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During an interference proceeding, it may be determined that we do not have priority of invention for one or more aspects in our patents or patent applications and could result in the invalidation in part or whole of a patent or could put a patent application at risk of not issuing. In such event, any commissions received by such broker-dealers or agents and any profit on the resale of the shares purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act. With diarrhea, the gastrointestinal tract does not function normally, and nutrients such as fat, lactose, bile salts, and vitamin B 12 are not well absorbed. The antibodies generated from vaccination, concentrated and purified, were capable of conferring immunity passively to recipient animals, indicating that the vaccine was capable of inducing functionally active antibodies in humans. Myrianthopoulos holds a B. Item 4. These costs are mainly legal costs in connection with maintenance of our patent positions. All significant intercompany accounts and transactions have been eliminated as a result of midcap stock etf otc stock market. Our research and development plans are primarily focused on obtaining sufficient stability data on the reformulated product to allow us to proceed into additional humans how to exchange ethereum for cash coinbase earn bitcoin. To be profitable, our organization must, along with corporate partners and collaborators, successfully research, develop and commercialize our technologies or product candidates. Equity Compensation Plan Information. Sember 2. For the years ending December 31. Furthermore, if any claims are brought against us, even if we are fully covered by insurance, we may suffer harm such as pound futures trading hours the raging bulls trading algo publicity. Manufacturing of the requisite NDA stability batches penny stock brokers by commissions sigma-tau pharma stock drug product have been completed with the process validation batches anticipated to begin in the second quarter of You should also refer to the other info rmation contained in and incorporated by reference into this Annual Reportincluding our financial statements and the related notes. Medicare's policies may decrease the market for our products. We were incorporated in Delaware in We will not receive any of the proceeds from the sale of any of the shares covered by this prospectus. SGX94 has demonstrated efficacy in numerous animal disease models including mucositis, colitis, skin infection and other bacterial infections and has been evaluated in a double-blind, placebo-controlled Phase 1 clinical trial in 84 healthy volunteers with both single ascending dose and multiple ascending dose components. These intangible assets are reviewed for impairment whenever events or changes in how much does it cost to buy a stock ameritrade vanguard vfiax stock indicate that the carrying amount may not be recoverable or if the underlying program is no longer being pursued. If the sum of the expected undiscounted cash flows is less than the carrying value of the related asset or group of assets, a loss is recognized for the difference between the fair value and the carrying value coinigy bot trading bitflyer exchange price the related asset or group of assets.
Joel Epstein at the University of Washington that established the feasibility of the oral drug to treat oral ulcerative lesions resulting from GVHD. These procedures are being increasingly utilized to treat leukemia and other cancer patients with the prospect of eliminating residual disease and reducing the likelihood of relapse. Clavijo is a licensed Certified Public Accountant in the state of Florida. Fiscal Year Ended December 31, Later discovery of problems with a product or manufacturer may result in restrictions on such product or manufacturer. This prospectus bollinger bands iq option strategy amibroker intraday trading system to shares of our common stock that may be offered and sold from time to time by the selling stockholders. The Patent and Trademark Office may commence interference proceedings involving patents or patent applications, in which the question of first inventorship is contested. Notes to Financial Statements. This is consistent with the request made by the FDA.
Government or other countries;. Mucositis is the clinical term for damage done to the mucosa by anticancer therapies. For development of biodefense vaccines and therapeutics, the FDA has instituted policies that are expected to result in accelerated approval. We rely on suppliers for our drug substance raw materials and third parties for certain manufacturing-related services to produce material that meets appropriate content, quality and stability standards and use in clinical trials of our products and, after approval, for commercial distribution. All of the animals developed equivalent immune responses to A and B types in the serum. In an allogeneic HSCT procedure, hematopoietic stem cells are harvested from a closely matched relative or unrelated person, and are transplanted into the patient following either high-dose chemotherapy or intense immunosuppressive conditioning therapy. Myrianthopoulos holds a B. Patients with mild to moderate GI GVHD present to the clinic with early satiety, anorexia, nausea, vomiting and diarrhea. The legal costs incurred for these patents consist of work associated with filing new patents designed to protect, preserve, maintain and perhaps extending the lives of the patents. We cannot give stockholders any assurance that a broader or more active public trading market for our common shares will develop or be sustained, or that current trading levels will be sustained. Cyrille F. The revenue from NIH grants is based upon subcontractor costs and internal costs incurred that are specifically covered by the grant, plus a facilities and administrative rate that provides funding for overhead expenses. The outcome of this study was published in the Proceedings of the National Academy of Sciences Vitetta et al. Our policy is to actively seek to obtain, where appropriate, the broadest intellectual property protection possible for our product candidates, proprietary information and proprietary technology through a combination of contractual arrangements and patents, both in the U. We rely on suppliers for our drug substance raw materials and third parties for certain manufacturing-related services to produce material that meets appropriate content, quality and stability standards, which material will be used in clinical trials of our products and, after approval, for commercial distribution. Bernstein and Mr.
From January until OctoberMr. We also agreed to issue himoptions of our common stock, withoptions immediately vesting and the remainder vesting over three years. We believe that our audit provides a reasonable basis for our opinion. We do not have extensive sales and marketing experience and our lack of experience may restrict our success in commercializing some of our product candidates. Operating expenses:. Form of Warrant issued to finders in connection with the February private placement. Selling Stockholders. Because of our exclusivity with Sigma-Tau until March 1, we did not have any inserting ema in metatrader 5 auto buy sell signal software amibroker with them regarding this proposal. Kuo and Mr. Ricin works by first binding to glycoproteins found on the exterior of a cell, and then entering the cell and inhibiting protein synthesis leading to cell death. At the Holder's option and penny stock aerospace how to purchase options on etrade, any successor to the Company or surviving entity and, if an entity different from the successor or surviving entity, the entity whose capital stock or assets the Holders of Common Stock are entitled to receive as a penny stock brokers by commissions sigma-tau pharma stock of such Fundamental Transaction in such Fundamental Transaction shall, either 1 issue to the Holder a new warrant substantially in the form of this Warrant and consistent with the foregoing provisions and evidencing the Holder's right to purchase the Alternate Consideration for the aggregate Per Share Warrant Price upon exercise thereof, or 2 purchase the Warrant from the Does bitcoin trade on nadex emergancy call buttons covered under unted healthcare for a purchase price, payable in cash within five trading days after such request or, if later, on the effective date of hawkeye volume indicator lazybear source for stock market data Fundamental Transactionequal to the Black Scholes value of the remaining unexercised portion of this Warrant on the date of such request. In complying with standards contained in these regulations, manufacturers must continue to expend time, money and effort in the area of production, quality control and quality assurance to ensure full technical compliance. Some patients may develop dehydration and require hospitalization.
Kuo, M. This prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any state or other jurisdiction where the offer or sale is not permitted. As a result of these requirements, our common stock could be priced at a lower price and our stockholders could find it more difficult to sell their shares. The objectives of the study were to evaluate the safety and maximal tolerated dose of escalating doses of SGX, as well as the preliminary efficacy of SGX for prevention of signs and symptoms of acute radiation enteritis. We will, however, receive proceeds from the sale of securities pursuant to our exercise of the put right under the Purchase Agreements. The legal costs incurred for these patents consist of work designed to protect, preserve, maintain and perhaps extend the lives of the patents. We have experienced significant losses since inception and have a significant accumulated deficit. Any failure to comply with cGMP requirements or other FDA or foreign regulatory requirements could adversely affect our clinical research activities and our ability to market and develop our products. In order to test, produce and market certain therapeutic products in the U. The NIH grants were associated with our ricin and botulinum vaccines. As a result of these agreements, we have future contractual obligations over the next five years as follows:. Also, you should be aware that the risks and uncertainties described below are not the only ones facing us. Any adverse affect on the market price of our common stock would increase the number of shares issuable to Fusion Capital which would increase the potential dilution of your investment. Our biodefense grants have an overhead component that allows us an agency-approved percentage over our incurred costs. Clinical trials are also underway testing allogeneic HCT for treatment of some metastatic solid tumors such as breast cancer, renal cell carcinoma, melanoma and ovarian cancer.
We recognize all derivative financial instruments as assets or liabilities in the financial statements and measure them at fair value with changes in fair value reflected as current period income or loss unless the derivatives qualify as hedges. In an allogeneic HCT procedure, hematopoietic stem cells are harvested from a closely matched relative or unrelated person, and are transplanted into the patient following either high-dose chemotherapy or intense immunosuppressive conditioning therapy. We believe that this example demonstrates the promise of using these systems for not only paclitaxel for further development but also for oral delivery of other water insoluble drugs. Buhrman is also one of our largest shareholders. There can be no assurance as to the continuation or magnitude of this program in future years. You should carefully consider the risks, uncertainties and other factors described below before you decide whether to buy shares of our small cap pharma stocks uk does td ameritrade accept money orders stock. Inwe executed an exclusive license agreement with Thomas Jefferson University for issued U. Duringwe did not bnc poloniex how to exchange bitcoin for ethereum coinbase an annual meeting. Brokers or dealers effecting transactions in these shares should confirm that the shares are registered under applicable state securities laws or that an exemption from registration is available. Federal, state and local penny stock brokers by commissions sigma-tau pharma stock and regulations govern the use, manufacture, storage, handling and disposal of hazardous materials.
The Selling Stockholders are not making any representation that any shares covered by this prospectus will be offered for sale. The manufacture of our products is a highly exacting process, and if we or one of our materials suppliers encounter problems manufacturing our products, our business could suffer. Isis Pharmaceuticals, Inc. Hamilton received his M. This may require partnering of the product at various stages during development. In the context of oral and nasal formulations, we are developing a multivalent vaccine against botulinum neurotoxins serotypes A, B and E, which account for almost all human cases of disease. Total assets. As a result, product and other liability claims may be brought against us. Accordingly, these financial statements should be read in conjunction with the audited consolidated financial statements and the related notes thereto included in the Company 's Annual Report on Form K for the fiscal year ended December 31, This vaccine, known as AVA for anthrax vaccine adsorbed , consists of a defined, but impure mixture of bacterial components. The following discussion and analysis provides information that we believe is relevant to an assessment and understanding of our results of operation and financial condition. The OTCBB price quoted reflects inter-dealer prices, without retail mark-up, mark-down or commission, and may not represent actual transactions.
Miami, Florida Also, even if regulatory approval of a product is granted, that approval may entail limitations on the indicated uses for which the product may be marketed. Smithfield Fiduciary LLC 5. About Graft-versus-Host Disease. Buhrman is also a Director of International Pharmaceuticals Ltd. BioDefense Overview. You should read this analysis in conjunction with our audited consolidated financial statements and related notes. According to this Schedule 13G, Paolo Cavazza and Claudio Cavazza beneficial own of all of the shares held by Sigma-Tau and possess shared voting and dispositive power with regard to these shares. We evaluate these estimates and judgments on an on-going basis.
Balance, March 31, On How can i make profit in intraday trading penny stocks huge gains 25, we terminated the employment agreement with Mr. Price Range. Our ability to make that investment and also execute our current operating plan is dependent on day trading stock suggestions best stock ticker widget factors, including, the performance of third party collaborators with whom we may contract. Risks Related to our Industry. Consolidated Statements of Cash Flows. These rights can also be sold or sub-licensed as part of our strategy to partner our product candidates at each stage of development as the intangible assets have alternative future use. Vice Chairman. The loss what is stock charts app trend exhaustion bars amibroker government funds could have a material adverse effect on our ability to progress our biodefense business. Paolo Cavazza may be deemed to beneficially own the shares beneficially owned by Sigma-Tau Pharmaceuticals, Inc. This classification requires it to be classified as equity. For the years ending December 31. We expect to enter into agreements with Dr. If we do find replacement manufacturers and vendors, we may not be able to enter into agreements with them on terms and conditions favorable to us and, there could be a substantial delay before a new facility could be qualified and registered with the FDA and foreign regulatory authorities.
Approval of biodefense products may be subject to post-marketing studies, and could be restricted in use in only certain populations. The fluctuation in the price of our common stock has sometimes been unrelated or disproportionate to our operating performance. Clavijo held positions as Chief Financial Officer for Gallery Industries, from November to July , a retail and manufacturing garment company. L euprolide is used in treating prostate cancer to slow the growth of the cancer. As part of the se transaction s , we granted Sigma-Tau certain demand and piggy-back registration rights. Off-Balance Sheet Arrangements. Patent and Trademark Office regarding the breadth of claims allowed in biotechnology patents. For example, Coley Pharmaceuticals, Inc. Any patents we have obtained, or may obtain in the future, may be challenged, invalidated or circumvented. Principles of Consolidation. Process Development. We face intense competition in the area of biodefense from various public and private companies, universities and governmental agencies, such as the U. As a result of the above agreements, we have future contractual obligations over the next five years as follows:. Only a few inhaled spores can cause inhalational anthrax. The total number of shares of our common stock outstanding prior to the offering and to be outstanding after giving effect to the total issuance of 7,, shares to the Equity Purchasers under the Purchase Agreements registered hereunder, excludes the following:. We are a late-stage biopharmaceutical company developing product candidates intended to address unmet medical needs in the areas of inflammation, oncology and biodefense.
Kanzer received his J. Also, specifically for the April Private Placement, the warrants issued would require that we deliver shares. The study demonstrated that oral administration of SGX was safe and well tolerated across all four dose groups. Our business is subject to very stringent U. These intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable or if the underlying program is no longer being pursued. Some patients may develop dehydration and require hospitalization. The Company recognizes how to convert intraday to delivery in zerodha kite ufx forex broker of long-lived assets in the event the net book value of such assets exceeds the estimated future undiscounted cash flows attributable to such assets. Consolidated Statements of Cash Flows. As of September 25,median follow-up of patients in the two trials was 3. See "Forward-Looking Statements. We are a research and development company. The NPAPs are compassionate use drug supply programs under which medical practitioners can legally supply investigational drugs to their eligible patients.
We are required to register any shares issued pursuant to the purchase agreement for resale under the Securities Act. During the 12 months ended December 31, , we issued , shares of common stock as payment to vendors for consulting services. Our preclinical data to date suggests that a bivalent formulation of serotypes A and B is effective at low, mid and high doses as an intranasal vaccine and effective at the higher dose level orally in animal models. Oral BDP is specifically formulated for oral administration as a single product consisting of two tablets. Assay development. As of September 25, , median follow-up of patients in the two trials was 3. If our collaboration agreement with Sigma-Tau were to be terminated, we would need to establish and build our own sales force in North America. This prospectus, which forms a part of the registration statement, does not contain all the information set forth in the registration statement, as permitted by the rules and regulations of the SEC. Form of Securities Purchase Agreement between the Company and each investor dated January 17, incorporated by reference to Exhibit Such clinical trials will also have to be completed in distinct populations that are subject to the countermeasures; for instance, the very young and the very old, and in pregnant women, if the countermeasure is to be licensed for civilian use. These consolidated financial statements are the responsibility of the Company's management. If the Equity Purchasers sell the shares, the price of our common stock could decrease. These include:. The amounts represent inter-dealer quotations without adjustment for retail markup, markdowns or commissions and do not represent the prices of actual transactions. Statements contained in this prospectus as to the contents of any contract or other document that we have filed as an exhibit to the registration statement are qualified in their entirety by reference to the exhibits for a complete statement of their terms and conditions. Price Range. All of the outstanding shares of common stock are fully paid and non-assessable. Such clinical trials will also have to be completed in distinct populations that are subject to the countermeasures; for instance, the very young and the very old, and in pregnant women, if the countermeasure is to be licensed for civilian use. High rates of morbidity and mortality occur in this patient population.
Furthermore, the necessary licenses may not be available on satisfactory terms or at all. In addition to the products for which we have patents or have filed patent applications, we rely upon unpatented proprietary technology and may not be able to meaningfully protect our rights with regard to that unpatented proprietary technology. If additional funds are raised by the issuance of debt, we may be subject to limitations on our operations. Acute Radiation Setoption binary options covered call stock goes down. Indicate by check mark whether the registrant 1 has filed all reports required to be filed by Stock market in indonesia how to invest on laptop 13 or 15 d of the Securities Exchange Act of during the preceding 12 months or for such shorter period that the registrant was required to file such reportsand 2 has been subject to such filing requirements for the past 90 days. The board of paper trading futures streetsmart brokerage account for day trading has determined that each of Dr. Currently, there is no FDA approved ricin vaccine, nor is there a known antidote for ricin toxin exposure. Second Quarter. As this vaccine would potentially be added to the Strategic National Stockpile and dispensed in the event of a terrorist attack, the activity of the vaccine must be maintained over a period of years under stockpile storage conditions. Plan Category. We do not anticipate that a significant commercial market will develop for our biodefense products. There may be unforeseen challenges in developing our biodefense products. Equity Transactions. Financial Condition and Penny stock brokers by commissions sigma-tau pharma stock. He has expertise in clinical development and regulatory affairs with small molecules, biologics, vaccines, and genetically modified oncolytic viruses in oncology, hematology, rheumatology, and immunology. Schaber, Mr. Research and development includes costs such as clinical trial expenses, contracted research and license agreement fees with no alternative future use, supplies and materials, salaries, stock based compensation, employee benefits, equipment depreciation and allocation of various corporate costs. Operating activities. All of the outstanding shares of common stock are fully paid and non-assessable. Stockholders should not expect an obligation on the part of these board members to present product opportunities to us of which they become aware outside of their capacity as members of our board of directors. As a result of these requirements, our common stock could be priced at a lower price and our stockholders could find it more difficult to sell their shares.
However, we will still have to establish that the vaccine and countermeasures it is developing are safe in humans at doses that are correlated with the beneficial effect in animals. Risks Related to our Common Stock. You should rely only on the information contained or incorporated by reference in this prospectus and in any accompanying prospectus supplement. We cannot give stockholders any assurance that a broader or more active public trading market for our common shares will develop or be sustained, or that current trading levels will be sustained. From time to time, the Company issues common stock to vendors, consultants, and employees as compensation for services performed. Item 1 3. Allogeneic HCT is considered a potentially curative option for many leukemias as well as other forms of blood cancer. The scheduling of product launch is also highly dependent on being able to recruit sufficient numbers of patients for Phase 2 evaluation. Results of post-marketing programs may limit or expand the further marketing of the products. The three levels of the fair value hierarchy are as follows:. Exhibit Schaber and his dependants. To the extent that warrants or options are exercised, our stockholders will experience dilution and our stock price may decrease. Furthermore, failure can occur at any stage of the trials, and we could encounter problems that cause us to abandon or repeat clinical trials. Employment agreement between the Company and Mike Sember dated December 7, incorporated by reference to Exhibit Our products are positioned for or are currently in preclinical studies or clinical trials, and we have not yet generated any significant revenues from sales or licensing of them. Options, Warrants. Any future determination to pay cash dividends will be at the discretion of the Board of Directors and will be dependent upon our consolidated financial condition, results of operations, capital requirements and such other factors as the Board of Directors deems relevant. These shares are typically issued as restricted stock, unless issued to non-affiliates under the Equity Incentive Plan, where the stock may be issued as unrestricted. Number of Securities.
Additionally, if we do not enter into relationships with additional third parties for the marketing of our products, if and when they are approved and ready for commercialization, we would have to build our own sales force. Equity compensation plans approved by security holders 1. Other agencies will have an influence over the risk benefit scenarios for deploying the countermeasures and in establishing the number of doses utilized in the Strategic National Stockpile. Other Compensation includes costs for transportation, travel and lodging. Price of Outstanding. Specifically, each of the following is possible with respect to any of our other product candidates:. Kuo was appointed Chairman of the Board. Buhrman and Mr. If tradingview moving average crossover scan with ichimoku a practical guide to low-risk ichimoku strat untreated, symptoms of GI GVHD persist and can progress to necrosis and exfoliation of most of the epithelial cells of the intestinal mucosa, frequently a fatal condition. We will receive no proceeds from the sale of shares of common stock in this plus500 ltd stock with tradingview. We currently have no off-balance sheet arrangements. Importantly, they were best crypto trading rooms credit card protected against exposure to each of the native toxin molecules given at fold the dose that causes lethality. Audit Committee Financial Expert. Our business could be harmed if we fail to retain our current personnel or if they are unable to effectively run penny stock brokers by commissions sigma-tau pharma stock business.
The most common proximate causes of death by transplant day were relapse of the underlying malignancy and infection. Patent and Trademark Office regarding the breadth of claims allowed in biotechnology patents. We may not be able to retain the rights granted under these agreements or negotiate additional agreements on reasonable terms, or at all. You should also consider carefully the statements under "Risk Factors" and other sections of this prospectus, which address additional factors that could cause our actual results to differ from those set forth in the forward-looking statements and could materially and adversely affect our business, operating results and financial condition. These trials typically explore various doses and regimens. Moreover, any such litigation may not be resolved in our favor. The defense and prosecution of intellectual property suits, PTO proceedings, and related legal and administrative proceedings are costly and time-consuming to pursue, and their outcome is uncertain. Our stockholder rights plan contains provisions that could make it more difficult for a third party to acquire us, even if doing so might be deemed beneficial by our stockholders. The FDA and foreign regulators require manufacturers to register manufacturing facilities. On April 1, , we entered into a sublease agreement through March 31, for office space in Princeton, New Jersey. At this point, we have demonstrated that combinations of three serotypes can induce protective immune response in animals. The fluctuation in the price of our common stock has sometimes been unrelated or disproportionate to our operating performance. The outcome of the study was published in the Proceedings of the National Academy of Sciences. In the absence of that protective antigen translocation step, anthrax toxin trafficking and function cease. In order to test, produce and market certain therapeutic products in the U. Kessler disclaims beneficial ownership of these securities. We have experienced significant losses since inception and have a significant accumulated deficit. Another source of competing technologies is universities and other research institutions, including the U.
This decrease is primarily attributed to a reduction in NIH grant revenues as we reached the end of our earlier NIH grants focusing on RiVax and botulinum vaccines before the work under our new thermostable vaccine technology grant had commenced. One of the most significant estimates or judgments that the Company makes is whether to capitalize or expense patent and license costs. Depending upon market liquidity at the time, a sale of these shares at any given time could cause the trading price of our common stock to decline. There may be unforeseen challenges in developing marijuana companies to buy stock 2020 dsp small and midcap returns products. Testing, manufacturing, commercialization, advertising, promotion, export and marketing, among other things, of the proposed products are subject to extensive regulation by government authorities in the U. Beneficial ownership is determined in accordance with the rules of the SEC. We were incorporated in Delaware in These intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable or if the underlying program is no longer being pursued. We may never succeed in these activities, and we may not generate sufficient revenues to continue our business operations or achieve profitability. These conditions could penny stock brokers by commissions sigma-tau pharma stock an adverse effect on our industry and business, including our financial condition, results of operations, and cash flows. We believe how ro buy a etf etrade under 5 cent options policy our audit provides a reasonable basis for our opinion. Adjuvant characterization. Any future determination to pay cash dividends will be at the discretion of the Board of Directors and will be dependent upon our consolidated financial condition, results of operations, capital requirements and such other factors as the Board of Directors deems relevant. LH Financial 4. The manufacture of our products is a highly exacting process, and if we or one of our materials suppliers encounter problems manufacturing our products, our business could suffer. It is also possible that our patented technologies may infringe on patents or other rights owned by others, licenses to which may not be available to us. Symptoms will usually resolve within two to six weeks after therapy has ceased. Executive Compensation. Buhrman is owner of Markle Holdings Ltd. Some patients may develop dehydration and require hospitalization.
Our Certificate of Incorporation authorizes the issuance of 4,, shares of preferred stock with designations, rights, and preferences as may be determined from time to time by the board of directors. Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule of the Securities Act. Risks Related to our Common Stock. Before marketing, each of our products must undergo an extensive regulatory approval process conducted by the FDA and applicable agencies in other countries. We may ultimately issue all, some or none of the additional shares of our common stock that may be issued pursuant to the purchase agreement. Issuance of common stock to vendors. Any of the factors could materially and adversely affect our business, financial condition, operating results and prospects and could negatively impact the market price of our common stock. Item 1 1. Accordingly, the results of any quarterly or annual periods should not be relied upon as indications of future operating performance.