercisable commencing six months and one day after closing.
Douglas A. McIntyre
The run up in Opexa Therapeutics (OPXA) was too good to be true.
The stock rose from $1.50 to almost $6.50 in day on news that it had favorable mid-stage results from test of its experimental multiple sclerosis drug. The results are early enough that they may mean very little.
Investors, wary about the firm’s future, drove the stock down 20% to $4.50. Without another hit of good news, the shares could go lower.
Douglas A. McIntyre
Opexa Therapeutics (OPXA) is trading sharply higher on news that its Tovaxin®, a personalized T-cell immunotherapy for multiple sclerosis demonstrated results from further analysis of the double-blind, placebo-controlled, 52-week Phase IIb TERMS clinical study of 150 patients with Relapsing Remitting MS (RRMS). This analysis evaluated patients with an annualized relapse rate of one or greater at study entry (ARR≥1). More than 83% of the Tovaxin-treated group (n=85) remained relapse free at one year and the annualized relapse rate after treatment decreased to 0.20, a 42% reduction compared to placebo.
Shares are up 50% to $2.31, giving the company a still-tiny market cap of $28 million. Read more
A week after Opexa (OPXA) cut a deal to sell stem cells to Novartis (NVS) and its shares reacted with a massive rally, it appears that investors are taking profits. Opexa received an upfront payment of $3 million as part of the transaction. The firm needed the cash badly to keep operating. Shares are down almost 10% to $1.30.
Opexa reported a net loss for the three months ended June 30, 2009, of approximately $0.9 million, or $0.07 per share (basic and diluted), compared with a net loss of approximately $3.6 million or $0.36 per share (basic and diluted), for the three months ended June 30, 2008.
Douglas A. McIntyre
Opexa Therapeutics, Inc. (NASDAQ: OPXA) has just done more than gotten itself on the map. It now is on the map and everyone wants to take a trip there. Shares are up exponentially based upon a deal that could ultimately give it ten-times yesterday’s value.
The company’s market cap was around $6 million yesterday, yet Novartis (NYSE: NVS) is acquiring the company’s stem cell technology. The gains from this are astronomical. Opexa was up 377% at $2.25 on over 5 million shares of stock mid-day. This micro-cap stock trades close to 60,000 shares on most days and it only crossed over 100,000 shares in nine trading sessions over the last 3 month period.
Novartis is paying $3 million to Opexa up front, and it is paying out another $1 million over six months.
But the milestones and royalties are where the real kicker is. Upon the successful development and marketing of the stem cell technology, Opexa could collect commercial milestone payments which might ultimately be worth more than $50 million.
As far as what is left now, the CEO of Opexa said that the deal will also allow Opexa to focus its attention its key clinical asset called Tovaxin as an anti-T-cell therapeutic vaccine which could be used in cancer treatments.
This looks like just one more exception to the unofficial investor rule that penny stocks never really work out.
JON C. OGG
AUGUST 7, 2009
Are Geron & Stem Cell Stocks The Biotech Winners of 2009? (GERN, STEM, OSIR, GENZ, ASTM, NBS, KOOL, OPXA)
Yesterday we saw a rally in stem cell players of Geron Corp. (NASDAQ: GERN) and StemCells Inc. (NASDAQ: STEM). These are both winners that are currently in a winning sector, assuming that Obama administration opens the stem cell floodgates that have been dammed up for the last eight years.
Last month StemCells (STEM) won FDA approval for clinical trials. Today we have Geron (GERN) leading the sector on FDA approval for starting trials for embryonic stem cell studies on spinal cord injuries.
Geron (GERN) is up huge today. Shares are up 35% at $7.10, a new 52-week and a high back to levels not seen since 2007. Geron closed out 2008 at $4.67, so this is now up 50% for 2009.
StemCells (STEM) is also following suit with its shares up almost 14% at $2.45. This stock closed out 2008 at $1.36. That makes a gain of 75% or so for 2009 so far.
Osiris Therapeutics (NASDAQ: OSIR) entered into a pact in recent months with Genzyme (NASDAQ: GENZ) to develop and commercialize first-in-class adult stem cell products. Osiris is up a mere 1.5% today at $19.13. That is about flat compared to its 2008 close-out of $19.16.
But there is play in the speculative names in the sector as well. Technically, all of these are speculative stocks in the stem cell sector. But here are some of the “even more speculative names” in stem cells:
Aastrom Biosciences, Inc. (ASTM) up 21% at $0.62, up from a 2008 close-out price of $0.50.
Neostem, Inc. (NBS) is up 26% at $0.95 today, up from $0.47 as a 2008 close-out stock price.
Thermogenesis Corp. (KOOL) is often overlooked as a stem cell stock. But this one is up over 8% at $0.59 today. It closed out 2008 at $0.43.
Opexa Therapeutics, Inc. (OPXA) is also one of the more speculative names, and its stock is up over 20% at $0.43 today. It is hard to get excited about penny stocks for most skep[tics, but this stock is currently now up more than 100% from the $0.19 stock price where it closed in 2008.
There are other stocks in teh sector, but these are the main ones we follow in thr group. We rarely include pink sheet and OTC stocks.
Jon C. Ogg
January 23, 2009
Tomorrow is the US Presidential Election, and while we do not have the known votes in, the exit polls for early voters and the polls taken from national sources are showing Obama over McCain by a small but widening margin. We are not a political sight and do not pretend to host any political opinions here. But there is one thing that looks more and more for sure: Stem Cells might as well be declared a winner regardless of who wins the election tomorrow.
In the past we have covered at 24/7 Wall St. how both Obama and Clinton attacked the Bush policies on stem cell research. After a quick review of “McCain Stem Cell” there is also a link on the McCain website showing that he has supported stem cell research.
StemCells Inc. (NASDAQ: STEM) has seen a monster rally today with shares up some 40% at $2.02 on more than 7 million shares (almost 20-times volume) after the stem cell company said that its proprietary HuCNS-SC product candidate made from purified human neural stem cells can protect the retina from progressive degeneration when transplanted into a well-established animal model. Retinal degeneration leads to loss of vision in diseases such as age-related macular degeneration and retinitis pigmentosa. We’d like to note that the company had that old shelf filing. StemCells had also received a patent for neural stem cells from all tissue sources.
What is interesting here is that there have been many bits of data today and in recent days on the topic. We can’t assure you that the administration that takes control can stop the rampage in speculative stocks in a bear market. But either candidate is going to be more “pro-stem cell research” in their policies than what we have seen over the last eaight years.
Shares of Geron Corp. (NASDAQ: GERN) are also up over 11% as the hopes that good news in one stem cell company will translate to universal benefits. Aastrom Biosciences, Inc. (NASDAQ: ASTM) is also up even much more with gains of 46% today, but its stock is well under $1.00 at $0.58.
NeoStem, Inc. (Amex: NBS) has agreed to acquire China Biopharmaceuticals Holdings, Inc. (OTCBB: CHBP). This acquisition is anticipated to expand the capabilities and reach of NeoStem, which is pioneering the pre-disease collection, processing and long-term storage of adult stem cells for future medical need. Suzhou Erye Pharmaceutical Co. Ltd., the primary subsidiary of China Biopharmaceuticals is located in Suzhou, China and is currently tracking to generate revenues of approximately US$50 million and net over US$7 million in 2008. NeoStem will hold a 51% controlling stake in Erye who currently manufactures over 100 drugs on seven GMP lines, including small molecule drugs. Erye has been in business for more than 50 years and is respected for its quality, service and reliability. Erye has begun its three year expansion and relocation program which is anticipated to enhance revenues, profits, and manufacturing capabilities in one of the fastest growing medical markets, the Peoples Republic of China.
This is an old feature, but a small company won a new patent in bone marrow & stem cell transplants.
Thermogenesis Corp. (NASDAQ: KOOL) is a small overlooked stem cell related stock engaged in the design, manufacture, and marketing of automated and semi-automated devices, and single-use processing disposables
Osiris Therapeutics, Inc. (NASDAQ: OSIR) reports earnings tomorrow, although revenues here are negligible.
Opexa Therapeutics, Inc. (NASDAQ: OPXA) is focused on autologous cellular therapy applications of its proprietary T-cell and stem cell therapies. In August it completed a $3 million private placement, to support the ongoing clinical development of Tovaxin, the company’s novel treatment for multiple sclerosis.
Advanced Cell Technology Inc. (OTC-ACTC) is involved in the development and commercialization of human embryonic and adult stem cell technology in the field of regenerative medicine. This is the most volatile of stem cell stocks and its stock has fallen from $1.00 to just over $0.04 of late. But the reason we have listed it here is because its shares are rather active and are active on most trading days.
Jon C. Ogg
November 3, 2008