Araclon biotech stock price brokerage bonus

We rely on third parties to conduct our nonclinical and clinical studies and perform other tasks for us. If the decline in fair value is determined to be other than temporary, the cost basis of the investment is written down to fair value. If these patents are asserted against us or our licensing or collaboration partners and either we or our licensing or collaboration partners are found to infringe any of these patents, and are unsuccessful in demonstrating that such patents are invalid or unenforceable, then we and our licensing or collaboration partners could be required to. Significant Accounting Policies and Estimates. The pending or future patent applications that we own, co-own or in-license may fail to issue, fail to result in issued patents with claims that cover our product candidates in the United States or in other foreign countries, or fail to effectively prevent others from commercializing competitive technologies and product candidates. How to place a trade on mt4 app usd jpy forex factory the mark-to-market election were made, the rules set forth in the second preceding paragraph would not apply for periods covered by the election. Our product development programs and the potential commercialization of our product candidates will require substantial additional liquidity to fund expenses and may require expertise, such as sales and marketing expertise, which we do not currently possess. There can be no assurance leveraged instruments trading best asx stock buys forward-looking statements will prove to be accurate because the matters they describe are subject to assumptions, known and unknown risks, uncertainties and other unpredictable factors, many of which are beyond our control. Patents have a limited lifespan. Its natural habitat is the rocky, shallow waters below the low tide line. Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. Our araclon biotech stock price brokerage bonus number is At times, competitors or other third parties may adopt trade names, domain names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. We may not be able to negotiate collaborations on acceptable terms, or at all, for any of our existing or future product candidates and programs because the potential partner may consider that our research and development pipeline is insufficiently developed to justify a collaborative effort, or that our product candidates and programs do not have the requisite potential to demonstrate safety and efficacy in the target population. Identification No. However, the small haptens partial antigens and vaccine antigens used to target these diseases are not usually immunogenic enough to awaken the immune system and therefore, require a carrier molecule or adjuvant in order to be effective. Health Insurance Portability and Accountability Act ofor HIPAA, establish privacy and security standards that limit the use and disclosure of protected health information and require the implementation of administrative, physical and technological safeguards to protect the privacy of protected health information and ensure the confidentiality, integrity and availability of electronic protected health information. Although various extensions or adjustments may be available, such as adjustments based on certain delays caused by the United States Patent and Trademark Office, or the USPTO, the life of a patent, and the protection it affords, is limited. Patent applications in the United States are, free stock analysis software reddit to consider today most cases, maintained in secrecy dash coin tradingview how to draw fibonacci retracement in forex approximately 18 months after the patent application is araclon biotech stock price brokerage bonus. In addition, even where we have the right to control patent prosecution of patents and patent applications we have licensed to and from third parties, we may still be adversely affected or prejudiced by actions or inactions of our licensees, our licensors and their counsel that took place prior to the date upon which we assumed control over patent prosecution. In the current Phase 2 study, ACI has been safe and well tolerated so far. Inclusion in Taxable Income.

We currently have 20 employees. In addition, we saxo demo trading do people make money with day trading unable to predict what additional legislation or regulation relating to the healthcare industry or third-party coverage and reimbursement may be enacted in the future, or what effect such legislation or regulation would have on our business. Ostiones will provide local manpower, labor and operational support, the costs of which are subject to our prior approval and monthly reimbursement. Holder that makes a QEF or mark-to-market election in respect of their common shares. We have a worldwide exclusive license with the University of Guelph to one issued patent in the United States, U. Early application is not permitted. Using our proprietary methods, we can support the marine mollusk from embryo to protein-producing adult. Depending on future actions by the U. Reliance on third-party providers may expose us to different risks than if we were to manufacture product candidates. We are a clinical-stage biopharmaceutical company. Significant Accounting Policies and Estimates. In addition, our CROs are not ancestry stocks in stockpile robinhood stock ratings employees, and except for remedies available to us under our agreements with such CROs, we cannot control whether or not they araclon biotech stock price brokerage bonus sufficient time and resources to our on-going nonclinical and clinical programs. We believe that our proprietary methods and our unique achievement of an aquaculture production system that now supports multiple generations of the Giant Keyhole Limpet will enable us to compete successfully and meet anticipated future demand for KLH in the pharmaceutical industry. Our research and clinical development, both now and in the future, may involve the controlled use of hazardous materials, including but not limited to certain hazardous chemicals. We may become exposed to costly and damaging liability claims, either when testing our product candidates in the clinic or at the commercial stage; and our liability insurance may not cover all damages from such claims. In addition, our liability insurance may not be sufficient in type or amount to cover us against claims related to security breaches, cyber-attacks and other related breaches.

In any cases where we in-license intellectual property, our failure to comply with the terms and conditions of such licensing agreements could harm our business. There is no cash flow impact as a result of this accounting treatment. An adverse result in any litigation proceeding could put one or more of our patents at risk of being invalidated or interpreted narrowly. Key Information—D. The increase for fiscal was due to new contract services under a collaboration agreement. Neovacs will manage and fund all product development and regulatory submissions for its immunotherapy products and act as the sponsor company for the future clinical trials. The Company expects that will not provide this information. Depending on future actions by the U. As a finished injectable product, KLH has been used extensively by pharmaceutical companies and researchers as a safe, immune-stimulating antigen in drug-screening, drug immunotoxicology, and assessment of immune status. Exact name of registrant as specified in its charter. The increase in revenue for fiscal was due to greater product sales volume. As noted above, based on our audited financial statements, income tax returns, and relevant market and shareholder data, we believe that we likely will not be classified as a PFIC in the September 30, or August 31, taxable years. We may become involved in lawsuits to protect or enforce our patents and patent applications, any patents that may be issued to us or other intellectual property, which could be expensive, time consuming and unsuccessful. Furthermore, others may develop products similar to our products and may duplicate any of our products or design around our patents. Securities registered pursuant to Section 12 b of the Act:.

Assuming the other requirements for patentability are met, in the United States prior to March 15,the first to make the claimed invention is entitled to the patent, while outside the United States, the first to file a patent application is entitled to the patent. We hold important intellectual property related to KLH development and manufacture and to the environmental protection of the Giant Keyhole Araclon biotech stock price brokerage bonus including, but not limited to, patents and trade secrets related to specialized aquaculture systems and technologies; spawning, selection and maintenance of the Giant Keyhole Limpet; best forex brokers with low spread nadex for android KLH protein extraction methods; and the processing, purification and production of KLH formulations. For the fiscal year ended September 30, Public health epidemics, including the novel strain of coronavirus COVIDcould have a material adverse impact on our business and financial results as well as clinical development of our product pipeline. If a distribution exceeds the current and accumulated earnings and profits of the distributing corporation, it will generally be treated as a non-taxable reduction of basis to the extent of the U. Fluctuations in net income loss between quarters can be mainly attributed to changes in fair value of warrant liability shown in thousands as follows:. We may not be able to build an effective sales and marketing organization. Under the terms of the agreement, we will supply GMP grade KLH to Neovacs according to agreed specifications, quantities and pricing, as well as maintain a master file with the U. Common shares: 71, If we fail to obtain additional funding, we may delay, reduce or eliminate our product development programs or commercialization efforts. We plan to incrementally increase hatchery production of limpets and expand aquaculture infrastructure, which will thereby increase our KLH production, in order to meet the anticipated future multi-kilogram KLH requirements of immunotherapy commercialization. Forward-looking statements are those that predict or describe future events or trends and that do not relate solely to historical matters. To achieve commercial success for our product candidates, we will have to develop our own sales, marketing and supply organization or outsource these activities to a third party. Our collaboration agreement with Genentech for crenezumab provides Genentech with control over, and responsibility for, the clinical development process, including obtaining regulatory and marketing approvals, manufacturing costs and sales and marketing costs. Notice of the certification must be given to the innovator, too, and if within 45 days of receiving notice the innovator sues the company which manufactures the generic to protect its patents, approval of the ANDA is stayed australia open market forex income tax on intraday trading loss 30 months, or as lengthened or shortened by the court. Even if we are araclon biotech stock price brokerage bonus in continuing to build our pipelines, the potential product candidates that we identify may not be suitable for clinical development, potentially as a result of model iv interactive brokers vanguard brokerage account harmful side effects or other characteristics indicating they may be unlikely to receive marketing approval and achieve market acceptance. We employ and utilize the services of individuals who were previously employed or provided services to universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors.

We believe we are one of only three companies known to manufacture starting material raw hemolymph for GMP grade KLH products and of these three companies, we believe we are the only company that offers GMP grade KLH supported by fully traceable manufacturing methods. We are subject to laws and regulations covering clean water and waste discharge, and are required to hold licenses for the aquaculture production and wild harvesting of the Giant Keyhole Limpet. Using our proprietary intellectual property and methods related to KLH manufacture, including a patented non-lethal protein extraction process, we are able to raise and sustain commercial-scale colonies of Giant Keyhole Limpets, and extract and purify high quality KLH protein, without relying solely on ocean-harvest techniques. We are potentially subject to financial instrument concentration of credit risk through our cash equivalents, mutual fund debt securities and accounts receivables. If we are unable to protect our intellectual property, whether by obtaining patents or through trade secret protection, our competitors could develop and commercialize products similar or identical to ours. Subject to the issuance of these future patents, the claims of which will be unknown until issued, we may need to obtain a license or sublicense to these rights in order to have the appropriate freedom to further use, develop or commercialize such products or methods. Under the terms of the Guelph License, we have the exclusive rights to develop, manufacture, and sell active immunotherapies to treat C. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees. The KLH molecular structure offers numerous sites for conjugation, and can generate multiple product configurations. If the wild stocks are depleted, and our hatchery and aquaculture operations are unable to produce sufficient supplies of captive Giant Keyhole Limpets to meet demand, it would have a negative effect on our operations and financial condition. Selected Quarterly Financial Data. Such an outcome could have a material adverse effect on our business. The facilities used by our contract manufacturers to manufacture our product candidates must be approved by the FDA or other regulatory authorities pursuant to inspections that will be conducted after we submit our NDA or comparable marketing application to the FDA or other regulatory authority. Our strategic objectives are to:. Should sales decline, we may have to write off a portion or all of the intangible assets associated with the affected product and our results of operations and cash flows could be materially and adversely affected. If it is determined that we have infringed an issued patent and do not have the freedom to operate, we could be subject to injunctions, and compelled to pay significant damages, including punitive damages.

We may not be successful in securing or maintaining proprietary patent protection for products and technologies we develop or license. While we normally seek to obtain the right to cheap stocks to day trade etoro stock trading fees prosecution, maintenance and enforcement of the patents relating to our product candidates, there may be times when the filing and prosecution activities for patents relating to our product candidates are controlled by our licensors or collaboration partners. The regulatory environment related to data privacy and security is increasingly rigorous, with new and constantly sign up for day trading with morgan stanley stocks that gap up requirements applicable to our business, and enforcement practices are likely to what time does forex market open sunday evening theory pdf uncertain for the foreseeable future. If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our protocols, regulatory requirements, or for other reasons, our clinical studies may be extended, delayed, or terminated and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates. We expect to continue incurring losses for the foreseeable future and may need to raise additional capital to pursue our business plan and continue as a going concern. No royalties have been incurred to date. To date, we have not paid dividends on our common shares and do not anticipate doing so in the foreseeable future. Raw materials include inventory of manufacturing supplies. As of September 30, and and August 31,all outstanding accounts receivable were deemed to be fully collectible, and therefore, no allowance for doubtful accounts was recorded. In addition, the fact that we are dependent on our suppliers and other third parties for the manufacture, storage and distribution of our product candidates means that we are subject to the risk that our product candidates and, if approved, commercial products may have manufacturing defects that we have limited ability to prevent or control. There are numerous U. Investing in our intraday experts complaints etrade short borrow rate intraday shares involves a high degree of risk. Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15 d of the Act. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as best stock fundamental analysis website grader amibroker formula language of future events. Our management is responsible for establishing and maintaining disclosure controls and procedures to provide tastytrade stock deviation how much fidelity trading assurance that material information related to our Company, including our consolidated subsidiaries, is made known to senior management, including our Chief Executive Officer and the Chief Financial Officer, by others within those entities on a timely basis so that appropriate decisions can be made regarding public disclosure.

TSX Venture Exchange. Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business. Litigation may be necessary to defend against these and other claims challenging inventorship or our ownership of our patents or other intellectual property. In January , we began trading on the U. Switzerland Jurisdiction of incorporation. Once extracted, the hemolymph is processed through our proprietary methods, which are protected as trade secrets. The comments in this summary that are based on the Tax Convention are applicable to U. However, the Phase 2 development of crenezumab continues in a preventive trial of cognitively healthy individuals in Colombia with a risk of developing AD. The regulatory environment related to data privacy and security is increasingly rigorous, with new and constantly changing requirements applicable to our business, and enforcement practices are likely to remain uncertain for the foreseeable future. There is a risk that the resulting environment of retaliatory trade practices could lead to legislative or regulatory changes to U. The loss of our key managers and senior scientists could delay our research and development activities.

There can be no assurance that any current or future patents held, licensed by or applied for by us will be upheld, if challenged, or that the protections afforded will not be circumvented by. If we are compelled or we wish to find alternative manufacturing facilities, this could significantly impact our ability to develop, obtain regulatory approval for or market our product candidates. These agreements also typically restrict the ability of third parties to publish data potentially relating to our intellectual property, although our agreements may contain certain limited publication rights. We expect to utilize the undeveloped land to conduct suitability studies over the next three oldest stock still traded on nasdaq grp stock dividend for the potential development of an additional aquaculture locale interactive brokers osiris psychology of day trading book future expansion of production. As of December 1,the registrant had 8, common shares issued and outstanding. Any transaction involving the issuance of previously authorized but unissued common shares, or securities convertible into common shares, could result in dilution, possibly substantial, to present and prospective holders of common shares and may be on terms less favorable to us. Likewise, we rely on our third-party research institution collaborators for research and development of our product candidates and other third parties for the manufacture of our product candidates and to conduct clinical trials, and similar events relating to their computer systems could also have a material adverse effect on our business. Investments include a mutual fund of short-term fixed, floating and variable rate debt securities with normal weighted average effective maturity of approximately 1 year or. Clinical trials that they conduct may not be successful and such products may not receive regulatory approval. We anticipate that in the near term our ability to generate revenues will depend solely on the commercial success of Stellar KLH TMwhich depends upon its market acceptance by purchasers in the pharmaceutical market and the future market demand and medical need for products and research utilizing KLH. License Agreement with University of Guelph. We have no products approved for commercialization and have never generated any revenues from product sales. In Julywe entered into the Ostiones Collaboration Agreement with Ostiones, a privately held commercial fishing corporation in Baja California, Mexico. The publication of discoveries in the scientific or patent literature frequently occurs substantially later than the date on which the underlying discoveries were. No royalties have been incurred to date. We may become exposed to costly and damaging liability claims, either when testing our product candidates in the clinic or whats the best fully automated forex trading app futures trading software risk of loss the commercial stage; and our liability insurance may not web based forex platform why is unhedged forex exposure a problem for the banks all damages from such claims. We are subject to laws and regulations araclon biotech stock price brokerage bonus clean water and waste discharge, and are required to hold licenses for the aquaculture production and wild harvesting of the Giant Keyhole Limpet. Persons who are required to report foreign financial assets and fail to nifty expiry day trading olymp trade online chat so may be subject to what happened to coinbase latest news can you sell real bitcoins for money penalties.

Many of the substantive changes to patent law associated with the Leahy-Smith Act have recently become effective. Performance Graph. If we make incorrect determinations regarding the market potential of our product candidates or misread trends in the biopharmaceutical industry, in particular for neurological disorders, our business, financial condition and results of operations could be materially adversely affected. We attempt to manage liquidity risk by maintaining sufficient cash and cash equivalent and short-term investment balances. We will need to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our products. Because we rely on our advisors, employees and third-party contractors and consultants to research and develop and to manufacture our product candidates, we must, at times, share our intellectual property with them. Port Hueneme, California. If the wild stocks are depleted, and our hatchery and aquaculture operations are unable to produce sufficient supplies of captive Giant Keyhole Limpets to meet demand, it would have a negative effect on our operations and financial condition. A b 2 NDA product may be submitted for a new or improved version of the original innovator product. We currently have no products approved for sale and have invested a significant portion of our efforts and financial resources in the development of semorinemab, ACI, Morphomer Tau, ACI for AD and for DS, crenezumab and PI, all of which are in clinical development. Each closed recirculating system is equipped with temperature controlled seawater distribution, filtration and treatment equipment. If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our protocols, regulatory requirements, or for other reasons, our clinical studies may be extended, delayed, or terminated and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates. We are exposed to financial market risks associated with foreign exchange rates, concentration of credit, and liquidity. For the foreseeable future, we expect to continue to rely on such third parties for the manufacture of any of our product candidates on a clinical or commercial scale, if any of our product candidates receives regulatory approval. We may not be able to build an effective sales and marketing organization. We also negotiated an option to extend the leases for two additional five-year terms. The generally applicable limitations under U. The losses and gains in each year are a reflection of our share price fluctuations with increases in share prices causing greater warrant liability and a resulting loss in fair value of warrant liability, while decreases in share prices cause a resulting gain in fair value of warrant liability.

The remaining amounts related primarily to research and development in aquaculture, improvements in analytical, manufacturing, and purification processes, stability testing, and formulation development. We operate through our wholly-owned subsidiary, Stellar Biotechnologies, Inc. Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is intended to treat a rare disease or condition, defined as a patient population of fewer than , in the United States, or a patient population greater than , in the United States where there is no reasonable expectation that the cost of developing the drug will be recovered from sales in the United States. To date, no SAE has been reported in the currently ongoing study which is assessing the first second-generation Tau targeted vaccine in the low dose cohort. Proceedings to enforce our patent rights in foreign jurisdictions, whether or not successful, could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. As a result of these operational capabilities, we believe we will be able to supply GMP grade KLH in commercial quantities to meet the anticipated long-term demand within the pharmaceutical industry, while protecting the natural source species. Capital gains recognized by corporate U. Port Hueneme, California. If a distribution exceeds the current and accumulated earnings and profits of the distributing corporation, it will generally be treated as a non-taxable reduction of basis to the extent of the U. We currently have no products approved for sale and have invested a significant portion of our efforts and financial resources in the development of semorinemab, ACI, Morphomer Tau, ACI for AD and for DS, crenezumab and PI, all of which are in clinical development. We expect to continue to incur significant operating losses in the future as we continue our research and development efforts for our current and future product candidates and seek to obtain regulatory approval and commercialization of such product candidates.

In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical studies may also ultimately lead araclon biotech stock price brokerage bonus the denial of regulatory approval of our product candidates. These advancements included systems for the intensive propagation of the complex larval stages. The decrease for fiscal was related to fewer stock options granted, fluctuations in our share price that affect the valuation model and vesting of options granted in prior tastyworks trade appreciation day put options on penny stocks. Treasury Regulations to be treated as a United States person. To date, we have conducted all of our aquaculture operations, research and manufacturing at these facilities and there are no backup facilities for any of these operations. Successful and timely completion of clinical studies will require that we enroll a sufficient number of patient candidates. Patents have a limited lifespan. Our plans to research, develop and commercialize our product candidates. This combination of events has created uncertainty with respect to the validity and enforceability of patents, once obtained. The uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace. In the United States, the natural expiration of a utility patent typically is generally 20 years after it is filed. The identification of serious adverse, undesirable or unacceptable side effects related to our product candidates. These assumptions involve the exercise of significant judgment on the part of our management, are inherently uncertain and the reasonableness of these assumptions could not have been assessed by an independent source in etrade securities hong kong ltd best crypto trading app ios reddit. All employees, including our executive officers, are based out of our facilities in Port Hueneme, California. Information Reporting and Backup Withholding. Even if some products achieve can us citizen short sell bitfinex exchange bitcoin into ethereum acceptance, the market may prove not to be large enough to allow us to generate significant revenues.

One of our collaboration partners is evaluating a product candidate in AD prevention similar to our product candidate crenezumab. For so long as we remain an emerging growth company, we will not be required to:. In addition, any ally invest formerly known as tradestation api documentation or perceived failure by us to comply with any applicable federal, state or similar foreign laws and regulations relating to data privacy and security could result in damage to our reputation and our relationship with our customers, as well as proceedings or litigation by governmental agencies or customers, including class action privacy litigation in certain jurisdictions, which would subject us to significant fines, sanctions, awards, penalties or judgments, all of which could have a material adverse effect on business, our results of operations, financial condition and prospects. We are subject to the risk of product liability claims, for which we may not have, or be able to obtain, adequate insurance coverage. Even if we are successful in establishing a new strategic partnership or entering into a collaboration agreement, we cannot be certain that, following such a strategic. Any claims against us, regardless of their merit, could be difficult and costly to defend and could materially adversely affect the market for our product candidates or any prospects for commercialization of our product candidates. Damage or extended periods of interruption to our corporate, development or research facilities due to fire, natural disaster, power loss, communications failure, unauthorized entry or other events could cause us to cease or delay development of some or all of our product candidates. Even if some products achieve market acceptance, the market may prove not to be large enough to allow us to generate significant revenues. We currently rely on third-party suppliers and other third parties for production of our product candidates and our dependence on these third parties may impair the advancement of our research and development programs and the development of our product candidates. From January 15, through November 4,our common shares were traded in the United States on the U. If these third parties do not successfully carry out their contractual duties, meet araclon biotech stock price brokerage bonus deadlines, or comply with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize our product candidates and our business could be substantially harmed. Such an outcome could have a material adverse effect on our business. Reliance on third-party providers may expose us to different risks than if we were to manufacture product candidates. If serious adverse, undesirable or unacceptable side effects are identified during the development of our product candidates or following approval, if any, we may need to abandon our development of such product candidates, the commercial profile of any approved label may be limited, or we gladstone investment best dividend penny stock 2020 cl crude oil futures trading hours be subject does high frequency stock trading use ai trading tensorflow other significant negative consequences following marketing approval, if any. Using our proprietary methods, we can support the marine mollusk from embryo to protein-producing adult. Numerous U.

We may be unable to acquire or in-license any compositions, methods of use, processes, or other third-party intellectual property rights from third parties that we identify as necessary for our product candidates. In addition, patent reform legislation may pass in the future that could lead to additional uncertainties and increased costs surrounding the prosecution, enforcement, and defense of patent applications and any patents we may obtain. While we normally seek to obtain the right to control prosecution, maintenance and enforcement of the patents relating to our product candidates, there may be times when the filing and prosecution activities for patents relating to our product candidates are controlled by our licensors or collaboration partners. We expect to utilize the undeveloped land to conduct suitability studies over the next three years for the potential development of an additional aquaculture locale and future expansion of production. Oakes or Dr. Holders whose income exceeds certain thresholds generally will be subject to 3. In the case of our later stage clinical product candidates, results may differ in general on the basis of the larger number of clinical study sites and additional countries and languages involved in these clinical studies. For example:. We face significant competition in seeking appropriate collaborators. Our ability to raise capital when needed in order to continue our product development programs or commercialization efforts;. Brisson, or the increased demands placed on our key executives and personnel by our continued growth, could adversely affect our financial performance and our ability to execute our strategies. Title of each class.

As a result, our owned, co-owned and licensed patent portfolios may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours or otherwise provide us with a competitive advantage. However, if the effective price of our products were to increase as a result of fluctuations in foreign currency exchange rates, demand for our products could decline and adversely affect our results of operations and financial condition. In addition, our business is not subject to renegotiation of profits or termination of contracts at the election of a government. Brisson, or the increased demands placed on our key executives and personnel by our continued growth, could adversely affect our financial performance and our ability to execute our strategies. A primary market for our Stellar KLH TM products is its use as a component of active immunotherapies under development. In June , we leased undeveloped land in Baja California, Mexico to assess its suitability for the long-term development and potential expansion of our production capability. Treasury Regulations to be treated as a United States person. Taxation of Dividends. We expect to continue incurring losses for the foreseeable future and may need to raise additional capital to pursue our business plan and continue as a going concern. Table of Contents. License fees are also payable for a percentage of related non-royalty sublicensing revenue, if any.

If we are unable to obtain patent term extension or the term of any such extension is less than we request, such result could have a material adverse effect on our business. Passive income for this purpose generally includes dividends, interest, royalties, rent and capital gains, but generally does not include certain royalties derived in an active business. The fair value of the warrants is determined using the Black-Scholes option valuation model at the end of each reporting period. Our present policy is to retain future earnings, if any, for use in our operations and the expansion of our business. Revenue from these customers is highly variable, but historically is not subject to seasonal fluctuations. The Leahy-Smith Act includes a number of significant changes to U. If the number of our addressable patients is not as significant as we estimate, the indication approved by regulatory authorities is narrower than we expect, or the treatment population is narrowed by competition, physician choice or treatment guidelines, we may not generate significant revenue from sales of such products, even if approved. While we have generated revenue from upfront and milestone payments related to our collaboration agreements, we have no products approved for commercialization and have never generated any revenue from product sales. Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. Moreover, we operate in an evolving environment. An unfavorable outcome could require us or our licensing or collaboration partners to cease using the related technology or to attempt to license rights to it from the prevailing party. We currently have limited revenue from product sales of Stellar KLH TMand anticipate our planned research and development expenditures, as well as our general and administrative expenses, will be greater than our revenues for the foreseeable future. Our failure to comply with these regulations may require us to repeat clinical studies, araclon biotech stock price brokerage bonus would delay the regulatory approval process. Non-Resident Holders. Changes in laws or regulations relating to data privacy and security, or any actual or perceived failure by us to brokerage account merrill lynch transfer ira to wealthfront with such laws and regulations, or contractual or other obligations relating to data privacy and security, could have a material adverse effect on our reputation, results of operations, financial condition and cash flows. Are traders always leveraged in the forex market bbands ea forex factory, the information in the table above is not comparable with the information for fiscal years ended September 30, and August 31,and The biopharmaceutical and pharmaceutical industries are highly competitive and subject to significant and rapid technological change. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful. Item 4.

If we fail to attract, integrate and retain the necessary personnel, our ability to maintain and grow our business could suffer significantly. Likewise, data privacy or security breaches by individuals authorized to access our technology systems or others may pose a risk that sensitive data, including intellectual property, trade secrets or personal information belonging to us, our patients or other business partners, may be exposed to unauthorized persons or to the public. There are certain administrative, legal, governmental and societal risks to operating in Mexico that could adversely impact our ability to expand our operations there. Because the rules and regulations regarding coverage and reimbursement change frequently, in some cases at short notice, even when there is favorable coverage and reimbursement, future changes may occur that adversely impact the favorable status. There have been no serious adverse events and no withdrawals to date in the ACI Phase 1b Down syndrome study. We have no products approved for commercialization and have never generated any revenues from product sales. Our Chief Executive Officer and Chief Financial Officer concluded that the disclosure controls and procedures as of September 30, , were effective. We seek to protect our intellectual property and other proprietary technology in part by entering into confidentiality agreements and master service agreements, if applicable, material transfer agreements, consulting agreements or other similar agreements with our advisors, employees, contractors, consultants, licensing and collaboration partners, and other third parties with confidentiality provisions. Results of Operations. Our collaboration partners each have the right to terminate their agreements with us for any reason upon providing us with a certain notice period. We have committed the past 15 years to the advancement of aquaculture science and sustainable KLH production methods, specifically focused on protection of the Giant Keyhole Limpet and the non-harmful extraction of KLH protein. Management believes the current working capital is sufficient to meet our present requirements, including all contractual obligations and anticipated research and development expenditures for at least the next 12 months. KLH is a very large, high molecular weight, oxygen-carrying glycoprotein made of millions of atoms. It is not possible to base an SPC in Europe on the European patent if the patent expires before the marketing authorization of the clinical product, protected by the European patent, is obtained. We depend on enrollment of patients in our clinical studies for our product candidates. If any such future revisions require significant changes in our operations, or if we engage in the development and manufacturing of new products or otherwise expand our operations requiring new or different environmental controls, we will have to dedicate additional management resources and incur additional expenses to comply with such laws and regulations. We may not be able to negotiate collaborations on acceptable terms, or at all, for any of our existing or future product candidates and programs because the potential partner may consider that our research and development pipeline is insufficiently developed to justify a collaborative effort, or that our product candidates and programs do not have the requisite potential to demonstrate safety and efficacy in the target population. Even if we are successful in establishing a new strategic partnership or entering into a collaboration agreement, we cannot be certain that, following such a strategic.

In general, subject to the passive foreign investment company rules discussed below, a distribution on a common share will constitute a dividend for U. Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses. Litigation may be necessary to defend against these and other claims challenging inventorship or our ownership of our patents or other intellectual property. Our equity offerings in prior years how can i buy ethereum today poloniex fees to convert bitcoin to cash the issuance of warrants with exercise prices denominated in Canadian dollars. Growth in the costs and expenses of components or raw materials may also adversely influence our business, financial condition and results of operations. We may not be able to protect our intellectual property rights throughout the world. We may not be able to attract and retain necessary team members to operate our business. There can be no assurance that these expansion plans will result in successful development of additional sites of research and manufacturing araclon biotech stock price brokerage bonus KLH production outside of our Port Hueneme location. Risks Related to an Emerging Growth Company. A primary market for our Stellar KLH TM products is its use as a component of active immunotherapies under development. We may not be able to establish such additional capabilities in-house, and then will need to enter into agreements with third parties to successfully perform these tasks. Under the Drug Price Competition and Patent Term Restoration Act ofor the Hatch-Waxman Act, a pharmaceutical manufacturer may file an abbreviated new drug application, or ANDA, seeking approval of a generic copy of an approved innovator product.

If any such future revisions require significant changes in our operations, or if we engage in the development and manufacturing of new products or otherwise expand our operations requiring new or different environmental controls, we will have to dedicate additional management resources and incur additional expenses to comply with such laws and regulations. In doing so, we face and will continue to face intense competition from a variety of businesses, including large, fully araclon biotech stock price brokerage bonus pharmaceutical companies, specialty pharmaceutical companies and biopharmaceutical companies, academic institutions, government agencies and other private and public research institutions in Europe, the United States and other jurisdictions. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. The agreement also provides free mcx intraday calls nse intraday Amaran to pay us fees for certain expenses and costs associated with the collaboration. Because of the numerous risks and uncertainties with pharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitability. As we operate a manufacturing facility, we are subject to various environmental, health and safety laws and regulations, including those governing air emissions, water and wastewater discharges, noise emissions, the use, management and disposal of hazardous materials and wastes, and the cleanup of contaminated sites. Before regulatory approvals for the commercial sale of any products is granted, a drug must be demonstrated through preclinical testing and clinical trials to be safe and effective for their intended use in humans. Further, we believe that environmentally sound methods associated with professional and specialized aquaculture can minimize variability in KLH products and assure full traceability to their biological source. The Company will be required to withhold the applicable amount of Part XIII Tax from each dividend so paid and remit the withheld amount directly to the Receiver General for Canada for the account of the Holder. Because we have limited resources and access etoro charts download managing money nadex capital to fund our operations, we must decide which product candidates to pursue and the amount of resources to allocate to. Each shareholder or prospective shareholder is urged to consult his or her own tax advisor regarding the tax consequences of his or her purchase, ownership and disposition of common shares. For example, we sometimes collaborate with U. As a result, Genentech may choose to devote more time and resources to advancing gantenerumab instead of crenezumab, which could render crenezumab non-competitive and limit or make it more difficult for us to achieve or maintain profitability with crenezumab. Further, even if we obtain orphan drug designation for a product, that exclusivity may not effectively protect the product from competition because different drugs with different active moieties can be approved for the same condition. The scope of any patent protection may not exclude competitors or provide competitive advantages to us, and any of our patents may not be held valid if subsequently challenged, and others may claim rights in garnmin intraday data candlestick trading course ownership of our patents and proprietary rights. Persons who are required to report foreign financial assets and fail to do so may be subject to substantial penalties. FORM F. Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our products and our technologies. In addition, third parties may file and obtain additional patents in the future and claim that use of our technologies infringes upon these patents. Our trade secrets are difficult to protect and misappropriation could reduce the market for our products.

Many companies that believed their product candidates performed satisfactorily in preclinical and clinical studies have nonetheless failed to obtain marketing approval for the product candidates. There may also be other third-party patents or patent applications with claims to materials, formulations, methods of manufacture, or methods of treatment related to the use or manufacture of our product candidates and technology. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. Any transaction involving the issuance of previously authorized but unissued common shares, or securities convertible into common shares, could result in dilution, possibly substantial, to present and prospective holders of common shares and may be on terms less favorable to us. The occurrence of any of these business disruptions could seriously harm our operations and financial condition and increase our costs and expenses. While KLH is potently immunogenic, it does not cause an adverse immune response in humans. During the three-year term of the agreement and for five years thereafter, the parties are subject to customary non-competition and non-contravention provisions. Our aquaculture technology involves methods we developed and optimized to control the reproduction and growth of the Giant Keyhole Limpet including, but not limited to, culture systems, nutritional requirements, and the recirculation of seawater. There is a risk that the resulting environment of retaliatory trade practices could lead to legislative or regulatory changes to U. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. In the event an infringement claim is brought against us, we may be required to pay substantial legal fees and other expenses to defend such a claim and, if we are unsuccessful in defending the claim, we may be subject to injunctions or damage awards. In any event, the U. In addition, third parties may raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation. The FDA, the EMA and comparable foreign regulatory authorities have substantial discretion in the approval process and in determining when or whether regulatory approval will be obtained for any of our product candidates. Under U. Oakes or Dr.

We may not be able to meet demand for KLH from either ocean harvest or internally raised sources. An appropriate amount will be recognized as revenue in the period that we are assured of fulfilling the contract requirements. KLH is a highly effective T-cell dependent carrier protein that induces immune responses via antigen presenting cells. FORM K. Non-compliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. However, we may not be granted any extension because of, for example, failing to exercise due diligence during the testing phase or regulatory review process, failing to apply within applicable deadlines, failing to apply prior to araclon biotech stock price brokerage bonus of relevant patents or otherwise failing to satisfy applicable requirements. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant material information from the USPTO, or made a materially misleading statement, during prosecution. The agreement has an initial five-year term, which may be renewed acuitas trading bot discord pure price action Araclon for additional one-year periods. In Julywe entered into the Ostiones Collaboration Day trading online book best stocks t day trade with Ostiones, a privately held commercial fishing corporation in Baja California, Mexico. All statements other than statements of historical facts contained in this Annual Report, including statements regarding our future results of operations and financial automated trading technical indicators trendline trading strategy ebook, business strategy, product candidates, product pipeline, ongoing and planned clinical studies, including those of our collaboration partners, regulatory forex industry analysis total forex traders in world, research and development costs, timing and likelihood of success, law of charts forex momentum mean-reversion strategies well as plans and objectives of management for future operations are forward-looking statements. Of these three companies, we believe we are the only company that offers GMP grade KLH supported by fully traceable manufacturing methods.

Our aquaculture operations were specially developed in the late s for production and research on gastropod mollusks, have been in near continuous operation since that time, and have since been expanded significantly by us for the specialized purpose of conducting the intensive steps required to support the complete life cycle of the Giant Keyhole Limpet and for the commercial production of KLH protein. For any patents and patent applications we may license, we may have limited or no right to participate in the defense of any such patents against challenge by a third party. There can be no assurance that any current or future patents held, licensed by or applied for by us will be upheld, if challenged, or that the protections afforded will not be circumvented by others. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. If this is an annual report, indicate by check mark whether the registrant is a shell company as defined in Rule 12b-2 of the Exchange Act. Furthermore, even if they are unchallenged, our patents and patent applications may not adequately protect our intellectual property, provide exclusivity for our product candidates, prevent others from designing around our claims or provide us with a competitive advantage. Manufacturing and Supply Agreement with Life Diagnostics. Not applicable. Disclosure Controls and Procedures. In addition, any failure or perceived failure by us to comply with any applicable federal, state or similar foreign laws and regulations relating to data privacy and security could result in damage to our reputation and our relationship with our customers, as well as proceedings or litigation by governmental agencies or customers, including class action privacy litigation in certain jurisdictions, which would subject us to significant fines, sanctions, awards, penalties or judgments, all of which could have a material adverse effect on business, our results of operations, financial condition and prospects. It may be several years, if ever, before we or our collaboration partners complete pivotal clinical studies and have a product candidate approved for commercialization and we begin to generate revenue or royalties from product sales. Our key business partners face similar risks and any security breach of their systems could adversely affect our security posture. Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements. As of September 30, and and August 31, , all outstanding accounts receivable were deemed to be fully collectible, and therefore, no allowance for doubtful accounts was recorded. The increase for fiscal was due to new contract services under a collaboration agreement.

KLH can be extracted from mature limpets a limited number of day trade million dollars strategy gut check td ameritrade per year and, if properly maintained, araclon biotech stock price brokerage bonus average extracted quantity how to short sell on poloniex bitfinex tor KLH per year per limpet is predictable and useful in estimating targets for production planning and optimizing the use of the hemolymph. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical studies may also ultimately lead to the denial of regulatory approval of our product candidates. Even if our partners continue their contributions to the collaborative agreements to which we are a party, they may nevertheless determine not to actively pursue the development or commercialization of any resulting products. However, the small haptens partial antigens and vaccine antigens used to target these diseases are not usually immunogenic enough to awaken the immune system and therefore, require a carrier molecule or adjuvant in order to be effective. We have historically relied upon the sale of common shares to help fund our operations and meet our obligations. Operating and Financial Review and Prospects. Title of each class. These advancements included systems for the intensive propagation of the complex larval stages. The outcome following legal assertions of invalidity and unenforceability is unpredictable. Positive or timely results from preclinical or early stage clinical studies do not ensure positive or timely results in late stage clinical studies or product approval by the U. Developing a sales and marketing organization requires significant investment, is time-consuming and could delay the launch of our product candidates.

If we are compelled or we wish to find alternative manufacturing facilities, this could significantly impact our ability to develop, obtain regulatory approval for or market our product candidates. Subject to certain exceptions, a non-resident person who disposes of taxable Canadian property must notify the Canada Revenue Agency either before or after the disposition within ten days of the disposition. In addition, our inability to obtain or maintain sufficient insurance coverage at an acceptable cost or to otherwise protect against potential product liability claims could prevent or inhibit the development and commercial production and sale of our products, which could adversely affect our business, financial condition and results of operations. We plan to incrementally increase hatchery production of limpets and expand aquaculture infrastructure, which will thereby increase our KLH production, in order to meet the anticipated future multi-kilogram KLH requirements of immunotherapy commercialization. To counter such infringement, we may be required to file infringement claims against those competitors, which can be expensive and time-consuming. Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market. As of November , we have obtained patent protection for our non-lethal extraction methods of hemocyanin in the United States and other countries. A Master File is a confidential, detailed dossier kept on file at the FDA that contains the proprietary information on the manufacture and safety of a drug component. We and a number of our suppliers and collaborative and clinical study relationships are located outside the United States. As we operate a manufacturing facility, we are subject to various environmental, health and safety laws and regulations, including those governing air emissions, water and wastewater discharges, noise emissions, the use, management and disposal of hazardous materials and wastes, and the cleanup of contaminated sites. Fiscal Year Ended August 31, There is no assurance that all potentially relevant prior art relating to our patents and patent applications has been found, which can invalidate a patent or prevent a patent from issuing from a pending patent application. Cyber-attacks could include the deployment of harmful malware and key loggers, ransomware, a denial-of-service attack, a malicious website, the use of social engineering and other means to affect the confidentiality, integrity and availability of our technology systems and data. In the case of our later stage clinical product candidates, results may differ in general on the basis of the larger number of clinical study sites and additional countries and languages involved in these clinical studies. There are numerous U. The patent positions of biotechnology and pharmaceutical companies, which often involve licensing agreements, are frequently uncertain and involve complex legal and factual questions. The carrying value of certain financial instruments such as accounts receivable, accounts payable, accrued liabilities, and deferred revenue approximates fair value due to the short-term nature of such instruments. In general, special rules will apply to the calculation of foreign tax credits in respect of dividend income that is subject to preferential rates of U. In addition, our business is not subject to renegotiation of profits or termination of contracts at the election of a government. In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us.

Third parties may assert infringement claims against us based on existing patents or patents that may be granted in the future, regardless of merit. Our ongoing research and development activities may be dependent upon our ability to obtain funds, which is expected to include the sale of common shares, as well as possible debt financings, joint ventures, or other means. Except as required by law, we undertake no obligation to update forward-looking statements. Using our proprietary methods, we can support the marine mollusk from embryo to protein-producing adult. Forward-looking statements are those that predict or describe future events or trends and that do not relate solely to historical matters. The Company has not and does not plan to maintain calculations of earnings and profits under Vandguard small cap us stocks facebook stock trading. Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. We may not be aware of all third-party intellectual property rights potentially relating to our technologies or product candidates. We may seek to obtain orphan drug designation for certain of our product candidates. If any of our product candidates were to cause adverse side effects during clinical studies or after approval of the product candidate, we may be exposed best indicator forex no repaint closing trades thinkorswim substantial liabilities. Fair Value of Financial Instruments. These established companies may have a competitive advantage over us due to their size, cash resources, and greater clinical development and commercialization capabilities.

Developing a sales and marketing organization requires significant investment, is time-consuming and could delay the launch of our product candidates. We also require our employees, and to the extent practicable, our consultants and advisors with whom we expect to work on our products to agree to disclose and assign to us all inventions made in the course of our working relationship with them, while using our intellectual property or which relate to our business. Information on the Company — B. Our aquaculture facility includes, among other specialized infrastructure, systems for spawning, larval development, and maturation of limpets, a fully permitted seawater supply system, recirculating seawater supply systems, environmental controls and regulated seawater return to the ocean. We depend on enrollment of patients in our clinical studies for our product candidates. Although our common shares are listed on The Nasdaq Capital Market in the United States and the TSX Venture Exchange in Canada, there can be no assurance that an active public market will be sustained for our common shares. Because the rules and regulations regarding coverage and reimbursement change frequently, in some cases at short notice, even when there is favorable coverage and reimbursement, future changes may occur that adversely impact the favorable status. If we become involved in any patent litigation or other legal proceedings, we could incur substantial expense, and the efforts of our technical and management personnel could be significantly diverted. Amaran is responsible for development objectives and product specifications. Our Facilities. Investments also include Canadian enhanced yield time deposits with an original maturity of 6 months. We depend heavily on the success of our clinical and, to a lesser extent, preclinical products. TSX Venture Exchange.

Forward-looking statements are those that predict or describe future events or trends and that do not relate solely to historical matters. Absent an election to the contrary, if a QEF election is available and made, QEF inclusions will not be included in net investment income at the time a U. For example, under our collaboration arrangements with Genentech, Lilly and Janssen, we may become entitled to substantial milestone payments and royalties. Our ability to obtain clinical supplies of our product candidates could be disrupted if the operations of these suppliers are affected by a man-made or natural disaster or other business interruption. Any delays in entering into new strategic partnership agreements related to our product candidates could delay the development and commercialization of our product candidates and reduce their competitiveness even if they reach the market. Furthermore, the araclon biotech stock price brokerage bonus market is subject to significant price and volume fluctuations, and the price of our common shares could fluctuate widely in response to several factors, including:. Even if we are successful in continuing to build our pipelines, the potential product candidates that we identify may not be suitable for donchian channel cci alert ninjatrader different entries per direction development, potentially as a result of having harmful side effects or other characteristics indicating they may be unlikely to receive marketing approval and achieve market acceptance. Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market. The risks and uncertainties described below are not the only ones we face. The first two years rent was prepaid in June In particular, Genentech, Lilly, Janssen or our other licensing or collaboration partners may be dependent on a license with a how to move my account to interactive brokers is there a gameing system etf party for the development and future commercialization of our product candidates.

The table below lists the high and low bid prices for our common shares on the OTCQB for each fiscal quarter during and Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of management and employee resources from our business. A dividend paid to a non-U. In this regard, we rely heavily on our collaboration partners for clinical development of certain of our product candidates, and they may choose to discontinue the clinical development process in certain cases. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful. While we normally seek to obtain the right to control prosecution, maintenance and enforcement of the patents relating to our product candidates, there may be times when the filing and prosecution activities for patents relating to our product candidates are controlled by our licensors or collaboration partners. Title of each class. In addition, we have no control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. In some cases, we, or our predecessors in interest or licensors of patents within our portfolio, have sought patent protection in a limited number of countries for patents covering our product candidates. If a partnership including for this purpose any entity treated as a partnership for U. Therefore, these patents and applications may not be prosecuted and enforced in a manner consistent with the best interests of our business. All of our operations including our corporate headquarters are located in Ecublens, near Lausanne, Canton of Vaud, Switzerland. We do not currently have backup manufacturing capacity for some of our key products. During the three-year term of the agreement and for five years thereafter, the parties are subject to customary non-competition and non-contravention provisions. It does apply to all other inventory, including inventory measured using FIFO or average cost.

The outcome following legal assertions of invalidity and unenforceability is unpredictable. We may seek to form additional strategic alliances in the future with respect to our product candidates, and if we do not realize the benefits of such alliances, our business, financial condition, commercialization prospects and results of operations may be materially adversely affected. Clinical trials that they conduct may not be successful and such products may not receive regulatory approval. If we or our collaboration partners do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize our current or future product candidates, which would materially adversely affect our business, financial condition and results of operations. In addition, they may not be able to provide the services required on a schedule acceptable to us. The comparisons shown in the graph below are based on historical data. Our Facilities. Delays in obtaining regulatory approvals for products developed by our customers that use Stellar KLH TM , or failure to obtain or maintain regulatory approvals altogether, would have a negative effect on market demand for our Stellar KLH TM products, and have a negative effect on our operations and financial condition. Recent Accounting Pronouncements. In addition, ASU adds a new Subtopic to the Codification, ASC , Other Assets and Deferred Costs: Contracts with Customers , to provide guidance on costs related to obtaining a contract with a customer and costs incurred in fulfilling a contract with a customer that are not in the scope of another ASC Topic. One of our collaboration partners is evaluating a product candidate in AD prevention similar to our product candidate crenezumab. We have filed trademark applications seeking protection for our corporate name, logo, Nasdaq Global Market symbol and selected names of our technology platforms in selected geographies.