Cover
Cover - USD ($) | 12 Months Ended | ||
Jun. 30, 2022 | Sep. 21, 2022 | Dec. 31, 2021 | |
Cover [Abstract] | |||
Entity Registrant Name | PALATIN TECHNOLOGIES, INC. | ||
Entity Central Index Key | 0000911216 | ||
Document Type | 10-K | ||
Amendment Flag | false | ||
Entity Voluntary Filers | No | ||
Current Fiscal Year End Date | --06-30 | ||
Entity Well Known Seasoned Issuer | No | ||
Entity Small Business | true | ||
Entity Shell Company | false | ||
Entity Emerging Growth Company | false | ||
Entity Current Reporting Status | Yes | ||
Document Period End Date | Jun. 30, 2022 | ||
Entity Filer Category | Non-accelerated Filer | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2022 | ||
Entity Common Stock Shares Outstanding | 9,290,481 | ||
Entity Public Float | $ 115,996,632 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity File Number | 001-15543 | ||
Entity Incorporation State Country Code | DE | ||
Entity Tax Identification Number | 95-4078884 | ||
Entity Address Address Line 1 | 4B Cedar Brook Drive | ||
Entity Address City Or Town | Cranbury | ||
Entity Address State Or Province | NJ | ||
Entity Address Postal Zip Code | 08512 | ||
City Area Code | 609 | ||
Icfr Auditor Attestation Flag | false | ||
Auditor Name | KPMG LLP | ||
Auditor Location | Philadelphia, Pennsylvania | ||
Local Phone Number | 495‑2200 | ||
Security 12b Title | Common Stock, par value $.01 per share | ||
Trading Symbol | PTN | ||
Security Exchange Name | NYSE | ||
Entity Interactive Data Current | Yes | ||
Auditor Firm Id | 185 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Jun. 30, 2022 | Jun. 30, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 29,939,154 | $ 60,104,919 |
Accounts receivable | 1,780,020 | 1,580,443 |
Inventories | 944,471 | 1,162,000 |
Prepaid expenses and other current assets | 1,932,454 | 3,059,679 |
Total current assets | 34,596,099 | 65,907,041 |
Property and equipment, net | 539,314 | 94,817 |
Right-of-use assets - operating leases | 878,465 | 1,237,813 |
Other assets | 56,916 | 56,916 |
Total assets | 36,070,794 | 67,296,587 |
Current liabilities: | ||
Accounts payable | 3,157,617 | 640,650 |
Accrued expenses | 6,875,216 | 5,797,378 |
Short-term operating lease liabilities | 371,124 | 351,853 |
Short-term finance lease liabilities | 100,921 | 0 |
Other current liabilities | 5,754,986 | 3,721,907 |
Total current liabilities | 16,259,864 | 10,511,788 |
Long-term operating lease liabilities | 529,398 | 900,520 |
Long-term finance lease liabilities | 152,407 | 0 |
Other long-term liabilities | 2,861,250 | 6,232,907 |
Total liabilities | 19,802,919 | 17,645,215 |
Escrowed proceeds | (15,000,000) | 0 |
Stockholders' equity: | ||
Preferred stock of $0.01 par value - authorized 10,000,000 shares: (including amounts authorized for Series B and Series C Redeemable Preferred stock) shares issued and outstanding designated as follows: Series A Convertible: authorized 4,030 as of June 30, 2022: issued and outstanding 4,030 shares as of June 30, 2022 and June 30, 2021 | 40 | 40 |
Common stock of $0.01 par value - authorized 300,000,000 shares: issued and outstanding 9,270,947 shares as of June 30, 2022 and 9,201,988 shares as of June 30, 2021 (Note 1) | 92,709 | 92,020 |
Additional paid-in capital | 404,168,822 | 401,354,709 |
Accumulated deficit | (387,993,696) | (351,795,397) |
Total stockholders' equity | 16,267,875 | 49,651,372 |
Total liabilities, redeemable convertible preferred stock, and stockholders' equity | 36,070,794 | 67,296,587 |
Series B And Series C Preferred Stock | ||
Stockholders' equity: | ||
Preferred stock of $0.01 par value - authorized 10,000,000 shares: (including amounts authorized for Series B and Series C Redeemable Preferred stock) shares issued and outstanding designated as follows: Series A Convertible: authorized 4,030 as of June 30, 2022: issued and outstanding 4,030 shares as of June 30, 2022 and June 30, 2021 | $ 15,000,000 | $ 0 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2022 | Jun. 30, 2021 |
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, Series A, 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 | 9,270,947 | 9,201,988 |
Common stock, shares outstanding | 9,270,947 | 9,201,988 |
Series B And Series C Preferred Stock | ||
Preferred stock, par value | $ 0.01 | |
Preferred stock, shares authorized | 9,000,000 | |
Preferred stock, Series A, shares issued | 9,000,000 | |
Preferred stock, Series A Convertible, shares outstanding | 9,000,000 | |
Preferred stock, liquidation | 15,000,000 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
REVENUES | ||
Product revenue, net | $ 1,218,457 | $ (283,286) |
License and contract | 250,000 | 94,689 |
Total revenues | 1,468,457 | (188,597) |
OPERATING EXPENSES | ||
Cost of products sold | 217,529 | 147,840 |
Research and development | 21,327,434 | 12,926,559 |
Selling, general and administrative | 16,511,942 | 17,336,913 |
Loss on license termination agreement | 0 | 2,784,192 |
Total operating expenses | 38,056,905 | 33,195,504 |
Loss from operations | (36,588,448) | (33,384,101) |
OTHER INCOME (EXPENSE) | ||
Investment income | 29,963 | 23,572 |
Foreign currency gain (loss) | 389,868 | (212,526) |
Interest expense | (29,682) | (23,440) |
Total other income (expense), net | 390,149 | (212,394) |
NET LOSS | $ (36,198,299) | $ (33,596,495) |
Basic and diluted net loss per common share | (379) | (355) |
Weighted average number of common shares outstanding used in computing basic and diluted net loss per common share (Note 1) | $ 9,543,762 | $ 9,466,004 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Redeemable Convertible Preferred Stock and Stockholders Equity - USD ($) | Total | Common Stock | Escrow Proceeds | Additional Paid-In Capital | Retained Earnings (Accumulated Deficit) | Preferred Stock Series B | Preferred Stock Series C | Preferred Stock Series A |
Balance, shares at Jun. 30, 2020 | 9,170,336 | 4,030 | ||||||
Balance, amount at Jun. 30, 2020 | $ 80,172,849 | $ 91,704 | $ 0 | $ 398,280,007 | $ (318,198,902) | $ 0 | $ 0 | $ 40 |
Stock-based compensation, shares | 38,323 | |||||||
Stock-based compensation, amount | 3,168,656 | $ 383 | 0 | 3,168,273 | 0 | 0 | 0 | 0 |
Withholding taxes related to restricted stock units, shares | (6,671) | |||||||
Withholding taxes related to restricted stock units, amount | (93,638) | $ (67) | 0 | (93,571) | 0 | 0 | 0 | 0 |
Net loss | (33,596,495) | $ 0 | 0 | 0 | (33,596,495) | 0 | 0 | $ 0 |
Balance, shares at Jun. 30, 2021 | 9,201,988 | 4,030 | ||||||
Balance, amount at Jun. 30, 2021 | 49,651,372 | $ 92,020 | 0 | 401,354,709 | (351,795,397) | 0 | 0 | $ 40 |
Stock-based compensation, shares | 69,406 | |||||||
Stock-based compensation, amount | 2,505,538 | $ 694 | 0 | 2,504,844 | 0 | 0 | 0 | 0 |
Withholding taxes related to restricted stock units, shares | (16,191) | |||||||
Withholding taxes related to restricted stock units, amount | (221,311) | $ (162) | 0 | (221,149) | 0 | 0 | 0 | 0 |
Net loss | (36,198,299) | 0 | 0 | 0 | (36,198,299) | $ 0 | $ 0 | 0 |
Issuance of Redeemable Convertible Preferred stock and warrants, shares | 8,100,000 | 900,000 | ||||||
Issuance of Redeemable Convertible Preferred stock and warrants, amount | $ 234,443 | $ 0 | (15,000,000) | 234,443 | 0 | $ 13,500,000 | $ 1,500,000 | 0 |
Warrant exercises, shares | 1,744 | 14,000 | ||||||
Warrant exercises, amount | $ 280,000 | $ 140 | 0 | 279,860 | 0 | 0 | 0 | 0 |
Option exercises, shares | 1,744 | |||||||
Option exercises, amount | 16,132 | $ 17 | 0 | 16,115 | 0 | $ 0 | $ 0 | $ 0 |
Balance, shares at Jun. 30, 2022 | 9,270,947 | 8,100,000 | 900,000 | 4,030 | ||||
Balance, amount at Jun. 30, 2022 | $ 16,267,875 | $ 92,709 | $ (15,000,000) | $ 404,168,822 | $ (387,993,696) | $ 13,500,000 | $ 1,500,000 | $ 40 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (36,198,299) | $ (33,596,495) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 126,668 | 51,121 |
Cash received in excess of loss on termination agreement | 0 | 19,084,192 |
Decrease in right-of-use asset | 359,348 | 330,839 |
Unrealized foreign currency transaction (gain) loss | (389,868) | 212,526 |
Non-cash warrant expense | 234,443 | 0 |
Stock-based compensation | 2,505,538 | 3,168,656 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (199,577) | (1,580,443) |
Prepaid expenses and other assets | 1,127,225 | (1,938,130) |
Inventories | 217,529 | (987,237) |
Accounts payable | 2,572,657 | (75,022) |
Accrued expenses | 1,077,838 | 558,281 |
Operating lease liabilities | (351,851) | (316,279) |
Other liabilities | (1,004,400) | (7,560,000) |
Net cash used in operating activities | (29,922,749) | (22,647,991) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of property and equipment | (261,374) | (5,722) |
Net cash used in investing activities | (261,374) | (5,722) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Payment of withholding taxes related to restricted stock units | (221,311) | (93,638) |
Payment of finance lease obligations | (56,463) | 0 |
Proceeds from exercise of warrants | 280,000 | 0 |
Proceeds from exercise of stock options | 16,132 | 0 |
Net cash provided by (used in) financing activities | 18,358 | (93,638) |
NET DECREASE IN CASH AND CASH EQUIVALENTS | (30,165,765) | (22,747,351) |
CASH AND CASH EQUIVALENTS, beginning of year | 60,104,919 | 82,852,270 |
CASH AND CASH EQUIVALENTS, end of year | 29,939,154 | 60,104,919 |
SUPPLEMENTAL CASH FLOW INFORMATION: | ||
Cash paid for interest | $ 29,682 | $ 23,440 |
ORGANIZATION
ORGANIZATION | 12 Months Ended |
Jun. 30, 2022 | |
ORGANIZATION | |
ORGANIZATION | (1) ORGANIZATION Nature of Business Melanocortin Receptor System. The Company’s commercial product, Vyleesi®, was approved by the U.S. Food and Drug Administration (“FDA”) in June 2019 and was being marketed in the United States by AMAG Pharmaceuticals, Inc. (“AMAG”) for the treatment of hypoactive sexual desire disorder (“HSDD”) in premenopausal women pursuant to a license agreement between them for Vyleesi for North America, which was entered into on January 8, 2017 (the “AMAG License Agreement”). As disclosed in Note 4, the AMAG License Agreement was terminated effective July 24, 2020, and the Company is now marketing Vyleesi in North America. 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. Reverse Stock Split Business Risks and Liquidity – As of June 30, 2022, the Company’s cash and cash equivalents were $29,939,154 and current liabilities were $16,259,864. Management intends to utilize existing capital resources for general corporate purposes and working capital, including establishing marketing and distribution capabilities for Vyleesi in the United States and preclinical and clinical development of the Company’s MC1r and MC4r programs, and development of other portfolio products. The Company follows the provisions of Financial Accounting Standards Board ("FASB") Accounting Standards Codification ("ASC") Topic 205-40, Presentation of Financial Statements — Going Concern, which requires management to assess the Company's ability to continue as a going concern for one year after the date the consolidated financial statements are issued. While the Company has raised funding in the past, the ability to raise funding in future periods is not considered probable, as defined under the accounting standards. As such, under the requirements of ASC 205-40, management may not consider the potential for future funding in their assessment of the Company's ability to meet its obligations for the next year. Based on the Company’s available cash and cash equivalents, management has concluded that substantial doubt exists about the Company’s ability to continue as a going concern for one year from the date these consolidated financial statements are issued. The Company is evaluating strategies to obtain additional funding for future operations which include but are not limited to obtaining equity financing, issuing debt, or reducing planned expenses. A failure to raise additional funding or to effectively implement cost reductions could harm the Company’s business, results of operations, and future prospects. If the Company is not able to secure adequate additional funding in future periods, the Company would be forced to make additional reductions in certain expenditures. This may include liquidating assets and suspending or curtailing planned programs. The Company may also have to delay, reduce the scope of, suspend, or eliminate one or more research and development programs or its commercialization efforts or pursue a strategic transaction. If the Company is unable to raise capital when needed or enter into a strategic transaction, then the Company may be required to cease operations, which could cause its stockholders to lose all or part of their investment. The consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the continuity of operations, the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. Assuming no additional funding and based on its current operating and development plans, the Company expects that its existing cash and cash equivalents as of the date of this filing will be sufficient to enable the Company to fund its operations into the second half of its fiscal year ending June 30, 2023. 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 2020, 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 will receive a royalty on sales of Vyleesi by its licensees. It has licensed third parties to sell Vyleesi in China and Korea. 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, including manufacturing, distribution, sales, and marketing of Vyleesi, and it has the potential to materially adversely affect its business, financial condition, and results of operations and cashflows during the fiscal year ending June 30, 2023 (“fiscal 2023”) and beyond. Concentrations – |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Jun. 30, 2022 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | (2) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Principles of Consolidation Use of Estimates Cash and Cash Equivalents Fair Value of Financial Instruments Credit Risk Trade Accounts Receivable Inventories On a quarterly basis, the Company reviews inventory levels to determine whether any obsolete, expired, or excess inventory exists. If any inventory is expected to expire prior to being sold, has a cost basis in excess of its net realizable value, is in excess of expected sales requirements as determined by internal sales forecasts, or fails to meet commercial sale specifications, the inventory is written down through a charge to operating expenses. Inventory consisting of Vyleesi has a shelf-life of three years from the date of manufacture. Property and Equipment Impairment of Long-Lived Assets Leases The ROU asset is initially measured at cost, which comprises the initial amount of the lease liability adjusted for lease payments made at or before the lease commencement date, plus any initial direct costs incurred less any lease incentives received. For operating leases, the ROU asset is subsequently measured throughout the lease term at the carrying amount of the lease liability, plus initial direct costs, plus (minus) any prepaid (accrued) lease payments, less the unamortized balance of lease incentives received. Lease expense for lease payments is recognized on a straight-line basis over the lease term. For finance leases, the ROU asset is subsequently amortized using the straight-line method from the lease commencement date to the earlier of the end of its useful life or the end of the lease term unless the lease transfers ownership of the underlying asset to the Company or the Company is reasonably certain to exercise an option to purchase the underlying asset. In those cases, the ROU asset is amortized over the useful life of the underlying asset. Amortization of the ROU asset is recognized and presented as an operating expense separately from interest expense on the lease liability. 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 selling, general and administrative expense in the statements 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. Revenue Recognition Revenue from Contracts with Customers In accordance with ASC Topic 606, the Company recognizes product revenue when its performance obligation is satisfied by transferring control of the product to a customer. Per the Company’s contracts with customers, control of the product is transferred upon the conveyance of title, which occurs when the product is sold to and received by a customer. Trade accounts receivable due to the Company from contracts with its customers are stated separately in the consolidated balance sheet, net of various allowances as described in the Trade Accounts Receivable policy above. Product revenues consist of sales of Vyleesi in the United States. The Company sells Vyleesi to specialty pharmacies at the wholesale acquisition cost and payment is currently made within approximately 30 days. In addition to distribution agreements with customers, the Company enters into arrangements with healthcare payers that provide for privately negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products. The Company records product revenues net of allowances for direct and indirect fees, discounts, co-pay assistance programs, estimated chargebacks and rebates. Product sales are also subject to return rights, which have not been significant to date. Gross product sales offset by product sales allowances for the year ended June 30, 2022 and 2021 are as follows: Year Ended June 30, 2022 2021 Gross product sales $ 5,816,530 $ 4,745,066 Provision for product sales allowances and accruals (4,598,073 ) (5,028,352 ) Net sales $ 1,218,457 $ (283,286 ) 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 is 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 in the future and such sales-based royalties and milestone payments will be 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 The Company’s Series B and Series C Redeemable Convertible Preferred Stock and warrants issued during the year ended June 30, 2022 met the definition of a participating security given their rights to participate in dividends if declared on common stock, which requires the Company to apply the two-class method to compute both basic and diluted net income or loss per share. The two-class method is an earnings allocation formula that treats participating securities as having rights to earnings that would otherwise have been available to common stockholders. In addition, as these securities are participating securities, the Company is required to calculate diluted net income or loss per share under the if-converted and treasury stock method in addition to the two-class method and utilize the most dilutive result. In periods where there is a net loss, no allocation of undistributed net loss to the Redeemable Convertible Preferred stockholders or warrant holders is performed as the holders of these securities are not contractually obligated to participate in the Company’s losses. For the years ended June 30, 2022 and 2021, 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 year ended June 30, 2022 and June 30, 2021 was 2,851,959 and 1,650,589 respectively. Included in the weighted average common shares used in computing basic and diluted net loss per common share are 363,780 and 326,563 vested restricted stock units that had not been issued as of June 30, 2022 and 2021, respectively, due to a provision in the restricted stock unit agreements to delay delivery. Translation of foreign currencies |
New and recently Adopted Accoun
New and recently Adopted Accounting Pronouncements | 12 Months Ended |
Jun. 30, 2022 | |
New and recently Adopted Accounting Pronouncements | |
New and recently adopted accounting pronouncements | (3) New and recently Adopted Accounting Pronouncements In May 2021, the FASB issued Accounting Standards Update (“ASU”) No. 2021-04, Earnings Per Share (Topic 260), Debt – Modifications and Extinguishments (Subtopic 470-50), Compensation – Stock Compensation (Topic 718), and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options In August 2020, the FASB issued ASU No. 2020-06, Debt (Topic 470) and Derivatives and Hedging (Topic 815): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments, |
AGREEMENTS WITH AMAG
AGREEMENTS WITH AMAG | 12 Months Ended |
Jun. 30, 2022 | |
AGREEMENTS WITH AMAG | |
AGREEMENTS WITH AMAG | (4) AGREEMENTS 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. Under the AMAG License Agreement, in addition to certain initial and milestone payments, AMAG reimbursed the Company for certain 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. On June 4, 2018, the FDA accepted the Vyleesi NDA for filing and on June 21, 2019, the FDA granted approval of Vyleesi for use in the United States. Effective July 24, 2020, the Company entered into a termination agreement (the “Termination Agreement”) with AMAG terminating the AMAG License Agreement. Under the terms of the Termination Agreement, the Company regained all development and commercialization rights for Vyleesi in the Territory. AMAG made a $12,000,000 payment to the Company at closing of the Termination Agreement and a $4,300,000 payment to the Company on March 31, 2021. The Company initially recorded a liability related to estimated losses on inventory purchase commitments of $18,194,000 as well as accrued expenses for an inventory production run obligation assumed of $2,300,000. The Company assumed all Vyleesi manufacturing agreements, and AMAG transferred information, data, and assets related exclusively to Vyleesi to the Company, including existing inventory and prepaid expenses with an estimated fair value of $5,817,795 as of the date of the Termination Agreement. As a result, the Company initially recorded a net gain for the Termination Agreement of $1,623,795. During the three months ended June 30, 2021, the Company reassessed the estimated net realizable value of the inventory, prepaid expenses and losses on the inventory purchase commitments resulting in recording of a loss on the Termination Agreement of $4,407,987 for the three months ended June 30, 2021 and a total loss on the Termination Agreement for the year ended June 30, 2021 of $2,784,192. Under the Termination Agreement, AMAG provided certain transitional services to the Company for a period to ensure continued patient access to Vyleesi during the transition back to the Company. The Company reimbursed AMAG for the agreed upon costs of the transition services. |
MANUFACTURING SUPPLY AGREEMENTS
MANUFACTURING SUPPLY AGREEMENTS FOR VYLEESI | 12 Months Ended |
Jun. 30, 2022 | |
MANUFACTURING SUPPLY AGREEMENTS FOR VYLEESI | |
MANUFACTURING SUPPLY AGREEMENTS FOR VYLEESI | (5) MANUFACTURING SUPPLY AGREEMENTS FOR VYLEESI Pursuant to the Termination Agreement, the Company assumed Vyleesi manufacturing contracts with Catalent Belgium S.A. (“Catalent”), a subsidiary of Catalent Pharma Solutions, Inc., to manufacture drug product and prefilled syringes and assemble prefilled syringes into an auto-injector device (the “Catalent Agreement”), Ypsomed AG (“Ypsomed”), to manufacture the auto-injector device (the “Ypsomed Agreement”), and Lonza Ltd. (“Lonza”), to manufacture the active pharmaceutical ingredient peptide (the “Lonza Agreement”). On September 29, 2020, the Company and Catalent entered into an agreement to terminate the Catalent Agreement (the “Catalent Termination Agreement”) in consideration for a one-time payment of six million euros (€6,000,000) which was paid in October 2020 and accrued as part of the estimated losses on inventory purchase commitments assumed as part of the Termination Agreement as discussed in Note 4. The Company and Catalent then entered into a new Vyleesi manufacturing agreement (the “New Catalent Agreement”) which includes reduced minimum annual purchase requirements (see Note 14) as compared to the original Catalent Agreement and modification of other financial terms. The New Catalent Agreement provides that Catalent will provide manufacturing and supply services to Palatin related to production of Vyleesi, including that Catalent will supply specified minimums of Palatin’s requirements for Vyleesi during the term of the New Catalent Agreement through August 21, 2025, unless earlier terminated in accordance with the terms of the New Catalent Agreement. The initial term of the New Catalent Agreement will be automatically extended for one 24-month period unless either party notifies the other of its desire to terminate as of the end of the initial term. The New Catalent Agreement also includes customary terms and conditions relating to forecasting and minimum commitments, ordering, delivery, inspection and acceptance, and termination, among other matters. The initial term of the Ypsomed Agreement is through December 31, 2025, with automatic renewal for successive one-year periods unless either party terminates the Ypsomed Agreement by ten months’ written notice prior to the expiration of the Ypsomed Agreement or any automatic renewal period. There are specified minimum purchase requirements under the Ypsomed Agreement, and under specified circumstances, termination fees may be payable upon termination of the Ypsomed Agreement by the Company (see Note 14). The term of the Lonza Agreement is through December 31, 2022, and Lonza has advised the Company that they will not renew the Lonza Agreement, but the Company remains in discussions with Lonza on extending contract peptide manufacturing services. The Company is actively evaluating potential new contract manufacturers but establishing a new contractual relationship and establishing and validating manufacturing in a manner that complies with FDA regulations is a time-consuming and costly process. There are specified minimum purchase requirements under the Lonza Agreement (see Note 14). |
AGREEMENT WITH FOSUN
AGREEMENT WITH FOSUN | 12 Months Ended |
Jun. 30, 2022 | |
AGREEMENT WITH FOSUN | |
AGREEMENT WITH FOSUN | (6) AGREEMENT WITH FOSUN On September 6, 2017, the Company entered into a license agreement with Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. (“Fosun”) for exclusive rights to commercialize Vyleesi in China (the “Fosun License Agreement”). 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 is entitled to 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. The Company 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. For the year ended June 30, 2022, the Company recorded $250,000 of license and contract revenue related to the Fosun License Agreement. |
AGREEMENT WITH KWANGDONG
AGREEMENT WITH KWANGDONG | 12 Months Ended |
Jun. 30, 2022 | |
AGREEMENT WITH KWANGDONG | |
AGREEMENT WITH KWANGDONG | (7) AGREEMENT WITH KWANGDONG On November 21, 2017, the Company entered into a license agreement with Kwangdong Pharmaceutical Co., Ltd. (“Kwangdong”) for exclusive rights to commercialize Vyleesi in Korea (the “Kwangdong License Agreement”). 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. The Company is entitled to receive a $3,000,000 milestone payment based on the first commercial sale in Korea. The Company 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. For the year ended June 30, 2021, the Company recorded $94,689 of license and contract revenue related to the Kwangdong License Agreement. |
PREPAID EXPENSES AND OTHER CURR
PREPAID EXPENSES AND OTHER CURRENT ASSETS | 12 Months Ended |
Jun. 30, 2022 | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | (8) PREPAID EXPENSES AND OTHER CURRENT ASSETS Prepaid expenses June 30, June 30, 2022 2021 Clinical / regulatory costs $ 310,573 $ 454,750 Insurance premiums 132,413 259,468 Vyleesi contractual advances 815,750 1,200,000 Other 673,718 1,145,461 $ 1,932,454 $ 3,059,679 |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 12 Months Ended |
Jun. 30, 2022 | |
FAIR VALUE MEASUREMENTS | |
FAIR VALUE MEASUREMENTS | (9) 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) June 30, 2022: Money market account $ 29,740,565 $ 29,740,565 $ - $ - June 30, 2021: Money market account $ 59,730,428 $ 59,730,428 $ - $ - |
INVENTORIES
INVENTORIES | 12 Months Ended |
Jun. 30, 2022 | |
INVENTORIES | |
INVENTORIES | (10) INVENTORIES Inventories consist of raw materials and finished goods related to Vyleesi. The following table summarizes the components of inventories: June 30, June 30, 2022 2021 Raw materials $ 526,000 $ 526,000 Finished goods 418,471 636,000 $ 944,471 $ 1,162,000 |
LEASES
LEASES | 12 Months Ended |
Jun. 30, 2022 | |
LEASES | |
LEASES | (11) LEASES The Company has operating leases for office and laboratory space, which expire on June 30, 2025 and October 31, 2023, respectively. The Company also has operating leases for copier equipment that expire March 31, 2023 and phone equipment that expires on June 30, 2023. The components of operating lease cost are as follows: Operating lease cost Year ended June 30, 2022 Year ended June 30, 2021 Operating lease cost $ 294,293 $ 287,440 Variable lease cost 114,418 108,023 Total operating lease cost $ 408,711 $ 395,463 The components of finance lease cost are as follows: Finance lease cost Year ended June 30, 2022 Year ended June 30, 2021 Right-of-use asset amortization $ 56,463 $ - Interest expense 8,812 - Total finance lease cost $ 65,275 $ - Supplemental lease term and discount rate information related to leases was as follows: June 30, 2022 June 30, 2021 Weighted-average remaining lease term (years) operating leases 2.6 3.5 Weighted-average remaining lease term (years) finance leases 2.4 - Weighted-average discount rate operating leases 5.50 % 5.50 % Weighted-average discount rate finance leases 5.29 % - Supplemental cash flow information related to leases was as follows: Year Ended June 30, 2022 Year Ended June 30, 2021 Cash paid for the amounts included in the measurement of lease liabilities: Operating cash flows for operating leases $ 410,007 $ 394,926 Operating cash flows for finance leases 8,812 - Financing cash flows for finance leases 56,463 - $ 475,282 $ 394,926 Supplemental non-cash information on lease liabilities arising from obtaining right-of-use assets: Right-of-use assets obtained in exchange for new operating lease obligation $ - $ 365,881 Right-of-use assets obtained in exchange for new finance lease obligations $ 309,791 $ - The following table summarizes the maturity of the Company’s lease liabilities as of June 30, 2022: Operating leases: Year Ending June 30 2023 $ 409,438 2024 323,003 2025 265,037 Less imputed interest (96,956 ) Total $ 900,522 Finance leases: Year Ending June 30 2023 $ 111,899 2024 111,899 2025 46,625 Less imputed interest (17,095 ) Total $ 253,328 |
PROPERTY AND EQUIPMENT, NET
PROPERTY AND EQUIPMENT, NET | 12 Months Ended |
Jun. 30, 2022 | |
PROPERTY AND EQUIPMENT, NET | |
PROPERTY AND EQUIPMENT, NET | (12) PROPERTY AND EQUIPMENT, NET Property and equipment, net, consists of the following: June 30, June 30, 2022 2021 Office equipment $ 1,229,300 $ 1,193,162 Laboratory equipment 1,038,610 648,673 Leasehold improvements 902,038 756,948 3,169,948 2,598,783 Less: Accumulated depreciation and amortization (2,630,634 ) (2,503,966 ) $ 539,314 $ 94,817 Included in property and equipment, net as of June 30, 2022 is $309,791 in equipment under finance leases and $56,463 related accumulated amortization. |
ACCRUED EXPENSES
ACCRUED EXPENSES | 12 Months Ended |
Jun. 30, 2022 | |
ACCRUED EXPENSES | |
ACCRUED EXPENSES | (13) ACCRUED EXPENSES Accrued expenses June 30, June 30, 2022 2021 Clinical / regulatory costs $ 3,944,798 $ 778,705 Other research related expenses 35,172 569,370 Professional services 351,257 84,094 Personnel costs 1,545,896 - Selling expenses 840,703 1,839,724 Inventory purchases - 2,340,000 Other 157,390 185,485 $ 6,875,216 $ 5,797,378 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Jun. 30, 2022 | |
COMMITMENTS AND CONTINGENCIES | |
COMMITMENTS AND CONTINGENCIES | (14) COMMITMENTS AND CONTINGENCIES Inventory Purchases Total Current 1 - 3 Years 4 - 5 Years Inventory purchase commitments $ 9,524,486 $ 6,174,986 $ 2,373,000 $ 976,500 As of June 30, 2022, the Company has $5,754,986 and $2,861,250 accrued within other current and long-term liabilities, respectively, in the consolidated balance sheet related to estimated losses for firm commitment contractual obligations under these agreements. As of June 30, 2021, $3,721,907 and $6,232,907 was accrued within other current and long-term liabilities, respectively. Losses on these firm commitment contractual obligations are recognized based upon the terms of the respective agreement and similar factors considered for the write-down of inventory, including expected sales requirements as determined by internal sales forecasts. The commitment contractual obligation amounts above are denominated in Swiss Francs and Euros and have been translated using period end exchange rates. The Company may experience a negative impact on future earnings and equity solely as a result of future foreign currency exchange rate fluctuations. Employment Agreements Employee Retirement Savings Plan Contingencies Loss Contingencies 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. |
REDEEMABLE CONVERTIBLE PREFERRE
REDEEMABLE CONVERTIBLE PREFERRED STOCK, ESCROWED PROCEEDS, AND STOCKHOLDERS EQUITY | 12 Months Ended |
Jun. 30, 2022 | |
Stockholders' equity: | |
REDEEMABLE CONVERTIBLE PREFERRED STOCK, ESCROWED PROCEEDS, AND STOCKHOLDERS' EQUITY | (15) REDEEMABLE CONVERTIBLE PREFERRED STOCK, ESCROWED PROCEEDS, AND STOCKHOLDERS’ EQUITY Series B and C Redeemable Convertible Preferred Stock The Series B Preferred Stock and Series C Preferred Stock is convertible, at the option of the holder from the date of the Company's reverse stock split on August 30, 2022 until 30 days following the reverse stock split, into 1,333,333 shares of common stock, computed by dividing the aggregate stated value of the preferred stock of $15,000,000 by the conversion price of $11.25. Alternatively, during the period from the date of stockholder approval of the Company's reverse stock split (see below) until 30 days following the reverse stock split the holders of Series B Preferred Stock and Series C Preferred Stock can elect to redeem for cash in an amount equal to the stated value or convert to notes, having an aggregate principal amount equal to the stated value. The investors will also receive a fee of $750,000, which was paid into the escrow account by the Company. The Series B Preferred Stock and Series C Preferred Stock are presented outside of stockholders' equity at their aggregate redemption value of $15,000,000 since their redemption is outside control of the Company. Given that the fee and other costs are not refundable to the Company as of June 30, 2022, regardless of the election selected by the investors, the fee, the fair value of the warrants ($234,443), and other costs of $150,995 were recorded as expenses within selling, general and administrative expenses during the year ended June 30, 2022. The Company called a meeting of stockholders on June 24, 2022 to seek approval of, among other things, an amendment to its certificate of incorporation authorizing a reverse stock split. Except as otherwise required by law, holders of the Series B Preferred Stock and Series C Preferred Stock were entitled to vote only on the reverse stock split and any adjournment of the meeting relating to the reverse stock split. The Company’s common stock, outstanding Series A Preferred Stock, the Series B Preferred Stock and the Series C Preferred Stock voted as a single class on an as-if converted basis. The holders of Series B Preferred Stock had votes equal to the number of shares of common stock into which the Series B Preferred Stock is convertible. The holders of Series C Preferred Stock were entitled to 20,000 votes per share of common stock into which the Series C Preferred Stock is convertible but could only vote in the same proportion as the shares of common stock, Series A preferred stock, and Series B preferred stock were voted on the reverse stock split or any adjournment of the stockholder meeting relating thereto. The holders of the Series B Preferred Stock agreed to vote in favor of the reverse stock split, which was approved and ultimately became effective on August 30, 2022. Subsequent to the reverse stock split, the Series B Preferred Stock and Series C Preferred Stock is also convertible into common stock at the option of the Company subject to the holders having the ability to resell the Company stock, the stock being traded on a national stock exchange or automated inter-dealer quotation system, and other conditions, as defined in the respective purchase agreement. To the extent any shares of Series B Preferred Stock or Series C Preferred Stock are converted to common shares or converted to debt, the Company will use such net proceeds from this offering for working capital and general corporate purposes. The holders of the Series B Preferred Stock and Series C Preferred Stock are entitled to certain registration rights, rights for approval of increases in authorized shares of the respective series, rights to limitation on the Company’s ability to incur indebtedness, and dividends paid on common stock on an as-if converted basis. In addition, in the event of any liquidation, dissolution, or winding-up of the Company, the holders of the Series B Preferred Stock and Series C Preferred Stock are entitled to receive the preferred stock’s stated value plus any declared but unpaid dividends before any payment is made to holders of common stock or any other class or series of stock ranking junior to the respective Series B Preferred Stock and Series C Preferred Stock. Series A Convertible Preferred Stock Financing Transactions No proceeds were raised under the 2019 Equity Distribution Agreement during the years ended June 30, 2022 and 2021. Proceeds raised under the 2019 Equity Distribution Agreement since its inception are as follows: Cumulative from inception Shares Proceeds Gross proceeds 378,420 $ 12,330,242 Fees - (369,908 ) Expenses - (90,000 ) Net proceeds 378,420 $ 11,870,334 Stock Purchase Warrants As of June 30, 2022, the Company had outstanding warrants for shares of common stock as follows: Shares of Common Exercise Price per Latest Termination Descripton Stock Share Date May 2022 warrants 66,666 $ 12.50 May 11, 2026 Warrants for 33,333 shares of common stock are exercisable immediately and warrants for 33,333 shares of common stock will become exercisable when the holder's of the Series B Preferred Stock and Series C Preferred Stock elect to redeem their shares for cash or convert to notes. The outstanding warrants are entitled to dividends and participation in subsequent equity offerings as if they were exercised for common shares. Stock Plan – The following table summarizes option activity and related information for the years ended June 30, 2022 and 2021: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Term in Years Aggregate Intrinsic Value Outstanding - June 30, 2020 796,097 $ 19.00 7.4 Granted 141,844 14.00 Forfeited (22,732 ) 18.75 Exercised - - Expired (39,910 ) 23.75 Outstanding - June 30, 2021 875,299 18.00 7.2 Granted 310,494 10.07 Forfeited (11,539 ) 16.67 Exercised (1,744 ) 9.25 Expired (8,548 ) 19.79 Outstanding - June 30, 2022 1,163,962 $ 15.98 7.1 $ - Exercisable at June 30, 2022 693,204 $ 18.50 5.8 $ - Expected to vest at June 30, 2022 470,758 $ 12.29 9.1 $ - 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 outstanding options in the table above are 166,233 and 18,921 unvested performance-based stock options granted to executive officers and other employees, respectively, which were granted in June 2020, 2021 and 2022. Grants in June 2020, 2021, and 2022 were 87,303, 95,167, and 60,566 respectively. The performance-based stock options vest on annual performance criteria through the fiscal years ending June 30, 2026 relating to advancement of MC1r programs, including initiation of clinical trials and licensing of Vyleesi in additional countries or regions. Also included in the table above are 43,000 and 4,700 performance-based options granted in December 2017 to executive officers and employees, respectively, which were eligible to vest during a performance period ended 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 Female Sexual Dysfunction (“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. During the year ended June 30, 2021, the performance period ended for the remaining performance-based stock options. As a result, 9,600 unearned stock options were forfeited and added back to the 2011 Stock Plan and available for future grant. For the years ended June 30, 2022 and 2021, the fair value of option grants was estimated at the grant date using the Black-Scholes model. The Company’s weighted average assumptions for the years ended June 30, 2022 and 2021 were as follows: Year Ended June 30, Year Ended June 30, 2022 2021 Risk-free interest rate 3.2 % 1.0 % Volatility factor 69.1 % 68.3 % Dividend yield 0 % 0 % Expected option life (years) 6.0 6.1 Weighted average grant date fair value $ 2.68 $ 8.50 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, 2022 and 2021, the Company recorded stock-based compensation related to stock options of $1,563,686 and $1,863,266, respectively. As of June 30, 2021, there was $2,070,413 of unrecognized compensation cost related to unvested options, which is expected to be recognized over a weighted-average period of 2.5 years. Restricted Stock Units – Year Ended June 30, Year Ended June 30, 2022 2021 Outstanding at beginning of year 593,629 518,620 Granted 131,352 129,774 Forfeited (6,426 ) (16,442 ) Vested (69,406 ) (38,323 ) Outstanding at end of year 649,149 593,629 For the years ended June 30, 2022 and 2021, the Company recorded stock-based compensation related to restricted stock units of $941,852 and $1,305,390, respectively. Included in outstanding restricted stock units in the table above are 363,780 vested shares that have not been issued as of June 30, 2022 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 48 months, 48 months, and 12 months, respectively. Included in the outstanding restricted stock units in the table above are 61,556 and 13,751 unvested performance-based restricted stock units granted to executive officers and other employees, respectively, which were granted in June 2019, 2020, 2021, and 2022. Grants in June 2019, 2020, 2021 and 2022 were 24,829, 52,679, 22,343, and 40,707 respectively. The performance-based restricted stock units vest on annual performance criteria through the fiscal years ending June 30, 2026 relating to advancement of MC1r programs, including initiation of clinical trials and licensing of Vyleesi in additional countries or regions. In June 2021, the Company granted 18,000 performance-based restricted stock units to its executive officers which vest if, prior to June 22, 2023, the price per share of the Company’s common stock, as traded on the NYSE American, was at least $50.00 for at least twenty consecutive trading days. In December 2017, the Company granted 43,000 performance-based restricted stock units to its executive officers and 26,800 performance-based restricted stock units to other employees which were eligible to vest during a performance period, ended 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 $37.50 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. During the year ended June 30, 2021, the performance period ended for the remaining performance based restricted stock units. As a result, 12,780 unearned restricted stock units were forfeited and added back to the 2011 Stock Plan and available for future grant. In connection with the vesting of restricted share units during the years ended June 30, 2022 and 2021, the Company withheld 16,191 and 6,671, shares, respectively, with aggregate values of $221,311 and $93,638, respectively, in satisfaction of minimum tax withholding obligations. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Jun. 30, 2022 | |
INCOME TAXES | |
INCOME TAXES | (16) INCOME TAXES For fiscal 2022 and 2021, the Company recorded no income tax expense as a result of the generation of operating losses that were subject to a full valuation allowance. 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, 2022, the Company had state net operating loss carryforwards of approximately $164,000,000, which will expire, if not utilized, between 2034 and 2042, federal net operating loss carryforwards of approximately $112,800,000 and federal research and development and Alternative Minimum Tax (“AMT”) credits of approximately $7,200,000, which expire, if not utilized, between 2035 and 2042, and foreign tax credits of $582,500, which expire, if not utilized, in 2028. 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. The Company assesses the available positive and negative evidence to estimate if sufficient future taxable income will be generated to use the existing deferred tax assets. The Company also considers the scheduled reversal of deferred tax liabilities (including the impact of available carryback and carryforward periods), projected future taxable income, and tax‑planning strategies in making this assessment. Based on a history of losses incurred, the Company has recognized a full valuation allowance against its net deferred tax assets during the years ended June 30, 2022 and 2021. The Company’s valuation allowance increased by $3,927,000 and $9,513,000 for the years ended June 30, 2022 and 2021, respectively. A sustained period of profitability in the Company’s operations is required before it would change its judgment regarding the need for a full valuation allowance against its net deferred tax assets. Until such time, the use of net operating loss carryforwards and tax credits to offset profits, if any, will reduce the overall level of deferred tax assets subject to valuation allowance. The Tax Reform Act of 1986 (the “Act”) provides for limitation on the use of the Company’s 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. Since its inception, the Company has completed several financings and sales of common stock which has resulted in multiple ownership changes defined by Section 382 of the Act. Accordingly, the Company’s ability to utilize the aforementioned carryforwards are subject to limitation under Section 382. If the Company undergoes a future ownership change or as it completes its Section 382 limitation assessments, any unutilized carryforwards that were not previously subject to a Section 382 limitation may become subject to limitation which may result in a significant limitation and loss of net operating loss carryforwards and research and development credits. 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. Accordingly, a portion of the carryforwards may expire unutilized. The Company’s net deferred tax assets are as follows: June 30, June 30, 2022 2021 Net operating loss carryforwards $ 35,331,000 $ 32,169,000 Research and development and AMT tax credits 7,171,000 6,461,000 Foreign tax credits 583,000 583,000 Basis differences in fixed assets and other 2,778,000 2,723,000 45,863,000 41,936,000 Valuation allowance (45,863,000 ) (41,936,000 ) Net deferred tax assets $ - $ - The Company recognizes interest expense and penalties on uncertain income tax positions as a component of interest expense. No interest expense or penalties were recorded for uncertain income tax matters in fiscal 2022 or 2021. As of June 30, 2022 and 2021, the Company had no liabilities for uncertain income tax matters. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Jun. 30, 2022 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Principles of Consolidation | Principles of Consolidation |
Use of Estimates | Use of Estimates |
Cash and Cash Equivalents | Cash and Cash Equivalents |
Fair Value of Financial Instruments | Fair Value of Financial Instruments |
Credit Risk | Credit Risk |
Trade Account Receivables | Trade Accounts Receivable |
Inventories | Inventories On a quarterly basis, the Company reviews inventory levels to determine whether any obsolete, expired, or excess inventory exists. If any inventory is expected to expire prior to being sold, has a cost basis in excess of its net realizable value, is in excess of expected sales requirements as determined by internal sales forecasts, or fails to meet commercial sale specifications, the inventory is written down through a charge to operating expenses. Inventory consisting of Vyleesi has a shelf-life of three years from the date of manufacture. |
Property and Equipment | Property and Equipment |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets |
Leases | Leases The ROU asset is initially measured at cost, which comprises the initial amount of the lease liability adjusted for lease payments made at or before the lease commencement date, plus any initial direct costs incurred less any lease incentives received. For operating leases, the ROU asset is subsequently measured throughout the lease term at the carrying amount of the lease liability, plus initial direct costs, plus (minus) any prepaid (accrued) lease payments, less the unamortized balance of lease incentives received. Lease expense for lease payments is recognized on a straight-line basis over the lease term. For finance leases, the ROU asset is subsequently amortized using the straight-line method from the lease commencement date to the earlier of the end of its useful life or the end of the lease term unless the lease transfers ownership of the underlying asset to the Company or the Company is reasonably certain to exercise an option to purchase the underlying asset. In those cases, the ROU asset is amortized over the useful life of the underlying asset. Amortization of the ROU asset is recognized and presented as an operating expense separately from interest expense on the lease liability. 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 selling, general and administrative expense in the statements 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. |
Revenue Recognition | Revenue Recognition Revenue from Contracts with Customers In accordance with ASC Topic 606, the Company recognizes product revenue when its performance obligation is satisfied by transferring control of the product to a customer. Per the Company’s contracts with customers, control of the product is transferred upon the conveyance of title, which occurs when the product is sold to and received by a customer. Trade accounts receivable due to the Company from contracts with its customers are stated separately in the consolidated balance sheet, net of various allowances as described in the Trade Accounts Receivable policy above. Product revenues consist of sales of Vyleesi in the United States. The Company sells Vyleesi to specialty pharmacies at the wholesale acquisition cost and payment is currently made within approximately 30 days. In addition to distribution agreements with customers, the Company enters into arrangements with healthcare payers that provide for privately negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products. The Company records product revenues net of allowances for direct and indirect fees, discounts, co-pay assistance programs, estimated chargebacks and rebates. Product sales are also subject to return rights, which have not been significant to date. Gross product sales offset by product sales allowances for the year ended June 30, 2022 and 2021 are as follows: Year Ended June 30, 2022 2021 Gross product sales $ 5,816,530 $ 4,745,066 Provision for product sales allowances and accruals (4,598,073 ) (5,028,352 ) Net sales $ 1,218,457 $ (283,286 ) 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 is 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 in the future and such sales-based royalties and milestone payments will be 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 | Research and Development Costs |
Accrued Expenses | Accrued Expenses – |
Stock-Based Compensation | Stock-Based Compensation – |
Income Taxes | Income Taxes |
Net Income (Loss) per Common Share | Net Loss per Common Share Earnings per Share The Company’s Series B and Series C Redeemable Convertible Preferred Stock and warrants issued during the year ended June 30, 2022 met the definition of a participating security given their rights to participate in dividends if declared on common stock, which requires the Company to apply the two-class method to compute both basic and diluted net income or loss per share. The two-class method is an earnings allocation formula that treats participating securities as having rights to earnings that would otherwise have been available to common stockholders. In addition, as these securities are participating securities, the Company is required to calculate diluted net income or loss per share under the if-converted and treasury stock method in addition to the two-class method and utilize the most dilutive result. In periods where there is a net loss, no allocation of undistributed net loss to the Redeemable Convertible Preferred stockholders or warrant holders is performed as the holders of these securities are not contractually obligated to participate in the Company’s losses. For the years ended June 30, 2022 and 2021, 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 year ended June 30, 2022 and June 30, 2021 was 2,851,959 and 1,650,589 respectively. Included in the weighted average common shares used in computing basic and diluted net loss per common share are 363,780 and 326,563 vested restricted stock units that had not been issued as of June 30, 2022 and 2021, respectively, due to a provision in the restricted stock unit agreements to delay delivery. |
Translation of Foreign Currency | Translation of foreign currencies |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Jun. 30, 2022 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Gross product sales | Year Ended June 30, 2022 2021 Gross product sales $ 5,816,530 $ 4,745,066 Provision for product sales allowances and accruals (4,598,073 ) (5,028,352 ) Net sales $ 1,218,457 $ (283,286 ) |
PREPAID EXPENSES AND OTHER CU_2
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables) | 12 Months Ended |
Jun. 30, 2022 | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | |
Schedule of prepaid expenses and other current assets | June 30, June 30, 2022 2021 Clinical / regulatory costs $ 310,573 $ 454,750 Insurance premiums 132,413 259,468 Vyleesi contractual advances 815,750 1,200,000 Other 673,718 1,145,461 $ 1,932,454 $ 3,059,679 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 12 Months Ended |
Jun. 30, 2022 | |
FAIR VALUE MEASUREMENTS | |
Schedule of fair value asset measurement | Carrying Value Quoted prices in active markets (Level 1) Other quoted/observable inputs (Level 2) Significant unobservable inputs (Level 3) June 30, 2022: Money market account $ 29,740,565 $ 29,740,565 $ - $ - June 30, 2021: Money market account $ 59,730,428 $ 59,730,428 $ - $ - |
INVENTORIES (Tables)
INVENTORIES (Tables) | 12 Months Ended |
Jun. 30, 2022 | |
INVENTORIES | |
Schedule of Inventories | June 30, June 30, 2022 2021 Raw materials $ 526,000 $ 526,000 Finished goods 418,471 636,000 $ 944,471 $ 1,162,000 |
LEASES (Tables)
LEASES (Tables) | 12 Months Ended |
Jun. 30, 2022 | |
LEASES | |
Schedule of operating lease cost | Operating lease cost Year ended June 30, 2022 Year ended June 30, 2021 Operating lease cost $ 294,293 $ 287,440 Variable lease cost 114,418 108,023 Total operating lease cost $ 408,711 $ 395,463 |
Schedule of finance lease cost | Finance lease cost Year ended June 30, 2022 Year ended June 30, 2021 Right-of-use asset amortization $ 56,463 $ - Interest expense 8,812 - Total finance lease cost $ 65,275 $ - |
Supplemental lease term and discount rate information | June 30, 2022 June 30, 2021 Weighted-average remaining lease term (years) operating leases 2.6 3.5 Weighted-average remaining lease term (years) finance leases 2.4 - Weighted-average discount rate operating leases 5.50 % 5.50 % Weighted-average discount rate finance leases 5.29 % - |
Supplemental cash flow information | Year Ended June 30, 2022 Year Ended June 30, 2021 Cash paid for the amounts included in the measurement of lease liabilities: Operating cash flows for operating leases $ 410,007 $ 394,926 Operating cash flows for finance leases 8,812 - Financing cash flows for finance leases 56,463 - $ 475,282 $ 394,926 Supplemental non-cash information on lease liabilities arising from obtaining right-of-use assets: Right-of-use assets obtained in exchange for new operating lease obligation $ - $ 365,881 Right-of-use assets obtained in exchange for new finance lease obligations $ 309,791 $ - |
Summary of operating lease liability maturity | Operating leases: Year Ending June 30 2023 $ 409,438 2024 323,003 2025 265,037 Less imputed interest (96,956 ) Total $ 900,522 Finance leases: Year Ending June 30 2023 $ 111,899 2024 111,899 2025 46,625 Less imputed interest (17,095 ) Total $ 253,328 |
PROPERTY AND EQUIPMENT NET (Tab
PROPERTY AND EQUIPMENT NET (Tables) | 12 Months Ended |
Jun. 30, 2022 | |
PROPERTY AND EQUIPMENT, NET | |
Schdule of Property and equipment | June 30, June 30, 2022 2021 Office equipment $ 1,229,300 $ 1,193,162 Laboratory equipment 1,038,610 648,673 Leasehold improvements 902,038 756,948 3,169,948 2,598,783 Less: Accumulated depreciation and amortization (2,630,634 ) (2,503,966 ) $ 539,314 $ 94,817 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 12 Months Ended |
Jun. 30, 2022 | |
ACCRUED EXPENSES | |
Schdule of Accrued Expenses | June 30, June 30, 2022 2021 Clinical / regulatory costs $ 3,944,798 $ 778,705 Other research related expenses 35,172 569,370 Professional services 351,257 84,094 Personnel costs 1,545,896 - Selling expenses 840,703 1,839,724 Inventory purchases - 2,340,000 Other 157,390 185,485 $ 6,875,216 $ 5,797,378 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Jun. 30, 2022 | |
COMMITMENTS AND CONTINGENCIES | |
Schedule of inventory purchase commitments | Total Current 1 - 3 Years 4 - 5 Years Inventory purchase commitments $ 9,524,486 $ 6,174,986 $ 2,373,000 $ 976,500 |
REDEEMABLE CONVERTIBLE PREFER_2
REDEEMABLE CONVERTIBLE PREFERRED STOCK, ESCROWED PROCEEDS, AND STOCKHOLDERS EQUITY (Table) | 12 Months Ended |
Jun. 30, 2022 | |
Stockholders' equity: | |
Schedule of proceeds raised under equity distribution | Cumulative from inception Shares Proceeds Gross proceeds 378,420 $ 12,330,242 Fees - (369,908 ) Expenses - (90,000 ) Net proceeds 378,420 $ 11,870,334 |
Outstanding Stock Purchase Warrants | Shares of Common Exercise Price per Latest Termination Descripton Stock Share Date May 2022 warrants 66,666 $ 12.50 May 11, 2026 |
Option activity | Number of Shares Weighted Average Exercise Price Weighted Average Remaining Term in Years Aggregate Intrinsic Value Outstanding - June 30, 2020 796,097 $ 19.00 7.4 Granted 141,844 14.00 Forfeited (22,732 ) 18.75 Exercised - - Expired (39,910 ) 23.75 Outstanding - June 30, 2021 875,299 18.00 7.2 Granted 310,494 10.07 Forfeited (11,539 ) 16.67 Exercised (1,744 ) 9.25 Expired (8,548 ) 19.79 Outstanding - June 30, 2022 1,163,962 $ 15.98 7.1 $ - Exercisable at June 30, 2022 693,204 $ 18.50 5.8 $ - Expected to vest at June 30, 2022 470,758 $ 12.29 9.1 $ - |
Weighted average assumptions | Year Ended June 30, Year Ended June 30, 2022 2021 Risk-free interest rate 3.2 % 1.0 % Volatility factor 69.1 % 68.3 % Dividend yield 0 % 0 % Expected option life (years) 6.0 6.1 Weighted average grant date fair value $ 2.68 $ 8.50 |
Restricted Stock Units | Year Ended June 30, Year Ended June 30, 2022 2021 Outstanding at beginning of year 593,629 518,620 Granted 131,352 129,774 Forfeited (6,426 ) (16,442 ) Vested (69,406 ) (38,323 ) Outstanding at end of year 649,149 593,629 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Jun. 30, 2022 | |
INCOME TAXES | |
Schdule of Deferred tax assets | June 30, June 30, 2022 2021 Net operating loss carryforwards $ 35,331,000 $ 32,169,000 Research and development and AMT tax credits 7,171,000 6,461,000 Foreign tax credits 583,000 583,000 Basis differences in fixed assets and other 2,778,000 2,723,000 45,863,000 41,936,000 Valuation allowance (45,863,000 ) (41,936,000 ) Net deferred tax assets $ - $ - |
ORGANIZATION (Details Narrative
ORGANIZATION (Details Narrative) - USD ($) | 12 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2020 | |
ORGANIZATION (Details Narrative) | |||
Accumulated deficit | $ 387,993,696 | $ 351,795,397 | |
Net loss | (36,198,299) | (33,596,495) | |
Cash and cash equivalents | 29,939,154 | 60,104,919 | $ 82,852,270 |
Total current liabilities | $ 16,259,864 | $ 10,511,788 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - Product Revenue - USD ($) | 12 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Gross product sales | $ 5,816,530 | $ 4,745,066 |
Provision for product sales allowances and accruals | 4,598,073 | 5,028,352 |
Net sales | $ 1,218,457 | $ (283,286) |
SUMMARY OF SIGNIFICANT ACCOUN_5
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) | 12 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||
Cash and cash equivalents | $ 29,740,565 | $ 59,730,428 |
Potential number of common shares excluded from diluted EPS | 2,851,959 | 1,650,589 |
Weighted average vested restricted stock units | 363,780 | 326,563 |
AGREEMENTS WITH AMAG (Details N
AGREEMENTS WITH AMAG (Details Narrative) - USD ($) | 3 Months Ended | 12 Months Ended | ||||
Jun. 30, 2022 | Jun. 30, 2021 | Sep. 30, 2020 | Jun. 30, 2022 | Mar. 31, 2021 | Jul. 24, 2020 | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | ||||||
Contract Termination Agreement Payments | $ 4,300,000 | $ 12,000,000 | ||||
Estimated loss on Invenntory purcahse | $ 1,623,795 | $ 18,194,000 | ||||
Accrued Expenses on Inventory Purchase | $ 2,300,000 | |||||
Gain on license termination agreement | $ 1,623,795 | |||||
Loss on the Termination Agreement | $ 4,407,987 | |||||
Total Loss on Agreement | $ 2,784,192 | |||||
Inventory and prepaid expenses estimated fair value | $ 5,817,795 |
AGREEMENT WITH FOSUN (Details N
AGREEMENT WITH FOSUN (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | |
Sep. 06, 2017 | Nov. 21, 2017 | Jun. 30, 2022 | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | |||
Company License Agreement Recievables | $ 4,500,000 | ||
Upfront Payments | 5,000,000 | $ 500,000 | |
Tax Expense | 500,000 | 82,500 | |
Milestone payment receivable | 7,500,000 | 3,000,000 | |
Additional Sales Recievable | $ 92,500,000 | $ 37,500,000 | |
License and contract revenue | $ 250,000 |
AGREEMENT WITH KWANGDONG (Detai
AGREEMENT WITH KWANGDONG (Details Narrative) - USD ($) | 1 Months Ended | |
Sep. 06, 2017 | Nov. 21, 2017 | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | ||
Recievable under company agreement | $ 417,500 | |
Upfront payments | $ 5,000,000 | 500,000 |
Tax Expense | 500,000 | 82,500 |
Additional Sales Recievable | 92,500,000 | 37,500,000 |
Milestone payment receivable | $ 7,500,000 | 3,000,000 |
License Agreement | $ 94,689 |
PREPAID EXPENSES AND OTHER CU_3
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Details) - USD ($) | Jun. 30, 2022 | Jun. 30, 2021 |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | ||
Clinical / regulatory costs | $ 310,573 | $ 454,750 |
Insurance premiums | 132,413 | 259,468 |
Vyleesi contractual advances | 815,750 | 1,200,000 |
Other | 673,718 | 1,145,461 |
Total prepaid expenses and other current assets | $ 1,932,454 | $ 3,059,679 |
FAIR VALUE MEASUREMENTS (Detail
FAIR VALUE MEASUREMENTS (Details) - USD ($) | Jun. 30, 2022 | Jun. 30, 2021 |
Money Market Account | $ 29,740,565 | $ 59,730,428 |
Level 2 | ||
Money Market Account | 0 | 0 |
Level 3 | ||
Money Market Account | 0 | 0 |
Level 1 | ||
Money Market Account | $ 29,740,565 | $ 59,730,428 |
INVENTORIES (Details)
INVENTORIES (Details) - USD ($) | Jun. 30, 2022 | Jun. 30, 2021 |
INVENTORIES | ||
Raw materials | $ 526,000 | $ 526,000 |
Finished goods | 418,471 | 636,000 |
Inventories | $ 944,471 | $ 1,162,000 |
LEASES (Details)
LEASES (Details) - USD ($) | 12 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
LEASES | ||
Operating lease cost | $ 294,293 | $ 287,440 |
Variable lease cost | 114,418 | 108,023 |
Total lease cost | $ 408,711 | $ 395,463 |
LEASES (Details 1)
LEASES (Details 1) - USD ($) | 12 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
LEASES | ||
Right of use asset amortization Finance lease cost | $ 56,463 | $ 0 |
Interest expense | 8,812 | 0 |
Total finance cost | $ 65,275 | $ 0 |
LEASES (Details 2)
LEASES (Details 2) - USD ($) | 12 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
LEASES | ||
Weighted -average remaining lease term (years) | 2.6 | 3.5 |
Weighted -average remaining lease term (years) finance lease | 2.4 | |
Weighted -average discount rate | 5.50% | 5.50% |
Weighted -average discount rate finance lease | 5.29% | 0% |
Operating cash flows for operating leases | $ 410,007 | $ 394,926 |
Operating cash flows for Finance lease | 8,812 | 0 |
Financing cash flows for Finance lease | 56,463 | 0 |
Right-of-use assets obtained in exchange for new lease obligation | 0 | 365,881 |
Total measurement of lease liabilities | 475,282 | 394,926 |
Right-of-use assets obtained in exchange for new finance lease obligation | $ 309,791 | $ 0 |
LEASES (Details 3)
LEASES (Details 3) | Jun. 30, 2022 USD ($) |
Year ending June 30, 2023 | $ 111,899 |
Year ending June 30, 2024 | 111,899 |
Year ending June 30, 2025 | 46,625 |
Less imputed interest | (17,095) |
Total | 253,328 |
Operating Lease [Member] | |
Year ending June 30, 2023 | 409,438 |
Year ending June 30, 2024 | 323,003 |
Year ending June 30, 2025 | 265,037 |
Less imputed interest | (96,956) |
Total | $ 900,522 |
LEASES (Details Narrative)
LEASES (Details Narrative) | 12 Months Ended |
Jun. 30, 2022 | |
LEASES | |
Description of office space | The Company has operating leases for office and laboratory space, which expire on June 30, 2025 and October 31, 2023 |
PROPERTY AND EQUIPMENT NET (Det
PROPERTY AND EQUIPMENT NET (Details) - USD ($) | Jun. 30, 2022 | Jun. 30, 2021 |
PROPERTY AND EQUIPMENT, NET | ||
Office equipment | $ 1,229,300 | $ 1,193,162 |
Laboratory equipment | 1,038,610 | 648,673 |
Leasehold improvements | 902,038 | 756,948 |
Gross | 3,169,948 | 2,598,783 |
Less: Accumulated depreciation and amortization | (2,630,634) | (2,503,966) |
Net | $ 539,314 | $ 94,817 |
PROPERTY AND EQUIPMENT NET (D_2
PROPERTY AND EQUIPMENT NET (Details Narrative) | Jun. 30, 2022 USD ($) |
PROPERTY AND EQUIPMENT, NET | |
Equipment under finance leases | $ 309,791 |
accumulated amortization | $ 56,463 |
ACCRUED EXPENSES (Details)
ACCRUED EXPENSES (Details) - USD ($) | Jun. 30, 2022 | Jun. 30, 2021 |
ACCRUED EXPENSES | ||
Clinical / regulatory costs | $ 3,944,798 | $ 778,705 |
Other research related expenses | 35,172 | 569,370 |
Professional services | 351,257 | 84,094 |
Inventory purchases | 0 | 2,340,000 |
Selling expenses | 840,703 | 1,839,724 |
Other | 157,390 | 185,485 |
Personal cost | 1,545,896 | 0 |
Total | $ 6,875,216 | $ 5,797,378 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES (Details) | Jun. 30, 2022 USD ($) |
Inventory purchase commitments | $ 9,524,486 |
Current | |
Inventory purchase commitments | 6,174,986 |
1 - 3 Years | |
Inventory purchase commitments | 2,373,000 |
4 - 5 Years | |
Inventory purchase commitments | $ 976,500 |
COMMITMENTS AND CONTINGENCIES_3
COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($) | Jun. 30, 2022 | Jun. 30, 2021 |
COMMITMENTS AND CONTINGENCIES | ||
Other Liabilities Current | $ 5,754,986 | $ 3,721,907 |
Accrued Other long-term Liabilities | 2,861,250 | 6,232,907 |
Company contributions | $ 220,864 | $ 168,210 |
REDEEMABLE CONVERTIBLE PREFER_3
REDEEMABLE CONVERTIBLE PREFERRED STOCK, ESCROWED PROCEEDS, AND STOCKHOLDERS EQUITY (Details) - 2019 Equity Distribution Agreement - Cumulative from inception | 12 Months Ended |
Jun. 30, 2022 USD ($) shares | |
Gross proceeds, shares | shares | 378,420 |
Gross proceeds | $ 12,330,242 |
Fees | 369,908 |
Expenses | $ (90,000) |
Net proceeds, shares | shares | 378,420 |
Net proceeds | $ 11,870,334 |
REDEEMABLE CONVERTIBLE PREFER_4
REDEEMABLE CONVERTIBLE PREFERRED STOCK, ESCROWED PROCEEDS, AND STOCKHOLDERS EQUITY (Details 1) | 12 Months Ended |
Jun. 30, 2022 $ / shares shares | |
Shares of Common Stock | 33,333 |
May 2022 Warrants | |
Shares of Common Stock | 66,666 |
Exercise Price per Share | $ / shares | $ 12.50 |
Latest Termination Date | May 11, 2026 |
REDEEMABLE CONVERTIBLE PREFER_5
REDEEMABLE CONVERTIBLE PREFERRED STOCK, ESCROWED PROCEEDS, AND STOCKHOLDERS EQUITY (Details 2) - USD ($) | 12 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Stockholders' equity: | ||
Number of Options Outstanding, Beginning | 875,299 | 796,097 |
Number of Options Granted | 310,494 | 141,844 |
Number of Options Forfeited | (11,539) | (22,732) |
Number of Options Exercised | 1,744 | |
Number of Options Expired | (8,548) | (39,910) |
Number of Options Outstanding, Ending | 1,163,962 | 875,299 |
Number of Options Exercisable | 693,204 | |
Number of Options Expected to vest | 470,758 | |
Weighted Average Exercise Price Outstanding, Beginning | $ 18 | $ 19 |
Weighted Average Exercise Price Granted | 10.07 | 14 |
Weighted Average Exercise Price Forfeited | 16.67 | 18.75 |
Weighted Average Exercise Price Exercised | 9.25 | 0 |
Weighted Average Exercise Price Expired | 19.79 | 23.75 |
Weighted Average Exercise Price Outstanding, Ending | 15.98 | $ 18 |
Weighted Average Exercise Price Exercisable | 18.50 | |
Weighted Average Exercise Price Options Expected to vest | $ 12.29 | |
Weighted Average Remaining Term in Years Options outstanding at beginning of year | 7 years 2 months 12 days | 7 years 4 months 24 days |
Weighted Average Remaining Term in Years Options outstanding at end of year | 7 years 1 month 6 days | 5 years 9 months 18 days |
Weighted Average Remaining Term in Years Options exercisable at end of year | 5 years 9 months 18 days | |
Weighted Average Remaining Term in Years Options Expected to vest | 9 years 1 month 6 days | |
Aggregate Intrinsic Value Options outstanding | $ 0 | |
Aggregate Intrinsic Value Options exercisable | 0 | |
Aggregate Intrinsic Value Options Expected to vest | $ 0 |
REDEEMABLE CONVERTIBLE PREFER_6
REDEEMABLE CONVERTIBLE PREFERRED STOCK, ESCROWED PROCEEDS, AND STOCKHOLDERS EQUITY (Details 3) - $ / shares | 12 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Stockholders' equity: | ||
Risk-free interest rate | 3.20% | 1% |
Volatility factor | 69.10% | 68.30% |
Dividend yield | 0% | 0% |
Expected option life (years) | 6 years | 6 years 1 month 6 days |
Weighted average grant date fair value | $ 2.68 | $ 8.50 |
REDEEMABLE CONVERTIBLE PREFER_7
REDEEMABLE CONVERTIBLE PREFERRED STOCK, ESCROWED PROCEEDS, AND STOCKHOLDERS EQUITY (Details 4) - shares | 12 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Stockholders' equity: | ||
Outstanding at beginning of year | 593,629 | 518,620 |
Granted | 131,352 | 129,774 |
Forfeited | (6,426) | (16,442) |
Vested | 69,406 | 38,323 |
Outstanding at ending of year | 649,149 | 593,629 |
REDEEMABLE CONVERTIBLE PREFER_8
REDEEMABLE CONVERTIBLE PREFERRED STOCK, ESCROWED PROCEEDS, AND STOCKHOLDERS EQUITY (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | ||||||
May 11, 2022 | Jun. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2017 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2019 | |
Stock based compensation, options | $ 1,563,686 | $ 1,863,266 | ||||||
Voting of shares description | The holders of Series C Preferred Stock were entitled to 20,000 votes per share | |||||||
Fair value of awards | 569,500 | 913,750 | 569,500 | |||||
Exercise price | $ 50 | $ 20 | $ 50 | |||||
Decription of commission | The Company pays Canaccord 3.0% of the gross proceeds as a commission | |||||||
Aggregate shares | 40,000,000 | |||||||
Vesting of restricted share | 16,191 | 6,671 | ||||||
Aggregate value | $ 221,311 | $ 93,638 | ||||||
Unvested performance-based restricted stock | $ 95,167 | $ 60,566 | 95,167 | $ 87,303 | ||||
Unvested performance-based stock options granted to executive officers and other employees | 166,233 | |||||||
Unvested performance-based stock options granted | 18,921 | |||||||
Unrecognized compensation cost | $ 2,070,413 | 2,070,413 | ||||||
Stock based compensation, restricted stock units | $ 941,852 | 1,305,390 | ||||||
Performance-based restricted stock | 18,000 | 4,700 | 43,000 | |||||
Fair value of options | $ 602,760 | |||||||
Options vested percentage | 50% | |||||||
Vested shares not issued | $ 363,780 | |||||||
Shares of Common Stock | 33,333 | |||||||
Convertible Preferred Stock | 33,333 | |||||||
Shares of Common Stock,value | $ 2,505,538 | $ 3,168,656 | ||||||
Convertible Preferred Stock were outstanding | 4,030 | 4,030 | 4,030 | |||||
Executive Officers | ||||||||
Unvested performance-based restricted stock units granted | 22,343 | 40,707 | 22,343 | 52,679 | 24,829 | |||
Outstanding restricted stock units | $ 61,556 | |||||||
Other Employees | ||||||||
Unvested performance-based restricted stock units granted | 13,751 | |||||||
Series A Convertible Preferred Stock | ||||||||
Aggregate value | $ 403,000 | |||||||
Convertible Preferred Stock were outstanding | 4,030 | |||||||
Conversion Price | $ 152.50 | $ 152.50 | ||||||
Convertible shares | $ 0.66 | $ 0.66 | ||||||
Distributable value of dividend | $ 100 | |||||||
Series B Convertible Preferred Stock | ||||||||
Selling, general and administrative expenses | 150,995 | |||||||
Fair value of the warrants | $ (234,443) | |||||||
Series J warrants | ||||||||
Shares of Common Stock | 14,000 | |||||||
Shares of Common Stock,value | $ 280,000 | |||||||
Exercise provisions | 14,000 | |||||||
Exercise Price per Share | $ 20 | |||||||
Proceeds from issue of shares | $ 280,000 | |||||||
Common stock share, issued | 14,000 | |||||||
2011 Stock Incentive Plan | ||||||||
Incentive for nonqualified stock option grants, restricted stock unit awards and other stock-based awards to employees, non-employee directors and consultants | 2,300,000 | |||||||
Shares available for grant | 211,821 | |||||||
Securities Purchase Agreement [Member] | Series B and C Redeemable Convertible Preferred Stock [Member] | ||||||||
Exercise price | $ 12.50 | |||||||
Convertible Preferred Stock | 900,000 | |||||||
Warrants to purchase up | 66,666 | |||||||
Total gross proceeds from the offering | $ 15,000,000 | |||||||
Shares sold | 8,100,000 | |||||||
Expiry of share issuance | 48 years |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) | Jun. 30, 2022 | Jun. 30, 2021 |
INCOME TAXES | ||
Net operating loss carryforwards | $ 35,331,000 | $ 32,169,000 |
Research and development and AMT tax credits | 7,171,000 | 6,461,000 |
Foreign tax credits | 583,000 | 583,000 |
Basis differences in fixed assets and other | 2,778,000 | 2,723,000 |
Gross | 45,863,000 | 41,936,000 |
Valuation allowance | (45,863,000) | (41,936,000) |
Net deferred tax assets | $ 0 | $ 0 |
INCOME TAXES (Details Narrative
INCOME TAXES (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Jun. 30, 2022 | |
Allowance increased | $ 9,513,000 | $ 3,927,000 |
Federal research and development credits | 164,000,000 | |
Federal | ||
Federal research and development credits | 7,200,000 | |
Net operating loss carryforwards | 112,800,000 | |
Foreign | ||
Net operating loss carryforwards | $ 582,500 |