TNI BIOTECH, INC. (Form: 10-12G, Received: 04/22/2013 06:03:01)

The nature of TNIB’s business creates potential liability for personal injury claims that could affect the Company’s financial condition.

TNIB’s business involves the testing of new drugs and medical devices on human volunteers. If marketing approval is given to permit patients to use experimental drugs, TNIB is exposed to the risk of liability for personal injury or death to patients resulting from (among other things) possible unforeseen adverse side effects or improper administration of a drug or device. Many of these volunteers and patients are already seriously ill, thus at risk of further illness or death. TNIB could be materially and adversely affected both financially and reputationally if required to pay damages or incur defense costs in connection with a claim outside the scope of indemnification agreements TNIB has with its clients and collaborative partners. If any indemnification agreement is not performed in accordance with its terms, TNIB’s liability exceeds the amount of any applicable indemnification limits, or the amount of money awarded a potential defendant exceeds the amount of insurance coverage, TNIB may face large costs and untenable insurance rate risks in the future.

If serious or unexpected adverse side effects are identified during the development of our treatment, we may need to abandon or limit our development of some or all of our treatments.

All of our treatments are in preclinical or clinical development and their risk of failure is high. If our treatments are associated with serious or unexpected adverse effects, we may need to abandon their development or limit development to certain uses or subpopulations in which these effects are less prevalent, less severe or more acceptable from a risk-benefit perspective.

TNIB may not obtain government approval for its products and/or uses.

The development and commercialization of pharmaceutical products are subject to extensive governmental regulation in the United States and foreign countries. Government approvals are required to develop, market and sell potential drug candidates. Obtaining government approval to develop, market and sell drug candidates is time-consuming and expensive. The clinical trial results for a particular drug candidate might not satisfy necessary requirements to obtain government approvals. Even if TNIB is successful in obtaining all required approvals to market and sell a drug candidate, post-approval requirements and the failure to comply with other regulations could result in suspension or limitation of government approvals.

In connection with drug discovery activities outside of the United States, TNIB and its strategic partners will be subject to foreign regulatory requirements governing testing, approval, manufacturing, labeling, marketing and sale of pharmaceutical products. These requirements vary with location. Even if approval has been obtained for a product in the United States, approval in a foreign country must be obtained prior to marketing the product. The approval process in foreign countries may be more or less rigorous than the United States and the time required for approval may be longer or shorter. Clinical studies conducted outside of a specific country may not be acceptable. The approval of a pharmaceutical product in one country does not guarantee approval in another.

Even if approved, the products TNIB may develop and market may be later withdrawn from the market or subject to promotional limitations.

We may not be able to obtain the labeling claims necessary or desirable for the promotion of our treatments if approved. We may also be required to undertake post-marketing clinical trials. If the results of such post-marketing studies are not satisfactory or if adverse events or other safety issues arise after approval, the FDA or a comparable regulatory agency in another country may withdraw marketing authorization or may condition continued marketing on commitments from us that may be expensive and/or time consuming to complete. In addition, if we or others identify adverse side effects after any of our products are on the market, or if manufacturing problems occur, regulatory approval may be withdrawn and reformulation of our products, additional clinical trials, changes in labeling of our products and additional marketing applications may be required. Any reformulation or labeling changes may limit the marketability of our products if approved.

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TNIB may not have enough trained personnel.

The novel nature of our products may result in fewer people being trained in or experienced with products of this type, which may make it difficult to recruit, hire and retain capable personnel for the research, development and manufacturing positions that will be required to continue development and commercialization of our treatment.

TNIB may incur substantial expenses by developing products that will never be successful, fully developed and/or commercialized.

TNIB has incurred, and expects to continue incurring, substantial research, development and other costs in connection with compound partnering agreements.

Our treatments, even if approved, may not be accepted in the marketplace; therefore, we may not be able to generate significant revenue, if any.

Even if TNIB products or other potential treatments that we develop in the future are approved for sale, physicians and the medical community may not ultimately use them or may use them only in applications more restricted than we anticipate. Our treatments, if successfully developed, will compete with a number of traditional products manufactured and marketed by major pharmaceutical and biotechnology companies. Our treatments may also compete with new products currently under development by such companies and others. Physicians will prescribe a product only if they determine, based on experience, clinical data, side effect profiles and other factors, that it is beneficial as compared to other products currently available and in use. Physicians also will prescribe a product based on their traditional preferences. Many other factors influence the adoption of new products, including patient perceptions and preferences, marketing and distribution restrictions, adverse publicity, product pricing, views of thought leaders in the medical community and reimbursement by government and private payers. Any of these factors could have a material adverse effect on our business, financial condition, and results of operations.

Health care reform measures could adversely affect our business.

In the United States and other jurisdictions, there have been a number of legislative and regulatory changes to the healthcare system that could affect our future results of operations. Specifically, there have been and continue to be a number of initiatives at the United States federal and state levels that seek to reduce healthcare costs. Most recently, in March, 2010, the Patient Protection and Affordable Health Care Act, as amended by the Health Care and Education Affordability Reconciliation Act (collectively, the “PPACA”), was enacted which includes measures to significantly change the way that health care is financed by both governmental and private insurers.

Many of the details regarding the implementation of the PPACA are yet to be determined, and at this time, it remains unclear what effect PPACA would have on our business, but there is a possibility that it will have a negative affect on TNIB.

Individual states have become increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, designed to encourage importation from other countries and bulk purchasing. Also, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. These initiatives could reduce the demand for our products or result in lower than expected product pricing which could negatively affect our business, results of operations, financial condition and prospects.

In addition, given recent federal and state government initiatives directed at lowering the overall cost of healthcare, Congress and state legislatures will likely continue to focus on healthcare reform, the cost of prescription drugs and biologics and the reform of the Medicare and Medicaid programs. While we cannot predict the full outcome of any such legislation, it may result in decreased reimbursement for drugs and biologics. This could harm our ability to generate revenues.

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TNIB’s operations may be affected by the occurrence of a natural disaster or other catastrophic event.

TNIB depends on its clients, investigators, collaboration partners, laboratories and other facilities for the continued operation of business. Although TNIB has contingency plans in effect for natural disasters or other catastrophic events, these events, including terrorist attacks, pandemic flu, hurricanes, ice storms, etc., could disrupt operations or prevent TNIB’s clients, investigators and collaboration partners from performing their necessary roles within TNIB. Although TNIB carries business interruption insurance policies and has provisions in its contracts for protection during certain natural disasters and other catastrophic events, TNIB might suffer a loss resulting in business interruptions exceeding the available coverage under such insurance policies or from events in which TNIB does not have coverage. Any natural disaster or catastrophic event affecting TNIB or its clients, investigators or collaboration partners could have a significantly negative impact on operations and financial performance.

Florida Law and our Articles of Incorporation may protect our Directors from certain types of lawsuits.

Florida law provides that our officers and directors will not be liable to us or our stockholders for monetary damages for all but certain types of conduct as officers and directors. Our Bylaws permit us broad indemnification powers to all persons against all damages incurred in connection with our business to the fullest extent provided or allowed by law. The exculpation provisions may have the effect of preventing stockholders from recovering damages against our officers and directors caused by their negligence, poor judgment or other circumstances. The indemnification provisions may require us to use our limited assets to defend our officers and directors against claims, including claims arising out of their negligence, poor judgment or other circumstances.

We may seek to grow our business through acquisitions of or investments in new or complementary businesses, products or technologies, and the failure to manage acquisitions or investments, or the failure to integrate them with our existing business, could have a material adverse effect on us.

From time to time we expect to consider opportunities to acquire or make investments in other technologies, products and businesses that may enhance our capabilities, complement our current products or expand the breadth of our markets or customer base. Potential and completed acquisitions and strategic investments involve numerous risks, including:

●	problems assimilating the purchased technologies, products or business operations;

●	issues maintaining uniform standards, procedures, controls and policies;

●	unanticipated costs associated with acquisitions;

●	diversion of management’s attention from our core business;

●	adverse effects on existing business relationships with suppliers and customers;

●	risks associated with entering new markets in which we have limited or no experience;

●	potential loss of key employees of acquired businesses; and

●	Increased legal and accounting compliance costs.

We have no current commitments with respect to any acquisition or investment. We do not know if we will be able to identify acquisitions we deem suitable, whether we will be able to successfully complete any such acquisitions on favorable terms or at all, or whether we will be able to successfully integrate any acquired business, product or technology into our business or retain any key personnel, suppliers or distributors. Our ability to successfully grow through acquisitions depends upon our ability to identify, negotiate, complete and integrate suitable target businesses and to obtain any necessary financing. These efforts could be expensive and time-consuming, and may disrupt our ongoing business and prevent management from focusing on our operations. If we are unable to integrate any acquired businesses, products or technologies effectively, our business, results of operations and financial condition will be materially adversely affected.

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We may expend our limited resources to pursue a particular opportunity and fail to capitalize on current research and products that may be more profitable or for which there is a greater likelihood of success.

Because we have limited financial and managerial resources, we have focused on specific research programs, treatments, and products. As a result, we may forego or delay pursuit of opportunities with other products or research that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial treatments or profitable market opportunities. Our spending on current and future research and development programs may not yield any commercially viable treatments.

We are subject to risks associated with our non-U.S. operations .

The Foreign Corrupt Practices Act (“FCPA”) and similar worldwide anti-bribery laws in non-U.S. jurisdictions generally prohibit companies and their intermediaries from making improper payments to non-U.S. officials for the purpose of obtaining or retaining business. The FCPA also imposes accounting standards and requirements on publicly traded U.S. corporations and their foreign affiliates which are intended to prevent the diversion of corporate funds to the payment of bribes and other improper payments, and to prevent the establishment of “off books” slush funds from which such improper payments can be made. Because of the predominance of government-sponsored healthcare systems around the world, many of our customer relationships outside of the United States are with governmental entities and are therefore subject to such anti-bribery laws. Our internal control policies and procedures may not always protect us from reckless or criminal acts committed by our employees or agents. Violations of these laws, or allegations of such violations, could disrupt our operations, involve significant management distraction and result in a material adverse effect on our business, results of operations and financial condition. We also could suffer severe penalties, including criminal and civil penalties, disgorgement and other remedial measures, including further changes or enhancements to our procedures, policies and controls, as well as potential personnel changes and disciplinary actions.

Furthermore, we are subject to the export controls and economic embargo rules and regulations of the United States, including, but not limited to, the Export Administration Regulations and trade sanctions against embargoed countries, which are administered by the Office of Foreign Assets Control within the Department of the Treasury, as well as the laws and regulations administered by the Department of Commerce. These regulations limit our ability to market, sell, distribute or otherwise transfer our products or technology to prohibited countries or persons. A determination that we have failed to comply, whether knowingly or inadvertently, may result in substantial penalties, including fines and enforcement actions and civil and/or criminal sanctions, the disgorgement of profits, the imposition of a court-appointed monitor, the denial of export privileges and/or an adverse effect on our reputation.

These and other factors may have a material adverse effect on our international operations or on our business, results of operations and financial condition generally.

Risks Related to Intellectual Property

TNIB’s inability to adequately protect its intellectual property rights could hurt business.

TNIB’s success will depend on its ability to protect the compositions, compounds, therapies, technologies, processes, software and other technologies developed during the drug development process. Additionally, one of TNIB’s core business strategies is in-licensing and/or out-licensing rights to drug candidates, thus entering into collaborations with pharmaceutical and biotechnology companies for the development of proprietary drug candidates. Inability to protect such intellectual property rights could materially and adversely affect TNIB’s business.

Any patents or licenses TNIB secures may not provide valuable protection for the covered technology or products. TNIB’s patent applications may never result in the issuance of a patent. Competitors might develop similar products or methods not covered by TNIB’s issued patent claims. Additionally, an issued patent might be narrowed or invalidated by a court challenge. The value of an issued patent could also diminish if a patent is issued to a competitor that blocks TNIB’s ability to use its patented technology. If blocked, TNIB may be forced to stop using some or all of its technology or may be forced to license technology from third parties on unfavorable terms.

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TNIB also relies on copyright, trademark and trade secret protection in addition to patent protection. In an effort to maintain the confidentiality and ownership of intellectual property, TNIB requires its employees, consultants and advisors to execute confidentiality and proprietary information agreements. These agreements and other procedures may not provide TNIB with adequate protection against improper use or disclosure of confidential information. In the event of unauthorized use or disclosure, adequate remedies may not exist or may not be feasible. Furthermore, TNIB may hire scientific personnel formerly employed by other companies involved in one or more areas similar to the activities TNIB conducts. In certain situations, TNIB’s confidentiality and proprietary information agreements might conflict with or be subject to the rights of third parties with whom employees, consultants or advisors have prior employment and consulting relationships. Although TNIB requires employees and consultants to maintain the confidentiality of such confidential information from previous employers, both the company and these individuals may be subject to allegations of trade secret misappropriation or other similar claims as a result of their prior affiliations. Finally, other individuals not connected to TNIB in any way may independently develop substantial and equivalent proprietary information or otherwise gain access to TNIB’s trade secrets. TNIB’s failure to protect such proprietary information and techniques might inhibit or limit its ability to exclude competitors from the market and execute business strategies.

The drug discovery and development industry has a history of patent and other intellectual property litigation; thus, TNIB may be involved in costly intellectual property lawsuits.

There has been substantial litigation and other proceedings regarding patent and other intellectual property rights in the pharmaceutical and biotechnology industries. We or one of our collaborators may be subject to third party claims in the future that would cause us to incur substantial expenses and, if successful against us, could cause us to pay substantial damages, including treble damages and attorney’s fees if we are found to be willfully infringing a third party’s patents. Further, if a patent infringement suit were brought against us or our collaborators, we or they could be forced to stop or delay research, development, manufacturing or sales of the product or drug candidate that is the subject of the suit. As a result of patent infringement claims, or in order to avoid potential claims, we or our collaborators may choose to seek, or be required to seek, a license from the third party and would most likely be required to pay license fees or royalties or both. These licenses may not be available on acceptable terms, or at all. Even if we or our collaborators were able to obtain a license, the rights may be nonexclusive, which would give our competitors access to the same intellectual property. Ultimately, we could be prevented from commercializing a product, or forced to redesign it, or to cease some aspect of our business operations if, as a result of actual or threatened patent infringement claims, we or our collaborators are unable to enter into licenses on acceptable terms. This could harm our business significantly.

In addition to infringement claims against us, if third parties prepare and file patent applications in the United States that also claim technology to which we have rights, we may have to participate in interference proceedings with the United States Patent and Trademark Office (“USPTO”) to determine the priority of invention. We may also become involved in similar opposition proceedings in the European Patent Office regarding our intellectual property rights with respect to our products and technology.

Restrictions on our patent rights may limit our ability to prevent third parties from competing against us .

Our success will depend, in part, on our ability to obtain and maintain patent protection for our drug candidates, preserve our trade secrets, prevent third parties from infringing upon our proprietary rights and operate without infringing upon the proprietary rights of others. Composition of Matter patents on APIs are generally considered to be the strongest form of intellectual property protection for pharmaceutical products, as they apply without regard to any method of use. Entirely new individual chemical compounds, often referred to as new chemical entities, are typically entitled to Composition of Matter coverage. However, we cannot be certain that the current law will remain the same, or that our drug candidates will be considered novel and non-obvious by the USPTO and courts.

In addition to Composition of Matter patents and patent applications, we also have filed Method of Use patent applications. This type of patent protects the use of the product only for the specified method. However, this type of patent does not prevent a competitor from making and marketing a product that is identical to our product for an indication that is outside the scope of the patented method. Moreover, even if these competitors do not actively promote their product for our targeted indication, physicians may prescribe these products “off-label.” Although off-label prescriptions may infringe or contribute to the infringement of Method of Use patents, the practice is common and such infringement is difficult to prevent or prosecute.

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Patent applications in the United States and most other countries are confidential for a period of time until they are published. The publication of discoveries in scientific or patent literature typically lags actual discoveries by several months or more. As a result, we cannot be certain whether the Company or another inventor were the inventors of the issued patents and applications or that the Company or another inventor were the first to conceive of the inventions covered by such patents and pending patent applications or that the Company or another inventor were the first to file patent applications covering such inventions.

We have numerous issued patents and some patent applications pending before the USPTO. The protection may lapse before we manage to obtain commercial value from the patents, which might result in increased competition and materially affect our position in the market.

We may be subject to claims that we or our employees or consultants have wrongfully used or disclosed alleged trade secrets of our employees’ or consultants’ former employers or their clients. These claims may be costly to defend and if we do not successfully do so, we may be required to pay monetary damages and may lose valuable intellectual property rights or personnel.

Many of our employees were previously employed at universities, biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although no claims against us are currently pending, we may be subject to claims that these employees or we have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these claims. If we fail in defending such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. A loss of key research personnel or their work product could hamper our ability to commercialize, or prevent us from commercializing our drug candidates, which could severely harm our business. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.

Some of our intellectual property that is discovered through government funded programs is subject to federal regulation such as “march-in” rights, certain reporting requirements, and a preference for United States industry. Compliance with such regulations may limit our exclusive rights, subject us to expenditure of resources with respect to reporting requirements, and limit our ability to contract with foreign manufacturers.

Some of our existing drug candidates, including LDN and MENK, and some of our research and development work are funded, at least in part, by the U.S. government and are therefore subject to certain federal regulations. For example, some of our research and development work on vaccine adjuvants and immunomodulation for biothreat applications are funded by government research grants. In addition, as noted on several of our patents were supported, at least in part, by the National Institute of Health (“NIH”) funding (U19-AI056690-01). Under the “march-in” provisions of the Bayh-Dole Act, the government may have the right under limited circumstances to require us to grant exclusive, partially exclusive or non-exclusive rights to third parties for intellectual property discovered through the government-funded program. The government can exercise its march-in rights if it determines that action is necessary because we fail to achieve practical application of the new invention or because action is necessary to alleviate health or safety needs of the public. Intellectual property discovered under the government-funded program is also subject to certain reporting requirements, compliance with which may require us to expend substantial resources. Such intellectual property is also subject to a preference for U.S. industry, which may limit our ability to contract with foreign product manufacturers for products covered by such intellectual property. We plan to apply for additional U.S. government funding, and it is possible that we may discover compounds or drug candidates as a result of such funding. Intellectual property under such discoveries would be subject to the applicable provisions of the Bayh-Dole Act.

Risks Related to Government Regulation

The regulatory approval process is expensive, time consuming and uncertain and may prevent us or our collaboration partners from obtaining approvals for the commercialization of some or all of our drug candidates.

The research, testing, manufacturing, labeling, approval, selling, import, export, marketing and distribution of drug products are subject to extensive regulation by the FDA and other regulatory authorities in the United States and other countries which regulations differ from country to country. Neither we nor our collaboration partners are permitted to market our drug candidates in the United States until we receive approval of a NDA from the FDA. Neither we nor our collaboration partners have submitted an application for or received marketing approval for any of our drug candidates. Obtaining approval of an NDA can be a lengthy, expensive and uncertain process. In addition, failure to comply with FDA and other applicable U.S. and foreign regulatory requirements may subject us to administrative or judicially imposed sanctions, including:

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●	warning letters;

●	civil and criminal penalties;

●	injunctions;

●	withdrawal of approved products;

●	product seizure or detention;

●	product recalls;

●	total or partial suspension of production; and

●	refusal to approve pending NDAs or supplements to approved NDAs.

Prior to receiving approval to commercialize any of our drug candidates in the United States or abroad, we and our collaboration partners must demonstrate with substantial evidence from well controlled clinical trials, and to the satisfaction of the FDA and other regulatory authorities abroad, that such drug candidates are safe and effective for their intended uses. Results from preclinical studies and clinical trials can be interpreted in different ways. Even if we and our collaboration partners believe the preclinical or clinical data for our drug candidates are promising, such data may not be sufficient to support approval by the FDA and other regulatory authorities. Administering any of our drug candidates to humans may produce undesirable side effects, which could interrupt, delay or halt clinical trials of our drug candidates and result in the FDA or other regulatory authorities denying approval of our drug candidates for any or all targeted indications.

Regulatory approval of an NDA or NDA supplement is not guaranteed, and the approval process is expensive and may take several years. The FDA also has substantial discretion in the approval process. Despite the time and expense exerted, failure can occur at any stage, and we could encounter problems that cause us to abandon or repeat clinical trials, or perform additional preclinical studies and clinical trials. The number of preclinical studies and clinical trials that will be required for FDA approval varies depending on the drug candidate, the disease or condition that the drug candidate is designed to address, and the regulations applicable to any particular drug candidate. The FDA can delay, limit or deny approval of a drug candidate for many reasons, including, but not limited to, the following:

●	a drug candidate may not be deemed safe or effective;

●	FDA officials may not find the data from preclinical studies and clinical trials sufficient;

●	the FDA might not approve our or our third party manufacturer’s processes or facilities; or

●	the FDA may change its approval policies or adopt new regulations.

If any of our drug candidates fail to demonstrate safety and efficacy in clinical trials or do not gain regulatory approval, our business and results of operations will be materially and adversely harmed.

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Even if we receive regulatory approval for a drug candidate, we will be subject to ongoing regulatory obligations and continued regulatory review which may result in significant additional expense and subject us to penalties if we fail to comply with applicable regulatory requirements.

Once regulatory approval has been granted, the approved product and its manufacturer are subject to continual review by the FDA and/or non-U.S. regulatory authorities. Any regulatory approval that we or our collaboration partners receive for our drug candidates may be subject to limitations on the indicated uses for which the product may be marketed or contain requirements for potentially costly post-marketing follow-up studies to monitor the safety and efficacy of the product. In addition, if the FDA and/or non-U.S. regulatory authorities approve any of our drug candidates, we will be subject to extensive and ongoing regulatory requirements by the FDA and other regulatory authorities with regard to the labeling, packaging, adverse event reporting, storage, advertising, promotion and recordkeeping for our products. In addition, manufacturers of our drug products are required to comply with current cGMP regulations which include requirements related to quality control and quality assurance as well as the corresponding maintenance of records and documentation. Further, regulatory authorities must approve these manufacturing facilities before they can be used to manufacture our drug products, and these facilities are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with cGMP regulations. If we or a regulatory authority discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, a regulatory authority may impose restrictions on that product, the manufacturer or us, including requiring withdrawal of the product from the market or suspension of manufacturing. If we, our drug candidates or the manufacturing facilities for our drug candidates fail to comply with regulatory requirements of the FDA and/or other non-U.S. regulatory authorities, we could be subject to administrative or judicially imposed sanctions, including:

●	warning letters;

●	civil or criminal penalties;

●	injunctions;

●	suspension of or withdrawal of regulatory approval;

●	suspension of any ongoing clinical trials;

●	voluntary or mandatory product recalls and publicity requirements;

●	refusal to approve pending applications for marketing approval of new drugs or supplements to approved applications filed by us;

●	restrictions on operations, including costly new manufacturing requirements; or

●	seizure or detention of our products or import bans.

The regulatory requirements and policies may change and additional government regulations may be enacted for which we may also be required to comply. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or in other countries. If we are not able to maintain regulatory compliance, we will not be permitted to market our future products and our business will suffer.

The availability of adequate third-party coverage and reimbursement for newly approved drugs is uncertain, and failure to obtain adequate coverage and reimbursement from third-party payors could impede our ability to market any future products we may develop and could limit our ability to generate revenue.

There is significant uncertainty related to the third-party payor coverage and reimbursement of newly approved drugs. The commercial success of our future products in both domestic and international markets depends on whether such third-party coverage and reimbursement is available for our future products. Governmental payors, including Medicare and Medicaid, health maintenance organizations and other third-party payors are increasingly attempting to manage their healthcare expenditures by limiting both coverage and the level of reimbursement of new drugs and, as a result, they may not cover or provide adequate reimbursement for our future products. These payors may not view our future products as cost-effective, and coverage and reimbursement may not be available to our customers or may not be sufficient to allow our future products to be marketed on a competitive basis. Third-party payors are exerting increasing influence on decisions regarding the use of, and coverage and reimbursement levels for, particular treatments. Such third-party payors, including Medicare, are challenging the prices charged for medical products and services, and many third-party payors limit or delay coverage and reimbursement for newly approved healthcare products. In particular, third-party payors may limit the covered indications. Cost-control initiatives could cause us to decrease the price we might establish for products, which could result in lower than anticipated product revenues. If the prices for our drug candidates decrease or if governmental and other third-party payors do not provide adequate coverage or reimbursement, our prospects for revenue and profitability will suffer.

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Failure to obtain regulatory approvals in foreign jurisdictions will prevent us from marketing our products internationally.

We intend to seek a distribution and marketing partner for IRT-101, IRT-102 and IRT-103 (LDN) outside North America that may market future products in international markets. In order to market our future products in the European Economic Area (“EEA”) (which is comprised of the 27 member states of the European Union (“EU”) plus Norway, Iceland and Liechtenstein) and many other foreign jurisdictions, we must obtain separate regulatory approvals. More concretely, in the EEA, medicinal products can only be commercialized after obtaining a Marketing Authorization (“MA”). There are two types of marketing authorizations:

●

The Community MA is issued by the European Commission through the Centralized Procedure, based on the opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency (“EMA”), and is valid throughout the entire territory of the EEA. The Centralized Procedure is mandatory for certain types of products, such as biotechnology medicinal products, orphan medicinal products, and medicinal products indicated for the treatment of AIDS, cancer, neurodegenerative disorders, diabetes, auto-immune and viral diseases. The Centralized Procedure is optional for products containing a new active substance not yet authorized in the EEA, or for products that constitute a significant therapeutic, scientific or technical innovation or which are in the interest of public health in the EU.

●

National MAs, which are issued by the competent authorities of the Member States of the EEA and only cover their respective territory, are available for products not falling within the mandatory scope of the Centralized Procedure. Where a product has already been authorized for marketing in a Member State of the EEA, this National MA can be recognized in another Member State through the Mutual Recognition Procedure. If the product has not received a National MA in any member state at the time of application, it can be approved simultaneously in various member states through the Decentralized Procedure.

Under the procedures described above, before granting the MA, the EMA or the competent authorities of the member states of the EEA make an assessment of the risk-benefit balance of the product on the basis of scientific criteria concerning its quality, safety and efficacy.

We have had limited interactions with foreign regulatory authorities. The approval procedures vary among countries, can involve additional clinical testing, and require time to obtain approval that may differ from that required to obtain FDA approval. Clinical trials conducted in one country may not be accepted by regulatory authorities in other countries. Approval by the FDA does not ensure approval by regulatory authorities in other countries, and approval by one or more foreign regulatory authorities does not ensure approval by regulatory authorities in other foreign countries or by the FDA. However, a failure or delay in obtaining regulatory approval in one country may have a negative effect on the regulatory process in others. The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval. We may not obtain foreign regulatory approvals on a timely basis, if at all. We may not be able to file for regulatory approvals and even if we file we may not receive necessary approvals to commercialize our products in any market.

Healthcare reform measures could hinder or prevent the commercial success of our drug candidates .

In the United States, there have been and we expect there will continue to be a number of legislative and regulatory changes to the healthcare system. These changes could affect our future revenues and profitability and the future revenue and profitability of our potential customers. Federal and state lawmakers regularly propose and, at times, enact legislation that would result in significant changes to the healthcare system, some of which are intended to contain or reduce the costs of medical products and services. For example, in March 2010, United States president Barack Obama signed one of the most significant healthcare reform measures in decades, the Affordable Care Act. It contains a number of provisions, including those governing enrollment in federal healthcare programs, reimbursement changes and fraud and abuse measures, all of which will impact existing government healthcare programs and will result in the development of new programs. The Affordable Care Act, among other things:

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●	imposes a non-deductible annual fee on certain pharmaceutical manufacturers or importers who sell “branded prescription drugs,” effective in 2011;

●	increases the minimum level of Medicaid rebates payable by manufacturers of brand-name drugs from 15.1% to 23.1%;

●	requires collection of rebates for drugs paid by Medicaid managed care organizations;

●

requires manufacturers to participate in a coverage gap discount program, under which manufacturers must agree to offer 50% point-of-sale discounts off of negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D, effective January 2011; and

●	mandates a further shift in the burden of Medicaid payments to the states.

A number of states have challenged the constitutionality of certain provisions of the Affordable Care Act, and many of these challenges are still pending final adjudication in several jurisdictions as well as the United States Supreme Court. Congress has also proposed a number of legislative initiatives, including possible repeal of the Affordable Care Act. At this time, it remains unclear whether there will be any changes made to the Affordable Care Act, whether to certain provisions or its entirety. We cannot assure you that the Affordable Care Act, as currently enacted or as amended in the future, will not adversely affect our business and financial results and we cannot predict how future federal or state legislative or administrative changes relating to healthcare reform will affect our business.

In addition, other legislative changes have been proposed and adopted since the Affordable Care Act was enacted. There likely will continue to be legislative and regulatory proposals at the federal and state levels directed at containing or lowering the cost of health care. We cannot predict the initiatives that may be adopted in the future or their full impact. The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of health care may adversely affect:

●	our ability to set a price we believe is fair for our products;

●	our ability to generate revenues and achieve or maintain profitability; and

●	the availability of capital.

If we fail to comply with healthcare regulations, we could face substantial penalties and our business, operations and financial condition could be adversely affected.

Even though we do not and will not control referrals of healthcare services or bill directly to Medicare, Medicaid or other third-party payors, certain federal and state healthcare laws and regulations pertaining to fraud and abuse and patients’ rights are and will be applicable to our business. We could be subject to healthcare fraud and abuse and patient privacy regulation by both the federal government and the states in which we conduct our business. The regulations that may affect our ability to operate include, without limitation:

●

the federal healthcare program Anti-Kickback Statute, which prohibits, among other things, any person from knowingly and willfully offering, soliciting, receiving or providing remuneration, directly or indirectly, to induce either the referral of an individual for an item or service or the purchasing or ordering of a good or service, for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs;

●

the federal False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, false claims, or knowingly using false statements, to obtain payment from the federal government, and which may apply to entities like us which provide coding and billing advice to customers;

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●	federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; and

●

the federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, which governs the conduct of certain electronic healthcare transactions and protects the security and privacy of protected health information; and state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers.

If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines and the curtailment or restructuring of our operations. Any penalties, damages, fines, curtailment or restructuring of our operations could adversely affect our ability to operate our business and our financial results. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert Management’s attention from the operation of our business. Moreover, achieving and sustaining compliance with applicable federal and state privacy, security and fraud laws may prove costly.

Risks Related to our Common Stock

Because of their significant stock ownership, our chief executive officer, our other executive officers, and our directors and principal stockholders may be able to exert control over us and our significant corporate decisions.

This concentration of ownership may harm the value of our common stock by, among other things:

●	delaying, deferring or preventing a change in control of our company;

●	impeding a merger, consolidation, takeover or other business combination involving our company; or

●	causing us to enter into transactions or agreements that are not in the best interests of all stockholders

The price of our common stock may be volatile, and you may not be able to resell your shares .

An active and liquid trading market for our common stock may not develop or be sustainable. Shareholders may be unable to sell shares of common stock at or above their purchase price due to fluctuations in the market price of our common stock. Factors that could cause volatility in the market price of our common stock include, but are not limited to:

●	results from, and delays in, clinical trial programs relating to our drug candidates, including the ongoing and planned clinical trials for IRT-103 (LDN), IRT-101 and IRT-102 and other drug candidates;

●	announcements of regulatory approvals or disapprovals of our drug candidates including IRT-103 (LDN), IRT-101 and IRT-102 or delays in any regulatory agency review or approval processes;

●	failure or discontinuation of any of our research programs;

●	announcements relating to future collaborations or our existing collaborations;

●	general economic conditions in the United States and abroad;

●	acquisitions and sales of new products, technologies or business;

●	delays in the commercialization of any of our drug candidates;

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●	market conditions in the pharmaceutical, biopharmaceutical and biotechnology sectors;

●	the issuance of new or changed securities analysts’ reports or recommendations regarding us, our competitors or our industry in general;

●	actual and anticipated fluctuations in our quarterly operating results;

●	disputes concerning our intellectual property or other proprietary rights;

●	introduction of technological innovations or new products by us or our competitors;

●	manufacturing issues related to our drug candidates for clinical trials or future products for commercialization;

●	market acceptance of our future products;

●	deviations in our operating results from the estimates of analysts;

●	third party payor coverage and reimbursement policies;

●	new legislation in the United States relating to the sale or pricing of pharmaceuticals;

●	FDA or other U.S. or foreign regulatory actions affecting us or our industry;

●	product liability claims or other litigation or public concern about the safety of our drug candidates or future drugs;

●	our ability to obtain necessary intellectual property licenses including, if necessary, those relating to IRT-103 (LDN) and other drug candidates;

●	the outcome of any future legal actions to which we are a party;

●	sales of our common stock by our officers, directors or significant stockholders;

●	frequent, irregular, under market, or large sales of shares of our common stock by any shareholder;

●	additions or departures of key personnel; and

●	external factors, including natural disasters and other crises.

In addition, the stock markets in general, and the markets for pharmaceutical, biopharmaceutical and biotechnology stocks in particular, have experienced extreme volatility that has often been unrelated to the operating performance of the issuer. These broad market fluctuations may adversely affect the trading price or liquidity of our common stock. In the past, when the market price of a stock has been volatile, holders of that stock have sometimes instituted securities class action litigation suits against the issuer. If any of our stockholders were to bring such a lawsuit against us, we could incur substantial costs defending the lawsuit and the attention of our management would be diverted from the operation of our business.

Future sales of our common stock or securities convertible or exchangeable for our common stock may depress our stock price.

If our existing stockholders or holders of our convertible notes, options or warrants sell, or indicate an intention to sell substantial amounts of our common stock in the public market, the trading price of our common stock could decline. The perception in the market place that these sales may occur could also cause the trading price of our common stock to decline.

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Certain holders of shares of our common stock, warrants to purchase our common stock, and shares of common stock issuable upon exercise of warrants will be entitled to rights with respect to the registration of their shares under the Securities Act. Registration of these shares under the Securities Act would result in the shares becoming freely tradable without restriction under the Securities Act, except for shares purchased by affiliates. In addition, our directors may, and we expect that our executive officers, will establish programmed selling plans under Rule 10b5-1 of the Exchange Act, for the purpose of effecting sales of our common stock. Any sales of securities by these stockholders, or the perception that those sales may occur, including the entry into such programmed selling plans, could have a material adverse effect on the trading price of our common stock.

If we sell shares of our common stock in future financings, common stockholders may experience immediate dilution and, as a result, our stock price may decline.

We may from time to time issue additional shares of common stock at a discount from the current trading price of our common stock. As a result, our common stockholders would experience immediate dilution upon the purchase of any shares of our common stock sold at such a discount. In addition, as opportunities present themselves, we may enter into financing or similar arrangements in the future, including the issuance of debt securities, preferred stock or common stock.

Provisions of our charter documents or Florida law could delay or prevent an acquisition of our company, even if the acquisition would be beneficial to our stockholders, and could make it more difficult for you to change management.

Provisions of our amended and restated certificate of incorporation and amended and restated bylaws may discourage, delay or prevent a merger, acquisition or other change in control that stockholders may consider favorable, including transactions in which stockholders might otherwise receive a premium for their shares. In addition, these provisions may frustrate or prevent any attempt by our stockholders to replace or remove our current management by making it more difficult to replace or remove our board of directors.

We do not anticipate paying any cash dividends on our capital stock in the foreseeable future, therefore capital appreciation, if any, of our common stock will be your sole source of gain for the foreseeable future.

We have never declared or paid cash dividends on our capital stock. We do not anticipate paying any cash dividends on our capital stock in the foreseeable future. We currently intend to retain all available funds and any future earnings to fund the development and growth of our business. As a result, capital appreciation, if any, of the common stock will be your sole source of gain for the foreseeable future.

If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.

The trading market for our common stock will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. Securities and industry analysts do not currently, and may never, publish research on our company. If no securities or industry analysts commence coverage of our company, the trading price for our stock would likely be negatively impacted. In the event securities or industry analysts initiate coverage, if one or more of the analysts who cover us downgrade our stock or publish inaccurate or unfavorable research about our business, our stock price would likely decline. In addition, if our operating results fail to meet the forecast of analysts, our stock price would likely decline. If one or more of these analysts cease coverage of our company or fail to publish reports on us regularly, demand for our stock could decrease, which might cause our stock price and trading volume to decline.

Our board of directors is authorized to issue and designate shares of our preferred stock in additional series without stockholder approval.

Our amended and restated certificate of incorporation authorizes our board of directors, without the approval of our stockholders, to issue shares of our preferred stock, subject to limitations prescribed by applicable law, rules and regulations and the provisions of our amended and restated certificate of incorporation, as shares of preferred stock in series, and to establish from time to time the number of shares to be included in each such series, and to fix the designation, powers, preferences and rights of the shares of each such series and the qualifications, limitations or restrictions thereof. The powers, preferences and rights of these additional series of preferred stock may be senior to or on parity with our common stock, which may reduce its value. We do not currently have any class of preferred stock authorized.

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Our shares may be subject to the “penny stock” rules, which may subject you to restrictions on marketability and limit your ability to sell your shares.

Broker-dealer practices in connection with transactions in “Penny Stocks” are regulated by certain penny stock rules adopted by the Securities and Exchange Commission (the “SEC”). Penny stocks generally are equity securities with a price of less than $5.00 per share (other than securities registered on certain national securities exchanges or quoted on the NASDAQ system). The penny stock rules require a broker-dealer, prior to a transaction in a penny stock not otherwise exempt from the rules, to deliver a standardized risk disclosure document that provides information about penny stocks and the risk associated with the penny stock market. The broker-dealer must also provide the customer with current bid and offer quotations for the penny stock, the compensation of the broker-dealer and its salesperson in the transaction, and monthly account statements showing the market value of each penny stock held in the customer’s account. In addition, the penny stock rules generally require that prior to a transaction in a penny stock, the broker-dealer must make a written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser’s written agreement to the transaction. These disclosure requirements may have the effect of reducing the level of trading activity in the secondary market for a stock that becomes subject to the penny stock rules. The Company’s securities may be subject to the penny stock rules, and investors may find it more difficult to sell their securities.

The market price of our Common Stock may fluctuate significantly, which could cause a decline in value of your shares.

The market price of our Common Stock may fluctuate significantly in response to factors, some of which are beyond our control. The market price of our Common Stock could be subject to significant fluctuations and the market price could be subject to any of the following factors:

●	our failure to achieve and maintain profitability;

●	changes in earnings estimates and recommendations by financial analysts;

●	actual or anticipated variations in our quarterly and annual results of operations;

●	changes in market valuations of similar companies;

●	announcements by us or our competitors of significant contracts, new services, acquisitions, commercial relationships, joint ventures or capital commitments;

●	loss of significant clients or customers;

●	loss of significant strategic relationships;

●	variations in the level of expenses related to our drug candidates or future development programs;

●	wholesalers’ buying patterns;

●	addition or termination of clinical trials or funding support;

●	regulatory developments affecting our drug candidates or those of our competitors;

●	the Company’s sales decrease internationally;

●	ability to secure new government contracts and allocation of our resources to or away from performing work under government contracts; and

●	general market, political and economic conditions.

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Recently, the stock market in general has experienced extreme price and volume fluctuations. Continued market fluctuations could result in extreme volatility in the price of shares of our Common Stock, which could cause a decline in the value of our shares. Price volatility may be worse if the trading volume of our Common Stock is low.

We will need additional capital, which we may be unable to obtain; should we fail to obtain sufficient financing, our potential revenues will be negatively impacted.

We may have insufficient revenues to cover our operating costs or be unable to obtain financing in the amounts needed or on terms acceptable to us, if at all, which will negatively affect our ability to complete development of our business, establish a marketing platform and revenue generating operations. Additionally, we will have legal and accounting costs associated with being an SEC reporting company should our registration statement be declared effective. You should consider the risks that we will be unable to obtain adequate capital financing, which will delay our operations, lead to accumulated losses, and negatively affect our ability to complete development of our services and to generate revenues.

Our Common Stock is quoted on the OTC Pink Market, which may have an unfavorable impact on our stock price and liquidity.

Our Common Stock is currently quoted on the OTC Pink Market under the trading symbol “TNIB.” The OTC Pink Market is a significantly more limited market than the New York Stock Exchange or NASDAQ. The quotation of our shares on the OTC Pink Market may result in a less liquid market available for existing and potential shareholders to trade shares of our Common Stock, could depress the trading price of our Common Stock and could have a long-term adverse impact on our ability to raise capital in the future.

If we fail to remain current on our SEC reporting requirements, we could be removed from any market on which our common stock trades, which may limit the liquidity of our stock and the price of our stock.

Companies trading on the OTCQB or OTC Bulletin Board must be reporting issuers under Section 12 of the Exchange Act, and must be current in their reports under Section 13 of the Exchange Act, in order to maintain price quotation privileges on the OTCQB or OTC Bulletin Board. If we fail to remain current on our reporting requirements, we could be removed from the OTCQB or OTC Bulletin Board. As a result, the market liquidity and the stock price for our securities would be adversely affected by limiting the ability of broker-dealers to sell our securities and the ability of shareholders to sell their securities in the secondary market.

We may not be able to operate our business or implement our operating policies and strategies successfully.

The results of our operations are dependent on many factors, including, without limitation, readily accessible funding in the financial markets and our ability to cost-effectively manage and produce events and productions as well as overall economic conditions. We may not be able to maintain any agreements with our lenders on favorable terms or at all. Furthermore, we may not be able to operate our business successfully or implement our operating policies and strategies as described in this Form 10, which could result in the loss of some or all of your investment.

ITEM 2. FINANCIAL INFORMATION.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion should be read in conjunction with the Financial Statements of the Company and notes thereto included elsewhere in this Registration Statement.

Forward Looking Statements

The following information specifies certain forward-looking statements of the management of the Company. Forward-looking statements are statements that estimate the happening of future events and are not based on historical fact. Forward-looking statements may be identified by the use of forward-looking terminology, such as may, shall, could, expect, estimate, anticipate, predict, probable, possible, should, continue, or similar terms, variations of those terms or the negative of those terms. The forward-looking statements specified in the following information statement have been compiled by our management on the basis of assumptions made by management and considered by management to be reasonable. Our future operating results, however, are impossible to predict and no representation, guaranty, or warranty is to be inferred from those forward-looking statements.

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The assumptions used for purposes of the forward-looking statements specified in the following information represent estimates of future events and are subject to uncertainty as to possible changes in economic, legislative, industry, and other circumstances. As a result, the identification and interpretation of data and other information and their use in developing and selecting assumptions from and among reasonable alternatives require the exercise of judgment. To the extent that the assumed events do not occur, the outcome may vary substantially from anticipated or projected results, and, accordingly, no opinion is expressed on the achievability of those forward-looking statements. We cannot guaranty that any of the assumptions relating to the forward-looking statements specified in the following information are accurate, and we assume no obligation to update any such forward-looking statements. Such forward-looking statements include statements regarding our anticipated financial and operating results, our liquidity, goals and plans.

All forward-looking statements in this Registration Statement are based on information available to us as of the date of this report, and we assume no obligation to update any forward-looking statements.

Overview

We have invested a significant portion of our time and financial resources in the acquisition and development of our most advanced drug candidate, IRT-103 low-dose naltrexone (“LDN”). While we currently have 3 other drug candidates in clinical trials, we anticipate that our ability to generate significant product revenues in the near term will depend primarily on the successful development, regulatory approval, marketing and commercialization of IRT-103 (LDN) by us or by one of our potential partners. It is uncertain whether IRT-103 (LDN) will have successful results in its development, regulatory approval, marketing and commercialization.

Results of Operations – Year Ended December 31, 2012 Compared to Year Ended December 31, 2011

Revenues

We had no revenues from operations for the years ended December 31, 2012 and 2011. We do not anticipate having any significant future revenues until we have sufficiently funded operations.

Operating Expenses

Selling, general and administrative expenses were $1,361,228 for 2012, as compared to $0 for 2011. We anticipate that certain operating expenses will continue to increase for fiscal year 2013 as we continue to build our infrastructure and develop our products. Our total operating expenses were $153,088,578 in 2012, compared to $0 in 2011, primarily due to the impairment of goodwill.

The Company’s carrying value of goodwill is the residual of the purchase price over the fair value of the net assets acquired from various acquisitions including the acquisition of TNI BioTech IP, Inc. In accordance with ASC Topic 350, “Goodwill and Other Intangible Assets ,” goodwill and intangible assets with indefinite useful lives are not amortized. The Company tests goodwill for impairment at the reporting unit level on an annual basis, as of December 31, or whenever potential impairment triggers occur, such as a significant change in business climate or regulatory changes that would indicate that an impairment may have occurred. Goodwill and indefinite lived intangible assets are required to be tested for impairment at least annually. The Company may use a qualitative test, known as “Step 0” or a two-step quantitative method to determine whether impairment has occurred. Based on the two-step tests performed during the quarter ended December 31, 2012, the Company determined that there was a material impairment of goodwill and recorded an impairment of $98,000,000. See Notes to the Financial Statements.

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Liquidity

Liquidity is measured by our ability to secure enough cash to meet our contractual and operating needs as they arise. We do not anticipate generating sufficient net positive cash flows from our operations to fund the next twelve months. Our cash flows from financing activities were primarily derived from the sale of common stock sold pursuant to a private placement. We had cash of $313,095 at the end of year 2012, compared to $12 at the end of year 2011.

Our cash reserves will not be sufficient to meet our operational needs and we need to raise additional capital to pay for our operational expenses and provide for capital expenditures. Above the basic operational expenses, which are estimated at $150,000 per month, we estimate that we need approximately $7-15 Million USD in 2013 to fully develop our products and for phase III clinical trials for Crohn’s disease. If we are not able to raise additional working capital, we may have to cease operations altogether.

For the years ended December 31, 2012 and 2011, we had net cash provided by (used in) operating activities from continuing operations of ($944,466) and ($38), respectively. The decrease in 2012 is primarily due to the loss of $175,220,849 from continuing operations. For the years ended December 31, 2012 and 2011, we had net cash used in investing activities from continued operations of ($1,062) and $0, respectively. The decrease in 2012 is due to the purchase of computer equipment.

We issued a total of 7,285,000 shares of common stock for cash in 2012, which generated $1,136,500 in proceeds. We additionally generated $146,128 from issued notes payable in 2012, compared to $0 of proceeds generated from issued notes in 2011.

Summary

Our ability to continue as a going concern is dependent entirely on raising funds through the sale of equity or debt. We anticipate that we will continue our attempt to raise capital through private equity transactions, develop a credit facility with a lender or the exercise of options and warrants; however, such additional capital may not be available to us at acceptable terms or available at all. In the event that we are unable to obtain additional capital, we would be forced to cease operations altogether.

Off-Balance Sheet Arrangements

During the year ended December 31, 2012, we did not engage in any off balance sheet arrangements as defined in item 303(a)(4) of the SEC’s Regulation S-K.

ITEM 3. PROPERTIES.

Bethesda Office

TNIB’s headquarters are located at 6701 Democracy Boulevard, Suite 300, Bethesda, Maryland 20817. Dr. Herberman is the TNIB executive stationed at the Bethesda Office. The Company also leases office space in Orlando, Florida on a month-to-month basis.

Malawi Clinic

The Company has begun preparing its Malawi Clinic. It is currently being cleaned and painted and the equipment is being installed in the building. Management anticipates that the Clinic will be open within 6 months.

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ITEM 4. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT.

The following table sets forth, as of the date of this filing, certain information concerning the beneficial ownership of our common stock by (i) each stockholder known by us to own beneficially 10% or more of our outstanding common stock; (ii) each director; (iii) each named executive officer; and (iv) all of our executive officers and directors as a group, and their percentage ownership and voting power.

Name and Address	Amount of Beneficial Ownership(1)			Percentage of Class %

Nicholas Plotnikoff		8,000,000	(2)		14.9
6701 Democracy Blvd. #300
Bethesda, Maryland 20817

Eugene Youkilis		1,000,000	(3)		1.9
6701 Democracy Blvd. #300
Bethesda, Maryland 20817

Noreen Griffin		3,900,000	(4)		7.3
6701 Democracy Blvd. #300
Bethesda, Maryland 20817

Gloria Herndon		1,684,182	(5)		3.1	(6)
6701 Democracy Blvd. #300
Bethesda, Maryland 20817

Christopher Pearce		4,900,000	(6)		9.1
6701 Democracy Blvd. #300
Bethesda, Maryland 20817

Fengping Shan		1,500,000			2.8
6701 Democracy Blvd. #300
Bethesda, Maryland 20817

Dr. Ronald Herberman		1,000,000	(7)		1.9
6701 Democracy Blvd. #300
Bethesda, Maryland 20817

All directors and officers as a group (7 persons)		21,984,182			41.0

_________________

	(1)	Except as otherwise indicated, each person possesses sole voting and investment power with respect to the shares shown as beneficially owned.
	(2)	These shares are held by the Plotnikoff Family Trust

(3)

1,000,000 shares are held in the name of CDR Youkilis, LLC, Eugene Youkilis is the manager

(4)

Represents 300,000 shares held in the name of Griffin Enterprises Group, LLC, Ms. Griffin is the manager; 1,000,000 shares held by the Griffin Family Trust, 600,000 held by Noreen Griffin, 1,000,000 shares issuable under her employment agreement and 1,000,000 shares issuable under her stock option warrants.

(5)

Represents 4,182 shares held by GB Investment Holdings Ltd, 180,000 held by Gloria Herndon and 1,500,000 held by The Gloria Herndon 2010 Irrevocable Trust

(6)

Represents 1,000,000 shares issuable upon the exercise of options, 1,000,000 shares issuable under his employment agreement, 1,000,000 held by Chris Pearce and 1,900,000 held by the Pearce Family Trust

(7)

These shares are held by Harriet Herberman

Unless otherwise indicated below, to our knowledge, all persons named in the table have sole voting and investment power with respect to their shares of our common stock, except to the extent authority is shared by spouses under community property laws. Unless otherwise indicated below, the address for beneficial ownership shall be the Company’s address at 6701 Democracy Blvd., Suite 300, Bethesda, Maryland 20817.

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ITEM 5. DIRECTORS AND EXECUTIVE OFFICERS.

Our directors and executive officers and additional information concerning them are as follows:

Name	Age	Term	Position
Noreen Griffin	60	2 Years	Chief Executive Officer and Director
Dr. Nicholas Plotnikoff	82	1 Year	Non-Executive Chairman of the Board
Christopher Pearce	69	2 Years	Chief Operating Officer and Director (*)
Dr. Eugene Youkilis	74	2 Years	President and Director
Peter Aronstam	61		Chief Financial Officer
Dr. Fengping Shan	54		Chief Science Officer and Director
Dr. Gloria B. Herndon	62	1 Year	Director and Advisory Board
Dr. Ronald Herberman	72		Chief Medical Officer and Director of Research and Development

_____________

(*) Mr. Pearce began his term as Chief Financial Officer of TNIB. Upon the appointment of Mr. Aronstam as Chief Financial Officer on January 1, 2013, Mr. Pearce was appointed Chief Operating Officer.

Directors and Officers

Dr. Nicholas Plotnikoff, Non-Executive Chairman of the Board

Professor Plotnikoff has a Ph.D. in Pharmacology and has over 20 years experience in the pharmaceutical industry working in Pharmacology, Toxicology and Clinical Research. Dr. Plotnikoff was a Professor of Pharmacology at the University of Illinois Medical Center in Chicago. Dr. Plotnikoff helped develop the immunological effects of MENK. He successfully managed the project teams that developed the new drug applications (“NDA”) on Traxene (Valium-like tranquilizer) and Cylert (non-amphetamine psychostimulant).

In his basic research, Dr. Plotnikoff was the first to identify the central nervous system effects of hypothalamic releasing factors (brain hormones), resulting in clinical developments for the treatment of depression and Parkinson’s disease. Dr Plotnikoff co-authored 25 publications with Dr. Andrew Schally, covering basic research in the field of depression and Parkinson’s disease. Dr. Plotnikoff was issued a number of international patents for the use of MENK in HIV/AIDS and cancer. TNI BioTech acquired the patents in 2012.

Noreen Griffin, Founder, Chief Executive Officer and Director

Noreen Griffin is one of the Founders and is the Chief Executive Officer of TNI BioTech, Inc. Ms. Griffin was a vital part of the acquisition of the patents and therapies involving MENK and LDN. She was involved with the inventors and patent holders for over 5 years before deciding to join the team that formed TNI BioTech, Inc.

Ms. Griffin has over 25 years of industry experience having founded and led a number of startup companies. She has played an integral role in raising multiple rounds of private and venture capital funds on behalf of clients. Ms. Griffin has owned and operated a small consulting firm located in Washington, D.C. and Florida. Ms. Griffin has served as chief financial officer and vice president of a number of small public companies over the last 10 years.

Dr. Eugene Youkilis, Director and President

Dr. Eugene Youkilis has a Ph.D. in Toxicology and is a Diplomate of the American Board of Toxicology. He was President and Founder of Clinical Bio-Tox Laboratories, Director of Toxicology and Immunobiology at Baxter International, Laboratory Section Chief and Director at Stroger Hospital (formerly Cook County Hospital) and is currently a Principal Associate with Toxicology Resource Associates. Dr. Youkilis has provided consulting services to industry organizations, research facilities and the legal profession in the areas of forensic, clinical and industrial/occupational toxicology. Dr. Youkilis has over 25 years of experience in the pharmaceutical and healthcare industry working in Toxicology, Pharmacology and Clinical Research. Dr. Youkilis was a Senior Research Investigator with G. D. Searle & Company. Dr. Youkilis is the author or co-author of over 25 presentations and publications, and from 1983 to present, has worked with Dr. Nicholas Plotnikoff on the patented technology for the treatment of HIV/AIDS and cancer patients acquired by TNIB.

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Dr. Fengping Shan, Director and Chief Science Officer

Fengping Shan has a Ph.D. in Microbiology/Immunology. Dr. Shan is Professor of Immunology and Vice Director of the Institute of Immunology, China Medical University in Shenyang, China. Dr. Shan was the Senior Scientist for Penta Biotech and Chief Scientist for the Institute of Microbiological Science and Studies at the Nation Cancer Research in Paris, France. Dr. Shan has authored 50 Publications, has been issued 11 patents and is a unique inventor of a thrombolytic enzyme from the earthworm. From 2000 to present, Dr. Shan has worked on the clinical trials with Dr. Nicholas Plotnikoff involving new immunotherapies for the treatment of cancer. Based on these trials, a number of patents were filed in China in 2009 and 2010, and approved in 2011.

Christopher Pearce, Director and Chief Operating Officer

Mr. Pearce was born in the United Kingdom and educated at Lord Wandsworth College and London University where he received his LLB (Bachelor of Law). He agreed to accept a position with TNIB in late 2011 because of his relationship with Dr. Nicholas Plotnikoff.

Mr. Pearce has over 30 years experience as director and chief operating officer of a New York Stock Exchange listed company with more than 5,000 employees worldwide $500,000,000 revenue per annum. His responsibilities included running large operations that require sourcing products and services, contract negotiation, marketing and advertising, scheduling, warehousing and inventory management and employee oversight.

Peter Aronstam, Chief Financial Officer

Peter Aronstam is Chief Financial Officer of TNI BioTech, Inc. Mr. Aronstam brings more than 30 years of experience in accounting, finance, banking, international trade and law to his clients. His career is marked by a progression of senior finance roles with growth and performance-driven enterprises, from start-up technology and internet companies to chief financial officer roles with small service providers ($50 Million USD) to very large international manufacturers ($25 Billion USD) to global banks.

Mr. Aronstam has advised publicly-held and privately-owned businesses since 1978, providing both full-time and part-time CFO services. His background includes start-up VC-backed entrepreneurial companies, manufacturing technology and service companies, serving as a public-company CFO, corporate and international banking in major multinational banks, managing HR and IT functions, and raising more than $500,000,000 in debt and equity for his companies and their customers.

From 2001 to 2006, Mr. Aronstam was the Chief Financial Officer of Airspan Networks, Inc., a public reporting company in Boca Raton, Florida. He also was the CFO of private company Mainstream Holdings, LLC in West Palm Beach, Florida from 2007 to 2008 and private company The Neptune Society in Plantation, Florida from 2008 to 2009. Since 2010, Mr. Aronstam has been a partner of B2B CFO Partners, LLC, doing business as B2B CFO. The firm provides CFO services to its clients on a part time basis.

Born and educated in South Africa, Mr. Aronstam earned his Bachelor of Commerce, Bachelor of Law and PhD from the University of the Witwatersrand in South Africa. Mr. Aronstam has worked in South Africa, Canada, and Florida. He currently lives in Boca Raton, FL.

Dr. Ronald B. Herberman, Chief Medical Officer and Director of Research and Development

Dr. Ronald Herberman was the founding director of University of Pittsburgh Cancer Institute (“UPCI”) and the UPMC Cancer Center, and Associate Vice Chancellor for cancer research within the School of Medicine, Department of Health Sciences. In serving as Vice Chancellor for cancer research, he has the responsibility for enhancing and facilitating the basic and clinical research activities of the 6 schools of the health sciences and of the University of Pittsburgh Medical Center (“UPMC”). Other appointments include Chief of the Division of Hematology/Oncology and the Hillman Professor of Oncology. He is also a professor of Medicine and Pathology. Dr. Herberman remains personally involved in several cancer research programs.

In 1968, prior to joining the University of Pittsburgh, Dr. Herberman was a senior investigator in the immunology branch of the National Cancer Institute, where he organized a research program related to tumor and cellular immunology. In 1971, he became head of a newly established cellular and tumor immunology section in the Laboratory of Cell Biology of the National Cancer Institute. During this period, he had responsibility for a research program of several investigators related to studies in animal model systems and in patients with cancer, studying the cell-mediated immune responses to tumors. As a result of this research, a new category of lymphocytes was discovered in Dr. Herberman’s laboratory and termed natural killer (“NK”) cells. Since then, much of Dr. Herberman’s research has been focused on the characterization of these natural effector cells and on their role in resistance to cancer growth.

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In 1975, the National Cancer Institute organized an intramural and extramural research program focused on immunodiagnostics of cancer. Dr. Herberman was selected as the chief of the new Laboratory of Immunodiagnostic and also assumed responsibility for the national contract program on immunodiagnostics of cancer.

In 1988, he was appointed chairman of the Biological Response Modifiers Committee of the National Institute of Allergy and Infectious Diseases (“NIAID”) AIDS Clinical Trials Group and also served as a member of the NIAID AIDS Clinical Drug Development Committee. Dr. Herberman left the National Cancer Institute in 1985 to establish the UPCI facility, now a National Cancer Institute-designated comprehensive cancer center specializing in innovative approaches to cancer treatment.

Dr. Herberman has served on the Board of Directors of the American Association for Cancer Research. He has been given the Award for Excellence in the Sciences by the governor of Pennsylvania and the Lifetime Science Award by the Institute for Advanced Studies in Immunology and Aging. He has also served as interim chairman of the National Surgical Adjuvant Breast and Bowel Project (“NSABP”) from 1994 to 1995. He currently serves as President of the American Association of Cancer Institutes and is the former president of the Society for Biological Therapy and the Society for Natural Immunity. He is also the first recipient of an endowed chair in oncology from the Hillman Foundation.

Dr. Herberman serves on the editorial boards of numerous scientific journals. He has been featured in several publications for his work in the field of immunology, particularly as it relates to cancer research and currently serves as editor-in-chief for the international journal Natural Immunity as he continues his efforts to gain a better understanding of cancer and improve modern methods of treatment. He is also the principal investigator of a cancer center support grant of over $250,000 from the National Institutes of Health.

The Advisory Board

Professor Angus Dalgleish MD, FRACP, FRCP, FRCPath, FMedSci

Professor Angus Dalgleish studied medicine at University College London where he obtained an MBBS and a BSc in Anatomy. He is a Fellow of The Royal College of Physicians of the UK and Australia, Royal College of Pathologists and The Academy of Medical Scientists. He also trained in Internal Medicine and Oncology in Brisbane and Sydney. Following an interest in how viruses caused cancer, he undertook a PhD with Professor Robin Weiss, a FRS at the Institute of Cancer Research and Royal Marsden Hospital before becoming a senior clinical scientist at the MRC Clinical Research Center in Northwick Park. He was appointed to Foundation Chair of Oncology at St. George’s University of London in 1991. His main interests there have been the immunology of cancer and the development of immunotherapies to treat, in particular, melanoma. In 1997, he founded Onyvax Ltd., a privately funded biotechnology company developing cancer vaccines and currently holds a position as Research Director.

Professor Dalgleish currently sits on 8 editorial boards, he has published over 300 peer-reviewed papers and authored or co-authored over 70 chapters in medical books. He is the co-editor of 5 medical books. He has been on numerous grant committees and is currently on the European Commission Cancer Board.

Professor Dalgleish’s career to date includes several key oncological discoveries that stemmed from an original interest in the pathogenesis of cancer. Some of these discoveries include: confirmation of the link between Hepatitis B (“HBV”) and liver cancer in native Australians, showing through the use of newly available sensitive assays that most instances were not due to alcohol as claimed before; co-discovered the CD4 receptor for HIV; published the first paper linking Slim Disease in East Africa with HIV; developed the theory of pathogenesis that HIV only causes AIDS by immune activation and not by cytopathic killing; and investigated anti-idiotype and allogeneic based vaccines for HIV and then applied the theory to cancer; pioneered melanoma vaccines in the U.K. (Megavax and CancerVax) and adapted this approach to prostate cancer. In Phase II active agent is 42% with near doubling of time to progression to disease, compared with matched cancers and the therapies (Journal Clinical Oncology 2005) and showed that even small volume colon cancer cause cell mediated immunosuppression, which is reverted following surgery and developed cancer arises due to chronic inflammation theory, thereby causing immunosuppression and angiogenesis and the ideal environment for stochastic changes to survival. Professor Angus Dalgleish currently has an active interest and group optimizing dendritic cell treatment for cancer, both basic research and clinical groups and the identification of novel anti-inflammatory agent in vaccinated goat serum therapy is patent pending.

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Dr. Gloria B. Herndon

Dr. Herndon earned her Bachelor Degrees in Economics and Political Science, as well as a Masters and a PhD in International Law and Economics from Johns Hopkins University. Subsequently, she worked for the U.S. Department of Agriculture as an economist, then joined the State Department and was posted to U.S. Embassy Commerce positions in Africa and Europe.

Upon leaving the State Department, Dr. Herndon founded GB Herndon and Associates, which is domiciled in the District of Columbia. The company initially focused structuring medical and benefits insurance for its corporate clients, but evolved into a multi-line insurance broker and is more than a decade old. Its diverse clientele includes the National Medical Association, embassies of foreign governments, the National Association of Postal and Federal Employees (“NAPFE”) and the University of the District of Columbia.

In recent years, Dr. Herndon has further diversified the company by forging strategic partnerships with leading providers of insurance and student financial services for the higher education market. GB Herndon and Associates maintains corporate affiliations with National Association for Equal Opportunity in Higher Education (“NAFEO”), the American Association of Community Colleges (“AACC”), and the Association of Community College Trustees (“ACCT”).

Dr. Herndon is active in the business and local communities through her involvement with various organizations, some of which include the Board of Trade, the DC Chamber of Commerce, the National Conference of Negro Women (“NCNW”), Africare, and Women’s Business Network. Corporations including Office Depot, Six Continent Hotels, and American Express have appointed her to Advisory Board positions. Dr. Herndon co-chairs the Board of Directors of the Women’s Business Center and chairs the Corporate Advisory Boards of the National Head Start Association (“NHSA”) and the National Association for Equal Opportunity in Higher Education (“NAFEO”). On occasion, she is a consulting resource for the National Institutes of Health (“NIH”) regarding the impact of the HIV/AIDS pandemic on the insurance industry and provides other AIDS-related information when requested by the United States Department of State.

Dr. Herndon is a published author, member of numerous public and private entity boards and the recipient of a number of awards. She also established the Small Business Administration’s (“SBA”) program for advising small and minority-owned businesses on the design and implementation of business and benefits insurance programs.

Dr. Ndiouga Dieng, PD

Dr. Ndiouga Dieng has been Senior Pharmacy Manager of John Hopkins Hospital since 2007. He manages the evening and overnight hospital operations and staff, supervises the preparation of admixtures including investigational medications. He has provided rapport to international patients, directed overseas pathologist projects between John Hopkins and Senegal, directed an overseas vaccination project between John Hopkins, the Serum Institute of India and Senegal. Dr. Dieng is a graduate of Howard University.

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ITEM 6. EXECUTIVE COMPENSATION.

The Company’s directors are not compensated. The Officers receive an annual salary as described in the table below for the services rendered on behalf of the Company.

	Annual Compensation
								Option		All Other
Name and Principal Position	Year	Salary (**)			Bonus (***)			Awards		Compensation			Total ($)

Noreen Griffin	2012	$	300,000	(1)	$	—	(2)	$	—	$	18,000	(3)	$	293,000
Chief Executive Officer	2011	$	—		$	—		$	—	$	—		$	—

Eugene Youkilis	2012	$	60,000		$	—	(4)	$	—	$	—		$	60,000
President	2011	$	—		$	—		$	—	$	—		$	—

Dr. Fengping Shan	2012	$	60,000		$	—	(5)	$	—	$	—
Chief Science Officer	2011	$	—		$	—		$	—	$	—		$	60,000

Christopher Pearce	2012	$	250,000	(6)	$	—	(7)	$	—	$	18,000	(8)	$	218,000
Chief Operating Officer (*)	2011	$	—		$	—		$	—	$	—		$	—

Dr. Ronald B. Herberman	2012	$	250,000		$	—	(9)	$	—	$	—		$	250,000
Chief Medical Officer and Director of Medical Research and Development	2011	$	—		$	—		$		$	—		$	—

Peter Aronstam (*)	2012	$	—		$	—		$	—	$	—		$	—
Chief Financial Officer	2011	$	—		$	—		$	—	$	—		$	—

Dr. Nicholas Plotnikoff	2012	$	—		$	—		$	—	$	—		$	—
Non-Executive Chairman of the Board	2011	$	—		$	—		$		$	—		$	—

______________

(1)	The Company issued Ms. Griffin common stock purchase warrants in TNIB to purchase up to 1,000,000 shares of common stock at a purchase price of $1.00 per share for 5 years as part of her salary.

(2)	The Company issued Ms. Griffin 3,000,000 shares of common stock as a signing bonus.

(3)	The Company pays Ms. Griffin $1,500 per month as unaccountable expenses during each month of the term.

(4)	The Company issued Dr. Youkilis 500,000 shares of common stock as a signing bonus.

(5)	The Company issued Dr. Shan 500,000 shares of common stock as a signing bonus.

(6)	The Company issued Mr. Pearce common stock purchase warrants to purchase up to 1,000,000 shares of common stock at a purchase price of $1.00 per share for 5 years as part of his salary.

(7)	The Company issued 2,000,000 shares of common stock to Mr. Pearce as a signing bonus.

(8)	The Company pays Mr. Pearce $1,500 per month as unaccountable expenses during each month of the term.

(9)	The Company issued Dr. Herberman 1,000,000 shares of common stock as a signing bonus.

(*) Mr. Pearce was the Chief Financial Officer of the Company during the 2012 term. He was appointed Chief Operating Officer on January 1, 2013 when Mr. Aronstam was appointed Chief Financial Officer.

(**) Salary is established by the market rate for the specific officer’s experience level and position and may be increased upon the Company’s receipt of sufficient capital. Compensation is only for an individual’s role as an officer of the Company, Directors receive no compensation for their role as a director.

(***) The Company, in its sole discretion, will determine whether to pay to an employee a bonus based on the Officers’ performance in comparison to the Company and the performance criteria set by the Board of Directors.

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ITEM 7. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE.

Director Independence

We are not currently listed on any national securities exchange that has a requirement that the board of directors be independent. At this time we do not have an “independent director” as that term is defined under the rules of the NASDAQ Capital Market.

Related Transactions

See the Notes to the Financial Statements.

ITEM 8. LEGAL PROCEEDINGS.

None.

ITEM 9. MARKET PRICE OF AND DIVIDENDS ON THE REGISTRANT’S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS.

a. Market information.

TNI BioTech is currently traded on the Over the Counter Pink Market (“OTC Pink Market”). The Company’s ticker symbol is “TNIB.” To have our securities quoted on OTC QB or OTCBB we must: (1) be a company that reports its current financial information to the Securities and Exchange Commission (“SEC”), banking regulators or insurance regulators; and (2) have at least one market maker who completes and files a Form 211 with FINRA. Over the Counter Markets differ substantially from national and regional stock exchanges because it: (a) operates through communication of bids, offers and confirmations between broker-dealers, rather than one centralized market or exchange; and (b) securities admitted to quotation are offered by one or more broker-dealers rather than “specialists” which operate in stock exchanges.

The following table sets forth the high and low transaction price for each quarter within the two most recent fiscal years as provided by OTC Markets Group, Inc. The information reflects prices between dealers, and does not include retail markup, markdown, or commission, and may not represent actual transactions.

	Over The Counter Pink Sheets Market(1)
Quarter Ended	High		Low
March 31, 2013	$	10.20	$	4.00
December 31, 2012	$	9.70	$	1.40
September 30, 2012	$	2.75	$	0.72
June 30, 2012	$	5.50	$	2.60
March 31, 2012	$	N/A	$	N/A
December 31, 2011	$	N/A	$	N/A
September 30, 2011	$	N/A	$	N/A
June 30, 2011	$	N/A	$	N/A
March 31, 2011	$	N/A	$	N/A

________________

(1)

Over The Counter Market quotations reflect inter-dealer prices without retail mark-up, mark-down or commission, and may not represent actual transactions. The transfer agent and registrar for our common stock is American Stock Transfer and Trust Company, LLC. As of the date of this report, we had approximately 401 shareholders of record, not including those common shares held in street name.

b. Holders.  

As of April 19, 2013, there are 401 holders of the Company’s common stock and there is no authorized preferred stock.

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c. Dividends.  

The Company issued a one-time dividend of 1,182,474 shares of TNIB to the existing shareholders of pH Environmental, Inc. (now known as TNI BioTech, Inc.) with a record date of April 23, 2012. The dividend was distributed in two installments due to a calculation error made by a previous transfer agent.

TNIB has no plans of paying cash dividends in the future.

ITEM 10. RECENT SALES OF UNREGISTERED SECURITIES.

The Company did not issued any shares of its stock during 2011 and 2010.

The Company has an outstanding note payable to K-C Operations (an unrelated party) issued on October 15, 2009. The balance as of December 31, 2012 and 2011 was $398,000 and $498,000, respectively. The note matured on October 31, 2010 and accrues interest at a rate of 6% per annum and is convertible to shares of common stock at a rate of $0.20 per share. The following conversions of principal and interest resulting in share issuances occurred in 2012: On March 25, 2012: $4,028 was converted to 20,140 shares; April 24, 2012: $100,000 was converted to 500,000 shares; May 25, 2012: $25,000 was converted to 125,000 shares; November 28, 2012: $2,500 was converted to 12,500 shares; November 29, 2012: $66,500 was converted to 332,500 shares. These issuances were subject to the requirements of Rule 144 of the Securities Act of 1933.

The Company has an outstanding note payable to Robert Johnson (former officer and director) issued on September 30, 2006 with a balance as of December 31, 2012 and 2011 of $21,546.60 and $161,547, respectively. The note matured on September 30, 2007 and is convertible to shares of common stock at a rate of $0.20 per share. On April 24, 2012, $140,000 of the note was converted to 700,000 shares of common stock. This issuance was subject to the requirements of Rule 144 of the Securities Act of 1933.

The Company has an outstanding note payable to Lexicon (an unrelated party) issued on January 15, 2009. The note is due upon demand. The balance as of December 31, 2012 and 2011 was $12,817 and $23,316, respectively. The note bears an interest rate of 6% per annum and is convertible to shares of common stock at a rate of $0.01 per share. On April 24, 2012, $10,850 of this note was converted into 1,085,000 shares of common stock. This issuance was subject to the requirements of Rule 144 of the Securities Act of 1933.

The Company issued a convertible promissory note on May 21, 2012 for $5,000. The note accrued interest at a rate of 9.875% per semi-annum. On December 5, 2012, the holder converted the $5,542.92 balance of the note into 1,310 shares of restricted common stock. This issuance was subject to the requirements of Rule 144 of the Securities Act of 1933.

Shares Issued for Subsidiary and Patent Acquisition:

The Company acquired TNI BioTech IP, Inc., its wholly-owned subsidiary in exchange for 20,250,000 shares of the Company’s common stock of which 8,000,000 shares were issued for the acquisition of the patent and the remaining 12,250,000 shares were issued to the founders of TNI IP in exchange for all of their right, title and interest in their TNI IP shares.

As part of the License Agreement for the intellectual property developed by Dr. Bernard Bihari, the Company is required to issue 540,000 shares of the Company’s common stock. The Company issued 300,000 shares under the Patent License Agreement for the acquisition of patent rights for the intellectual property of Dr. Jill Smith and LDN Research Group, LLC. The Company issued 600,000 shares of its restricted Common Stock to Penn State University under the exclusive license agreement with the Penn State Research Foundation executed on January 18, 2013. (For additional information on the license and patent acquisitions, see Note 10 of the Notes to the Financial Statements).

Shares Issued under Private Placement:

The Company conducted a private placement of units consisting of common stock and common stock purchase warrants. During 2012, the Company received $1,134,000 from the sale of units consisting of a total of 7,260,000 shares of common stock and common stock purchase warrants for the purchase of up to 7,260,000 shares of common stock at exercise prices ranging from $1.00 to $1.50. The Offering was exempt from registration under the Securities Act Rule 506. These shares are not registered and are restricted in accordance with Rule 144 until they are either registered or an exemption from registration is available. The stock certificates bear a restrictive legend.

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Shares Issued For Services, Consulting and Prepaid Consulting:

All Shares issued for Services are restricted; certificates representing restricted shares will contain a legend stating that the shares have not been registered under the Securities Act and the restrictions on transferability under the Securities Act. During the year ended December 31, 2012, the Company issued 6,966,800 shares of common stock for services, which included founder shares, and 6,790,000 shares of common stock for consulting fees. The Company valued these shares based upon the fair market value of the common stock at the date of the agreements.

Dividend

The Company issued a 6% dividend calculated based on the number of shares that were to be outstanding after the issuance for the acquisition of TNI (now known as TNI BioTech IP, Inc.) and awarded to shareholders of record before the close of the acquisition. The Company’s former transfer agent mistakenly issued a dividend based on the number of shares outstanding before the close of the share exchange. The Company has instructed its new transfer agent, Issuer Direct, to deliver the correct number of shares authorized under the dividend to the shareholders according to their ownership percentage of common shares as of the record date. The estimated number of shares issued under the dividend was 1,182,474.

Warrant Exercises

On October 8, 2012 a warrant holder exercised its rights to purchase 25,000 shares for $2,500. Certificates representing restricted shares will contain a legend stating that the shares have not been registered under the Securities Act and the restrictions on transferability under the Securities Act.

The Company made an offer to the holders of Common Stock Purchase Warrants issued in the Company’s 2012 Private Placement offering a reduced exercise price of $0.75 per share if they exercised by the deadline, which was subsequently extended to March 22, 2013.

During the first quarter of 2013, warrant holders purchased a total of 1,180,434 shares at the reduced exercise price of $0.75 per share for a total for $885,326. Under the terms of the exercise, warrant holders exercising at the Reduced Warrant Price newly-issued five-year Common Stock Purchase Warrants with an exercise price of $15 per share (the “Series C Warrants”). The number of shares purchasable under the Series C Warrants will equal 25% the total number of shares exercised at the Reduced Warrant Price.

ITEM 11. DESCRIPTION OF REGISTRANT’S SECURITIES TO BE REGISTERED.

Common Stock

The Company is authorized to issue 500,000,000 shares of Common Stock at a par value of $0.001 per share. The Common Stock of the corporation that is issued and outstanding shall be entitled to vote 100% of the stockholder voting rights. Each holder of Common Stock shall be entitled to one vote per share.

As of March 18, 2012, the Company reversed the Common Stock leaving approximately 113,644 shares issued and outstanding.

On April 24, 2012, the Company acquired TNI BioTech, Inc. for 20,250,000 shares as part of a share exchange agreement.

The Company issued a one-time dividend of 1,182,474 shares to the existing shareholders of ph Environmental, Inc. (now TNI BioTech, Inc.), with a record date of April 23, 2012. The dividend shares were issued in two installments.

As of April 19, 2013 there are 53,676,535 shares of common stock issued and outstanding an no shares of Preferred Stock authorized, issued or outstanding.

ITEM 12. INDEMNIFICATION OF DIRECTORS AND OFFICERS.

The Company’s Articles of Incorporation and Bylaws provide for the indemnification of a present or former director or officer to the fullest extent permitted by Florida law, against all expense, liability and loss reasonably incurred or suffered by the officer or director in connection with any action against such officer or director. The Company also maintains director and officer liability insurance.

ITEM 13. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.

Please see our financial statements attached at the end of this registration statement.

Notes to the Financial Statements for December 31, 2012 and 2011

ITEM 14. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

The Company has not had a change in its independent registered public accounting firm during its last two fiscal years or through the date of this filing. The Company notes that it has not had any disagreements with its current public accounting firm during the last two fiscal years or through the date of this filing on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedure, which disagreement, if not resolved to the satisfaction of the public accounting firm, would have caused it to make reference to the subject matter of the disagreement in connection with its report on the Company’s financial statements.

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ITEM 15. FINANCIAL STATEMENTS AND EXHIBITS.

List of Financial Statements

Exhibits Schedule

The following exhibits are filed with this Form 10:

Exhibit		Description
3.1		Restated Articles of Incorporation
3.2		Bylaws
23.1		Opinion of Turner Stone

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SIGNATURES

Pursuant to the requirements of Section 12 of the Securities Exchange Act of 1934, the registrant has duly caused this registration statement to be signed on its behalf by the undersigned, hereunto duly authorized.

	TNI BioTech, Inc.

	By:	/s/ Noreen Griffin
		Noreen Griffin
		Chief Executive Officer

Report of Independent Registered Public Accounting Firm

Board of Directors and Stockholders

TNI BioTech, Inc.

Bethesda, Maryland

We have audited the accompanying balance sheets of TNI BioTech, Inc. (the “Company”) as of December 31, 2012 and 2011 and the related statements of operations, changes in stockholders’ equity (deficit) and cash flows for the years then ended. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audit.

We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audit provides a reasonable basis for our opinion.

In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of TNI BioTech, Inc. as of December 31, 2012 and 2011, and the results of its operations and its cash flows for the years then ended in conformity with accounting principles generally accepted in the United States of America.

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company has suffered recurring losses from operations since inception and has a working capital deficiency both of which raise substantial doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

/s/ Turner, Stone & Company, L.L.P.

Dallas, Texas

April 9, 2013

F-1

TNI BIOTECH, INC.

BALANCE SHEETS

DECEMBER 31, 2012 AND 2011

	2012			2011
ASSETS
Current Assets:
Cash and cash equivalents	$	313,095		$	12

Total current assets		313,095			12

Fixed Assets:
Computer equipment, net of accumulated depreciation
of $118 and $0 respectively		944			-

Intangible Assets:
Patents and licenses, net of amortization
of $1,570,114 and $0, respectively (Note 2 and 10)		18,688,270			-

Deposits		24,928			-
Net assets of discontinued operations		-			911,614

Total assets	$	19,027,237		$	911,626

LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)

Current Liabilities:
Accounts payable	$	286,698		$	-
Payable to officer		76,000			-
Accrued liabilities		427,211			69,185
Current portion patent liability		200,000			-
Notes payable		432,363			682,863
Net liabilities of discontinued operations		-			1,106,987

Total current liabilities		1,422,272			1,859,035

Non-current Liabilities:
Notes payable related party		121,128			-
Long-term portion patent liability		140,000			-
Total non-current liabilities		261,128			-

Total Liabilities		1,683,400			1,859,035

Stockholders' Equity (Deficit):
Common stock - par value $0.001; 500,000,000 shares authorized;
45,489,368 and 113,644 shares issued and outstanding respectively		45,489			114
Additional paid in capital		196,632,775			1,005,603
Stock issuances due		3,690,960			-
Prepaid services		(6,082,771	)		-
Accumulated deficit		(176,942,616	)		(1,953,126	)

Total stockholders' equity (deficit)		17,343,837			(947,409	)
Total liabilities and stockholders' equity (deficit)	$	19,027,237		$	911,626

The accompanying footnotes are an integral part of these financial statements.

F-2

TNI BIOTECH, INC.

STATEMENTS OF OPERATIONS

FOR THE YEARS ENDED DECEMBER 31, 2012 AND 2011

	2012			2011

Revenues, net	$	-		$	-

Operating expenses:
Selling, general and administrative		1,361,228			-
Research and development expense		181,190			-
Depreciation and amortization expense		1,570,232			-
Impairment of goodwill		98,000,000			-
Stock issued for services		9,160,980			-
Amortization of stock issued for prepaid services		17,004,479
Stock warrant expense		25,810,469			-
Total operating expenses		153,088,578			-

Loss from operations		(153,088,578	)		-

Other income (expense):
Interest expense		(27,003	)		(31,279	)
Loss on settlement of debt		(22,105,265	)		-
Total other income (expense)		(22,132,268	)		(31,279	)

Loss from continuing operations		(175,220,846	)		(31,279	)

Gain (loss) from discontinued operations		231,356			(94,376	)

Net loss	$	(174,989,490	)	$	(125,655	)

Basic and diluted loss per share:
Loss from continuing operations	$	(6.85	)	$	(0.28	)
Gain (loss) from discontinued operations		0.01			(0.83	)
	$	(6.84	)	$	(1.11	)

Weighted average number of shares outstanding		25,583,111			113,644

The accompanying footnotes are an integral part of these financial statements.

F-3

TNI BIOTECH, INC.

STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT)

FOR THE YEARS ENDED DECEMBER 31, 2012 AND 2011

	Common Stock						Additional Paid			Stock to		Prepaid			Accumulated
	Shares			Amount			in Capital			Be Issued		Services			Deficit			Total

Balance, December 31, 2010 as originally reported		113,644,000		$	113,644		$	892,073		$	-	$	-		$	(1,827,471	)	$	(821,754	)

Effect of reverse stock split		(113,530,356	)		(113,530	)		113,530			-		-			-			-

Adjusted balance, December 31, 2010		113,644			114			1,005,603			-		-			(1,827,471	)		(821,754	)

Net loss		-			-			-			-		-			(125,655	)		(125,655	)

Balance, December 31, 2011		113,644			114			1,005,603			-		-			(1,953,126	)		(947,409	)

Issuance of common stock for services		6,966,800			6,967			9,150,053			-		-			-			9,157,020

Issuance of common stock - dividend		1,182,474			1,182			(1,182	)		-		-			-			-

Issuance of common stock in exchange for debt		2,901,450			2,901			22,472,407			-		-			-			22,475,308

Issuance of common stock for Acquisition of TNI Biotech IP		12,250,000			12,250			97,987,750			-		-			-			98,000,000

Issuance of common stock issued for Dr. Plotnikoff Patents		8,000,000			8,000			15,998,000			-		-			-			16,006,000

Issuance of common stock issued for prepaid services		6,790,000			6,790			23,080,460			-		(23,087,250	)		-			-

Amortization of prepaid services		-			-			-					17,004,479			-			17,004,479

Issuance of common stock for cash		7,285,000			7,285			1,129,215			-		-			-			1,136,500

Issuance of common stock issued for warrants		-			-			25,810,469			-		-			-			25,810,469

Shares to be issued for patents and licenses		-			-			-			3,687,000		-			-			3,687,000

Shares to be issued for services		-			-			-			3,960		-			-			3,960

Net loss		-			-			-			-		-			(174,989,490	)		(174,989,490	)

Balance, December 31, 2012		45,489,368		$	45,489		$	196,632,775		$	3,690,960	$	(6,082,771	)	$	(176,942,616	)	$	17,343,837

The accompanying footnotes are an integral part of these financial statements.

F-4

TNI BIOTECH, INC.

STATEMENTS OF CASH FLOWS

FOR THE YEARS ENDED DECEMBER 31, 2012 AND 2011

	2012			2011

CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$	(174,989,490	)	$	(125,655	)
(Gain) loss from discontinued operations		(231,356	)		94,376
Loss from continuing operations		(175,220,846	)		(31,279	)

Adjustments to reconcile loss from continuing operations to
net cash flows provided by (used in) operating activities:
Depreciation		118			-
Amortization		1,570,114			-
Impairment of goodwill		98,000,000			-
Stock issued for services		9,160,980			-
Amortization of stock issued for prepaid services		17,004,479			-
Loss on settlement of debt		22,105,265			-
Stock warrant expense		25,810,469			-
Changes in operating assets and liabilities:
Deposits		(24,928	)		-
Accrued liabilities		452,569			31,241
Payable to officer		76,000			-
Accounts payable		121,314			-
Net cash provided by (used in) operating activities
from continuing operations		(944,466	)		(38	)

CASH FLOWS FROM INVESTING ACTIVITIES
Purchase of computer equipment		(1,062	)		-
Net cash used in investing activities
from continuing operations		(1,062	)		-

CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from sale of common stock		1,136,500			-
Proceeds from notes payable		146,128			-
Payments made on patent liability		(60,000	)		-

Net cash provided by financing activities
from continuing operations		1,222,628			-

CASH FLOWS FROM DISCONTINUED OPERATIONS
Net cash provided by operating activities		35,983			-

Increase (decrease) in cash		313,083			(38	)
Cash, beginning of year		12			50
Cash, end of year	$	313,095		$	12

The accompanying footnotes are an integral part of these financial statements.

F-5

TNI BIOTECH, INC.

STATEMENTS OF CASH FLOWS

FOR THE YEARS ENDED DECEMBER 31, 2012 AND 2011

	2012		2011

SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:

Cash paid for interest	$	-	$	-

SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES:

Stock to be issued for patents and licenses	$	3,687,000	$	-

Debt assumed for Bihari patent	$	400,000	$	-

Accrued liabilities for purchase of Smith LDN patent	$	165,384	$	-

Conversion of debt and accrued interest to common stock	$	370,043	$	-

Common shares issued for acquisition of TNI Biotech IP	$	98,000,000	$	-

Common shares issued for Plotnikoff patent	$	16,006,000	$	-

Common shares issued for prepaid services	$	23,087,250	$	-

Stock dividend	$	1,182	$	-

The accompanying footnotes are an integral part of these financial statements.

F-6

TNI BioTech, Inc.

Notes to the Financial Statements

December 31, 2012 and 2011

1. Organization and Description of Business

TNI BioTech, Inc. (the “Company”) was initially incorporated in Florida on December 2, 1993 as Resorts Clubs International, Inc. (“Resorts Club”). It was formed to manage and market golf course properties in resort markets throughout the United States. Galliano International Ltd. (“Galliano”) was incorporated in Delaware on June 27, 1998. The Company began trading in November 1999 through the filing of a 15C-211. On November 3, 2004, Galliano merged with Resorts Club International, Inc. Resorts Club was the surviving corporation. On August 10, 2010, Resorts Club changed its name to pH Environmental, Inc. (“pH Environmental”). On April 23, 2012, pH Environmental completed a name change to TNI BioTech, Inc., and on April 24, 2012 pH Environmental executed a share exchange agreement for the acquisition of all of the outstanding shares of TNI BioTech, Inc., (“TNI”).

TNI BioTech is a biopharmaceutical company focused on developing and commercializing therapeutics to treat cancer, HIV/AIDS and autoimmune diseases by combating these chronic and often life-threatening diseases through the activation and rebalancing of the body’s immune system. The Company has been developing active and adoptive forms of immunotherapies through the acquisition of patents, INDs (investigational new drug) and clinical data and all proprietary technical information, know-how, procedures, protocols, methods, prototypes, designs, data and reports, which are not readily available to others through public means, and which are owned, generated or developed through experiments or testing by Dr. Plotnikoff, Professor Shan, Dr. Bernard Bihari, Dr. Ian Zagon, Dr. Jill Smith, Dr. Patricia J. McLaughlin and Moshe Rogosnitzky. The Company currently has offices in Bethesda, Maryland and Orlando, Florida.

Going Concern

The Company has incurred significant net losses since inception and has relied on its ability to fund its operations through private equity financings. Management expects operating losses and negative cash flows to continue at more significant levels in the future. As the Company continues to incur losses, transition to profitability is dependent upon the successful development, approval, and commercialization of its product candidate and achieving a level of revenues adequate to support the Company’s cost structure. The Company may never achieve profitability, and unless and until it does, the Company will continue to need to raise additional cash. Management intends to fund future operations through additional private or public debt or equity offerings, and may seek additional capital through arrangements with strategic partners or from other sources. Based on the Company’s operating plan, existing working capital at December 31, 2012 was not sufficient to meet the cash requirements to fund planned operations through December 31, 2013 without additional sources of cash. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying financial statements have been prepared assuming that the Company will continue as a going concern and do not include adjustments that might result from the outcome of this uncertainty. This basis of accounting contemplates the recovery of the Company’s assets and the satisfaction of liabilities in the normal course of business.

The Company has experienced a net loss from operations of $174,989,490 and has used cash and cash equivalents for operations in the amount of $944,466 during the year ended December 31, 2012, resulting in stockholder’s equity of $17,343,837.

2. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying financial statements have been prepared in accordance with United States (U.S.) generally accepted accounting principles (U.S. GAAP) and include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented.

The Company recommends that the footnote disclosures made herein with its financial statements be read in conjunction with its financial report. In the opinion of management, our financial statements and footnote disclosures fairly present our financial position and results of operations of the Company for the year ended December 31, 2012.

F-7

TNI BioTech, Inc.

Notes to the Financial Statements

December 31, 2012 and 2011

Use of Estimates

The preparation of the Company’s financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from such estimates.

Cash, Cash Equivalents, and Short-Term Investments

The Company considers all highly liquid investments with original maturities at the date of purchase of three months or less to be cash equivalents. Cash and cash equivalents include bank demand deposits, marketable securities with maturities of three months or less at purchase, and money market funds that invest primarily in certificates of deposits, commercial paper and U.S. government and U.S. government agency obligations. Cash equivalents are reported at fair value.

Marketable securities with original maturities greater than three months and less than one year are considered to be short-term investments. Short-term investments are reported at fair market value and unrealized gains and losses are included as a separate component of stockholders’ equity (deficit). Realized gains, realized losses, the amortization of premiums and discounts, interest earned and dividends earned are included in other income (expense). The cost of investments for purposes of computing realized and unrealized gains and losses is based on the specific identification method. Investments with maturities beyond one year are classified as long-term. A decline in the market value of a security below its cost value that is deemed to be other than temporary is charged to earnings, and results in the establishment of a new cost basis for the security.

Concentration of Credit Risk

Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash and cash equivalents. The Company is exposed to credit risk, subject to federal deposit insurance, in the event of a default by the financial institutions holding its cash and cash equivalents to the extent of amounts recorded on the balance sheets.

Segment and Geographic Information

Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment and does not segment the business for internal reporting or decision making.

Fair Value of Financial Instruments

In accordance with the reporting requirements of Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic 825, “ Financial Instruments” , the Company calculates the fair value of its assets and liabilities which qualify as financial instruments under this standard and includes this additional information in the notes to the financial statements when the fair value is different than the carrying value of those financial instruments. Cash, patents and license, accounts payable, payable to officer, patent liability and net liabilities of discontinued operations are accounted for at cost which approximates fair value due to the relatively short maturity of these instruments. The carrying value of notes payable and notes payable related party also approximate fair value since they bear market rates of interest and other terms. None of these instruments are held for trading purposes.

F-8

TNI BioTech, Inc.

Notes to the Financial Statements

December 31, 2012 and 2011

Property and Equipment

Property and equipment are stated at cost, less accumulated depreciation. Depreciation is determined on a straight-line basis over the estimated useful lives of the assets, which generally range from three to five years. Leasehold improvements are amortized over the shorter of the useful life of the asset or the term of the related lease. Maintenance and repairs are charged against expense as incurred. Depreciation expense from continuing operations for the years ended December 31, 2012 and December 31, 2011 was $118 and $0, respectively.

Intangible Assets

Costs incurred to acquire and/or develop the Company’s product licenses and patents are capitalized and amortized by straight-line methods over estimated useful lives of seven to sixteen years. Intangible assets are stated at the lower of cost or estimated fair market value. During the year ended December 31, 2012, the Company capitalized $20,258,384 of such costs incurred for the acquisition of the Company’s patents. (See Note 10.) Amortization expense for the years ended December 31, 2012 and December 31, 2011 was $1,570,114 and $0, respectively. The Company estimates its amortization expense related to these assets will approximate $2,600,000 each year.

Impairment of Long-Lived Assets

The Company evaluates long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable as prescribed by ASC Topic 360-10-05, “ Property, Plant and Equipment ” (formerly SFAS No. 144 “Accounting for the Impairment of Long-Lived Assets”). If the carrying amount of the asset, including any intangible assets associated with that asset, exceeds its estimated undiscounted net cash flow, before interest, the Company will recognize an impairment loss equal to the difference between its carrying amount and its estimated fair value. No impairment losses were recognized for the year ended December 31, 2012.

Research and Development Costs

Research and development costs are charged to expense as incurred and are typically comprise of salaries and benefits, pre-clinical studies, clinical trial activities, drug development and manufacturing, fees paid to consultants and other entities that conduct certain research and development activities on the Company’s behalf and third-party service fees, including clinical research organizations and investigative sites. Costs for certain development activities, such as clinical trials are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or information provided by vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as operating expenses.

Income Taxes

The Company follows FASB ASC Topic 740, “Income Taxes” , which requires recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Under this method, deferred tax assets and liabilities are based on the differences between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance to the extent management concludes it is more likely than not that the asset will not be realized. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.

The standard addresses the determination of whether tax benefits claimed or expected to be claimed on a tax return should be recorded in the financial statements. Under ASC Topic 740, the Company may recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the tax authorities, based on the technical merits of the position. The tax benefits recognized in the financial statements from such a position should be measured based on the largest benefit that has a greater than fifty percent likelihood of being realized upon ultimate settlement. ASC Topic 740 also provides guidance on de-recognition, classification, interest and penalties on income taxes, accounting in interim periods and requires increased disclosures. At the date of adoption, and as of December 31, 2012, the Company does not have a liability for unrecognized tax uncertainties.

F-9

TNI BioTech, Inc.

Notes to the Financial Statements

December 31, 2012 and 2011

The Company’s policy is to record interest and penalties on uncertain tax positions as income tax expense. As of December 31, 2012, the Company has no accrued interest or penalties related to uncertain tax positions.

Stock-Based Compensation and Issuance of Stock for Non-Cash Consideration

The Company measures and recognizes compensation expense for all share-based payment awards made to employees and directors, including employee stock options, based on estimated fair values equaling either the market value of the shares issued or the value of consideration received, whichever is more readily determinable. The majority of the non-cash consideration pertains to services rendered by consultants and others and has been valued at the estimated value of the services to be provided on the dates issued.

The Company’s accounting policy for equity instruments issued to consultants and vendors in exchange for goods and services follows the provisions of ASC Topic 505-50, “ Equity-Based Payments to Non-Employees .” The measurement date for the fair value of the equity instruments issued is determined at the earlier of (i) the date at which a commitment for performance by the consultant or vendor is reached or (ii) the date at which the consultant or vendor’s performance is complete.

Net Loss per Share

Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by dividing the net loss by the weighted-average number of common share equivalents outstanding for the period determined using the treasury-stock method and the if-converted method. Dilutive common stock equivalents are comprised of common stock purchase warrants and options outstanding. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position.

Potentially dilutive securities not included in the calculation of diluted net loss per share because to do so would be anti-dilutive are as follows (in common equivalent shares):

	Year Ended December 31,
	2012		2011
Common Stock Purchase Warrants		7,260,000		-

Total		7,260,000		-

Recent Accounting Standards

During the year ended December 31, 2012 and through April 9, 2013, there were several new accounting pronouncements issued by the Financial Accounting Standards Board. Each of these pronouncements, as applicable, has been or will be adopted by the Company. Management does not believe the adoption of any of these accounting pronouncements has had or will have a material impact on the Company’s financial statements.

Goodwill

F-10

TNI BioTech, Inc.

Notes to the Financial Statements

December 31, 2012 and 2011

In 2012, the Company elected to evaluate the goodwill via the two step methodology whereby the first step, used to identify potential impairment, compares the fair value of the reporting unit with its carrying value including goodwill. The fair value of each reporting unit is estimated using a discounted cash flow methodology. This analysis requires significant judgments, including estimation of future cash flows, which is dependent on internal forecasts, estimation of the long-term growth rate for our business, the useful life over which cash flows will occur and the determination of our weighted cost of capital. If the fair value of a reporting unit is less than the carrying amount, goodwill of the reporting unit is considered impaired and the second test is performed. The second step of the impairment test performed, when required, compares the implied fair value of the reporting unit goodwill with the carrying amount of that goodwill. If the carrying amount of the reporting unit goodwill exceeds the implied fair value of that goodwill, an impairment charge is recognized for the amount equal to that excess.

Based on the tests performed during the quarter ended December 31, 2012, the Company determined that there was a material impairment of goodwill and recorded an impairment of $98,000,000 (Note 10).

3. Property and Equipment

	December 31,
	2012				2011
Property and equipment:
Computer equipment		$	1,062			$
Furniture and fixtures

Total property and equipment
Less accumulated depreciation			(118	)			(-	)

Property and equipment, net		$	944			$	-

The Company utilizes the straight-line method for depreciation, using two to five-year depreciable asset lives. Depreciation expense was not material for all periods presented.

4. Accrued Expenses and Other Liabilities

Accrued expenses and other liabilities consist of the following:

	December 31,
	2012				2011
Worldpoints Travel Rewards Card		$	(242	)		$	-
Accrued Payroll to Officer			(355,603	)			-
Accrued Interest - Notes Payable			(3,288	)			(69,185	)
Payroll Liabilities			(62,478	)			-
State Payroll Taxes			(5,600	)			-

Other			-				-

Total accrued expenses and other liabilities		$	(427,211	)		$	(69,185	)

F-11

TNI BioTech, Inc.

Notes to the Financial Statements

December 31, 2012 and 2011

5. Promissory Notes

During 2012 the Company issued 2,901,450 shares of common stock for the retirement of $370,043 of promissory notes payable and accrued interest. The Company recognized a loss on conversion of the above debt of $22,105,265.

6. Capital Structure—Common Stock and Common Stock Purchase Warrants

Each holder of common stock is entitled to vote on all matters and is entitled to one vote for each share held. No holder of shares of stock of any class shall be entitled as a matter of right to subscribe for or purchase or receive any part of any new or additional issue of shares of stock of any class, or of securities convertible into shares of stock or any class, whether now hereafter authorized or whether issued for money, for consideration other than money, or by way of dividend.

As of December 31, 2012 and December 31, 2011, the Company was authorized to issue 500,000,000 common shares at a par value of $0.001 per share.

On March 18, 2012, the Company affected a 1 for 1000 reverse stock split of the Company’s Common Stock, resulting in a reduction of the number of shares outstanding of the Company from approximately 113,644,000 to approximately 113,644. Persons holding less than 1000 shares of Common Stock received one share of Common Stock. The rights and privileges of the holders of shares of Common Stock were substantially unaffected by the reverse stock split. All issued and outstanding options, warrants and convertible securities were appropriately adjusted for the reverse stock split automatically on the effective date of the reverse stock split, and have been presented in the financial statements to adjust for the reverse stock split.

As of December 31, 2012 the Company had 45,489,368 shares of common stock outstanding and 113,644 outstanding as of December 31, 2011.

The Company on April 12, 2012 issued a one-time dividend of 1,182,474 shares to the existing shareholders of TNI BioTech, Inc., with a record date of April 23, 2012.

The Company acquired TNI BioTech IP, Inc., for 20,250,000 shares as part of a share exchange agreement on April 24, 2012 (Note 10).

The Company conducted a private placement of units consisting of common stock and common stock purchase warrants. During 2012, the Company received $1,136,500 from the sale of units consisting of a total of 7,285,000 shares of common stock and common stock purchase warrants for the purchase of up to 7,260,000 shares of common stock at exercise prices ranging from $1.00 to $1.50.

F-12

TNI BioTech, Inc.

Notes to the Financial Statements

December 31, 2012 and 2011

Stock Warrants

Between September and December 2012, the Company issued 7,260,000 warrants, exercisable into one share of common stock of the Company for each warrant at prices between $1.00 and $1.50 per share. The warrants expire between September and December 2017.

Fair value of $25,810,469 was calculated using the Black-Scholes Model. Variables used in the Black-Scholes option-pricing model during the year ended December 31, 2012, include (1) 0.76% discount rate, (2) warrant life is the expected remaining life of the options as of each year end, (3) expected volatility recorded during the year ended December 31, 2012, related to these options.

Following is a summary of outstanding stock warrants at December 31, 2012 and 2011 and activity during the years then ended:

	Number of Shares		Exercise Price		Weighted Average Price
Warrants as of December 31, 2011		-		-		-

Issued in 2012		7,260,000	$	1.00 – 1.50	$	1.02

Expired		-		-		-

Exercised		-		-		-

Warrants as of December 31, 2012		7,260,000	$	1.00 – 1.50	$	1.02

Summary of outstanding warrants as of December 31, 2012:

Expiration Date	Number of Shares		Exercise Price		Remaining Life (years)
2013		-		-		-
2014		-		-		-
2015		-		-		-
2016		-		-		-
September 2017		2,565,000	$	1.00-1.50		4.8
October 2017		2,385,000	$	1.00		4.8
November 2017		2,300,000	$	1.00 – 1.50		4.9
December 2017		10,000	$	1.00		5.0

7. Stock Compensation

Founders’ Shares and Shares Issued for Services

During the year ended December 31, 2012, the Company issued 6,966,800 shares of common stock for services, which included founder shares, and 6,790,000 shares of common stock for consulting fees. The Company valued these shares based upon the fair market value of the common stock at the date of the agreements. The consulting fees are amortized over the contract periods which are typically twelve months. The Company recognized an expense from common stock issued for services of $9,160,980 and $0 for the years ended December 31, 2012 and 2011, respectively. The amortization of prepaid services totaled $17,004,479 and $0 for the years ended December 31, 2012 and 2011.

F-13

TNI BioTech, Inc.

Notes to the Financial Statements

December 31, 2012 and 2011

8. Income Taxes - Results of Operations

There was no income tax expense reflected in the results of operations for the years ended December 31, 2012 and 2011.

Deferred tax assets reflect the net income tax effect of temporary differences between the carrying amounts of the assets and liabilities for financial reporting purposes and the amounts used for income taxes.

Deferred tax assets:	2012			2011

Net operating losses	$	26,223,000		$	43,000
Valuation allowance		(26,223,000	)		(43,000	)

Total deferred tax assets	$	-		$	-

The Company has recognized no tax benefit for the losses generated for the periods through December 31, 2012. ASC Topic 740 requires that a valuation allowance be provided if it is more likely than not that some portion or all of a deferred tax asset will not be realized. The Company’s ability to realize the benefit of its deferred tax asset will depend on the generation of future taxable income. Because the Company has yet to recognize revenue, we believe that the full valuation allowance should be provided.

Our effective tax rate for fiscal years 2011 and 2012 was 0%. Our tax rate can be affected by recurring items, such as tax rates in foreign jurisdictions and the relative amount of income we earn in jurisdictions. It may also be affected by discrete items that may occur in any given year, but are not consistent from year to year.

As of December 31, 2012, we have estimated federal and state income tax net operating loss (“NOL”) carry-forwards of $98,700,000, which will expire in 2031-2032. $32,897.31 of which is the allowable carry forward amount pursuant to 26 USC § 382.

	2012						2011
	Amount			Percent			Amount			Percent
Benefits for income tax at federal statutory rate	$	59,500,000			34	%	$	43,000			34	%
Change in valuation allowance		(26,180,000	)		(15	)	$	(43,000	)		(34	)
Non-deductible impairment of goodwill		(33,320,000	)		(19	)		-			-
	$	-			-	%	$	-			-	%

9. Discontinued Operations

In April 2012, TNI BioTech, Inc., divested itself of certain assets and liabilities related to its previous activities in the hospitality business (“Resorts Club”) by transferring them to Resorts Club International Corporation Georgia. Accordingly, the operations of that business have been reflected as discontinued operations in the financial statements.

The result of this transfer was a Gain from Discontinued Operations of $231,356. This transfer is not expected to affect the cash flow of the remaining operations.

These financial statements reflect the results of Resorts Club as a discontinued operation for all periods presented.

F-14

TNI BioTech, Inc.

Notes to the Financial Statements

December 31, 2012 and 2011

The net sales and earnings of discontinued operations were as follows:

	Twelve Months Ended December 31
	2012		2011

Net Sales		0		1,062

Earnings before Income Taxes		231,356		(94,376	)

Income Taxes		0		0

Net Earnings from Discontinued Operations		231,356		(94,376	)

The balance sheet and statement of cash flows exclude the divested hospitality business. The Net Liabilities of discontinued operations of the divested business were as follows:

	Twelve Months Ended December 31
	2012		2011

Current Assets		0		0

Fixed Assets, Net		0		1,100

Non-Current Assets		0		910,514

Less:

Current Liabilities		0		1,106,987

Other Liabilities		0		0

Net Liabilities of Discontinued Operations		0		195,373

Cash flows from operating and investing activities of discontinued operations for the years ended December 31, 2012 and 2011 were $35,983 and $0, respectively.

F-15

TNI BioTech, Inc.

Notes to the Financial Statements

December 31, 2012 and 2011

10. Licenses and Supply Agreements

Patent and Subsidiary Acquisition

The Company entered into a share exchange agreement April 24, 2012 to acquire all of the outstanding shares of TNI Biotech IP, Inc., (“TNI IP”) a biotechnology firm incorporated in Florida formed to acquire patents related to the treatment of cancer and HIV/AIDS and autoimmune diseases, using Met-enkephalin (“MENK”) and Naltraxone (“LDN”). The goal of TNI IP’s management is to enable mankind and civilization to combat fatal diseases by activating and mobilizing the body’s own immune system using TNI IP’s patented use of methionine-enkephalin (referred to herein as MENK).

The first patents acquired by TNI IP were acquired from Dr. Nicholas P. Plotnikoff and Professor Fengping Shan in 2012. Dr. Plotnikoff and Dr. Shan have been specializing in research activities directed toward the study of cytokines, which are hormones naturally produced by the immune system. The primary cytokine, among many others currently being studied by TNI IP, is MENK. The Company is focused on the treatment of cancer, HIV/AIDS and other infectious diseases through the use of our lead compounds.

TNI IP changed its name from TNI BioTech Inc to TNI Biotech IP, Inc. on April 23, 2012. TNI BioTech IP, Inc., is the wholly-owned subsidiary of the Company. TNI IP was acquired in exchange for 20,250,000 shares of the Company’s common stock of which 8,000,000 shares were issued for the acquisition of the patent and the remaining 12,250,000 shares were issued to the founders of TNI IP in exchange for all of their right, title and interest in their TNI IP shares. The goodwill arising on the acquisition of TNI BioTech IP, Inc. was valued at $98,000,000 and license agreements arising from the acquisition of TNI BioTech IP, Inc. was valued at $16,006,000.

At the time of the acquisition, the valuation of goodwill and other intangible assets were determined using the fair market price for the Company’s common stock which were exchanged for shares of TNI BioTech IP, Inc. In the fourth quarter of 2012, the Company performed an annual valuation to determine whether any goodwill or intangible assets that had been acquired by the Company were impaired. The result of this valuation was that material impairments were identified. The Company recognized an impairment of the goodwill arising on the acquisition of TNI BioTech IP, Inc. of $98,000,000.

Patent License Agreements

On August 13, 2012, the Company signed a License Agreement with Ms. Jacqueline Young for the intellectual property developed by Dr. Bernard Bihari relating to treatments with opioid antagonists such as naltrexone and et-enkephalin for a variety of diseases and conditions including malignant lymphoma, chronic lymphocytic leukemia, Hodgkin’s lymphoma, and non-Hodgkin’s lymphoma, chronic herpes virus infections, chronic herpes viral infections such as chronic genital herpes caused by the herpes simplex virus Type 2 and chronic infections due to the Epstein-Barr virus and a treatment method for humans infected with HTLV-III (AIDS) virus including patients clinically diagnosed as suffering from AIDS and those suffering from AIDS-related complex (ARC). The Bihari patents were acquired in exchange for 540,000 shares of the Company’s common stock with a fair market value of $972,000 and assumed liabilities of $400,000 which is payable to Ms. Young over a twenty-four month period in equal installments to reimburse her for the costs of a New York city office in accordance with the patent license agreement. The patent liability at December 31, 2012 totaled $340,000. The cost of the patent totaled $1,372,000. Additionally, the Company will pay the licensor a royalty payment of 1% of gross MENK sales and provide the licensor a position as non-executive chairman of the Company.

On December 24, 2012, the Company signed an agreement for the acquisition of patent rights for the intellectual property of Dr. Jill Smith and LDN Research Group, LLC (the “Patent License Agreement”), whose members are Dr. Ian S. Zagon, Dr. Patricia J. McLaughlin and Moshe Rogosnitzky and orphan drug designation by the FDA to a novel late-stage drug, trademarked “LDN,” for the treatment of Pediatric Crohn’s Disease. The patent covers methods and formulations for treatment of the inflammatory and ulcerative diseases of the bowel, using naltrexone in low doses as an opioid antagonist. Endogenous opioids and opioid antagonists have been shown to play a role in stimulating and rebalancing the immune system and the healing and repair of tissues. These patents were acquired in exchange for 300,000 shares of the Company’s common stock with a fair market value of $2,715,000 and expenses of $165,384 which totaled $2,880,384.

F-16

TNI BioTech, Inc.

Notes to the Financial Statements

December 31, 2012 and 2011

In partial consideration of the Patent License Agreement, the Company agreed to pay to the members the applicable milestone payments listed below after substantial achievement of each milestone event is achieved by the Company, its Affiliates or Sublicensees.

A.	Upon initial of each phase III trial, the Company will pay $350,000.

B.	Upon positive completion of each phase III clinical trial of the therapeutic use of an LDN compound in the field of Use, the Company will pay $150,000.

C.	When an NDA is accepted for review by the FDA, the Company will pay $250,000.

D.	When FDA approval to market the NDA is approved, the Company will pay $750,000.

E.	Upon the first dosing of the first patient in a phase III clinical trial for each Licensed Product, the Company will pay 250,000 shares of the Company’s common stock.

F.	Upon the first sale of each Licensed Product, the Company will issue 400,000 shares of the Company’s common stock.

G.	Upon the achievement of $20 Million USD in cumulative sales for each licensed product covered by NDAs, the Company will issue 500,000 shares of the Company’s common stock.

As part of the Patent License Agreement, TNI BioTech has the right to apply to the Food and Drug Administration (FDA) for the transfer of the orphan drug status, the investigational new drug applications (INDs), and the right to acquire the relevant clinical data set from Dr. Smith. The FDA has designated orphan drug status for the use of low dose naltrexone in the treatment of pediatric patients with Crohn’s disease and ulcerative colitis.

The Patent License Agreement calls for the formation of a Development Committee to monitor the clinical progress of the Licensed Products and will consist of independent scientific and technical leaders who are highly regarded by the scientific community in the Field of Use of each Licensed Product. The development committee consists of at least one representative from the Licensor Parties and one representative from the Company in addition to outside experts in the field.

Naltrexone in low dose is a platform immunomodulatory technology that the Company expects to clinically test in the treatment of other immune-mediated or immune-deficient diseases for which it has previously acquired additional patents.

The Company signed an exclusive licensing agreement with The Penn State Research Foundation on January 18, 2013 to license all of the intellectual property developed by Dr. Ian S. Zagon, Dr. Patricia J. McLaughlin and Dr. Jill P. Smith for the treatment of cancer titled “Opioid Growth Factor and Cancer” and “Combination Therapy with Opioid Growth Factor and Taxanes for the Treatment of Cancer” (the “Licensing Agreement”).

The patent covers methods and formulations related to the treatment and prevention of different cancers. More specifically, the present inventions describe the use of drugs that interact with opioid receptors (naltrexone, naloxone and the pentapeptide growth factor Met-enkephalin) to inhibit and arrest the growth of cancer. Endogenous opioids and opioid antagonists have been shown to play a role in stimulating and rebalancing the immune system and the healing and repair of tissues. Such efficacy has been discovered to be partially due to the functional manipulation of the zeta opioid receptor through exogenous and endogenous Met-enkephalin. This receptor has been determined to be present in a variety of cancers, including pancreatic and colon cancer.

As part of the Licensing Agreement, TNI BioTech is working to acquire the orphan drug designation (IND) and clinical data set from Dr. Jill Smith.

The Licensing Agreement calls for TNI BioTech to (a) use commercially reasonable efforts to develop, commercialize, market and sell Licensed Products in a manner consistent with the Business Plan; (b) will expend a minimum of $110,000 (per annum) to develop and commercialize Licensed Products as soon as practicable, consistent with sound business practices and judgment; (c) be responsible for obtaining all requisite regulatory approvals needed to use or sell Licensed Products in the Field of Use; and (d) make the first commercial sale of a Licensed Product by December 31, 2016.

The Licensing Agreement calls for the formation of a Development Committee to monitor the clinical progress of the Licensed Products, which will consist of independent scientific and technical leaders who are highly regarded by the scientific community in the Field of Use of each Licensed Product.

F-17

TNI BioTech, Inc.

Notes to the Financial Statements

December 31, 2012 and 2011

11. Commitments and Contingencies

Malawi Treatment Facilities

On July 14, 2012, GB Oncology and Imaging Group LTD (“GBOIG”) in partnership with TNIB signed a letter of intent agreement to collaborate with the Government of Malawi to assist in expanding the treatment of cancer, HIV/AIDS and other infectious diseases.

The Company and GB will work in connection with the government of Malawi to open and operate clinics that provide treatments for HIV/AIDS, cancer and other infectious diseases. GBOIG and TNIB expect to have the oncology and infectious disease clinic fully operational within 12 months of the signing of the Agreement, and hope to begin treatment for HIV patients within 180 days. Under the letter of intent, TNIB and GBOIG will begin by providing HIV/AIDS treatment to 25,000 patients and hopefully expanding to 500,000 within 24 months.

GB Oncology and Imaging Group LTD., a subsidiary of GB Energie LLC is a Washington D.C. based minority woman-owned business managed by Dr. Gloria B. Herndon. Dr. Herndon is also a director of TNI BioTech, Inc.

Distribution Agreement in Nigeria

Effective November 9, 2012, TNI BioTech, Inc., signed an exclusive Distribution Agreement with G-Ex Technologies/St. Maris Pharma and GB Pharma Holdings, LLC for the Federal Republic of Nigeria. Under the terms of the Distribution Agreement, G-Ex Technologies/St. Maris Pharma and GB Pharma Holdings LLC will have exclusive marketing and distribution rights to IRT-103 LDN and IRT-104 LDN cream in Nigeria. TNIB will be responsible for the manufacture and supply of IRT-103 LDN and IRT-104 LDN cream. As part of the Distribution Agreement, G-Ex Technologies/St. Maris Pharma will provide TNIB with a revolving letter of credit for the minimum purchase of 750,000 doses monthly of IRT-103 LDN or IRT-104 LDN cream priced at $1.00 per dose.

The Distribution Agreement calls for G-Ex Technologies/St. Maris Pharma and GB Pharma Holdings, LLC to purchase a minimum of 15,000,000 doses monthly within 24 months to maintain the exclusivity of the Agreement. Once G-Ex Technologies/St. Maris Pharma and GB Pharma Holdings, LLC reach sales of 1,000,000 doses per day TNIB has agreed to joint venture a factory in the Federal Republic of Nigeria to meet local demands.

G-Ex Technologies/St. Maris Pharma is a consortium of companies organized under the laws of the Republic of Nigeria operated by management, consultant, general pharmaceutical, clinical pharmacy and marketing executives, each with over twenty-five years of industry experience and well versed in the changing dynamics of the prescription and over-the-counter drug international marketplace. G-Ex Technologies/St. Maris Pharma has been actively supported by medical practice professionals in business and academia who have been involved in the management of related drug therapies for many years.

Strategic Framework Agreement with Zhongzhu Group

On October 9, 2012, the Company signed a Strategic Framework Agreement for Cooperation with the Zhongzhu Group. Under the Strategic Framework Agreement, the parties will work together to further the development of new products and conduct research and development on TNI’s licensed patented technology. Specifically, the parties aim to co-invest to develop and market products focusing on HIV, cancer and related autoimmune system therapies, develop co-ventured manufacturing facilities in China, and develop co-ventured distribution of the developed products in China and Africa.

Operating Leases

The Company leases office space in Bethesda, Maryland and Orlando, Florida under a month-to-month lease agreement. Rental expense for the years ended December 31, 2012 and 2011 was $10,303 and $0, respectively.

F-18

TNI BioTech, Inc.

Notes to the Financial Statements

December 31, 2012 and 2011

12. Related Party Transactions

Effective September 15, 2012, TNI BioTech, Inc. entered into a one-year employment agreement with Joseph Griffin, the brother of the Company's Chief Executive Officer, in which base salary, the grant of a common stock, and health insurance coverage were defined. As a signing bonus, Mr. Griffin received 250,000 shares of restricted common stock of the Company. During the year ended December 31, 2012, the Company paid cash compensation totaling $11,146. There were no compensation payments to Mr. Griffin in 2011.

In 2012, Webfoot, Inc., provided financing to the Company and as of December 31, 2012, the Company owed Webfoot, Inc., $121,128. Webfoot, Inc., is owned by the son of Noreen Griffin. On February 21, 2013, the Company entered into a formal loan agreement to evidence the amount owed on December 31, 2012. The loan bears interest at an annual rate of 6%. The interest is repayable at maturity. The note matures on February 21, 2004.

In 2012, Noreen Griffin made payments on the Company's behalf covering the costs of incorporation and merger-related expenses. At December 31, 2012, the Company owed Ms. Griffin $30,000. On February 13, 2013, the Company entered into a formal loan agreement to evidence repayment of the amount owed on December 31, 2012. The loan bears interest at an annual rate of 6%. The interest is repayable at maturity.

In 2012, Griffin Enterprises, Inc. made payments on the Company's behalf covering the cost of incorporation and merger-related expenses. Griffin Enterprises, Inc. is wholly owned by Noreen Griffin. At December 31, 2012, the company owed Griffin Enterprises, Inc. $46,000. On February 13, 2013, the Company entered into a formal loan agreement to evidence repayment of the amount owed on December 31, 2012. The loan bears interest at an annual rate of 6%. The interest is repayable at maturity.

13. Subsequent Events

The Company evaluated events that occurred subsequent to December 31, 2012 through April 9, 2013, the date the financial statements were available to be issued.

Related Party Transaction

On January 3, 2013, the Company formalized the terms under which Kelly O’Brien Wilson, the daughter-in-law of the Company's Chief Executive Officer has been employed. Ms. Wilson had been working with the Company in 2012 and her three-year employment agreement is effective as of December 1, 2012. The terms of the agreement define her base salary, a grant of a common stock, and health insurance coverage. As a signing bonus, Ms. Wilson is entitled to receive 50,000 shares of common stock of the Company. During the year ended December 31, 2012, the Company paid cash compensation totaling $4,035. There were no compensation payments to Ms. Wilson in 2011.

Commissioned Processing Contract, Addendum to Venture Cooperation and Strategic Framework Agreement

The Company signed a Commissioned Processing Contract, Addendum to Venture Cooperation and Strategic Framework Agreement with Hubei Qianjiang Pharmaceutical Co., LTD (“HBQ”) on February 24, 2013. Under the Commissioned Processing Contract, HBQ will manufacture low dose Naltrexone for TNI. The Addendum to Venture Cooperation expands the scope of the originally executed agreement in October to include clinical trials on pancreatic and liver cancer. Under the Strategic Framework Agreement, the parties will work together to further the research and development and marketing of new products. Specifically, the parties aim to co-invest to develop and market products focusing on HIV-AIDS and develop co-ventured distribution of the developed products in China, Central America, South America, Africa and the United States.

F-19

TNI BioTech, Inc.

Notes to the Financial Statements

December 31, 2012 and 2011

Common Stock Purchase Warrant Exercises

Warrant holders purchased a total of 1,180,434 shares at the reduced exercise price of $0.75 per share for a total for $885,326.

Under the terms of the exercise, warrant holders exercising at the Reduced Warrant Price newly-issued five-year Common Stock Purchase Warrants with an exercise price of $15 per share (the “Series C Warrants”). The number of shares purchasable under the Series C Warrants will equal 25% the total number of shares exercised at the Reduced Warrant Price.

The following is a schedule of shares issued subsequent to year-end.

	Shares

Shares issued for services		5,533,000
Shares issued to Penn State University		600,000
Shares issued to Foundation		100,000
Shares issued for debt		345,833
Shares issued for promissory notes		60,000
Shares issued for warrant exercise		1,180,434
Shares issued to Founders		1,500,000
		9,319,267

F-20

AMENDED AND RESTATED

BYLAWS OF

TNI BioTech, Inc.

a Florida Corporation

Revised and Adopted on November 7, 2012

ARTICLE I

Shareholders

Section 1. Annual Meetings. An annual meeting of shareholders shall be held for the election of directors on such date, and at such time and place as the Board of Directors may, from time to time, determine. Any other proper business may be transacted at an annual meeting. If the annual meeting is not held on the date designated, it may be held as soon thereafter as convenient and shall be called the annual meeting.

Section 2. Special Meetings. Special meetings of the shareholders, for any purpose or purposes, unless otherwise prescribed by the Laws of the State of Florida, may be called by the President or the Board of Directors. The shareholders do not have the authority to call a special meeting of the shareholders.

Section 3. Shareholder Proposals/Nominees.

Shareholder Proposals. Shareholders seeking to place shareholder proposals on the agenda for a shareholders' meeting must (i) notify the Corporation of such proposal not less than Thirty (30) nor more than Sixty (60) days prior to the date of the meeting; provided, however, that if the Corporation provides shareholders with less than Forty (40) days advance notice of the date of the meeting, the shareholder notice must be given no later than the close of business on the Tenth (10 th ) day following the day the Corporation's notice was mailed or publicly disclosed. Such notice must provide the Corporation with adequate information regarding the proposal.

Shareholder Director Nominees. Shareholders director nominations must (i) be in writing and contain adequate information about the nominee; and (ii) be received by the secretary of the Corporation not less than Thirty (30) nor more than Sixty (60) days prior to the date of the meeting at which Directors will be elected; provided, however, that if the Corporation provides shareholders with less than Forty (40) days advance notice of the date of the meeting, the shareholder notice must be given no later than the close of business on the Tenth (10 th ) day following the day the Corporation's notice was mailed or publicly disclosed.

Section 4. Notice of Meetings. Whenever shareholders are required or permitted to take any action at a meeting, a written notice of the meeting will be given that states the place, date and hour of the meeting, and in the case of a special meeting, the purpose(s) for which the meeting is called. Unless otherwise provided by law, the Articles of Incorporation or these Bylaws, the written notice of any meeting will be given not less than Ten (10) nor more than Sixty (60) days before the date of the meeting to each shareholder entitled to vote at such meeting. If mailed, such notice will be deemed to be given when deposited in the United States mail, postage prepaid, directed to the shareholder at his or her address as it appears in the records of the Corporation.

Section 5. Waiver of Notice. A shareholder may waive notice of any meeting; provided that a shareholder's attendance at a meeting shall constitute waiver of notice of such meeting, except when the shareholder attends a meeting for the express purpose of objecting to the transaction of any business to be transacted at the meeting, and not for the purpose of objecting to the purpose of the meeting.

Section 6. Adjournments. Any meeting of shareholders, annual or special, may adjourn from time to time to reconvene at the same or some other place, and notice need not be given of any such adjourned meeting if the time and place are announced at the meeting at which the adjournment is taken. At the adjourned meeting, the Corporation may transact any business that might have been transacted at the original meeting. If the adjournment is for more than Thirty (30) days, or if after the adjournment a new record date is fixed for the adjourned meeting, pursuant to Section 1.4, notice of the adjourned meeting will be given to each shareholder of record entitled to vote at the meeting.

Section 7. Record Date.

Determination of Record Date. For purposes of determining the number and identity of shareholders for any purpose, the Board of Directors may fix a date in advance as the record date for any such determination of shareholders, provided that the record date may not precede the date of the resolution fixing the record date. The record date may not be more than Sixty (60) days prior to the date that the particular action requiring the determination of shareholders is to occur. If to determine the shareholders entitled to notice of, or to vote at, a meeting of shareholders, the record date may not be fewer than Ten (10) days prior to the meeting. The record date for determining shareholders for any other purpose shall be at the close of business on the day on which the Board of Directors adopts the resolution relating thereto. A determination of shareholders of record entitled to notice of, or to vote at, a meeting of shareholders will apply to any adjournment of the meeting; provided that the Board of Directors may fix a new record date for the adjourned meeting.

Failure to Fix Record Date. If the stock transfer books are not closed and no record date is fixed for the determination of shareholders entitled to notice or to vote, or to receive payment of a dividend, the date on which the notice is mailed or the Board of Directors resolution declaring the dividend is adopted, as the case may be, will be the record date for such determination of shareholders.

Section 8. List of Shareholders Entitled to Vote. At least Ten (10) days before each meeting of shareholders, the officer or agent charged with overseeing the stock transfer books of the Corporation will compile a complete list of the shareholders entitled to vote at such meeting, or any adjournment thereof, arranged in alphabetical order, with the address of and the number of shares held by each. Such list will be kept on file at the Corporation's principal office for the Ten (10) days before the meeting and will be subject to the inspection of any shareholder during that Ten (10) day period during normal business hours for any purpose related to the meeting and during the meeting.

Section 9. Quorum. Except as otherwise provided by law, the Articles of Incorporation, or these Bylaws, a majority of the outstanding shares of the Corporation entitled to vote, represented in person or by proxy, will constitute a quorum at a meeting of shareholders. If less than a majority of the outstanding shares are represented at the meeting, a majority of the shares so represented may adjourn the meeting from time to time without further notice. If a quorum is present or represented at such adjourned meeting, any business may be transacted that might have been transacted at the meeting as originally notified. The shareholders present at a duly organized meeting may continue to transact business until adjournment, notwithstanding the withdrawal of enough shareholders to leave less than a quorum.

Section 10. Voting.

a.	One Vote Per Share. Unless otherwise provided by the Articles of Incorporation (or action of the Board of Directors as provided therein) or these Bylaws, each outstanding share entitled to vote will be entitled to one vote on each matter submitted to a vote at a meeting of shareholders.

Shares Held By Other Than the Record Owner. Shares held by an administrator, executor, guardian or conservator may be voted by him or her, in person or by proxy, without the transfer of such shares into his or her name. Shares held in the name of a trustee may be voted by him or her, in person or by proxy, only if the shares are transferred into the trustee's name. Shares held in the name of, by or under the control of a receiver may be voted by the receiver without transferring the shares into the receiver's name if authority to do so is evidenced in an order from the court that appointed the receiver. A shareholder whose shares are pledged shall be entitled to vote his or her shares until the shares are transferred into the name of the pledgee, and thereafter, the pledgee will be entitled to vote the shares so transferred. Shares belonging to the Corporation or held by it in a fiduciary capacity may not be voted, directly or indirectly, at any meeting, and will not be counted in determining the total number of outstanding shares at any given time.

Section 11. Proxies.

General. At all meetings of shareholders, a shareholder may vote by proxy. Proxies must be written, signed by the shareholder or by his or her duly authorized attorney-in-fact, and filed with the Secretary of the Corporation before or at the time of a meeting where a proxy is granted. No proxy is valid after Six (6) months from the date of its execution, unless otherwise provided in the proxy or coupled with an interest.

b.	Irrevocable Proxies. A proxy may be irrevocable if it states that it is irrevocable and if, and only as long as, it is coupled with an interest sufficient in law to support an irrevocable power.

Revocation of a Proxy. A shareholder may revoke any proxy that is not irrevocable by attending the meeting and voting in person or by filing an instrument in writing revoking the proxy or by delivering a proxy in accordance with applicable law bearing a later date to the Secretary of the Corporation.

Section 12. Shareholder Action by Written Consent Without a Meeting.

Action. Any action required to be taken at any annual or special meeting of shareholders of the Corporation, or any action that may be taken at any annual or special meeting of such shareholders may be taken without a meeting, without prior notice, and without a vote, if a consent in writing, setting forth the action so taken, is signed by the holders of outstanding stock having not less than the minimum number of votes that would be necessary to authorize or take such action at a meeting at which all shares entitled to vote thereon were present and voted.

ARTICLE II

Board of Directors

Section 1. Number, Qualifications. The Board of Directors shall consist of that number of directors as are set from time to time by the affirmative vote of a majority of the members of the Board of Directors. A director will hold office until his or her successor is elected and qualified. Directors need not be shareholders of the corporation.

Section 2. Election; Resignation; Vacancies. The Board of Directors will initially consist of the persons designated by the Incorporator, and each director so elected will hold office until the first annual meeting of shareholders and until his or her successor is elected and qualified. At the first annual meeting of shareholders, the shareholders will elect directors to the Board of Directors. A director may resign at any time on written notice to the Corporation. Any vacancy occurring in the Board of Directors, whether by reason of death, resignation, removal, or an increase in the number of directors, may be filled by the affirmative vote of the majority of the remaining directors, though less than a quorum of the Board of Directors, or by election at an annual meeting or at a special meeting of the shareholders called for that purpose. A director elected to fill a vacancy will be elected for the unexpired term of his predecessor in office.

Section 3. Regular Meetings. A regular meeting of the Board of Directors for the election of officers and the transaction of any other business that may properly come before the meeting shall be held immediately after, and at the same place as, each annual meeting of shareholders, if a quorum of directors is then present or as soon thereafter as may be convenient. Regular meetings of the Board of Directors may be held at such places within or without the State of Florida and at such times as the Board of Directors may from time to time determine. The Board of Directors may provide, by resolution, the date, time and place for the holding of additional regular meetings without other notice than such resolution.

Section 4. Special Meetings. Special meetings of the Board of Directors may be called by or at the request of the President or any director. The person(s) authorized to call special meetings of the Board of Directors may fix any place, within or without the State of Florida, to hold a special meeting of the Board of Directors. Notice of a special meeting must be given to each director by the person(s) calling the meeting at least Two (2) days before the meeting.

Section 5. Waiver of Notice. A director may waive notice of any meeting. A director's attendance at a meeting shall constitute waiver of notice of such meeting; provided that, when a director attends a meeting for the express purpose of objecting to the transaction of any business to be transacted at the meeting, the director will not be deemed to have waived notice of such meeting.

Section 6. Telephonic Meetings Permitted. Members of the Board of Directors, or any committee designated by the Board of Directors, may participate in a meeting thereof by means of telephonic conference, or similar communications equipment that permits all persons participating in the meeting to hear each other, and participation in a meeting pursuant to this Bylaw will constitute presence at such meeting.

Section 7. Quorum. Vote Required for Action. At all meetings of the Board of Directors, a majority of the whole Board of Directors will constitute a quorum for the transaction of business. Unless required by the Laws of the State of Florida, the Articles of Incorporation or these Bylaws, the vote of a majority of the directors present at a meeting at which a quorum is present will be the act of the Board of Directors. If less than a majority is present at a meeting, a majority of the directors present may adjourn the meeting from time to time without further notice. Once a quorum has been established at a duly organized meeting, the Board of Directors may continue to transact corporate business until adjournment, notwithstanding the withdrawal of enough members to leave less than a quorum.

Section 8. Action of the Board of Directors . The vote of a majority of the directors present at a meeting at which a quorum is present shall be the act of the Board of Directors, unless the question or action is one upon which a different vote is required by express provision of statute, the Articles of Incorporation or these Bylaws, in which case such provision shall govern the vote on the decision of such question or action. Each director present shall have one vote.

Section 9. Payment of Expenses. By resolution of the Board of Directors, directors may be paid their expenses, if any, of attendance at each meeting of the Board of Directors. Directors may be paid also either a fixed sum for attendance at each meeting of the Board of Directors or a stated salary as director. Such payment will not preclude any director from serving the Corporation in any other capacity and receiving compensation therefore.

Section 9. Dissent to Corporate Action. A director who is present at a meeting of the Board of Directors at which action on any corporate matter is taken shall be presumed to have assented to the action taken unless he or she (i) enters his or her dissent in the minutes of the meeting, (ii) files written dissent to such action with the Secretary of the meeting before adjournment, or (iii) expresses such dissent by written notice to the Secretary of the Corporation within One (1) day after the adjournment of the meeting. The right to dissent shall not apply to a director who voted in favor of such action.

Section 10. Action by Written Consent. Any action required or permitted to be taken at a meeting of the Board of Directors may be taken without a meeting if a majority of the Board of Directors sign a written consent with respect to such action. Such consent shall be filed with the minutes of proceedings of the Board of Directors.

ARTICLE III

Committees

Section 1. Committees. The Board of Directors may, by resolution passed by a majority of the whole Board of Directors, designate one or more committees, each to consist of one or more of the directors. The Board of Directors may designate one or more directors as alternate members of any committee, who may replace any absent or disqualified member at any meeting of the committee. In the absence or disqualification of a member of the committee, the member or members thereof present at any meeting and not disqualified from voting, whether or not constituting a quorum, may unanimously appoint another member of the Board of Directors to act at the meeting in place of any such absent or disqualified member. Any such committee, to the extent permitted by the Laws of the State of Florida and to the extent provided in the resolution of the Board of Directors, will have and may exercise all the powers and authority of the Board of Directors in the management of the business and affairs of the Corporation, and may authorize the seal of the Corporation to be affixed to all papers that may require it.

Section 2. Committee Rules. Unless the Board of Directors otherwise provides, each committee designated by the Board of Directors may make, alter and repeal rules for the conduct of its business. In the absence of such rules, each committee will conduct its business pursuant to Article II of these Bylaws.

ARTICLE IV

Officers

Section 1. Officers. The officers of the Corporation may be a President, Vice President, Secretary, and Treasurer. Other officers and assistant officers may be authorized and elected or appointed by the Board of Directors. An individual is permitted to hold more than one office.

Section 2. Election. The officers of the Corporation will be elected annually by the Board of Directors at the first meeting of the Board of Directors held after each annual meeting of the shareholders. If the election of officers is not held at such meeting, it will be held as soon thereafter as convenient. Each officer will hold office until his or her successor is duly elected and qualified, or until his or her death, resignation or removal.

Section 3. Removal. Any officer, elected or appointed, may be removed by the Board of Directors, but such removal shall be without prejudice to the contract rights, if any, of the person so removed.

Section 4. Vacancy. A vacancy in any office for any reason may be filled by majority vote of the Board of Directors, and any officer so elected will serve for the unexpired portion of the term of such office.

Section 5. President. The President presides at all meetings of the Board of Directors and of shareholders and has general charge and control over the affairs of the Corporation subject to the Board of Directors. The President signs or countersigns all certificates, contracts and other instruments of the Corporation as authorized by the Board of Directors and performs such other duties incident to the office or required by the Board of Directors.

Section 6. Vice President. The Vice President exercises the functions of the President in the President's absence, and has such powers and duties as may be assigned to him or her from time to time by the Board of Directors.

Section 7. Secretary. The Secretary issues all required notices for meetings of the Board of Directors and of the shareholders, keeps a record of the minutes of the proceedings of the meetings of the Board of Directors and of the shareholders, has charge of the Corporate Seal and the corporate books, and makes such reports and performs such other duties as are incident to the office or required by the Board of Directors.

Section 8. Treasurer. The Treasurer has custody of all monies and securities of the Corporation, keeps regular books of account, disburses the funds of the Corporation, renders account to the Board of Directors of all transactions made on behalf of the Corporation and of the financial condition of the Corporation from time to time as the Board requires, and performs all duties incident to the office or properly required by the Board of Directors.

Section 9. Additional Officers. The Corporation may have such additional officers as the Board of Directors deems necessary or appropriate including, without limitation, a Chairman of the Board, Chief Executive Officer, Chief Operating Officer, Chief Financial Officer, Assistant Vice Presidents, Assistant Secretaries and Assistant Treasurers. Each such officer shall perform those duties as determined or assigned by the Board of Directors.

Section 10. Salaries. The salaries of all officers will be fixed by the Board of Directors, and may be changed from time to time by a majority vote of the Board of Directors.

ARTICLE V

Certificate of Shares

Section 1. Certificates. The Corporation may issue certificates representing shares of the Corporation, which will be in the form determined by the Board of Directors, and will be signed by the President of the Corporation or any other officers permitted by law, certifying the number of shares owned by him or her in the Corporation. Any of or all the signatures on the certificate may be a facsimile. If any officer, transfer agent or registrar who has signed, or whose facsimile signature has been placed upon, a certificate ceases to hold that position before the certificate is issued, it may be issued by the Corporation with the same effect as if the officer, transfer agent or registrar continued to hold that position at the date of issue.

Section 2. Lost, Stolen or Destroyed Stock Certificates; Issuance of New Certificates. If a certificate is lost, stolen or destroyed, a new one may be issued on such terms and indemnity to the Corporation as the Board of Directors may prescribe.

ARTICLE VI

Indemnification of Directors and Officers

Section 1. Directors.

Right to Indemnification Insurance. Every person who was or is a party to, or is threatened to be made a party to, or is involved in any action, suit or proceeding, whether civil, criminal, administrative or investigative, by reason of the fact that he or she, or a person of whom he is the legal representative, is or was a director or officer, or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation, or as its representative in another enterprise (an "Indemnitee"), shall be indemnified and held harmless by the Corporation to the fullest extent legally permissible under the laws of the State of Florida against all judgments, fines, penalties, excise taxes, amounts paid in settlement and costs, charges and expenses (including attorneys' fees and disbursements) actually and reasonably incurred or suffered by him or her in connection therewith, subject to the standards of conduct, the procedures, and other applicable provisions of the Laws of the State of Florida. Such right of indemnification is a contract right which may be enforced in any manner desired by such person. The Corporation may purchase and maintain insurance on behalf of an Indemnitee against any liability arising out of such status, whether or not the corporation would have the power to indemnify such person.

Inurement. The right to indemnification shall inure whether or not the claim asserted is based on matters that predate the adoption of this Article VI, will continue as to an Indemnitee who has ceased to hold the position by virtue of which he or she was entitled to indemnification, and will inure to the benefit of his or her heirs and personal representatives.

Non-exclusivity of Rights. The right to indemnification and to the advancement of expenses conferred by this Section 6.1 are not exclusive of any other rights that an Indemnitee may have or acquire under any statute, bylaw, agreement, vote of shareholders or disinterested directors, this Articles of Incorporation or otherwise.

Advancement of Expenses. The Corporation shall, from time to time, reimburse or advance to any Indemnitee the funds necessary for payment of expenses, including attorneys' fees and disbursements, incurred in connection with defending any proceeding for which he or she is indemnified by the Corporation, in advance of the final disposition of such proceeding; provided that, if then required by the Laws of the State of Florida, the expenses incurred by or on behalf of an Indemnitee may be paid in advance of the final disposition of a proceedings only upon receipt by the Corporation of an undertaking by or on behalf of such Indemnitee to repay any such amount so advanced if it is ultimately determined by a final and unappealable judicial decision that the Indemnitee is not entitled to be indemnified for such expenses.

Section 2. Officers, Employees and Agents. The Board of Directors may, on behalf of the Corporation, grant indemnification to any officer, employee, agent or other individual to such extent and in such manner as the Board of Directors in its sole discretion may from time to time and at any time determine, in accordance with the Laws of the State of Florida.

ARTICLE VII

General Provisions

Section 1. Fiscal Year. The fiscal year of the Corporation will be fixed by the Board of Directors.

Section 2. Amendments. These Bylaws may be amended or repealed or new Bylaws may be adopted (i) at any regular or special meeting of shareholders at which a quorum is present or represented, by the vote of the holders of a majority of the shares entitled to vote in the election of any directors, provided notice of the proposed alteration, amendment or repeal is contained in the notice of such meeting; or (ii) by affirmative vote of a majority of the Board of Directors at any regular or special meeting thereof.

Section 3. Books and Records; Examination. Any records maintained by the corporation in the regular course of its business, including its stock ledger, books of account, and minute books, may be kept on, or be in any form of information storage, provided that the records can be converted into clearly legible form within a reasonable time. The books and records of the Corporation may be kept outside of the State of Florida. Except as may otherwise be provided by the Laws of the State of Florida, the Board of Directors will have the power to determine from time to time whether and to what extent and at what times and places and under what conditions any of the accounts, records and books of the Corporation are to be open to the inspection of any shareholder.

Section 4. Dividends. Subject to the provisions, if any, of the Laws of the State of Florida and the Articles of Incorporation, dividends on the capital shares of the Corporation may be declared by the Board of Directors at any regular or special meeting. Dividends may be paid in cash, in property or in shares of the capital stock. Before payment of any dividend, the Board of Directors may set aside out of any funds of the Corporation available for dividends such reserves for any purpose that the directors will think conducive to the interests of the Corporation.

Section 5. Seal. The Corporation may or may not have a corporate seal, as may from time to time be determined by resolution of the Board of Directors. If a corporate seal is adopted, it will have inscribed thereon the name of the corporation and the words "Corporate Seal" and "Florida". The seal may be used by causing it or a facsimile thereof to be impressed or affixed or in any manner reproduced or by causing the word {SEAL}, in brackets, to appear where the seal is required to be impressed or affixed.

Florida
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

6701 Democracy Blvd., Suite 300, Bethesda, Maryland		20817
(Address of principal executive office)		(Zip Code)

Common Stock, par value $0.001		None
(Title of class)		Name of each exchange on which each class is to be registered

o	Large accelerated filer	o	Accelerated filer
o	Non-accelerated filer (Do not check if a smaller reporting company)	þ	Smaller reporting company

		Page
Item 1.	Business		4
Item 1A.	Risk Factors		18
Item 2.	Financial Information		46
Item 3.	Properties		48
Item 4.	Security Ownership of Certain Beneficial Owners and Management		49
Item 5.	Directors and Executive Officers		50
Item 6.	Executive Compensation		54
Item 7.	Certain Relationships and Related Transactions, and Director Independence		55
Item 8.	Legal Proceedings		55
Item 9.	Market Price of and Dividends on the Registrant’s Common Equity and Related Stockholder Matters		55
Item 10.	Recent Sales of Unregistered Securities		56
Item 11.	Description of Registrant’s Securities to be Registered		60
Item 12.	Indemnification of Directors and Officers		60
Item 13.	Financial Statements and Supplementary Data		60
Item 14.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure		60
Item 15.	Financial Statements and Exhibits		61