posted
I got into this one 2 months ago at .40 a share!!! Time for my happy dance.....
Opexa Announces Stem Cell Agreement with Leading Global Pharmaceutical Company Friday 08/07/2009 7:00 AM ET - Businesswire
Related Companies Symbol Last %Chg NVS 44.60 -1.22% OPXA 2.34 396.79%
As of 10:51 AM ET 8/7/09 Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company developing a novel T-cell immunotherapy for multiple sclerosis (MS), today announced that it has entered into an exclusive agreement with Novartis, one of the world's largest pharmaceutical companies, for the further development of Opexa's novel stem cell technology. This technology, which has generated preliminary data showing the potential to generate monocyte derived islet cells from peripheral blood mononuclear cells, was in early preclinical development at Opexa.
Under the terms of the agreement, Novartis will acquire the stem cell technology from Opexa and Novartis will have full responsibility for funding and carrying out all research, development and commercialization activities. Opexa will receive an upfront cash payment of $3 million, plus an additional $1 million as a technology transfer fee to be paid over the course of a six month period. Total payments to Opexa, including the upfront payment, the technology transfer fee and development and commercial milestone payments could exceed $50 million not including royalties. Opexa is also eligible to receive royalty payments from the sale of any products resulting from the use of the technology and retains an option on certain manufacturing rights.
"This represents a great opportunity for Opexa," stated Neil K. Warma, Opexa's president and chief executive officer. "Novartis is one of the premier pharmaceutical companies and the expertise they bring to this program will undoubtedly advance the technology significantly. This agreement will also allow us to firmly focus our attention on our key clinical asset, Tovaxin(R).
About Opexa
Opexa Therapeutics, Inc. is dedicated to the development of patient-specific cellular therapies for the treatment of autoimmune diseases. The Company's leading therapy, Tovaxin, is an individualized cellular immunotherapy treatment in Phase IIb clinical development for Multiple Sclerosis (MS). Tovaxin is derived from T-cells isolated from peripheral blood, expanded ex vivo, and reintroduced into the patients via subcutaneous injections. This process triggers a potent immune response against specific subsets of autoreactive T-cells known to attack myelin and, thereby, reduces the risk of relapse over time. Data from the first Phase IIb clinical study showed compelling evidence that Relapsing Remitting MS patients treated with Tovaxin saw overall clinical, MRI, and immunological benefits over the placebo group, including statistical significance for decrease in the Annualized Relapse Rate (ARR), improvement in disability score (EDSS), and improvement in quality of life measures (MSQLI), as well as an excellent safety profile with no serious adverse events related to Tovaxin treatment.
Cautionary Statement Relating to Forward - Looking Information for the Purpose of "Safe Harbor" Provisions of the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements in this release do not constitute guarantees of future performance. Investors are cautioned that statements in this press release which are not strictly historical statements, including, without limitation, statements regarding current or future financial payments, returns, royalties, performance and position, management's strategy, plans and objectives for future operations, plans and objectives for product development, plans and objectives for present and future clinical trials and results of such trials, plans and objectives for regulatory approval, litigation, intellectual property, product development, manufacturing plans and performance, constitute forward-looking statements.
posted
Thank you, I am so excited I am about to pee my pants,lol. now if I can figure out when or if to fold, watched one of these biotech stocks go up to 11.00 per share a couple of weeks ago... I am so clueless, wish smash would show up.... He is like a stock rock star!!!!
Hmmm...when to fold, when to fold. I would bet that this takes a nose dive tomorrow. Look at another senior exchange stock, symbol: INO .
It went up like 300%+ one day, then dropped half the next. This may be a great long-term play if that's your investment strategy, but I'm always for taking your profits at the height of interest.
IN MY OPINION (But please don't base your decision soley on this) - I'd exit now if you haven't already done so, and buy tomorrow when it crashes if you still want in.
Take a look at INO, selling on the day of news would have been great, then buying on the 50% collapse the next day would have been great too.
Get out and don't look back if it keeps going today or tomorrow would be my advice.
Posts: 406 | From: San Diego | Registered: Jun 2009
| IP: Logged |
posted
Sounds like a plan to me, thanks hot-pepper, smash, have you two looked at KOOL, kinda going the same way...but who knows, has great news out today.Has your funds setteled yet Smash? I have some that will settle Monday, be ready to rock and roll!!!You like a rock star!!!
posted
LOL..thanks!! My funds settle on Monday. So Monday and Tuesday I'll be working hard to find a winner. Monday is kind of hard because I'm at work, but I'll spend the whole trading session in front of the computer tuesday.
Posts: 406 | From: San Diego | Registered: Jun 2009
| IP: Logged |
posted
If you also bought KOOL,depending on the price, and when you bought it. It semms to me that it will climb some. Yesterday was moving too. I would wait till next week to see what it will do, but if you think that you have made a reasonable money and based on what you paid for it, I would not be greedy because you can always buy it back after sale at a much lower price.
Posts: 602 | From: Minneapolis | Registered: Jul 2009
| IP: Logged |
posted
I work this crazy weekend shift, work 2- 16 hr shift and an 8, wears me out, but I have all week to make real money,,lol(or lose it) I'll be searching too, but I have yet to get the streaming screaming news..Got to get that ASAP. KOOL: holding for now, news out but volume low, maybe it hasn't got everyone's attention yet.I had another one with killer news and it just sit there....Oh well, it is still a good stock.
posted
More news out today on this one, I don't know if anyone else is playing this, but I've made a chunk of change off of it.
Opexa Triggers Milestone Payment Under Recently Announced Stem Cell Agreement Wednesday 09/23/2009 8:00 AM ET - Businesswire
Related Companies Symbol Last %Chg NVS 49.37 0.47% OPXA 4.34 25.43%
As of 10:28 AM ET 9/23/09 Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company developing Tovaxin(R), a personalized T-cell immunotherapy for multiple sclerosis (MS), today announced that it has achieved its first technology transfer milestone in connection with the company's recently announced exclusive stem cell agreement with Novartis, one of the world's largest healthcare companies. The milestone was completed on schedule and triggers a payment of $500,000 to Opexa.
Opexa recently announced that it entered into an exclusive agreement with Novartis for the further development of Opexa's novel stem cell technology. Under the terms of the agreement, Opexa received an upfront cash payment of $3 million and was entitled to an additional $1 million as a technology transfer fee to be paid over the course of a six month period. The $500,000 milestone is part of this $1 million technology transfer fee. Total payments to Opexa, including the upfront payment, the technology transfer fee and development and commercial milestone payments could exceed $50 million not including royalties. Opexa is also eligible to receive royalty payments from the sale of any products resulting from the use of the technology and retains an option on certain manufacturing rights.
posted
Opexa has news again..Made a chunk of change on this one
Opexa Therapeutics Reports Third Quarter 2009 Financial Results and Corporate Update Wednesday 11/04/2009 8:33 AM ET - Businesswire
Related Companies Symbol Last %Chg OPXA 1.98 1.56%
As of 12:12 PM ET 11/4/09 Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company developing a novel T-cell therapy for multiple sclerosis (MS), today reported financial results for the quarter ended September 30, 2009, and provided details on further developments.
Recent highlights include:
-- 3rd quarter net income of $2.2 million as a consequence of the gain on the sale of the Company's stem cell technology;
-- Closing of sale of early stage adult stem cell technology to Novartis and achievement of first technology transfer milestone; and
-- Receipt of approximately $1.2 million in additional cash from warrant exercises before and after quarter end.
"As we move forward during the fourth quarter and look ahead to 2010, we are quite pleased with our overall situation, especially in comparison to our circumstances last year at this time," stated Neil K. Warma, president and chief executive officer of Opexa. "The Novartis stem cell transaction bolstered our financial resources and consequently leaves us with $4.1 million in cash as of the end of October. The terms of the agreement allow Opexa to benefit considerably from progress in the stem cell technology's clinical development and potential commercial success in Novartis' capable hands. We have a very novel, late stage clinical asset in Tovaxin(R), our autologous cellular immunotherapy treatment for MS -- a current $9 billion market with a still significant unmet medical need and currently served by several approved drug therapies. Our enthusiasm for Tovaxin comes not only from its attractive clinical efficacy but also from its very compelling risk/benefit relationship, an aspect of the regulatory approval pathway that is gaining increasing importance."
"In the weeks ahead, our primary focus will continue to be on advancing our ongoing partnership discussions around Tovaxin. At the same time, our strengthened financial position has provided us with the opportunity to become more aggressive and invest back into Tovaxin's clinical development as we prepare for the next clinical trial. Supporting this is the on-going analysis from the TERMS trial which has recently focused on the vast array of immunological data which is providing valuable insight into and support of Tovaxin's potential mechanism of action," continued Mr. Warma.
"2010 promises to be an exciting year for Opexa and we look forward to sharing developments with our various stakeholders as the year unfolds. We will continue our undeterred focus on what we believe to be one of the most promising therapies in development for MS. At our current burn rate, today's cash resources are sufficient to fund the company's operations through the 2010 calendar year," added Mr. Warma.
Third Quarter Financial Results
Opexa recorded no sales for the three months ended September 30, 2009 or in the comparable prior-year period.
Research and development expense was approximately $0.5 million for the three months ended September 30, 2009, compared to approximately $2.4 million for the three months ended September 30, 2008. The decrease in expenses was primarily due to the completion of the Phase IIb clinical trial in August 2008, closing the extension trial, a reduction in staff and a decrease in non-cash stock compensation expense.
General and administrative expense was approximately $666,000 for the three months ended September 30, 2009, as compared to approximately $661,000, for the three months ended September 30, 2008. The increase in expenses was due to a senior management bonus accrual and increased legal fees which were largely offset by a decrease in non-cash stock compensation expense, overhead expenses, board compensation fees and a reduction in staff.
Opexa recognized a gain on the sale of assets of $3 million for the three months ended September 30, 2009. The gain is attributable to the sale of the Company's stem cell technology program to Novartis for an upfront payment of $3 million.
Opexa recognized other income of $0.5 million for the three months ended September 30, 2009 attributable to the completion of the initial $0.5 million technology transfer fee milestone and pursuant to the terms of the stem cell technology acquisition agreement with Novartis. Payment was received subsequent to quarter end.
Opexa reported net income for the three months ended September 30, 2009, of approximately $2.2 million, or $0.18 per basic share and $0.14 per diluted share, compared with a net loss of approximately $3.1 million or $0.28 per share (basic and diluted), for the three months ended September 30, 2008. The income in 2009 is attributable to the sale of the Company's stem cell technology program to Novartis for an upfront payment of $3 million and a reduction of costs associated with the Phase IIb clinical trial of Tovaxin that was completed in 2008, a reduction in staff and a decrease in non-cash stock compensation expense.
The Company had cash and cash equivalents of approximately $4 million as of September 30, 2009, compared with approximately $1.2 million as of December 31, 2008. The September 30, 2009 quarter-end cash balance includes initial proceeds of $3 million for the sale of the Company's stem cell technology program to Novartis but does not include a $0.5 million payment from Novartis received subsequent to the end of the quarter for completing the first of two technology transfer milestones.
Year-to-Date Financial Results
Opexa recorded no sales in the nine months ended September 30, 2009 or in the comparable prior-year period.
Research and development expense was approximately $1.7 million for the nine months ended September 30, 2009, compared to approximately $7.1 million for the nine months ended September 30, 2008. The decrease in expenses was primarily due to the completion of the Phase IIb clinical trial in August 2008, closing the extension trial, a reduction in staff and a decrease in non-cash stock compensation expense.
General and administrative expense was approximately $1.5 million for the nine months ended September 30, 2009, as compared to approximately $2.7 million, for the nine months ended September 30, 2008. The decrease in expenses is due to a decrease in non-cash stock compensation expense, overhead expenses, professional service fees, board compensation fees and a reduction in staff.
Opexa recognized a gain on the sale of assets of $3 million for the nine months ended September 30, 2009. The gain is attributable to the sale of the Company's stem cell technology program to Novartis for an upfront payment of $3 million.
Opexa recognized other income of $0.5 million for the nine months ended September 30, 2009 attributable to the completion of the initial $0.5 million technology transfer fee milestone pursuant to the terms of the stem cell technology acquisition agreement with Novartis. Payment of $0.5 million was received subsequent to quarter end.
Opexa recognized a non-cash loss on derivative instruments of $366,774 for the nine months ended September 30, 2009. This loss is a result of the net unrealized (non-cash) change in the fair value of our derivative instrument liabilities related to warrants associated with the August 2008 financing which had been accounted for under FASB ASC 815 and which accounting treatment was discontinued on June 1, 2009.
Opexa reported a net loss for the nine months ended September 30, 2009, of approximately $0.3 million, or $0.02 per share (basic and diluted), compared with a net loss of approximately $9.9 million or $0.99 per share (basic and diluted), for the nine months ended September 30, 2008. The decrease in net loss is primarily due to the $3 million gain on sale of technology, a reduction of costs associated with the Phase IIb clinical trial of Tovaxin that was completed in 2008, a reduction in staff and a decrease in non-cash stock compensation expense.
UBBFriend: Email this page to someone!
Printer-friendly view of this topic
![[Were Up]](graemlins/wereup.gif)
![[Cool]](cool.gif)
