Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Mar. 31, 2020 | May 08, 2020 | |
Document And Entity Information | ||
Entity Registrant Name | PALATIN TECHNOLOGIES INC | |
Entity Central Index Key | 0000911216 | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2020 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --06-30 | |
Is Entity's Reporting Status Current? | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Emerging Growth Company | false | |
Entity Small Business | true | |
Entity Shell Company | false | |
Entity Interactive Data Current | Yes | |
Entity Incorporation, State or Country Code | DE | |
Entity File Number | 001-15543 | |
Entity Common Stock, Shares Outstanding | 229,258,400 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2020 |
Consolidated Balance Sheets (Un
Consolidated Balance Sheets (Unaudited) - USD ($) | Mar. 31, 2020 | Jun. 30, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 88,947,368 | $ 43,510,422 |
Accounts receivable | 0 | 60,265,970 |
Prepaid expenses and other current assets | 675,443 | 637,289 |
Total current assets | 89,622,811 | 104,413,681 |
Property and equipment, net | 153,660 | 141,539 |
Right-of-use assets | 98,491 | 0 |
Other assets | 179,916 | 179,916 |
Total assets | 90,054,878 | 104,735,136 |
Current liabilities: | ||
Accounts payable | 1,612,164 | 504,787 |
Accrued expenses | 1,657,237 | 2,848,692 |
Notes payable, net of discount | 0 | 332,896 |
Other current liabilities | 89,429 | 499,517 |
Total current liabilities | 3,358,830 | 4,185,892 |
Other liabilities | 9,062 | 0 |
Total liabilities | 3,367,892 | 4,185,892 |
Stockholders' equity: | ||
Preferred stock of $0.01 par value - authorized 10,000,000 shares; shares issued and outstanding designated as follows: Series A Convertible: authorized 264,000 shares: issued and outstanding 4,030 shares as of March 31, 2020 and June 30, 2019 | 40 | 40 |
Common stock of $0.01 par value - authorized 300,000,000 shares: issued and outstanding 229,240,596 shares as of March 31, 2020 and 226,815,363 shares as of June 30, 2019 | 2,292,406 | 2,268,154 |
Additional paid-in capital | 395,294,270 | 394,053,929 |
Accumulated deficit | (310,899,730) | (295,772,879) |
Total stockholders' equity | 86,686,986 | 100,549,244 |
Total liabilities and stockholders' equity | $ 90,054,878 | $ 104,735,136 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2020 | Jun. 30, 2019 |
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 | 4,030 | 4,030 |
Preferred stock, Series A Convertible, shares outstanding | 4,030 | 4,030 |
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 300,000,000 | 300,000,000 |
Common stock, shares issued | 229,240,596 | 226,815,363 |
Common stock, shares outstanding | 229,240,596 | 226,815,363 |
Consolidated Statements of Oper
Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2020 | Mar. 31, 2019 | Mar. 31, 2020 | Mar. 31, 2019 | |
REVENUES: | ||||
License and contract | $ 0 | $ 0 | $ 117,989 | $ 34,505 |
OPERATING EXPENSES: | ||||
Research and development | 3,641,250 | 3,943,982 | 10,026,363 | 10,528,329 |
General and administrative | 2,072,032 | 1,818,796 | 6,308,567 | 5,947,943 |
Total operating expenses | 5,713,282 | 5,762,778 | 16,334,930 | 16,476,272 |
Loss from operations | (5,713,282) | (5,762,778) | (16,216,941) | (16,441,767) |
OTHER INCOME (EXPENSE): | ||||
Investment income | 331,285 | 107,460 | 1,101,921 | 361,212 |
Interest expense | (278) | (71,812) | (11,831) | (370,981) |
Total other income (expense), net | 331,007 | 35,648 | 1,090,090 | (9,769) |
NET LOSS | $ (5,382,275) | $ (5,727,130) | $ (15,126,851) | $ (16,451,536) |
Basic and diluted net loss per common share | $ (0.02) | $ (0.03) | $ (0.06) | $ (0.08) |
Weighted average number of common shares outstanding used in computing basic and diluted net loss per common share | 235,322,087 | 207,016,304 | 234,449,813 | 206,148,695 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) | Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
Beginning balance, shares at Jun. 30, 2018 | 4,030 | 200,554,205 | |||
Beginning balance at Jun. 30, 2018 | $ 40 | $ 2,005,542 | $ 357,005,233 | $ (332,045,906) | $ 26,964,909 |
Cumulative effect of accounting change | 500,000 | 500,000 | |||
Stock-based compensation, shares | 319,817 | ||||
Stock-based compensation | $ 3,198 | 2,863,581 | 2,866,779 | ||
Withholding taxes related to restricted stock units, shares | (67,038) | ||||
Withholding taxes related to restricted stock units | $ (670) | (65,322) | (65,992) | ||
Sale of common stock, net of costs, shares | 2,256,445 | ||||
Sale of common stock, net of costs | $ 22,564 | 2,230,244 | 2,252,808 | ||
Net loss | (16,451,536) | (16,451,536) | |||
Ending balance, shares at Mar. 31, 2019 | 4,030 | 203,063,429 | |||
Ending balance at Mar. 31, 2019 | $ 40 | $ 2,030,634 | 362,033,736 | (347,997,442) | 16,066,968 |
Beginning balance, shares at Dec. 31, 2018 | 4,030 | 203,063,429 | |||
Beginning balance at Dec. 31, 2018 | $ 40 | $ 2,030,634 | 361,379,336 | (342,270,312) | 21,139,698 |
Stock-based compensation | 654,400 | 654,400 | |||
Net loss | (5,727,130) | (5,727,130) | |||
Ending balance, shares at Mar. 31, 2019 | 4,030 | 203,063,429 | |||
Ending balance at Mar. 31, 2019 | $ 40 | $ 2,030,634 | 362,033,736 | (347,997,442) | 16,066,968 |
Beginning balance, shares at Jun. 30, 2019 | 4,030 | 226,815,363 | |||
Beginning balance at Jun. 30, 2019 | $ 40 | $ 2,268,154 | 394,053,929 | (295,772,879) | 100,549,244 |
Stock-based compensation, shares | 589,617 | ||||
Stock-based compensation | $ 5,896 | 2,328,901 | 2,334,797 | ||
Withholding taxes related to restricted stock units, shares | (87,179) | ||||
Withholding taxes related to restricted stock units | $ (872) | (103,364) | (104,236) | ||
Sale of common stock, net of costs, shares | 1,895,934 | ||||
Sale of common stock, net of costs | $ 18,959 | 1,562,539 | 1,581,498 | ||
Warrant repurchases | (2,547,466) | (2,547,466) | |||
Warrant exercises, shares | 26,861 | ||||
Warrant exercises | $ 269 | (269) | |||
Net loss | (15,126,851) | (15,126,851) | |||
Ending balance, shares at Mar. 31, 2020 | 4,030 | 229,240,596 | |||
Ending balance at Mar. 31, 2020 | $ 40 | $ 2,292,406 | 395,294,270 | (310,899,730) | 86,686,986 |
Beginning balance, shares at Dec. 31, 2019 | 4,030 | 229,174,754 | |||
Beginning balance at Dec. 31, 2019 | $ 40 | $ 2,291,748 | 394,592,802 | (305,517,455) | 91,367,135 |
Stock-based compensation, shares | 65,842 | ||||
Stock-based compensation | $ 658 | 701,468 | 702,126 | ||
Net loss | (5,382,275) | (5,382,275) | |||
Ending balance, shares at Mar. 31, 2020 | 4,030 | 229,240,596 | |||
Ending balance at Mar. 31, 2020 | $ 40 | $ 2,292,406 | $ 395,294,270 | $ (310,899,730) | $ 86,686,986 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (15,126,851) | $ (16,451,536) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | ||
Depreciation and amortization | 50,759 | 43,526 |
Non-cash interest expense | 438 | 47,312 |
Decrease in right-of-use asset | 220,078 | 0 |
Stock-based compensation | 2,334,797 | 2,866,779 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 60,265,970 | 0 |
Prepaid expenses and other assets | (38,154) | (183,490) |
Accounts payable | 1,107,377 | (1,748,920) |
Accrued expenses | (1,191,455) | 537,187 |
Operating lease liability | (220,078) | 0 |
Other liabilities | 0 | 51,643 |
Net cash provided by (used in) operating activities | 47,402,881 | (14,837,499) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of property and equipment | (62,880) | (36,139) |
Net cash used in investing activities | (62,880) | (36,139) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Payment of withholding taxes related to restricted stock units | (104,236) | (65,992) |
Payments on notes payable obligations | (832,851) | (5,500,000) |
Warrant repurchases | (2,547,466) | 0 |
Proceeds from the sale of common stock, net of costs | 1,581,498 | 2,252,808 |
Net cash used in financing activities | (1,903,055) | (3,313,184) |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 45,436,946 | (18,186,822) |
CASH AND CASH EQUIVALENTS, beginning of period | 43,510,422 | 38,000,171 |
CASH AND CASH EQUIVALENTS, end of period | 88,947,368 | 19,813,349 |
SUPPLEMENTAL CASH FLOW INFORMATION: | ||
Cash paid for interest | $ 8,132 | $ 316,159 |
ORGANIZATION
ORGANIZATION | 9 Months Ended |
Mar. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
ORGANIZATION | Nature of Business Melanocortin Receptor System. The Company’s lead product, Vyleesi®, was approved by the U.S. Food and Drug Administration (“FDA”) in June 2019 and is currently being marketed in North America by AMAG Pharmaceuticals, Inc. (“AMAG”) for the treatment of hypoactive sexual desire disorder (“HSDD”) in premenopausal women. As disclosed in Note 5, AMAG has announced its plan to divest Vyleesi and another product. The Company’s new product development activities focus primarily on MC1r agonists, with potential to treat inflammatory and autoimmune diseases such as dry eye disease, which is also known as keratoconjunctivitis sicca, uveitis, diabetic retinopathy and inflammatory bowel disease. The Company believes that the MC1r agonist peptides in development have broad anti-inflammatory effects and appear to utilize mechanisms engaged by the endogenous melanocortin system in regulation of the immune system and resolution of inflammatory responses. The Company is also developing peptides that are active at more than one melanocortin receptor, and MC4r peptide and small molecule agonists with potential utility in obesity and metabolic-related disorders, including rare disease and orphan indications. Natriuretic Peptide Receptor System Business Risks and Liquidity – As of March 31, 2020, the Company’s cash and cash equivalents were $88,947,368 and current liabilities were $3,358,830. Management intends to utilize existing capital resources for general corporate purposes and working capital, including preclinical and clinical development of the Company’s MC1r and MC4r peptide programs and natriuretic peptide program, and development of other portfolio products. Management believes that the Company’s existing capital resources will be adequate to fund the Company’s planned operations through at least March 31, 2022. The Company will need additional funding to complete required clinical trials for its other product candidates and, assuming those clinical trials are successful, as to which there can be no assurance, to complete submission of required applications to the FDA. If the Company is unable to obtain approval or otherwise advance in the FDA approval process, the Company’s ability to sustain its operations could be materially adversely affected. The Company may seek the additional capital necessary to fund its operations through public or private equity offerings, collaboration agreements, debt financings or licensing arrangements. Additional capital that is required by the Company may not be available on reasonable terms, or at all. In March 2020, the World Health Organization declared COVID-19, a disease caused by a novel strain of coronavirus, a pandemic. The Company has taken steps to ensure the safety and well-being of its employees and clinical trial patients to comply with guidance from federal, state and local authorities, while working to ensure the sustainability of its business operations as this unprecedented situation continues to evolve. In mid-March, the Company transitioned to a company-wide work from home policy. Business-critical activities continue to be subject to heightened precautions to ensure safety of employees. The Company continues to assess its policies, business continuity plans and employee support. The Company continues to evaluate the impact of COVID-19 on the healthcare system and work with contract research organizations supporting its clinical, research, and development programs to mitigate risk to patients and its business and community partners, taking into account regulatory, institutional, and government guidance and policies. The Company receives a royalty on sales of Vyleesi by our licensees. AMAG is currently selling Vyleesi in the United States, and Fosun and Kwangdong have licenses to sell Vyleesi in China and Korea, respectively. The Company does not know the effect of the COVID-19 coronavirus on sales of Vyleesi in the United States, but it could have a negative impact on sales, which would adversely impact royalty revenues. The COVID-19 coronavirus could adversely impact the time required to obtain regulatory approvals to sell Vyleesi in China and Korea, which would delay when the Company receives royalty income from sales in those countries. The Company cannot be certain what the overall impact of the COVID-19 pandemic will be on its business and it has the potential to materially adversely affect its business, financial condition and results of operations and cashflows during fiscal year 2020 and beyond. Concentrations – |
BASIS OF PRESENTATION
BASIS OF PRESENTATION | 9 Months Ended |
Mar. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
BASIS OF PRESENTATION | The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q. Accordingly, they do not include all of the information and footnote disclosures required to be presented for complete financial statements. In the opinion of management, these consolidated financial statements contain all adjustments (consisting of normal recurring adjustments) considered necessary for fair presentation. The results of operations for the three and nine months ended March 31, 2020 may not necessarily be indicative of the results of operations expected for the full year. The accompanying unaudited consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended June 30, 2019, filed with the Securities and Exchange Commission (“SEC”), which includes consolidated financial statements as of June 30, 2019 and 2018 and for each of the fiscal years in the three-year period ended June 30, 2019. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Mar. 31, 2020 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | Principles of Consolidation Use of Estimates Cash and Cash Equivalents Fair Value of Financial Instruments Credit Risk Property and Equipment Impairment of Long-Lived Assets Revenue Recognition Revenue from Contracts with Customers On July 1, 2018, the Company adopted ASC Topic 606 using the modified retrospective approach, a practical expedient permitted under ASC Topic 606, and applied this approach only to contracts that were not completed as of July 1, 2018. For licenses of intellectual property, the Company assesses, at contract inception, whether the intellectual property is distinct from other performance obligations identified in the arrangement. If the licensing of intellectual property is determined to be distinct, revenue is recognized for nonrefundable, upfront license fees when the license is transferred to the customer and the customer can use and benefit from the license. If the licensing of intellectual property is determined not to be distinct, then the license will be bundled with other promises in the arrangement into one performance obligation. The Company needs to determine if the bundled performance obligation is satisfied over time or at a point in time. If the Company concludes that the nonrefundable, upfront license fees will be recognized over time, the Company will need to assess the appropriate method of measuring proportional performance. Regulatory milestone payments are excluded from the transaction price due to the inability to estimate the probability of reversal. Revenue relating to achievement of these milestones is recognized in the period in which the milestone is achieved. Sales-based royalty and milestone payments resulting from customer contracts solely or predominately for the license of intellectual property will only be recognized upon occurrence of the underlying sale or achievement of the sales milestone and such sales-based royalties and milestone payments are recognized in the same period earned. The Company recognizes revenue for reimbursements of research and development costs under collaboration agreements as the services are performed. The Company records these reimbursements as revenue and not as a reduction of research and development expenses as the Company is the principal in the research and development activities based upon its control of such activities, which is considered part of its ordinary activities. Development milestone payments are generally due 30 business days after the milestone is achieved. Sales milestone payments are generally due 45 business days after the calendar year in which the sales milestone is achieved. Royalty payments are generally due on a quarterly basis 20 business days after being invoiced. Research and Development Costs Accrued Expenses – Stock-Based Compensation – Income Taxes Net Loss per Common Share - Earnings per Share For the three and nine months ended March 31, 2020 and 2019, no additional common shares were added to the computation of diluted EPS because to do so would have been anti-dilutive. The potential number of common shares excluded from diluted EPS during the three and nine months ended March 31, 2020 and 2019 was 33,166,477 and 40,819,113 respectively. Included in the weighted average common shares used in computing basic and diluted net loss per common share are 6,079,250 and 3,952,875 vested restricted stock units that had not been issued as of March 31, 2020 and 2019, respectively, due to a provision in the restricted stock unit agreements to delay delivery. |
NEW AND RECENTLY ADOPTED ACCOUN
NEW AND RECENTLY ADOPTED ACCOUNTING PRONOUNCEMENTS | 9 Months Ended |
Mar. 31, 2020 | |
Accounting Standards Update and Change in Accounting Principle [Abstract] | |
NEW AND RECENTLY ADOPTED ACCOUNTING PRONOUNCEMENTS | In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. In November 2018, the FASB issued ASU No. 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606. This update provides clarification on the interaction between Revenue Recognition (Topic 606) and Collaborative Arrangements (Topic 808), including the alignment of unit of account guidance between the two topics . The guidance is effective for public entities for fiscal years beginning after December 15, 2019, and for interim periods within those fiscal years, with early adoption permitted. The guidance is applicable to the Company beginning July 1, 2020. The Company is currently evaluating the potential effects of this guidance on its consolidated financial statements. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments, On July 1, 2019, the Company adopted the requirements of ASU No.2016-02, Leases At lease inception, the Company determines whether an arrangement is or contains a lease. Operating leases are included in operating lease ROU assets, current operating lease liabilities, and noncurrent operating lease liabilities in the consolidated financial statements. ROU assets represent the Company’s right to use leased assets over the term of the lease. Lease liabilities represent the Company’s contractual obligation to make lease payments over the lease term. For operating leases, ROU assets and lease liabilities are recognized at the commencement date. The lease liability is measured as the present value of the lease payments over the lease term. The Company uses the rate implicit in the lease if it is determinable. When the rate implicit in the lease is not determinable, the Company uses an estimate based on a hypothetical rate provided by a third party as the Company currently does not have issued debt. Operating ROU assets are calculated as the present value of the remaining lease payments plus unamortized initial direct costs plus any prepayments less any unamortized lease incentives received. Lease terms may include renewal or extension options to the extent they are reasonably certain to be exercised. The assessment of whether renewal or extension options are reasonably certain to be exercised is made at lease commencement. Factors considered in determining whether an option is reasonably certain of exercise include, but are not limited to, the value of any leasehold improvements, the value of renewal rates compared to market rates, and the presence of factors that would cause incremental costs to the Company if the option were not exercised. Lease expense is recognized on a straight-line basis over the lease term. The Company has elected not to recognize an ROU asset and obligation for leases with an initial term of twelve months or less. The expense associated with short term leases is included in general and administrative expense in the statement of operations. To the extent a lease arrangement includes both lease and non-lease components, the Company has elected to account for the components as a single lease component. |
AGREEMENT WITH AMAG
AGREEMENT WITH AMAG | 9 Months Ended |
Mar. 31, 2020 | |
Fair value of restricted stock units granted, amortized over 24 month vesting period | |
AGREEMENT WITH AMAG | On January 8, 2017, the Company entered into the AMAG License Agreement pursuant to which the Company granted AMAG (i) an exclusive license in all countries of North America (the “Territory”), with the right to grant sub-licenses, to research, develop and commercialize products containing Vyleesi (each a “Product”, and collectively, “Products”), (ii) a non-exclusive license in the Territory, with the right to grant sub-licenses, to manufacture the Products, and (iii) a non-exclusive license in all countries outside the Territory, with the right to grant sub-licenses, to research, develop and manufacture (but not commercialize) the Products. Following the satisfaction of certain conditions to closing, the AMAG License Agreement became effective on February 2, 2017, and AMAG paid the Company $60,000,000 as a one-time initial payment. Under the AMAG License Agreement, AMAG was required to reimburse the Company up to an aggregate amount of $25,000,000 for reasonable, documented, direct out-of-pocket expenses incurred by the Company following February 2, 2017, in connection with development and regulatory activities necessary to file a New Drug Application (“NDA”) for Vyleesi for HSDD in the United States. The Company determined there was no stand-alone value for the license, and that the license and the reimbursable direct out-of-pocket expenses, pursuant to the terms of the AMAG License Agreement, represented a combined unit of accounting which totaled $85,000,000. The Company recognized revenue of the combined unit of accounting over the arrangement using the input-based proportional method as the Company completed its development obligations. During the nine months ended March 31, 2020, license and contract revenue included additional billings for AMAG related Vyleesi costs of $117,989. During the nine months ended March 31, 2019, license and contract revenue included additional billings for AMAG related Vyleesi costs of $34,505. On June 4, 2018, the FDA accepted the Vyleesi NDA for filing. The FDA’s acceptance triggered a $20,000,000 milestone payment to Palatin from AMAG. As a result, the Company recognized $20,000,000 in revenue related to regulatory milestones in fiscal 2018. On June 21, 2019, the FDA granted approval of Vyleesi for use in the United States. The FDA’s approval triggered a $60,000,000 milestone payment to Palatin from AMAG. As a result, the Company recognized $60,000,000 in revenue related to regulatory milestones in fiscal 2019. In addition, pursuant to the terms of and subject to the conditions in the AMAG License Agreement, the Company is eligible to receive from AMAG up to $300,000,000 in sales milestone payments based on achievement of certain annual net sales for all Products in the Territory. AMAG is also obligated to pay the Company tiered royalties on annual net sales of Products, on a product-by-product basis, in the Territory ranging from the high single-digits to the low double-digits. The royalties will expire on a product-by-product and country-by-country basis upon the latest to occur of (i) the earliest date on which there are no valid claims of the Company’s patent rights covering such Product in such country, (ii) the expiration of the regulatory exclusivity period for such Product in such country and (iii) ten years following the first commercial sale of such Product in such country. Such royalties are subject to reductions in the event that: (a) AMAG must license additional third-party intellectual property in order to develop, manufacture or commercialize a Product, or (b) generic competition occurs with respect to a Product in a given country, subject to an aggregate cap on such deductions of royalties otherwise payable to the Company. After the expiration of the applicable royalties for any Product in a given country, the license for such Product in such country will become a fully paid-up, royalty-free, perpetual and irrevocable license. The Company engaged Greenhill & Co. LLC (“Greenhill”) as the Company’s sole financial advisor in connection with a potential transaction with respect to Vyleesi. Under the engagement agreement with Greenhill, the Company was obligated to pay Greenhill a fee equal to 2% of all proceeds and consideration, as defined, paid or to be paid to the Company by AMAG in connection with the AMAG License Agreement, subject to a minimum fee of $2,500,000. The minimum fee of $2,500,000, less a credit of $50,000 for an advisory fee previously paid by the Company, was paid to Greenhill and recorded as an expense upon the closing of the licensing transaction. This amount was credited toward amounts that were to become due to Greenhill, provided that the aggregate fee payable to Greenhill would not be less than 2% of all proceeds and consideration, as defined, paid or to be paid to the Company by AMAG in connection with the AMAG License Agreement. On November 21, 2019, the Company and Greenhill mutually agreed to terminate the engagement agreement. As a result, the Company made a final payment to Greenhill of $625,000, which was recorded in general and administrative expenses during the nine months ended March 31, 2020. The Company has no future payment obligations to Greenhill. Pursuant to the AMAG License Agreement, the Company has assigned to AMAG the Company’s manufacturing and supply agreements with Catalent Belgium S.A. to perform fill, finish and packaging of Vyleesi. On January 9, 2020, AMAG announced plans to divest Vyleesi and Intrarosa® (prasterone), both women’s healthcare products. While AMAG indicated that it has received preliminary expressions of interest to acquire or sublicense rights to these products, there have been no public disclosures of any potential licensees of AMAG’s rights to Vyleesi in North America. After FDA approval of Vyleesi in June 2019, AMAG launched Vyleesi nationally in September 2019 through select specialty pharmacies with its maternal and women’s health sales force. Under the AMAG License Agreement, AMAG has a contractual obligation to use commercially reasonable efforts to commercialize Vyleesi, and if AMAG materially breaches its obligations, the Company could have the right to terminate the AMAG License Agreement and require AMAG to assign and transfer certain Vyleesi rights to the Company. |
AGREEMENT WITH FOSUN
AGREEMENT WITH FOSUN | 9 Months Ended |
Mar. 31, 2020 | |
Agreement With Fosun Abstract | |
AGREEMENT WITH FOSUN | On September 6, 2017, the Company entered into a license agreement with Fosun (“Fosun License Agreement”) for exclusive rights to commercialize Vyleesi in China. Under the terms of the agreement, the Company received $4,500,000 in October 2017, which consisted of an upfront payment of $5,000,000 less $500,000 that was withheld in accordance with tax withholding requirements in China and recorded as an expense during the year ended June 30, 2018. The Company will receive a $7,500,000 milestone payment when regulatory approval in China is obtained, provided that a commercial supply agreement for Vyleesi has been entered into. Palatin has the potential to receive up to $92,500,000 in additional sales related milestone payments and high single-digit to low double-digit royalties on net sales in the licensed territory. All development, regulatory, sales, marketing, and commercial activities and associated costs in the licensed territory will be the sole responsibility of Fosun. |
AGREEMENT WITH KWANGDONG
AGREEMENT WITH KWANGDONG | 9 Months Ended |
Mar. 31, 2020 | |
Notes Payable Details | |
AGREEMENT WITH KWANGDONG | On November 21, 2017, the Company entered into a license agreement with Kwangdong (“Kwangdong License Agreement”) for exclusive rights to commercialize Vyleesi in Korea. Under the terms of the agreement, the Company received $417,500 in December 2017, consisting of an upfront payment of $500,000, less $82,500, which was withheld in accordance with tax withholding requirements in Korea and recorded as an expense during the year ended June 30, 2018. Based upon certain refund provisions, the upfront payment was recorded as non-current deferred revenue at December 31, 2017. On July 1, 2018, in conjunction with the adoption of ASC Topic 606, a one-time transition adjustment of $500,000 was recorded to the opening balance of accumulated deficit as the Company determined a significant revenue reversal would not occur in a future period. The Company will receive a $3,000,000 milestone payment based on the first commercial sale in Korea. Palatin has the potential to receive up to $37,500,000 in additional sales related milestone payments and mid-single-digit to low double-digit royalties on net sales in the licensed territory. All development, regulatory, sales, marketing, and commercial activities and associated costs in the licensed territory will be the sole responsibility of Kwangdong. |
PREPAID EXPENSES AND OTHER CURR
PREPAID EXPENSES AND OTHER CURRENT ASSETS | 9 Months Ended |
Mar. 31, 2020 | |
Prepaid Expense and Other Assets, Current [Abstract] | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | Prepaid expenses March 31 June 30, 2020 2019 Clinical / Regulatory costs $ 97,020 $ 61,798 Insurance premiums 8,090 87,937 Other 570,333 487,554 $ 675,443 $ 637,289 |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 9 Months Ended |
Mar. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS | The fair value of cash equivalents 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’s 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 active markets(Level 1) Other quoted/observable inputs (Level 2) Significant unobservable inputs(Level 3) March 31, 2020: Money Market Account $ 88,736,048 $ 88,736,048 $ - $ - June 30, 2019: Money Market Account $ 43,381,556 $ 43,831,556 $ - $ - |
LEASES
LEASES | 9 Months Ended |
Mar. 31, 2020 | |
Leases [Abstract] | |
LEASES | The Company has operating leases of office and laboratory space, each of which expires on June 30, 2020. The Company also has operating leases of copier equipment that expire October 15, 2021. The components of lease expense are as follows: Lease cost Three months ended March 31, 2020 Nine months ended March 31, 2020 Operating lease cost $ 53,454 $ 152,712 Variable lease cost 17,824 53,473 Short-term lease cost 3,600 15,720 Total lease cost $ 74,878 $ 221,905 Supplemental balance sheet information related to leases was as follows: March 31, 2020 Operating lease ROU asset and liability $ 98,491 Supplemental lease term and discount rate information related to leases was as follows: Weighted-average remaining lease term (years) 0.5 Weighted-average discount rate 6.25 % Supplemental cash flow information related to leases was as follows: Three months ended March 31, 2020 Nine months ended March 31, 2020 Cash paid for the amounts included in the measurement of lease liabilities: Operating cash flows for operating leases $ 77,096 $ 226,031 Supplemental non-cash information on lease liabilities arisng from obtaining right-of-use assets: Right-of-use assets obtained in exchange for new lease obligation $ - $ 93,435 The following table summarizes the maturity of the Company’s operating lease liability as of March 31, 2020: March 31, 2020 Year Ending June 30 2020 $ 77,097 2021 18,360 2022 4,590 Less imputed interest (1,556 ) Total $ 98,491 As of June 30, 2019, the Company had $225,120 in future lease payments for the year ending June 30, 2020 under ASC Topic 840. |
ACCRUED EXPENSES
ACCRUED EXPENSES | 9 Months Ended |
Mar. 31, 2020 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES | Accrued expenses March 31, June 30, 2020 2019 Clinical / Regulatory costs $ 725,858 $ 943,721 Other research related expenses 799,755 1,361,414 Professional services 32,000 317,500 Other 99,624 226,057 $ 1,657,237 $ 2,848,692 |
NOTES PAYABLE
NOTES PAYABLE | 9 Months Ended |
Mar. 31, 2020 | |
Notes Payable [Abstract] | |
NOTES PAYABLE | Notes payable consist of the following: June 30, 2019 Notes payable under venture loan $ 333,333 Unamortized related debt discount (295 ) Unamortized debt issuance costs (142 ) Notes payable 332,896 Less: current portion 332,896 Long-term portion $ - On December 23, 2014, the Company closed on a $10,000,000 venture loan which was led by Horizon Technology Finance Corporation (“Horizon”). The debt facility was a four-year senior secured term loan that bore interest at a floating coupon rate of one-month LIBOR (floor of 0.50%) plus 8.50%, and provided for interest-only payments for the first eighteen months followed by monthly payments of principal of $333,333 plus accrued interest through January 1, 2019. The lenders also received five-year immediately exercisable Series D 2014 warrants to purchase 666,666 shares of common stock exercisable at an exercise price of $0.75 per share. The Company recorded a debt discount of $267,820 equal to the fair value of these warrants at issuance, which was amortized to interest expense over the term of the related debt. This debt discount was offset against the note payable balance and included in additional paid-in capital on the Company’s balance sheet. In addition, a final incremental payment of $500,000 was due on January 1, 2019, or upon early repayment of the loan. This final incremental payment was accreted to interest expense over the term of the related debt and included in other liabilities on the consolidated balance sheet. The Company incurred $209,367 of costs in connection with the loan. These costs were capitalized as deferred financing costs and were offset against the note payable balance. These debt issuance costs were amortized to interest expense over the term of the related debt. During the three months ended December 31, 2018, the loan matured, and on December 31, 2018, the Company made the final incremental payment of $500,000. On July 2, 2015, the Company closed on a $10,000,000 venture loan led by Horizon. The debt facility was a four-year senior secured term loan that bore interest at a floating coupon rate of one-month LIBOR (floor of 0.50%) plus 8.50% and provided for interest-only payments for the first eighteen months followed by monthly payments of principal of $333,333 plus accrued interest through August 1, 2019. The lenders also received five-year immediately exercisable Series G warrants to purchase 549,450 shares of the Company’s common stock exercisable at an exercise price of $0.91 per share. The Company recorded a debt discount of $305,196 equal to the fair value of these warrants at issuance, which were amortized to interest expense over the term of the related debt. This debt discount was offset against the note payable balance and was included in additional paid-in capital on the Company’s balance sheet. In addition, a final incremental payment of $500,000 was due on August 1, 2019. This final incremental payment was accreted to interest expense over the term of the related debt and was included in other current liabilities on the consolidated balance sheet. The Company incurred $146,115 of costs in connection with the loan agreement. These costs were capitalized as deferred financing costs and were offset against the note payable balance. These debt issuance costs were amortized to interest expense over the term of the related debt. During the nine months ended March 31, 2020, the loan matured, and on July 31, 2019, the Company made the final incremental payment of $500,000. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 9 Months Ended |
Mar. 31, 2020 | |
Stockholders' equity: | |
STOCKHOLDERS' EQUITY | Financing Transactions – For the nine months ended March 31, 2020, 1,895,934 shares of common stock were sold through Canaccord under the 2019 Equity Distribution Agreement for net proceeds of $1,581,498 after payment of commission fees of $51,696 and other related expenses of $90,000. From inception of the 2019 Equity Distribution Agreement through March 31, 2020, a total of 9,460,509 shares of common Stock were sold for net proceeds of $11,870,334 after payment of commission fees of $369,907 and other related expenses of $90,000. For nine months ended March 31, 2019, 2,256,445 shares of the Company’s common stock were sold through Canaccord under the 2018 Equity Distribution Agreement for net proceeds of $2,252,808 after payment of commission fees of $69,674. From inception of the 2018 Equity Distribution Agreement through June 26, 2019, a total of 18,504,993 shares of common Stock were sold for net proceeds of $24,249,997 after payment of commission fees of $750,000, and the 2018 Equity Distribution Agreement is deemed completed. Stock Purchase Warrants During the nine months ended March 31, 2020, the Company entered into several warrant termination agreements to repurchase and cancel the following previously issued Series F, Series H and Series J warrants for the following aggregate buyback prices, plus additional consideration upon any sale of the Company within six months of the respective agreement: Nine months ended March 31, 2020 Warrants Buyback price Series F Warrants 297,352 $ 62,712 Series H Warrants 1,466,432 577,373 Series J Warrants 4,774,889 1,907,381 6,538,673 $ 2,547,466 During the nine months ended March 31, 2020, the Company issued 26,861 shares of common stock upon the cashless exercise provisions of 666,666 Series D warrants at an exercise price of $0.75 per share. Stock Options – In July 2018, the terms of certain options were modified to accelerate vesting and extend the option exercise period. As a result, the Company recorded additional stock-based compensation of $109,004 during the nine months ended March 31, 2019. A summary of stock option activity is as follows: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Term in Years Aggregate Intrinsic Value Outstanding - June 30, 2019 14,435,650 0.85 7.3 Granted 104,500 0.58 Forfeited (104,537 ) 1.03 Exercised - - Expired (77,100 ) 2.72 Outstanding - March 31, 2020 14,358,513 $ 0.84 6.6 $ 146,877 Exercisable at March 31, 2020 9,038,250 $ 0.77 5.6 $ 84,309 Expected to vest at March 31, 2020 5,320,263 $ 0.94 8.3 $ 62,568 Stock options granted to the Company’s executive officers and employees generally vest over a 48-month period, while stock options granted to its non-employee directors vest over a 12-month period. Included in the options outstanding above are 1,075,000 and 117,500 performance-based options granted in December 2017 to executive officers and employees, respectively, which vest during a performance period ending on December 31, 2020, if and upon either i) as to 100% of the target number of shares upon achievement of a closing price for the Company’s common stock equal to or greater than $1.50 per share for 20 consecutive trading days, which is considered a market condition; or ii) as to thirty percent (30%) of the target number of shares, upon the acceptance for filing by the FDA of an NDA for Vyleesi for HSDD in premenopausal women during the performance period, which is considered a performance condition; iii) as to fifty percent (50%) of the target number of shares, upon the approval by the FDA of an NDA for Vyleesi for HSDD in premenopausal women during the performance period, which is also considered a performance condition; iv) as to twenty percent (20%) of the target number of shares, upon entry into a licensing agreement during the performance period for the commercialization of Vyleesi for FSD in at least two of the following geographic areas (a) four or more countries in Europe, (b) Japan, (c) two or more countries in Central and/or South America, (d) two or more countries in Asia, excluding Japan and China, and (e) Australia, which is also considered a performance condition. The fair value of these options was $602,760. The Company amortized the fair value over the derived service period of 1.1 years or upon the attainment of the performance condition. Pursuant to the FDA acceptance of the NDA filing of Vyleesi, 30% of the target number of options vested in June 2018 and 50% of the target number of options vested in June 2019 upon FDA approval of Vyleesi. Restricted Stock Units – A summary of restricted stock unit activity is as follows: RSUs Outstanding at July 1, 2019 10,327,833 Granted - Forfeited (123,438 ) Vested (612,275 ) Outstanding at March 31, 2020 9,592,120 Included in outstanding restricted stock units in the table above are 6,079,250 vested shares that have not been issued as of March 31, 2020 due to a provision in the restricted stock unit agreements to delay delivery. Time-based restricted stock units granted to the Company’s executive officers, employees and non-employee directors generally vest over 24 months, 48 months and 12 months, respectively. In June 2019, the Company granted 438,000 performance-based restricted stock units to its executive officers and 182,725 performance-based restricted stock units to other employees which vest during a performance period ending June 24, 2023. The performance-based restricted stock units vest on performance criteria relating to advancement of MC1r programs, including initiation of clinical trials and licensing of Vyleesi in additional countries or regions. In December 2017, the Company granted 1,075,000 performance-based restricted stock units to its executive officers and 670,000 performance-based restricted stock units to other employees which vest during a performance period, ending on December 31, 2020, if and upon either i) as to 100% of the target number of shares upon achievement of a closing price for the Company’s common stock equal to or greater than $1.50 per share for 20 consecutive trading days, which is considered a market condition; or ii) as to thirty percent (30%) of the target number of shares, upon the acceptance for filing by the FDA of an NDA for Vyleesi for HSDD in premenopausal women during the performance period, which is considered a performance condition; iii) as to fifty percent (50%) of the target number of shares, upon the approval by the FDA of an NDA for Vyleesi for HSDD in premenopausal women during the performance period, which is also considered a performance condition; iv) as to twenty percent (20%) of the target number of shares, upon entry into a licensing agreement during the performance period for the commercialization of Vyleesi for FSD in at least two of the following geographic areas (a) four or more countries in Europe, (b) Japan, (c) two or more countries in Central and/or South America, (d) two or more countries in Asia, excluding Japan and China, and (e) Australia, which is also considered a performance condition. The fair value of these awards was $913,750 and $569,500, respectively. The Company amortized the fair value over the derived service period of 1.1 years or upon the attainment of the performance condition. Pursuant to the FDA acceptance of the NDA filing for Vyleesi, 30% of the target number of shares vested in June 2018. Pursuant to the FDA approval of Vyleesi, 50% of the target number of shares vested in June 2019. |
ORGANIZATION (Policies)
ORGANIZATION (Policies) | 9 Months Ended |
Mar. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Business | Nature of Business Melanocortin Receptor System. The Company’s lead product, Vyleesi®, was approved by the U.S. Food and Drug Administration (“FDA”) in June 2019 and is currently being marketed in North America by AMAG Pharmaceuticals, Inc. (“AMAG”) for the treatment of hypoactive sexual desire disorder (“HSDD”) in premenopausal women. As disclosed in Note 5, AMAG has announced its plan to divest Vyleesi and another product. The Company’s new product development activities focus primarily on MC1r agonists, with potential to treat inflammatory and autoimmune diseases such as dry eye disease, which is also known as keratoconjunctivitis sicca, uveitis, diabetic retinopathy and inflammatory bowel disease. The Company believes that the MC1r agonist peptides in development have broad anti-inflammatory effects and appear to utilize mechanisms engaged by the endogenous melanocortin system in regulation of the immune system and resolution of inflammatory responses. The Company is also developing peptides that are active at more than one melanocortin receptor, and MC4r peptide and small molecule agonists with potential utility in obesity and metabolic-related disorders, including rare disease and orphan indications. Natriuretic Peptide Receptor System |
Business Risks and Liquidity | Business Risks and Liquidity – As of March 31, 2020, the Company’s cash and cash equivalents were $88,947,368 and current liabilities were $3,358,830. Management intends to utilize existing capital resources for general corporate purposes and working capital, including preclinical and clinical development of the Company’s MC1r and MC4r peptide programs and natriuretic peptide program, and development of other portfolio products. Management believes that the Company’s existing capital resources will be adequate to fund the Company’s planned operations through at least March 31, 2022. The Company will need additional funding to complete required clinical trials for its other product candidates and, assuming those clinical trials are successful, as to which there can be no assurance, to complete submission of required applications to the FDA. If the Company is unable to obtain approval or otherwise advance in the FDA approval process, the Company’s ability to sustain its operations could be materially adversely affected. The Company may seek the additional capital necessary to fund its operations through public or private equity offerings, collaboration agreements, debt financings or licensing arrangements. Additional capital that is required by the Company may not be available on reasonable terms, or at all. In March 2020, the World Health Organization declared COVID-19, a disease caused by a novel strain of coronavirus, a pandemic. The Company has taken steps to ensure the safety and well-being of its employees and clinical trial patients to comply with guidance from federal, state and local authorities, while working to ensure the sustainability of its business operations as this unprecedented situation continues to evolve. In mid-March, the Company transitioned to a company-wide work from home policy. Business-critical activities continue to be subject to heightened precautions to ensure safety of employees. The Company continues to assess its policies, business continuity plans and employee support. The Company continues to evaluate the impact of COVID-19 on the healthcare system and work with contract research organizations supporting its clinical, research, and development programs to mitigate risk to patients and its business and community partners, taking into account regulatory, institutional, and government guidance and policies. The Company receives a royalty on sales of Vyleesi by our licensees. AMAG is currently selling Vyleesi in the United States, and Fosun and Kwangdong have licenses to sell Vyleesi in China and Korea, respectively. The Company does not know the effect of the COVID-19 coronavirus on sales of Vyleesi in the United States, but it could have a negative impact on sales, which would adversely impact royalty revenues. The COVID-19 coronavirus could adversely impact the time required to obtain regulatory approvals to sell Vyleesi in China and Korea, which would delay when the Company receives royalty income from sales in those countries. The Company cannot be certain what the overall impact of the COVID-19 pandemic will be on its business and it has the potential to materially adversely affect its business, financial condition and results of operations and cashflows during fiscal year 2020 and beyond. |
Concentrations | Concentrations – |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Mar. 31, 2020 | |
Accounting Policies [Abstract] | |
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. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the 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 $88,736,048 and $43,381,556 in a money market account at March 31, 2020 and June 30, 2019, respectively. |
Fair Value of Financial Instruments | The Company’s financial instruments consist primarily of cash equivalents, accounts receivable and accounts payable. Management believes that the carrying values of cash equivalents, accounts receivable and accounts payable are representative of their respective fair values based on the short-term nature of these instruments. |
Credit Risk | Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. Total cash and cash equivalent balances have exceeded balances insured by the Federal Depository Insurance Company (“FDIC”). |
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. Accumulated depreciation and amortization was $2,439,403 and $2,388,644 as of March 31, 2020 and June 30, 2019, respectively. |
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. |
Revenue Recognition | In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers On July 1, 2018, the Company adopted ASC Topic 606 using the modified retrospective approach, a practical expedient permitted under ASC Topic 606, and applied this approach only to contracts that were not completed as of July 1, 2018. For licenses of intellectual property, the Company assesses, at contract inception, whether the intellectual property is distinct from other performance obligations identified in the arrangement. If the licensing of intellectual property is determined to be distinct, revenue is recognized for nonrefundable, upfront license fees when the license is transferred to the customer and the customer can use and benefit from the license. If the licensing of intellectual property is determined not to be distinct, then the license will be bundled with other promises in the arrangement into one performance obligation. The Company needs to determine if the bundled performance obligation is satisfied over time or at a point in time. If the Company concludes that the nonrefundable, upfront license fees will be recognized over time, the Company will need to assess the appropriate method of measuring proportional performance. Regulatory milestone payments are excluded from the transaction price due to the inability to estimate the probability of reversal. Revenue relating to achievement of these milestones is recognized in the period in which the milestone is achieved. Sales-based royalty and milestone payments resulting from customer contracts solely or predominately for the license of intellectual property will only be recognized upon occurrence of the underlying sale or achievement of the sales milestone and such sales-based royalties and milestone payments are recognized in the same period earned. The Company recognizes revenue for reimbursements of research and development costs under collaboration agreements as the services are performed. The Company records these reimbursements as revenue and not as a reduction of research and development expenses as the Company is the principal in the research and development activities based upon its control of such activities, which is considered part of its ordinary activities. Development milestone payments are generally due 30 business days after the milestone is achieved. Sales milestone payments are generally due 45 business days after the calendar year in which the sales milestone is achieved. Royalty payments are generally due on a quarterly basis 20 business days after being invoiced. |
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 the Company’s development activities. The Company reviews the activities performed under all contracts each quarter and accrues expenses and the amount of any reimbursement to be received from its 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 the Company does not identify services performed for it but not billed by the service-provider, or if it underestimates or overestimates 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. Compensation costs for stock-based awards with time-based vesting are determined using the quoted market price of the Company’s common stock on the date of grant or for stock options, the value determined utilizing the Black-Scholes option pricing model, and are recognized on a straight-line basis, while awards containing a market condition are valued using multifactor Monte Carlo simulations. Compensation costs for awards containing a performance condition are determined using the quoted price of the Company’s common stock on the date of grant or for stock options, the value is determined utilizing the Black Scholes option pricing model, and are recognized based on the probability of achievement of the performance condition over the service period. Forfeitures are recognized as they occur. |
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 and continues to maintain a full valuation allowance against its deferred tax assets based on the history of losses incurred and lack of experience projecting future sales-based royalty and milestone payments. |
Net Loss per Common Share | Basic and diluted loss per common share (“EPS”) are calculated in accordance with the provisions of FASB Accounting Standards Codification (“ASC”) Topic 260, Earnings per Share For the three and nine months ended March 31, 2020 and 2019, no additional common shares were added to the computation of diluted EPS because to do so would have been anti-dilutive. The potential number of common shares excluded from diluted EPS during the three and nine months ended March 31, 2020 and 2019 was 33,166,477 and 40,819,113 respectively. Included in the weighted average common shares used in computing basic and diluted net loss per common share are 6,079,250 and 3,952,875 vested restricted stock units that had not been issued as of March 31, 2020 and 2019, respectively, due to a provision in the restricted stock unit agreements to delay delivery. |
PREPAID EXPENSES AND OTHER CU_2
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables) | 9 Months Ended |
Mar. 31, 2020 | |
Prepaid Expense and Other Assets, Current [Abstract] | |
Schedule of prepaid expenses and other current assets | March 31 June 30, 2020 2019 Clinical / Regulatory costs $ 97,020 $ 61,798 Insurance premiums 8,090 87,937 Other 570,333 487,554 $ 675,443 $ 637,289 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 9 Months Ended |
Mar. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Schedule of assets at fair value | Carrying Value Quoted prices in active markets(Level 1) Other quoted/observable inputs (Level 2) Significant unobservable inputs(Level 3) March 31, 2020: Money Market Account $ 88,736,048 $ 88,736,048 $ - $ - June 30, 2019: Money Market Account $ 43,381,556 $ 43,831,556 $ - $ - |
LEASES (Tables)
LEASES (Tables) | 9 Months Ended |
Mar. 31, 2020 | |
Leases [Abstract] | |
Schedule of lease cost | Lease cost Three months ended March 31, 2020 Nine months ended March 31, 2020 Operating lease cost $ 53,454 $ 152,712 Variable lease cost 17,824 53,473 Short-term lease cost 3,600 15,720 Total lease cost $ 74,878 $ 221,905 |
Supplemental information related to leases | Supplemental balance sheet information related to leases was as follows: March 31, 2020 Operating lease ROU asset and liability $ 98,491 Supplemental lease term and discount rate information related to leases was as follows: Weighted-average remaining lease term (years) 0.5 Weighted-average discount rate 6.25 % Supplemental cash flow information related to leases was as follows: Three months ended March 31, 2020 Nine months ended March 31, 2020 Cash paid for the amounts included in the measurement of lease liabilities: Operating cash flows for operating leases $ 77,096 $ 226,031 Supplemental non-cash information on lease liabilities arisng from obtaining right-of-use assets: Right-of-use assets obtained in exchange for new lease obligation $ - $ 93,435 |
Summary of operating lease liability maturity | March 31, 2020 Year Ending June 30 2020 $ 77,097 2021 18,360 2022 4,590 Less imputed interest (1,556 ) Total $ 98,491 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 9 Months Ended |
Mar. 31, 2020 | |
Payables and Accruals [Abstract] | |
Schedule of accrued expenses | March 31, June 30, 2020 2019 Clinical / Regulatory costs $ 725,858 $ 943,721 Other research related expenses 799,755 1,361,414 Professional services 32,000 317,500 Other 99,624 226,057 $ 1,657,237 $ 2,848,692 |
NOTES PAYABLE (Tables)
NOTES PAYABLE (Tables) | 9 Months Ended |
Mar. 31, 2020 | |
Notes Payable [Abstract] | |
Summary of notes payable | June 30, 2019 Notes payable under venture loan $ 333,333 Unamortized related debt discount (295 ) Unamortized debt issuance costs (142 ) Notes payable 332,896 Less: current portion 332,896 Long-term portion $ - |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 9 Months Ended |
Mar. 31, 2020 | |
Stockholders' equity: | |
Schedule of warrant buybacks | Nine months ended March 31, 2020 Warrants Buyback price Series F Warrants 297,352 $ 62,712 Series H Warrants 1,466,432 577,373 Series J Warrants 4,774,889 1,907,381 6,538,673 $ 2,547,466 |
Schedule of option activity | Number of Shares Weighted Average Exercise Price Weighted Average Remaining Term in Years Aggregate Intrinsic Value Outstanding - June 30, 2019 14,435,650 0.85 7.3 Granted 104,500 0.58 Forfeited (104,537 ) 1.03 Exercised - - Expired (77,100 ) 2.72 Outstanding - March 31, 2020 14,358,513 $ 0.84 6.6 $ 146,877 Exercisable at March 31, 2020 9,038,250 $ 0.77 5.6 $ 84,309 Expected to vest at March 31, 2020 5,320,263 $ 0.94 8.3 $ 62,568 |
Schedule of restricted stock unit activity | RSUs Outstanding at July 1, 2019 10,327,833 Granted - Forfeited (123,438 ) Vested (612,275 ) Outstanding at March 31, 2020 9,592,120 |
ORGANIZATION (Details Narrative
ORGANIZATION (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | ||||
Mar. 31, 2020 | Mar. 31, 2019 | Mar. 31, 2020 | Mar. 31, 2019 | Jun. 30, 2019 | Jun. 30, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||||
Accumulated deficit | $ 310,899,730 | $ 310,899,730 | $ 295,772,879 | |||
Net (loss) income | (5,382,275) | $ (5,727,130) | (15,126,851) | $ (16,451,536) | ||
Cash and cash equivalents | 88,947,368 | 19,813,349 | 88,947,368 | 19,813,349 | 43,510,422 | $ 38,000,171 |
Current liabilities | 3,358,830 | 3,358,830 | $ 4,185,892 | |||
License and contract revenue | $ 0 | $ 0 | $ 117,989 | $ 34,505 |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Mar. 31, 2020 | Mar. 31, 2019 | Mar. 31, 2020 | Mar. 31, 2019 | Jun. 30, 2019 | |
Accounting Policies [Abstract] | |||||
Cash equivalents | $ 88,736,048 | $ 88,736,048 | $ 43,381,556 | ||
Accumulated depreciation and amortization | $ 2,439,403 | $ 2,439,403 | $ 2,388,644 | ||
Potential number of common shares excluded from diluted EPS | 33,166,477 | 40,819,113 | 33,166,477 | 40,819,113 |
PREPAID EXPENSES AND OTHER CU_3
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Details) - USD ($) | Mar. 31, 2020 | Jun. 30, 2019 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Clinical/regulatory costs | $ 97,020 | $ 61,798 |
Insurance premiums | 8,090 | 87,937 |
Other | 570,333 | 487,554 |
Total prepaid expenses and other current assets | $ 675,443 | $ 637,289 |
FAIR VALUE MEASUREMENTS (Detail
FAIR VALUE MEASUREMENTS (Details) - USD ($) | Mar. 31, 2020 | Jun. 30, 2019 |
Money market account | $ 88,736,048 | $ 43,381,556 |
Level 1 | ||
Money market account | 88,736,048 | 43,381,556 |
Level 2 | ||
Money market account | 0 | 0 |
Level 3 | ||
Money market account | $ 0 | $ 0 |
LEASES (Details)
LEASES (Details) - USD ($) | 3 Months Ended | 9 Months Ended |
Mar. 31, 2020 | Mar. 31, 2020 | |
Leases [Abstract] | ||
Operating lease cost | $ 53,454 | $ 152,712 |
Variable lease cost | 17,824 | 53,473 |
Short-term lease cost | 3,600 | 15,720 |
Total lease cost | $ 74,878 | $ 221,905 |
LEASES (Details 1)
LEASES (Details 1) - USD ($) | 3 Months Ended | 9 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2020 | Jun. 30, 2019 | |
Leases [Abstract] | |||
Operating lease ROU asset and liability | $ 98,491 | $ 98,491 | $ 0 |
Weighted -average remaining lease term (years) | 6 months | 6 months | |
Weighted -average discount rate | 6.25% | 6.25% | |
Operating cash flows for operating leases | $ 77,096 | $ 226,031 | |
Right-of-use assets obtained in exchange for new lease obligation | $ 0 | $ 93,435 |
LEASES (Details 2)
LEASES (Details 2) | Mar. 31, 2020USD ($) |
Leases [Abstract] | |
Year ending June 30, 2020 | $ 77,097 |
Year ending June 30, 2021 | 18,360 |
Year ending June 30, 2022 | 4,590 |
Less imputed interest | (1,556) |
Total | $ 98,491 |
LEASES (Details Narrative)
LEASES (Details Narrative) | Jun. 30, 2019USD ($) |
Leases [Abstract] | |
Future lease payments for the year ending June 30, 2020 | $ 225,120 |
ACCRUED EXPENSES (Details)
ACCRUED EXPENSES (Details) - USD ($) | Mar. 31, 2020 | Jun. 30, 2019 |
Payables and Accruals [Abstract] | ||
Clinical/regulatory costs | $ 725,858 | $ 943,721 |
Other research related expenses | 799,755 | 1,361,414 |
Professional services | 32,000 | 317,500 |
Other | 99,624 | 226,057 |
Accrued expenses | $ 1,657,237 | $ 2,848,692 |
NOTES PAYABLE (Details)
NOTES PAYABLE (Details) - USD ($) | Mar. 31, 2020 | Jun. 30, 2019 |
Notes Payable [Abstract] | ||
Notes payable under venture loan | $ 333,333 | |
Unamortized related debt discount | (295) | |
Unamortized debt issuance costs | (142) | |
Notes payable | 332,896 | |
Less: current portion | $ 0 | 332,896 |
Long-term portion | $ 0 |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) | 9 Months Ended |
Mar. 31, 2020USD ($)shares | |
Warrants | shares | 6,538,673 |
Buyback price | $ | $ 2,547,466 |
Series F Warrants | |
Warrants | shares | 297,352 |
Buyback price | $ | $ 62,712 |
Series H Warrants | |
Warrants | shares | 1,466,432 |
Buyback price | $ | $ 577,373 |
Series J Warrants | |
Warrants | shares | 4,774,889 |
Buyback price | $ | $ 1,907,381 |
STOCKHOLDERS' EQUITY (Details 1
STOCKHOLDERS' EQUITY (Details 1) | 9 Months Ended |
Mar. 31, 2020USD ($)$ / sharesshares | |
Stockholders' equity: | |
Number of options outstanding, beginning | shares | 14,435,650 |
Number of options granted | shares | 104,500 |
Number of options forfeited | shares | (104,537) |
Number of options exercised | shares | 0 |
Number of options expired | shares | (77,100) |
Number of options outstanding, ending | shares | 14,358,513 |
Number of options exercisable | shares | 9,038,250 |
Number of options expected to vest | shares | 5,320,263 |
Weighted average exercise price outstanding, beginning | $ / shares | $ .85 |
Weighted average exercise price granted | $ / shares | 0.58 |
Weighted average exercise price forfeited | $ / shares | 1.03 |
Weighted average exercise price exercised | $ / shares | 0 |
Weighted average exercise price expired | $ / shares | 2.72 |
Weighted average exercise price outstanding, ending | $ / shares | 0.84 |
Weighted average exercise price exercisable | $ / shares | 0.77 |
Weighted average exercise price options expected to vest | $ / shares | $ 0.94 |
Weighted average remaining term in years options outstanding at beginning of year | 7 years 3 months 18 days |
Weighted average remaining term in years options outstanding at end of year | 6 years 7 months 6 days |
Weighted average remaining term in years options exercisable at end of year | 5 years 7 months 6 days |
Weighted average remaining term in years options expected to vest | 8 years 3 months 18 days |
Aggregate intrinsic value options outstanding | $ | $ 146,877 |
Aggregate intrinsic value options exercisable | $ | 84,309 |
Aggregate intrinsic value options expected to vest | $ | $ 62,568 |
STOCKHOLDERS' EQUITY (Details 2
STOCKHOLDERS' EQUITY (Details 2) | 9 Months Ended |
Mar. 31, 2020shares | |
Stockholders' equity: | |
Outstanding at beginning of year | 10,327,833 |
Granted | 0 |
Forfeited | (123,438) |
Vested | (612,275) |
Outstanding at end of year | 9,592,120 |
STOCKHOLDERS' EQUITY (Details N
STOCKHOLDERS' EQUITY (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2020 | Mar. 31, 2019 | Mar. 31, 2020 | Mar. 31, 2019 | |
Stockholders' equity: | ||||
Stock based compensation, options | $ 348,880 | $ 244,528 | $ 1,027,604 | $ 885,935 |
Additional stock based compensation, options | 109,004 | |||
Stock based compensation, restricted stock units | $ 353,246 | $ 409,871 | $ 1,307,193 | $ 1,871,839 |