Cover
Cover - USD ($) | 12 Months Ended | ||
Jun. 30, 2023 | Sep. 27, 2023 | Dec. 30, 2022 | |
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, 2023 | ||
Entity Filer Category | Non-accelerated Filer | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2023 | ||
Entity Common Stock Shares Outstanding | 11,946,646 | ||
Entity Public Float | $ 25,882,442 | ||
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, 2023 | Jun. 30, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 7,989,582 | $ 29,939,154 |
Marketable securities | 2,992,890 | 0 |
Accounts receivable | 2,915,760 | 1,780,020 |
Inventories | 526,000 | 944,471 |
Prepaid expenses and other current assets | 1,897,281 | 1,932,454 |
Total current assets | 16,321,513 | 34,596,099 |
Property and equipment, net | 684,910 | 539,314 |
Right-of-use assets - operating leases | 876,101 | 878,465 |
Other assets | 56,916 | 56,916 |
Total assets | 17,939,440 | 36,070,794 |
Current liabilities: | ||
Accounts payable | 4,303,527 | 3,157,617 |
Accrued expenses | 6,511,059 | 6,875,216 |
Short-term operating lease liabilities | 354,052 | 371,124 |
Short-term finance lease liabilities | 106,392 | 100,921 |
Other current liabilities | 3,856,800 | 5,754,986 |
Total current liabilities | 15,131,830 | 16,259,864 |
Long-term operating lease liabilities | 544,323 | 529,398 |
Long-term finance lease liabilities | 46,014 | 152,407 |
Other long-term liabilities | 2,083,200 | 2,861,250 |
Total liabilities | 17,805,367 | 19,802,919 |
Series B and Series C Redeemable Convertible Preferred Stock of $0.01 par value: authorized 9,000,000 shares, 9,000,000 shares issued and outstanding as of June 30, 2022, with a liquidation preference of $15,000,000 | 40 | 40 |
Escrowed proceeds | 0 | (15,000,000) |
Stockholders' equity: | ||
Common stock of $0.01 par value - authorized 300,000,000 shares: issued and outstanding 11,656,714 shares as of June 30, 2023 and 9,270,947 shares as of June 30, 2022 (Note 1) | 116,567 | 92,709 |
Additional paid-in capital | 415,553,049 | 404,168,822 |
Accumulated deficit | (415,535,583) | (387,993,696) |
Total stockholders' equity | 134,073 | 16,267,875 |
Total liabilities, redeemable convertible preferred stock, and stockholders' equity | 17,939,440 | 36,070,794 |
Series B And Series C Preferred Stock | ||
Current liabilities: | ||
Series B and Series C Redeemable Convertible Preferred Stock of $0.01 par value: authorized 9,000,000 shares, 9,000,000 shares issued and outstanding as of June 30, 2022, with a liquidation preference of $15,000,000 | $ 0 | $ 15,000,000 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) | Jun. 30, 2023 | Jun. 30, 2022 |
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 300,000,000 | 300,000,000 |
Common stock, shares issued | 11,656,714 | 9,270,947 |
Common stock, shares outstanding | 11,656,714 | 9,270,947 |
Series B And Series C Preferred Stock | ||
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 9,000,000 | 9,000,000 |
Preferred stock, shares issued | 9,000,000 | 9,000,000 |
Preferred stock, shares outstanding | 9,000,000 | 9,000,000 |
Preferred stock liquidation preference | $ 15,000,000 | $ 15,000,000 |
Series A Convertible Preferred Stock | ||
Preferred stock, shares authorized | 4,030 | 4,030 |
Preferred stock, shares issued | 4,030 | 4,030 |
Preferred stock, shares outstanding | 4,030 | 4,030 |
Consolidated Statements of Oper
Consolidated Statements of Operations (unaudited) - USD ($) | 12 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
REVENUES | ||
Product revenue, net | $ 4,850,678 | $ 1,218,457 |
License and contract | 3,000 | 250,000 |
Total revenues | 4,853,678 | 1,468,457 |
OPERATING EXPENSES | ||
Cost of products sold | 418,470 | 217,529 |
Research and development | 22,630,577 | 21,327,434 |
Selling, general and administrative | 15,290,836 | 16,511,942 |
Gain on purchase commitment | (1,027,322) | 0 |
Total operating expenses | 37,312,561 | 38,056,905 |
Loss from operations | (32,458,883) | (36,588,448) |
OTHER INCOME (EXPENSE) | ||
Investment income | 691,981 | 29,963 |
Foreign currency (loss) gain | (429,971) | 389,868 |
Interest expense | (20,013) | (29,682) |
Total other income (expense), net | 241,997 | 390,149 |
Loss before income taxes | (32,216,886) | (36,198,299) |
Income tax benefit | 4,674,999 | 0 |
NET LOSS | $ (27,541,887) | $ (36,198,299) |
Basic and diluted net loss per common share | $ (2.53) | $ (3.79) |
Weighted average number of common shares outstanding used in computing basic and diluted net loss per common share (Note 1) | 10,890,159 | 9,543,762 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Redeemable Convertible Preferred Stock and Stockholders Equity (unaudited) - USD ($) | Total | Series A Convertible Preferred Stock | Preferred Stock Series B | Preferred Stock Series C | Common Stock | Escrow Proceeds | Additional Paid-In Capital | Retained Earnings (Accumulated Deficit) |
Balance, shares at Jun. 30, 2021 | 4,030 | 9,201,988 | ||||||
Balance, amount at Jun. 30, 2021 | $ 49,651,372 | $ 40 | $ 0 | $ 0 | $ 92,020 | $ 0 | $ 401,354,709 | $ (351,795,397) |
Stock-based compensation, shares | 69,406 | |||||||
Stock-based compensation, amount | 2,505,538 | 0 | $ 0 | $ 0 | $ 694 | 0 | 2,504,844 | 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 | $ 13,500,000 | $ 1,500,000 | $ 0 | (15,000,000) | 234,443 | 0 |
Withholding taxes related to restricted stock units, shares | 16,191 | |||||||
Withholding taxes related to restricted stock units, amount | (221,311) | 0 | 0 | 0 | $ (162) | 0 | (221,149) | 0 |
Warrant exercises, shares | 14,000 | |||||||
Warrant exercises, amount | $ 280,000 | 0 | 0 | 0 | $ 140 | 0 | 279,860 | 0 |
Option exercises, shares | 1,744 | 1,744 | ||||||
Option exercises, amount | $ 16,132 | 0 | 0 | 0 | $ 17 | 0 | 16,115 | 0 |
Net loss | (36,198,299) | $ 0 | $ 0 | $ 0 | $ 0 | 0 | 0 | (36,198,299) |
Balance, shares at Jun. 30, 2022 | 4,030 | 8,100,000 | 900,000 | 9,270,947 | ||||
Balance, amount at Jun. 30, 2022 | 16,267,875 | $ 40 | $ 13,500,000 | $ 1,500,000 | $ 92,709 | (15,000,000) | 404,168,822 | (387,993,696) |
Stock-based compensation, shares | 84,062 | |||||||
Stock-based compensation, amount | 1,410,917 | 0 | 0 | 0 | $ 841 | 0 | 1,410,076 | |
Withholding taxes related to restricted stock units, shares | 20,468 | |||||||
Withholding taxes related to restricted stock units, amount | (146,062) | 0 | 0 | 0 | $ (205) | 0 | (145,857) | 0 |
Warrant exercises, shares | 798,182 | |||||||
Warrant exercises, amount | 78 | 0 | 0 | 0 | $ 7,982 | 0 | (7,904) | 0 |
Net loss | (27,541,887) | 0 | $ 0 | $ 0 | 0 | 0 | 0 | (27,541,887) |
Redemption of convertible series B & series C preferred stock, shares | (8,100,000) | (900,000) | ||||||
Redemption of convertible series B & series C preferred stock, amount | 0 | 0 | $ (13,500,000) | $ (1,500,000) | $ 0 | 15,000,000 | 0 | 0 |
Sale of common stock and warrants, net of costs, shares | 1,524,034 | |||||||
Sale of common stock and warrants, net of costs, amount | 10,143,152 | 0 | 0 | 0 | $ 15,240 | 0 | 10,127,912 | 0 |
Reverse stock split fractional shares, shares | (43) | |||||||
Reverse stock split fractional shares, amount | 0 | $ 0 | 0 | 0 | $ 0 | 0 | 0 | 0 |
Balance, shares at Jun. 30, 2023 | 4,030 | 11,656,714 | ||||||
Balance, amount at Jun. 30, 2023 | $ 134,073 | $ 40 | $ 0 | $ 0 | $ 116,567 | $ 0 | $ 415,553,049 | $ (415,535,583) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (unaudited) - USD ($) | 12 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (27,541,887) | $ (36,198,299) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 288,331 | 126,668 |
Decrease in right-of-use asset | 371,339 | 359,348 |
Unrealized foreign currency transaction loss | 429,971 | (389,868) |
Non-cash warrant expense | 0 | 234,443 |
Stock-based compensation | 1,410,917 | 2,505,538 |
Gain on purchase commitment | (1,027,322) | 0 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (1,135,740) | (199,577) |
Prepaid expenses and other assets | 35,173 | 1,127,225 |
Inventories | 418,471 | 217,529 |
Accounts payable | 1,109,541 | 2,572,657 |
Accrued expenses | (364,157) | 1,077,838 |
Operating lease liabilities | (371,122) | (351,851) |
Other liabilities | (2,042,516) | (1,004,400) |
Net cash used in operating activities | (28,419,001) | (29,922,749) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of marketable securities | (2,992,890) | 0 |
Purchases of property and equipment | (433,927) | (261,374) |
Net cash used in investing activities | (3,426,817) | (261,374) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Payment of withholding taxes related to restricted stock units | (146,062) | (221,311) |
Proceeds from the sale of common stock and warrants, net of costs | 10,143,152 | 0 |
Payment of finance lease obligations | (100,922) | (56,463) |
Proceeds from exercise of warrants | 78 | 280,000 |
Proceeds from exercise of stock options | 0 | 16,132 |
Net cash provided by financing activities | 9,896,246 | 18,358 |
NET DECREASE IN CASH AND CASH EQUIVALENTS | (21,949,572) | (30,165,765) |
CASH AND CASH EQUIVALENTS, beginning of year | 29,939,154 | 60,104,919 |
CASH AND CASH EQUIVALENTS, end of year | 7,989,582 | 29,939,154 |
SUPPLEMENTAL CASH FLOW INFORMATION: | ||
Cash paid for interest | $ 20,013 | $ 29,682 |
ORGANIZATION
ORGANIZATION | 12 Months Ended |
Jun. 30, 2023 | |
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 for the treatment of hypoactive sexual desire disorder (“HSDD”) in premenopausal women and is being marketed by the Company 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. Business Risks and Liquidity – As of June 30, 2023, the Company’s cash, cash equivalents and marketable securities were $10,982,472 and current liabilities were $15,131,830. 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 Based on the Company’s cash, cash equivalents and marketable securities at June 30, 2023, 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 existing cash, cash equivalents and marketable securities as of the date of this filing will be sufficient to fund currently anticipated operating expenses through calendar year 2023. 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. There may be delays in obtaining regulatory approvals to sell Vyleesi in China and Korea, which would delay when the Company receives royalty income from sales in those countries. Concentrations – |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Jun. 30, 2023 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | (2) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Principles of Consolidation Use of Estimates Cash, Cash Equivalents Marketable Securities 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 years ended June 30, 2023 and 2022 are as follows: Year Ended June 30, 2023 2022 Gross product sales $ 12,460,140 $ 5,816,530 Product sales allowances and accruals (7,609,462 ) (4,598,073 ) Net sales $ 4,850,678 $ 1,218,457 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 required 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 was 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 was performed as the holders of these securities were not contractually obligated to participate in the Company’s losses. For the years ended June 30, 2023 and 2022, 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, 2023 and June 30, 2022 was 4,161,377 and 2,851,959 respectively. Included in the weighted average common shares used in computing basic and diluted net loss per common share are 356,003 and 363,780 vested restricted stock units that had not been issued as of June 30, 2023 and 2022, 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, 2023 | |
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 June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses: Measurement of Credit Losses on Financial Instruments, |
MANUFACTURING SUPPLY AGREEMENTS
MANUFACTURING SUPPLY AGREEMENTS FOR VYLEESI | 12 Months Ended |
Jun. 30, 2023 | |
MANUFACTURING SUPPLY AGREEMENTS FOR VYLEESI | |
MANUFACTURING SUPPLY AGREEMENTS FOR VYLEESI | (4) MANUFACTURING SUPPLY AGREEMENTS FOR VYLEESI The Company has 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. The Company and Catalent then entered into a new Vyleesi manufacturing agreement (the “Catalent Agreement”) which includes reduced minimum annual purchase requirements (see Note 13) as compared to the original Catalent Agreement and modification of other financial terms. The 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 Catalent Agreement through August 21, 2025, unless earlier terminated in accordance with the terms of the Catalent Agreement. The initial term of the 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 Catalent Agreement also includes customary terms and conditions relating to forecasting and minimum commitments, ordering, delivery, inspection and acceptance, and termination, among other matters (See Note 13). 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 13). The term of the Lonza Agreement was set to expire on December 31, 2022. In November 2022, Lonza and the Company amended the Lonza Agreement to extend contract peptide manufacturing services until June 30, 2024. The Company intends to seek to extend contract peptide manufacturing services with Lonza past June 30, 2024, and is also actively evaluating potential new contract manufacturers. 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. The amendment reduced certain minimum purchase commitments that were previously accrued for. As a result, the Company recorded a gain on the purchase commitment of $1,027,322 upon the reversal of the accrual (see Note 13). |
AGREEMENT WITH FOSUN
AGREEMENT WITH FOSUN | 12 Months Ended |
Jun. 30, 2023 | |
AGREEMENT WITH FOSUN | |
AGREEMENT WITH FOSUN | (5) 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. the Company recorded $3,000 and $250,000 of license and contract revenue related to the Fosun License Agreement for the years ended June 30, 2023 and 2022, respectively. |
AGREEMENT WITH KWANGDONG
AGREEMENT WITH KWANGDONG | 12 Months Ended |
Jun. 30, 2023 | |
AGREEMENT WITH KWANGDONG | |
AGREEMENT WITH KWANGDONG | (6) 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. |
PREPAID EXPENSES AND OTHER CURR
PREPAID EXPENSES AND OTHER CURRENT ASSETS | 12 Months Ended |
Jun. 30, 2023 | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | (7) PREPAID EXPENSES AND OTHER CURRENT ASSETS Prepaid expensesand other current assets consist of the following: June 30, June 30, 2023 2022 Clinical / regulatory costs $ 141,512 $ 310,573 Insurance premiums 342,645 132,413 Vyleesi contractual advances 816,750 815,750 Other 596,374 673,718 $ 1,897,281 $ 1,932,454 |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 12 Months Ended |
Jun. 30, 2023 | |
FAIR VALUE MEASUREMENTS | |
FAIR VALUE MEASUREMENTS | (8) 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, 2023: Cash Equivalents - Money market funds $ 2,808,598 $ 2,808,598 Cash Equivalents - Treasury bill 2,980,620 2,980,620 Marketable securities - Treasury bill 2,992,890 2,992,890 Total $ 8,782,108 $ 8,782,108 $ - $ - June 30, 2022: Money market account $ 29,740,565 $ 29,740,565 $ - $ - |
INVENTORIES
INVENTORIES | 12 Months Ended |
Jun. 30, 2023 | |
INVENTORIES | |
INVENTORIES | (9) INVENTORIES Inventories consist of raw materials and finished goods related to Vyleesi. The following table summarizes the components of inventories: June 30, June 30, 2023 2022 Raw materials $ 526,000 $ 526,000 Finished goods - 418,471 $ 526,000 $ 944,471 |
LEASES
LEASES | 12 Months Ended |
Jun. 30, 2023 | |
LEASES | |
LEASES | (10) LEASES The Company has operating leases for office and laboratory space, which expire on June 30, 2025 and October 31, 2026, respectively. The components of operating lease cost are as follows: Operating lease cost Year ended June 30, 2023 Year ended June 30, 2022 Operating lease cost $ 291,878 $ 294,293 Variable lease cost 114,441 114,418 Total operating lease cost $ 406,319 $ 408,711 The components of finance lease cost are as follows: Finance lease cost Year ended June 30, 2023 Year ended June 30, 2022 Right-of-use asset amortization $ 100,922 $ 56,463 Interest expense 10,975 8,812 Total finance lease cost $ 111,897 $ 65,275 Supplemental lease term and discount rate information related to leases was as follows: June 30, 2023 June 30, 2022 Weighted-average remaining lease term (years) operating leases 2.3 2.6 Weighted-average remaining lease term (years) finance leases 1.4 2.4 Weighted-average discount rate operating leases 5.50 % 5.50 % Weighted-average discount rate finance leases 5.29 % 5.29 % Supplemental cash flow information related to leases was as follows: Year Ended June 30, 2023 Year Ended June 30, 2022 Cash paid for the amounts included in the measurement of lease liabilities: Operating cash flows for operating leases $ 406,319 $ 410,007 Operating cash flows for finance leases 10,975 8,812 Financing cash flows for finance leases 100,922 56,463 $ 518,216 $ 475,282 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 $ 368,975 $ - 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, 2023: Operating leases: Year Ending June 30 2024 $ 387,909 2025 397,611 2026 134,973 2027 33,894 Less imputed interest (56,012 ) Total $ 898,375 Finance leases: Year Ending June 30 2024 $ 111,899 2025 46,625 Less imputed interest (6,118 ) Total $ 152,406 |
PROPERTY AND EQUIPMENT, NET
PROPERTY AND EQUIPMENT, NET | 12 Months Ended |
Jun. 30, 2023 | |
PROPERTY AND EQUIPMENT, NET | |
PROPERTY AND EQUIPMENT, NET | (11) PROPERTY AND EQUIPMENT, NET Property and equipment, net, consists of the following: June 30, June 30, 2023 2022 Office equipment $ 1,229,300 $ 1,229,300 Laboratory equipment 1,177,868 1,038,610 Leasehold improvements 1,196,706 902,038 3,603,874 3,169,948 Less: Accumulated depreciation and amortization (2,918,964 ) (2,630,634 ) $ 684,910 $ 539,314 Included in property and equipment, net as of June 30, 2023 is $309,791 in equipment under finance leases and $157,385 related accumulated amortization. |
ACCRUED EXPENSES
ACCRUED EXPENSES | 12 Months Ended |
Jun. 30, 2023 | |
ACCRUED EXPENSES | |
ACCRUED EXPENSES | (12) ACCRUED EXPENSES Accrued expensesconsist of the following: June 30, June 30, 2023 2022 Clinical / regulatory costs $ 2,960,126 $ 3,944,798 Other research related expenses 121,121 35,172 Professional services 339,258 351,257 Personnel costs 1,563,847 1,545,896 Selling expenses 1,266,653 840,703 Other 260,054 157,390 $ 6,511,059 $ 6,875,216 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Jun. 30, 2023 | |
COMMITMENTS AND CONTINGENCIES | |
COMMITMENTS AND CONTINGENCIES | (13) COMMITMENTS AND CONTINGENCIES Inventory Purchases The term of the Lonza Agreement was set to expire on December 31, 2022. In November 2022, Lonza and the Company amended the Lonza Agreement to extend contract peptide manufacturing services until June 30, 2024. The Company intends to seek to extend contract peptide manufacturing services with Lonza past June 30, 2024, and is also actively evaluating potential new contract manufacturers. 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. The amendment reduced certain minimum purchase commitments that were previously accrued for. As a result, the Company recorded a gain on the purchase commitment of $1,027,322. The following table summarizes the contractual obligations under the New Catalent Agreement, Yposmed Agreement, and Lonza Agreement as of June 30, 2023: Total Current 1 - 3 Years 4 - 5 Years Inventory purchase commitments $ 6,896,800 $ 4,813,600 $ 2,083,200 $ - As of June 30, 2023, the Company has $3,856,800 and $2,083,200 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, 2022, $5,754,986 and $2,861,250 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, 2023 | |
REDEEMABLE CONVERTIBLE PREFERRED STOCK, ESCROWED PROCEEDS, AND STOCKHOLDERS EQUITY | |
REDEEMABLE CONVERTIBLE PREFERRED STOCK, ESCROWED PROCEEDS, AND STOCKHOLDERS' EQUITY | (14) REDEEMABLE CONVERTIBLE PREFERRED STOCK, ESCROWED PROCEEDS, AND STOCKHOLDERS’ EQUITY Series B and C Redeemable Convertible Preferred Stock Given that the fee and other costs were not refundable to the Company as of June 30, 2022, regardless of the election selected by the investors, the $750,000 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. Series A Convertible Preferred Stock Financing Transactions – The Common Warrants have an exercise price of $5.83 per share, are exercisable beginning six months after the date of issuance and will expire five and one-half years from the date of issuance. The Pre-Funded Warrants have an exercise price of $0.0001 per share, are exercisable upon issuance, and will expire when exercised in full. The Common Warrants will be exercisable for cash, or, solely during any period when a registration statement for the issuance or resale of the shares of common stock issuable upon exercise of the Common Warrants to or by the holder of such Common Warrants is not in effect, on a cashless basis. During the year ended June 30, 2023, the institutional investor exercised the outstanding Pre-Funded Warrants to purchase 798,182 shares of the Company’s common stock. The proceeds from the Offering, after deducting the placement agent fees and expenses and other estimated offering expenses, were $9,109,117. On April 12, 2023, the Company entered into a new equity distribution agreement with Canaccord Genuity LLC (the “2023 Equity Distribution Agreement”), pursuant to which the Company may, from time to time, sell shares of the Company’s common stock at market prices by methods deemed to be an “at-the-market offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended. The 2023 Equity Distribution Agreement and related prospectus is limited to sales of up to an aggregate maximum $50.0 million of shares of the Company’s common stock. The Company pays Canaccord 3.0% of the gross proceeds as a commission. For the year ended June 30, 2023, a total of 504,034 shares of common stock were sold through Canaccord under the 2023 Equity Distribution Agreement for net proceeds of $1,034,035 after payment of commission fees of $35,902 and other related expenses of $126,801. Sale of shares after July 1, 2023 is reported in Note 16, Subsequent events. As of June 30, 2023, the Company had outstanding warrants for shares of common stock as follows: Shares of Common Exercise Price Latest Expiration Description Stock per Share Date May 2022 Warrants 66,666 $ 12.50 May 11, 2026 November 2022 Common Warrants 1,818,182 $ 5.83 May 2, 2028 November 2022 Placement Agent Warrants 90,909 $ 6.88 October 31, 2027 Stock Plan – The following table summarizes option activity and related information for the years ended June 30, 2023 and 2022: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Term in Years Aggregate Intrinsic Value 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 Granted 712,310 2.30 Forfeited (274,440 ) 12.00 Exercised - - Expired (51,232 ) 17.45 Outstanding - June 30, 2023 1,550,600 8.27 8.4 $ - Exercisable at June 30, 2023 537,802 $ 14.33 6.4 $ - Expected to vest at June 30, 2023 1,012,798 $ 5.05 9.4 $ - On December 16, 2022, Carl Spana, President and CEO of the Company, and Stephen T. Wills, CFO, COO and Executive Vice President of the Company, voluntarily contributed stock options previously issued to them to purchase 143,360 and 124,220 shares, respectively, of the Company’s common stock to the 2011 Stock Incentive Plan. The stock options were forfeited and cancelled without payment of any consideration by the Company. 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 318,813 and 57,999 unvested performance-based stock options granted to executive officers and other employees, respectively, which were granted in June 2020, 2021, 2022 and 2023. Grants in June 2020, 2021, 2022 and 2023 were 87,303, 95,167, 60,566, and 238,838, respectively. The performance-based stock options vest on annual performance criteria through the fiscal years ending June 30, 2027 relating to advancement of MC1r programs, including initiation of clinical trials and licensing of Vyleesi in additional countries or regions. For the years ended June 30, 2023 and 2022, 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, 2023 and 2022 were as follows: Year Ended June 30, Year Ended June 30, 2023 2022 Risk-free interest rate 3.9 % 3.2 % Volatility factor 65.6 % 69.1 % Dividend yield 0 % 0 % Expected option life (years) 6.1 6.0 Weighted average grant date fair value $ 0.99 $ 2.68 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, 2023 and 2022, the Company recorded stock-based compensation related to stock options of $794,735 and $1,563,686, respectively. As of June 30, 2023, there was $1,670,986 of unrecognized compensation cost related to unvested options, which is expected to be recognized over a weighted-average period of 2.6 years. Restricted Stock Units – Year Ended June 30, Year Ended June 30, 2023 2022 Outstanding at beginning of year 649,149 593,629 Granted 425,750 131,352 Forfeited (3,312 ) (6,426 ) Vested (84,062 ) (69,406 ) Fractional shares (4 ) - Outstanding at end of year 987,521 649,149 For the years ended June 30, 2023 and 2022, the Company recorded stock-based compensation related to restricted stock units of $616,182 and $941,852, respectively. Included in outstanding restricted stock units in the table above are 356,003 vested shares that have not been issued as of June 30, 2023 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 217,833 and 37,116 unvested performance-based restricted stock units granted to executive officers and other employees, respectively, which were granted in June 2020, 2021, 2022, and 2023. Grants in June 2020, 2021, 2022 and 2023 were 52,679, 22,343, 40,707, and 152,432 restricted stock units, 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 connection with the vesting of restricted share units during the years ended June 30, 2023 and 2022, the Company withheld 20,468 and 16,191, shares, respectively, with aggregate values of $146,062 and $221,311, respectively, in satisfaction of minimum tax withholding obligations. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Jun. 30, 2023 | |
INCOME TAXES | |
INCOME TAXES | (15) INCOME TAXES The Company has participated in the State of New Jersey’s Technology Business Tax Certificate Transfer Program (the “Program”) sponsored by The New Jersey Economic Development Authority. The Program enables approved biotechnology companies with unused Net Operating Losses (“NOLs”) and unused research and development credits (“R&D credits”) to sell these tax benefits for at least 80% of the value of the tax benefits to unaffiliated, profitable corporate taxpayers in the State of New Jersey. The Company received final approval in December 2022 for the sale of NOLs and R&D credits that resulted in the receipt of $4,674,999 in January 2023. As a result, the Company recorded an income tax benefit for the year ended June 30, 2023. For fiscal 2023 and 2022, 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, 2023, the Company had state NOL carryforwards of approximately $155,000,000, which will expire, if not utilized, between 2036 and 2043, federal NOL carryforwards of approximately $138,000,000 and federal R&D and Alternative Minimum Tax (“AMT”) credits of approximately $8,100,000, which expire, if not utilized, between 2035 and 2043, 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 deferred tax assets during the years ended June 30, 2023 and 2022. The Company’s valuation allowance increased by $5,653,000 and $3,927,000 for the years ended June 30, 2023 and 2022, 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 NOL 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, 2023 2022 Net operating loss carryforwards $ 40,073,000 $ 35,331,000 Research and development and AMT tax credits 8,094,000 7,171,000 Foreign tax credits 583,000 583,000 Basis differences in fixed assets and other 2,766,000 2,778,000 51,516,000 45,863,000 Valuation allowance (51,516,000 ) (45,863,000 ) 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 2023 or 2022. As of June 30, 2023 and 2022, the Company had no liabilities for uncertain income tax matters. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Jun. 30, 2023 | |
SUBSEQUENT EVENTS | |
SUBSEQUENT EVENTS | (16) SUBSEQUENT EVENTS Between July 1, 2023 and September 27, 2023, a total of 217,027 shares of common stock were sold through Canaccord under the 2023 Equity Distribution Agreement for net proceeds of $531,369 after payment of commission fees of $16,434. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Jun. 30, 2023 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Principles of Consolidation | Principles of Consolidation |
Use of Estimates | Use of Estimates |
Cash and Cash Equivalents | Cash, Cash Equivalents |
Marketable Securities | Marketable Securities |
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 years ended June 30, 2023 and 2022 are as follows: Year Ended June 30, 2023 2022 Gross product sales $ 12,460,140 $ 5,816,530 Product sales allowances and accruals (7,609,462 ) (4,598,073 ) Net sales $ 4,850,678 $ 1,218,457 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 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 required 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 was 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 was performed as the holders of these securities were not contractually obligated to participate in the Company’s losses. For the years ended June 30, 2023 and 2022, 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, 2023 and June 30, 2022 was 4,161,377 and 2,851,959 respectively. Included in the weighted average common shares used in computing basic and diluted net loss per common share are 356,003 and 363,780 vested restricted stock units that had not been issued as of June 30, 2023 and 2022, respectively, due to a provision in the restricted stock unit agreements to delay delivery. |
Translation of foreign currencies | Translation of foreign currencies |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Jun. 30, 2023 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Schedule of sales | Year Ended June 30, 2023 2022 Gross product sales $ 12,460,140 $ 5,816,530 Product sales allowances and accruals (7,609,462 ) (4,598,073 ) Net sales $ 4,850,678 $ 1,218,457 |
PREPAID EXPENSES AND OTHER CU_2
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables) | 12 Months Ended |
Jun. 30, 2023 | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | |
Schedule of prepaid expenses and other current assets | June 30, June 30, 2023 2022 Clinical / regulatory costs $ 141,512 $ 310,573 Insurance premiums 342,645 132,413 Vyleesi contractual advances 816,750 815,750 Other 596,374 673,718 $ 1,897,281 $ 1,932,454 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 12 Months Ended |
Jun. 30, 2023 | |
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, 2023: Cash Equivalents - Money market funds $ 2,808,598 $ 2,808,598 Cash Equivalents - Treasury bill 2,980,620 2,980,620 Marketable securities - Treasury bill 2,992,890 2,992,890 Total $ 8,782,108 $ 8,782,108 $ - $ - June 30, 2022: Money market account $ 29,740,565 $ 29,740,565 $ - $ - |
INVENTORIES (Tables)
INVENTORIES (Tables) | 12 Months Ended |
Jun. 30, 2023 | |
INVENTORIES | |
Schedule of inventory | June 30, June 30, 2023 2022 Raw materials $ 526,000 $ 526,000 Finished goods - 418,471 $ 526,000 $ 944,471 |
LEASES (Tables)
LEASES (Tables) | 12 Months Ended |
Jun. 30, 2023 | |
LEASES | |
Schedule of components of operating lease | Operating lease cost Year ended June 30, 2023 Year ended June 30, 2022 Operating lease cost $ 291,878 $ 294,293 Variable lease cost 114,441 114,418 Total operating lease cost $ 406,319 $ 408,711 |
Schedule of components of financing lease | Finance lease cost Year ended June 30, 2023 Year ended June 30, 2022 Right-of-use asset amortization $ 100,922 $ 56,463 Interest expense 10,975 8,812 Total finance lease cost $ 111,897 $ 65,275 |
Lease term and discount rate information | June 30, 2023 June 30, 2022 Weighted-average remaining lease term (years) operating leases 2.3 2.6 Weighted-average remaining lease term (years) finance leases 1.4 2.4 Weighted-average discount rate operating leases 5.50 % 5.50 % Weighted-average discount rate finance leases 5.29 % 5.29 % |
Schedule of cash flow information | Year Ended June 30, 2023 Year Ended June 30, 2022 Cash paid for the amounts included in the measurement of lease liabilities: Operating cash flows for operating leases $ 406,319 $ 410,007 Operating cash flows for finance leases 10,975 8,812 Financing cash flows for finance leases 100,922 56,463 $ 518,216 $ 475,282 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 $ 368,975 $ - Right-of-use assets obtained in exchange for new finance lease obligations $ - $ 309,791 |
Schedule of maturity of lease liabilities | Operating leases: Year Ending June 30 2024 $ 387,909 2025 397,611 2026 134,973 2027 33,894 Less imputed interest (56,012 ) Total $ 898,375 Finance leases: Year Ending June 30 2024 $ 111,899 2025 46,625 Less imputed interest (6,118 ) Total $ 152,406 |
PROPERTY AND EQUIPMENT, NET (Ta
PROPERTY AND EQUIPMENT, NET (Tables) | 12 Months Ended |
Jun. 30, 2023 | |
PROPERTY AND EQUIPMENT, NET | |
Schedule of property and equipment net | June 30, June 30, 2023 2022 Office equipment $ 1,229,300 $ 1,229,300 Laboratory equipment 1,177,868 1,038,610 Leasehold improvements 1,196,706 902,038 3,603,874 3,169,948 Less: Accumulated depreciation and amortization (2,918,964 ) (2,630,634 ) $ 684,910 $ 539,314 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 12 Months Ended |
Jun. 30, 2023 | |
ACCRUED EXPENSES | |
Schdule of Accrued Expenses | June 30, June 30, 2023 2022 Clinical / regulatory costs $ 2,960,126 $ 3,944,798 Other research related expenses 121,121 35,172 Professional services 339,258 351,257 Personnel costs 1,563,847 1,545,896 Selling expenses 1,266,653 840,703 Other 260,054 157,390 $ 6,511,059 $ 6,875,216 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Jun. 30, 2023 | |
COMMITMENTS AND CONTINGENCIES | |
Schedule of inventory purchase commitments | Total Current 1 - 3 Years 4 - 5 Years Inventory purchase commitments $ 6,896,800 $ 4,813,600 $ 2,083,200 $ - |
STOCKHOLDERS EQUITY AND REDEEMA
STOCKHOLDERS EQUITY AND REDEEMABLE CONVERTIBLE PREFERRED STOCK (Tables) | 12 Months Ended |
Jun. 30, 2023 | |
REDEEMABLE CONVERTIBLE PREFERRED STOCK, ESCROWED PROCEEDS, AND STOCKHOLDERS EQUITY | |
Outstanding Stock Purchase Warrants | Shares of Common Exercise Price Latest Expiration Description Stock per Share Date May 2022 Warrants 66,666 $ 12.50 May 11, 2026 November 2022 Common Warrants 1,818,182 $ 5.83 May 2, 2028 November 2022 Placement Agent Warrants 90,909 $ 6.88 October 31, 2027 |
Option activity | Number of Shares Weighted Average Exercise Price Weighted Average Remaining Term in Years Aggregate Intrinsic Value 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 Granted 712,310 2.30 Forfeited (274,440 ) 12.00 Exercised - - Expired (51,232 ) 17.45 Outstanding - June 30, 2023 1,550,600 8.27 8.4 $ - Exercisable at June 30, 2023 537,802 $ 14.33 6.4 $ - Expected to vest at June 30, 2023 1,012,798 $ 5.05 9.4 $ - |
Weighted average assumption | Year Ended June 30, Year Ended June 30, 2023 2022 Risk-free interest rate 3.9 % 3.2 % Volatility factor 65.6 % 69.1 % Dividend yield 0 % 0 % Expected option life (years) 6.1 6.0 Weighted average grant date fair value $ 0.99 $ 2.68 |
Restricted Stock Units | Year Ended June 30, Year Ended June 30, 2023 2022 Outstanding at beginning of year 649,149 593,629 Granted 425,750 131,352 Forfeited (3,312 ) (6,426 ) Vested (84,062 ) (69,406 ) Fractional shares (4 ) - Outstanding at end of year 987,521 649,149 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Jun. 30, 2023 | |
INCOME TAXES | |
Schedule of deferred tax assets | June 30, June 30, 2023 2022 Net operating loss carryforwards $ 40,073,000 $ 35,331,000 Research and development and AMT tax credits 8,094,000 7,171,000 Foreign tax credits 583,000 583,000 Basis differences in fixed assets and other 2,766,000 2,778,000 51,516,000 45,863,000 Valuation allowance (51,516,000 ) (45,863,000 ) Net deferred tax assets $ - $ - |
ORGANIZATION (Details Narrative
ORGANIZATION (Details Narrative) - USD ($) | 12 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
ORGANIZATION | ||
Accumulated deficit | $ 415,535,583 | $ 387,993,696 |
Net loss | (27,541,887) | (36,198,299) |
Cash and cash equivalents | 10,982,472 | |
Total current liabilities | $ 15,131,830 | $ 16,259,864 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - Product Revenue - USD ($) | 12 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Gross product sales | $ 12,460,140 | $ 5,816,530 |
Provision for product sales allowances and accruals | (7,609,462) | (4,598,073) |
Net sales | $ 4,850,678 | $ 1,218,457 |
SUMMARY OF SIGNIFICANT ACCOUN_5
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) | 12 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ||
Cash and cash equivalents | $ 5,789,218 | $ 29,740,565 |
Potential number of common shares excluded from diluted EPS | 4,161,377 | 2,851,959 |
Weighted average vested restricted stock units | 356,003 | 363,780 |
MANUFACTURING SUPPLY AGREEMEN_2
MANUFACTURING SUPPLY AGREEMENTS FOR VYLEESI (Details Narrative) | 12 Months Ended |
Jun. 30, 2023 USD ($) | |
MANUFACTURING SUPPLY AGREEMENTS FOR VYLEESI | |
Gain on the purchase commitment | $ 1,027,322 |
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, 2023 | Jun. 30, 2022 | |
AGREEMENT WITH FOSUN | ||||
Company License Agreement Recievables | $ 4,500,000 | |||
Upfront Payments | 5,000,000 | $ 500,000 | ||
Milestone payment receivable | 7,500,000 | 3,000,000 | ||
Additional Sales Recievable | $ 92,500,000 | $ 37,500,000 | ||
License and contract revenue | $ 3,000 | $ 250,000 |
AGREEMENT WITH KWANGDONG (Detai
AGREEMENT WITH KWANGDONG (Details Narrative) - USD ($) | 1 Months Ended | |
Sep. 06, 2017 | Nov. 21, 2017 | |
AGREEMENT WITH KWANGDONG | ||
Recievable under company agreement | $ 417,500 | |
Upfront payments | $ 5,000,000 | 500,000 |
Tax Expense | 82,500 | |
Additional Sales Recievable | 92,500,000 | 37,500,000 |
Milestone payment receivable | $ 7,500,000 | $ 3,000,000 |
PREPAID EXPENSES AND OTHER CU_3
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Details) - USD ($) | Jun. 30, 2023 | Jun. 30, 2022 |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | ||
Clinical / regulatory costs | $ 141,512 | $ 310,573 |
Insurance premiums | 342,645 | 132,413 |
Vyleesi contractual advances | 816,750 | 815,750 |
Other | 596,374 | 673,718 |
Total prepaid expenses and other current assets | $ 1,897,281 | $ 1,932,454 |
FAIR VALUE MEASUREMENTS (Detail
FAIR VALUE MEASUREMENTS (Details) - USD ($) | Jun. 30, 2023 | Jun. 30, 2022 |
Cash Equivalents - Money market funds | $ 2,808,598 | $ 29,740,565 |
Cash Equivalents - Treasury bill | 2,980,620 | |
Marketable securities - Treasury bill | 2,992,890 | |
Total | 8,782,108 | |
Level 2 | ||
Cash Equivalents - Money market funds | 0 | 0 |
Level 3 | ||
Cash Equivalents - Money market funds | 0 | 0 |
Level 1 | ||
Cash Equivalents - Money market funds | 2,808,598 | $ 29,740,565 |
Cash Equivalents - Treasury bill | 2,980,620 | |
Marketable securities - Treasury bill | 2,992,890 | |
Total | $ 8,782,108 |
INVENTORIES (Details)
INVENTORIES (Details) - USD ($) | Jun. 30, 2023 | Jun. 30, 2022 |
INVENTORIES | ||
Raw materials | $ 526,000 | $ 526,000 |
Finished goods | 0 | 418,471 |
Inventories | $ 526,000 | $ 944,471 |
LEASES (Details)
LEASES (Details) - USD ($) | 12 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
LEASES | ||
Operating lease cost | $ 291,878 | $ 294,293 |
Variable lease cost | 114,441 | 114,418 |
Total operating lease cost | $ 406,319 | $ 408,711 |
LEASES (Details 1)
LEASES (Details 1) - USD ($) | 12 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
LEASES | ||
Right of use asset amortization Finance lease cost | $ 100,922 | $ 56,463 |
Interest expense | 10,975 | 8,812 |
Total finance cost | $ 111,897 | $ 65,275 |
LEASES (Details 2)
LEASES (Details 2) - USD ($) | 12 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
LEASES | ||
Weighted -average remaining lease term (years) | 2.3 | 2.6 |
Weighted -average remaining lease term (years) finance lease | 1.4 | 2.4 |
Weighted -average discount rate | 5.50% | 5.50% |
Weighted -average discount rate finance lease | 5.29% | 5.29% |
Operating cash flows for operating leases | $ 406,319 | $ 410,007 |
Operating cash flows for Finance lease | 10,975 | 8,812 |
Financing cash flows for Finance lease | 100,922 | 56,463 |
Total measurement of lease liabilities | 518,216 | 475,282 |
Right-of-use assets obtained in exchange for new lease obligation | 368,975 | 0 |
Right-of-use assets obtained in exchange for new finance lease obligation | $ 0 | $ 309,791 |
LEASES (Details 3)
LEASES (Details 3) | Jun. 30, 2023 USD ($) |
Year ending June 30, 2024 | $ 111,899 |
Year ending June 30, 2025 | 46,625 |
Less imputed interest | (6,118) |
Total | 152,406 |
Operating Lease [Member] | |
Year ending June 30, 2024 | 387,909 |
Year ending June 30, 2025 | 397,611 |
Year ending June 30, 2026 | 134,973 |
Year ending June 30, 2027 | 33,894 |
Less imputed interest | (56,012) |
Total | $ 898,375 |
LEASES (Details Narrative)
LEASES (Details Narrative) | 12 Months Ended |
Jun. 30, 2023 | |
LEASES | |
Description of office space | The Company has operating leases for office and laboratory space, which expire on June 30, 2025 and October 31, 2026, respectively |
PROPERTY AND EQUIPMENT NET (Det
PROPERTY AND EQUIPMENT NET (Details) - USD ($) | Jun. 30, 2023 | Jun. 30, 2022 |
PROPERTY AND EQUIPMENT, NET | ||
Office equipment | $ 1,229,300 | $ 1,229,300 |
Laboratory equipment | 1,177,868 | 1,038,610 |
Leasehold improvements | 1,196,706 | 902,038 |
Gross | 3,603,874 | 3,169,948 |
Less: Accumulated depreciation and amortization | (2,918,964) | (2,630,634) |
Net | $ 684,910 | $ 539,314 |
PROPERTY AND EQUIPMENT NET (D_2
PROPERTY AND EQUIPMENT NET (Details Narrative) | Jun. 30, 2023 USD ($) |
PROPERTY AND EQUIPMENT, NET | |
Equipment under finance leases | $ 309,791 |
Accumulated amortization | $ 157,385 |
ACCRUED EXPENSES (Details)
ACCRUED EXPENSES (Details) - USD ($) | Jun. 30, 2023 | Jun. 30, 2022 |
ACCRUED EXPENSES | ||
Clinical / regulatory costs | $ 2,960,126 | $ 3,944,798 |
Other research related expenses | 121,121 | 35,172 |
Professional services | 339,258 | 351,257 |
Personal cost | 1,563,847 | 1,545,896 |
Selling expenses | 1,266,653 | 840,703 |
Other | 260,054 | 157,390 |
Total | $ 6,511,059 | $ 6,875,216 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES (Details) | Jun. 30, 2023 USD ($) |
Inventory purchase commitments | $ 6,896,800 |
Current | |
Inventory purchase commitments | 4,813,600 |
1 - 3 Years | |
Inventory purchase commitments | $ 2,083,200 |
COMMITMENTS AND CONTINGENCIES_3
COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($) | 12 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
COMMITMENTS AND CONTINGENCIES | ||
Other Liabilities Current | $ 3,856,800 | $ 5,754,986 |
Accrued Other long-term Liabilities | 2,083,200 | 2,861,250 |
Gain on purchase commitment | 1,027,322 | |
Employee retirement savings contribution plan | $ 294,431 | $ 220,864 |
REDEEMABLE CONVERTIBLE PREFER_2
REDEEMABLE CONVERTIBLE PREFERRED STOCK, ESCROWED PROCEEDS, AND STOCKHOLDERS EQUITY (Details) | 12 Months Ended |
Jun. 30, 2023 $ / shares shares | |
May 2022 Warrants | |
Shares of Common Stock | shares | 66,666 |
Exercise Price per Share | $ / shares | $ 12.50 |
Latest Termination Date | May 11, 2026 |
November 2022 Common Warrants | |
Shares of Common Stock | shares | 1,818,182 |
Exercise Price per Share | $ / shares | $ 5.83 |
Latest Termination Date | May 2, 2028 |
November 2022 Placement Agent Warrants | |
Shares of Common Stock | shares | 90,909 |
Exercise Price per Share | $ / shares | $ 6.88 |
Latest Termination Date | October 31, 2027 |
REDEEMABLE CONVERTIBLE PREFER_3
REDEEMABLE CONVERTIBLE PREFERRED STOCK, ESCROWED PROCEEDS, AND STOCKHOLDERS EQUITY (Details 1) - USD ($) | 12 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
REDEEMABLE CONVERTIBLE PREFERRED STOCK, ESCROWED PROCEEDS, AND STOCKHOLDERS EQUITY | ||
Number of Options Outstanding, Beginning | 1,163,962 | 875,299 |
Number of Options Granted | 712,310 | 310,494 |
Number of Options Forfeited | (274,440) | (11,539) |
Number of Options Exercised | (1,744) | |
Number of Options Expired | (51,232) | (8,548) |
Number of Options Outstanding, Ending | 1,550,600 | 1,163,962 |
Number of Options Exercisable | 537,802 | |
Number of Options Expected to vest | 1,012,798 | |
Weighted Average Exercise Price Outstanding, Beginning | $ 15.98 | $ 18 |
Weighted Average Exercise Price Granted | 2.30 | 10.07 |
Weighted Average Exercise Price Forfeited | 12 | 16.67 |
Weighted Average Exercise Price Exercised | 0 | 9.25 |
Weighted Average Exercise Price Expired | 17.45 | 19.79 |
Weighted Average Exercise Price Outstanding, Ending | 8.27 | $ 15.98 |
Weighted Average Exercise Price Exercisable | 14.33 | |
Weighted Average Exercise Price Options Expected to vest | $ 5.05 | |
Weighted Average Remaining Term in Years Options outstanding at beginning of year | 7 years 1 month 6 days | 7 years 2 months 12 days |
Weighted Average Remaining Term in Years Options outstanding at end of year | 8 years 4 months 24 days | 7 years 1 month 6 days |
Weighted Average Remaining Term in Years Options exercisable at end of year | 6 years 4 months 24 days | |
Weighted Average Remaining Term in Years Options Expected to vest | 9 years 4 months 24 days | |
Aggregate Intrinsic Value Options outstanding | $ 0 | |
Aggregate Intrinsic Value Options exercisable | 0 | |
Aggregate Intrinsic Value Options Expected to vest | $ 0 |
REDEEMABLE CONVERTIBLE PREFER_4
REDEEMABLE CONVERTIBLE PREFERRED STOCK, ESCROWED PROCEEDS, AND STOCKHOLDERS EQUITY (Details 2) - $ / shares | 12 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
REDEEMABLE CONVERTIBLE PREFERRED STOCK, ESCROWED PROCEEDS, AND STOCKHOLDERS EQUITY | ||
Risk-free interest rate | 3.90% | 3.20% |
Volatility factor | 65.60% | 69.10% |
Dividend yield | 0% | 0% |
Expected option life (years) | 6 years | 6 years 1 month 6 days |
Weighted average grant date fair value | $ 0.99 | $ 2.68 |
REDEEMABLE CONVERTIBLE PREFER_5
REDEEMABLE CONVERTIBLE PREFERRED STOCK, ESCROWED PROCEEDS, AND STOCKHOLDERS EQUITY (Details 3) - shares | 12 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
REDEEMABLE CONVERTIBLE PREFERRED STOCK, ESCROWED PROCEEDS, AND STOCKHOLDERS EQUITY | ||
Outstanding at beginning of year | 649,149 | 593,629 |
Granted | 425,750 | 131,352 |
Forfeited | (3,312) | (6,426) |
Vested | (84,062) | (69,406) |
Fractional shares | (4) | 0 |
Outstanding at ending of year | 987,521 | 649,149 |
REDEEMABLE CONVERTIBLE PREFER_6
REDEEMABLE CONVERTIBLE PREFERRED STOCK, ESCROWED PROCEEDS, AND STOCKHOLDERS EQUITY (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | |||||
May 11, 2022 | Dec. 16, 2022 | Oct. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2020 | |
Net proceeds from issue of stocks | $ 10,143,152 | $ 0 | |||||
Stock based compensation, options | 794,735 | 1,563,686 | |||||
Unrecognized compensation cost related to unvested options | $ 1,670,986 | ||||||
Weighted average expected recognized period | 2 years 7 months 6 days | ||||||
Number of common stock share | 798,182 | ||||||
Fees and expenses | $ 9,109,117 | ||||||
Voting of shares description | The holders of Series C Preferred Stock were entitled to 20,000 votes per share | ||||||
Exercise price per share | $ 5.83 | ||||||
Exercise price | $ 0.0001 | ||||||
Description of commission | The Company pays Canaccord 3.0% of the gross proceeds as a commission | ||||||
Unvested performance-based restricted stock | $ 238,838 | 60,566 | $ 95,167 | $ 87,303 | |||
Unvested performance-based stock options granted to executive officers and other employees | 318,813 | ||||||
Unvested performance-based stock options granted | 57,999 | ||||||
Stock based compensation, restricted stock units | $ 616,182 | 941,852 | |||||
Outstanding vested restricted stock unit | 356,003 | ||||||
Description of securities purchase | 1,020,000 shares of the Company’s common stock, (ii) prefunded warrants (the “Pre-Funded Warrants”) to purchase up to 798,182 shares of the Company’s common stock, and (iii) common stock warrants (the “Common Warrants”) to purchase up to 1,818,182 shares of the Company’s common stock. Each share of common stock was offered with one accompanying Common Warrant with a combined offering price of $5.50. Each Pre-Funded Warrant was offered with one accompanying Common Warrant with a combined offering price of $5.4999 | ||||||
Total gross proceeds | $ 15,000,000 | ||||||
Selling, general and administrative expenses | $ 15,290,836 | $ 16,511,942 | |||||
2023 Equity Distribution Agreement [Member] | |||||||
Sale of common stock | 504,034 | ||||||
Payment of commission | $ 35,902 | ||||||
Net proceeds from issue of stocks | 1,034,035 | ||||||
Other related expenses | $ 126,801 | ||||||
Description of equity distribution agreement | The 2023 Equity Distribution Agreement and related prospectus is limited to sales of up to an aggregate maximum $50.0 million of shares of the Company’s common stock | ||||||
Vesting of restricted share units | 20,468 | 16,191 | |||||
Vesting of restricted share units value aggregate | $ 146,062 | $ 221,311 | |||||
Executive Officers | |||||||
Unvested performance-based restricted stock units granted | 152,432 | 40,707 | 22,343 | 52,679 | |||
Other Employees | |||||||
Outstanding restricted stock units | $ 217,833 | ||||||
Unvested performance-based restricted stock units granted | 37,116 | ||||||
2011 Stock Incentive Plan [Member] | |||||||
Incentive for nonqualified stock option grants, restricted stock unit awards and other stock-based awards to employees, non-employee directors and consultants | 3,300,000 | ||||||
Shares available for grant | 405,145 | ||||||
2011 Stock Incentive Plan [Member] | President and CEO [Member] | |||||||
Voluntarily contributed stock options number of share | 143,360 | ||||||
2011 Stock Incentive Plan [Member] | CFO and COO [Member] | |||||||
Voluntarily contributed stock options number of share | 124,220 | ||||||
Series B Convertible Preferred Stock | |||||||
Fee | $ 750,000 | ||||||
Selling, general and administrative expenses | 150,995 | ||||||
Fair value of the warrants | $ (234,443) | ||||||
Convertible Series A Preferred Stock | |||||||
Convertible preferred stock were outstanding | 4,030 | ||||||
Aggregate value | $ 403,000 | ||||||
Conversion price | $ 114.77 | ||||||
Convertible shares | $ 0.66 | ||||||
Distributable value of dividend | $ 100 | ||||||
Distributable value of dividend additional | 100 | ||||||
Series B Redeemable Convertible Preferred Stock [Member] | Securities Purchase Agreement [Member] | |||||||
Shares sold | 8,100,000 | ||||||
Series C Redeemable Convertible Preferred Stock [Member] | Securities Purchase Agreement [Member] | |||||||
Shares sold | 900,000 | ||||||
Share purchase price | $ 1.67 | ||||||
Series B and C Redeemable Convertible Preferred Stock [Member] | Securities Purchase Agreement Plan [Member] | |||||||
Exercise price | $ 12.50 | ||||||
Account to release | 15,750,000 | ||||||
Fee | 750,000 | ||||||
Warrants to purchase up | 66,666 | ||||||
Total gross proceeds from the offering | $ 15,000,000 | ||||||
Expiry of share issuance | 48 months |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) | Jun. 30, 2023 | Jun. 30, 2022 |
INCOME TAXES | ||
Net operating loss carryforwards | $ 40,073,000 | $ 35,331,000 |
Research and development and AMT tax credits | 8,094,000 | 7,171,000 |
Foreign tax credits | 583,000 | 583,000 |
Basis differences in fixed assets and other | 2,766,000 | 2,778,000 |
Gross | 51,516,000 | 45,863,000 |
Valuation allowance | (51,516,000) | (45,863,000) |
Net deferred tax assets | $ 0 | $ 0 |
INCOME TAXES (Details Narrative
INCOME TAXES (Details Narrative) - USD ($) | 12 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Income tax benefit | $ 4,674,999 | $ 0 |
Sale value of the tax benefits to unaffiliated | 80% | |
Allowance increased | $ 5,653,000 | $ 3,927,000 |
Federal research and development credits | 155,000,000 | |
Federal | ||
Net operating loss carryforwards | 138,000,000 | |
Federal research and development credits | 8,100,000 | |
Foreign | ||
Net operating loss carryforwards | $ 582,500 |
SUBSEQUENT EVENT (Details Narra
SUBSEQUENT EVENT (Details Narrative) - USD ($) | 3 Months Ended | 12 Months Ended | |
Sep. 27, 2023 | Jun. 30, 2023 | Jun. 30, 2022 | |
Sale of common stock | $ 10,143,152 | $ 0 | |
Fees and expenses | $ 9,109,117 | ||
Subsequent Event | |||
Sale of common stock | $ 531,369 | ||
Shares of Common Stock | 217,027 | ||
Fees and expenses | $ 16,434 |