Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 10-K

 

 

 

x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended May 31, 2013

or

 

¨ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                      to                     

Commission file number 000-49908

 

 

CYTODYN INC.

(Exact name of registrant as specified in its charter)

 

 

 

Colorado   75-3056237

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

5 Centerpointe Drive, Suite 400, Lake Oswego, Oregon   97035
(Address of principal executive offices)   (Zip Code)

Registrant’s Telephone Number, including area code: (971) 204-0382

Securities registered pursuant to Section 12(b) of the Act: None

Securities registered pursuant to Section 12(g) of the Act:

Title of class

Common Stock, no par value

 

 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.    ¨  Yes    x  No

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.    ¨  Yes    x  No

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    x  Yes    ¨  No

Indicate by checkmark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    x  Yes    ¨  No

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.  ¨

Indicate by checkmark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in rule 12b-2 of the Exchange Act.

 

Large accelerated filer   ¨    Accelerated filer   ¨
Non-accelerated filer   ¨    Smaller reporting company   x

Indicate by check mark whether the registrant is a shell company (as defined in rule 12b-2 of the Act).    ¨  Yes    x  No

State the aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which the common equity was last sold, or the average bid and asked price of such common equity, as of the last business day of the registrant’s most recently completed second fiscal quarter: $43,356,952 (as of November 30, 2012).

Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date. As of July 31, 2013, the registrant had 30,798,150 shares of common stock outstanding.

DOCUMENTS INCORPORATED BY REFERENCE

 

Document

   Parts Into  Which
Incorporated

Portions of Proxy Statement for the 2013 Annual Meeting of Shareholders (“Proxy Statement”)

   Part III

 

 

 


Table of Contents

CYTODYN INC.

FORM 10-K FOR THE YEAR ENDED MAY 31, 2013

Table of Contents

 

         Page  
PART I      2   

ITEM 1.

 

BUSINESS

     2   

ITEM 1A.

 

RISK FACTORS

     9   

ITEM 1B.

 

UNRESOLVED STAFF COMMENTS

     21   

ITEM 2.

 

PROPERTIES

     21   

ITEM 3.

 

LEGAL PROCEEDINGS

     21   

ITEM 4.

 

MINE SAFETY DISCLOSURES

     21   
PART II      21   

ITEM 5.

 

MARKET FOR REGISTRANTS COMMON EQUITY , RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

     21   

ITEM 6.

 

SELECTED FINANCIAL DATA

     22   

ITEM 7.

 

MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

     22   

ITEM 7A.

 

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

     26   

ITEM 8.

 

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

     27   

ITEM 9.

 

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

     62   

ITEM 9A.

 

CONTROLS AND PROCEDURES

     62   

ITEM 9B.

 

OTHER INFORMATION

     63   
PART III      64   

ITEM 10.

 

DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

     64   

ITEM 11.

 

EXECUTIVE COMPENSATION

     64   

ITEM 12.

 

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

     64   

ITEM 13.

 

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE

     64   

ITEM 14.

 

PRINCIPAL ACCOUNTANT FEES AND SERVICES

     64   
PART IV      64   

ITEM 15.

 

EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

     64   

 

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THROUGHOUT THIS FILING, WE MAKE FORWARD-LOOKING STATEMENTS. THE WORDS “ANTICIPATE,” “BELIEVE,” “EXPECT,” “INTEND,” “PREDICT,” “PLAN,” “SEEK,” “ESTIMATE,” “PROJECT,” “WILL,” “CONTINUE,” “COULD,” “MAY,” AND SIMILAR TERMS AND EXPRESSIONS WILL FREQUENTLY IDENTIFY FORWARD-LOOKING STATEMENTS. THESE STATEMENTS INCLUDE, AMONG OTHERS, INFORMATION REGARDING FUTURE OPERATIONS, FUTURE CAPITAL NEEDS, EXPENDITURES AND ADEQUACY, AND FUTURE NET CASH FLOWS. SUCH STATEMENTS REFLECT THE COMPANY’S CURRENT VIEWS WITH RESPECT TO FUTURE EVENTS AND FINANCIAL PERFORMANCE AND INVOLVE RISKS AND UNCERTAINTIES, INCLUDING, WITHOUT LIMITATION, RISKS AND UNCERTAINTIES RELATING TO (i) GENERAL ECONOMIC AND BUSINESS CONDITIONS, (ii) CHANGES IN FOREIGN, POLITICAL, AND SOCIAL CONDITIONS, (iii) REGULATORY INITIATIVES, COMPLIANCE WITH GOVERNMENTAL REGULATIONS AND THE REGULATORY APPROVAL PROCESS, (iv) OUR ABILITY TO DEVELOP AND ACHIEVE APPROVAL OF A MARKETABLE PRODUCT, (v) DESIGN, IMPLEMENTATION AND CONDUCT OF CLINICAL TRIALS, (vi) THE POSSIBILITY OF UNFAVORABLE CLINICAL TRIAL RESULTS, (vii) THE SPECIFIC RISK FACTORS DISCUSSED IN ITEM 1A. BELOW, AND (viii) VARIOUS OTHER MATTERS, MANY OF WHICH ARE BEYOND THE COMPANY’S CONTROL. SHOULD ONE OR MORE OF THESE RISKS OR UNCERTAINTIES DEVELOP, OR SHOULD UNDERLYING ASSUMPTIONS PROVE TO BE INCORRECT, ACTUAL RESULTS MAY VARY MATERIALLY AND ADVERSELY FROM THOSE ANTICIPATED, BELIEVED, ESTIMATED, OR OTHERWISE INDICATED BY OUR FORWARD–LOOKING STATEMENTS.

PART I

 

Item 1. Business.

Overview / Corporate History

CytoDyn Inc. (the “Company”) is a Colorado corporation, with its principal business office at 5 Centerpointe Drive, Suite 400, Lake Oswego, Oregon 97035; telephone: (971) 204-0382, and website address: www.cytodyn.com. Unless the context otherwise requires, references in this report to “CytoDyn,” “our,” “we,” “us,” or the “Company” are to CytoDyn Inc. and its subsidiaries.

We are a publicly traded development stage biotechnology company focused on developing and potentially marketing a class of therapeutic monoclonal antibodies to treat Human Immunodeficiency Virus (“HIV”) infection. Our lead product candidate, PRO 140, belongs to a class of HIV therapies known as entry inhibitors. These therapies potentially block HIV from entering into and infecting certain cells. Although CytoDyn intends to focus its efforts on PRO 140, the Company also holds certain rights in two proprietary platform technologies: Cytolin®, a monoclonal antibody targeting HIV with a mechanism of action which may prove to be synergistic to that of PRO 140 and other treatments, and CytoFeline™, a monoclonal antibody targeting Feline Immunodeficiency Virus (“FIV”).

PRO 140

We believe the PRO 140 antibody shows promise as a powerful anti-viral agent while not being a drug, which means fewer side effects and less frequent dosing requirements as compared to daily drug therapies currently in use. The PRO 140 antibody belongs to a class of HIV therapies known as entry inhibitors that block HIV from entering into and infecting certain cells. PRO 140 blocks HIV from entering a cell by binding to a molecule called CCR5, a normal cell surface receptor protein to which HIV attaches as part of HIV’s entry into a cell.

PRO 140 is an antibody and not a drug, and through preliminary, short-term trials it has demonstrated efficacy without issues relating to toxicity and autoimmune resistance. Moreover, these trials suggested that PRO 140 does not affect the normal function of the CCR5 receptor. Instead, PRO 140 binds to a precise site on CCR5 that HIV uses to enter the cell and, in doing so, inhibits the ability of HIV to infect the cell without affecting the cell’s normal function.

 

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PRO 140 was originally developed by Progenics Pharmaceuticals, Inc. (“Progenics”). Progenics led, and contributed to funding of, PRO 140 development and trials through 2011. We acquired the asset from Progenics in October 2012. Current collaborative research relating to PRO 140 planned for late 2013 is being conducted by Jeffrey M. Jacobson, M.D., Professor of Medicine, Microbiology and Immunology, Chief, Drexel University College of Medicine (“Drexel”), and is partially funded through two grants awarded to Drexel and Dr. Jacobson by the National Institutes of Health (“NIH”).

To date, PRO 140 has only been tested and administered to test subjects either intravenously or as a subcutaneous injection. We believe, however, that, if PRO 140 is approved for use as an injectible by the U.S. Food and Drug Administration (the “FDA”), it may be an attractive and marketable therapeutic option (for patients with healthy CCR5) particularly in the following scenarios:

 

   

Patients with multi-drug resistant viruses;

 

   

Patients with difficulty adhering to daily drug regimens;

 

   

Patients who poorly tolerate existing therapies;

 

   

Patients with compromised organ function, such as HCV co-infection; and

 

   

Patients with complex concomitant medical requirements.

We believe PRO 140 has demonstrated potent, long-lived (as compared to existing treatments) antiretroviral activity and an encouraging safety profile in initial clinical testing, that PRO 140 has the potential to be the first long-acting (weekly or every other week), self-administered HIV therapy, and that PRO 140 may inhibit CCR5-tropic HIV while preserving CCR5’s natural activity. PRO 140 also appears to broadly inhibit drug-resistant CCR5-tropic HIV viruses, including those resistant to small-molecule anti-CCR5 HIV therapies. It has no effect on strains of HIV that enter through the CXCR4 cell portal. Overall, we believe PRO 140 represents a distinct class of CCR5 inhibitors with unique virological and immunological properties and may provide another distinct tool to treat HIV-infected subjects developing resistance to other therapies.

The Company acquired PRO 140, as well as certain other related assets, including the existing inventory of PRO 140 bulk drug substance, intellectual property, and FDA regulatory filings, pursuant to an Asset Purchase Agreement, dated as of July 25, 2012, (the “Progenics Agreement”) between CytoDyn and Progenics. The terms of the Progenics Agreement provided for an initial cash payment of $3,500,000, which was paid at closing in October 2012, as well as the following milestone payments and royalties to be paid to Progenics in the future: (i) $1,500,000 at the time of the first dosing in a U.S. Phase III trial or non-U.S. equivalent; (ii) $5,000,000 at the time of FDA approval of the first U.S. new drug application or other non-U.S. approval for the sale of PRO 140; and (iii) royalty payments of 5% of net sales during the period beginning on the date of the first commercial sale of PRO 140 until the later of (a) the expiration of the last to expire patent included in the acquired assets, and (b) 10 years following the first commercial sale of PRO 140, in each case determined on a country-by-country basis.

In connection with the Progenics Agreement, the Company assumed Progenics’ rights and obligations under an additional license agreement (the “PDL License”) with Protein Design Labs, Inc. (now AbbVie, Inc.), pursuant to which CytoDyn is required to pay the following milestone payments and royalties: (i) $1,000,000 upon initiation of a Phase III clinical trial of a licensed product; (ii) $500,000 at filing a new drug application for PRO 140 in the U.S. or non-U.S. equivalent; (iii) $500,000 at the time of FDA approval of the first U.S. new drug application or other approval for sale by certain non-U.S. regulatory bodies; and (iv) royalties of up to seven and one-half percent (7.5%) of net sales payable to licensors or sublicensees during the period beginning on the date of the first commercial sale of PRO 140 until the later of (a) the expiration of the last to expire patent licensed and (b) 10 years following the first commercial sale of PRO 140. The PDL License also provides for an annual maintenance fee of $150,000 until royalties exceed that amount.

As an integral part of CytoDyn’s acquisition of PRO 140, we entered into a collaboration agreement with Drexel, whereby CytoDyn will provide Drexel with the necessary quantity of PRO 140 to conduct the clinical trials and CytoDyn will have access to all clinical trial data and the right to use such data to maintain the IND (Investigational New Drug application) for PRO 140 and to support its application to the FDA.

 

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Other Product Candidates

A second product candidate, Cytolin, is also a monoclonal antibody. It targets a normal cell molecule called CD11a, part of the heterodimer that makes up the cell adhesion molecule lymphocyte function cell associated antigen. Published reports have suggested that blocking or engaging CD11a might limit or prevent HIV infection of CD4 cells and monocytes. We acquired rights to Cytolin in October 2003 pursuant to an agreement with CytoDyn of New Mexico, Inc. (“CytoDyn NM”). As part of the transaction, we acquired the drug candidate Cytolin and were assigned rights under the patent license agreement dated July 1, 1994, between CytoDyn NM and Allen D. Allen, covering United States Patent No. 5,651,970 (which describes a method for treating HIV disease with the use of monoclonal antibodies), including the worldwide, exclusive right to develop, market and sell compounds disclosed by the patent, to practice methods taught by the patent, and to exploit specified technology related to the patent. This patent is for a murine (mouse) version of the drug. The license agreement expires on the original expiration date of the patent in July 2014. On September 23, 2011, the Company filed a provisional patent application (Serial No. 61/534,942) in the United States for its humanized version of Cytolin, a monoclonal antibody for the treatment of HIV infection. On September 13, 2012, we filed an international patent application (Serial No. PCT/US2012/055132) claiming priority to a United States provisional patent application for our humanized version of Cytolin.

In May 2011, we formed CytoDyn Veterinary Medicine LLC (“CVM”) to explore the possible application of feline reactive monoclonal antibodies for the treatment of FIV. On June 17, 2011, the Company filed a provisional patent application in the United States (Serial No. 61/498,029) for the use of these antibodies, as well as selected small molecule antagonists and agonists for the treatment of FIV. On June 15, 2012, the Company filed an international patent application (Serial No. PCT/US2012/042693) claiming priority to this provisional patent application.

Until the clinical trials for PRO 140 commence, we plan to devote only a modest amount of resources towards the approval or commercialization of Cytolin or CytoFeline.

Product Development and Research Status of PRO 140

Phase I and IIa clinical trials of PRO 140 were completed by Dr. Jacobson of Drexel prior to our acquisition of PRO 140. A total of 113 subjects were treated for a period of up to three weeks with as much as a 324 mg dose of PRO 140 administered weekly subcutaneously and 10mg/kg intravenously. Clinical results indicated a reduction of circulating HIV RNA—an index of circulating virus—of up to 2.17 logs intravenously and 1.77 logs subcutaneously (nearly a factor of a hundred) that persists for at least two weeks between injections at the 324 mg dose level. This response is similar in magnitude to that seen with any other single anti-HIV therapeutic agent. With respect to subcutaneously-administered trials, no significant safety signals were observed, with only minor irritation at the injection site in some subjects. While all protein therapeutic products are likely to have some immunogenicity—that is, to cause the recipient to make antibodies against the protein therapeutic product—only mild immunogenic responses were seen in a small number of subjects, and none of the immune response was associated with adverse effects or with an interference in the ability of PRO 140 to bind to its intended CCR5 target. Further trials are needed to determine the exposure time required for immunogenic responses to become significant.

Information regarding past and current study design, objectives and results are available at www.clinicaltrials.gov. To review these records, enter “PRO 140” as the search term.

As clinical protocols are finalized for planned clinical trials expected to commence in late 2013, management, its clinical advisors, and Dr. Jacobson intend to meet with the FDA to ensure that the final clinical protocols are fully aligned with the FDA’s prior guidance to Progenics, wherein the FDA designated PRO 140 as a candidate for fast track approval, and to independently confirm that such protocols are fully aligned with what is believed to be the most important clinical evaluation criteria supporting the highest commercial opportunities for PRO 140.

Research History of Cytolin Compound

In 1993, six HIV-infected patients were treated with murine Cytolin. Blood and skin tests of these patients suggested that the antibody might be producing improvements in the immune function of each patient.

 

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Based on the results of this pilot study, a compassionate use trial was initiated. In this study a relatively small number of physicians in the United States administered Cytolin to their HIV-infected patients over two years. As results from this initial use became available, other physicians obtained and administered Cytolin to their patients as well. Four of the doctors using Cytolin allowed the Company’s predecessor to send in an independent Institutional Review Board to inspect the medical records of approximately 200 patients treated with Cytolin once or twice a month over 18 months. Data were recorded and summarized and formed part of the material presented to the FDA as an early indication of the safety and potential efficacy of Cytolin.

To date, only the murine version of Cytolin has been tested in clinical, research and development studies. The Company understands that registrational studies will require similar testing and confirmation of activity with its proprietary humanized version of Cytolin should it want to pursue this product.

The Company may explore the initiation of a study of Cytolin and PRO 140 used in combination to evaluate the possibility of collaborating with other companies in an effort to develop a course of treatment similar to the current standard known as HAART—Highly Active Antiretroviral Therapy—based on antibodies. Current business plans, however, are focused on PRO 140.

Under a Clinical Trial Agreement dated September 28, 2009 and as amended to date (the “Clinical Trial Agreement”), in exchange for a research grant by the Company, Massachusetts General Hospital (“MGH”) in Boston, Massachusetts conducted an ex-vivo study of murine Cytolin in accordance with a study protocol entitled “An observational study to determine the in-vitro immunologic and virology activity of Cytolin” (the “Study”). In addition to providing financial support for the Study, the Company agreed to provide MGH with supplies of Cytolin needed for the Study. Under the Clinical Trial Agreement, Eric S. Rosenberg, M.D. was designated as the Principal Investigator for the Study.

Ten adults with early HIV infection and 10 healthy adults were enrolled in the Study, all of whom were required to participate for six months. Each patient enrolled in the study donated blood to allow the study of the effects of Cytolin when it was added in the test tube to their peripheral blood mononuclear cells. The Study design and objectives are available at www.clinicaltrials.gov, ID NCT01048372. To review public records for the Study on the government’s website, enter “Cytolin” as the search term (case sensitive).

The Study was completed in December 2012. Dr. Rosenberg submitted a manuscript detailing his results, which can be found at Rychert J, Jones L, McGrath G, et al. A monoclonal antibody against lymphocyte function-associated antigen-1 decreases HIV-1 replication by inducing the secretion of an antiviral soluble factor. J Virol. 2013; 10:120. The release of this or any data from the Study is entirely dependent on Dr. Rosenberg.

The Study was a science-intensive research study and was not intended to function as a registrational study (see “Registrational Clinical Trials Process” below). A clinical trial would be necessary to continue to explore Cytolin and none is currently planned. The Company will determine if clinical trials with the humanized version of Cytolin are warranted based on results from studies with the murine molecule and available resources.

Patents and Proprietary Technology

Protection of our intellectual property rights is important to our business. We may file patent applications in the U.S., Canada, Japan, European countries that are party to the European Patent Convention and other countries on a selective basis in order to protect inventions we consider to be important to the development of our business.

Generally, patents issued in the U.S. are effective for either (i) 20 years from the earliest asserted filing date, if the application was filed on or after June 8, 1995, or (ii) the longer of 17 years from the date of issue or 20 years from the earliest asserted filing date, if the application was filed prior to that date, subject to a five-year extension in certain instances. The duration of foreign patents varies in accordance with the provisions of applicable local law, although most countries provide for patent terms of 20 years from the earliest asserted filing date and allow patent extensions similar to those permitted in the U.S.

Patents may not enable us to preclude competitors from commercializing drugs in direct competition with our products, and consequently may not provide us with any meaningful competitive advantage. See Item 1A below. We

 

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may also rely on trade secrets and proprietary know-how to develop and attempt to achieve a competitive position in our product areas. We generally require our employees, consultants and partners who have access to our proprietary information to sign confidentiality agreements in an effort to protect our intellectual property.

Information with respect to our current patent portfolio is set forth below.

 

     Number of Patents             Number of Patent
Applications
 

Product Candidates

   U.S.      International      Expiration
Dates(1)
     U.S.      International  

PRO 140

     15         18         2015-2031         6         17   

Cytolin(2)

     1         —           2014         1         1   

CytoFeline(2)

     —           —           —           —           1   

 

(1) 

Patent term extensions and pending patent applications may extend periods of patent protection.

(2) 

Our former patent counsel has filed liens against two applications relating to humanized Cytolin (PCT/US2012/055132) and to CytoFeline (PCT/US2012/042693) based on related unpaid legal fees.

Additional detail regarding our patents and patent applications is available upon request. In connection with our acquisition of rights to PRO 140, our patent counsel conducted a freedom-to-operate search that identified other patents that could relate to our proposed PRO 140 drug candidate. Sufficient research and analysis was conducted to enable us to reach the conclusion that PRO 140 likely does not infringe those patent rights. However, we did not have an exhaustive analysis conducted as to the identified patent rights because doing so would have been more costly than appeared to be justified. The validity of issued patents, patentability of claimed inventions in pending applications and applicability of any of our development programs are uncertain and subject to change, and patent rights asserted against us could adversely affect our ability to commercialize or collaborate with others on specific products. See Item 1A below.

Research, development and commercialization of a biopharmaceutical product often require choosing between alternative development and optimization routes at various stages in the development process. Preferred routes depend upon current—and may be affected by subsequent—discoveries and test results, availability of financial resources, and other factors, and cannot be identified with certainty. There are numerous third-party patents in fields in which we work, and we may need to obtain licenses under patents of others in order to pursue a preferred development route of one or more of our product candidates. The need to obtain a license would decrease the ultimate value and profitability of an affected product. If we cannot negotiate such a license, we might have to pursue a less desirable development route or terminate the program altogether.

Government Regulation

Regulation of Health Care Industry

The health care industry is highly regulated, and state and federal health care laws and regulations are applicable to certain aspects of our business. For example, there are federal and state health care laws and regulations that apply to the operation of clinical laboratories, the business relationships between health care providers and suppliers, the privacy and security of health information and the conduct of clinical research.

Regulation of Products

The design, testing, manufacture, safety, effectiveness, labeling, storage, record keeping, approval, advertising and promotion of our products is regulated by numerous third parties, including the FDA, foreign governments, independent standards auditors and our customers.

In the United States, biological products have long been subject to regulation by various federal and state agencies, primarily as to product safety, efficacy, manufacturing, advertising, labeling, import, export and safety reporting. The exercise of broad regulatory powers by the FDA through its Center for Devices and Radiological

 

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Health and its Center for Biological Evaluation and Research continues to result in increases in the amounts of testing and documentation for FDA clearance of current and new biologic products. The FDA can ban certain biological products; detain or seize adulterated or misbranded biological products; order repair, replacement or refund of these products; and require notification of health professionals and others with regard to biological products that present unreasonable risks of substantial harm to the public health. The FDA may also enjoin and restrain certain violations of the Federal Food, Drug and Cosmetic Act, as amended, or the Public Health Service Act pertaining to certain biological products or initiate action for criminal prosecution of such violations.

The lengthy process of seeking drug approvals, and the subsequent compliance with applicable statutes and regulations, require the expenditure of substantial resources. Failure to comply with applicable regulations can result in refusal by the FDA to approve product license applications. The FDA also has the authority to revoke previously granted product approvals.

Regulation of Laboratory Operations

Clinical laboratories that perform laboratory testing (except for research purposes only) on human subjects are subject to regulation under Clinical Laboratory Improvement Amendments (“CLIA”). CLIA regulates clinical laboratories by requiring that the laboratory be certified by the federal government, licensed by the state and comply with various operational, personnel and quality requirements intended to ensure that clinical laboratory test results are accurate, reliable and timely. State law and regulations also apply to the operation of clinical laboratories.

State Governments

Most states in which we operate have regulations that parallel federal regulations. Most states conduct periodic unannounced inspections and require licensing under such state’s procedures. Our research and development activities and the manufacture and marketing of our products are and will be subject to rigorous regulations relating to product safety and efficacy by numerous governmental authorities in the United States and other countries.

Other Laws and Regulations

We are subject to various laws and regulations relating to safe working conditions, clinical, laboratory and manufacturing practices, the experimental use of animals and the use and disposal of hazardous or potentially hazardous substances, including radioactive compounds and infectious disease agents, used in connection with our research. The extent of government regulation applying to our business that might result from any legislative or administrative action cannot be accurately predicted.

Environmental

We are subject to a variety of federal, state and local environmental protection measures. We believe that our operations comply in all material respects with applicable environmental laws and regulations. Our compliance with these regulations did not have during the past year and is not expected to have a material effect upon our capital expenditures, cash flows, earnings or competitive position.

Registrational Clinical Trials Process

Described below is the traditional registrational drug development track. Under the Company’s current business plan, most of this initial work may be sponsored and conducted by Drexel, or a different clinical trial research facility, as determined at some point in the future. After these trials have been initiated, the Company could enter into a strategic alliance with a larger pharmaceutical company after development has progressed to a certain point.

Phase I

Phase I includes the initial introduction of an investigational new drug or biologic into humans. These studies are closely monitored and may be conducted in patients, but are usually conducted in a small number of healthy volunteer subjects. These studies are designed to determine the metabolic and pharmacologic actions of the investigational product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase I, sufficient information about the investigational product’s pharmacokinetics and pharmacological effects are obtained to permit the design of well-controlled, scientifically valid, Phase II studies.

 

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Phase II

Phase II includes the early controlled clinical studies conducted to obtain some preliminary data on the effectiveness of the drug for a particular indication or indications in patients with the disease or condition. This phase of testing also helps determine the common short-term side effects and risks associated with the drug. Phase II studies are typically well-controlled, closely monitored, and conducted in a relatively small number of patients, usually involving several hundred people. In some cases, depending upon the need for a new drug, it may be licensed for sale in interstate commerce after a “pivotal” Phase II trial.

Phase II is often broken into Phase IIa, which can be used to refer to “pilot trials,” or more limited trials evaluating exposure response in patients, and Phase IIb trials that are designed to evaluate dosing efficacy and ranges. We believe trials to be commenced in late 2013 under the direction of Dr. Jacobson at Drexel will collectively constitute a Phase IIb trial.

Phase III

Phase III studies are expanded controlled clinical studies. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained in Phase II, and are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit/risk relationship of the drug. Phase III studies also provide an adequate basis for extrapolating the results to the general population and transmitting that information in the physician labeling. Phase III studies usually include several hundred to several thousand people.

As described above, we are currently working with Dr. Jacobson to begin two additional clinical trials of PRO 140, which we believe will satisfy requirements for Phase IIb study of the product candidate. Dr. Jacobson has received two NIH grants to fund these clinical trials. It is critical to our business strategy and estimated capital requirements that the current clinical trials by Dr. Jacobson both be fully funded by the existing NIH grants and achieve results that enable us to proceed further along the regulatory approval process and maintain PRO 140’s status as a candidate for fast track consideration by the FDA.

Competition

The pharmaceutical and biotechnology industries are characterized by rapidly evolving technology and intense competition. We compete with other more established biotechnology companies that have greater financial and managerial resources than we do.

Our current focus is on developing PRO 140 and, to a lesser extent, Cytolin, which are both monoclonal antibodies that have been shown to act as HIV entry inhibitors in preliminary testing. PRO 140 blocks a cell receptor called CCR5, which is the entry point for most strains of HIV virus. Pfizer’s maraviroc (Selzentry®) is the only currently approved CCR5 blocking agent. Another recent entry into the HIV treatment space is Truvada, an HIV drug produced by Gilead Sciences, Inc. Both of these drugs must be taken daily and have significant side effects. For these reasons, we believe that our monoclonal antibody products may prove to be useful in patients that cannot tolerate existing HIV therapies. Nonetheless, manufacturers of current therapies, such as Pfizer and Gilead Sciences, are very large, multi-national corporations with significant resources. We expect that these companies will compete fiercely to defend and expand their market share.

Our potential competitors include entities that develop and produce therapeutic agents. These include numerous public and private academic and research organizations and pharmaceutical and biotechnology companies pursuing production of, among other things, biologics from cell cultures, genetically engineered drugs and natural and chemically synthesized drugs. All of these potential competitors have substantially greater capital resources, management expertise, research and development capabilities, manufacturing and marketing resources and experience than we do.

 

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Our competitors may succeed in developing potential drugs or processes that are more effective or less costly than any that may be developed by us, or that gain regulatory approval prior to our potential drugs. Worldwide, there are many antiviral drugs for treating HIV. In seeking to manufacture, distribute and market the various potential drugs we intend to develop, we face competition from established pharmaceutical companies. All of our potential competitors in this field have considerably greater financial and management resources than we possess. We also expect that the number of our competitors and potential competitors will increase as more potential drugs receive commercial marketing approvals from the FDA or analogous foreign regulatory agencies. Any of these competitors may be more successful than us in manufacturing, marketing and distributing our potential drugs.

Research and Development Costs

Our sponsored research and development expenses were $619,838, $530,027 and $3,379,333 in fiscal 2013, 2012 and for the period October 28, 2003 through May 31, 2013, respectively. We expect that research and development expenses will continue to be a significant expense as we seek to develop our current and future product pipeline.

Employees and Consultants

We have two full-time employees, our CEO and CFO, as well as several independent consultants assisting us with preparations for our Phase IIb clinical trials of PRO 140. There can be no assurance that we will be able to identify or hire and retain additional employees or consultants on acceptable terms in the future.

 

Item 1A. Risk Factors.

The risks enumerated below are not the only risks we face. The risk factors are not intended to be an all-inclusive discussion of all of the potential risks relating to CytoDyn. Any of the risk factors described below could significantly and adversely affect our business, prospects, financial condition and results of operations. Additional risks and uncertainties not currently known or that are currently considered to be immaterial may also materially and adversely affect our business.

We are a development-stage company and have a history of significant operating losses; we expect to continue to incur operating losses, and we may never achieve or maintain profitability.

We have not generated any revenue from product sales or licensing to date. Since our inception, we have incurred operating losses in each year due to costs incurred in connection with our collaborative research and development activities and general and administrative expenses associated with our operations. Our drug candidates are in the early stages of testing, and we or our current and future partners must conduct significant additional clinical trials before we can seek the regulatory approvals necessary to begin commercial sales of our products. We expect to incur losses for at least several more years as we continue development of, and seek regulatory approvals for, our drug candidates and commercialize any approved products. If our drug candidates fail or do not gain regulatory approval, or if our products do not achieve market acceptance, we will not be profitable, nor be able to explore other opportunities to enhance shareholder value. If we fail to become and remain profitable, or if we are unable to fund our continuing losses, our shareholders could lose all or part of their investments.

We will need substantial additional funding, which may not be available or, if it is available, such financing may substantially dilute our existing shareholders.

The discovery, development, and commercialization of new treatments, such as our PRO 140 product candidate, is costly. As a result, to the extent continued review of our product candidate by us or our partners is promising and we elect to fund the development or commercialization of a product, we will need to raise additional capital, or enter into strategic partnerships, to enable us to:

 

   

fund clinical trials and seek regulatory approvals;

 

   

build or access manufacturing and commercialization capabilities;

 

   

develop, test, and market our product candidates;

 

   

implement additional internal systems and infrastructure; and

 

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hire and support additional management and scientific personnel.

Until we can generate a sufficient amount of product revenue to finance our cash requirements, which we may never achieve, we expect to finance our cash needs primarily through public or private equity offerings, debt financings or through strategic alliances. We cannot be certain that additional funding will be available on acceptable terms or at all. If we are not able to secure additional funding when needed, we may have to delay, reduce the scope of or eliminate one or more of our clinical trials, collaborative development programs or future commercialization initiatives. In addition, any additional funding that we do obtain will dilute the ownership held by our existing security holders. The amount of this dilution may be substantially increased if the trading price of our common stock is lower at the time of any financing then it is now or was at the time shares were acquired. Any debt financing could involve substantial restrictions on activities and creditors could seek a pledge of some or all of our assets. We have not identified the sources for the additional financing that we will require, and we do not have commitments from any third parties to provide this future financing. If we fail to obtain additional funding as needed, we may be forced to cease or scale back operations, and our results, financial condition and stock price would be adversely affected.

The amount of financing we require will depend on a number of factors, many of which are beyond our control. Our results of operations, financial condition and stock price are likely to be adversely affected if our funding requirements increase or are otherwise greater than we expect.

Our future funding requirements will depend on many factors, including, but not limited to:

 

   

our stock price, which, if it stays flat or declines, would serve as a disincentive to holders of the Company’s convertible promissory notes, totaling approximately $7.2 million at July 31, 2013, to exercise their conversion rights, thereby prolonging our interest expense burden and increasing the probability that repayment of principal of $1.8 million will be required in fiscal 2014, none in fiscal 2015, and $5.4 million in fiscal 2016;

 

   

the rate of progress and costs borne by us related to clinical trials of PRO 140 being conducted at Drexel and other development activities;

 

   

our ability to attract strategic partners to pay for or share costs related to our product development efforts;

 

   

the costs and timing of seeking and obtaining regulatory approvals and related milestone payments due to Progenics and other third parties;

 

   

the costs of filing, prosecuting, maintaining and enforcing patents and other intellectual property rights and defending against potential claims of infringement;

 

   

whether or not we decide to hire additional scientific or administrative personnel or consultants; and

 

   

the presence or absence of adverse developments in our collaborative research program.

If any of these factors cause our funding needs to be greater than expected, our operations, financial condition, ability to continue operations and stock price may be adversely affected.

Our future cash requirements may differ significantly from our current estimates.

We recognize that we will need to raise a significant amount of capital now and in the future in order to pursue our business plans. Our cash requirements may differ significantly from our estimates from time to time, depending on a number of factors, including:

 

   

The ability to maintain and benefit from our Clinical Research Collaboration Agreement with Drexel;

 

   

the results of clinical trials to be performed with PRO 140;

 

   

the time and costs involved in obtaining regulatory approvals, if any are sought;

 

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whether or not we receive additional cash upon the exercise of our outstanding common stock warrants;

 

   

whether or not we are required to pay our debt obligations, including repayment of our outstanding promissory notes totaling approximately $7.7 million at July 31, 2013, in cash, which will depend on whether noteholders exercise rights to convert their notes into other securities;

 

   

the ability to obtain funding under future licensing agreements, strategic partnerships, or other collaborative relationships, if any;

 

   

the costs involved in obtaining and maintaining patents or pursuing or defending litigation regarding intellectual property rights;

 

   

the costs of compliance with laws, regulations, or judicial decisions applicable to us, including federal and state securities laws; and

 

   

the costs of general and administrative infrastructure required to manage our business and protect shareholder assets.

If we cannot raise the funds we need to pursue our business strategies and operate our business, we will need to scale back our business plans or may even be forced to discontinue our operations. Our business, financial condition, and stock price would be negatively affected by any of these outcomes.

We have significant debt as a result of prior financings, all of which is scheduled to mature at various dates over the next three years. Our substantial indebtedness could adversely affect our business, financial condition and results of operations.

Our level of debt, which includes convertible promissory notes totaling $7.2 million and other promissory notes in the amount of $0.5 million at July 31, 2013, could have significant consequences on our future operations, including, among others:

 

   

making it more difficult for us to meet our other obligations or raise additional capital;

 

   

resulting in an event of default, if we fail to comply with our payment obligations;

 

   

reducing the availability of any financing proceeds to fund operating expenses, debt repayment, and working capital, particularly if we are required to repay notes in the amounts of (i) $1.1 million, at maturities scheduled to occur before the close of fiscal 2014, and (ii) $1.2 million on February 1, 2014, or earlier certain rights to require repayment are triggered and exercised;

 

   

limiting our financial flexibility and hindering our ability to obtain additional financing; and

 

   

placing us at a disadvantage compared to our competitors that have less debt or are less leveraged.

Any of the above-listed factors could have a material adverse effect on our business, financial condition, results of operations, and ability to continue as a going concern.

Our ability to make interest and principal payments on our outstanding promissory notes will depend entirely on our ability to raise sufficient funds to satisfy our debt service obligations and our noteholders’ willingness to convert their notes to common shares, which will likely depend on our stock price from time to time. If noteholders do not elect to convert, it is likely that we will need to borrow or raise additional funds to make required principal and interest payments, as such payment become due and payable, or undertake alternative financing plans, such as refinancing or restructuring our debt, selling additional shares of capital stock, selling assets or reducing or delaying investments in our business. Additional funds or alternative financing may not be available to us. Any inability to obtain additional funds or alternative financing on acceptable terms would likely cause us to be unable to meet our payment obligations, which could have a material adverse effect on our business, financial condition and results of operations and our ability to continue to operate.

 

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The Progenics Agreement and related license agreements assumed in the PRO 140 acquisition require us to make significant milestone, royalty, and other payments, which will require additional financing and, in the event we do commercialize our PRO 140 product, decrease the revenues we may ultimately receive on sales.

Under the Progenics Agreement, we must pay to Progenics and third party licensors significant milestone payments and royalties as described in Item 1 above. For more information, please see the Progenics Agreement, which is attached as an exhibit to the Company’s Current Report on Form 8-K filed with the SEC on July 30, 2012, and PDL License, which is filed as an exhibit to this report. In order to make the various milestone payments that are required, we will need to raise additional funds. In addition, our royalty obligations will reduce the economic benefits to us of future sales if we do receive regulatory approval and seek to commercialize PRO 140.

Our proposed clinical trials of PRO 140 depend on funding from the NIH grants awarded to Drexel and its principal investigator, Dr. Jacobson.

Prior to our acquisition of PRO 140, Progenics and Drexel and its principal investigator, Dr. Jacobson, were awarded various grants from the NIH to fund clinical trials of PRO 140, including two grants that remain open. In order to benefit from this continued funding, we are dependent on Dr. Jacobson’s cooperation in structuring the protocols for the NIH-funded clinical trials in a manner that facilitates efforts to maintain PRO 140’s “fast track” drug candidate designation by the FDA and obtain regulatory approval of commercially viable uses of PRO 140 in HIV-infected patients. We believe these clinical trials will constitute a Phase IIb study of PRO 140, but there can be no assurance that will be the case. If study protocols are not designed in a manner that provides commercial and regulatory benefits for us or if NIH funding is not awarded, withdrawn, or proves insufficient, we will need significant additional financing to self-fund our trials, and our expected costs and time to completion would increase significantly.

Clinical trials are expensive, time-consuming and subject to delay.

Clinical trials are subject to rigorous regulatory requirements and are expensive and time-consuming to design and implement. The length of time and number of trial sites and patients required for clinical trials vary substantially based on the type, complexity, novelty, intended use and any safety concerns relating to a drug candidate. We estimate that the clinical trials of our current drug candidate and any other drug candidates we decide to pursue will require several years to complete. Specifically, we estimate that it will take at least three years to complete the necessary clinical trials, obtain regulatory approval from the FDA or other non-U.S. regulatory agency, and begin to commercialize PRO 140. Clinical trials for our other drug candidates, including Cytolin, may take significantly longer to complete, if they are pursued at all.

The commencement and completion of our clinical trials could be delayed or prevented by many factors, including, but not limited to:

 

   

our ability to obtain regulatory or other approvals to commence and conduct clinical trials in the manner we or our partners consider appropriate for timely development;

 

   

our ability to identify and reach agreement on acceptable terms with prospective clinical trial sites and entities involved in the conduct of our clinical trials;

 

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slower than expected rates of patient recruitment and enrollment, including as a result of competition with other clinical trials for patients; limited numbers of patients that meet the enrollment criteria; or the introduction of alternative therapies or drugs by others;

 

   

delays in reaching agreement with our partners, such as Drexel, as to appropriate clinical development strategies or funding requirements;

 

   

delays in paying third-party vendors of biopharmaceutical services;

 

   

lack of effectiveness of our drug candidates during clinical trials;

 

   

unforeseen safety issues; or

 

   

inadequate supply of clinical trial materials.

Testing of our primary product candidate, PRO 140, is in early stages and our clinical trial results may not ultimately confirm initial positive indications, which would materially and adversely affect our business, financial condition and stock price.

Our efforts to commercialize PRO 140 are dependent on obtaining FDA or other non-U.S. regulatory agency approval of its use in HIV-infected patients. Although early test results are positive, the process of obtaining approval of a drug product for use in humans is extremely lengthy and time-consuming, and numerous factors may prevent our successful development of PRO 140, including negative results in future clinical trials, the development of other products with equal or better results by competitors, or inability to obtain sufficient additional funding to continue to pursue development. In addition, although PRO 140 has not demonstrated significant immunogenic response in trials conducted to date, these trials have been quite short (up to three weeks) and further trials are needed to determine whether the length of time until development of immunogenic response in humans is long enough for PRO 140 to be a viable treatment regimen. Failure to successfully develop PRO 140 would have a material and adverse effect on our business, financial condition and stock price, and would threaten our ability to continue to operate our business, particularly since PRO 140 is the only product candidate we are actively pursuing at this time.

Although PRO 140 has been designated as a candidate for fast track approval by the FDA, our ability to obtain accelerated approval may be lost.

The FDA designated PRO 140 as a candidate for fast track consideration in 2006. The letter ascribing this designation stated that, if the clinical development program pursued for PRO 140 did not continue to meet the criteria for fast track designation, the Investigational New Drug (“IND”) application would not be reviewed under the fast track program. There is no assurance that the FDA will ultimately consider PRO 140 for approval on an accelerated basis. Any failure to maintain eligibility for fast track review will likely result in requirements for longer or additional clinical trials and a slower approval process, resulting in additional costs and further delay in the potential realization of revenues from commercialization of PRO 140.

Any failure to attract and retain skilled directors, executives, employees and consultants could impair our drug development and commercialization activities.

Our business depends on the skills, performance, and dedication of our directors, executive officers and key scientific and technical advisors. Currently, we have only two employees, our President and Chief Executive Officer and our Chief Financial Officer. All of our current scientific advisors are independent contractors and are either self-employed or employed by other organizations. As a result, they may have conflicts of interest or other commitments, such as consulting or advisory contracts with other organizations, which may affect their ability to provide services to us in a timely manner. We may need to recruit additional directors, executive management employees, and advisers, particularly scientific and technical personnel, which will require additional financial resources. In addition, there is currently intense competition for skilled directors, executives and employees with relevant scientific and technical expertise, and this competition is likely to continue. If we are unable to attract and retain persons with sufficient scientific, technical and managerial experience, we may be forced to limit or delay our product development activities or may experience difficulties in successfully conducting our business, which would adversely affect our operations and financial condition.

 

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We do not have a chief medical officer, internal research and development operations, or a sales and marketing staff, which will increase our dependence on consulting relationships and strategic alliances with industry partners.

We currently have no chief medical officer, research and development staff or coordinators, or internal sales, marketing or distribution capabilities. We rely and intend to continue to rely on third parties for many of these functions. As a result, we will be dependent on consultants and strategic partners in our development and commercialization activities, and it may be administratively challenging to monitor and coordinate these relationships. If we are unable to successfully manage our relationships with third parties, we may not be able to successfully manage development and approval of our PRO 140 drug candidate or other products or commercialize any products that are approved.

We may not be able to identify, negotiate and maintain the strategic alliances necessary to develop and commercialize our products and technologies, and we will be dependent on our corporate partners if we do.

We may seek to enter into a strategic alliance with a pharmaceutical company for the further development and approval of one or more of our product candidates. Strategic alliances potentially provide us with additional funds, expertise, access, and other resources in exchange for exclusive or non-exclusive licenses or other rights to the technologies and products that we are currently developing or may explore in the future. We cannot give any assurance that we will be able to enter into additional strategic relationships with a pharmaceutical company or others in the near future or at all, or maintain our current relationships. In addition, we cannot assure you that any agreements we do reach will achieve our goals or be on terms that prove to be economically beneficial to us. When we do enter into strategic or contractual relationships, we become dependent on the successful performance of our partners or counter-parties. If they fail to perform as expected, such failure could adversely affect our financial condition, lead to increases in our capital needs, or hinder or delay our development efforts.

We will need to outsource and rely on third parties for the clinical development and manufacture, sales and marketing of product candidates, and our future success will be dependent on the timeliness and effectiveness of the efforts of these third parties.

We are dependent on third parties, such as Drexel, for important aspects of our product development strategy. We do not have the required financial and human resources to carry out independently the pre-clinical and clinical development for our product candidate, and do not have the capability or resources to manufacture, market or sell our current product candidates. As a result, we contract with and rely on third parties for important functions, including testing, storing, and manufacturing our products and managing and conducting clinical trials from which we may obtain a benefit. We have recently entered into several agreements with third parties for such services. In addition, we are dependent on clinical trials to be conducted by Dr. Jacobson at Drexel for completion of Phase IIb clinical trials that may enable us to proceed further in the regulatory approval process. If problems develop in our relationships with third parties, or if such parties fail to perform as expected, it could lead to delays or lack of progress, significant cost increases, changes in our strategies, and even failure of our product initiatives.

Clinical trials may fail to demonstrate the desired safety and efficacy of our drug candidates, which could prevent or significantly delay completion of clinical development and regulatory approval.

Prior to receiving approval to commercialize PRO 140 or any other drug candidates, we must adequately demonstrate to the FDA and any foreign regulatory authorities in jurisdiction in which we seek approval that it or any other product candidate is sufficiently safe and effective with substantial evidence from well-controlled clinical trials. In clinical trials, we will need to demonstrate efficacy for the treatment of specific indications and monitor safety throughout the clinical development process and following approval. If clinical work by us or others leads to undesirable adverse effects in patients, it could delay or prevent the filing of an Investigational New Drug application with respect to our potential drug candidates or cause us to cease clinical trials with respect to any drug candidate. If our current or future preclinical studies or clinical trials are unsuccessful, our business will be significantly harmed and our stock price would be negatively affected.

 

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Our drug candidates are subject to the risks of failure inherent in drug-related product development. Preclinical studies may not yield results that adequately support an IND application. Even if these applications are filed with respect to our drug candidates, the results of preclinical studies do not necessarily predict the results of clinical trials. In addition, even if we believe the data collected from clinical trials of our drug candidates are promising, these data may not be sufficient to support approval by the FDA or foreign regulatory authorities. If regulatory authorities do not approve our products or if we fail to maintain regulatory compliance, we would be unable to commercialize our products, and our business, results of operations and financial condition would be harmed.

Even if we obtain regulatory approvals, our products will be subject to ongoing regulatory review.

Following any initial regulatory approval of any products we may develop, we will also be subject to continuing regulatory review, including the review of adverse drug experiences and clinical results that are reported after our products are made commercially available. This would include results from any post-marketing tests or vigilance required as a condition of approval. The manufacturer and manufacturing facilities we use to make any of our products will also be subject to periodic review and inspection by the FDA. The discovery of any previously unknown problems with the product, manufacturer or facility may result in restrictions on the product or manufacturer or facility, including withdrawal of the product from the market. Reliance on third-party manufacturers entails risks, including the continuation of a contractual or other relationship with the third-party manufacturer, and reliance on the third-party manufacturer for regulatory compliance. Our product promotion and advertising also will be subject to regulatory requirements and continuing FDA review.

Our competitors may develop drugs that are more effective, safer and less expensive than ours, which may diminish or eliminate the commercial success of any drug candidates that we may commercialize.

We are engaged in the HIV treatment sector of the biopharmaceutical industry, which is intensely competitive and changes rapidly. We expect that new developments by other companies and academic institutions in the areas of HIV treatment will continue. If approved for marketing by the FDA, depending on the approved clinical indication, our drug candidates may be competing with existing and future antiviral treatments for HIV.

Our competitors may:

 

   

develop drug candidates and market drugs that are less expensive or more effective than our drugs;

 

   

commercialize competing drugs before we or our partners can launch any products developed from our drug candidates;

 

   

hold or obtain proprietary rights that could prevent us from commercializing our products;

 

   

develop drug candidates and market drugs that increase the levels of safety or efficacy that our drug candidates will need to show in order to obtain regulatory approval; or

 

   

introduce therapies or market drugs that render our potential drugs obsolete.

We will compete against large pharmaceutical and biotechnology companies and smaller companies that are collaborating with larger pharmaceutical companies, new companies, academic institutions, government agencies and other public and private research organizations. These competitors in nearly all cases operate research and development programs and have substantially greater financial resources than we do. Our competitors also have significantly greater experience in:

 

   

developing drug candidates;

 

   

undertaking preclinical testing and clinical trials;

 

   

building relationships with key customers and opinion-leading physicians;

 

   

obtaining and maintaining FDA and other regulatory approvals;

 

   

formulating and manufacturing drugs;

 

   

launching, marketing and selling drugs; and

 

   

providing management oversight for all of the above-listed operational functions.

 

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If our competitors market drugs that are less expensive, safer or more efficacious than our potential drugs, or that reach the market sooner or gain or maintain greater market acceptance, we may not achieve commercial success. In addition, if we fail to achieve technical superiority over other treatments, we may be unable to compete effectively.

We expect to rely on third party manufacturers and will be dependent on their quality and effectiveness.

Our primary drug candidate and potential drug candidates require precise, high-quality manufacturing. The failure to achieve and maintain high manufacturing standards, including failure to detect or control anticipated or unanticipated manufacturing errors or the frequent occurrence of such errors, could result in patient injury or death, discontinuance or delay of ongoing or planned clinical trials, delays or failures in product testing or delivery, cost overruns, product recalls or withdrawals and other problems that could seriously hurt our business. Contract drug manufacturers often encounter difficulties involving production yields, quality control and quality assurance and shortages of qualified personnel. These manufacturers are subject to stringent regulatory requirements, including the FDA’s current good-manufacturing-practices regulations and similar foreign laws and standards.

If one of our contract manufacturers fails to maintain ongoing compliance at any time, the production of our drug candidates could be interrupted, resulting in delays or discontinuance of our clinical trials, additional costs and loss of potential revenues. In addition, failure of any third-party manufacturers, or us, to comply with applicable regulations could result in sanctions. These sanctions could include fines, injunctions, civil penalties, failure of regulatory authorities to grant marketing approval of our products, delay, suspension or withdrawal of approvals, license revocation, product seizures or recalls, operational restrictions and criminal prosecutions, any of which could significantly and adversely affect our business.

We may not be able to successfully scale-up manufacturing of our drug candidates in sufficient quality and quantity, which would delay or prevent us from developing our drug candidates and commercializing resulting approved drugs, if any.

To date, our drug candidates have been manufactured in small quantities for preclinical studies and early-stage clinical trials. In order to conduct larger-scale or late-stage clinical trials for a drug candidate and for commercialization of the resulting product, if that drug candidate is approved for sale, we will need to manufacture it in larger quantities. We may not be able to successfully increase the manufacturing capacity for any of our drug candidates, whether in collaboration with third-party manufacturers or on our own, in a timely or cost-effective manner or at all. In addition, quality issues may arise during those scale-up activities. If we are unable to successfully scale up the manufacture of any of our drug candidates in sufficient quality and quantity, the development and testing of that drug candidate and regulatory approval or commercial launch of any resulting drugs may be delayed, which could significantly harm our business.

There is uncertainty relating to our drug candidate Cytolin, and our business may be adversely affected if it later proves not to have the novel and beneficial characteristics we currently believe it to possess.

Until late 2012, the primary focus of our business was on the development of Cytolin, a monoclonal antibody that has, what we believe, are novel mechanisms of action directed against the replication of HIV. We do not understand all of the biomechanical mechanisms of Cytolin at this time and we are not actively pursuing its development and review at this time. If we cannot determine how Cytolin acts to reduce the viral load of HIV infection, we may not seek or be able to obtain regulatory approval of its use in human patients.

We may be subject to potential product liability and other claims that could materially impact our business and financial condition.

The development and sale of medical products exposes us to the risk of significant damages from product liability and other claims. The use of our drug candidates in clinical trials may result in adverse effects. We cannot predict all the possible harms or adverse effects that may result. We do not maintain product liability insurance, but plan to obtain product liability insurance prior to the commencement of further clinical trials of PRO 140. We may

 

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not have sufficient resources to pay for any liabilities resulting from a personal injury or other claim, even if we do later become insured. In addition to the possibility of direct claims, we may be required to indemnify third parties against damages and other liabilities arising out of our development, commercialization and other business activities, which would increase our liability exposure. If third parties that have agreed to indemnify us fail to do so, we may be held responsible for those damages and other liabilities as well.

Legislative, regulatory, or medical cost reimbursement changes may adversely impact our business.

New laws, regulations and judicial decisions, or new interpretations of existing laws, regulations and decisions, that relate to the health care system in the U.S. and in other jurisdictions may change the nature of and regulatory requirements relating to drug discovery, clinical testing and regulatory approvals, limit or eliminate payments for medical procedures and treatments, or subject the pricing of pharmaceuticals to government control. Outside the U.S., and particularly in the European Union, the pricing of prescription pharmaceuticals is subject to governmental control. In addition, third-party payers in the U.S. are increasingly attempting to contain health care costs by limiting both coverage and the level of reimbursement of new drug products. Consequently, significant uncertainty exists as to the reimbursement status of newly approved health care products. Significant changes in the health care system in the U.S. or elsewhere, including changes resulting from adverse trends in third-party reimbursement programs, could have a material adverse effect on our projected future operating results and our ability to raise capital, commercialize products, and remain in business.

If we are unable to effectively implement or maintain a system of internal control over financial reporting, we may not be able to accurately or timely report our financial results and our stock price could be adversely affected.

Section 404 of the Sarbanes-Oxley Act of 2002 and related regulations require us to evaluate the effectiveness of our internal control over financial reporting as of the end of each fiscal year, and to include a management report assessing the effectiveness of our internal control over financial reporting in our Annual Report on Form 10-K for that fiscal year. Management determined that as of both May 31, 2012, and May 31, 2013, our disclosure controls and procedures and internal control over financial reporting were not effective due to material weaknesses in our internal control over financial reporting related to inadequate segregation of duties over authorization, review and recording of transactions as well as the financial reporting of such transactions. Any failure to implement new or improved controls necessary to remedy the material weaknesses described above, or difficulties encountered in the implementation or operation of these controls, could harm our operations, decrease the reliability of our financial reporting, and cause us to fail to meet our financial reporting obligations, which could adversely affect our business and reduce our stock price.

Our success depends substantially upon our ability to obtain and maintain intellectual property protection relating to our drug candidates and research technologies.

Due to evolving legal standards relating to the patentability, validity and enforceability of patents covering pharmaceutical inventions and the claim scope of patents, our ability to enforce our existing patents and to obtain and enforce patents that may issue from any pending or future patent applications is uncertain and involves complex legal, scientific and factual questions. To date, no consistent policy has emerged regarding the breadth of claims allowed in biotechnology and pharmaceutical patents. Thus, we cannot be sure that any patents will issue from any pending or future patent applications owned by or licensed to us. Even if patents do issue, we cannot be sure that the claims of these patents will be held valid or enforceable by a court of law, will provide us with any significant protection against competing products, or will afford us a commercial advantage over competitive products. If one or more products resulting from our drug candidates is approved for sale by the FDA and we do not have adequate intellectual property protection for those products, competitors could duplicate them for approval and sale in the U.S. without repeating the extensive testing required of us or our partners to obtain FDA approval.

 

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Known third party patent rights could delay or otherwise adversely affect our planned development and sale of PRO 140. We have identified but not exhaustively analyzed other patents that could relate to our proposed products.

We are aware of patent rights held by a third party that may cover certain compositions within our PRO 140 drug candidate. The patent holder has the right to prevent others from making, using, or selling a drug that incorporates the patented compositions, while the patent remains in force. We believe that the third party’s patent rights will not affect our planned development, regulatory clearance, and eventual marketing, commercial production, and sale of PRO 140. The relevant patent expires before we expect to commercially introduce that drug candidate. In addition, the Hatch-Waxman exemption to U.S. patent law permits all uses of compounds in clinical trials and for other purposes reasonably related to obtaining FDA clearance of drugs that will be sold only after patent expiration, so our use of PRO 140 in those FDA-related activities does not infringe the patent holder’s rights. However, were the patent holder to assert its rights against us before expiration of the patent for activities unrelated to FDA clearance, the development and ultimate sale of a PRO 140 product could be significantly delayed, and we could incur the expense of defending a patent infringement suit and potential liability for damages for periods prior to the patent’s expiration.

In connection with our acquisition of rights to PRO 140, our patent counsel conducted a freedom-to-operate search that identified other patents that could relate to our proposed PRO 140 drug candidate. Sufficient research and analysis was conducted to enable us to reach the conclusion that PRO 140 likely does not infringe those patent rights. However, we did not have an exhaustive analysis conducted as to the identified patent rights, because doing so would have been more costly than appeared to be justified. If any of the holders of the identified patents were to assert patent rights against us, the development and sale of PRO 140 could be delayed, we could be required to spend time and money defending patent litigation, and we could incur liability for infringement or be enjoined from producing our products if the patent holders prevailed in an infringement suit.

If we are sued for infringing on third-party intellectual property rights, it will be costly and time-consuming, and an unfavorable outcome would have a significant adverse effect on our business.

Our ability to commercialize our product candidates depends on our ability to use, manufacture and sell those products without infringing the patents or other proprietary rights of third parties. Numerous U.S. and foreign issued patents and pending patent applications owned by third parties exist in the monoclonal antibody therapeutic area in which we are developing drug candidates and seeking new potential drug candidates. There may be existing patents, unknown to us, on which our activities with our drug candidates could infringe.

If a third party claims that our actions infringe on its patents or other proprietary rights, we could face a number of issues that could seriously harm our competitive position, including, but not limited to:

 

   

infringement and other intellectual property claims that, even if meritless, can be costly and time-consuming, delay the regulatory approval process and divert management’s attention from our core business operations;

 

   

substantial damages for infringement, if a court determines that our drugs or technologies infringe a third party’s patent or other proprietary rights;

 

   

a court prohibiting us from selling or licensing our products or technologies unless the holder licenses the patent or other proprietary rights to us, which it is not required to do; and

 

   

even if a license is available from a holder, we may have to pay substantial royalties or grant cross-licenses to our patents or other proprietary rights.

If any of these events occur, it could significantly harm our operations and financial condition and negatively affect our stock price.

 

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We may undertake infringement or other legal proceedings against third parties, causing us to spend substantial resources on litigation and exposing our own intellectual property portfolio to challenge.

We may come to believe that third parties are infringing on our patents or other proprietary rights. To prevent infringement or unauthorized use, we may need to file infringement and/or misappropriation suits, which are very expensive and time-consuming and would distract management’s attention. Also, in an infringement or misappropriation proceeding a court may decide that one or more of our patents is invalid, unenforceable, or both, in which case third parties may be able to use our technology without paying license fees or royalties. Even if the validity of our patents is upheld, a court may refuse to stop the other party from using the technology at issue on the ground that the other party’s activities are not covered by our patents.

We may become involved in disputes with our present or future contract partners over intellectual property ownership or other matters, which would have a significant effect on our business.

Inventions discovered in the course of performance of contracts with third parties, may become jointly owned by our strategic partners and us, in some cases, and the exclusive property of one of us, in other cases. Under some circumstances, it may be difficult to determine who owns a particular invention or whether it is jointly owned, and disputes could arise regarding ownership or use of those inventions. Other disputes may also arise relating to the performance or alleged breach of our agreements with third parties. Any disputes could be costly and time-consuming, and an unfavorable outcome could have a significant adverse effect on our business.

The significant number of common shares issuable upon conversion of outstanding notes and exercise of outstanding warrants could adversely affect the trading price of our common shares.

Conversion of outstanding notes into common shares and the sale of such shares into the trading market of common shares or exercise of our warrants could depress the market price of our common shares.

Our auditors have issued a going concern opinion and it is likely we will not be able to achieve our objectives and will have to cease operations unless our future attempts to raise capital are successful.

Our auditors issued a going concern opinion in connection with the audit of our annual financial statements for the fiscal year ended May 31, 2013. A going concern opinion means that there is doubt that the company can continue as an ongoing business for the next 12 months. We will need to raise additional funds within the next three to six months in order to continue our business operations. There is no assurance that we will be able to adequately fund our operations.

The market price for our common shares has been and is likely to continue to be volatile.

The market price for our common shares has been and is likely to continue to be volatile. The volatile nature of our common share price may cause investment losses for our shareholders. The market price of stock in a development stage biotech company may often be driven by investor sentiment, expectation and perception, all of which are independent of fundamental valuation metrics or traditional financial performance metrics, thereby exacerbating volatility. In addition, our common shares are quoted on the OTCQB of the OTC Markets marketplace, which may increase price quotation volatility and could limit liquidity, all of which may adversely affect the market price of our shares—and thus, the economic incentive for noteholders to convert into common shares—and our ability to raise additional capital. The stock market has experienced significant volatility, particularly with respect to pharmaceutical, biotechnology and other life sciences company stocks.

 

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You may experience dilution of your ownership because of the future issuance of additional common shares or other securities.

We may conduct sales of our securities at prices per share below the current market price for our common stock, resulting in dilution to shareholders at the time. Sales of substantial amounts of shares in the public market, or the perception that such sales could occur, may adversely affect the prevailing market price of our common stock and make it more difficult for us to raise additional capital.

We do not expect any cash dividends to be paid on our shares in the foreseeable future.

We have never declared or paid a cash dividend and we do not anticipate declaring or paying dividends for the foreseeable future. We expect to use future financing proceeds and earnings, if any, to fund operating expenses. Consequently, shareholders’ only opportunity to achieve a return on their investment is, if the price of our stock appreciates and they sell their shares at a profit. We cannot assure shareholders of a positive return on their investment when they sell their shares, nor can we assure that shareholders will not lose the entire amount of their investment.

If the beneficial ownership of our stock continues to be highly concentrated, it may prevent you and other shareholders from influencing significant corporate decisions.

Our significant shareholders may exercise substantial influence over the outcome of corporate actions requiring shareholder approval, including the election of directors, any merger, consolidation or sale of all or substantially all of our assets or any other significant corporate transactions. These shareholders may also vote against a change of control, even if such a change of control would benefit our other shareholders.

Our common shares are classified as “penny stock” and trading of our shares may be restricted by the SEC’s penny stock regulations.

Rules 15g-1 through 15g-9 promulgated under the Exchange Act impose sales practice and disclosure requirements on certain brokers-dealers who engage in transactions involving a “penny stock.” The SEC has adopted regulations which generally define “penny stock” to be any equity security that has a market price of less than $5.00 per share or an exercise price of less than $5.00 per share, subject to certain exceptions. Our common shares are covered by the penny stock rules, which impose additional sales practice requirements on broker-dealers who sell to persons other than established customers and “accredited investors.” 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 in a form prepared by the SEC which provides information about penny stocks and the nature and level of risks in the penny stock market. The broker-dealer also must 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 require that, prior to a transaction in a penny stock that is not otherwise exempt, the broker-dealer must make a special 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 stock that is subject to these penny stock rules. Consequently, these penny stock rules may affect the ability of broker-dealers to trade our securities. We believe that the penny stock rules may discourage investor interest in and limit the marketability of our common shares.

We may continue to have potential liability with respect to the rights of some shareholders to rescind their investment in our securities.

In March 2011, we disclosed that certain of our shares sold between 2008 and the date of disclosure may have been sold in violation of the federal securities laws of the United States. For further information on the sale of securities in violation of federal and state securities laws, please see Note 3 to our Consolidated Financial Statements included in Item 8 of this report. Management’s analysis, based upon various statutes of limitations,

 

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among other issues, indicates that the Company’s estimated rescission liability as of May 31, 2013, has declined to a total of $536,500. Since the issue of potential rescission liability was first disclosed by the Company in early 2011, no investor has asserted rescission rights.

 

Item 1B. Unresolved Staff Comments.

None.

 

Item 2. Properties.

On October 25, 2012, the Board approved relocating the Company’s principal offices to Lake Oswego, Oregon, a suburb of Portland. We presently lease approximately 617 square feet in a full service office suite pursuant to a lease that expires on October 31, 2013 at a cost of $4,149 per month, plus voice and data line expenses.

 

Item 3. Legal Proceedings.

From time to time, the Company is involved in claims and suits that arise in the ordinary course of its business. Management currently believes that resolving any such claims against us will not have a material adverse effect on our business, financial condition or results of operations.

 

Item 4. Mine Safety Disclosures.

Not applicable.

PART II

 

Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.

Market Information

Our common stock is presently quoted on the OTCQB of the OTC Markets marketplace under the trading symbol CYDY. Historically, trading in our stock has been very limited and the trades that have occurred cannot be characterized as amounting to an established public trading market. As a result, the trading prices of our common stock may not reflect the price that would result if our stock was actively traded.

The following are high and low bid prices quoted on the OTCQB during the periods indicated. The quotations reflect inter-dealer prices, without retail mark-up, mark-down or commission and may not represent actual transactions:

 

     High      Low  

Fiscal Year Ended May 31, 2013

     

First quarter ended August 31, 2012

   $ 1.55       $ 0.62   

Second quarter ended November 30, 2012

   $ 2.10       $ 0.67   

Third quarter ended February 28, 2013

   $ 1.60       $ 0.76   

Fourth quarter ended May 31, 2013

   $ 0.96       $ 0.41   

Fiscal Year Ended May 31, 2012

     

First quarter ended August 31, 2011

   $ 2.75       $ 1.70   

Second quarter ended November 30, 2011

   $ 3.00       $ 1.85   

Third quarter ended February 29, 2012

   $ 4.40       $ 2.52   

Fourth quarter ended May 31, 2012

   $ 2.80       $ 1.46   

Holders

The number of record holders of our common stock on May 31, 2013, was approximately 200.

 

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Dividends

Holders of our common stock are entitled to receive dividends as may be declared from time to time by our Board. We have not paid any cash dividends since inception on our common stock and do not anticipate paying any in the foreseeable future. Management’s current policy is to retain earnings, if any, for use in our operations.

Purchases of Equity Securities by the Issuer and Affiliated Purchasers

There were no repurchases of our equity securities during the three months ended May 31, 2013.

 

Item 6. Selected Financial Data.

Not applicable.

 

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the other sections of this Annual Report, including our consolidated financial statements and related notes set forth in Item 8. This discussion and analysis contains forward-looking statements, including information about possible or assumed results of our financial condition, operations, plans, objectives and performance that involve risks, uncertainties and assumptions. The actual results may differ materially from those anticipated and set forth in such forward-looking statements.

Results of Operations

Results of operations for the year ended May 31, 2013, compared to May 31, 2012 are as follows:

For the years ended May 31, 2013 and 2012, we had no activities that produced revenues from operations.

For the years ended May 31, 2013 and 2012, we had net losses of approximately $9.6 million and $7.5 million, respectively. The increase in net loss of approximately $2.1 million for fiscal 2013 over fiscal 2012 was primarily attributable to increased amortization of discount on convertible debt, which is reported as interest expense, coupled with higher general and administrative expenses.

The operating expenses for the years ended May 31, 2013 and 2012, are as follows:

 

     2013      2012  

Accounting and consulting

   $ 421,000       $ 524,000   

Stock-based compensation

     3,262,000         2,858,000   

Legal

     946,000         1,469,000   

Salaries and other compensation

     1,411,000         1,623,000   

Research and development

     620,000         530,000   

Depreciation and amortization

     223,000         2,000   

Other

     1,110,000         450,000   
  

 

 

    

 

 

 

Total

   $ 7,993,000       $ 7,456,000   
  

 

 

    

 

 

 

The increase in fiscal 2013 operating expenses of approximately $537,000 over fiscal 2012 was primarily related to higher stock-based compensation, patent amortization, which was attributable to our recently acquired PRO 140 patent portfolio, and increased research and development expenditures. These comparably higher expenses for fiscal 2013 were offset, in part, by lower legal expenses, salaries, accounting and consulting as compared to fiscal 2012.

Accounting and consulting expenses decreased approximately $103,000 from $524,000 in fiscal year 2012 to approximately $421,000 for the year ended May 31, 2013. The decrease in accounting and consulting expenses for fiscal 2013 as compared to fiscal 2012 reflects a more efficient utilization of third party resources.

Stock-based compensation increased approximately $404,000 from approximately $2,858,000 for the year ended May 31, 2012, to $3,262,000 for the year ended May 31, 2013. The increase relates to the acceleration of

 

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vesting of certain options granted to the Company’s former CEO in connection with his Transition Agreement, and option grants made to other Company executives, as well as warrants granted to certain consultants with immediate vesting rights. Additionally, as disclosed in Notes 9 and 11 to the consolidated financial statements in Item 8, the Company granted warrants and common stock pursuant to the Settlement Agreement during fiscal 2012.

Legal expenses decreased approximately $523,000 from approximately $1,469,000 for the year ended May 31, 2012, to $946,000 for the year ended May 31, 2013. The trend in the Company’s legal expenses will depend on the Company’s future capital raising efforts, complexity of certain regulatory filings, effective management of intellectual property, and continued strengthening of the internal staff.

Salaries and other compensation decreased approximately $212,000 from approximately $1,623,000 in fiscal year 2012, to $1,411,000 for the year ended May 31, 2013. The decrease in fiscal 2013 from fiscal 2012 is directly attributable to significant reductions in staffing levels and incentive compensation. Incentive compensation accrued in fiscal 2013 for executives was based upon achievement of certain corporate performance goals, in addition to specific individual performance goals for each executive. The performance evaluations of each executive against their respective annual goals were approved by the compensation committee of the board of directors.

Research and development expenses for fiscal 2013 increased approximately $90,000 over fiscal 2012. While the advancement of PRO 140 is the Company’s highest priority, increased expenditures to further the preparation of PRO 140 for clinical trials were nearly offset by a significant reduction of expenditures in fiscal 2013 for Cytolin, as compared to fiscal 2012.

Other operating expenses of $1,110,000 for fiscal 2013 were approximately $660,000 higher than fiscal 2012 owing to increased expense levels for travel, investor relations, insurance and corporate governance, among others, as compared to fiscal 2012.

For fiscal 2013, the Company realized a gain of approximately $373,000 in connection with the negotiated settlements of previously accrued expenses, for which approximately $322,000 was related to legal fees and $50,000 for consulting services.

The increase in interest expense of approximately $1.9 million in fiscal 2013 over fiscal 2012 was primarily attributable to the Company’s private placement of convertible promissory notes totaling approximately $6.6 million. In addition to the stated rate of interest, which ranges from 5% to 10% per annum, generally accepted accounting principles require the recognition of a debt discount, which must be amortized over the term of the note. The debt discount is defined by the sum of the intrinsic value of the beneficial conversion feature of the notes and the fair value of the attached warrants, for which the amortization of both elements is reported as a component of interest expense.

The future trends in all of our expenses will be driven, in part, by the future outcomes of the clinical trials and the correlative effect on general and administrative expenses, especially FDA regulatory requirements, in addition to the possibility that all or a portion of the holders of the Company’s outstanding convertible notes may elect to convert their notes into common stock, which would reduce future interest expense. See, in particular, Item 1A Risk Factors.

 

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Liquidity and Capital Resources

We had cash and cash equivalents of approximately $0.6 million as of May 31, 2013, compared with $0.3 million as of May 31, 2012. The net increase in our cash and cash equivalents over a year ago was attributable primarily to proceeds from the issuance of promissory notes totaling approximately $7.1 million, which was reduced by our payment of $3.5 million to acquire PRO 140, along with cash used by operating activities of approximately $3.4 million.

As of May 31, 2013, the Company had negative working capital of approximately $2.4 million, which compares to negative working capital a year ago of $4.0 million.

Cash Flows

Net cash used in operating activities was approximately $3.4 million during fiscal year 2013, which represents a decrease of approximately $1.0 million from net cash used in operating activities of approximately $4.4 million in fiscal 2012. The decrease in the net cash used in operating activities for fiscal 2013 as compared to fiscal 2012 was primarily attributable to higher amortization of discount on convertible debt and stock-based compensation, together with increases in accounts payable and accrued interest, offset in part by a higher net loss.

The increase in cash used in investing activities for fiscal 2013 over fiscal 2012 represents the purchase of PRO 140 in October 2012.

Cash flows provided by financing activities of approximately $7.2 million during fiscal 2013 increased approximately $3.6 million over fiscal 2012. The increase in cash provided by financing activities was attributable primarily to the proceeds from the sale of approximately $6.6 million of convertible notes payable, $0.5 million of one note payable to a related party, offset by an approximate $3.4 million reduction in proceeds from the sale of common stock, which only occurred in fiscal 2012.

As shown in the accompanying consolidated financial statements in Item 8, for the years ended May 31, 2013 and 2012, and since October 28, 2003 through May 31, 2013, we incurred net losses of approximately $9,568,000 and $7,474,000 and $32,401,000, respectively. As of May 31, 2013, we have not emerged from the development stage. In view of these matters, our ability to continue as a going concern is dependent upon our ability to begin operations and to achieve a level of profitability. Since inception, we have financed our activities principally from the sale of public and private equity securities and proceeds from notes payable. We intend to finance our future development activities and our working capital needs largely from the sale of equity securities with some additional funding from other traditional financing sources.

As previously mentioned, since October 28, 2003, we have financed our operations largely from the sale of common stock and preferred stock and proceeds from notes payable. From October 28, 2003 through May 31, 2013 we raised cash of approximately $10,504,000 (net of offering costs) through private placements of common stock and preferred stock financings, and $8,165,000 through the issuance of related party notes payable and convertible notes. The Company has raised approximately $612,000 from the issuance of common stock and preferred stock in conjunction with certain acquisitions in prior years. Additionally, the Company raised approximately $556,000 from the exercise of common stock options and warrants. We intend to continue to finance our operations through the sale of our shares.

Since October 28, 2003 through May 31, 2013, we have incurred approximately $3,379,000 of research and development costs and approximately $30,288,000 in operating expenses. We have incurred significant net losses and negative cash flows from operations since our inception. As of May 31, 2013, we had an accumulated deficit of approximately $34,003,000 and negative working capital of approximately $2,388,000.

 

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Recent Sales of Convertible and Other Notes

During the period from October 1, 2012, to November 30, 2012, we raised a total of $5,648,250 through the sale of unsecured convertible promissory notes in a private placement. These notes bear interest at an annual rate ranging from 5% to 10% payable semi-annually, are convertible into common shares at a price of $0.75 per share, and mature three years from the date of issuance. A portion of the proceeds from the sale of the notes was used to pay the purchase price due under the Progenics Agreement. Of these notes, notes with a total principal amount of $567,000 were converted into common shares in December 2012. In connection with sale of the notes, we issued two-year warrants to purchase a total of 7,530,676 common shares. Of these warrants, 3,000,000 are exercisable at a price of $1.50 per share and 4,530,676 are exercisable at a price of $2.00 per share. Holders must pay cash to exercise the warrants.

Between December 1, 2012, and March 31, 2013, we raised a total of $560,000 through the sale of additional convertible promissory notes on similar terms, except that one note in the amount of $250,000 matures one year from the date of issuance. We issued two-year warrants to purchase a total of 705,001 common shares in these transactions exercisable at a price of $2.00 per share.

On April 11, 2013, Jordan Naydenov, a director, purchased an unsecured promissory note in the principal amount of $500,000. The principal of the note is due on April 11, 2014, and bears interest at the annual rate of 15%. Accrued interest is payable semi-annually in common shares at a rate of $0.50 per share, up to a total of 150,000 shares.

Effective May 31, 2013, we raised a total of $380,000 through the sale of additional unsecured convertible promissory notes bearing interest at an annual rate of 5%, with a conversion price of $0.65 per share, and maturing six months from the date of issuance. In connection with these note sales, we issued two-year warrants to purchase a total of 292,307 common shares exercisable at a price of $0.75 per share.

On July 31, 2013, we completed a financing transaction, in connection with which we raised an additional $1,200,000 through the sale of unsecured convertible promissory notes with an annual interest rate of 5%, a conversion price of $0.65 per share, and a maturity date of February 1, 2014. In the event of default in repayment, the conversion price will decrease by $0.10 per share, to a minimum of $0.35 per share, for each month that the default continues. Until October 1, 2013, holders of the notes have the right to convert the principal amount of the notes plus accrued but unpaid interest into Units consisting of two shares of common stock plus a warrant to purchase one share of common stock. Each Unit is valued at $1.30 for purposes of this conversion right. Each Unit warrant, if any, issued upon conversion will have an exercise price of $0.75 per share and a five-year term. If we raise $3,000,000 on or after August 1, 2013, holders of notes may, within 15 days of announcement, require payment in full of their notes. The notes were placed by a placement agent, who received a cash fee equal to 10% of the amount raised. In connection with these note sales, we issued three-year warrants to purchase a total of 923,072 common shares exercisable at a price of $0.50 per share.

The Company is current with its interest payment obligations to all note holders and is in compliance with all other terms of outstanding promissory notes. As of July 31, 2013, the Company had a total of approximately $7.7 million outstanding in promissory notes; of these, $7.2 million is convertible into shares of common stock, and $0.5 million is not convertible into common stock and matures in the fourth quarter of fiscal 2014. In the event our promissory notes, which mature as early as November 30, 2013, do not convert into shares of common stock, the Company’s ability to continue as a going concern will be contingent upon its ability to raise additional capital to meet these obligations. If the Company is unsuccessful in raising additional capital in the future, it may be required to cease its operations.

We have not generated revenue to date, and will not generate product revenue in the foreseeable future. We may incur increased operating losses as we proceed with our collaborative research efforts with respect to PRO 140 and continue to advance it through the product development and regulatory process. In addition to increasing research and development expenses, we expect general and administrative costs to increase, as we add personnel and other administrative expenses associated with our current efforts.

Going Concern

We will require additional funding in order to continue with research and development efforts.

 

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The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As shown in the accompanying consolidated financial statements, the Company is currently in the development stage with losses for all periods presented. As of May 31, 2013, these factors, among others, raise substantial doubt about the Company’s ability to continue as a going concern.

The consolidated financial statements do not include any adjustments relating to the recoverability and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. The Company’s continuation as a going concern is dependent upon its ability to obtain additional operating capital, complete development of its product candidates, obtain FDA approval, outsource manufacturing of its products, and ultimately to attain profitability. The Company intends to seek additional funding through equity offerings or licensing agreements to fund its business plan. There is no assurance that the Company will be successful in these endeavors.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.

Critical Accounting Policies and Estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.

We believe that the following critical policies affect our more significant judgments and estimates used in preparation of our consolidated financial statements.

We use the Black-Scholes option pricing model to estimate the fair value of stock-based awards on the date of grant utilizing certain assumptions that require judgments and estimates. These assumptions include estimates for volatility, expected term, and risk-free interest rates in determining the fair value of the stock-based awards.

We issue common stock to consultants for various services. Costs for these transactions are measured at the fair value of the consideration received or the fair value of the equity instruments issued, whichever is more readily measurable. This determination requires judgment in terms of the consideration being measured.

We issue convertible promissory notes with detachable warrants to purchase common stock. The conversion options are fixed, but beneficial to the note holders at the respective commitment dates. The valuation of the warrants to record the debt discount requires the use of certain assumptions inherent in the Black-Scholes option pricing model, which requires judgments and estimates.

We estimated an amount that is a probable indicator of our rescission liability and recorded rescission liabilities for May 31, 2013 and May 31, 2012 of $536,500 and $3,749,000, respectively. These amounts represent the believed potential rescission liability as of the dates presented, including any contingent interest payable to investors who accept the rescission right, and forfeit their shares. For the purpose of calculating and disclosing rescission liability, the Company has assumed that portions of the state claims are barred by the statutes of limitations of certain states. Although the Company has assumed that affirmative defenses based upon the expiration of the statutes of limitations in these states may be generally available to bar these state claims, it has not had legal counsel undertake a detailed analysis of case law that might apply to defer or avoid application of a bar to such claims; thus, if rescission claims are made for those assumed to be barred by a statute of limitations and such claims are contested by the Company, until such affirmative defenses are ruled upon in a proceeding adjudicating the rights at issue, no assurances can be made that, if asserted, such defenses would actually bar the rescission claims in these states. See Note 3 to our consolidated financial statements in Item 8 for further information.

 

Item 7A. Quantitative and Qualitative Disclosures about Market Risk.

This item is not required for smaller reporting companies.

 

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Item 8. Financial Statements and Supplementary Data.

CYTODYN INC.

(A DEVELOPMENT STAGE COMPANY)

 

CONTENTS    PAGE  

REPORTS OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

     28   

CONSOLIDATED BALANCE SHEETS AS OF MAY 31, 2013 AND MAY 31, 2012

     30   

CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE YEARS ENDED MAY 31, 2013 AND 2012, AND FOR THE PERIOD FROM OCTOBER 28, 2003 THROUGH MAY 31, 2013

     31   

CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ (DEFICIT) FOR THE PERIOD FROM OCTOBER 28, 2003 THROUGH MAY 31, 2013

     32   

CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE YEARS ENDED MAY 31, 2013 AND 2012, AND FOR THE PERIOD FROM OCTOBER 28, 2003 THROUGH MAY 31, 2013

     50   

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

     52   

 

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Report of Independent Registered Public Accounting Firm

Board of Directors and Shareholders

CytoDyn Inc. (A Development Stage Company)

Lake Oswego, Oregon

We have audited the accompanying consolidated balance sheet of CytoDyn Inc. (a development stage company) as of May 31, 2013, and the related consolidated statements of operations, changes in stockholders’ (deficit), and cash flows for the year then ended and the period from October 28, 2003 through May 31, 2013. These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated 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 consolidated financial statements are free of material misstatement. The Company is not required at this time, to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audit included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the consolidated financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall consolidated financial statement presentation. We believe that our audit provides a reasonable basis for our opinion.

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of CytoDyn Inc. as of May 31, 2013 and the results of its operations and its cash flows for the year then ended and the period from October 28, 2003 through May 31, 2013 in conformity with accounting principles generally accepted in the United States of America.

The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern. As discussed in Note 2 to the consolidated financial statements, the Company incurred a net loss of $9,568,301 for the year ended May 31, 2013, has a working capital deficit of $2,388,138, and has an accumulated deficit of $34,002,819 through May 31, 2013, which raises a substantial doubt about its ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

/s/ Warren Averett, LLC

Warren Averett, LLC

Certified Public Accountants

Tampa, Florida

August 29, 2013

 

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Report of Independent Registered Public Accounting Firm

Board of Directors and Shareholders

CytoDyn Inc. (A Development Stage Company)

Lutz, Florida

We have audited the accompanying consolidated balance sheet of CytoDyn Inc. (a development stage company) as of May 31, 2012 and the related consolidated statements of operations, changes in stockholders’ (deficit), and cash flows for the year then ended. These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated 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 consolidated financial statements are free of material misstatement. The Company is not required at this time, to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audit included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the consolidated financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall consolidated financial statement presentation. We believe that our audit provides a reasonable basis for our opinion.

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of CytoDyn Inc. as of May 31, 2012 and the results of its operations and its cash flows for the years then ended and the period from October 28, 2003 through May 31, 2012 in conformity with accounting principles generally accepted in the United States of America.

The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern. As discussed in Note 2 to the consolidated financial statements, the Company incurred a net loss of $7,474,224 for the year ended May 31, 2012, has a working capital deficit of $4,015,969, which raises a substantial doubt about its ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

/s/ Pender Newkirk & Company LLP

Pender Newkirk & Company LLP

Certified Public Accountants

Tampa, Florida

August 21, 2012

 

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Table of Contents

CytoDyn Inc.

(A Development Stage Company)

Consolidated Balance Sheets

 

     May 31,  
     2013     2012  

Assets

    

Current Assets:

    

Cash

   $ 603,681      $ 284,991   

Prepaid expenses

     139,849        65,982   

Deferred offering costs

     96,930        677,327   
  

 

 

   

 

 

 

Total current assets

     840,460        1,028,300   
  

 

 

   

 

 

 

Intangible assets, net

     3,317,239        38,610   

Furniture and equipment, net

     —          800   

Other assets

     —          3,125   
  

 

 

   

 

 

 
   $ 4,157,699      $ 1,070,835   
  

 

 

   

 

 

 

Liabilities and Shareholders’ (Deficit)

    

Current liabilities:

    

Accounts payable

   $ 1,111,285      $ 831,336   

Accrued liabilities

     321,884        150,573   

Accrued salaries and severance

     364,698        189,249   

Indebtedness to related parties

     509,000        83,493   

Accrued interest payable

     56,884        40,618   

Convertible notes payable, net

     328,347        —     

Stock rescission liability

     536,500        3,749,000   
  

 

 

   

 

 

 

Total current liabilities

     3,228,598        5,044,269   

Long-term liabilities

    

Convertible notes payable, net

     1,153,017        —     
  

 

 

   

 

 

 

Total liabilities

     4,381,615        5,044,269   

Shareholders’ (deficit):

    

Series B Convertible Preferred Stock, no par value; 400,000 shares authorized, 95,100 and 98,900 shares issued and outstanding at May 31, 2013 and 2012, respectively

     274,091        451,993   

Common stock, no par value; 100,000,000 shares authorized, 30,798,150 and 28,636,530 outstanding at May 31, 2013 and 2012, respectively; 30,998,150 and 28,836,530 issued at May 31, 2013 and May 31, 2012, respectively

     16,244,673        15,150,261   

Common stock payable

     117,778        388,000   

Additional paid-in capital

     17,523,796        8,020,533   

Common and Preferred Stock subject to rescission

     (536,500     (3,749,000

Treasury stock, at cost, 200,000 and 200,000 shares held at May 31, 2013 and 2012, respectively

     (100,000     (100,000

Additional paid-in capital - treasury stock

     255,065        299,297   

Accumulated deficit on unrelated dormant operations

     (1,601,912     (1,601,912

Deficit accumulated during development stage

     (32,400,907     (22,832,606
  

 

 

   

 

 

 

Total shareholders’ (deficit)

     (223,916     (3,973,434
  

 

 

   

 

 

 
   $ 4,157,699      $ 1,070,835   
  

 

 

   

 

 

 

See accompanying notes to consolidated financial statements.

 

30


Table of Contents

CytoDyn Inc.

(A Development Stage Company)

Consolidated Statements of Operations

 

     Year ended May 31,    

October 28,

2003 through

 
     2013     2012     May 31, 2013  

Operating expenses:

      

General and administrative

   $ 6,204,865      $ 5,454,477      $ 22,666,757   

Amortization / depreciation

     222,684        2,013        405,546   

Research and development

     619,838        530,027        3,379,333   

Legal fees

     946,030        1,469,129        3,836,661   
  

 

 

   

 

 

   

 

 

 

Total operating expenses

     7,993,417        7,455,646        30,288,297   
  

 

 

   

 

 

   

 

 

 

Operating loss

     (7,993,417     (7,455,646     (30,288,297

Interest income

     1,167        —          2,794   

Gain on settlement of accounts payable

     372,759        —          710,101   

Interest expense:

      

Amortization of discount on convertible debt

     (1,703,616     (2,063 )     (2,440,542

Interest on notes payable

     (245,194     (16,515     (384,963
  

 

 

   

 

 

   

 

 

 

Loss before income taxes

     (9,568,301     (7,474,224     (32,400,907

Income tax provision

     —          —          —     
  

 

 

   

 

 

   

 

 

 

Net loss

   $ (9,568,301   $ (7,474,224   $ (32,400,907
  

 

 

   

 

 

   

 

 

 

Constructive preferred stock dividends

   $  —        $  —        $ (6,000,000
  

 

 

   

 

 

   

 

 

 

Convertible preferred stock dividends

   $ (2,190   $ (88,743   $ (99,483
  

 

 

   

 

 

   

 

 

 

Net loss applicable to common shareholders

   $ (9,570,491   $ (7,562,967   $ (38,500,390
  

 

 

   

 

 

   

 

 

 

Basic and diluted loss per share

   $ (0.32   $ (0.31   $ (2.43
  

 

 

   

 

 

   

 

 

 

Basic and diluted weighted average common shares outstanding

     29,942,393        24,618,812        15,843,957   
  

 

 

   

 

 

   

 

 

 

See accompanying notes to consolidated financial statements.

 

31


Table of Contents

CytoDyn Inc.

(A Development Stage Company)

Consolidated Statements of Changes in Shareholders’ (Deficit)

Period October 28, 2003 through May 31, 2013

 

     Preferred Stock      Common Stock      Additional
Paid-In Capital
     Subject to
Rescission
 
     Shares      Amount      Shares      Amount        

Balance at October 28, 2003, following recapitalization

     —         $ —          6,252,640       $ 1,425,334       $ 23,502       $ —    

February through April 2004, sale of common stock less offering costs of $54,000 ($.30/share)

     —           —           1,800,000         486,000         —           —     

February 2004, shares issued to former officer as payment for working capital advance ($.30/share)

     —           —           16,667         5,000         —           —     

Net loss for year ended May 31, 2004

     —           —           —           —           —           —     
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Balance at May 31, 2004

     —           —           8,069,307         1,916,334         23,502         —     

July 2004, capital contribution by an officer

     —           —           —           —           512         —     

November 2004, common stock warrants granted

     —           —           —           —           11,928         —     

February 2005, capital contribution by an officer

     —           —           —           —           5,000         —     

Net loss for year ended May 31, 2005

     —           —           —           —           —           —     
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Balance at May 31, 2005

     —           —           8,069,307         1,916,334         40,942         —     

 

32


Table of Contents

CytoDyn Inc.

(A Development Stage Company)

Consolidated Statements of Changes in Shareholders’ (Deficit)

Period October 28, 2003 through May 31, 2013

 

     Treasury
Stock APIC
     Stock for
Prepaid
Services
     Accumulated
Deficit
    Deficit
Accumulated
During
Development
Stage
    Total  

Balance at October 28, 2003, following recapitalization

   $ —          —         $ (1,594,042   $  —        $ (145,206

February through April 2004, sale of common stock less offering costs of $54,000 ($.30/share)

     —           —           —          —          486,000   

February 2004, shares issued to former officer as payment for working capital advance ($.30/share)

     —           —           —          —          5,000   

Net loss for year ended May 31, 2004

     —           —           (7,870     (338,044     (345,914
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Balance at May 31, 2004

     —           —           (1,601,912     (338,044     (120

July 2004, capital contribution by an officer

     —           —           —          —          512   

November 2004, common stock warrants granted

     —           —           —          —          11,928   

February 2005, capital contribution by an officer

     —           —           —          —          5,000   

Net loss for year ended May 31, 2005

     —           —           —          (777,083     (777,083
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Balance at May 31, 2005

     —           —           (1,601,912     (1,115,127     (759,763

See accompanying notes to consolidated financial statements.

 

33


Table of Contents

CytoDyn Inc.

(A Development Stage Company)

Consolidated Statements of Changes in Shareholders’ (Deficit)

Period October 28, 2003 through May 31, 2013

 

     Preferred Stock      Common Stock      Additional
Paid-In Capital
 
     Shares      Amount      Shares      Amount     

June through July 2005, sale of common stock less offering costs of $27,867 ($.75/share)

     —           —           289,890         189,550         —     

August 2005, common shares issued to extinguish promissory notes payable and related interest ($.75/share)

     —           —           160,110         120,082         —     

May 2006, common shares issued to extinguish convertible debt

     —           —           350,000         437,500         —     

November 2005, 94,500 warrants exercised ($.30/share)

     —           —           94,500         28,350         —     

January through April 2006, common shares issued for prepaid services

     —           —           183,857         370,750         —     

Amortization of prepaid stock services

     —           —           —           —           —     

January through May 2006, warrants issued with convertible debt

     —           —           —           —           274,950   

January through May 2006, beneficial conversion feature of convertible debt

     —           —           —           —           234,550   

March through May 2006, stock options granted to consultants

     —           —           —           —           687,726   

 

34


Table of Contents

CytoDyn Inc.

(A Development Stage Company)

Consolidated Statements of Changes in Shareholders’ (Deficit)

Period October 28, 2003 through May 31, 2013

 

     Treasury Stock
APIC
     Stock for
Prepaid
Services
    Accumulated
Deficit
     Deficit
Accumulated
During
Development
Stage
     Total  

June through July 2005, sale of common stock less offering costs of $27,867 ($.75/share)

     —           —          —           —           189,550   

August 2005, common shares issued to extinguish promissory notes payable and related interest ($.75/share)

     —           —          —           —           120,082   

May 2006, common shares issued to extinguish convertible debt

     —           —          —           —           437,500   

November 2005, 94,500 warrants exercised ($.30/share)

     —           —          —           —           28,350   

January through April 2006, common shares issued for prepaid services

     —           (370,750     —           —           —     

Amortization of prepaid stock services

     —           103,690        —           —           103,690   

January through May 2006, warrants issued with convertible debt

     —           —          —           —           274,950   

January through May 2006, beneficial conversion feature of convertible debt

     —           —          —           —           234,550   

March through May 2006, stock options granted to consultants

     —           —          —           —           687,726   

See accompanying notes to consolidated financial statements.

 

35


Table of Contents

CytoDyn Inc.

(A Development Stage Company)

Consolidated Statements of Changes in Shareholders’ (Deficit)

Period October 28, 2003 through May 31, 2013

 

     Preferred Stock      Common Stock      Additional
Paid-In Capital
 
     Shares      Amount      Shares      Amount     

March 2006, stock options issued to extinguish debt

     —           —           —           —           86,341   

Net loss for year ended May 31, 2006

     —           —           —           —           —     
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Balance at May 31, 2006

     —           —           9,147,664         3,062,566         1,324,509   

Common stock issued to extinguish convertible debt

     —           —           119,600         149,500         —     

Common stock issued for AITI acquisition

     —           —           2,000,000         934,399         —     

Amortization of prepaid stock services

     —           —           —           —           —     

Common stock payable for prepaid services

     —           —           —           —           120,000   

Stock-based compensation

     —           —           —           —           535,984   

Warrants issued with convertible debt

     —           —           —           —           92,500   

Common stock issued for services

     —           —           30,000         26,400         —     

Preferred shares issued to AGTI

     100,000         167,500         —           —           —     

Net loss for year ended May 31, 2007

     —           —           —           —           —     
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Balance at May 31, 2007

     100,000         167,500         11,297,264         4,172,865         2,072,993   

 

36


Table of Contents

CytoDyn Inc.

(A Development Stage Company)

Consolidated Statements of Changes in Shareholders’ (Deficit)

Period October 28, 2003 through May 31, 2013

 

     Treasury Stock
APIC
     Stock for
Prepaid
Services
    Accumulated
Deficit
    Deficit
Accumulated
During
Development
Stage
    Total  

March 2006, stock options issued to extinguish debt

     —           —          —          —          86,341  

Net loss for year ended May 31, 2006

     —           —          —          (2,053,944     (2,053,944
  

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Balance at May 31, 2006

     —           (267,060     (1,601,912     (3,169,071     (650,968

Common stock issued to extinguish convertible debt

     —           —          —          —          149,500  

Common stock issued for AITI acquisition

     —           —          —          —          934,399  

Amortization of prepaid stock services

     —           267,060       —          —          267,060  

Common stock payable for prepaid services

     —           (106,521     —          —          13,479  

Stock-based compensation

     —           —          —          —          535,984  

Warrants issued with convertible debt

     —           —          —          —          92,500  

Common stock issued for services

     —           —          —          —          26,400  

Preferred shares issued to AGTI

     —           —          —          —          167,500  

Net loss for year ended May 31, 2007

     —           —          —          (2,610,070     (2,610,070
  

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Balance at May 31, 2007

     —           (106,521     (1,601,912     (5,779,141     (1,074,216

See accompanying notes to consolidated financial statements.

 

37


Table of Contents

CytoDyn Inc.

(A Development Stage Company)

Consolidated Statements of Changes in Shareholders’ (Deficit)

Period October 28, 2003 through May 31, 2013

 

     Preferred Stock      Common Stock     Additional
Paid-In Capital
     Subject to
Rescission
 
     Shares      Amount      Shares     Amount       

Amortization of prepaid stock for services

     —           —           —          —          —           —     

Stock-based compensation

     —           —           —          —          461,602         —     

Common stock issued to extinguish convertible debt

     —           —           750,000        75,000        —           —     

Rescission of common stock issued for services

     —           —           (142,857     (100,000     —           —     

Original issue discount convertible debt with warrants

     —           —           —          —          3,662         —     

Original issue discount convertible debt with beneficial conversion feature

     —           —           —          —          75,000         —     

Stock issued for cash ($.50/share)

     —           —           642,000        321,000        —           (321,000

Net loss for year ended May 31, 2008

     —           —           —          —          —           —     
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

    

 

 

 

Balance at May 31, 2008

     100,000         167,500         12,546,407        4,468,865        2,613,257         (321,000

 

38


Table of Contents

CytoDyn Inc.

(A Development Stage Company)

Consolidated Statements of Changes in Shareholders’ (Deficit)

Period October 28, 2003 through May 31, 2013

 

     Treasury Stock
APIC
     Stock for
Prepaid
Services
     Accumulated
Deficit
    Deficit
Accumulated
During
Development
Stage
    Total  

Amortization of prepaid stock for services

     —           106,521         —          —          106,521   

Stock-based compensation

     —           —           —          —          461,602   

Common stock issued to extinguish convertible debt

     —           —           —          —          75,000   

Rescission of common stock issued for services

     —           —           —          —          (100,000

Original issue discount convertible debt with warrants

     —           —           —          —          3,662   

Original issue discount convertible debt with beneficial conversion feature

     —           —           —          —          75,000   

Stock issued for cash ($.50/share)

     —           —           —          —          —     

Net loss for year ended May 31, 2008

     —           —           —          (1,193,684     (1,193,684
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Balance at May 31, 2008

     —           —           (1,601,912     (6,972,825     (1,646,115

See accompanying notes to consolidated financial statements.

 

39


Table of Contents

CytoDyn Inc.

(A Development Stage Company)

Consolidated Statements of Changes in Shareholders’ (Deficit)

Period October 28, 2003 through May 31, 2013

 

     Preferred Stock      Common Stock      Additional
Paid-In Capital
     Subject to
Rescission
 
     Shares      Amount      Shares      Amount        

Stock issued for cash ($.50/share)

     —          —          3,023,308         1,511,654         —          (1,494,000

Stock issued for services ($.50/share)

     —          —          388,200         194,100         —          —    

Stock issued for services ($.37/share)

     —          —          150,000         55,500         —          —    

Stock-based compensation

     —          —          —          —          371,996         —    

Stock issued in payment of accounts payable ($.50/share)

     —          —          98,000         49,000         —          —    

Stock issued for services ($.42/share)

     —          —          15,400         6,468         —          —    

Capital contribution

     —          —          —          —          8,900         —    

Net loss for year ended May 31, 2009

     —          —          —          —          —          —    
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Balance at May 31, 2009

     100,000         167,500         16,221,315         6,285,587         2,994,153         (1,815,000

Stock issued for cash ($.50/share)

     —          —          236,400         118,200         —          (118,200

Stock issued for cash ($.50/share)

     —          —          632,000         290,500         —          (290,500

Stock issued for cash ($.50/share)

     —          —          304,580         137,061         —          (137,061

Conversion of debt to common stock ($.45/share)

     —          —          325,458         146,456         —          —    

 

40


Table of Contents

CytoDyn Inc.

(A Development Stage Company)

Consolidated Statements of Changes in Shareholders’ (Deficit)

Period October 28, 2003 through May 31, 2013

 

     Treasury Stock      Treasury
Stock APIC
     Stock for
Prepaid
Services
     Accumulated
Deficit
    Deficit
Accumulated
During
Development
Stage
    Total  
   Shares      Amount               

Stock issued for cash ($.50/share)

     —          —          —          —          —         —         17,654   

Stock issued for services ($.50/share)

     —          —          —          —          —         —         194,100   

Stock issued for services ($.37/share)

     —          —          —          —          —         —         55,500   

Stock-based compensation

     —          —          —          —          —         —         371,996   

Stock issued in payment of accounts payable ($.50/share)

     —          —          —          —          —         —         49,000   

Stock issued for services ($.42/share)

     —          —          —          —          —         —         6,468   

Capital contribution

     —          —          —          —          —         —         8,900   

Net loss for year ended May 31, 2009

     —          —          —          —          —         (1,306,004     (1,306,004
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Balance at May 31, 2009

     —          —          —          —          (1,601,912     (8,278,829     (2,248,501

Stock issued for cash ($.50/share)

     —          —          —          —          —         —         —    

Stock issued for cash ($.50/share)

     —          —          —          —          —         —         —    

Stock issued for cash ($.50/share)

     —          —          —          —          —         —         —    

Conversion of debt to common stock ($.45/share)

     —          —          —          —          —         —         146,456   

See accompanying notes to consolidated financial statements.

 

41


Table of Contents

CytoDyn Inc.

(A Development Stage Company)

Consolidated Statements of Changes in Shareholders’ (Deficit)

Period October 28, 2003 through May 31, 2013

 

     Preferred Stock     Common Stock      Additional
Paid-In Capital
     Subject to
Rescission
 
     Shares     Amount     Shares      Amount        

Conversion of preferred stock to common stock

     (100,000     (167,500     2,356,142         167,500         —          —    

Stock-based compensation

     —         —         —           —          1,671,118         —    

Original issue discount convertible debt with beneficial conversion feature

     —         —         —           —          38,604         —    

Expiration of rescission liabilities

     —         —         —           —          —          903,550   

Repurchase of common stock ($.28/share)

     —         —         —           —          —          —    

Repurchase of common stock ($.50/share)

     —         —         —           —          —          —    

Stock issued for cash ($.50/share)

     —         —         —           —          —          (277,000

Stock issued for services ($1.45/share)

     —         —         —           —          —          —    

Stock issued for cash ($.50/share)

     —         —         —           —          —          (253,789

 

42


Table of Contents

CytoDyn Inc.

(A Development Stage Company)

Consolidated Statements of Changes in Shareholders’ (Deficit)

Period October 28, 2003 through May 31, 2013

 

     Treasury Stock     Treasury
Stock APIC
     Stock for
Prepaid
Services
    Accumulated
Deficit
     Deficit
Accumulated
During
Development
Stage
        
     Shares     Amount                Total  

Conversion of preferred stock to common stock

     —         —         —          —         —          —          —    

Stock-based compensation

     —         —         —          —         —          —          1,671,118   

Original issue discount convertible debt with beneficial conversion feature

     —         —         —          —         —          —          38,604   

Expiration of rescission liabilities

     —         —         —          —         —          —          903,550   

Repurchase of common stock ($.28/share)

     (1,200,000     (336,000     —          —         —          —          (336,000

Repurchase of common stock ($.50/share)

     (200,000     (100,000     —          —         —          —          (100,000

Stock issued for cash ($.50/share)

     550,000        154,000        123,000         —         —          —          —    

Stock issued for services ($1.45/share)

     81,580        22,842        95,449         (118,291     —          —          —    

Stock issued for cash ($.50/per share)

     568,420        159,158        94,631         —         —          —          —    

See accompanying notes to consolidated financial statements.

 

43


Table of Contents

CytoDyn Inc.

(A Development Stage Company)

Consolidated Statements of Changes in Shareholders’ (Deficit)

Period October 28, 2003 through May 31, 2013

 

     Preferred Stock     Common Stock      Additional
Paid-In Capital
    Subject to
Rescission
Amount
 
     Shares     Amount     Shares      Amount       

Amortization of prepaid stock for services

     —          —         —          —          —         —    

Series B Convertible Preferred Stock issued for cash ($5.00/share)

     400,000        2,009,000        —          —          —         (2,009,000

Net loss for year ended May 31, 2010

     —          —         —          —          —         —    
  

 

 

   

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Balance at May 31, 2010

     400,000        2,009,000        20,075,895         7,145,304         4,703,875        (3,997,000

Conversion of Series B Convertible Preferred Stock to Common Stock

     (88,200     (442,984     882,000         442,984         —         —    

Stock issued for services ($1.23/share)

     —          —         150,000         184,500         —         —    

Capital contribution

     —          —         —          —          229,500        —    

Stock issued for cash ($1.00/share)

     —          —         1,365,987         1,365,987         —         (1,365,987

Series B Convertible Preferred Stock dividends

     —          —         17,100         8,550         (8,550     —    

Stock-based compensation

     —          —         —          —          952,316        —    

Rescission expirations and exclusions

     —          —         —          —          —         511,987   

Amortization of prepaid stock for services

     —          —         —          —          —         —    

Net loss for year ended May 31, 2011

     —          —         —          —          —         —    
  

 

 

   

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Balance at May 31, 2011

     311,800        1,566,016        22,490,982         9,147,325         5,877,141        (4,851,000

 

44


Table of Contents

CytoDyn Inc.

(A Development Stage Company)

Consolidated Statements of Changes in Shareholders’ (Deficit)

Period October 28, 2003 through May 31, 2013

 

     Treasury Stock     Treasury
Stock
APIC
     Stock for
Prepaid
Services
    Accumulated
Deficit
    Deficit
Accumulated
During
Development
Stage
    Total  
     Shares     Amount             

Amortization of prepaid stock for services

     —         —         —          69,003        —         —         69,003   

Series B Convertible Preferred stock issued for cash ($5.00/share)

     —         —          —          —         —         —         —    

Net loss for year ended May 31, 2010

     —         —          —          —         —         (3,359,865     (3,359,865
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Balance at May 31, 2010

     (200,000     (100,000     313,080         (49,288     (1,601,912     (11,638,694     (3,215,635

Conversion of Series B Convertible Preferred Stock to Common Stock

     —         —         —          —         —         —         —    

Stock issued for services ($1.23/share)

     —         —         —          —         —         —         184,500   

Capital contribution

     —         —         —          —         —         —         229,500   

Stock issued for cash ($1.00/share)

     —         —         —          —         —         —         —    

Series B Convertible Preferred Stock dividends

             

Stock-based compensation

     —         —         —          —         —         —         952,316   

Rescission expirations and exclusions

     —         —         —          —         —         —         511,987   

Amortization of prepaid stock for services

     —         —         —          49,288        —         —         49,288   

Net loss for year ended May 31, 2011

     —         —         —          —         —         (3,719,688     (3,719,688
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Balance at May 31, 2011

     (200,000     (100,000     313,080         —         (1,601,912     (15,358,382     (5,007,732

See accompanying notes to consolidated financial statements.

 

45


Table of Contents

CytoDyn Inc.

(A Development Stage Company)

Consolidated Statements of Changes in Shareholders’ (Deficit)

Period October 28, 2003 through May 31, 2013

 

 

     Preferred Stock     Common Stock     Common
Stock
Payable
     Additional
Paid-In Capital
    Subject to
Rescission

Amount
 
     Shares     Amount     Shares      Amount         

Rescission expirations and exclusions

     —         —         —          —         —          —         1,102,000   

Conversion of Series B Convertible Preferred Stock to Common Stock

     (212,900     (1,064,500     2,129,000         1,064,500        —          —         —    

Series B Convertible Preferred Stock Dividends

     —         —         177,485         88,743        —          (88,743     —    

Series B Convertible Preferred Stock Cash Dividends

     —         —         —          —         —          (1,500     —    

Common Stock issued to consultants for services ($2.55-$2.80/share)

     —         —         72,500         203,000        —          —         —    

Common Stock issued to directors for services ($2.07/share)

     —         —         16,675         34,560        —          —         —    

Common Stock issued for cash ($1.50/share)

     —         —         1,997,388         2,996,024        —          —         —    

Exercise of Common Stock options ($.30-$1.00/share)

     —         —         527,500         326,900        —          —         —    

Common shares issued from escrow liability ($1.00/share)

     —         —         1,425,000         1,425,000        —          —         —    

Common stock to be issued related to legal settlement ($0.97/share)

     —         —         —          —         388,000         —         —    

Amortization of deferred offering costs related to rescission liability

     —         (49,523     —          (135,791     —          —         —    

Capital Contribution

     —         —         —          —         —          1,336        —    

Stock-based compensation

     —         —         —          —         —          1,692,290        —    

Warrants to be issued related to legal settlement

     —         —         —          —         —          540,009        —    

Net loss for year ended May 31, 2012

     —         —         —          —         —          —         —    
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

Balance at May 31, 2012

     98,900      $ 451,993        28,836,530       $ 15,150,261      $ 388,000       $ 8,020,533      $ (3,749,000

 

46


Table of Contents

CytoDyn Inc.

(A Development Stage Company)

Consolidated Statements of Changes in Shareholders’ (Deficit)

Period October 28, 2003 through May 31, 2013

 

     Treasury Stock     Treasury
Stock
APIC
    Stock for
Prepaid
Services
     Accumulated
Deficit
    Deficit
Accumulated
During
Development
Stage
    Total  
     Shares     Amount             

Rescission expirations and exclusions

     —         —         —         —          —         —         1,102,000  

Conversion of Series B Convertible Preferred Stock to Common Stock

     —         —         —         —          —         —         —    

Series B Convertible Preferred Stock Dividends

     —         —         —         —          —         —         —    

Series B Convertible Preferred Stock Cash Dividends

     —         —         —         —          —         —         (1,500

Common Stock issued to consultants for services ($2.55-$2.80/share)

     —         —         —         —          —         —         203,000  

Common Stock issued to directors for services ($2.07/share)

     —         —         —         —          —         —         34,560  

Common Stock issued for cash ($1.50/share)

     —         —         —         —          —         —         2,996,024  

Exercise of Common Stock options ($.30-1.00/share)

     —         —         —         —          —         —         326,900  

Common shares issued from escrow liability ($1.00/share)

     —         —         —         —          —         —         1,425,000  

Common stock to be issued related to legal settlement ($0.97/share)

     —         —         —         —          —         —         388,000  

Amortization of deferred offering costs related to rescission liability

     —         —         (13,783     —          —         —         (199,097

Capital Contribution

     —         —         —         —          —         —         1,336  

Stock based compensation

     —         —         —         —          —         —         1,692,290  

Warrants to be issued related to legal settlement

     —         —         —         —          —         —         540,009  

Net loss for year ended May 31, 2012

     —         —         —         —          —         (7,474,224     (7,474,224
  

 

 

   

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

 

Balance at May 31, 2012

     (200,000   $ (100,000   $ 299,297       —        $ (1,601,912   $ (22,832,606   $ (3,973,434

See accompanying notes to consolidated financial statements.

 

47


Table of Contents

CytoDyn Inc.

(A Development Stage Company)

Consolidated Statements of Changes in Shareholders’ (Deficit)

Period October 28, 2003 through May 31, 2013

 

     Preferred Stock     Common Stock     Common
Stock
Payable
    Additional
Paid-In Capital
    Rescission
Amount
 
     Shares     Amount     Shares      Amount        

Rescission expirations and exclusions

     —         —         —          —         —         —         3,212,500  

Amortization of deferred offering costs related to rescission liability

     —          (158,902     —          (377,258     —         —         —    

Conversion of Series B Convertible Preferred Stock to Common Stock

     (3,800     (19,000     38,000        19,000       —         —         —    

Series B Convertible Preferred Stock Dividends

     —         —         4,380        2,190       —         (2,190     —    

Common Stock issued related to legal settlement ($.97/share)

     —         —         400,000        388,000       (388,000 )     —         —    

Common Stock issued to consultants for services ($2.68/share)

     —         —         60,000        160,800       —         —         —    

Amortization of prepaid stock service

     —         —         —          —         —         —         —    

Common Stock issued to directors for services ($1.60/share)

     —         —         7,810        12,496       —         —         —    

Common Stock issued to directors for services ($.77/share)

     —         —         16,230        12,497       —         —         —    

Common Stock issued to directors for services ($1.00/share)

     —         —         12,500        12,500       —         —         —    

Common Stock issued to directors for services ($.80/share)

     —          —         14,980        11,984       —         —         —    

Exercise of Common Stock warrants ($.25/share)

     —         —         750,000        187,500       —         —         —    

Exercise of Common Stock warrants ($1.00/share)

     —         —         5,000        5,000       —         —         —    

Exercise of Common Stock options ($.34/share)

     —         —         25,000        8,500       —         —         —    

Conversion of convertible debt to common stock ($.75/share)

     —         —         756,000        567,000       —         —         —    

Conversion of accrued interest on convertible debt to common stock ($.75/share)

     —         —         5,604        4,203       —         —         —    

Issuance of common stock for accounts payable ($1.21/share)

     —         —         66,116        80,000       —         —         —    

Common stock issuable for accrued interest

     —         —         —          —         10,278       —         —    

Common stock issuable for bonuses

     —         —         —          —         107,500         —    

Stock-based compensation

     —         —         —          —         —         3,261,951       —    

Debt discount related to warrants and beneficial conversion feature associated with convertible debt

     —         —         —          —         —         6,243,502       —    

Net Loss for year ended May 31, 2013

     —         —         —          —         —         —         —    
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Balance at May 31, 2013

     95,100     $ 274,091       30,998,150      $ 16,244,673     $ 117,778     $ 17,523,796     $ (536,500
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

See accompanying notes to consolidated financial statements.

 

48


Table of Contents

CytoDyn Inc.

(A Development Stage Company)

Consolidated Statements of Changes in Shareholders’ (Deficit)

Period October 28, 2003 through May 31, 2013

 

     Treasury Stock     Treasury
Stock
APIC
    Stock for
Prepaid
Services
    Accumulated
Deficit
    Deficit
Accumulated
During
Development
Stage
    Total  
     Shares     Amount            

Rescission expirations and exclusions

     —         —         —         —         —         —          3,212,500  

Amortization of deferred offering costs related to rescission liability

     —         —         (44,232     —         —         —         (580,392

Conversion of Series B Convertible Preferred Stock to Common Stock

     —         —         —         —         —         —         —    

Series B Convertible Preferred Stock Dividends

     —         —         —         —         —         —         —    

Common Stock issued related to legal settlement ($.97/share)

     —         —         —         —         —         —         —    

Common Stock issued to consultants for services ($2.68/share)

     —         —         —         (160,800     —         —      

Amortization of prepaid stock service

     —         —         —         160,800       —         —         160,800  

Common Stock issued to directors for services ($1.60/share)

     —         —         —         —         —         —         12,496  

Common Stock issued to directors for services ($.77/share)

     —         —         —         —         —         —         12,497  

Common Stock issued to directors for services ($1.00/share)

     —         —         —         —         —         —         12,500  

Common Stock issued to directors for services ($.80/share)

     —         —         —         —         —         —         11,984  

Exercise of Common Stock warrants ($.25/share)

     —         —         —         —         —         —         187,500  

Exercise of Common Stock warrants ($1.00/share)

     —         —         —         —         —         —         5,000  

Exercise of Common Stock options ($.34/share)

     —         —         —         —         —         —         8,500  

Conversion of convertible debt to common stock ($.75/share)

     —         —         —         —         —         —         567,000  

Conversion of accrued interest on convertible debt to common stock ($.75/share)

     —         —         —         —         —         —         4,203  

Issuance of common stock for accounts payable ($1.21/share)

     —         —         —         —         —         —         80,000  

Common stock issuable for accrued interest

     —         —         —         —         —         —         10,278  

Common stock issuable for bonuses

     —         —         —         —         —         —         107,500  

Stock-based compensation

     —         —         —         —         —         —         3,261,951  

Debt discount related to warrants and beneficial conversion feature associated with convertible debt

       —         —         —         —         —         6,243,502  

Net Loss for the year ended May 31, 2013

     —         —         —         —         —         (9,568,301     (9,568,301
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance at May 31, 2013

     (200,000   $ (100,000   $ 255,065       —       $ (1,601,912   $ (32,400,907 )   $ (223,916
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

See accompanying notes to consolidated financial statements.

 

49


Table of Contents

CytoDyn Inc.

(A Development Stage Company)

Consolidated Statements of Cash Flows

 

     Year Ended May 31,     October 28, 2003
through May 31, 2013
 
     2013     2012    

Cash flows from operating activities

      

Net loss

   $ (9,568,301   $ (7,474,224   $ (32,400,907

Adjustments to reconcile net loss to net cash used by operating activities:

      

Amortization / depreciation

     222,684        2,013        405,546   

Loss on disposal of furniture and equipment

     —         2,560        2,560   

Amortization of discount on convertible debt

     1,703,616        2,063        2,422,881   

Gain on settlement of accounts payable

     (372,759     —         (710,101

Purchased in process research and development

     —         —         274,399   

Stock-based compensation

     3,590,011        2,857,859        12,167,995   

Changes in current assets and liabilities:

      

Increase in accrued salaries

     175,449        189,249        364,698   

Increase in prepaid expenses

     (73,867     (6,707     (139,849

(Increase) decrease in other assets

     5,744        (25,987     —       

Increase in accounts payable, accrued interest and accrued liabilities

     924,490        62,079        2,210,482   
  

 

 

   

 

 

   

 

 

 

Net cash used in operating activities

     (3,392,933     (4,391,095     (15,402,296
  

 

 

   

 

 

   

 

 

 

Cash flows from investing activities:

      

Asset acquisition of intangibles

     (3,500,000     —         (3,500,000

Furniture and equipment purchases

     (3,135     —         (24,218
  

 

 

   

 

 

   

 

 

 

Net cash used in investing activities

     (3,503,135     —         (3,524,218
  

 

 

   

 

 

   

 

 

 

Cash flows from financing activities:

      

Capital contributions by executive

     —         1,336        15,748   

Preferred stock dividends

     —         (1,500     (1,500

Proceeds from notes payable to related parties

     500,000        —         1,205,649   

Payments on notes payable to related parties

     (74,492     (74,492     (314,482

Proceeds from notes payable issued to individuals

     —         —         145,000   

Payments on notes payable issued to individuals

     —         —         (34,500

Proceeds from convertible notes payable

     6,588,250        —         7,274,250   

Proceeds from sale of common stock

     —          3,386,024        8,966,072   

Proceeds from Series B preferred stock

     —         —         2,009,000   

Purchase of treasury stock

     —         —         (436,000

Proceeds from sale of treasury stock

     —         —         559,210   

Deferred offering costs

     —         —         (1,029,940

Proceeds from issuance of stock in AITI acquisition

     —         —         512,200   

Proceeds from issuance of stock in AGTI acquisition

     —         —         100,000   

Proceeds from exercise of warrants and options

     201,000        326,900        556,250   
  

 

 

   

 

 

   

 

 

 

Net cash provided by financing activities

     7,214,758        3,638,268        19,526,957   
  

 

 

   

 

 

   

 

 

 

Net change in cash

     318,690        (752,827     600,443   

Cash, beginning of period

     284,991        1,037,818        3,238   
  

 

 

   

 

 

   

 

 

 

Cash, end of period

   $ 603,681      $ 284,991      $