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Home  /   Forum   /   BioPharma   /   OPXA - Merck partner

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OPXA - Merck partner

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  2. [verwijderd] 26 februari 2014 15:00
    Als het om de cijfers gaat verwacht ik niet veel nieuws.
    Wel van belang is of na de emissie van december vorige jaar, tegen $ 1,70/a, met de opbrengst van $ 8 mio de schulden zijn afgelost: dan zouden ze nu zo'n beetje schuldenvrij moeten zijn.

    Verder misschien nieuws over de samenwerking met Merck.
  4. [verwijderd] 28 februari 2014 10:08
    OPEXA THERAPEUTICS REPORTS YEAR END 2013 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE

    02/27/2014

    THE WOODLANDS, Texas--(BUSINESS WIRE)-- Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biotechnology company developing a novel T-cell immunotherapy for multiple sclerosis (MS), today reported financial results for the year ended December 31, 2013, and provided an overview of recent corporate developments.

    2013 and recent highlights include:

    Clinical
    As of February 27, 2014, enrolled over 80% of the total number of patients expected to be enrolled in the Phase IIb "Abili-T" clinical study of Tcelna® (imilecleucel-T) in patients with Secondary Progressive Multiple Sclerosis (SPMS). The Abili-T clinical trial is a randomized, double-blind, placebo-controlled study designed to enroll 180 patients at approximately 35 leading clinical sites in the U.S. and Canada; and
    Furthered the accumulation of comprehensive patient data to support Opexa's Immune Monitoring Program which is being conducted in conjunction with the Abili-T trial. The goals of this Program are to identify potential novel biomarkers that could distinguish responders, to strengthen our intellectual property protection, and to broaden our understanding of the mechanism of action of Tcelna and the pathophysiology of SPMS patients.

    Financial/Operational
    Reported cash and cash equivalents of $23,644,542 as of December 31, 2013;
    Closed two underwritten public offerings of an aggregate of 17,638,000 shares of common stock during the second half of 2013 for aggregate gross proceeds of approximately $27.4 million, or net proceeds of approximately $24.8 million after deducting underwriting discounts and commissions and offering expenses;
    Eliminated debt on Opexa's consolidated balance sheet through the conversion into common stock of the July 2012 convertible secured promissory notes in an aggregate principal amount of $4.1 million, and unencumbered all of our intellectual property and physical assets previously pledged as collateral;
    Strengthened the team with the addition of several talented individuals dedicated to furthering the Company's development initiatives, including enhancing the manufacturing and delivery of Tcelna;
    Secured an option and license agreement with Merck Serono which, if exercised by Merck Serono, has the potential to bring in up to $220 million in milestone payments plus 8-15% royalties;
    Secured the 50th patent for the T-cell immunotherapy platform (U.S. and international jurisdictions, collectively); and
    Laid the foundation to explore potential disease indications beyond MS that could be addressed through use of our T-cell platform.
  6. [verwijderd] 12 maart 2014 10:56
    Vasthouden nu, die 3K, is mijn advies.

    One biotech name that investors should consider for long term investment is Opexa Therapeutics (OPXA). Opexa is engaged in creating novel immunuotherapies specific to patients' needs. One such lead candidate is Tcelna which is being developed specifically for patients with Secondary Progressive Multiple Sclerosis.

    Tcelna has the opportunity to provide patients with a first in line therapy for Secondary Progressive Multiple Sclerosis that is not toxic.
    Opexa investors that remain long term have the ability to reap huge rewards if the phase 2b trial comes out with positive efficacy.
    Opexa stands to make $7 billion dollars in sales with Tcelna, and could be used for other disease indications.

    Uit artikel van 10 maart jl.: seekingalpha.com/article/2078363-opex...

    Is natuurlijk het verhaal van een fervent aanhanger, maar het is geen onzin wat hij schrijft.

    Een beetje geduld hebben, dat is alles.
    Ik was eerst van plan om boven de $ 2 te verkopen, en een winst van 20-25% te realiseren, maar ben van gedachten veranderd: ik hou ze vast, en verkoop de helft zodra ik met de andere helft gratis kan doorspelen.
    Want het blijft natuurlijk een casino.
  8. [verwijderd] 13 maart 2014 16:50
    Bij een positieve uitkomst van fase IIb (in 2016) ontvangt OPXA direct $ 225 miljoen van Merck: dat is bij het huidige aantal aandelen $ 10,60 per aandeel.
    Dat zal m.i. toch wel een positieve impuls blijven geven, zolang er geen slechte berichten uit het lab komen.
    Over goedkeuring in 2019 hebben we het maar niet, dat geeft tot 15% fee over de verkopen: volgens schrijver artikel SA is het aandeel dan $ 249 waard.
    Met een bescheiden bedrag 100x je inzet terug, of alles kwijt: een redelijke risk/reward lijkt mij.
    Alleen, bij positieve geluiden uit het lab zal dit een utopie zijn, OPXA is dan allang van de beurs gehaald (door Merck).
    Waarom zou Merck over 2 jaar $ 225 mio betalen, als dat volgend jaar ook voor minder kan?
  13. [verwijderd] 9 mei 2014 17:54

    Opexa Therapeutics: An Optimal Buyout Candidate Pending Successful Topline Results From Abili-T

    Apr. 29, 2014 9:00 AM ET | 19 comments | About: OPXA, Includes: BIIB, MRK, SNY

    Disclosure: I have no positions in any stocks mentioned, but may initiate a long position in OPXA over the next 72 hours. (More...)

    Summary
    •Opexa is an emerging biopharmaceutical company listed on the Nasdaq.
    •Its main drug candidate, Tcelna, could have a profound impact on patients with Secondary Progressive Multiple Sclerosis as the first personalized T-cell immunotherapy to target this disease.
    •The company's option and license arrangement with Merck Serono, which secures 8-15% royalties for future global Tcelna sales, serves as leverage for an acquisition pending positive topline results of Abili-T.
    •Investors should also be aware of an imminent value-driving catalyst as patient enrollment for Abili-T is expected to be completed in Q2 2014.
    •The latest market correction offers a rare and unique opportunity to accumulate the stock at a substantial 25% discount. However, this opportunity is fleeting since shares could trade higher soon.

    Today we are considering a long position in an emerging micro cap called Opexa Therapeutics (OPXA). This company operates within the biopharmaceutical sector, has a $45 million market cap and is listed on the Nasdaq. One of the primary reasons that we are considering a long position is that we believe the ongoing clinical success of Opexa's lead drug candidate, Tcelna (imilecleucel-T), could translate to regulatory approval and potentially fill a significantly unmet medical need in patients with Secondary Progressive Multiple Sclerosis (SPMS). In conjunction, we believe Merck Serono, the biopharmaceutical division of Merck (MRK), which has option and licensing rights to Tcelna, could purchase Opexa at a substantial discount before exercising this agreement.

    Of course, our thesis is contingent on whether the topline results (expected in mid-2016) from the Phase IIb "Abili-T" clinical study are positive. But also keep in mind that Merck Serono has the option to exercise the license at any point during the trial, which is not likely given the lack of incentive, but possible nonetheless. If topline results are positive, a buyout is probable since it would allow Merck Serono to avoid up to $220 million milestone payments, as well as tiered 8-15% royalty payments to Opexa on the future global net sales of Tcelna, a drug that could become only the second FDA approved treatment for SPMS. Opexa's three main pipeline developments, in order of priority, are:
    1.Tcelna for SPMS (Fast-Track FDA Designation)
    2.Tcelna for Relapsing Remitting Multiple Sclerosis (RRMS)
    3.Monocyte-Derived Stem Cells (MDSC) for Diabetes Mellitus

  14. [verwijderd] 9 mei 2014 17:55
    These clinical developments target large, underserved markets. For instance, the market for SPMS is approximately $7 billion alone, while the total market for MS is expected to increase to $17.6 billion by 2019. Further, MDSC for Diabetes represents a $28 billion market opportunity, affecting more than 275 million people worldwide.

    After extensive research and our insightful interviews with Neil Warma, President and Chief Executive Officer (CEO) of Opexa, and Karthik Radhakrishnan, Chief Financial Officer (CFO), as well as with Dr. Christopher James of Brinson Patrick, we believe the company is substantially undervalued. As the market conditions settle and an uptrend takes effect (which some analysts believe is happening now), a short-term potential gain of 25%+ could be realized, representing a pre-market correction price of roughly $2.05-$2.10 a share. We are encouraged in this claim by the support of Mr. Warma, who believes that the current stock price does not reflect the value of the company's assets nor the revenue potential/licensing agreement with Merck Serono for Tcelna. Further, he believes that the investment community is not optimally aware of Opexa's clinical developments, and the market could soon take notice when completion of patient enrollment for Abili-T is expected during Q2 2014. We are also encouraged by Dr. James' recent coverage initiation on Opexa at Market Outperform, with an initial price target of $6.

    The market correction makes Opexa attractive

    Is Opexa rightfully the analyst-proclaimed villain of Wall Street? It is hard to forget the tantalizing day of August 7, 2013 when the stock reached an intraday high of $3.70 (representing well over a 100% gain) after positive rumors circulated about Tcelna. However, these gains were obliterated the very next day when the company announced a common stock offering. Despite a small recovery in the following months, it appears that investor confidence in Opexa was shattered, and both the volume and stock price have subsequently declined.
  15. [verwijderd] 9 mei 2014 17:55
    Granted Opexa's stock chart bears a striking resemblance to earthquake data from the Richter's Scale; anyone would admit that it is difficult to look at. The stock has lost more than half its value and recently plunged to a 52-week low of $1.25. While our intention is not to make excuses for poor stock performance, this extreme depreciation is not isolated to Opexa. Take a look at the overall NASDAQ Biotech Index.

    Everyone wants to know whether or not the carnage is over. The NBI has lost nearly 500 points since March 14, and some analysts believe that the market is primed for a 10% to 20% correction. Evidently, one answer is the carnage is only beginning; however, as we have previously argued, we perceive this as emotionally driven since a correction of this purported magnitude is, in our opinion, completely unwarranted (after all, the NBI has recovered 100 points since our initial prediction). Indeed, the condition of the market has left scars, and it appears that it has prompted an exodus out of the biopharmaceutical sector. However, we urge investors to consider the possibility that the recent drop in micro caps like Opexa poses a rare and unique buying opportunity. As the stock price has recovered 22% (or $0.33) to $1.58 as of the close on April 24, we believe that the opportunity to establish a position is fleeting since the completion of patient enrollment for Abili-T is expected in Q2 2014, and the announcement of a new drug indication could send shares above pre-correction levels.

    In the meantime, consider this question: has any fundamental aspect of the company changed since the correction? A quote from a Reuters report answers this question perfectly: "So far, the selloff has come in a near-vacuum of fundamental news." Likewise, as we will discuss, nothing has changed other than the continued progression of patient enrollment for Abili-T, along with a series of complementary PR events and non-events listed below:
    •OPEXA THERAPEUTICS, INC. Files SEC form 8-K, Financial Statements and Exhibits (March 20)
    •Lawsuits, Clinical Studies, Financial Results, and Stock Movements - Analyst Notes on Idenix, BG Medicine, Progenics, Omeros, and Opexa (March 21)
    •OPEXA THERAPEUTICS, INC. Files SEC form 8-K, Regulation FD Disclosure, Financial Statements and Exhibits (Mar 24)
    •RedChip Global Online CEO Conference, April 23-24, Featuring Presentations From 30+ Small-Cap Companies (April 21)
    •Opexa Therapeutics to Attend the American Academy of Neurology Annual Meeting (April 22)

    As always, we encourage our readers to double check our work. Please access the links and reach the conclusion that deems fit.

    Analyst coverage

    The recent coverage initiation on Opexa by analyst Christopher S. James, M.D. of Brinson Patrick cannot be ignored. On March 24, when the stock traded at $1.98, the firm initiated Opexa with a Market Outperform rating and an initial price target of $6.00. This represents nearly a 300% premium to the company's current stock price. In order to better understand why the firm is so confident in Opexa, we conducted an interview with Dr. James. Following are excerpts from that interview:

    Recently your firm initiated a $6 price target for Opexa with a Market Outperform rating. Given that the stock is trading at a fraction of that figure, is this target actually ascertainable?
    •a. Our valuation of Opexa is driven by future sales of Tcelna in SPMS, which we believe could exceed $2B in the US.
    •b. Our $6 PT has an implied valuation of less than $200M, which we think is easily attainable given value of the platform both in MS and other autoimmune diseases.
    •c. With a market cap below $50M, and a $20M enterprise value, OPXA shares are incredibly undervalued when you consider the option value of the Merck Serono deal.
  16. [verwijderd] 9 mei 2014 17:56
    If Tcelna continues to show success in clinical studies, what are probable exit strategies for Opexa?
    •a. We believe Merck Serono would have to consider an acquisition of Opexa if Tcelna is successful in the current Phase IIb Abili-T Study. As a reminder, payments could reach $220M based upon the success of Tcelna.
    •b. We highlight that Opexa is exploring the T-cell platform's potential in other autoimmune diseases and could announce an additional indication.

    What makes this drug so compelling? If it does yield this enormous potential as reflected in your $6 price target, why is the stock trading so low?
    •a. Tcelna showed compelling evidence in subpopulations of patients with SPMS in earlier studies. Tcelna demonstrated a 55% reduction in ARR compared to placebo, 88% reduction in whole brain atrophy, and a statistically significant improvement with EDSS (p<0.045).
    •b. Tcelna represents a personalized T-cell approach. It approaches SPMS similar to vaccine therapy where the virus is attenuated and injected back into the patient to mount a tailored immune response. In the case of Tcelna, attenuated T-cells from the patient are reintroduced via a subcutaneous injection to trigger a therapeutic immune response.
    •c. We agree that the stock is significantly undervalued at a $44M market cap. As Abili-T becomes fully enrolled in the coming weeks, and Tcelna continues to show progress, we believe the stock will begin to appreciate in value.

    Regardless of your price target, what do you believe is a fair valuation for Opexa now?

    Over the next 12 months, we see the stock trading at a multiple to its current valuation. Our $6 price target is fair considering the value of the platform.

    Do you believe analysts and the investor community are optimally aware of the company's current developments?
    •a. While I cannot speak for other analysts, we believe the stock will gain momentum over the next 12 months. The next catalyst, which is full enrollment of Abili-T, should garner additional interest.
    •b. I would point out that my background and training in neurosurgery is a possible differentiating factor. It has been an enormous asset to my assessment of Tcelna's potential in SPMS.

    (End of interview)

    Why Tcelna could be an important treatment for SPMS

    There are five main challenges to treating SPMS that doctors and pharmaceutical companies would like to resolve:
    •SPMS is often disabling and associated with low health related quality of life.
    •Interferon beta medications (e.g. Gilenya, Aubagio and Tecfidere) for relapsing forms of MS do not specifically target SPMS, leaving many patients with only one other medication to turn to;
    •Novantrone (mitoxantrone) is the only FDA approved medication specifically for SPMS, but as a chemotherapeutic agent, it has a terrible safety profile and is rarely used.
    •Overall, MS costs the average patient $2,200,000 over their lifetime, while the annual cost of existing RRMS therapies exceeds $50,000.
    •Studies suggest that money would be better spent on alternative ways to improve quality of life than on interferon beta medications.

    While the challenges above are extensive, we believe that Opexa is positioned to address them because Tcelna is safe, personalized and advanced in diminishing symptoms of SPMS. Further, as we will discuss, Tcelna has previously proven to reverse the progression of the disease altogether, representing an unprecedented step in immunotherapy that we believe no drug on the market can claim.

    In order to gain more insight, we conducted an interview with Neil Warma, President and CEO of Opexa, and CFO Karthik Radhakrishnan.
  17. [verwijderd] 9 mei 2014 17:57
    The interview

    Neil Warma holds an impressive resume and an MBA. Before assuming the position as President and Chief Executive Officer of Opexa in June 2008, Mr. Warma served as President and CEO and a member of the Board of Directors of Viron Therapeutics Inc., where he positioned the company as a leader in the treatment of serious inflammatory disorders. Prior to that, he held several senior management positions with Novartis Pharmaceuticals (NVS), and was co-founder and President of MedExact USA, Inc., an Internet company serving physicians and pharmaceutical companies which was ultimately sold to a large European firm. Mr. Warma holds an honors degree in neuroscience from the University of Toronto and an International MBA from the Schulich School of Business at York University in Toronto.

    Karthik Radhakrishnan also holds an impressive resume and MBA. Before assuming the position of Chief Financial Officer of Opexa in March of 2013, he served as Vice President at ING Investment Management in New York, where he was responsible for healthcare investments in the small and small-mid cap core/growth products. Prior to that, he held senior analyst positions at Eagle Asset Management and The Dow Chemical Company (DOW). Mr. Radhakrishnan holds an MBA from the University of Michigan and a Masters in Engineering from the State University of New York. Following are excerpts from the interview:

    In layman's terms, could you explain what Opexa is all about?

    CEO Warma: Opexa is developing a personalized T-cell immunotherapy to treat the more advanced form of multiple sclerosis, known as Secondary Progressive MS (SPMS). We are currently running a large 180 patient clinical trial in the US and Canada in SPMS patients. Since there are very few treatment options for individuals with SPMS, Opexa believes that its lead therapy, Tcelna® has the potential to be the treatment of choice for this group of patients, which could represent a $7 billion market opportunity.

    In all autoimmune diseases, the body's immune system does not function properly, resulting in serious, often debilitating conditions for the individual. Opexa's therapy aims to restore the function of the body's immune system such that the body is able to fight the disease itself. In a previous Phase IIb clinical study conducted in Relapsing Remitting MS patients, data showed Tcelna may be able to reverse the disability in patients.

    Opexa prides itself on its targeted approach to Precision Immunotherapy. Each annual course of therapy is individually tailored to match the patient's unique disease profile. We believe this approach could result in a favorable benefit:risk profile for Tcelna.

    Opexa has developed a true platform technology and believes that its platform can be leveraged to treat other autoimmune diseases with the same personalized approach.

    Our focus remains fixed on the execution of the Phase IIb "Abili-T" clinical study in SPMS patients. We are targeting Q2 2014 to complete enrollment, with top line data expected in mid-2016. As we also believe the potential of the platform to treat other numerous autoimmune diseases is high, we are evaluating what our next disease target could possibly be using our proprietary platform technology.

    Could you give a technical explanation?

    CEO Warma: Tcelna® (imilecleucel-T) is a personalized T-cell immunotherapy in a Phase IIb clinical development program (the Abili-T trial) for the treatment of Secondary Progressive Multiple Sclerosis. Tcelna is specifically tailored to each patient's immune response profile to myelin and is designed to reduce the number and/or functional activity of specific subsets of myelin-reactive T-cells (MRTC) known to attack myelin. Tcelna is manufactured using ImmPath®, Opexa's proprietary method for the production of a patient-specific T-cell immunotherapy, which encompasses the collection of blood from the MS patient, isolation of peripheral blood mononuclear cells, generation of an autologous pool of myelin-reactive T-cells (MRTCs) raised against selected peptides from myelin basic protein (MBP), myelin oligodendrocyte glycoprotein (MOG) and proteolipid protein (PLP), and the return of these expanded, irradiated T-cells back to the patient. These attenuated T-cells are reintroduced into the patient via subcutaneous injection to trigger a therapeutic immune system response.

    To what degree are your therapies validated?

    CEO Warma: We believe Tcelna is validated in several ways. Firstly, we have been granted Fast Track designation by the FDA for Tcelna in SPMS based on the potential of the therapy to treat SPMS and the significant unmet medical need. Additionally, we believe our therapy and platform has also been validated through the agreement we signed with Merck Serono, one of the largest pharmaceutical companies worldwide. This option and license agreement, once exercised, and if successful, could lead to a significant future cash flow for Opexa and provide for a more streamlined development program given Merck Serono's expertise is MS. Validation of the program has also been demonstrated by the comprehensive clinical development program we have undertaken at Opexa. To date, we have invested approximately $140 million in the development of Tcelna for MS and this has yielded encouraging clinical efficacy data in both relapsing remitting and secondary progressive MS patients and a superb safety profile.

    Are there any major pharmaceutical companies conducting complementary research to Opexa?

    CEO Warma: Opexa is one of the pioneers in this personalized T-cell immunotherapy approach, across the biotech and pharmaceutical industry.

    In 2008, Opexa announced positive results on the Phase IIb TERMS clinical study on Tcelna. Are the results encouraging/discouraging, and if so, can you please explain why?

    CEO Warma: The Phase IIb TERMS clinical study was completed in 2008 and yielded encouraging efficacy and safety data. The TERMS study was a multi-center, randomized, double blind, placebo- controlled trial in 150 patients with RRMS or high risk Clinically Isolated Syndrome. A key inclusion criterion for TERMS was an EDSS score of 0 to 5.5. Patients received a total of five subcutaneous injections at weeks 0, 4, 8, 12 and 24. Key results from the TERMS trial included:

    •In the modified intent to treat patient population consisting of all patients who received at least one dose of study product and had at least one MRI scan at week 28 or later (n=142), the ARR for Tcelna-treated patients was 0.214 as compared to 0.339 for placebo treated patients, which represented a 37% decrease in ARR for Tcelna as compared to placebo in the general population;

    •In a prospective group of patients with more active disease (ARR>1, n=50), Tcelna demonstrated a 55% reduction in ARR as compared to placebo, an 88% reduction in whole brain atrophy and a statistically significant improvement in disability (EDSS) compared to placebo (p<0.045) at week 52 during the 24-week period following the administration of the full course of treatment; and

    •In a retrospective analysis in patients nai¨ve to previous disease modifying treatment, the results showed that patients, when treated with Tcelna, had a 56% to 73% reduction in ARR versus placebo for the various subsets and p values ranged from 0.009 to 0.06.
  18. [verwijderd] 9 mei 2014 17:57
    How does the company plan to proceed with developing the Tcelna candidate?

    CEO Warma: Opexa is currently conducting a 180-patient Phase IIb clinical trial in Secondary Progressive MS with Tcelna. Opexa received Fast Track designation from the U.S. FDA for Tcelna in Secondary Progressive MS.

    What differentiates your therapies from others on the market, as well as those currently in development?

    CEO Warma: Tcelna is differentiated, we believe in several ways. It appears to have a superior safety profile to most if not all, MS therapies currently on the market or in development. Additionally, efficacy also looks to be encouraging. In a previously conducted Phase IIb trial, Tcelna was shown to actually improve the disability of patients with more active MS. Achieving this result, we believe, is unprecedented.

    We are differentiated in that we are focused on the more advanced stage of MS - Secondary Progressive MS. Currently, there are very limited treatment options for these patients. Only one drug has FDA approval in the US for the treatment of SPMS, and it has limited long-term use due to severe side effects. There are no drugs approved in Europe or Asia for SPMS. Opexa is committed to the SPMS patient population.

    We are, quite possibly, the only company developing a truly personalized therapy for MS patients. Every individual receives a precisely manufactured T-cell therapy tailored to his or her disease profile. In a disease as complex as MS, this may result in a more favorable benefit/risk profile.

    What is your current pipeline priority?

    CEO Warma: Our focus and top priority remains fixed on the execution of the Phase IIb "Abili-T" clinical study in SPMS patients. We are targeting Q2 2014 to complete enrollment with top line data expected in mid-2016. As we also believe the potential of the platform to treat other numerous autoimmune diseases is high, we are evaluating what our next disease target could possibly be using our proprietary platform technology.

    As noted on the Opexa website, the market for Multiple Sclerosis (MS) is approximately more than $9 billion as of 2008. Can you please explain how the company is preparing to address this growing market?

    CEO Warma: The MS market has been growing significantly over the past several years. All the drugs on the market currently are approved for Relapsing Remitting MS. Market reports suggest that these drugs generate approximately $10-12 billion annually. There are very limited treated options for patients with Secondary Progressive MS. This market, with very limited competition could represent an additional $7 billion in annual revenue. Opexa is dedicating its effort in becoming a treatment of choice ideally for all MS patients, with a primary focus on addressing the significant SPMS patient population first.

    In what ways are you planning/operating to address other markets?

    CEO Warma: Our focus remains fixed on the execution of the Phase IIb "Abili-T" clinical study in SPMS patients. We are targeting Q2 2014 to complete enrollment with top line data expected in mid- 2016. As we also believe the potential of the platform to treat other numerous autoimmune diseases is high, we are evaluating what our next disease target could possibly be using our proprietary platform technology.

    Does Opexa have any partnership or collaboration with another company or institution?

    CEO Warma: In 2013, Opexa signed an agreement with Merck Serono, one of the largest pharmaceutical companies in the world. This option and license agreement provides Merck Serono with the option to license Tcelna for all MS indications worldwide, excluding Japan.

    How does this translate to revenue potential?

    CEO Warma: Under the terms of the agreement, Opexa received an upfront fee of $5 million for granting an option to Merck Serono for the exclusive license of the Tcelna program for the treatment of MS. The option may be exercised prior to or upon completion of Opexa's ongoing Phase IIb clinical trial in patients with SPMS. Upon exercising this licensing option, Merck Serono would pay an upfront license fee of either $25 million or $15 million (depending upon whether certain conditions are met), and in return receive worldwide development and commercial rights to Tcelna in MS, excluding Japan. After exercising the option Merck Serono would be wholly responsible for funding clinical development, subject to Opexa's co-funding option, as well as regulatory and commercialization activities for the MS program. Additional financial considerations of the agreement include development and commercial milestone payments to Opexa of up to $195 million. Opexa also has the potential to receive a royalty on net sales ranging from 8-15%. Once the sales of Tcelna reach $2 billion, for example, Opexa would receive 15% of that as a form of royalty.

    Under the agreement, Opexa will have an option right to co-fund development, under which the Company would participate in economic support for future clinical development of the program in exchange for additional royalty consideration. In addition to retaining rights to all other diseases off the platform (outside of MS) as well as retaining the ability to commercialize Tcelna in Japan, Opexa also retains certain manufacturing rights related to the program. Further details of the transaction are included in a Form 8-K that was filed this morning by Opexa with the United States Securities and Exchange Commission.

    In your opinion, are there risks in your current business that are under-appreciated by investors?

    CEO Warma: Opexa's risk factors are outlined in our Forms 10-Q and 10-K that are filed with the U.S. SEC.

    In what ways do you feel the current stock price does not value the company's strengths or weaknesses?

    CEO Warma: We do not believe the current valuation is a true representation of our current assets or our potential. As investors begin to further understand our points of differentiation and realize our full potential, we could see effect on valuation. We have demonstrated validation of the technology on numerous fronts, we believe, through Fast Track designation from the FDA, a partnership with Merck Serono, encouraging clinical efficacy and safety data and by the fact that we are developing a novel personalized approach, which appears unique in the industry. The market potential of our targeted disease area may be in excess of $7 billion with very little competition. As we continue to execute on our goals, generate data and broaden our communication, this may have a positive effect on valuation.

    Do you believe Opexa is receiving appropriate media coverage, and do you think the investment community is optimally aware of your current developments?

    CEO Warma: Awareness in Opexa is increasing. As we continue to execute on target, the Opexa story is generating more and more interest. People are beginning to realize that if Opexa is successful in the treatment of Secondary Progressive MS the ROI will be substantial. A key milestone in this endeavor will be closing out recruitment of Opexa's ongoing Phase IIb "Abili-T" clinical trial in SPMS, which we are targeting for Q2 2014.
  19. [verwijderd] 9 mei 2014 17:57
    What's your overview on the future of your specialization or niche in the pharmaceutical business?

    CEO Warma: We are specialized in the delivery of Precision Immunotherapy TM. We are attempting to restore the function of the body's immune system and are doing so through the administration of truly personalized therapies.

    We believe therapies that are able to modulate the immune system will yield significant medical breakthroughs in the next 10-20 years. We have developed a potent immunotherapy platform at Opexa that, we believe, has the potential to address numerous autoimmune diseases. We are addressing the root cause of the disease - with our first indication being multiple sclerosis.

    Additionally, we are specialized in delivering a truly personalized therapy. Each individual receives a precisely manufactured therapy that matches their unique disease profile.

    What can investors broadly expect from Opexa in the short and long term?

    CEO Warma: Drug development is a long-term process that requires a long-term investment strategy. Opexa is developing a truly novel technology based on delivering personalized medicines. We do not believe anyone is addressing MS with the elegance and personalization that Opexa's therapy offers. Additionally, we are currently focused on Secondary Progressive MS, a disease with a significant unmet medical need and very little competition. If the results from the ongoing Phase IIb study, expected in mid-2016, are positive, then the return on an investment made today should be substantial. As we execute on our plans, we expect to report on the completion of enrollment in the Phase IIb study, possible entry into another disease off the T-cell platform and top line data on the SPMS trial.

    Is there anything else that you would like our readers to know about Opexa?

    CEO Warma: Opexa aims to become a leader in the treatment of autoimmune diseases through the development of truly personalized therapies. It has a potent T-cell platform that has shown promise in the treatment of Multiple Sclerosis and the potential to be expended to several other autoimmune diseases. Ownership of its T-cell platform should enable Opexa to carefully control quality and also ensure that it maintains tight control on costs such that it can deliver a safe and effective treatment with attractive margins.

    At the current valuation, Opexa represents a very attractive investment opportunity in our eyes given the achievements to date and its future potential.

    What is the adequacy of your funding relative to your goals?

    CFO Radhakrishnan: As of Dec 31, 2013, Opexa had $23.6 million in cash and cash equivalents. This positions the company to focus on successful execution of the clinical trial. Top line data is expected in mid-2016.

    Could you please go over insider ownership?

    CFO Radhakrishnan: Management is incentivized through a combination of stock options and restricted stock. The beneficial ownership of management as disclosed in the 10-K is approximately 5%. This figure includes options and warrants that are exercisable within the next 60 days. Please refer to the 10-K and our proxy statements for further information.

    What's your current financial position?

    CFO Radhakrishnan: Cash as of December 31, 2013 was $23.6 million. The market cap is $45 million.

    What is your current revenue growth?

    CFO Radhakrishnan: Opexa has no marketed products at this time.

    What's your cash burn? Given that rate, do you envision the need to return to the capital market to raise additional money?

    CFO Radhakrishnan: We expect the cash position to take us into the fourth quarter of 2015, assuming a continued focus on the current activities.

    The Company does not comment on timing of capital raises. We have capital to Q4 2015 and are currently focused on executing on the enrollment of the Abili-T trial.

    With the company currently advancing multiple clinical programs, do you have an idea of what the associated costs will be?

    CFO Radhakrishnan: Opexa is currently conducting a Phase IIb clinical trial in Secondary Progressive MS. As of December 31, 2013, we had $23.6 million in the bank, which is expected to take us to Q4 2015.

    (End of interview)
  20. [verwijderd] 9 mei 2014 18:00
    Interview key points

    Number 1. As an interviewer and analyst, it is rare to come across an instance where a CEO openly states that their company is undervalued, especially in the case of clinical-stage biopharmacetuicals. Thus, we are encouraged by Mr. Warma's remarks regarding why he believes the current stock price of Opexa does not reflect the value of its pipeline assets and the overall sales potential of Tcelna. In particular, he provided us with an example of what Opexa's future valuation could look like if Merck Serono exercises its licensing option on Tcelna, and if the drug receives regulatory approval. We will now provide several hypothetical SPMS sales scenarios (excluding RRMS), in order of desirability, that elucidate the long-term investment opportunity in Opexa to complement Mr. Warma's remarks.
    •Scenario A) Sales of Tcelna exceed $2 billion. Opexa's royalty payment of 15% equates to $300 million, which does not account for $170 million in upfront milestone payments payable to the company depending on FDA filing ($35 million), EU filing ($30 million), Phase III trial ($25 million) and commercial milestone payments ($80 million). Opexa's current market cap is only $45 million, representing a fair market value of $12.11 a share. Further, if the license fee of $15-$25 million is considered in addition to the $170 million in milestone payments, Opexa's market cap would range between $555-$565 million, and a conservative estimate would place shares at ~ $16.50 a share.
    •Scenario B) Sales of Tcelna reach $1 billion. Opexa's royalty payment would be around 11.5%, which equates to $150 million, excluding $170 million in milestone payments and the license fee of $15-$25 million. This represents a fair market value of $6.84 a share ($195 million/$45 million= ~4.3X current share price of $1.58). For our purposes, let's assume that Opexa receives an additional $15 million from the license fee and $150 million in milestone payments. The market cap would be $360 million, representing a fair market value of ~ $12.64 a share.
    •Scenario C) Sales of Tcelna reach $500 million. Opexa's royalty payment of around 11.5% equates to $57.5 million, excluding the milestone payments and license fee. This represents a fair market value of $3.60 ($102.5 million/$45 million= ~2.3X current share price of $1.58). If Opexa receives an additional $15 million from the license fee and $130 million in milestone payments, the market cap would be $247.5 million, representing a fair market value of ~ $8.69 a share.
    •Scenario D) Sales of Tcelna reach $250 million. Opexa's royalty payment of 8% equates to $22.5 million, excluding the milestone payments and license fee. This represents a fair market value of $2.40 ($67.5 million/$45 million= ~1.5X current share price of $1.58). If Opexa receives an additional $15 million from the license fee and $110 million in milestone payments, the market cap would be $118 million, representing a fair market value of ~ $4.14 a share.

    (Note #1: Opexa has sole rights to market Tcelna in Japan, which offers additional sales potential that we excluded in the fair market share values calculated in scenarios A-D)

    (Note #2: The agreed Royalty payments take the form of a tiered structure from 8-15%, at points $500 million, $1 billion and $2 billion. Since the specified percentages of each tier have not been disclosed at this time, we have used 11.5% as an approximation)

    While there is substantial variation in fair market value between scenarios A-D, the least ideal scenario (D) is approximately 260% higher than Opexa's current stock price of $1.58. While our intention in providing these scenarios is not to mislead investors into believing that there are no alternative outcomes to A-D, it is important nonetheless to offer a perspective on what Opexa's potential valuation could be if Tcelna receives regulatory approval, the partnership executes properly and the market demand for the drug aligns with analyst expectations.

    Number 2. We cannot stress enough how significant the lack of treatments for SPMS is to Opexa's market opportunity and overall valuation potential. As Mr. Warma repeatedly emphasized, Novantrone (which he did not name), the only FDA approved chemotherapeutic medication specifically for SPMS on the market since 2000 is less desirable due to its inferior safety profile. Case in point, in 2005 the FDA added a black box warning to the prescribing information of this medication, stating the dangers of cardiotoxicity, Secondary acute myelogenous leukemia (AML), infections and other serious conditions that have ultimately hampered sales of the drug.

    In fact, Pfizer (PFE), which markets a generic version of Novantrone called Mitoxantrone, did not care to specify the sales of the drug in its most recent 10-K, and it surely does not help that the EU's 2006 hazard classification for this compound is DANGER, accompanied by the scary image above. According to a representative of Merck Serono (the company that markets Novantrone), "We believe [the black box warning] is not going to have an effect on the product. The product is for very severe forms of MS, for people who have no choice." Nevertheless, four years later in 2010, the side effects noted in the black box warning, i.e. cardiotoxicity and AML, were found to be worse than previously thought. The risk for heart damage is about 12% and less than 0.5% for heart failure, meaning for every eight people given mitoxantrone, one will develop heart damage. Further, the risk for AML is about less than 1%, meaning for every 123 people given mitoxantrone, one will develop AML. As more research is conducted on the degree of prevalence of these side effects, we expect a continued increase in accordance with a previous rise in AML and cardiotoxicity cases from 2000-2005, as well as during 2005-2010 (post-black box warning). Clearly, the representative's 2006 prediction failed to account for these externalities.
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