Document_and_Entity_Informatio
Document and Entity Information | 12 Months Ended |
Jun. 30, 2014 | |
Document And Entity Information | ' |
Entity Registrant Name | 'PALATIN TECHNOLOGIES INC |
Entity Central Index Key | '0000911216 |
Document Type | 'S-1 |
Document Period End Date | 30-Jun-14 |
Amendment Flag | 'false |
Current Fiscal Year End Date | '--06-30 |
Is Entity a Well-known Seasoned Issuer? | 'No |
Is Entity a Voluntary Filer? | 'No |
Is Entity's Reporting Status Current? | 'Yes |
Entity Filer Category | 'Smaller Reporting Company |
Consolidated_Balance_Sheets
Consolidated Balance Sheets (USD $) | Jun. 30, 2014 | Jun. 30, 2013 |
Current assets: | ' | ' |
Cash and cash equivalents | $12,184,605 | $19,167,632 |
Short-term investments | 0 | 5,249,654 |
Prepaid expenses and other current assets | 156,393 | 332,267 |
Total current assets | 12,340,998 | 24,749,553 |
Property and equipment, net | 160,748 | 266,415 |
Other assets | 57,308 | 58,131 |
Total assets | 12,559,054 | 25,074,099 |
Current liabilities: | ' | ' |
Capital lease obligations | 261,280 | 338,726 |
Accounts payable | 1,508,958 | 1,701,727 |
Accrued expenses | 0 | 19,909 |
Unearned revenue | 1,000,000 | 0 |
Total current liabilities | 2,770,238 | 2,060,362 |
Deferred rent | 0 | 35,460 |
Total liabilities | 2,770,238 | 2,095,822 |
Stockholders' equity: | ' | ' |
Preferred stock of $.01 par value - authorized 10,000,000 shares; Series A Convertible; issued and outstanding 4,697 shares as of June 30, 2014 and 2013, respectively | 47 | 47 |
Common stock of $.01 par value - authorized 300,000,000 shares; issued and outstanding 39,416,595 shares as of June 30, 2014 and 39,116,948 as of June 30, 2013, respectively | 394,166 | 391,169 |
Additional paid-in capital | 283,428,356 | 282,692,520 |
Accumulated deficit | -274,033,753 | -260,105,459 |
Total stockholders' equity | 9,788,816 | 22,978,277 |
Total liabilities and stockholders' equity | $12,559,054 | $25,074,099 |
Consolidated_Balance_Sheets_Pa
Consolidated Balance Sheets (Parenthetical) (USD $) | Jun. 30, 2014 | Jun. 30, 2013 |
Statement of Financial Position [Abstract] | ' | ' |
Preferred stock, par value | $0.01 | $0.01 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, Series A Convertible, shares issued | 4,697 | 4,697 |
Preferred stock, Series A Convertible, shares outstanding | 4,697 | 4,697 |
Common stock, par value | ' | $0.01 |
Common stock, shares authorized | 300,000,000 | 300,000,000 |
Common stock, shares issued | 39,416,595 | 39,116,948 |
Common stock, shares outstanding | 39,416,595 | 39,116,948 |
Consolidated_Statements_of_Ope
Consolidated Statements of Operations (USD $) | 12 Months Ended | ||
Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2012 | |
Income Statement [Abstract] | ' | ' | ' |
License and contract | $0 | $10,361 | $73,736 |
OPERATING EXPENSES: | ' | ' | ' |
Research and development | 10,826,921 | 10,528,691 | 13,813,376 |
General and administrative | 4,960,731 | 5,066,830 | 5,045,741 |
Total operating expenses | 15,787,652 | 15,595,521 | 18,859,117 |
Loss from operations | -15,787,652 | -15,585,160 | -18,785,381 |
OTHER INCOME (EXPENSE): | ' | ' | ' |
Investment income | 18,923 | 42,734 | 32,133 |
Interest expense | -6,211 | -8,411 | -10,411 |
Increase in fair value of warrants | 0 | -7,069,165 | 0 |
Gain on disposition of supplies and equipment | 0 | 4,620 | 442,248 |
Total other income (expense), net | 12,712 | -7,030,222 | 463,970 |
Loss before income taxes | -15,774,940 | -22,615,382 | -18,321,411 |
Income tax benefit | 1,846,646 | 1,753,208 | 1,068,233 |
NET LOSS | ($13,928,294) | ($20,862,174) | ($17,253,178) |
Basic and diluted net loss per common share | ($0.13) | ($0.21) | ($0.49) |
Weighted average number of common shares outstanding used in computing basic and diluted net loss per common share | 106,679,476 | 97,618,714 | 34,900,591 |
Consolidated_Statements_Shareh
Consolidated Statements Shareholders Equity (USD $) | Preferred Stock | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total |
Stockholders' equity (deficit) - beginning at Jun. 30, 2012 | $50 | $349,006 | $240,725,127 | ($239,243,285) | $1,830,898 |
Common stock, shares - beginning at Jun. 30, 2012 | ' | 34,900,591 | ' | ' | ' |
Preferred stock, shares - beginning at Jun. 30, 2012 | 4,997 | ' | ' | ' | ' |
Sale of common stock units, net of costs | ' | 38,730 | 17,403,075 | 0 | 17,441,805 |
Sale of common stock units, net of costs, shares | ' | 3,873,000 | ' | ' | ' |
Reclassification of warrants from liability to equity | ' | ' | 24,030,128 | 0 | 24,030,128 |
Exercise of options, shares | ' | ' | ' | ' | 0 |
Stock-based compensation | ' | 5,000 | 620,031 | 0 | 625,031 |
Stock-based compensation, shares | ' | 500,000 | ' | ' | ' |
Payment of witholding taxes related to restricted stock units | ' | -1,583 | -85,828 | 0 | -87,411 |
Payment of witholding taxes related to restricted stock units, shares | ' | -158,264 | ' | ' | ' |
Series A Conversion | -3 | 16 | -13 | 0 | 0 |
Series A Conversion, shares | -300 | 1,621 | ' | ' | ' |
NET LOSS | 0 | 0 | 0 | -20,862,174 | -20,862,174 |
Stockholders' equity (deficit) - ending at Jun. 30, 2013 | 47 | 391,169 | 282,692,520 | -260,105,459 | 22,978,277 |
Common stock, shares - ending at Jun. 30, 2013 | ' | 39,116,948 | ' | ' | 39,116,948 |
Preferred stock, shares outstanding at Jun. 30, 2013 | 4,697 | ' | ' | ' | 4,697 |
Exercise of warrants | 0 | 500 | 37,000 | 0 | 37,500 |
Exercise of warrants, shares | 0 | 50,000 | ' | ' | ' |
Exercise of options, shares | ' | ' | ' | ' | 0 |
Stock-based compensation | 0 | 3,788 | 817,552 | 0 | 821,340 |
Stock-based compensation, shares | 0 | 378,750 | ' | ' | ' |
Taxes withheld related to restricted stock units | ' | -1,291 | -118,716 | 0 | -120,007 |
Taxes withheld related to restricted stock units, shares | ' | -129,103 | ' | ' | ' |
NET LOSS | 0 | 0 | 0 | -13,928,294 | -13,928,294 |
Stockholders' equity (deficit) - ending at Jun. 30, 2014 | $47 | $394,166 | $283,428,356 | ($274,033,753) | $9,788,816 |
Common stock, shares - ending at Jun. 30, 2014 | ' | 39,416,595 | ' | ' | 39,416,595 |
Preferred stock, shares outstanding at Jun. 30, 2014 | 4,697 | ' | ' | ' | 4,697 |
Consolidated_Statements_of_Cas
Consolidated Statements of Cash Flows (USD $) | 12 Months Ended | ||
Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2012 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ' | ' | ' |
Net loss | ($13,928,294) | ($20,862,174) | ($17,253,178) |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' | ' |
Depreciation and amortization | 111,906 | 111,844 | 949,542 |
Accrued interest and amortization on premium/discount | 0 | -1,365 | 0 |
Gain on sale of supplies and equipment | 0 | -4,620 | -442,248 |
Stock-based compensation | 821,340 | 625,031 | 892,301 |
Increase in fair value of warrants | 0 | 7,069,165 | 0 |
Changes in operating assets and liabilities: | ' | ' | ' |
Accounts receivable | 0 | 27,631 | 103,518 |
Prepaid expenses, restricted cash and other assets | 176,697 | 816,605 | -340,268 |
Accounts payable | -77,446 | 43,832 | -202,014 |
Accrued expenses, compensation and deferred rent | -311,859 | -1,475,319 | 851,550 |
Unearned revenues | 1,000,000 | 0 | -46,105 |
Net cash used in operating activities | -12,207,656 | -13,649,370 | -15,486,902 |
CASH FLOWS FROM INVESTING ACTIVITIES: | ' | ' | ' |
Purchases of investments | 5,249,654 | 750,000 | 0 |
Proceeds from sale/maturity of investments | 0 | 4,620 | 494,384 |
Proceeds from sale of supplies and equipment | -6,239 | -59,607 | -15,000 |
Purchases of property and equipment | 0 | -5,998,289 | 0 |
Net cash provided by (used in) investing activities | 5,243,415 | -5,303,276 | 479,384 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ' | ' | ' |
Payments on capital lease obligations | -19,909 | -22,277 | -34,923 |
Payment of withholding taxes related to restricted stock units | -36,377 | -87,411 | 0 |
Proceeds from the sale of common stock units | 37,500 | 34,402,768 | 0 |
Net cash provided by (used in) financing activities | -18,786 | 34,293,080 | -34,923 |
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS | -6,983,027 | 15,340,434 | -15,042,441 |
CASH AND CASH EQUIVALENTS, beginning of period | 19,167,632 | 3,827,198 | 18,869,639 |
CASH AND CASH EQUIVALENTS, end of period | 12,184,605 | 19,167,632 | 3,827,198 |
SUPPLEMENTAL CASH FLOW INFORMATION: | ' | ' | ' |
Cash paid for interest | $6,211 | $8,411 | $9,984 |
1_ORGANIZATION
1. ORGANIZATION | 12 Months Ended |
Jun. 30, 2014 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ' |
1. ORGANIZATION | ' |
Nature of Business – Palatin Technologies, Inc. (Palatin or the Company) is a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential. Palatin’s programs are based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems. The melanocortin system is involved in a large and diverse number of physiologic functions, and therapeutic agents modulating this system may have the potential to treat a variety of conditions and diseases, including sexual dysfunction, obesity and related disorders, cachexia (wasting syndrome) and inflammation-related diseases. The natriuretic peptide receptor system has numerous cardiovascular functions, and therapeutic agents modulating this system may be useful in treatment of acute asthma, heart failure, hypertension and other cardiovascular diseases. | |
The Company’s primary product in development is bremelanotide for the treatment of female sexual dysfunction (FSD). The Company also has drug candidates or development programs for cardiovascular diseases, pulmonary diseases, obesity, erectile dysfunction, inflammatory diseases and dermatologic diseases. The Company has a license, co-development and commercialization agreement with Gedeon Richter Plc. (Gedeon Richter) to commercialize bremelanotide for FSD in Europe and selected countries, and an exclusive global research collaboration and license agreement with AstraZeneca AB (AstraZeneca) to commercialize compounds that target melanocortin receptors for the treatment of obesity, diabetes and related metabolic syndrome. | |
Key elements of the Company’s business strategy include using its technology and expertise to develop and commercialize therapeutic products; entering into alliances and partnerships with pharmaceutical companies to facilitate the development, manufacture, marketing, sale and distribution of product candidates that the Company is developing; and partially funding its product candidate development programs with the cash flow generated from third parties. | |
Business Risk and Liquidity – The Company has incurred negative cash flows from operations since its inception, and has expended, and expects to continue to expend in the future, substantial funds to complete its planned product development efforts. As shown in the accompanying consolidated financial statements, the Company had an accumulated deficit as of June 30, 2014 of $274.0 million and incurred a net loss for fiscal 2014 of $13.9 million. The Company anticipates incurring additional losses in the future as a result of spending on its development programs. To achieve profitability, the Company, alone or with others, must successfully develop and commercialize its technologies and proposed products, conduct successful preclinical studies and clinical trials, obtain required regulatory approvals and successfully manufacture and market such technologies and proposed products. The time required to reach profitability is highly uncertain, and there can be no assurance that the Company will be able to achieve profitability on a sustained basis, if at all. | |
As of June 30, 2014, the Company’s cash and cash equivalents were $12.2 million. In September 2014 the Company received $8.8 million pursuant to its license, co-development and commercialization agreement with Gedeon Richter on bremelanotide for FSD in Europe and selected countries. The Company intends to utilize existing capital resources for general corporate purposes and working capital, including preparing for the Phase 3 clinical trial program with bremelanotide for FSD, preclinical development of its peptide melanocortin receptor-1 program, preclinical and clinical development of its PL-3994 program and preclinical development of other portfolio products. Management believes that the Phase 3 clinical trial program with bremelanotide, including regulatory filings for product approval, will cost at least $80.0 million. The Company is preparing to initiate patient enrollment in the Phase 3 program in the fourth quarter of calendar 2014, but may curtail or delay clinical trial initiation unless we have adequate funds, or commitments for adequate funds, to complete Phase 3 clinical trials. The Company intends to seek additional capital to support the Phase 3 program through collaborative arrangements on bremelanotide, in addition to the Company’s agreement with Gedeon Richter, public or private equity or debt financings, or other sources. | |
Management believes that the Company’s existing capital resources, including $8.8 million paid by Gedeon Richter pursuant to the agreement on bremelanotide for FSD, will be adequate to fund its planned operations through the quarter ending September 30, 2015, not including initiation of our pivotal Phase 3 clinical trials for bremelanotide for FSD or other planned clinical trials. We will need additional funding to complete required clinical trials of bremelanotide for FSD and our other product candidates and, assuming those clinical trials are successful, as to which there can be no assurance, complete submission of required regulatory applications to the FDA for any of our product candidates. | |
Concentrations – Concentrations in the Company’s assets and operations subject it to certain related risks. Financial instruments that subject the Company to concentrations of credit risk primarily consist of cash and cash equivalents. The Company’s cash and cash equivalents are primarily invested in one money market fund sponsored by a large financial institution. In the two-year period ended June 30, 2013, all license and contract revenues were from AstraZeneca. |
2_SUMMARY_OF_SIGNIFICANT_ACCOU
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Jun. 30, 2014 | |
Accounting Policies [Abstract] | ' |
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ' |
Principles of Consolidation – The consolidated financial statements include the accounts of Palatin and its wholly-owned inactive subsidiary. All intercompany accounts and transactions have been eliminated in consolidation. | |
Use of Estimates – The preparation of consolidated financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amount of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. | |
Cash and Cash Equivalents – Cash and cash equivalents include cash on hand, cash in banks and all highly liquid investments with a purchased maturity of less than three months. Cash equivalents consist of $9,495,656 and $16,284,184 in a money market fund at June 30, 2014 and 2013, respectively. | |
Investments – The Company determines the appropriate classification of its investments in debt and equity securities at the time of purchase and reevaluates such determinations at each balance sheet date. Debt securities are classified as held-to-maturity when the Company has the intent and ability to hold the securities to maturity. Debt securities for which the Company does not have the intent or ability to hold to maturity are classified as available-for-sale. Held-to-maturity securities are recorded as either short-term or long-term on the balance sheet, based on the contractual maturity date and are stated at amortized cost. Marketable securities that are bought and held principally for the purpose of selling them in the near term are classified as trading securities and are reported at fair value, with unrealized gains and losses recognized in earnings. Debt and marketable equity securities not classified as held-to-maturity or as trading are classified as available-for-sale and are carried at fair market value, with the unrealized gains and losses, net of tax, included in the determination of comprehensive loss. | |
The fair value of substantially all securities is determined by quoted market prices. The estimated fair value of securities for which there are no quoted market prices is based on similar types of securities that are traded in the market. | |
Fair Value of Financial Instruments – The Company’s financial instruments consist primarily of cash equivalents, short-term investments, accounts payable and capital lease obligations. Management believes that the carrying values of these assets and liabilities are representative of their respective fair values based on quoted market prices for investments and the short-term nature of the other instruments. | |
Property and Equipment – Property and equipment consists of office and laboratory equipment, office furniture and leasehold improvements and includes assets acquired under capital leases. Property and equipment are recorded at cost. Depreciation is recognized using the straight-line method over the estimated useful lives of the related assets, generally five years for laboratory and computer equipment, seven years for office furniture and equipment and the lesser of the term of the lease or the useful life for leasehold improvements. Amortization of assets acquired under capital leases is included in depreciation expense. Maintenance and repairs are expensed as incurred while expenditures that extend the useful life of an asset are capitalized. | |
Impairment of Long-Lived Assets – The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be fully recoverable. To determine recoverability of a long-lived asset, management evaluates whether the estimated future undiscounted net cash flows from the asset are less than its carrying amount. If impairment is indicated, the long-lived asset would be written down to fair value. Fair value is determined by an evaluation of available price information at which assets could be bought or sold, including quoted market prices, if available, or the present value of the estimated future cash flows based on reasonable and supportable assumptions. | |
Deferred Rent – The Company’s operating leases provide for rent increases over the terms of the leases. Deferred rent consists of the difference between periodic rent payments and the amount recognized as rent expense on a straight-line basis, as well as tenant allowances for leasehold improvements. Rent expenses are being recognized ratably over the terms of the leases. | |
Revenue Recognition – Revenue from corporate collaborations and licensing agreements consists of up-front fees, research and development funding, and milestone payments. Non-refundable up-front fees are deferred and amortized to revenue over the related performance period. The Company estimates the performance period as the period in which it performs certain development activities under the applicable agreement. Reimbursements for research and development activities are recorded in the period that the Company performs the related activities under the terms of the applicable agreements. Revenue resulting from the achievement of milestone events stipulated in the applicable agreements is recognized when the milestone is achieved, provided that such milestone is substantive in nature. | |
Research and Development Costs – The costs of research and development activities are charged to expense as incurred, including the cost of equipment for which there is no alternative future use. | |
Accrued Expenses – Third parties perform a significant portion of our development activities. We review the activities performed under significant contracts each quarter and accrue expenses and the amount of any reimbursement to be received from our collaborators based upon the estimated amount of work completed. Estimating the value or stage of completion of certain services requires judgment based on available information. If we do not identify services performed for us but not billed by the service-provider, or if we underestimate or overestimate the value of services performed as of a given date, reported expenses will be understated or overstated. | |
Stock-Based Compensation – The Company charges to expense the fair value of stock options and other equity awards granted. The Company determines the value of stock options utilizing the Black-Scholes option pricing model. Compensation costs for share-based awards with pro-rata vesting are allocated to periods on a straight-line basis. | |
Income Taxes – The Company and its subsidiary file consolidated federal and separate-company state income tax returns. Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of assets and liabilities and their respective tax basis and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences or operating loss and tax credit carryforwards are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the period that includes the enactment date. The Company has recorded a valuation allowance against its deferred tax assets based on the history of losses incurred. | |
During the years ended June 30, 2014, 2013 and 2012, the Company sold New Jersey state net operating loss carryforwards, which resulted in the recognition of $1,846,646, $1,753,208, and $1,068,233, respectively, in tax benefits. | |
Net Loss per Common Share – Basic and diluted earnings per common share (EPS) are calculated in accordance with the provisions of Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic 260, “Earnings per Share,” which includes guidance pertaining to the warrants, issued in connection with the July 3, 2012 private placement offering, that are exercisable for nominal consideration and, therefore, are to be considered in the computation of basic and diluted net loss per common share. The Series A 2012 warrants to purchase up to 31,988,151 shares of common stock were exercisable starting at July 3, 2012 and, therefore, are included in the weighted average number of common shares outstanding used in computing basic and diluted net loss per common share starting on July 3, 2012. | |
The Series B 2012 warrants to purchase up to 35,488,380 shares of common stock were considered contingently issuable shares and were not included in computing basic net loss per common share until the Company received stockholder approval for the increase in authorized underlying common stock on September 27, 2012 (see note 9). For diluted EPS, contingently issuable shares are to be included in the calculation as of the beginning of the period in which the conditions were satisfied, unless the effect would be anti-dilutive. The Series B 2012 warrants have been excluded from the calculation of diluted net loss per common share during the period from July 3, 2012 until September 27, 2012 as the impact would be anti-dilutive. | |
As of June 30, 2014, 2013 and 2012, there were 29,358,926, 29,136,527, and 27,179,180 common shares issuable upon conversion of Series A Convertible Preferred Stock, the exercise of outstanding options and warrants (excluding the warrants issued in connection with the July 3, 2013 private placement offering), and the vesting of restricted stock units, respectively. These share amounts have been excluded from the calculation of net loss per share as the impact would be anti-dilutive. |
3_NEW_AND_RECENTLY_ADOPTED_ACC
3. NEW AND RECENTLY ADOPTED ACCOUNTING PRONOUNCEMENTS | 12 Months Ended |
Jun. 30, 2014 | |
New And Recently Adopted Accounting Pronouncements | ' |
3. New and recently adopted accounting pronouncements | ' |
In May 2014, the FASB issued ASU No. 2014-09, “Revenue from Contracts with Customers,” which requires an entity to recognize the amount of revenue to which it expects to be entitled for the transfer of promised goods or services to customers. The ASU will replace most existing revenue recognition guidance in U.S. GAAP when it becomes effective. The new standard is effective for the Company on July 1, 2017. Early application is not permitted. The standard permits the use of either the retrospective or cumulative effect transition method. The Company is evaluating the effect that ASU 2014-09 will have on its consolidated financial statements and related disclosures. The Company has not yet determined the effect of the standard on its ongoing financial reporting. |
4_AGREEMENT_WITH_ASTRAZENECA
4. AGREEMENT WITH ASTRAZENECA | 12 Months Ended |
Jun. 30, 2014 | |
Agreement With Astrazeneca | ' |
4. AGREEMENT WITH ASTRAZENECA | ' |
In January 2007, the Company entered into an exclusive global research collaboration and license agreement with AstraZeneca to discover, develop and commercialize compounds that target melanocortin receptors for the treatment of obesity, diabetes and related metabolic syndrome. In June 2008, the license agreement was amended to include additional compounds and associated intellectual property developed by the Company. In December 2008, the license agreement was further amended to include additional compounds and associated intellectual property developed by the Company and extended the research collaboration for an additional year through January 2010. In September 2009, the license agreement was further amended to modify royalty rates and milestone payments. The collaboration is based on the Company’s melanocortin receptor obesity program and includes access to compound libraries, core technologies and expertise in melanocortin receptor drug discovery and development. As part of the September 2009 amendment to the research collaboration and license agreement, the Company agreed to conduct additional studies on the effects of melanocortin receptor specific compounds on food intake, obesity and other metabolic parameters. | |
In December 2009 and 2008, the Company also entered into clinical trial sponsored research agreements with AstraZeneca, under which the Company agreed to conduct studies of the effects of melanocortin receptor specific compounds on food intake, obesity and other metabolic parameters. Under the terms of these clinical trial agreements, AstraZeneca paid $5,000,000 as of March 31, 2009 upon achieving certain objectives and paid all costs associated with these studies. The Company recognized $10,361 and $73,736, respectively, as revenue in the years ended June 30, 2013 and 2012 under these clinical trial sponsored research agreements. | |
The Company received an up-front payment of $10,000,000 from AstraZeneca on execution of the research collaboration and license agreement. Under the September 2009 amendment the Company was paid an additional $5,000,000 in consideration of reduction of future milestones and royalties and providing specific materials to AstraZeneca. The Company is now eligible for milestone payments totaling up to $145,250,000, with up to $85,250,000 contingent on development and regulatory milestones and the balance contingent on achievement of sales targets. In addition, the Company is eligible to receive mid to high single digit royalties on sales of any approved products. AstraZeneca assumed responsibility for product commercialization, product discovery and development costs, with both companies contributing scientific expertise in the research collaboration. The Company provided research services to AstraZeneca through January 2010, the expiration of the research collaboration portion of the research collaboration and license agreement, at a contractual rate per full-time-equivalent employee. | |
AstraZeneca is evaluating its program and next steps. No assurance can be given that AstraZeneca will continue to develop compounds that target melanocortin receptors for the treatment of obesity, diabetes and related metabolic syndrome, or that AstraZeneca will be successful in developing any such compound. |
5_FAIR_VALUE_MEASUREMENTS
5. FAIR VALUE MEASUREMENTS | 12 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
Fair Value Disclosures [Abstract] | ' | ||||||||||||||||
5. FAIR VALUE MEASUREMENTS | ' | ||||||||||||||||
The fair value of cash equivalents and short-term investments is classified using a hierarchy prioritized based on inputs. Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 inputs are quoted prices for similar assets and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument. Level 3 inputs are unobservable inputs based on management’s own assumptions used to measure assets and liabilities at fair value. A financial asset or liability’s classification within the hierarchy is determined based on the lowest level input that is significant to the fair value measurement. | |||||||||||||||||
The following table provides the assets carried at fair value: | |||||||||||||||||
Carrying Value | Quoted prices in | Other quoted/observable inputs (Level 2) | Significant unobservable inputs | ||||||||||||||
active markets | (Level 3) | ||||||||||||||||
(Level 1) | |||||||||||||||||
June 30, 2014: | |||||||||||||||||
Money Market Fund | $ | 9,495,656 | $ | 9,495,656 | $ | - | $ | - | |||||||||
June 30, 2013: | |||||||||||||||||
Money Market Fund | $ | 16,284,184 | $ | 16,284,184 | $ | - | $ | - | |||||||||
U.S. Government Securities | 5,249,654 | 5,249,160 | - | - | |||||||||||||
TOTAL | $ | 21,533,838 | $ | 21,533,344 | $ | - | $ | - | |||||||||
6_PROPERTY_AND_EQUIPMENT_NET
6. PROPERTY AND EQUIPMENT, NET | 12 Months Ended | ||||||||
Jun. 30, 2014 | |||||||||
Property, Plant and Equipment [Abstract] | ' | ||||||||
6. PROPERTY AND EQUIPMENT, NET | ' | ||||||||
Property and equipment, net, consists of the following: | |||||||||
June 30, | June 30, | ||||||||
2014 | 2013 | ||||||||
Office equipment | $ | 1,180,210 | $ | 1,180,210 | |||||
Laboratory equipment | 317,608 | 311,369 | |||||||
Leasehold improvements | 751,226 | 751,226 | |||||||
2,249,044 | 2,242,805 | ||||||||
Less: Accumulated depreciation and amortization | (2,088,296 | ) | (1,976,390 | ) | |||||
$ | 160,748 | $ | 266,415 | ||||||
The aggregate cost of assets acquired under capital leases was $66,115 as of June 30, 2014 and June 30, 2013, respectively. Accumulated amortization associated with assets acquired under capital leases was $40,771 as of June 30, 2014 and $27,548 as of June 30, 2013. |
7_ACCRUED_EXPENSES
7. ACCRUED EXPENSES | 12 Months Ended | ||||||||
Jun. 30, 2014 | |||||||||
Payables and Accruals [Abstract] | ' | ||||||||
7. ACCRUED EXPENSES | ' | ||||||||
Accrued expenses consist of the following: | |||||||||
June 30, | June 30, | ||||||||
2014 | 2013 | ||||||||
Clinical study costs | $ | 617,055 | $ | 1,054,270 | |||||
Other research related expenses | 463,695 | 186,241 | |||||||
Professional services | 211,711 | 208,731 | |||||||
Insurance premiums payable | - | 125,671 | |||||||
Other | 216,497 | 126,814 | |||||||
$ | 1,508,958 | $ | 1,701,727 | ||||||
8_COMMITMENTS_AND_CONTINGENCIE
8. COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Jun. 30, 2014 | |
Commitments and Contingencies Disclosure [Abstract] | ' |
8. COMMITMENTS AND CONTINGENCIES | ' |
Operating Leases – Effective January 31, 2011, the Company terminated the lease on 12,000 square feet of laboratory space in another building in the same center as the Company’s corporate offices and research and development facilities, which lease would have otherwise terminated in February 2012. Under the lease termination agreement the Company paid a $60,000 termination fee, which was charged to expense. Effective July 31, 2012, the lease on 28,000 square feet of the Company’s research and development facilities expired. The Company currently leases facilities under a non-cancelable operating lease, which expires in June 2015. The remaining lease payments under this lease total $236,335. The Company has started the process of reviewing its lease renewal options. | |
For the years ended June 30, 2014, 2013 and 2012, rent expense was $219,686, $372,754, and $915,469, respectively. | |
Capital Leases – The Company has acquired certain of its equipment under leases classified as capital leases. The remaining capital lease was paid in full during fiscal year 2014. | |
Employment Agreements – The Company has employment agreements with two executive officers which provide a stated annual compensation amount, subject to annual increases, and annual bonus compensation in an amount to be approved by the Company’s Board of Directors. Each agreement allows the Company or the employee to terminate the agreement in certain circumstances. In some circumstances, early termination by the Company may result in severance pay to the employee for a period of 18 to 24 months at the salary then in effect, continuation of health insurance premiums over the severance period and immediate vesting of all stock options and restricted stock units. Termination following a change in control will result in a lump sum payment of one and one-half to two times the salary then in effect and immediate vesting of all stock options and restricted stock units. | |
Employee Retirement Savings Plan – The Company maintains a defined contribution 401(k) plan for the benefit of its employees. The Company currently matches a portion of employee contributions to the plan. For the years ended June 30, 2014, 2013 and 2012, Company contributions were $140,870, $150,256, and $124,351, respectively. | |
Contingencies – The Company accounts for litigation losses in accordance with ASC 450-20, “Loss Contingencies.” Under ASC 450-20, loss contingency provisions are recorded for probable losses when management is able to reasonably estimate the loss. Any outcome upon settlement that deviates from the Company’s best estimate may result in additional expense or in a reduction in expense in a future accounting period. The Company records legal expenses associated with such contingencies as incurred. | |
The Company is involved, from time to time, in various claims and legal proceedings arising in the ordinary course of its business. The Company is not currently a party to any such claims or proceedings that, if decided adversely to it, would either individually or in the aggregate have a material adverse effect on its business, financial condition or results of operations. |
9_STOCKHOLDERS_EQUITY
9. STOCKHOLDERS EQUITY | 12 Months Ended | ||||||||||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||||||||||
Equity [Abstract] | ' | ||||||||||||||||||||||||
9. STOCKHOLDERS' EQUITY | ' | ||||||||||||||||||||||||
Series A Convertible Preferred Stock – As of June 30, 2014, 4,697 shares of Series A Convertible Preferred Stock were outstanding. Each share of Series A Convertible Preferred Stock is convertible at any time, at the option of the holder, into the number of shares of common stock equal to $100 divided by the Series A Conversion Price. As of June 30, 2014, the Series A Conversion Price was $8.89, so each share of Series A Convertible Preferred Stock is currently convertible into approximately 11.25 shares of common stock. The Series A Conversion Price is subject to adjustment, under certain circumstances, upon the sale or issuance of common stock for consideration per share less than either (i) the Series A Conversion Price in effect on the date of such sale or issuance, or (ii) the market price of the common stock as of the date of such sale or issuance. The Series A Conversion Price is also subject to adjustment upon the occurrence of a merger, reorganization, consolidation, reclassification, stock dividend or stock split which will result in an increase or decrease in the number of shares of common stock outstanding. Shares of Series A Convertible Preferred Stock have a preference in liquidation, including certain merger transactions, of $100 per share, or $469,700 in the aggregate as of June 30, 2014. Additionally, the Company may not pay a dividend or make any distribution to holders of any class of stock unless the Company first pays a special dividend or distribution of $100 per share to holders of the Series A Convertible Preferred Stock. | |||||||||||||||||||||||||
Common Stock Transactions – On July 3, 2012, the Company closed on a private placement offering in which the Company sold, for aggregate proceeds of $35.0 million, 3,873,000 shares of its common stock, Series A 2012 warrants to purchase up to 31,988,151 shares of common stock, and Series B 2012 warrants to purchase up to 35,488,380 shares of common stock. These warrants are exercisable at an exercise price of $0.01 per share, and expire ten years from the date of issuance. The holders may exercise the warrants on a cashless basis. The warrants are subject to a blocker provision prohibiting exercise of the warrants if the holder and its affiliates would beneficially own in excess of 9.99% of the total number of shares of common stock of the Company following such exercise (as may be adjusted to the extent set forth in the warrant). The warrants also provide that in the event of a Company Controlled Fundamental Transaction (as defined in the warrants), the Company may, at the election of the warrant holder, be required to redeem all or a portion of the warrants at an amount tied to the greater of the then market price of the Company’s common stock or the amount per share paid to any other person. | |||||||||||||||||||||||||
Because there were not sufficient authorized shares to cover all the outstanding Series B 2012 warrants in the private placement offering as of closing, under ASC 815, “Derivatives and Hedging,” the portion of the warrants above the then authorized level of common stock was required to be classified as a liability and carried at fair value on the Company’s balance sheet. The fair value, including the initial fair value liability of $16,960,963, was calculated by multiplying the number of shares underlying the Series B 2012 warrants above the then authorized level of the Company’s common stock by the closing price of its common stock less the exercise price of $0.01 per share. The warrants were liability classified through September 27, 2012, at which time the then fair value of the warrant liability was reclassified into stockholders’ equity upon stockholder approval of the increase in authorized common stock. The increase in fair value, as a result of the Company’s common stock increasing from $0.50 per share at date of issuance to $0.71 per share upon shareholder approval, of $7,069,165 has been recorded as a non-operating expense for the year ended June 30, 2013. | |||||||||||||||||||||||||
The purchase agreement for the private placement provides that the purchasers, funds under the management of QVT Financial LP, have certain rights until July 3, 2018, including rights of first refusal and participation in any subsequent equity or debt financing, provided that the funds own at least 20% of the outstanding common stock of the Company calculated as if warrants held by the funds were exercised. The purchase agreement also contains certain restrictive covenants so long as the funds continue to hold specified amounts of warrants or beneficially own specified amounts of the outstanding shares of common stock. | |||||||||||||||||||||||||
The net proceeds to the Company were $34.4 million, after deducting offering expenses payable by the Company and excluding the proceeds to the Company, if any, from the exercise of the warrants issued in the offering. | |||||||||||||||||||||||||
Outstanding Stock Purchase Warrants – As of June 30, 2014, the Company had outstanding warrants exercisable for shares of common stock as follows: | |||||||||||||||||||||||||
Shares of Common | Exercise Price per | Latest Termination | |||||||||||||||||||||||
Stock | Share | Date | |||||||||||||||||||||||
331,969 | 3.3 | 17-Aug-14 | |||||||||||||||||||||||
50,000 | 0.6 | 9-Nov-14 | |||||||||||||||||||||||
50,000 | 1 | 9-Nov-14 | |||||||||||||||||||||||
100,000 | 1.5 | 9-Nov-14 | |||||||||||||||||||||||
575,000 | 1 | 23-Feb-16 | |||||||||||||||||||||||
2,000,000 | 1 | 1-Mar-16 | |||||||||||||||||||||||
21,000,000 | 1 | 2-Mar-17 | |||||||||||||||||||||||
31,988,151 | 0.01 | 3-Jul-22 | |||||||||||||||||||||||
35,488,380 | 0.01 | 27-Sep-22 | |||||||||||||||||||||||
91,583,500 | |||||||||||||||||||||||||
During the fiscal year ended June 30, 2012, the Company issued warrants to consultants as part of their compensation to purchase up to 350,000 shares of the Company’s common stock. These warrants vest at various times and under certain conditions through November 2012. For the year ended June 30, 2012, the Company recorded stock-based compensation related to these warrants of $26,000. | |||||||||||||||||||||||||
In January 2014, the Company received $37,500 and issued 50,000 shares of common stock pursuant to the exercise of warrants at an exercise price of $0.75 per share. | |||||||||||||||||||||||||
Stock Plan – The Company’s 2011 Stock Incentive Plan was approved by the Company’s stockholders at the annual meeting of stockholders held in May 2011 and amended at the annual meeting of stockholders held on June 27, 2013. The 2011 Stock Incentive Plan provides for incentive and nonqualified stock option grants and other stock-based awards to employees, non-employee directors and consultants for up to 7,000,000 shares of common stock. The 2011 Stock Incentive Plan is administered under the direction of the Board of Directors, which may specify grant terms and recipients. Options granted by the Company generally expire ten years from the date of grant and generally vest over three to four years. The 2005 Stock Plan was terminated and replaced by the 2011 Stock Incentive Plan, and shares of common stock that were available for grant under the 2005 Stock Plan became available for grant under the 2011 Stock Incentive Plan. No new awards can be granted under the 2005 Stock Plan, but awards granted under the 2005 Stock Plan remain outstanding in accordance with their terms. As of June 30, 2014, 1,929,056 shares were available for grant under the 2011 Stock Incentive Plan. | |||||||||||||||||||||||||
The Company also has outstanding options that were granted under a previous plan. The Company expects to settle option exercises under any of its plans with authorized but currently unissued shares. | |||||||||||||||||||||||||
The following table summarizes option activity for the years ended June 30, 2014, 2013 and 2012: | |||||||||||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||||||||||
Number of Shares | Weighted Average Exercise Price | Number of Shares | Weighted Average Exercise Price | Number of Shares | Weighted Average Exercise Price | ||||||||||||||||||||
Outstanding at | |||||||||||||||||||||||||
beginning of year | 3,851,448 | $ | 1.99 | 2,181,853 | $ | 3.5 | 2,231,898 | $ | 4.05 | ||||||||||||||||
Granted | 603,400 | 1.02 | 1,807,300 | 0.65 | 75,000 | 0.65 | |||||||||||||||||||
Forfeited | (161,900 | ) | 0.68 | (74,985 | ) | 5.2 | (90,870 | ) | 3.64 | ||||||||||||||||
Expired | (50,975 | ) | 24.95 | (62,720 | ) | 11.91 | (34,175 | ) | 33.07 | ||||||||||||||||
Outstanding at | |||||||||||||||||||||||||
end of year | 4,241,973 | 1.63 | 3,851,448 | 1.99 | 2,181,853 | 3.5 | |||||||||||||||||||
Exercisable at | |||||||||||||||||||||||||
end of year | 2,507,573 | 2.19 | 1,673,973 | 3.64 | 1,323,965 | 5.1 | |||||||||||||||||||
Weighted average | |||||||||||||||||||||||||
grant-date fair | |||||||||||||||||||||||||
value of options | |||||||||||||||||||||||||
granted during | |||||||||||||||||||||||||
the year | $ | 0.8 | $ | 0.56 | $ | 0.47 | |||||||||||||||||||
The following table summarizes options outstanding as of June 30, 2014: | |||||||||||||||||||||||||
Number of Shares | Weighted Average Exercise Price | Weighted Average Remaining Term in Years | Aggregate Intrinsic Value | ||||||||||||||||||||||
Options outstanding at end of | |||||||||||||||||||||||||
year | 4,241,973 | $ | 1.63 | 7.7 | $ | 694,711 | |||||||||||||||||||
Options vested and exercisable | |||||||||||||||||||||||||
at end of year | 2,507,573 | $ | 2.19 | 6.8 | $ | 373,709 | |||||||||||||||||||
Unvested options expected to | |||||||||||||||||||||||||
vest | 1,504,254 | $ | 0.8 | 8.8 | $ | 294,435 | |||||||||||||||||||
The fair value of option grants is estimated at the grant date using the Black-Scholes model. For grants during the year ended June 30, 2014, the Company’s weighted average assumptions for expected volatility, dividends, term and risk-free interest rate were 97.1%, 0%, 6.1 years and 1.9%, respectively. For grants during the year ended June 30, 2013, the Company’s weighted average assumptions for expected volatility, dividends, term and risk-free interest rate were 101%, 0%, 8.6 years and 1.8%, respectively. For grants during the year ended June 30, 2012, the Company’s weighted average assumptions for expected volatility, dividends, term and risk-free interest rate were 103%, 0%, 5.0 years and 0.92%, respectively. Expected volatilities are based on the Company’s historical volatility. The expected term of options is based upon the simplified method, which represents the average of the vesting term and the contractual term. The risk-free interest rate is based on U.S. Treasury yields for securities with terms approximating the expected term of the option. | |||||||||||||||||||||||||
For the years ended June 30, 2014, 2013 and 2012 the Company recorded stock-based compensation related to stock options of $520,855, $379,264 and $533,445, respectively. As of June 30, 2014, there was $910,028 of unrecognized compensation cost related to unvested options, which is expected to be recognized over a weighted-average period of 2.61 years. | |||||||||||||||||||||||||
In June 2014, the Company granted 325,000 options to its executive officers, 143,400 options to its employees and 135,000 options to its non-employee directors under the Company’s 2011 Stock Incentive Plan. The Company will amortize the fair value of these options of $265,726, $117,247 and $97,530, respectively, over the vesting period. | |||||||||||||||||||||||||
In June 2013, the Company granted 525,000 options to its executive officers, 394,300 options to its employees and 270,000 options to its non-employee directors under the Company’s 2011 Stock Incentive Plan. The Company is amortizing the fair value of these options of $287,000, $204,000 and $148,000, respectively, over the vesting period. | |||||||||||||||||||||||||
In July 2012, the Company granted 285,000 options to its executive officers, 182,500 options to its employees and 112,500 options to its non-employee directors under the Company’s 2011 Stock Incentive Plan. The Company is amortizing the fair value of these options of $182,000, $108,000 and $72,000, respectively, over the vesting period. | |||||||||||||||||||||||||
Stock options granted to the Company’s executive officers and employees vest over a 48 month period, while stock options granted to its non-employee directors vest over a 12 month period. | |||||||||||||||||||||||||
During the year ended June 30, 2014, the Company made the following modifications to certain stock options that were granted to certain terminated employees in recognition of their prior services; i) accelerated the vesting, and ii) extended the date to exercise vested stock options to 24 months from the date of termination. An incremental $22,000 of stock-based compensation expense was recognized during the year ended June 30, 2014 and included in research and development expense in connection with these activities. | |||||||||||||||||||||||||
Restricted Stock Units – The following table summarizes restricted stock award activity for the years ended June 30, 2014, 2013 and 2012: | |||||||||||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||||||||||
Outstanding at beginning of year | 757,500 | 250,000 | 500,000 | ||||||||||||||||||||||
Granted | 603,400 | 757,500 | - | ||||||||||||||||||||||
Forfeited | (25,000 | ) | - | - | |||||||||||||||||||||
Vested | (378,750 | ) | (250,000 | ) | (250,000 | ) | |||||||||||||||||||
Outstanding at end of year | 957,150 | 757,500 | 250,000 | ||||||||||||||||||||||
For the years ended June 30, 2014, 2013 and 2012 the Company recorded stock-based compensation related to restricted stock units of $300,485, $219,767 and $317,722, respectively. | |||||||||||||||||||||||||
In June 2014, the Company granted 325,000 restricted stock units to its executive officers, 143,400 restricted stock units to its employees and 135,000 restricted stock units to its non-employee directors under the Company’s 2011 Stock Incentive Plan. The Company will amortize the fair value of these restricted stock units of $331,500, $146,268 and $137,700, respectively, over the vesting period. Restricted stock units granted to the Company’s executive officers, employees and non-employee directors in 2014 vest over 24 months, 48 months and 12 months, respectively. | |||||||||||||||||||||||||
In June 2013, the Company granted 420,000 restricted stock units to its executive officers and 115,000 restricted stock units to employees under the Company’s 2011 Stock Incentive Plan. The Company is amortizing the fair value of these restricted stock units of $260,000 and $71,000, respectively, over the 24 month vesting period ending June 30, 2015 | |||||||||||||||||||||||||
In July 2012, the Company granted 222,500 restricted stock units to its executive officers under the Company’s 2011 Stock Incentive Plan. The Company is amortizing the fair value of these restricted stock units of $160,000 over the 24 months ending July 2014. | |||||||||||||||||||||||||
In June 2011, the Company granted 500,000 restricted stock units to its executive management under the Company’s 2011 Stock Incentive Plan. The grant date fair value of these restricted stock units of $430,000 was amortized over the 24 month vesting period of the award. | |||||||||||||||||||||||||
In connection with the vesting of restricted share units during the years ended June 30, 2014 and 2013, the Company withheld 129,103 and 158,264 shares with aggregate values of $120,007 and $87,411, respectively, in satisfaction of minimum tax withholding obligations. | |||||||||||||||||||||||||
During the year ended June 30, 2014, the Company accelerated the vesting of certain restricted stock units that were granted to a terminated employee in recognition of prior services. An incremental $12,000 of stock-based compensation expense was recognized during the year ended June 30, 2014 and included in research and development expense in connection with these activities. |
10_INCOME_TAXES
10. INCOME TAXES | 12 Months Ended | ||||||||
Jun. 30, 2014 | |||||||||
Income Tax Disclosure [Abstract] | ' | ||||||||
10. INCOME TAXES | ' | ||||||||
The Company has had no income tax expense or benefit since inception because of operating losses, except for amounts recognized for sales of New Jersey state net operating loss carryforwards. Deferred tax assets and liabilities are determined based on the estimated future tax effect of differences between the financial statement and tax reporting basis of assets and liabilities, as well as for net operating loss carryforwards and research and development credit carryforwards, given the provisions of existing tax laws. | |||||||||
As of June 30, 2014, the Company had federal and state net operating loss carryforwards of approximately $235 million and $93 million, respectively, which expire between 2014 and 2034 if not utilized. As of June 30, 2014, the Company had federal research and development credits of approximately $6,871,000 that will begin to expire in 2014, if not utilized. | |||||||||
The Tax Reform Act of 1986 (the Act) provides for limitation on the use of net operating loss and research and development tax credit carryforwards following certain ownership changes (as defined by the Act) that could limit the Company’s ability to utilize these carryforwards. The Company may have experienced various ownership changes, as defined by the Act, as a result of past financings. Accordingly, the Company’s ability to utilize the aforementioned carryforwards may be limited. Additionally, U.S. tax laws limit the time during which these carryforwards may be applied against future taxes; therefore, the Company may not be able to take full advantage of these carryforwards for federal income tax purposes. | |||||||||
The Company’s net deferred tax assets are as follows: | |||||||||
June 30, | June 30, | ||||||||
2014 | 2013 | ||||||||
Net operating loss carryforwards | $ | 87,801,000 | $ | 83,470,000 | |||||
Research and development tax credits | 6,871,000 | 6,605,000 | |||||||
Accrued expenses, deferred revenue and other | 1,003,000 | 1,698,000 | |||||||
95,675,000 | 91,773,000 | ||||||||
Valuation allowance | (95,675,000 | ) | (91,773,000 | ) | |||||
Net deferred tax assets | $ | - | $ | - | |||||
In assessing the realizability of deferred tax assets, the Company considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income and the application of loss limitation provisions related to ownership changes. Due to the Company’s history of losses, the deferred tax assets are fully offset by a valuation allowance as of June 30, 2014 and 2013. | |||||||||
During the years ended June 30, 2014, 2013 and 2012, the Company sold New Jersey state net operating loss carryforwards, which resulted in the recognition of $1,846,646, $1,753,208, and $1,068,233, respectively, in tax benefits. |
11_CONSOLIDATED_QUARTERLY_FINA
11. CONSOLIDATED QUARTERLY FINANCIAL DATA b UNAUDITED | 12 Months Ended | |||||||
Jun. 30, 2014 | ||||||||
Quarterly Financial Information Disclosure [Abstract] | ' | |||||||
11. CONSOLIDATED QUARTERLY FINANCIAL DATA b UNAUDITED | ' | |||||||
The following tables provide quarterly data for the years ended June 30, 2014 and 2013: | ||||||||
Three Months Ended | ||||||||
June 30, | March 31, | December 31, | September 30, | |||||
2014 | 2014 | 2013 | 2013 | |||||
(amounts in thousands, except per share data) | ||||||||
Revenues | $ - | $ - | $ - | $ - | ||||
Operating expenses | 4,321 | 3,364 | 3,610 | 4,492 | ||||
Other income (expense), net | 1 | 4 | 4 | 3 | ||||
Loss before income taxes | (4,320) | (3,360) | (3,606) | (4,489) | ||||
Income tax benefit | - | 1,847 | - | - | ||||
Net loss | $ (4,320) | $ (1,513) | $ (3,606) | $ (4,489) | ||||
Basic and diluted net loss per | ||||||||
common share | $ (0.04) | $ (0.01) | $ (0.03) | $ (0.04) | ||||
Weighted average number of | ||||||||
common shares outstanding | ||||||||
used in computing basic and | ||||||||
diluted net loss per common | ||||||||
share | 106,735,765 | 106,709,340 | 106,668,186 | 106,609,720 | ||||
Three Months Ended | ||||||||
June 30, | March 31, | December 31, | September 30, | |||||
2013 | 2013 | 2012 | 2012 | |||||
(amounts in thousands, except per share data) | ||||||||
Revenues | $ - | $ - | $ 7 | $ 3 | ||||
Operating expenses | 4,720 | 4,024 | 3,447 | 3,404 | ||||
Other income (expense), net | 2 | 9 | 11 | (7,052) | ||||
Loss before income taxes | (4,718) | (4,015) | (3,429) | (10,453) | ||||
Income tax benefit | - | - | 1,753 | - | ||||
Net loss | $ (4,718) | $ (4,015) | $ (1,676) | $ (10,453) | ||||
Basic and diluted net loss per | ||||||||
common share | $ (0.04) | $ (0.04) | $ (0.02) | $ (0.15) | ||||
Weighted average number of | ||||||||
common shares outstanding | ||||||||
used in computing basic and | ||||||||
diluted net loss per common | ||||||||
share | 106,435,741 | 106,424,443 | 106,424,443 | 71,669,170 | ||||
12_SUBSEQUENT_EVENT
12. SUBSEQUENT EVENT | 12 Months Ended |
Jun. 30, 2014 | |
Subsequent Events [Abstract] | ' |
12. SUBSEQUENT EVENT | ' |
In August 2014, the Company entered into a license, co-development and commercialization agreement with Gedeon Richter on bremelanotide for FSD in Europe and selected countries. In August 2013, the Company received an initial payment of $1.0 million from Gedeon Richter as a non-refundable option fee on the license, co-development and commercialization agreement, and in September 2014, the Company received $8.8 million on execution of the definitive agreement. Under the agreement, Gedeon Richter will pay the Company a milestone payment of €2.5 million ($3.3 million) upon the initiation of the Company’s Phase 3 clinical trial program in the United States. The Company has the potential to receive up to €80 million ($105.6 million) in regulatory and sales related milestones, and will receive low double-digit royalties on net sales in the licensed territory. | |
Under the agreement the Company will contribute, with Gedeon Richter, to the costs of co-development activities for obtaining regulatory approval in Europe. Gedeon Richter will exclusively market bremelanotide for FSD in the licensed territory, and will be responsible for all sales, marketing and commercial activities, including associated costs, in the licensed territory. The agreement remains in effect as long as Gedeon Richter is selling bremelanotide on which a royalty is owed. The agreement may be terminated by either party upon notice in the event of a material breach or insolvency. In the event Gedeon Richter terminates the agreement because the Company breached the agreement or is insolvent, Gedeon Richter’s license will becomes fully paid-up, royalty free, perpetual and irrevocable. If the Company fails to initiate its Phase 3 program by an agreed date, Gedeon Richter at its option may elect to terminate the license and receive a specified payment. In the event that the Company terminates the agreement because Gedeon Richter breached the agreement or is insolvent, upon timely request all regulatory approvals for bremelanotide in the licensed territory will be transferred to the Company or its designee. |
1_ORGANIZATION_Policies
1. ORGANIZATION (Policies) | 12 Months Ended |
Jun. 30, 2014 | |
Organization Policies | ' |
Nature of Business | ' |
Nature of Business – Palatin Technologies, Inc. (Palatin or the Company) is a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential. Palatin’s programs are based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems. The melanocortin system is involved in a large and diverse number of physiologic functions, and therapeutic agents modulating this system may have the potential to treat a variety of conditions and diseases, including sexual dysfunction, obesity and related disorders, cachexia (wasting syndrome) and inflammation-related diseases. The natriuretic peptide receptor system has numerous cardiovascular functions, and therapeutic agents modulating this system may be useful in treatment of acute asthma, heart failure, hypertension and other cardiovascular diseases. | |
The Company’s primary product in development is bremelanotide for the treatment of female sexual dysfunction (FSD). The Company also has drug candidates or development programs for cardiovascular diseases, pulmonary diseases, obesity, erectile dysfunction, inflammatory diseases and dermatologic diseases. The Company has a license, co-development and commercialization agreement with Gedeon Richter Plc. (Gedeon Richter) to commercialize bremelanotide for FSD in Europe and selected countries, and an exclusive global research collaboration and license agreement with AstraZeneca AB (AstraZeneca) to commercialize compounds that target melanocortin receptors for the treatment of obesity, diabetes and related metabolic syndrome. | |
Key elements of the Company’s business strategy include using its technology and expertise to develop and commercialize therapeutic products; entering into alliances and partnerships with pharmaceutical companies to facilitate the development, manufacture, marketing, sale and distribution of product candidates that the Company is developing; and partially funding its product candidate development programs with the cash flow generated from third parties. | |
Business Risk and Liquidity | ' |
Business Risk and Liquidity – The Company has incurred negative cash flows from operations since its inception, and has expended, and expects to continue to expend in the future, substantial funds to complete its planned product development efforts. As shown in the accompanying consolidated financial statements, the Company had an accumulated deficit as of June 30, 2014 of $274.0 million and incurred a net loss for fiscal 2014 of $13.9 million. The Company anticipates incurring additional losses in the future as a result of spending on its development programs. To achieve profitability, the Company, alone or with others, must successfully develop and commercialize its technologies and proposed products, conduct successful preclinical studies and clinical trials, obtain required regulatory approvals and successfully manufacture and market such technologies and proposed products. The time required to reach profitability is highly uncertain, and there can be no assurance that the Company will be able to achieve profitability on a sustained basis, if at all. | |
As of June 30, 2014, the Company’s cash and cash equivalents were $12.2 million. In September 2014 the Company received $8.8 million pursuant to its license, co-development and commercialization agreement with Gedeon Richter on bremelanotide for FSD in Europe and selected countries. The Company intends to utilize existing capital resources for general corporate purposes and working capital, including preparing for the Phase 3 clinical trial program with bremelanotide for FSD, preclinical development of its peptide melanocortin receptor-1 program, preclinical and clinical development of its PL-3994 program and preclinical development of other portfolio products. Management believes that the Phase 3 clinical trial program with bremelanotide, including regulatory filings for product approval, will cost at least $80.0 million. The Company is preparing to initiate patient enrollment in the Phase 3 program in the fourth quarter of calendar 2014, but may curtail or delay clinical trial initiation unless we have adequate funds, or commitments for adequate funds, to complete Phase 3 clinical trials. The Company intends to seek additional capital to support the Phase 3 program through collaborative arrangements on bremelanotide, in addition to the Company’s agreement with Gedeon Richter, public or private equity or debt financings, or other sources. | |
Management believes that the Company’s existing capital resources, including $8.8 million paid by Gedeon Richter pursuant to the agreement on bremelanotide for FSD, will be adequate to fund its planned operations through the quarter ending September 30, 2015, not including initiation of our pivotal Phase 3 clinical trials for bremelanotide for FSD or other planned clinical trials. We will need additional funding to complete required clinical trials of bremelanotide for FSD and our other product candidates and, assuming those clinical trials are successful, as to which there can be no assurance, complete submission of required regulatory applications to the FDA for any of our product candidates. | |
Concentrations | ' |
Concentrations – Concentrations in the Company’s assets and operations subject it to certain related risks. Financial instruments that subject the Company to concentrations of credit risk primarily consist of cash and cash equivalents. The Company’s cash and cash equivalents are primarily invested in one money market fund sponsored by a large financial institution. In the two-year period ended June 30, 2013, all license and contract revenues were from AstraZeneca. |
2_SUMMARY_OF_SIGNIFICANT_ACCOU1
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Jun. 30, 2014 | |
Summary Of Significant Accounting Policies Policies | ' |
Principles of Consolidation | ' |
Principles of Consolidation – The consolidated financial statements include the accounts of Palatin and its wholly-owned inactive subsidiary. All intercompany accounts and transactions have been eliminated in consolidation. | |
Use of Estimates | ' |
Use of Estimates – The preparation of consolidated financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amount of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. | |
Cash and Cash Equivalents | ' |
Cash and Cash Equivalents – Cash and cash equivalents include cash on hand, cash in banks and all highly liquid investments with a purchased maturity of less than three months. Cash equivalents consist of $9,495,656 and $16,284,184 in a money market fund at June 30, 2014 and 2013, respectively. | |
Investments | ' |
Investments – The Company determines the appropriate classification of its investments in debt and equity securities at the time of purchase and reevaluates such determinations at each balance sheet date. Debt securities are classified as held-to-maturity when the Company has the intent and ability to hold the securities to maturity. Debt securities for which the Company does not have the intent or ability to hold to maturity are classified as available-for-sale. Held-to-maturity securities are recorded as either short-term or long-term on the balance sheet, based on the contractual maturity date and are stated at amortized cost. Marketable securities that are bought and held principally for the purpose of selling them in the near term are classified as trading securities and are reported at fair value, with unrealized gains and losses recognized in earnings. Debt and marketable equity securities not classified as held-to-maturity or as trading are classified as available-for-sale and are carried at fair market value, with the unrealized gains and losses, net of tax, included in the determination of comprehensive loss. | |
The fair value of substantially all securities is determined by quoted market prices. The estimated fair value of securities for which there are no quoted market prices is based on similar types of securities that are traded in the market. | |
Fair Value of Financial Instruments | ' |
Fair Value of Financial Instruments – The Company’s financial instruments consist primarily of cash equivalents, short-term investments, accounts payable and capital lease obligations. Management believes that the carrying values of these assets and liabilities are representative of their respective fair values based on quoted market prices for investments and the short-term nature of the other instruments. | |
Property and Equipment | ' |
Property and Equipment – Property and equipment consists of office and laboratory equipment, office furniture and leasehold improvements and includes assets acquired under capital leases. Property and equipment are recorded at cost. Depreciation is recognized using the straight-line method over the estimated useful lives of the related assets, generally five years for laboratory and computer equipment, seven years for office furniture and equipment and the lesser of the term of the lease or the useful life for leasehold improvements. Amortization of assets acquired under capital leases is included in depreciation expense. Maintenance and repairs are expensed as incurred while expenditures that extend the useful life of an asset are capitalized. | |
Impairment of Long-Lived Assets | ' |
Impairment of Long-Lived Assets – The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be fully recoverable. To determine recoverability of a long-lived asset, management evaluates whether the estimated future undiscounted net cash flows from the asset are less than its carrying amount. If impairment is indicated, the long-lived asset would be written down to fair value. Fair value is determined by an evaluation of available price information at which assets could be bought or sold, including quoted market prices, if available, or the present value of the estimated future cash flows based on reasonable and supportable assumptions. | |
Deferred Rent | ' |
Deferred Rent – The Company’s operating leases provide for rent increases over the terms of the leases. Deferred rent consists of the difference between periodic rent payments and the amount recognized as rent expense on a straight-line basis, as well as tenant allowances for leasehold improvements. Rent expenses are being recognized ratably over the terms of the leases. | |
Revenue Recognition | ' |
Revenue Recognition – Revenue from corporate collaborations and licensing agreements consists of up-front fees, research and development funding, and milestone payments. Non-refundable up-front fees are deferred and amortized to revenue over the related performance period. The Company estimates the performance period as the period in which it performs certain development activities under the applicable agreement. Reimbursements for research and development activities are recorded in the period that the Company performs the related activities under the terms of the applicable agreements. Revenue resulting from the achievement of milestone events stipulated in the applicable agreements is recognized when the milestone is achieved, provided that such milestone is substantive in nature. | |
Research and Development Costs | ' |
Research and Development Costs – The costs of research and development activities are charged to expense as incurred, including the cost of equipment for which there is no alternative future use. | |
Accrued Expenses | ' |
Accrued Expenses – Third parties perform a significant portion of our development activities. We review the activities performed under significant contracts each quarter and accrue expenses and the amount of any reimbursement to be received from our collaborators based upon the estimated amount of work completed. Estimating the value or stage of completion of certain services requires judgment based on available information. If we do not identify services performed for us but not billed by the service-provider, or if we underestimate or overestimate the value of services performed as of a given date, reported expenses will be understated or overstated. | |
Stock-Based Compensation | ' |
Stock-Based Compensation – The Company charges to expense the fair value of stock options and other equity awards granted. The Company determines the value of stock options utilizing the Black-Scholes option pricing model. Compensation costs for share-based awards with pro-rata vesting are allocated to periods on a straight-line basis. | |
Income Taxes | ' |
Income Taxes – The Company and its subsidiary file consolidated federal and separate-company state income tax returns. Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of assets and liabilities and their respective tax basis and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences or operating loss and tax credit carryforwards are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the period that includes the enactment date. The Company has recorded a valuation allowance against its deferred tax assets based on the history of losses incurred. | |
During the years ended June 30, 2014, 2013 and 2012, the Company sold New Jersey state net operating loss carryforwards, which resulted in the recognition of $1,846,646, $1,753,208, and $1,068,233, respectively, in tax benefits. | |
Net Loss per Common Share | ' |
Net Loss per Common Share – Basic and diluted earnings per common share (EPS) are calculated in accordance with the provisions of Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic 260, “Earnings per Share,” which includes guidance pertaining to the warrants, issued in connection with the July 3, 2012 private placement offering, that are exercisable for nominal consideration and, therefore, are to be considered in the computation of basic and diluted net loss per common share. The Series A 2012 warrants to purchase up to 31,988,151 shares of common stock were exercisable starting at July 3, 2012 and, therefore, are included in the weighted average number of common shares outstanding used in computing basic and diluted net loss per common share starting on July 3, 2012. | |
The Series B 2012 warrants to purchase up to 35,488,380 shares of common stock were considered contingently issuable shares and were not included in computing basic net loss per common share until the Company received stockholder approval for the increase in authorized underlying common stock on September 27, 2012 (see note 9). For diluted EPS, contingently issuable shares are to be included in the calculation as of the beginning of the period in which the conditions were satisfied, unless the effect would be anti-dilutive. The Series B 2012 warrants have been excluded from the calculation of diluted net loss per common share during the period from July 3, 2012 until September 27, 2012 as the impact would be anti-dilutive. | |
As of June 30, 2014, 2013 and 2012, there were 29,358,926, 29,136,527, and 27,179,180 common shares issuable upon conversion of Series A Convertible Preferred Stock, the exercise of outstanding options and warrants (excluding the warrants issued in connection with the July 3, 2013 private placement offering), and the vesting of restricted stock units, respectively. These share amounts have been excluded from the calculation of net loss per share as the impact would be anti-dilutive. |
5_FAIR_VALUE_MEASUREMENTS_Tabl
5. FAIR VALUE MEASUREMENTS (Tables) | 12 Months Ended | ||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||
Fair value of restricted stock units granted, amortized over 24 month vesting period | ' | ||||||||||||||||
Schedule of assets at fair value | ' | ||||||||||||||||
Carrying Value | Quoted prices in | Other quoted/observable inputs (Level 2) | Significant unobservable inputs | ||||||||||||||
active markets | (Level 3) | ||||||||||||||||
(Level 1) | |||||||||||||||||
June 30, 2014: | |||||||||||||||||
Money Market Fund | $ | 9,495,656 | $ | 9,495,656 | $ | - | $ | - | |||||||||
June 30, 2013: | |||||||||||||||||
Money Market Fund | $ | 16,284,184 | $ | 16,284,184 | $ | - | $ | - | |||||||||
U.S. Government Securities | 5,249,654 | 5,249,160 | - | - | |||||||||||||
TOTAL | $ | 21,533,838 | $ | 21,533,344 | $ | - | $ | - | |||||||||
6_PROPERTY_AND_EQUIPMENT_NET_T
6. PROPERTY AND EQUIPMENT, NET (Tables) | 12 Months Ended | ||||||||
Jun. 30, 2014 | |||||||||
Property, Plant and Equipment [Abstract] | ' | ||||||||
Property and equipment | ' | ||||||||
June 30, | June 30, | ||||||||
2014 | 2013 | ||||||||
Office equipment | $ | 1,180,210 | $ | 1,180,210 | |||||
Laboratory equipment | 317,608 | 311,369 | |||||||
Leasehold improvements | 751,226 | 751,226 | |||||||
2,249,044 | 2,242,805 | ||||||||
Less: Accumulated depreciation and amortization | (2,088,296 | ) | (1,976,390 | ) | |||||
$ | 160,748 | $ | 266,415 | ||||||
7_ACCRUED_EXPENSES_Tables
7. ACCRUED EXPENSES (Tables) | 12 Months Ended | ||||||||
Jun. 30, 2014 | |||||||||
Accrued Expenses Tables | ' | ||||||||
Accrued Expenses | ' | ||||||||
June 30, | June 30, | ||||||||
2014 | 2013 | ||||||||
Clinical study costs | $ | 617,055 | $ | 1,054,270 | |||||
Other research related expenses | 463,695 | 186,241 | |||||||
Professional services | 211,711 | 208,731 | |||||||
Insurance premiums payable | - | 125,671 | |||||||
Other | 216,497 | 126,814 | |||||||
$ | 1,508,958 | $ | 1,701,727 | ||||||
9_STOCKHOLDERS_EQUITY_Tables
9. STOCKHOLDERS EQUITY (Tables) | 12 Months Ended | ||||||||||||||||||||||||
Jun. 30, 2014 | |||||||||||||||||||||||||
Stockholders Equity Tables | ' | ||||||||||||||||||||||||
Outstanding Stock Purchase Warrants | ' | ||||||||||||||||||||||||
Shares of Common | Exercise Price per | Latest Termination | |||||||||||||||||||||||
Stock | Share | Date | |||||||||||||||||||||||
331,969 | 3.3 | 17-Aug-14 | |||||||||||||||||||||||
50,000 | 0.6 | 9-Nov-14 | |||||||||||||||||||||||
50,000 | 1 | 9-Nov-14 | |||||||||||||||||||||||
100,000 | 1.5 | 9-Nov-14 | |||||||||||||||||||||||
575,000 | 1 | 23-Feb-16 | |||||||||||||||||||||||
2,000,000 | 1 | 1-Mar-16 | |||||||||||||||||||||||
21,000,000 | 1 | 2-Mar-17 | |||||||||||||||||||||||
31,988,151 | 0.01 | 3-Jul-22 | |||||||||||||||||||||||
35,488,380 | 0.01 | 27-Sep-22 | |||||||||||||||||||||||
91,583,500 | |||||||||||||||||||||||||
Option activity | ' | ||||||||||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||||||||||
Number of Shares | Weighted Average Exercise Price | Number of Shares | Weighted Average Exercise Price | Number of Shares | Weighted Average Exercise Price | ||||||||||||||||||||
Outstanding at | |||||||||||||||||||||||||
beginning of year | 3,851,448 | $ | 1.99 | 2,181,853 | $ | 3.5 | 2,231,898 | $ | 4.05 | ||||||||||||||||
Granted | 603,400 | 1.02 | 1,807,300 | 0.65 | 75,000 | 0.65 | |||||||||||||||||||
Forfeited | (161,900 | ) | 0.68 | (74,985 | ) | 5.2 | (90,870 | ) | 3.64 | ||||||||||||||||
Expired | (50,975 | ) | 24.95 | (62,720 | ) | 11.91 | (34,175 | ) | 33.07 | ||||||||||||||||
Outstanding at | |||||||||||||||||||||||||
end of year | 4,241,973 | 1.63 | 3,851,448 | 1.99 | 2,181,853 | 3.5 | |||||||||||||||||||
Exercisable at | |||||||||||||||||||||||||
end of year | 2,507,573 | 2.19 | 1,673,973 | 3.64 | 1,323,965 | 5.1 | |||||||||||||||||||
Weighted average | |||||||||||||||||||||||||
grant-date fair | |||||||||||||||||||||||||
value of options | |||||||||||||||||||||||||
granted during | |||||||||||||||||||||||||
the year | $ | 0.8 | $ | 0.56 | $ | 0.47 | |||||||||||||||||||
Outstanding options | ' | ||||||||||||||||||||||||
Number of Shares | Weighted Average Exercise Price | Weighted Average Remaining Term in Years | Aggregate Intrinsic Value | ||||||||||||||||||||||
Options outstanding at end of | |||||||||||||||||||||||||
year | 4,241,973 | $ | 1.63 | 7.7 | $ | 694,711 | |||||||||||||||||||
Options vested and exercisable | |||||||||||||||||||||||||
at end of year | 2,507,573 | $ | 2.19 | 6.8 | $ | 373,709 | |||||||||||||||||||
Unvested options expected to | |||||||||||||||||||||||||
vest | 1,504,254 | $ | 0.8 | 8.8 | $ | 294,435 | |||||||||||||||||||
Restricted Stock Units | ' | ||||||||||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||||||||||
Outstanding at beginning of year | 757,500 | 250,000 | 500,000 | ||||||||||||||||||||||
Granted | 603,400 | 757,500 | - | ||||||||||||||||||||||
Forfeited | (25,000 | ) | - | - | |||||||||||||||||||||
Vested | (378,750 | ) | (250,000 | ) | (250,000 | ) | |||||||||||||||||||
Outstanding at end of year | 957,150 | 757,500 | 250,000 | ||||||||||||||||||||||
10_INCOME_TAXES_Tables
10. INCOME TAXES (Tables) | 12 Months Ended | ||||||||
Jun. 30, 2014 | |||||||||
Income Taxes Tables | ' | ||||||||
Deferred tax assets | ' | ||||||||
June 30, | June 30, | ||||||||
2014 | 2013 | ||||||||
Net operating loss carryforwards | $ | 87,801,000 | $ | 83,470,000 | |||||
Research and development tax credits | 6,871,000 | 6,605,000 | |||||||
Accrued expenses, deferred revenue and other | 1,003,000 | 1,698,000 | |||||||
95,675,000 | 91,773,000 | ||||||||
Valuation allowance | (95,675,000 | ) | (91,773,000 | ) | |||||
Net deferred tax assets | $ | - | $ | - | |||||
11_CONSOLIDATED_QUARTERLY_FINA1
11. CONSOLIDATED QUARTERLY FINANCIAL DATA UNAUDITED (Tables) | 12 Months Ended | |||||||
Jun. 30, 2014 | ||||||||
Consolidated Quarterly Financial Data Unaudited Tables | ' | |||||||
QUARTERLY FINANCIAL DATA | ' | |||||||
The following tables provide quarterly data for the years ended June 30, 2014 and 2013: | ||||||||
Three Months Ended | ||||||||
June 30, | March 31, | December 31, | September 30, | |||||
2014 | 2014 | 2013 | 2013 | |||||
(amounts in thousands, except per share data) | ||||||||
Revenues | $ - | $ - | $ - | $ - | ||||
Operating expenses | 4,321 | 3,364 | 3,610 | 4,492 | ||||
Other income (expense), net | 1 | 4 | 4 | 3 | ||||
Loss before income taxes | (4,320) | (3,360) | (3,606) | (4,489) | ||||
Income tax benefit | - | 1,847 | - | - | ||||
Net loss | $ (4,320) | $ (1,513) | $ (3,606) | $ (4,489) | ||||
Basic and diluted net loss per | ||||||||
common share | $ (0.04) | $ (0.01) | $ (0.03) | $ (0.04) | ||||
Weighted average number of | ||||||||
common shares outstanding | ||||||||
used in computing basic and | ||||||||
diluted net loss per common | ||||||||
share | 106,735,765 | 106,709,340 | 106,668,186 | 106,609,720 | ||||
Three Months Ended | ||||||||
June 30, | March 31, | December 31, | September 30, | |||||
2013 | 2013 | 2012 | 2012 | |||||
(amounts in thousands, except per share data) | ||||||||
Revenues | $ - | $ - | $ 7 | $ 3 | ||||
Operating expenses | 4,720 | 4,024 | 3,447 | 3,404 | ||||
Other income (expense), net | 2 | 9 | 11 | (7,052) | ||||
Loss before income taxes | (4,718) | (4,015) | (3,429) | (10,453) | ||||
Income tax benefit | - | - | 1,753 | - | ||||
Net loss | $ (4,718) | $ (4,015) | $ (1,676) | $ (10,453) | ||||
Basic and diluted net loss per | ||||||||
common share | $ (0.04) | $ (0.04) | $ (0.02) | $ (0.15) | ||||
Weighted average number of | ||||||||
common shares outstanding | ||||||||
used in computing basic and | ||||||||
diluted net loss per common | ||||||||
share | 106,435,741 | 106,424,443 | 106,424,443 | 71,669,170 | ||||
5_FAIR_VALUE_MEASUREMENTS_Deta
5. FAIR VALUE MEASUREMENTS (Details) (USD $) | Jun. 30, 2014 | Jun. 30, 2013 |
Money Market Fund | $9,495,656 | $16,284,184 |
U.S. Government Securities | 0 | 5,249,654 |
Total | 9,495,656 | 21,533,838 |
Level 1 | ' | ' |
Money Market Fund | 9,495,656 | 16,284,184 |
U.S. Government Securities | 0 | 5,249,160 |
Total | 9,495,656 | 21,533,344 |
Level 2 | ' | ' |
Money Market Fund | 0 | 0 |
U.S. Government Securities | 0 | 0 |
Total | 0 | 0 |
Level 3 | ' | ' |
Money Market Fund | 0 | 0 |
U.S. Government Securities | 0 | 0 |
Total | $0 | $0 |
6_PROPERTY_AND_EQUIPMENT_NET_D
6. PROPERTY AND EQUIPMENT, NET (Details) (USD $) | Jun. 30, 2014 | Jun. 30, 2013 |
Property, Plant and Equipment [Abstract] | ' | ' |
Office equipment | $1,180,210 | $1,180,210 |
Laboratory equipment | 317,608 | 311,369 |
Leasehold improvements | 751,226 | 751,226 |
Gross | 2,249,044 | 2,242,805 |
Less: Accumulated depreciation and amortization | -2,088,296 | -1,976,390 |
Net | $160,748 | $266,415 |
6_PROPERTY_AND_EQUIPMENT_NET_D1
6. PROPERTY AND EQUIPMENT, NET (Details Narrative) (USD $) | Jun. 30, 2014 | Jun. 30, 2013 |
Property And Equipment Net Details Narrative | ' | ' |
Aggregate cost of assets acquired under capital leases | $66,115 | $66,115 |
Accumulated amortization associated with assets acquired under capital leases | $40,771 | $27,548 |
7_ACCRUED_EXPENSES_Details
7. ACCRUED EXPENSES (Details) (USD $) | Jun. 30, 2014 | Jun. 30, 2013 |
Accrued Expenses Tables | ' | ' |
Clinical study costs | $617,055 | $1,054,270 |
Other research related expenses | 463,695 | 186,241 |
Professional services | 211,711 | 208,731 |
Insurance premiums payable | 0 | 125,671 |
Other | 216,497 | 126,814 |
Accrued expenses | $1,508,958 | $1,701,727 |
9_STOCKHOLDERS_EQUITY_Details
9. STOCKHOLDERS EQUITY (Details) (USD $) | 12 Months Ended |
Jun. 30, 2014 | |
Shares of Common Stock | 91,583,500 |
Range 1 | ' |
Shares of Common Stock | 331,969 |
Exercise Price per Share | 3.3 |
Latest Termination Date | 17-Aug-14 |
Range 2 | ' |
Shares of Common Stock | 50,000 |
Exercise Price per Share | 0.6 |
Latest Termination Date | 9-Nov-14 |
Range 3 | ' |
Shares of Common Stock | 50,000 |
Exercise Price per Share | 1 |
Latest Termination Date | 9-Nov-14 |
Range 4 | ' |
Shares of Common Stock | 100,000 |
Exercise Price per Share | 1.5 |
Latest Termination Date | 9-Nov-14 |
Range 5 | ' |
Shares of Common Stock | 575,000 |
Exercise Price per Share | 1 |
Latest Termination Date | 23-Feb-16 |
Range 6 | ' |
Shares of Common Stock | 2,000,000 |
Exercise Price per Share | 1 |
Latest Termination Date | 1-Mar-16 |
Range 7 | ' |
Shares of Common Stock | 21,000,000 |
Exercise Price per Share | 1 |
Latest Termination Date | 2-Mar-17 |
Range 8 | ' |
Shares of Common Stock | 31,988,151 |
Exercise Price per Share | 0.01 |
Latest Termination Date | 3-Jul-22 |
Range 9 | ' |
Shares of Common Stock | 35,488,380 |
Exercise Price per Share | 0.01 |
Latest Termination Date | 27-Sep-22 |
9_STOCKHOLDERS_EQUITY_Details_
9. STOCKHOLDERS EQUITY (Details 1) (USD $) | 12 Months Ended | ||
Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2012 | |
Stockholders Equity Tables | ' | ' | ' |
Number of Options Outstanding, Beginning | 3,851,448 | 2,181,853 | 2,231,898 |
Number of Options Granted | 603,400 | 1,807,300 | 75,000 |
Number of Options Forfeited | -161,900 | -74,985 | -90,870 |
Number of Options Exercised | 0 | 0 | 0 |
Number of Options Expired | -50,975 | -62,720 | -34,175 |
Number of Options Outstanding, Ending | 4,241,973 | 3,851,448 | 2,181,853 |
Number of Options Exercisable | 2,507,573 | 1,673,973 | 1,323,965 |
Weighted Average Exercise Price Outstanding, Beginning | $1.99 | $3.50 | $4.05 |
Weighted Average Exercise Price Granted | $1.02 | $0.65 | $0.65 |
Weighted Average Exercise Price Forfeited | $0.68 | $5.20 | $3.64 |
Weighted Average Exercise Price Exercised | $0 | $0 | $0 |
Weighted Average Exercise Price Expired | $24.95 | $11.91 | $33.07 |
Weighted Average Exercise Price Outstanding, Ending | $1.63 | $1.99 | $3.50 |
Weighted Average Exercise Price Exercisable | $2.19 | $3.64 | $5.10 |
Weighted average grant date fair value of options granted during the year | $0.80 | $0.56 | $0.47 |
9_STOCKHOLDERS_EQUITY_Details_1
9. STOCKHOLDERS EQUITY (Details 2) (USD $) | 12 Months Ended | |||
Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2012 | Jun. 30, 2011 | |
Stockholders Equity Tables | ' | ' | ' | ' |
Number of Options Outstanding, Ending | 4,241,973 | 3,851,448 | 2,181,853 | 2,231,898 |
Options vested and exercisable at end of year | 2,507,573 | ' | ' | ' |
Unvested options expected to vest | 1,504,254 | ' | ' | ' |
Weighted Average Exercise Price Outstanding, Ending | $1.63 | $1.99 | $3.50 | $4.05 |
Weighted Average Exercise Price Options vested and exercisable at end of year | $2.19 | ' | ' | ' |
Weighted Average Exercise Price Unvested options expected to vest | $0.80 | ' | ' | ' |
Weighted Average Remaining Term in Years Options outstanding at end of year | '7 years 8 months 12 days | ' | ' | ' |
Weighted Average Remaining Term in Years Options vested and exercisable at end of year | '6 years 9 months 18 days | ' | ' | ' |
Weighted Average Remaining Term in Years Unvested options expected to vest | '8 years 9 months 18 days | ' | ' | ' |
Aggregate Intrinsic Value Options outstanding at end of | $694,711 | ' | ' | ' |
Aggregate Intrinsic Value Options vested and exercisable at the end of year | 373,709 | ' | ' | ' |
Aggregate Intrinsic Value Unvested options expected to vest | $294,435 | ' | ' | ' |
9_STOCKHOLDERS_EQUITY_Details_2
9. STOCKHOLDERS EQUITY (Details 3) | 12 Months Ended | ||
Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2012 | |
Stockholders Equity Tables | ' | ' | ' |
Outstanding at beginning of year | 757,500 | 250,000 | 500,000 |
Granted | 603,400 | 757,500 | 0 |
Forfeited | -25,000 | 0 | 0 |
Vested | -378,750 | -250,000 | -250,000 |
Outstanding at end of year | 957,150 | 757,500 | 250,000 |
10_INCOME_TAXES_Details
10. INCOME TAXES (Details) (USD $) | Jun. 30, 2014 | Jun. 30, 2013 |
Income Taxes Tables | ' | ' |
Net operating loss carryforwards | $87,801,000 | $83,470,000 |
Research and development tax credits | 6,871,000 | 6,605,000 |
Accrued expenses, deferred revenue and other | 1,003,000 | 1,698,000 |
Gross | 95,675,000 | 91,773,000 |
Valuation allowance | -95,675,000 | -91,773,000 |
Net deferred tax assets | $0 | $0 |
10_INCOME_TAXES_Details_Narrat
10. INCOME TAXES (Details Narrative) (USD $) | Jun. 30, 2014 | Jun. 30, 2013 |
Federal research and development credits | $6,871,000 | $6,605,000 |
Federal | ' | ' |
Net operating loss carryforwards | 234,000,000 | ' |
Federal research and development credits | 7,050,000 | ' |
State | ' | ' |
Net operating loss carryforwards | 92,000,000 | ' |
Federal research and development credits | $0 | ' |
11_CONSOLIDATED_QUARTERLY_FINA2
11. CONSOLIDATED QUARTERLY FINANCIAL DATA UNAUDITED (Details) (USD $) | 3 Months Ended | 12 Months Ended | |||||||||
Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2012 | Sep. 30, 2012 | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2012 | |
Consolidated Quarterly Financial Data Unaudited Tables | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Revenues | $0 | $0 | $0 | $0 | $0 | $0 | $7,000 | $3,000 | ' | ' | ' |
Operating expenses | 4,321,000 | 3,364,000 | 3,610,000 | 4,492,000 | 4,720,000 | 4,024,000 | 3,447,000 | 3,404,000 | 15,787,652 | 15,595,521 | 18,859,117 |
Other income/(expense), net | 1,000 | 4,000 | 4,000 | 3,000 | 2,000 | 9,000 | 11,000 | -7,052,000 | 12,712 | -7,030,222 | 463,970 |
Loss before income taxes | -4,320,000 | -3,360,000 | -3,606,000 | -4,489,000 | -4,718,000 | -4,015,000 | -3,429,000 | -10,453,000 | -15,774,940 | -22,615,382 | -18,321,411 |
Income tax benefit | 0 | 1,847,000 | 0 | 0 | 0 | 0 | 1,753,000 | 0 | 1,846,646 | 1,753,208 | 1,068,233 |
Net loss | ($4,320,000) | ($1,513,000) | ($3,606,000) | ($4,489,000) | ($4,718,000) | ($4,015,000) | ($1,676,000) | ($10,453,000) | ($13,928,294) | ($20,862,174) | ($17,253,178) |
Basic and diluted net loss per common share | ($0.04) | ($0.01) | ($0.03) | ($0.04) | ($0.04) | ($0.04) | ($0.02) | ($0.15) | ($0.13) | ($0.21) | ($0.49) |
Weighted average number of common shares outstanding used in computing basic and diluted net loss per common share | 106,735,765 | 106,709,340 | 106,668,186 | 106,609,720 | 106,435,741 | 106,424,443 | 106,424,443 | 71,669,170 | 106,679,476 | 97,618,714 | 34,900,591 |