Delaware
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26-2593535
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(State or other jurisdiction of Incorporation or organization)
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(I.R.S. Employer Identification No.)
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Title of Each Class
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Name of Each Exchange on Which Registered
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Common Stock, $0.0001 par value per share
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The NASDAQ Stock Market LLC
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Large accelerated filer
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Accelerated filer
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Non-accelerated filer
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Smaller reporting company
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(Do not check if a smaller reporting company)
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three U.S. patents (5,824,703; 5,840,767; 6,167,887), three Australian patents (690,277; 722,417; 759,557), and two Canadian patents (2,239,170; 2,311,122) pertaining to the use and application of PFCs as gas transport agents in blood substitutes and liquid ventilation with an average remaining life of approximately 5 years;
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exclusive in-licenses to three fundamental gas transport patent applications that represent the core technology used in our products and product candidates with an average remaining life of approximately 17 years; and
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numerous patent applications for treatment of several medical and dermatological conditions such as TBI, acne, burns and wounds with an average remaining life of approximately 18 years.
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methods to treat certain diseases and conditions and for biological gas exchange;
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therapies for burn and wound victims;
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delivery of oxygenated PFC;
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various formulations containing PFC; and
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methods and compositions for controlled and sustained production and delivery of peroxide and/or oxygen for biological and industrial applications.
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the incurrence of additional indebtedness without the consent of the holders of the Preferred Stock;
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the issuance of additional securities, subject to standard exceptions; and
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the payment of cash dividends on shares of capital stock outstanding.
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our ability to obtain additional funding to develop our product candidates;
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the need to obtain regulatory approval of our most advanced product candidate, Oxycyte, for the potential treatment of TBI;
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potential risks related to any collaborations we may enter into for our product candidates, including Oxycyte;
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delays in the commencement, enrollment and completion of clinical testing, as well as the analysis and reporting of results from such clinical testing;
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the success of clinical trials of our Oxycyte product candidate or future product candidates;
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any delays in regulatory review and approval of product candidates in development;
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market acceptance of our cosmetic product candidates;
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our ability to establish an effective sales and marketing infrastructure;
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competition from existing products or new products that may emerge;
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the ability to receive regulatory approval or commercialize our products;
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potential side effects of our product candidates that could delay or prevent commercialization;
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potential product liability claims and adverse events;
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potential liabilities associated with hazardous materials;
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our ability to maintain adequate insurance policies;
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our dependency on third-party manufacturers to supply or manufacture our products;
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our ability to establish or maintain collaborations, licensing or other arrangements;
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our ability, our partners’ abilities, and third parties’ abilities to protect and assert intellectual property rights;
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costs related to and outcomes of potential ongoing property litigation;
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compliance with obligations under intellectual property licenses with third parties;
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our ability to adequately support future growth; and
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our ability to attract and retain key personnel to manage our business effectively.
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the scope, rate of progress and cost of our clinical trials and other research and development activities;
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the costs and timing of regulatory approval;
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the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;
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the effect of competing technological and market developments;
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the terms and timing of any collaboration, licensing or other arrangements that we may establish;
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the cost and timing of completion of clinical and commercial-scale manufacturing activities; and
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the costs of establishing sales, marketing and distribution capabilities for our cosmetic products and any product candidates for which we may receive regulatory approval.
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capital resources;
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research and development resources, including personnel and technology;
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expertise in prosecution of intellectual property rights;
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manufacturing and distribution experience; and
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sales and marketing resources and experience.
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we may not be able to control the amount and timing of resources that our partners may devote to the development or commercialization of product candidates or to their marketing and distribution;
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partners may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;
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disputes may arise between us and our partners that result in the delay or termination of the research, development or commercialization of our product candidates or that result in costly litigation or arbitration that diverts management’s attention and resources;
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partners may experience financial difficulties;
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partners may not properly maintain or defend our intellectual property rights, or may use our proprietary information, in such a way as to invite litigation that could jeopardize or invalidate our intellectual property rights or proprietary information or expose us to potential litigation;
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business combinations or significant changes in a partner’s business strategy may adversely affect a partner’s willingness or ability to meet its obligations under any arrangement;
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a partner could independently move forward with a competing product candidate developed either independently or in collaboration with others, including our competitors; and
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the collaborations with our partners may be terminated or allowed to expire, which would delay the development and may increase the cost of developing our product candidates.
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reaching agreements on acceptable terms with prospective CROs and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
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obtaining regulatory approval to commence a clinical trial;
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obtaining institutional review board, or IRB, approval to conduct a clinical trial at numerous prospective sites;
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recruiting and enrolling patients to participate in clinical trials for a variety of reasons, including meeting the enrollment criteria for our study and competition from other clinical trial programs for the same indication as our product candidates;
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retaining patients who have initiated a clinical trial but may be prone to withdraw due to the treatment protocol, lack of efficacy, personal issues or side effects from the therapy or who are lost to further follow-up;
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maintaining and supplying clinical trial material on a timely basis; and
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collecting, analyzing and reporting final data from the clinical trials.
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failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;
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inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities resulting in the imposition of a clinical hold;
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unforeseen safety issues or any determination that a trial presents unacceptable health risks; and
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lack of adequate funding to continue the clinical trial, including unforeseen costs due to enrollment delays, requirements to conduct additional trials and studies and increased expenses associated with the services of our CROs and other third parties.
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The data obtained from laboratory testing and clinical trials are susceptible to varying interpretations, which could delay, limit or prevent FDA and other regulatory approvals
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Adverse events could cause the FDA and other regulatory authorities to halt trials
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At any time the FDA and other regulatory agencies could change policies and regulations that could result in delay and perhaps rejection of our products, and
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Even after extensive testing and clinical trials, there is no assurance that regulatory approval will ever be obtained for any of our products.
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The federal anti-kickback statute is a criminal statute that makes it a felony for individuals or entities knowingly and willfully to offer or pay, or to solicit or receive, direct or indirect remuneration, in order to induce the purchase, order, lease, or recommending of items or services, or the referral of patients for services, that are reimbursed under a federal health care program, including Medicare and Medicaid;
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The federal False Claims Act imposes liability on any person who knowingly submits, or causes another person or entity to submit, a false claim for payment of government funds. Penalties include three times the government’s damages plus civil penalties of $5,500 to $11,000 per false claim. In addition, the False Claims Act permits a person with knowledge of fraud, referred to as a qui tam plaintiff, to file a lawsuit on behalf of the government against the person or business that committed the fraud, and, if the action is successful, the qui tam plaintiff is rewarded with a percentage of the recovery;
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Health Insurance Portability and Accountability Act imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;
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The Social Security Act contains numerous provisions allowing the imposition of a civil money penalty, a monetary assessment, exclusion from the Medicare and Medicaid programs, or some combination of these penalties; and
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Many states have analogous state laws and regulations, such as state anti-kickback and false claims laws. In some cases, these state laws impose more strict requirements than the federal laws. Some state laws also require pharmaceutical companies to comply with certain price reporting and other compliance requirements.
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Our inability to recruit and retain adequate numbers of effective sales and marketing personnel;
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The inability of sales personnel to obtain access to or persuade adequate numbers of physicians to prescribe our products;
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The lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and
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Unforeseen costs and expenses associated with creating and sustaining an independent sales and marketing organization.
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We may be required to relinquish important rights to our products or product candidates;
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We may not be able to control the amount and timing of resources that our distributors or collaborators may devote to the commercialization of our product candidates;
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Our distributors or collaborators may experience financial difficulties;
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Our distributors or collaborators may not devote sufficient time to the marketing and sales of our products; and
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Business combinations or significant changes in a collaborator’s business strategy may adversely affect a collaborator’s willingness or ability to complete its obligations under any arrangement.
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others may be able to make compositions or formulations that are similar to our product candidates but that are not covered by the claims of our patents;
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we might not have been the first to make the inventions covered by our issued patents or pending patent applications;
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we might not have been the first to file patent applications for these inventions;
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others may independently develop similar or alternative technologies or duplicate any of our technologies;
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it is possible that our pending patent applications will not result in issued patents;
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our issued patents may not provide us with any competitive advantages, or may be held invalid or unenforceable as a result of legal challenges by third parties;
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we may not develop additional proprietary technologies that are patentable; or
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the patents of others may have an adverse effect on our business.
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These agreements may be breached;
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These agreements may not provide adequate remedies for the applicable type of breach; or
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Our trade secrets or proprietary know-how will otherwise become known.
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Decreased demand for our products and any product candidates that we may develop;
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Injury to our reputation;
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Withdrawal of clinical trial participants;
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Costs to defend the related litigation;
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Substantial monetary awards to trial participants or patients;
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Loss of revenue; and
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The inability to commercialize any products that we may develop.
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actual or anticipated fluctuations in our financial condition and operating results;
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status and/or results of our clinical trials;
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status of ongoing litigation;
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results of clinical trials of our competitors’ products;
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regulatory actions with respect to our products or our competitors’ products;
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actions and decisions by our collaborators or partners;
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actual or anticipated changes in our growth rate relative to our competitors;
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actual or anticipated fluctuations in our competitors’ operating results or changes in their growth rate;
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competition from existing products or new products that may emerge;
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issuance of new or updated research or reports by securities analysts;
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fluctuations in the valuation of companies perceived by investors to be comparable to us;
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share price and volume fluctuations attributable to inconsistent trading volume levels of our shares;
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market conditions for biopharmaceutical stocks in general;
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status of our search and selection of future management and leadership; and
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general economic and market conditions.
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Year-Ended April 30, 2011
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High
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Low
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||||||
First Quarter
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$ | 5.01 | $ | 2.39 | ||||
Second Quarter
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$ | 3.33 | $ | 1.88 | ||||
Third Quarter
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$ | 2.75 | $ | 1.87 | ||||
Fourth Quarter
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$ | 2.22 | $ | 1.70 |
Year-Ended April 30, 2012
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High
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Low
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||||||
First Quarter
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$ | 3.55 | $ | 1.71 | ||||
Second Quarter
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$ | 3.08 | $ | 1.85 | ||||
Third Quarter
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$ | 2.36 | $ | 1.30 | ||||
Fourth Quarter
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$ | 3.20 | $ | 1.78 |
Period |
Total Number
of Shares
Purchased (1)
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Average Price
Paid per
Share (2)
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Total Number
of Shares
Purchased as
Part of Publicly Announced Plans
or Programs
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Approximate Dollar Value of Shares
that May Yet Be Purchased Under
the Plans
or Programs
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February 1, 2012 – February 29, 2012
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438 | $ | 2.00 | - | - | |||||||||||
March 1, 2012 – March 31, 2012
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438 | 2.69 | - | - | ||||||||||||
April 1, 2012 – April 30, 2012
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436 | 2.35 | - | - | ||||||||||||
Total
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1,312 | $ | 2.35 | - | - |
(1)
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Represents shares repurchased in connection with tax withholding obligations under the 1999 Amended Stock Plan.
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(2)
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Represents the average price paid per share for the shares repurchased in connection with tax withholding obligations under the 1999 Amended Stock Plan.
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Year ended April 30,
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Increase/ | % Increase/ | ||||||||||||||
2012
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2011
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(Decrease) | (Decrease) | |||||||||||||
Wholesale & retail revenue
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$ | 74,519 | $ | 101,582 | $ | (27,063 | ) | (27 | ) % | |||||||
Distibutor revenue
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26,000 | 220,767 | (194,767 | ) | (88 | )% | ||||||||||
Product revenue
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100,519 | 322,349 | (221,830 | ) | (69 | )% | ||||||||||
Cost of sales
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51,253 | 219,182 | (167,929 | ) | (77 | )% | ||||||||||
Gross profit
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49,266 | 103,167 | (53,901 | ) | (52 | )% |
Year ended April 30,
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Increase/
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% Increase/
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||||||||||||||
2012
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2011
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(Decrease) | (Decrease) | |||||||||||||
Government grant revenue
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$ | 314,515 | $ | - | $ | 314,515 | — | % |
Year ended April 30,
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Increase/
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% Increase/
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||||||||||||||
2012
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2011
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(Decrease) | (Decrease) | |||||||||||||
Marketing and sales expense
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$ | 393,922 | $ | 926,411 | $ | (532,489 | ) | (57 | ) % |
Year ended April 30,
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Increase/
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%
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||||||||||||||
2012
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2011
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(Decrease) | Increase/ | |||||||||||||
Personnel costs
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$ | 1,747,055 | $ | 3,358,590 | $ | (1,611,535 | ) | (48 | ) % | |||||||
Legal and professional fees
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3,086,350 | 2,149,046 | 937,304 | 44 | % | |||||||||||
Facilities
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284,694 | 330,078 | (45,384 | ) | (14 | ) % | ||||||||||
Other costs
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414,204 | 658,918 | (244,714 | ) | (37 | ) % | ||||||||||
Depreciation and amortization
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165,581 | 259,044 | (93,463 | ) | (36 | ) % |
Year ended April 30,
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Increase/
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% | ||||||||||||||
2012
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2011
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(Decrease) | Increase/ | |||||||||||||
Personnel costs
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$ | 947,374 | $ | 883,018 | $ | 64,356 | 7 | % | ||||||||
Consulting
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382,374 | 154,882 | 227,492 | 147 | % | |||||||||||
Clinical and preclinical development
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814,646 | 1,301,584 | (486,938 | ) | (37 | ) % | ||||||||||
Facilities
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181,248 | 157,611 | 23,637 | 15 | % | |||||||||||
Other costs
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95,900 | 132,636 | (36,736 | ) | (28 | ) % | ||||||||||
Depreciation
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41,096 | 51,982 | (10,886 | ) | (21 | ) % |
Year ended April 30, |
Increase/
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% Increase/
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||||||||||||||
2012
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2011
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(Decrease) | (Decrease) | |||||||||||||
Other expense (income), net
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$ | 80,159 | $ | (285,944 | ) | $ | 366,103 | - | % |
Year ended April 30, |
Increase/
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% Increase/
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||||||||||||||
2012
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2011
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(Decrease) | (Decrease) | |||||||||||||
Interest expense
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$ | 7,412,054 | $ | 171,563 | $ | 7,240,491 | 4220 | % |
For the year ended April 30,
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2012
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2011 | |||||||
Net cash used in operating activities | (8,278,366 | ) | (8,403,142 | ) | ||||
Net cash used in investing activities | (261,146 | ) | (463,939 | ) | ||||
Net cash provided by financing activities | 9,467,440 | 9,186,319 |
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Cash collected from customers was approximately $766,000 and $245,000 for the years ended April 30, 2012 and 2011, respectively. The $521,000 increase in cash collected from customers in the current year was due primarily to $523,000 received under our research grant and an increase of $35,000 in cash received from cosmetic sales during the current year; partially offset by a decrease of $38,000 in cash received from subleasing unused lab space in our California facility.
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Other operating cash receipts decreased $245,000 in the current year due to an award under the PPACA received in the prior year.
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Cash paid to employees, supplies, and vendors was approximately $9.0M and $8.9M for the years ended April 30, 2012 and 2011, respectively. The slight increase in cash payments is due to a reduction in operating expenses, including cost of sales; partially offset by an increase in other current assets, and a reduction in current liabilities.
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The initiation, progress, timing and completion of clinical trials for our product candidates and potential product candidates;
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The outcome, timing and cost of regulatory approvals and the regulatory approval process;
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Delays that may be caused by changing regulatory requirements;
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The number of product candidates that we pursue;
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The costs involved in filing and prosecuting patent applications and enforcing and defending patent claims;
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The timing and terms of future in-licensing and out-licensing transactions;
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The cost and timing of establishing sales, marketing, manufacturing and distribution capabilities;
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The cost of procuring clinical and commercial supplies of our product candidates;
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The extent to which we acquire or invest in businesses, products or technologies; and
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The possible costs of litigation.
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Fees paid to CROs in connection with clinical trials,
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Fees paid to research institutions in conjunction with preclinical research studies, and
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Fees paid to contract manufacturers and service providers in connection with the production and testing of active pharmaceutical ingredients and drug materials for use in preclinical studies and clinical trials.
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Report of Independent Registered Accounting Firm
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47 | |||
BALANCE SHEETS
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48 | |||
STATEMENTS OF OPERATIONS
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49 | |||
STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
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50 | |||
STATEMENTS OF CASH FLOWS | 51 | |||
NOTES TO FINANCIAL STATEMENTS | 53 |
Period from May 26, 1967 (Inception) to
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Year ended April 30,
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April 30, 2012 |
2012
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2011
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Product revenue
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$ | 470,254 | $ | 100,519 | $ | 322,349 | ||||||
Cost of sales
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309,468 | 51,253 | 219,182 | |||||||||
Net product revenue
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160,786 | 49,266 | 103,167 | |||||||||
Government grant revenue
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314,515 | 314,515 | - | |||||||||
Total net revenue
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475,301 | 363,781 | 103,167 | |||||||||
Operating expenses
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Selling, general, and administrative
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46,909,067 | 6,091,806 | 7,682,087 | |||||||||
Research and development
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22,075,312 | 2,462,638 | 2,681,713 | |||||||||
Loss on impairment of long-lived assets
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363,691 | 29,534 | 302,044 | |||||||||
Total operating expenses
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69,348,070 | 8,583,978 | 10,665,844 | |||||||||
Net operating loss
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68,872,769 | 8,220,197 | 10,562,677 | |||||||||
Interest expense
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39,723,563 | 7,412,054 | 171,563 | |||||||||
Loss on extinguishment of debt
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250,097 | - | - | |||||||||
Other expense (income)
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(1,218,145 | ) | 80,159 | (285,944 | ) | |||||||
Net loss
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$ | 107,628,284 | $ | 15,712,410 | $ | 10,448,296 | ||||||
Net loss per share, basic
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$ | (0.61 | ) | $ | (0.45 | ) | ||||||
Weighted average number of common shares outstanding, basic
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25,928,263 | 23,346,496 | ||||||||||
Net loss per share, diluted
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$ | (0.70 | ) | $ | (0.45 | ) | ||||||
Weighted average number of common shares outstanding, diluted
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27,752,386 | 23,346,496 |
Common Stock |
Additional
paid-in
capital
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Stock
subscription receivable |
Defecit
accumulated during the development stage |
Total stockholders'
equity (deficit) |
||||||||||||||||||||
Number of Shares
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Amount
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|||||||||||||||||||||||
Balance at April 30, 2010
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21,457,265 | $ | 2,146 | $ | 83,092,470 | $ | 500,000 | $ | (81,467,578 | ) | $ | 2,127,038 | ||||||||||||
Common stock sold, net of offering costs
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1,910,806 | 191 | 4,901,208 | 4,901,399 | ||||||||||||||||||||
Common stock issued for convertible debt
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2,350 | - | 8,707 | 8,707 | ||||||||||||||||||||
Common stock subscription receivable
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(500,000 | ) | (500,000 | ) | ||||||||||||||||||||
Compensation on options and restricted stock issued
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20,868 | 2 | 186,627 | 186,629 | ||||||||||||||||||||
Exercise of warrants and options
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2,018 | - | - | - | ||||||||||||||||||||
Net loss
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(10,448,296 | ) | (10,448,296 | ) | ||||||||||||||||||||
Balance at April 30, 2011
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23,393,307 | $ | 2,339 | $ | 88,189,012 | $ | - | $ | (91,915,874 | ) | $ | (3,724,523 | ) | |||||||||||
Common stock sold, net of offering costs
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3,368,422 | 337 | 7,999,664 | 8,000,001 | ||||||||||||||||||||
Common stock issued for convertible preferred stock
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1,874,244 | 187 | 3,462,136 | 3,462,323 | ||||||||||||||||||||
Common stock issued as interest on convertible debt
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243,830 | 24 | 549,809 | 549,833 | ||||||||||||||||||||
Common stock issued as dividend on convertible preferred stock
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44,816 | 5 | 81,886 | 81,891 | ||||||||||||||||||||
Compensation on options and restricted stock issued
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32,022 | 4 | 192,894 | 192,898 | ||||||||||||||||||||
Issuance of warrants
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3,130,808 | 3,130,808 | ||||||||||||||||||||||
Exercise of warrants and options
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461,077 | 46 | 733,583 | 733,629 | ||||||||||||||||||||
Beneficial conversion feature of convertible debt
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2,939,504 | 2,939,504 | ||||||||||||||||||||||
Net loss
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(15,712,410 | ) | (15,712,410 | ) | ||||||||||||||||||||
Balance at April 30, 2012
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29,417,718 | $ | 2,942 | $ | 107,279,296 | $ | - | $ | (107,628,284 | ) | $ | (346,046 | ) |
Defecit
accumulated
during the development stage |
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Common Stock |
Additional
paid-in capital |
Total stockholders'
equity (deficit) |
||||||||||||||||||
Number of Shares | Amount | |||||||||||||||||||
Balance at May 26, 1967
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- | $ | - | $ | - | $ | - | $ | - | |||||||||||
Common stock sold, net of offering costs
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15,466,112 | 1,058,966 | 39,749,887 | 40,808,853 | ||||||||||||||||
Issuance of common stock for promissory notes
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7,310,518 | 243,621 | 23,773,189 | 24,016,810 | ||||||||||||||||
Compensation on options and restricted stock issued
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417,026 | 36,486 | 12,682,051 | 12,718,537 | ||||||||||||||||
Warrants issued with debt instruments
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- | - | 8,619,525 | 8,619,525 | ||||||||||||||||
Issuance of warrants
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- | - | 7,805,328 | 7,805,328 | ||||||||||||||||
Exercise of warrants and options
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1,265,175 | 164,696 | 3,630,188 | 3,794,884 | ||||||||||||||||
Common stock issued for convertible preferred stock
|
1,874,244 | 187 | 3,462,136 | 3,462,323 | ||||||||||||||||
Beneficial conversion on convertible debt
|
- | - | 3,292,648 | 3,292,648 | ||||||||||||||||
Beneficial conversion feature of convertible debt
|
- | - | 2,939,504 | 2,939,504 | ||||||||||||||||
Common stock issued in conjunction with funding agreements and services rendered
|
358,425 | 53,764 | 883,160 | 936,924 | ||||||||||||||||
Contributions of capital by shareholders
|
- | - | 581,818 | 581,818 | ||||||||||||||||
Common stock issued as interest on convertible debt
|
243,830 | 24 | 549,809 | 549,833 | ||||||||||||||||
Issuance of common stock to officers to retire shareholder loans
|
69,630 | 10,444 | 177,556 | 188,000 | ||||||||||||||||
Common stock issued as dividend on convertible preferred stock
|
44,816 | 5 | 81,886 | 81,891 | ||||||||||||||||
Contributions of capital for services rendered
|
- | - | 65,700 | 65,700 | ||||||||||||||||
Exchange of warrants
|
2,363,767 | 3,544 | (2,583,884 | ) | (2,580,340 | ) | ||||||||||||||
Common stock par value change
|
- | (1,541,114 | ) | 1,541,114 | - | |||||||||||||||
Fractional shares of common stock due to reverse stock split
|
4,175 | (27,681 | ) | 27,681 | - | |||||||||||||||
Net loss
|
(107,628,284 | ) | (107,628,284 | ) | ||||||||||||||||
Balance at April 30, 2012
|
29,417,718 | $ | 2,942 | $ | 107,279,296 | $ | (107,628,284 | ) | $ | (346,046 | ) |
Period from May 26, 1967 (Inception) to | Year ended April 30, | |||||||||||
April 30, 2012 | 2012 | 2011 | ||||||||||
CASH FLOWS FROM OPERATING ACTIVITIES
|
||||||||||||
Net Loss
|
$ | (107,628,284 | ) | $ | (15,712,410 | ) | $ | (10,448,296 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities
|
||||||||||||
Depreciation and amortization
|
2,070,808 | 206,677 | 311,026 | |||||||||
Amortization of deferred compensation
|
336,750 | - | - | |||||||||
Interest on debt instruments
|
39,315,994 | 7,397,357 | 171,563 | |||||||||
Loss (gain) on debt settlement and extinguishment
|
163,097 | - | - | |||||||||
Loss on impairment, disposal and write down of long-lived assets
|
791,173 | 123,518 | 302,044 | |||||||||
Issuance and vesting of compensatory stock options and warrants
|
8,290,661 | 65,373 | 127,220 | |||||||||
Issuance of common stock below market value
|
695,248 | - | - | |||||||||
Issuance of common stock as compensation
|
682,526 | 127,525 | 59,409 | |||||||||
Issuance of common stock for services rendered
|
1,265,279 | - | - | |||||||||
Issuance of note payable for services rendered
|
120,000 | - | - | |||||||||
Contributions of capital through services rendered by stockholders
|
216,851 | - | - | |||||||||
Changes in operating assets and liabilities
|
||||||||||||
Accounts receivable, prepaid expenses and other assets
|
(793,537 | ) | (74,760 | ) | 38,870 | |||||||
Inventory
|
230,746 | (7,280 | ) | 238,026 | ||||||||
Accounts payable and accrued liabilities
|
1,942,136 | (404,366 | ) | 796,996 | ||||||||
Net cash used in operating activities
|
(52,300,552 | ) | (8,278,366 | ) | (8,403,142 | ) | ||||||
CASH FLOWS FROM INVESTING ACTIVITIES
|
||||||||||||
Purchase of property and equipment
|
(1,761,743 | ) | (17,652 | ) | (240,824 | ) | ||||||
Proceeds from the sale of property and equipment
|
4,243 | 4,243 | ||||||||||
Capitalization of patent costs and license rights
|
(1,762,076 | ) | (247,737 | ) | (223,115 | ) | ||||||
Net cash used in investing activities
|
(3,519,576 | ) | (261,146 | ) | (463,939 | ) | ||||||
CASH FLOWS FROM FINANCING ACTIVITIES
|
||||||||||||
Proceeds from sale of common stock and exercise of stock options and warrants, net of related expenses and payments
|
44,478,293 | 8,733,629 | 4,901,400 | |||||||||
Repurchase of outstanding warrants
|
(2,836,520 | ) | - | - | ||||||||
Proceeds from stockholder notes payable
|
977,692 | - | - | |||||||||
Proceeds from issuance of notes payable, net of issuance costs
|
7,518,521 | 837,692 | 4,389,701 | |||||||||
Proceeds from convertible notes, net of issuance costs
|
13,321,447 | 4,514,162 | - | |||||||||
Proceeds from convertible preferred stock
|
3,500,000 | 3,500,000 | - | |||||||||
Payments on notes - short-term
|
(1,259,433 | ) | (118,043 | ) | (104,782 | ) | ||||||
Payments on notes - long-term
|
(8,000,000 | ) | (8,000,000 | ) | - | |||||||
Net cash provided by financing activities
|
57,700,000 | 9,467,440 | 9,186,319 | |||||||||
Net change in cash and cash equivalents
|
1,879,872 | 927,928 | 319,238 | |||||||||
Cash and cash equivalents, beginning of period
|
- | 951,944 | 632,706 | |||||||||
Cash and cash equivalents, end of period
|
$ | 1,879,872 | $ | 1,879,872 | $ | 951,944 | ||||||
Cash paid for:
|
||||||||||||
Interest
|
$ | 265,303 | $ | 14,697 | $ | 3,203 | ||||||
Income taxes
|
$ | 27,528 | $ | - | $ | - |
-
|
The Company issued 243,830 shares of restricted common stock for the payment of interest accrued on convertible notes. The shares were issued at a conversion price of $2.255 for the payment of $561,332 interest payable on convertible notes with a gross carrying value of $4,900,000.
|
-
|
The Company issued 1,583,326 shares of its common stock to redeem 2,332 shares of convertible preferred stock with a fair value of $2,931,406.
|
-
|
The Company issued 2,350 shares of common stock for the conversion of notes payable with a gross carrying value of $8,707 at a conversion price of $3.705 per share. The notes included a discount totaling $5,206 that was recognized as interest expense upon conversion.
|
-
|
Fees paid to CROs in connection with clinical trials,
|
-
|
Fees paid to research institutions in conjunction with preclinical research studies, and
|
-
|
Fees paid to contract manufacturers and service providers in connection with the production and testing of active pharmaceutical ingredients and drug materials for use in preclinical studies and clinical trials.
|
Laboratory equipment
|
3 – 5 years
|
Office equipment
|
5 years
|
Office furniture and fixtures
|
7 years
|
Computer equipment and software
|
3 years
|
Leasehold improvements
|
Shorter of useful life or remaining lease term
|
Year ended April 30,
|
||||||||
2012
|
2011
|
|||||||
Historical net loss per share:
|
||||||||
Numerator
|
||||||||
Net loss, as reported
|
$ | (15,712,410 | ) | $ | (10,448,296 | ) | ||
Less: Effect of amortization of interest expense on convertible notes
|
(3,817,550 | ) | - | |||||
Net loss attributed to common stockholders (diluted)
|
(19,529,960 | ) | (10,448,296 | ) | ||||
Denominator
|
||||||||
Weighted-average common shares outstanding
|
25,928,263 | 23,346,496 | ||||||
Effect of dilutive securities
|
1,824,123 | - | ||||||
Denominator for diluted net loss per share
|
27,752,386 | 23,346,496 | ||||||
Basic net loss per share
|
$ | (0.61 | ) | $ | (0.45 | ) | ||
Diluted net loss per share
|
$ | (0.70 | ) | $ | (0.45 | ) |
Year ended April 30,
|
||||||||
2012 | 2011 | |||||||
Warrants to purchase common stock
|
5,239,964 | 3,581,347 | ||||||
Convertible preferred shares outstanding
|
582,834 | - | ||||||
Options to purchase common stock
|
351,823 | 781,738 | ||||||
Convertible note shares outstanding
|
1,942 | 1,942 |
Fair Value Measurements at Reporting Date Using
|
||||||||||||||||
Balance as of
April 30, 2012 |
Quoted prices in Active Markets for Identical Securities (Level 1)
|
Significant Other Observable Inputs (Level 2)
|
Significant Unobservable Inputs (Level 3)
|
|||||||||||||
Current Assets
|
||||||||||||||||
Cash and cash equivalents
|
$ | 1,879,872 | $ | 1,879,872 | $ | - | $ | - | ||||||||
Current Liabilities
|
||||||||||||||||
Series A convertible preferred stock
|
$ | 1,247,266 | $ | - | $ | - | $ | 1,247,266 |
Fair Value Measurements at Reporting Date Using
|
||||||||||||||||
Balance as of
April 30, 2011 |
Quoted prices in Active Markets for Identical Securities (Level 1)
|
Significant Other Observable Inputs (Level 2)
|
Significant Unobservable Inputs (Level 3)
|
|||||||||||||
Current Assets
|
||||||||||||||||
Cash and cash equivalents
|
$ | 951,944 | $ | 951,944 | $ | - | $ | - | ||||||||
Current Liabilities
|
||||||||||||||||
Series A convertible preferred stock
|
$ | - | $ | - | $ | - | $ | - |
Series A Convertible Preferred Stock
|
||||
Issued on December 12, 2011:
|
$ | 3,500,000 | ||
Conversions to Common Stock
|
(3,462,338 | ) | ||
Redemptions
|
- | |||
Adjustments to fair value as of April 30, 2012
|
1,209,604 | |||
Transfers in and/or out of Level 3
|
- | |||
Balance as of April 30, 2012
|
$ | 1,247,266 |
April 30, 2012
|
April 30, 2011
|
|||||||
Raw materials
|
$ | 25,579 | $ | 107,271 | ||||
Work in process
|
- | 124,308 | ||||||
Finished goods
|
57,791 | 25,803 | ||||||
$ | 83,370 | $ | 257,382 |
April 30, 2012
|
April 30, 2011
|
|||||||
R&D materials
|
$ | 116,936 | $ | - | ||||
Dermacyte samples
|
19,529 | 1,052 | ||||||
Other
|
26,344 | 7,090 | ||||||
$ | 162,809 | $ | 8,142 |
April 30, 2012
|
April 30, 2011
|
|||||||
Laboratory equipment
|
$ | 968,101 | $ | 970,463 | ||||
Office furniture and fixtures
|
140,255 | 140,255 | ||||||
Computer equipment and software
|
134,005 | 153,234 | ||||||
Leasehold improvements
|
4,810 | 4,810 | ||||||
1,247,171 | 1,268,762 | |||||||
Less: Accumulated depreciation and amortization
|
(953,565 | ) | (826,176 | ) | ||||
$ | 293,606 | $ | 442,586 |
April 30, 2012
|
April 30, 2011
|
|||||||
Prepaid royalty fee
|
$ | 50,000 | $ | 50,000 | ||||
Other
|
15,666 | 15,086 | ||||||
Reimbursable patent expenses- Glucometrics
|
- | 82,522 | ||||||
$ | 65,666 | $ | 147,608 |
April 30, 2012
|
April 30, 2011
|
|||||||
Section 409A tax liability
|
$ | 532,350 | $ | 532,350 | ||||
Deferred government grant revenue
|
244,013 | - | ||||||
Employee related
|
352,400 | 493,640 | ||||||
Convertible note interest payable
|
59,583 | |||||||
Preferred stock dividend payable
|
21,479 | - | ||||||
Other
|
64,012 | 74,583 | ||||||
Clinical trial related
|
- | 150,000 | ||||||
$ | 1,273,837 | $ | 1,250,573 |
April 30, 2012
|
April 30, 2011
|
|||||||
Current portion of notes payable
|
$ | 55,763 | $ | 36,100 | ||||
Current portion of convertible notes payable
|
7,195 | 7,195 | ||||||
Current portion of notes payable, net
|
$ | 62,958 | $ | 43,295 | ||||
Long-term portion of notes payable
|
$ | - | $ | 6,881,600 | ||||
Less: Unaccreted premium
|
- | (2,417,965 | ) | |||||
- | 4,463,635 | |||||||
Long-term portion of convertible notes payable
|
$ | 4,900,001 | $ | - | ||||
Less: Unamortized discount
|
(3,538,891 | ) | - | |||||
1,361,110 | - | |||||||
Long-term portion of notes payable, net
|
$ | 1,361,110 | $ | 4,463,635 |
Liquidation preference
|
In the event of the Company’s voluntary or involuntary dissolution, liquidation or winding up, each holder of Preferred Stock will be entitled to be paid a liquidation preference equal to the initial stated value of such holder’s Preferred Stock of $2.22 per share, plus accrued and unpaid dividends and any other payments that may be due on such shares, before any distribution of assets may be made to holders of capital stock ranking junior to the Preferred Stock.
|
Voting rights
|
Shares of Preferred Stock will generally have no voting rights, except as required by law and except that the consent of holders of a majority of the outstanding. Preferred Stock will be required to amend the terms of the Preferred Stock.
|
Equity Conditions
|
The “Equity Conditions” will be satisfied on any date if: (i) on each day during the 30 trading days prior to such measurement date, all shares of Common Stock issued and issuable upon conversion of the Preferred Stock , as dividends on the Preferred Stock and upon exercise of the 2011 Warrants will have been issued or, to the extent not yet issued will be eligible for sale without restriction and without the need for registration under the securities laws; (ii) on each such day, the Common Stock is listed on The NASDAQ Capital Market, on one of several named alternative markets and, if subject to certain delisting proceedings or a failure to meet the maintenance standards of such an exchange, the Company must meet the minimum listing conditions of one of the other permitted markets (including the OTC Bulletin Board); (iii) on each such day, the Company has delivered Common Stock upon conversion by holders of Preferred Stock on a timely basis, as and if required; (iv) any applicable shares to be issued in connection with the determination may be issued in full without violating the ownership limitations described below or the rules of the Company’s principal market (except that the ownership limitations will not prevent the Company from delivering Common Stock in amounts up to such limits); (v) during such period, the Company has made timely payments as required; (vi) there has been no triggering event or potential triggering event under the certificate of designations; (vii) the Company has no knowledge of any fact that would cause the shares of Common Stock issuable in connection with the Preferred Stock or Preferred Warrants not to be eligible for sale without restriction; (viii) the Company meets certain minimum average trading volume qualifications on its principal market (i.e., a $375,000 aggregate dollar volume over the applicable 20 trading days); and (ix) we are otherwise in material compliance with our covenants and representations in the related Preferred Stock transaction documents, including the certificate of designations.
|
Installement Date
|
Pre-delivery Date
|
Preferred Shares Redeemedable
|
Less: Preferred
Shares Redeemed / Converted at 4/30/12 |
Balance of
Preferred Stock at 4/30/12 |
Fair Value
of Preferred Stock at 4/30/12 |
|||||||||||||
1/12/2012
|
12/12/2011
|
583 | (583 | ) | - | $ | - | |||||||||||
2/13/2012
|
1/10/2012
|
583 | (583 | ) | - | - | ||||||||||||
3/12/2012
|
2/10/2012
|
583 | (583 | ) | - | - | ||||||||||||
4/12/2012
|
3/10/2012
|
583 | (583 | ) | - | - | ||||||||||||
5/12/2012
|
4/10/2012
|
583 | 583 | 622,565 | ||||||||||||||
6/12/2012
|
5/10/2012
|
583 | 583 | 622,565 | ||||||||||||||
7/12/2012
|
6/8/2012
|
2 | 2 | 2,136 | ||||||||||||||
Convertible preferred stock
|
3,500 | (2,332 | ) | 1,168 | $ | 1,247,266 |
Interest expense on conversion of preferred stock
|
Amount
|
|||
Dividends paid in common stock
|
$ | 81,890 | ||
Dividends paid in common stock with redemptions
|
- | |||
Fair value of warrants issued with preferred shares | 1,170,322 | |||
Interest expense on redemption of preferred stock
|
530,943 | |||
Fair value adjustment to preferred stock
|
678,661 | |||
Accrued dividends payable
|
21,479 | |||
Non-cash interest expense as of April 30, 2012
|
$ | 2,483,295 |
Asset Category
|
Value Assigned
|
Weighted Average Amortization Period (in Years)
|
Impairments
|
Accumulated Amortization
|
Carrying Value (Net of Impairments and Accumulated Amortization)
|
|||||||||||||||
Patents
|
$ | 546,624 | 11.7 | $ | - | $ | (233,989 | ) | $ | 312,635 | ||||||||||
License Rights
|
540,668 | 16.6 | - | (89,429 | ) | 451,239 | ||||||||||||||
Trademarks
|
138,631 | N/A | (29,534 | ) | - | 109,097 | ||||||||||||||
Total
|
$ | 1,225,923 | $ | (29,534 | ) | $ | (323,418 | ) | $ | 872,971 |
Asset Category
|
Value Assigned
|
Weighted Average Amortization Period (in Years)
|
Impairments
|
Accumulated Amortization
|
Carrying Value (Net of Impairments and Accumulated Amortization)
|
|||||||||||||||
Patents
|
$ | 566,564 | 10.1 | $ | (202,934 | ) | $ | (214,840 | ) | $ | 148,790 | |||||||||
License Rights
|
558,532 | 17.6 | (68,602 | ) | (63,395 | ) | 426,535 | |||||||||||||
Trademarks
|
155,134 | N/A | (30,508 | ) | - | 124,626 | ||||||||||||||
Total
|
$ | 1,280,230 | $ | (302,044 | ) | $ | (278,235 | ) | $ | 699,951 |
Year ending April 30,
|
Amount
|
|||
2013
|
$ | 51,620 | ||
2014
|
50,590 | |||
2015
|
50,226 | |||
2016
|
49,650 | |||
2017
|
45,733 | |||
Therafter
|
516,055 | |||
$ | 763,874 |
Year ending April 30,
|
||||||||
2012
|
2011
|
|||||||
Product revenue
|
||||||||
United States
|
$ | 74,519 | $ | 101,582 | ||||
Latin America
|
26,000 | - | ||||||
Europe
|
- | 220,767 | ||||||
Total product revenue
|
$ | 100,519 | $ | 322,349 |
Year ending April 30,
|
||||||||
2012
|
2011
|
|||||||
Segment loss (income)
|
||||||||
United States
|
$ | 355,241 | $ | 831,529 | ||||
Latin America
|
(10,585 | ) | - | |||||
Europe
|
- | (17,406 | ) | |||||
Unallocated revenues
|
||||||||
Government grant revenue
|
(314,515 | ) | - | |||||
Unallocated expenses
|
||||||||
General and administrative
|
5,697,884 | 6,764,797 | ||||||
Research and development
|
2,462,638 | 2,681,713 | ||||||
Loss on impairment of long-lived assets
|
29,534 | 302,044 | ||||||
Net interest and other expense (income)
|
7,492,213 | (114,381 | ) | |||||
Net loss
|
$ | 15,712,410 | $ | 10,448,296 |
Warrants
|
Weighted Average
Exercise Price |
|||||||||
Outstanding at April 30, 2010
|
3,322,154 | $ | 3.89 | |||||||
Granted
|
732,758 | 5.32 | ||||||||
Exercised
|
- | - | ||||||||
Cancelled
|
- | - | ||||||||
Forfeited
|
(618,119 | ) | 4.62 | |||||||
Other
|
144,554 | 2.90 | ||||||||
Outstanding at April 30, 2011
|
3,581,347 | $ | 3.90 | |||||||
Granted
|
2,961,239 | 2.45 | ||||||||
Exercised
|
(453,744 | ) | 1.62 | |||||||
Forfeited
|
(1,656,396 | ) | 3.68 | |||||||
Other
|
807,518 |
(1)
|
1.31 | |||||||
Outstanding at April 30, 2012
|
5,239,964 | $ | 2.08 | (1) |
(1)
|
The Company has warrants outstanding that contain anti-dilution clauses requiring a repricing in the event of subsequent equity sales. Subsequent to the closing of the Series A Preferred Stock Offering, the repricing of these warrants resulted in an increase of 807,518 potentially issuable shares and a $0.84 reduction in the weighted average exercise price of the Company’s outstanding warrants.
|
Shares Available for Grant
|
||||
Balances, at April 30, 2010
|
182,424 | |||
Options granted
|
(60,345 | ) | ||
Options cancelled/forfeited
|
129,253 | |||
Restricted stock granted
|
(7,500 | ) | ||
Restricted stock cancelled/forfeited
|
- | |||
Balances, at April 30, 2011
|
243,832 | |||
Additional shares reserved
|
5,200,000 | |||
Options granted
|
(107,309 | ) | ||
Options cancelled/forfeited
|
263,224 | |||
Restricted stock granted
|
(209,461 | ) | ||
Restricted stock cancelled/forfeited
|
141,344 | |||
Balances, at April 30, 2012
|
5,531,630 |
Outstanding Options
|
||||||||||||
Number of Shares
|
Weighted Average Exercise Price
|
Aggregate Intrinsic Value
|
||||||||||
Balances, at April 30, 2010
|
585,172 | |||||||||||
Options granted
|
60,345 | $ | 2.49 | |||||||||
Options exercised
|
(1,193 | ) | $ | 1.69 | $ | 1,436 | (1) | |||||
Options cancelled
|
(129,253 | ) | $ | 4.22 | ||||||||
Balances, at April 30, 2011
|
515,071 | $ | 4.54 | |||||||||
Options granted
|
107,309 | $ | 1.94 | |||||||||
Options exercised
|
(7,333 | ) | $ | 1.96 | $ | 3,227 | (1) | |||||
Options cancelled
|
(263,224 | ) | $ | 4.19 | ||||||||
Balances, at April 30, 2012
|
351,823 | $ | 4.06 | $ | 3,673 | (2) |
(1)
|
Amounts represent the difference between the exercise price and fair value of Oxygen Biotherapeutics’ stock at the time of exercise.
|
(2)
|
Amount represents the difference between the exercise price and $1.78, the closing price of Oxygen Biotherapeutics’ stock on April 30, 2012, as reported on The NASDAQ Capital Market, for all in-the-money options outstanding.
|
Options Outstanding at April 30, 2012
|
Options Exercisable and Vested at April 30, 2012
|
|||||||||||||||||
Exercise Price
|
Number of
Options
|
Weighted Average
Remaining
Contractual Life (Years)
|
Number of
Options
|
Weighted Average
Exercise Price
|
||||||||||||||
$ | 1.35 to $2.15 | 99,647 | 8.9 | 41,742 | $ | 1.91 | ||||||||||||
$ | 2.25 to $4.78 | 99,672 | 5.0 | 90,948 | $ | 3.24 | ||||||||||||
$ | 5.00 to $6.00 | 100,504 | 1.9 | 99,447 | $ | 5.58 | ||||||||||||
$ | 6.15 to $10.80 | 52,000 | 1.9 | 51,778 | $ | 6.99 | ||||||||||||
351,823 | 4.8 | 283,915 | $ | 4.55 |
Number of Option Shares
|
Weighted Average Exercise Price
|
Aggregate Intrinsic Value (1)
|
Weighted Average Remaining Contractual Life (Years)
|
|||||||||||||
Vested
|
283,915 | $ | 4.55 | $ | 2,723 | 3.6 | ||||||||||
Vested and expected to vest
|
324,799 | $ | 4.23 | $ | 2,723 | 4.3 |
(1)
|
Amount represents the difference between the exercise price and $1.78, the closing price of Oxygen Biotherapeutics’ stock on April 30, 2012, as reported on The NASDAQ Capital Market, for all in-the-money options outstanding.
|
For the year ended April 30
|
||||||||
2012
|
2011
|
|||||||
Risk-free interest rate (weighted average)
|
1.79 | % | 2.08 | % | ||||
Expected volatility (weighted average)
|
78.88 | % | 83.89 | % | ||||
Expected term (in years)
|
7 | 7 | ||||||
Expected dividend yield
|
0.00 | % | 0.00 | % |
Risk-Free Interest Rate
|
The risk-free interest rate assumption was based on U.S. Treasury instruments with a term that is consistent with the expected term of our stock options.
|
Expected Volatility
|
The expected stock price volatility for our common stock was determined by examining the historical volatility and trading history for our common stock over a term consistent with the expected term of our options.
|
Expected Term
|
The expected term of stock options represents the weighted average period the stock options are expected to remain outstanding. It was calculated based on the historical experience that we have had with our stock option grants.
|
Expected Dividend Yield
|
The expected dividend yield of 0% is based on our history and expectation of dividend payouts. We have not paid and do not anticipate paying any dividends in the near future.
|
Forfeitures
|
As stock-based compensation expense recognized in the statement of operations for the years ended 2012 and 2011 is based on awards ultimately expected to vest, it has been reduced for estimated forfeitures. ASC 718 requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Forfeitures were estimated based on our historical experience.
|
Outstanding Restricted Stock Grants
|
||||||||
Number of Shares
|
Weighted Average Grant Date Fair Value
|
|||||||
Balances, at April 30, 2011
|
- | |||||||
Restricted stock granted
|
209,461 | $ | 2.07 | |||||
Restricted stock vested
|
(32,022 | ) | $ | 2.08 | ||||
Restricted stock cancelled
|
(17,301 | ) | $ | 2.00 | ||||
Restricted stock forfeited
|
(124,043 | ) | $ | 2.04 | ||||
Balances, at April 30, 2012
|
36,095 | $ | 2.19 |
April 30,
|
||||||||
2012
|
2011
|
|||||||
U.S. federal taxes (benefit) at statutory rate
|
$ | (5,342,219 | ) | $ | (3,552,421 | ) | ||
Interest expense
|
1,458,660 | - | ||||||
Stock compensation expense
|
22,227 | 43,255 | ||||||
Others
|
(95,003 | ) | 270,400 | |||||
Change in valuation allowance
|
3,956,335 | 3,238,766 | ||||||
- | - |
April 30,
|
||||||||
Deferred tax assets
|
2012
|
2011
|
||||||
Net operating loss carryforwards
|
$ | 24,172,571 | $ | 21,101,227 | ||||
Interest
|
1,511,360 | - | ||||||
Accruals and others
|
244,207 | 298,026 | ||||||
Depreciation and amortization
|
(32,473 | ) | (15,773 | ) | ||||
Total deferred tax assets
|
25,895,665 | 21,383,480 | ||||||
Less: Valuation allowance
|
(25,895,665 | ) | (21,383,480 | ) | ||||
Net deferred tax assets
|
$ | - | $ | - |
Installement Date
|
Pre-delivery Date
|
Preferred Shares Redeemedable
|
Less: Preferred Shares Redeemed / Converted
|
Balance of Preferred Stock
|
||||||||||
7/16/2012
|
6/15/2012
|
667 | (667 | ) | - | |||||||||
8/15/2012
|
7/13/2012
|
667 | - | 667 | ||||||||||
9/17/2012
|
8/14/2012
|
667 | - | 667 | ||||||||||
10/15/2012
|
9/12/2012
|
500 | - | 500 | ||||||||||
2,500 | (667 | ) | 1,833 |
-
|
Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our assets;
|
-
|
Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with GAAP, and that our receipts and expenditures are being made only in accordance with authorizations of our management and our Board of Directors; and
|
-
|
Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on our financial statements.
|
-
|
Reports of Independent Registered Public Accounting Firm.
|
-
|
Balance Sheets as of April 30, 2012 and 2011.
|
-
|
Statements of Operations for each of the two years ended April 30, 2012 and April 30, 2011 and for the period May 26, 1967 (Date of Inception) to April 30, 2012.
|
-
|
Statements of Stockholders’ Equity (Deficit) for each of the two years ended April 30, 2012 and April 30, 2011 and for the period May 26, 1967 (Date of Inception) to April 30, 2012.
|
-
|
Statements of Cash Flows for each of the two years ended April 30, 2012 and April 30, 2011 and for the period May 26, 1967 (Date of Inception) to April 30, 2012.
|
-
|
Notes to the Financial Statements.
|
OXYGEN BIOTHERAPEUTICS, INC. | |||
Date: July 24, 2012
|
By:
|
/s/ Michael B. Jebsen | |
Michael B. Jebsen | |||
Chief Financial Officer and Interim Chief Executive Officer |
Name
|
Title
|
Date
|
||
/s/ Michael B. Jebsen
|
Chief Financial Officer
|
July 24, 2012
|
||
Michael B. Jebsen |
Interim Chief Executive Officer
(Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer)
|
|||
/s/ Ronald R. Blanck
|
Director
|
July 24, 2012
|
||
Ronald R. Blanck, DO
|
||||
/s/ Gregory Pepin
|
Director
|
July 24, 2012
|
||
Gregory Pepin
|
||||
/s/ William A. Chatfield
|
Director
|
July 24, 2012
|
||
William A. Chatfield
|
||||
/s/ Chris A. Rallis
|
Director
|
July 24, 2012
|
||
Chris A. Rallis
|
||||
/s/ Anthony DiTonno
|
Director
|
July 24, 2012
|
||
Anthony DiTonno
|
Exhibit No.
|
|
Exhibits Required by Item 601 of Regulation S-K
|
2.1
|
|
Agreement and Plan of Merger dated April 28, 2008 (1)
|
3.1
|
|
Certificate of Incorporation (1)
|
3.2
|
Certificate of Amendment of the Certificate of Incorporation (14)
|
|
3.3
|
Certificate of Designations*
|
|
3.4
|
|
Amended and Restated Bylaws (22)
|
4.1
|
|
Specimen Stock Certificate (19)
|
10.1
|
|
Agreement with Leland C. Clark, Jr., Ph.D. dated November 20, 1992 with amendments, Assignment of Intellectual Property/ Employment (2)
|
10.2
|
|
Agreement between the Registrant and Keith R. Watson, Ph.D. Assignment of Invention (2)
|
10.3
|
|
Children’s Hospital Research Foundation License Agreement dated February 28, 2001 (2)
|
10.4
|
Exclusive License Agreement with Virginia Commonwealth University dated May 22, 2008 (9)
|
|
10.5
|
Amendment no. 1 to the Exclusive License Agreement with Virginia Commonwealth University Intellectual Property Foundation (10)
|
|
10.6
|
Amendment no. 2 to the Exclusive License Agreement with Virginia Commonwealth University Intellectual Property Foundation (10)
|
|
10.7
|
Agreement with Hospira to manufacture Oxycyte (8)
|
|
10.8
|
Termination Agreement between the Company and Hospira, dated August 30, 2011 (23)
|
10.9
|
Exclusive Supply Agreement with Exfluor dated November 12, 2009 (10)
|
|
10.10
|
Master Agreement with Dermacyte Switzerland (18)
|
|
10.11
|
Amendment no. 1 to Master Agreement with Dermacyte Switzerland (18)
|
|
10.12
|
|
Form of Option issued to Executive Officers and Directors (2)
|
10.13
|
|
Form of Option issued to Employees (2)
|
10.14
|
|
Restricted Stock Award Agreement (22)
|
10.15
|
|
Form of Warrant issued to Unsecured Note Holders 2006-2007 (3)
|
10.16
|
|
Form of Convertible Note – 2008 (4)
|
10.17
|
|
Form of Warrant issued to Convertible Note Holders (4)
|
10.18
|
|
Form of Purchase Agreement – US Purchase (without exhibits, which are included as exhibits 10.16 and 10.17, above) (4)
|
10.19
|
|
Form of Purchase Agreement – Non-US Purchase (without exhibits, which are included as exhibits 10.16 and 10.17, above) (4)
|
10.20
|
|
Form of Purchase Agreement – US Note Exchange (without exhibits, which are included as exhibits 10.16 and 10.17, above) (4)
|
10.21
|
|
Form of Purchase Agreement – Non-US Note Exchange (without exhibits, which are included as exhibits 10.16 and 10.17, above) (4)
|
10.22
|
|
Form of Warrant issued to Financing Consultants (5)
|
10.23
|
|
1999 Amended Stock Plan (amended 2008) (5)
|
10.24
|
|
Employment Agreement with Chris J. Stern dated February 1, 2009 (12)
|
10.25
|
Amended and Restated Employment Agreement with Chris J. Stern dated May 13, 2011 (20)
|
|
10.26
|
|
Business Consultant Agreement with Institute for Efficient Management, Inc., as amended March 26, 2008 (5)
|
10.27
|
|
Engagement and Consulting Agreement with Bruce Spiess (5)
|
10.28
|
|
Engagement and Consulting Agreement with Gerald L. Klein (5)
|
10.29
|
Employment Agreement with Gerald L. Klein dated May 13, 2011 (20)
|
|
10.30
|
|
Business Consultant Agreement with Edward Sitnik (8)
|
10.31
|
|
Business Consultant Agreement with J. Melville Engle (8)
|
10.32
|
|
Employment Agreement with Richard Kiral, restated February 1, 2009 (8)
|
10.33
|
Resignation of Employment and Consulting Agreement with Richard Kiral (20)
|
|
10.34
|
Employment Agreement with Michael B. Jebsen dated December 1, 2010 (16)
|
|
10.35
|
Amended and Restated Employment Agreement with Michael B. Jebsen dated May 19, 2011 (20)
|
|
10.36
|
Form of Indemnification Agreement (20)
|
|
10.37
|
|
Description of Non-Employee Director Compensation (25)
|
10.38
|
|
Securities Purchase Agreement (including exhibits) between Oxygen Biotherapeutics and Vatea Fund, Segregated Portfolio dated June 8, 2009 (6)
|
10.39
|
|
Amendment no. 1 to the Securities Purchase Agreement between Oxygen Biotherapeutics and Vatea Fund, Segregated Portfolio (11)
|
10.40
|
|
Amendment no. 2 to the Securities Purchase Agreement between Oxygen Biotherapeutics and Vatea Fund, Segregated Portfolio (12)
|
10.41
|
|
Amendment no. 3 to the Securities Purchase Agreement between Oxygen Biotherapeutics and Vatea Fund, Segregated Portfolio (23)
|
10.42
|
Form of Exchange Agreement dated July 20, 2009 (7)
|
|
10.43
|
Waiver—Convertible Note (10)
|
|
10.44
|
Amendment—Common Stock Purchase Warrant (10)
|
|
10.45
|
Form of Warrant for May 2010 offering (13)
|
|
10.46
|
Form of Subscription Agreement for May 2010 offering (13)
|
|
10.47
|
Warrant issued to Blaise Group International, Inc. (14)
|
|
10.48
|
Note Purchase Agreement between Oxygen Biotherapeutics and JP SPC 1 Vatea, Segregated Portfolio (15)
|
|
10.49
|
Form of Promissory Note under Note Purchase Agreement between Oxygen Biotherapeutics and JP SPC 1 Vatea, Segregated Portfolio (15)
|
|
10.50
|
First Amendment to Note Purchase Agreement between Oxygen Biotherapeutics and JP SPC 1 Vatea, Segregated Portfolio (17)
|
|
10.51
|
Lease Agreement for North Carolina corporate office (18)
|
|
10.52
|
Standard Industrial Lease relating to OBI’s California facility (12)
|
|
10.53
|
Task Order between the Company and NextPharma, dated November 15, 2011 (23)
|
|
10.54
|
Form of Convertible Note for July 2011 offering (included in exhibit 10.56)
|
|
10.55
|
Form of Warrant for July 2011 offering (included in exhibit 10.56)
|
|
10.56
|
Form of Convertible Note and Warrant Purchase Agreement for July 2011 offering (21)
|
(1)
|
These documents were filed as exhibits to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on June 30, 2008, and are incorporated herein by this reference.
|
(2)
|
These documents were filed as exhibits to the annual report on Form 10-K filed by Oxygen Biotherapeutics with the SEC on August 13, 2004, and are incorporated herein by this reference.
|
(3)
|
These documents were filed as exhibits to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on September 6, 2006, and are incorporated herein by this reference.
|
(4)
|
These documents were filed as exhibits to the quarterly report on Form 10-Q filed by Oxygen Biotherapeutics with the SEC on March 21, 2008, and are incorporated herein by this reference.
|
(5)
|
These documents were filed as exhibits to the annual report on Form 10-K filed by Oxygen Biotherapeutics with the SEC on August 13, 2008, and are incorporated herein by this reference.
|
(6)
|
This document was filed as an exhibit to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on June 8, 2009, and is incorporated herein by this reference.
|
(7)
|
This document was filed as an exhibit to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on July 21, 2009, and is incorporated herein by this reference.
|
(8)
|
These documents were filed as exhibits to the annual report on Form 10-K filed by Oxygen Biotherapeutics with the SEC on August 12, 2009, and are incorporated herein by this reference.
|
(9)
|
This document was filed as an exhibit to the quarterly report on Form 10-Q filed by Oxygen Biotherapeutics with the SEC on September 22, 2008, and is incorporated herein by this reference.
|
(10)
|
These documents were filed as exhibits to the quarterly report on Form 10-Q filed by Oxygen Biotherapeutics with the SEC on March 19, 2010, and are incorporated herein by this reference.
|
(11)
|
This document was filed as an exhibit to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on September 2, 2009, and is incorporated herein by this reference.
|
(12)
|
These documents were filed as exhibits to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on April 28, 2010, and are incorporated herein by this reference.
|
(13)
|
These documents were filed as exhibits to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on May 4, 2010, and are incorporated herein by this reference.
|
(14)
|
These documents were filed as exhibits to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on November 13, 2009, and are incorporated herein by reference.
|
(15)
|
These documents were filed as exhibits to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on October 13, 2010, and are incorporated herein by this reference.
|
(16)
|
These documents were filed as exhibits to the quarterly report on Form 10-Q filed by Oxygen Biotherapeutics with the SEC on December 9, 2010, and are incorporated herein by this reference.
|
(17)
|
This document was filed as an exhibit to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on December 30, 2010, and is incorporated herein by this reference.
|
(18)
|
These documents were filed as exhibits to the quarterly report on Form 10-Q filed by Oxygen Biotherapeutics with the SEC on March 21, 2011, and are incorporated herein by this reference.
|
(19)
|
These documents were filed as exhibits to the annual report on Form 10-K filed by Oxygen Biotherapeutics with the SEC on July 23, 2010, and are incorporated herein by this reference.
|
(20)
|
This document was filed as an exhibit to the annual report on Form 10-K filed by Oxygen Biotherapeutics with the SEC on July 15, 2011, and is incorporated herein by this reference.
|
(21)
|
This document was filed as an exhibit to the current report on Form 8-K/A filed by Oxygen Biotherapeutics with the SEC on July 1, 2011, and is incorporated herein by this reference.
|
(22)
|
This document was filed as an exhibit to the quarterly report on Form 10-Q filed by Oxygen Biotherapeutics with the SEC on December 15, 2011, and is incorporated herein by this reference.
|
(23)
|
These documents were filed as exhibits to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on November 16, 2011, and are incorporated herein by this reference.
|
(24)
|
These documents were filed as exhibits to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on December 9, 2011, and are incorporated herein by this reference.
|
(25)
|
This document was filed as an exhibit to the quarterly report on Form 10-Q filed by Oxygen Biotherapeutics with the SEC on March 15, 2012, and is incorporated herein by this reference.
|
(26)
|
This document was filed as an exhibit to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on June 15, 2012, and is incorporated herein by this reference.
|
*
|
Filed herewith.
|
**
|
Pursuant to Rule 406T of Regulation S-T, the Interactive Data Files in Exhibit 101 hereto are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, and otherwise are not subject to liability under those sections.
|
OXYGEN BIOTHERAPEUTICS, INC.
|
|||
Date
|
By:
|
/s/ Michael B. Jebsen | |
Name: Michael B. Jebsen | |||
Title:
Interim Chief Executive Officer and
Chief Financial Officer |
|||
OXYGEN BIOTHERAPEUTICS, INC.
|
|||
|
By:
|
||
Name: | |||
Title: | |||
Date: July 24, 2012 | OXYGEN BIOTHERAPEUTICS, INC. | ||
|
By:
|
/s/ Michael B. Jebsen | |
Michael B. Jebsen
|
|||
Chief Financial Officer and Interim Chief Executive Officer
|
|||
Date: July 24, 2012
|
/s/ Michael B. Jebsen | ||
Michael B. Jebsen
|
|||
Interim Chief Executive Officer, President and Chief Financial Officer
(Principal Executive Officer)
(Principal Financial Officer)
|
|||