Cover
Cover - shares | 3 Months Ended | |
Dec. 31, 2022 | Feb. 10, 2023 | |
Cover [Abstract] | ||
Entity Registrant Name | CEL-SCI CORPORATION | |
Entity Central Index Key | 0000725363 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Current Fiscal Year End Date | --09-30 | |
Entity Small Business | true | |
Entity Shell Company | false | |
Entity Emerging Growth Company | false | |
Entity Current Reporting Status | Yes | |
Document Period End Date | Dec. 31, 2022 | |
Entity Filer Category | Non-accelerated Filer | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2023 | |
Entity Common Stock Shares Outstanding | 43,738,865 | |
Entity File Number | 001-11889 | |
Entity Incorporation State Country Code | CO | |
Entity Tax Identification Number | 84-0916344 | |
Entity Interactive Data Current | Yes | |
Entity Address Address Line 2 | Suite 802 | |
Entity Address City Or Town | Vienna | |
Entity Address State Or Province | VA | |
Entity Address Postal Zip Code | 22182 | |
City Area Code | 703 | |
Local Phone Number | 506-9460 | |
Security 12b Title | Common Stock | |
Trading Symbol | CVM | |
Security Exchange Name | NYSE | |
Entity Address Address Line 1 | 8229 Boone Boulevard | |
Document Quarterly Report | true | |
Document Transition Report | false |
CONDENSED BALANCE SHEETS
CONDENSED BALANCE SHEETS - USD ($) | Dec. 31, 2022 | Sep. 30, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 18,017,319 | $ 22,672,138 |
Prepaid expenses | 538,291 | 762,063 |
Supplies used for R&D and manufacturing | 1,848,720 | 2,001,715 |
Total current assets | 20,404,330 | 25,435,916 |
Finance lease right of use assets | 10,486,344 | 10,937,797 |
Operating lease right of use assets | 1,839,418 | 1,884,464 |
Property and equipment, net | 11,520,968 | 11,889,029 |
Patent costs, net | 202,070 | 212,201 |
Supplies used for R&D and manufacturing | 104,607 | 164,299 |
Total assets | 44,557,737 | 50,523,706 |
Current liabilities: | ||
Accounts payable | 1,599,812 | 1,618,290 |
Accrued expenses | 800,838 | 842,492 |
Due to employees | 550,575 | 471,488 |
Lease liabilities, current portion | 1,790,716 | 1,731,481 |
Total current liabilities | 4,741,941 | 4,663,751 |
Finance lease obligations, net of current portion | 11,295,512 | 11,721,368 |
Operating lease obligations, net of current portion | 1,803,663 | 1,850,380 |
Other liabilities | 125,000 | 125,000 |
Total liabilities | 17,966,116 | 18,360,499 |
STOCKHOLDERS' EQUITY | ||
Preferred stock, $.01 par value-200,000 shares authorized; -0- shares issued and outstanding | 0 | 0 |
Common stock, $.01 par value - 600,000,000 shares authorized; 43,725,636 and 43,448,317 shares issued and outstanding at December 31, 2022 and September 30, 2022, respectively | 437,256 | 434,484 |
Additional paid-in capital | 488,904,967 | 486,625,816 |
Accumulated deficit | (462,750,602) | (454,897,093) |
Total stockholders' equity | 26,591,621 | 32,163,207 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ 44,557,737 | $ 50,523,706 |
CONDENSED BALANCE SHEETS (Paren
CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2022 | Sep. 30, 2022 |
CONDENSED BALANCE SHEETS | ||
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 600,000,000 | 600,000,000 |
Common stock, shares issued | 43,725,636 | 43,448,317 |
Common stock, shares outstanding | 43,725,636 | 43,448,317 |
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 200,000 | 200,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
CONDENSED STATEMENTS OF OPERATI
CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED) - USD ($) | 3 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating expenses: | ||
Research and development | $ 5,392,546 | $ 6,083,167 |
General and administrative | 2,258,003 | 2,760,208 |
Total operating expenses | 7,650,549 | 8,843,375 |
Operating loss | (7,650,549) | (8,843,375) |
Other expense | (50,171) | 0 |
Gain on derivative instruments | 0 | 364,596 |
Other non-operating gains | 0 | (30,793) |
Interest expense, net | (152,789) | (273,034) |
Net loss | (7,853,509) | (8,782,606) |
Modification of warrants | (171,552) | 0 |
Net loss available to common shareholders | $ (8,025,061) | $ (8,782,606) |
Net loss per common share - basic | $ (0.18) | $ (0.20) |
Weighted average common shares outstanding - basic | 43,440,387 | 43,077,961 |
Net loss per common share - diluted | $ (0.18) | $ (0.20) |
Weighted average common shares outstanding - diluted | 44,440,387 | 43,083,420 |
STATEMENTS OF STOCKHOLDERS' EQU
STATEMENTS OF STOCKHOLDERS' EQUITY (UNAUDITED) - USD ($) | Total | Common Stock | Additional Paid-In Capital | Accumulated Deficit |
Balance, shares at Sep. 30, 2021 | 43,207,183 | |||
Balance, amount at Sep. 30, 2021 | $ 56,534,226 | $ 432,072 | $ 474,298,566 | $ (418,196,412) |
Warrant exercises, shares | 19,705 | |||
Warrant exercises, amount | 157,954 | $ 197 | 157,757 | 0 |
Equity based compensation - employees | 3,262,296 | $ 0 | 3,262,296 | 0 |
401(k) contributions paid in common stock, shares | 7,605 | |||
401(k) contributions paid in common stock, amount | 52,555 | $ 76 | 52,479 | 0 |
Stock and options issued to nonemployees for service, shares | 18,020 | |||
Stock and options issued to nonemployees for service, amount | $ 143,160 | $ 180 | 142,980 | 0 |
Option exercises, shares | 6,500 | 6,500 | ||
Option exercises, amount | $ 29,835 | $ 65 | 29,770 | 0 |
Share issuance costs | (45,965) | 0 | (45,965) | 0 |
Net loss | (8,782,606) | $ 0 | 0 | (8,782,606) |
Balance, shares at Dec. 31, 2021 | 43,259,013 | |||
Balance, amount at Dec. 31, 2021 | 51,351,455 | $ 432,590 | 477,897,883 | (426,979,018) |
Balance, shares at Sep. 30, 2022 | 43,448,317 | |||
Balance, amount at Sep. 30, 2022 | 32,163,207 | $ 434,484 | 486,625,816 | (454,897,093) |
Warrant exercises, shares | 217,752 | |||
Warrant exercises, amount | 447,291 | $ 2,177 | 445,114 | 0 |
Equity based compensation - employees | 1,703,931 | $ 0 | 1,703,931 | 0 |
401(k) contributions paid in common stock, shares | 21,331 | |||
401(k) contributions paid in common stock, amount | 50,178 | $ 213 | 49,965 | 0 |
Stock and options issued to nonemployees for service, shares | 40,236 | |||
Stock and options issued to nonemployees for service, amount | 91,623 | $ 402 | 91,221 | 0 |
Net loss | (7,853,509) | $ 0 | 0 | (7,853,509) |
2014 Incentive Stock Forfeited, shares | (2,000) | |||
Incentive Stock Forfeited, amount | (11,100) | $ (20) | (11,080) | |
Balance, shares at Dec. 31, 2022 | 43,725,636 | |||
Balance, amount at Dec. 31, 2022 | $ 26,591,621 | $ 437,256 | $ 488,904,967 | $ (462,750,602) |
CONDENSED STATEMENTS OF CASH FL
CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED) - USD ($) | 3 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED) | ||
Net loss | $ (7,853,509) | $ (8,782,606) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 988,543 | 887,930 |
Non-cash lease expense | 5,078 | 24,997 |
Share-based payments for services | 148,858 | 218,318 |
Equity-based compensation | 1,692,831 | 3,262,296 |
Common stock contributed to 401(k) plan | 50,178 | 52,555 |
Gain on short-term investments | 0 | (615) |
Loss on patent impairment | 0 | 30,793 |
Gain on derivative instruments | 0 | (364,596) |
(Increase)/decrease in assets: | ||
Prepaid expenses | 111,537 | 144,542 |
Supplies used for R&D and manufacturing | 212,687 | (61,139) |
Increase/(decrease) in liabilities: | ||
Accounts payable | (115,285) | (523,152) |
Accrued expenses | 13,346 | 95,685 |
Due to employees | 79,087 | 209,046 |
Net cash used in operating activities | (4,666,649) | (4,805,946) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Proceeds from maturity of US treasury bills | 0 | 6,152,000 |
Purchases of property and equipment | (53,580) | (17,036) |
Expenditures for patent costs | 0 | (22,741) |
Net cash (used in) provided by investing activities | (53,580) | 6,112,223 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Payments of stock issuance costs | (9,010) | (32,800) |
Proceeds from exercises of warrants and options | 447,291 | 117,200 |
Payments on obligations under finance lease | (372,871) | (340,908) |
Net cash provided by (used in) financing activities | 65,410 | (256,508) |
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS | (4,654,819) | 1,049,769 |
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD | 22,672,138 | 36,060,148 |
CASH AND CASH EQUIVALENTS, END OF PERIOD | 18,017,319 | 37,109,917 |
SUPPLEMENTAL SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||
Property and equipment included in current liabilities | 105,318 | 469,005 |
Finance lease obligation included in accounts payable | 1,853 | 771 |
Prepaid consulting services paid with issuance of common stock | 91,623 | 233,753 |
Exercise of derivative liabilities | 0 | 70,589 |
Financing costs included in current liabilities | 0 | 13,165 |
Cash paid for interest | $ 277,853 | $ 290,212 |
BASIS OF PRESENTATION AND SUMMA
BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
Dec. 31, 2022 | |
BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | A. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying condensed financial statements of CEL-SCI Corporation (the Company) are unaudited and certain information and footnote disclosures normally included in the annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been omitted pursuant to the rules and regulations of the Securities and Exchange Commission. While management of the Company believes that the disclosures presented are adequate to make the information presented not misleading, these interim condensed financial statements should be read in conjunction with the financial statements and notes included in the Company’s annual report on Form 10-K for the year ended September 30, 2022. In the opinion of management, the accompanying unaudited condensed financial statements contain all adjustments necessary for a fair presentation of the Company’s financial position as of December 31, 2022 and the results of its operations for the three months then ended. The condensed balance sheet as of September 30, 2022 is derived from the September 30, 2022 audited financial statements. Due to recurring losses from operations and future liquidity needs, there is substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. Refer to discussion in Note B. Summary of Significant Accounting Policies: Cash and Cash Equivalents U.S. Treasury Bills – Property and Equipment Supplies used for R&D and manufacturing – Patents Leases – Derivative Instruments Accounting for Derivative Instruments and Hedging Activities The Company adopted Accounting Standards Update (ASU) 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in an Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity Stock-Based Compensation Compensation – Stock Compensation The Company has Incentive Stock Option Plans, Non-Qualified Stock Option Plans, Stock Compensation Plans, Stock Bonus Plans and an Incentive Stock Bonus Plan. These Plans are collectively referred to as the “Plans”. All Plans have been approved by the Company’s stockholders. The Company’s stock options are not transferable, and the actual value of the stock options that an employee may realize, if any, will depend on the excess of the market price on the date of exercise over the exercise price. For options issued with service conditions only, the Company has based its assumption for stock price volatility on the variance of daily closing prices of the Company’s stock. The risk-free interest rate assumption is based on the U.S. Treasury rate at the date of grant with the term equal to the expected life of the option. Forfeitures are accounted for when they occur. The expected term of options represents the period that options granted are expected to be outstanding and has been determined based on an analysis of historical exercise behavior. If any of the assumptions used in the Black-Scholes model change significantly, stock-based compensation expense for new awards may differ materially in the future from that recorded in the current period. Restricted stock granted under the Incentive Stock Bonus Plan and options granted under the 2021 and 2020 Non-Qualified Stock Option Plan are subject to service, performance and market conditions and meet the classification of equity awards. These awards were measured at fair value on the grant dates using a Monte Carlo simulation for issuances where the attainment of performance criteria is uncertain. The total compensation cost will be expensed over the estimated requisite service period. Research and Development Costs Net Loss Per Common Share Earnings Per Share Income Taxes The Company adopted ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes Use of Estimates New Accounting Pronouncements The Company has considered all recently issued accounting pronouncements and does not believe the adoption of such pronouncements will have a material impact on its financial statements. |
LIQUIDITY
LIQUIDITY | 3 Months Ended |
Dec. 31, 2022 | |
LIQUIDITY | |
LIQUIDITY | B. LIQUIDITY The Company has incurred significant costs since its inception for the acquisition of certain proprietary technology and scientific knowledge relating to the human immunological defense system, patent applications, research and development, administrative costs, construction and expansion of manufacturing and laboratory facilities and participation in clinical trials. The Company has funded such costs primarily with proceeds from loans and the public and private sale of its securities. The Company will be required to raise additional capital or find additional long-term financing to continue with its efforts to bring Multikine to market. The ability to raise capital may be dependent upon market conditions that are outside the control of the Company. The ability of the Company to obtain approval from the U.S. Food and Drug Administration (FDA) for the sale of products to be developed on a commercial basis is uncertain. Ultimately, the Company must complete the development of its products, obtain the appropriate regulatory approvals and obtain sufficient revenues to support its cost structure. The Company believes there is a high likelihood that it will continue to receive funds from private and public offerings and warrant exercises similar to the way it has funded operations in the past. However, there can be no assurance that the Company will be able to raise sufficient capital to support its operations. To finance the Company through marketing approval, the Company plans to raise additional capital in the form of warrant exercises, corporate partnerships, and debt and/or equity financings. The Company believes that it will be able to obtain additional financing because it has done so consistently in the past and because it showed great survival benefit in the Phase 3 study in one of the two treatment arms for advanced primary head and neck cancer. However, there can be no assurance that the Company will be successful in raising additional funds on a timely basis or that the funds will be available to the Company on acceptable terms or at all. If the Company does not raise the necessary amounts of money, it may have to curtail its operations until such time as it is able to raise the required funding. Due to the Company’s recurring losses from operations and future liquidity needs, there is substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. Impact of the COVID-19 Pandemic In response to the global outbreak of COVID-19 and the World Health Organization’s classification of the outbreak as a pandemic, the Company continues to take the necessary precautions to ensure the safety of its employees and to minimize interruptions to its operations. Management follows the Centers for Disease Control and Prevention’s (“CDC”) guidance and the recommendations and restrictions provided by state and local authorities. The full impact of the COVID-19 outbreak continues to evolve as of the date of this report. As such, it is uncertain as to the full magnitude of impact the pandemic will have on the Company’s financial condition, liquidity and future results of operations. Management is actively monitoring the risks to public health and the impact of overall global business activity on its financial condition, liquidity, operations, suppliers, industry, and workforce. |
STOCKHOLDERS EQUITY
STOCKHOLDERS EQUITY | 3 Months Ended |
Dec. 31, 2022 | |
STOCKHOLDERS EQUITY | |
STOCKHOLDERS' EQUITY | C. STOCKHOLDERS’ EQUITY Equity Compensation Underlying share information for equity compensation plans as of December 31, 2022 is as follows: Name of Plan Total Shares Reserved Under Plans Incentive Stock Option Plans 138,400 Non-Qualified Stock Option Plans 13,787,200 Stock Bonus Plans 783,760 Stock Compensation Plans 634,000 Incentive Stock Bonus Plan 640,000 Stock option activity Three Months Ended December 31, 2022 2021 Options granted 2,500 251,000 Options exercised - 6,500 Options forfeited 96,832 13,000 Options expired 45,400 - During the quarter ended December 31, 2021, the Company granted 250,000 performance-based stock options from the 2020 Non-Qualified Stock Option Plan to officers. Each option entitles the holder to purchase one share of the Company’s common stock at a price of $10.48 per share, the fair value on the date of issuance. The stock options will vest 100% upon approval of the first marketing application for any pharmaceutical based upon the Company’s Multikine technology in any of the USA, Canada, UK, Germany, France, Italy, Spain, Japan, or Australia. All options which have not vested as of November 18, 2031 will be canceled. On the grant date, the options were valued using a Monte Carlo Simulation approach. A Monte Carlo Simulation is a statistical technique that is used to model probabilistic systems and establish the probabilities for a variety of outcomes. However, because attainment of the performance condition cannot be considered probable, no compensation cost was recognized relating to these options as of December 31, 2022. Management will re-assess the probability of achieving the performance condition at each reporting date. Stock-Based Compensation Expense Three months Ended December 31, 2022 2021 Employees $ 1,692,831 $ 3,262,296 Non-employees $ 148,858 $ 218,318 Employee compensation expense includes the expense related to options and restricted stock that is expensed over the vesting periods. Non-employee expense includes the expense related to options and stock issued to consultants expensed over the period of the related service contracts. Warrants and Non-Employee Options The following chart represents the warrants and non-employee options outstanding at December 31, 2022: Warrant/Options Issue Date Shares Issuable upon Exercise of Warrants/ Options Exercise Price Expiration Date Reference Series N 8/18/2008 85,339 $ 3.00 8/18/2024 * Series UU 6/11/2018 93,603 $ 2.80 6/30/2024 * Series X 1/13/2016 120,000 $ 9.25 7/13/2024 * Series Y 2/15/2016 26,000 $ 12.00 8/15/2024 * Series MM 6/22/2017 333,432 $ 1.86 6/22/2024 * Series NN 7/24/2017 200,087 $ 2.52 7/24/2024 * Series RR 10/30/2017 234,009 $ 1.65 10/30/2024 2 Series SS 12/19/2017 - $ 2.09 12/18/2022 2 Series TT 2/5/2018 600 $ 2.24 2/5/2023 * Consultant Options 7/28/2017 10,000 $ 2.18 7/27/2027 3 * No current period changes for these warrants 1. Derivative Liabilities The table below presents the gains on the warrant liabilities for the three months ended December 31: 2022 2021 Series Z warrants $ - $ 64,787 Series AA warrants - 274,635 Series CC warrants - 24,372 Series HH warrants - 802 Net gain on warrant liabilities $ - $ 364,596 The Company reviews all outstanding warrants in accordance with the requirements of ASC 815. This topic provides that an entity should use a two-step approach to evaluate whether an equity-linked financial instrument (or embedded feature) is indexed to its own stock, including evaluating the instrument’s contingent exercise and settlement provisions. The warrant agreements provide for adjustments to the exercise price for certain dilutive events. Under the provisions of ASC 815, the warrants are not considered indexed to the Company’s stock because future equity offerings or sales of the Company’s stock are not an input to the fair value of a “fixed-for-fixed” option on equity shares, and equity classification is therefore precluded. In accordance with ASC 815, derivative liabilities must be measured at fair value upon issuance and re-valued at the end of each reporting period through expiration. Any change in fair value between the respective reporting dates is recognized as a gain or loss. Changes in Warrant Liabilities During the three months ended December 31, 2022, no warrant liabilities were outstanding. During the three months ended December 31, 2021, 15,205 Series CC warrants were exercised at an exercise price of $5.00 for gross proceeds of $76,000. On December 8, 2021, 640 Series CC warrants, with an exercise price of $5.00, expired. On November 23, 2021, 184,800 Series Z warrants, with an exercise price of $13.75, expired. 2. Equity Warrants Changes in Equity Warrants The following warrants recorded as equity were exercised during the three months ended December 31, 2022. Warrants Warrants Exercised Exercise Price Proceeds Series RR 17,752 $ 1.65 $ 29,291 Series SS 200,000 $ 2.09 418,000 217,752 $ 447,291 The following warrants recorded as equity were exercised during the three months ended December 31, 2021. Warrants Warrants Exercised Exercise Price Proceeds Series NN 4,500 $ 2.52 $ 11,340 Series TT 10,000 $ 2.24 22,400 14,500 $ 33,740 On October 28, 2022, the expiration date of the Series RR warrants was extended two years from October 30, 2022 to October 30, 2024. The incremental cost of this extension was approximately $172,000, which was recorded as a deemed dividend in the financial statements for the three months ended December 31, 2022. The Series RR warrants are held by Geert Kersten, Patricia Prichep (current Officers of the Company) and the de Clara Trust, of which the Company’s CEO, Geert Kersten, is a beneficiary. 3. Options and Shares Issued to Consultants During the three months ended December 31, 2022 and 2021, the Company issued 40,236 and 18,020 shares of restricted common stock, respectively, to consultants for services. The weighted average grant date fair value of the shares issued to consultants was $2.53 and $9.93 per share, respectively, during the three months ended December 31, 2022 and 2021. During the three months ended December 31, 2022, 5,000 options with an exercise price of $11.61 issued to a consultant expired. As of December 31, 2022, 10,000 options issued to consultants remained outstanding, all of which were issued from the Non-Qualified Stock Option plans. All 10,000 options are vested as of December 31, 2022. During the three months ended December 31, 2022 and 2021, the Company recorded total expense of approximately $149,000 and $218,000, respectively, relating to the share based compensation under these consulting agreements. At December 31, 2022 and September 30, 2022, approximately $183,000 and $295,000, respectively, are included in prepaid expenses and will be amortized over the remaining service periods. |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 3 Months Ended |
Dec. 31, 2022 | |
FAIR VALUE MEASUREMENTS | |
FAIR VALUE MEASUREMENTS | D. FAIR VALUE MEASUREMENTS In accordance with ASC 820-10, Fair Value Measurements, ASC 820-10 establishes a fair value hierarchy that prioritizes the inputs used to measure fair value. The hierarchy gives the highest priority to active markets for identical assets and liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The Company classifies fair value balances based on the observability of those inputs. The three levels of the fair value hierarchy are as follows: · Level 1 – Observable inputs such as quoted prices in active markets for identical assets or liabilities · Level 2 – Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and amounts derived from valuation models where all significant inputs are observable in active markets · Level 3 – Unobservable inputs that reflect management’s assumptions. Assumptions from market participants are used when pricing the asset or liabilities, given there is no readily available market information. For disclosure purposes, assets and liabilities are classified in their entirety in the fair value hierarchy level based on the lowest level of input that is significant to the overall fair value measurement. The Company’s assessment of the significance of an input to the fair value measurement requires judgment and may affect the placement within the fair value hierarchy levels. The Company purchased short-term U.S. Treasury bills during the year ended September 30, 2021. The Treasury bills matured in December 2021 and yielded a weighted average interest rate of 0.10%. As of December 31, 2022 and September 30, 2022, the Company does not have any derivative instruments that are classified as Level 3 on the fair value hierarchy. The following sets forth a reconciliation of beginning and ending balances related to fair value measurements using significant unobservable inputs (Level 3): 3 months ended December 31, 2022 3 months ended December 31, 2021 Beginning balance - $ 437,380 Issuances - - Exercises - (70,589 ) Realized and unrealized (gains) and losses - (364,596 ) Ending balance $ - $ 2,195 The fair values of the Company’s derivative instruments disclosed above under Level 3 are primarily derived from valuation models where significant inputs such as historical price and volatility of the Company’s stock, as well as U.S. Treasury Bill rates, are observable in active markets. At December 31, 2022 and September 30, 2022, the Company did not have any Level 3 derivative instruments. |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 3 Months Ended |
Dec. 31, 2022 | |
RELATED PARTY TRANSACTIONS | |
RELATED PARTY TRANSACTIONS | E. RELATED PARTY TRANSACTIONS On October 28, 2022, the expiration dates of the Series RR warrants held by Geert Kersten, Patricia Prichep (current Officers of the Company) and the de Clara Trust, of which the Company’s CEO, Geert Kersten, is a beneficiary were extended by two years. The incremental cost of these modifications was $172,552 and was recorded as a deemed dividend in the financial statements for the three months ended December 31, 2022. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 3 Months Ended |
Dec. 31, 2022 | |
Commitments and contingencies | |
COMMITMENTS AND CONTINGENCIES | F. COMMITMENTS AND CONTINGENCIES Clinical Research Agreement Under co-development and revenue sharing agreements with Ergomed, Ergomed agreed to contribute up to $12 million towards the Company’s Phase 3 Clinical Trial in the form of discounted clinical services in exchange for a single digit percentage of milestone and royalty payments, up to a specific maximum amount. The Company accounted for the co-development and revenue sharing agreements in accordance with ASC 808 “Collaborative Arrangements”. The Company determined the payments to Ergomed are within the scope of ASC 730 Research and Development Lease Agreements The Company leases a manufacturing facility near Baltimore, Maryland (the San Tomas lease). The building was remodeled in accordance with the Company’s specifications so that it can be used by the Company to manufacture Multikine for the Company’s Phase 3 clinical trial and sales of the drug if approved by the FDA. The lease is for a term of twenty years and requires annual base rent to escalate each year at 3%. The Company is required to pay all real estate and personal property taxes, insurance premiums, maintenance expenses, repair costs and utilities. The lease allows the Company, at its election, to extend the lease for two ten-year periods or to purchase the building at the end of the 20-year lease, which expires in October 2028. The renewal options are not included in the calculation of the right of use asset and lease liability because exercise of those options is not reasonably certain. On December 31, 2022 and September 30, 2022, the net book value of the finance lease right of use asset is approximately $10.5 million and $10.9 million, respectively and the balance of the finance lease liability is approximately $12.9 million and $13.3 million, respectively, of which approximately $1.6 million is current in each quarter. These amounts include the San Tomas lease as well as several other smaller finance leases for office equipment. The finance right of use assets are being depreciated using the straight-line method over the underlying lease terms. Total cash paid related to finance leases during the three months ended December 31, 2022 and 2021 was approximately $0.6 million for both periods, of which approximately $0.3 million was for interest in each quarter. As of December 31, 2022, the weighted average discount rate of the Company’s finance leases is 8.45% and the weighted average time to maturity is 5.08 years. The Company was required to deposit the equivalent of one year of base rent in accordance with the lease. Under the landlord’s $2.4 million financing arrangement, the Company was required to deposit an additional $0.2 million in March 2021. When the Company meets the minimum cash balance required by the lease, the deposit will be returned to the Company. During the quarter ended December 31, 2021, it was determined that the Company met the minimum cash requirement and the deposits were returned in January 2022. Approximate future minimum lease payments under finance leases as of December 31, 2022 are as follows: Nine months ending September 30, 2023 $ 1,937,000 Year ending September 30, 2024 2,655,000 2025 2,741,000 2026 2,832,000 2027 2,923,000 2028 3,015,000 Thereafter 252,000 Total future minimum lease obligation 16,355,000 Less imputed interest on finance lease obligations (3,446,000 ) Net present value of finance lease obligations $ 12,909,000 The Company leases two facilities under operating leases. The lease for the Company’s office headquarters will expire on November 30, 2025. The lease for its research and development laboratory was renewed in September 2021 for an additional ten years and will expire on February 29, 2032. The renewal was considered a modification for accounting purposes and the right of use asset and liability were remeasured as of the date of the renewal. This resulted in an increase of approximately $1.1 million to the operating lease right of use asset and liability. The operating leases include escalating rental payments. The Company is recognizing the related rent expense on a straight-line basis over the terms of the leases. As of December 31, 2022 and September 30, 2022, the net book value of the operating lease right of use assets is approximately $1.8 million and $1.9 million, respectively. As of December 31, 2022 and September 30, 2022, the balance of the operating lease liabilities is approximately $2.0 million, of which approximately $0.2 million, is current in each quarter. The Company incurred lease expense for operating leases of approximately $91,000 for both the three months ended December 31, 2022 and 2021. Total cash paid related to operating leases during the three months ended December 31, 2022 and 2021 was approximately $85,000 and $66,000, respectively. The weighted average discount rate of the Company’s operating leases is 9.10% and the weighted average time to maturity is 7.6 years. As of December 31, 2022, future minimum lease payments on operating leases are as follows: Nine months ending September 30, 2023 262,000 Year ending September 30, 2024 357,000 2025 366,000 2026 287,000 2027 277,000 2028 285,000 Thereafter 1,040,000 Total future minimum lease obligation 2,874,000 Less imputed interest on operating lease obligation (893,000 ) Net present value of operating lease obligation $ 1,981,000 |
PATENTS
PATENTS | 3 Months Ended |
Dec. 31, 2022 | |
PATENTS | |
PATENTS | G. PATENTS During the three months ended December 31, 2022 and 2021, the Company recorded approximately $0 and $31,000 in patent impairment charges. During the three months ended December 31, 2022 and 2021, amortization of patent costs totaled approximately $10,000 and $14,000, respectively. Approximate estimated future amortization expense is as follows: Nine months ending September 30, 2023 $ 28,000 Year ending September 30, 2024 30,000 2025 28,000 2026 24,000 2027 21,000 2028 17,000 Thereafter 54,000 Total $ 202,000 |
LOSS PER COMMON SHARE
LOSS PER COMMON SHARE | 3 Months Ended |
Dec. 31, 2022 | |
LOSS PER COMMON SHARE | |
LOSS PER COMMON SHARE | H. LOSS PER COMMON SHARE Basic loss per share is computed by dividing net loss available to common shareholders by the weighted average number of common shares outstanding during the period. For the periods presented, the gain on warrant liabilities is excluded from the numerator and the incremental shares, determined using the treasury stock method, are added to the denominator in calculating diluted loss per share. The following tables provide the details of the basic and diluted loss per-share computations: Three months ended December 31, 2022 2021 Loss per share – basic Net loss available to common shareholders - basic $ (8,025,061 ) $ (8,782,606 ) Weighted average shares outstanding - basic 43,440,387 43,077,961 Basic loss per common share $ (0.18 ) $ (0.20 ) Loss per share – diluted Net loss available to common shareholders - basic $ (8,025,061 ) $ (8,782,606 ) Gain on derivatives (1) - (25,114 ) Net loss available to common shareholders - diluted $ (8,025,061 ) $ (8,807,720 ) Weighted average shares outstanding - basic 43,440,387 43,077,961 Incremental shares underlying dilutive - warrants and options (1) - 5,459 Weighted average shares outstanding – diluted 43,440,387 43,083,420 Diluted loss earnings per common share $ (0.18 ) $ (0.20 ) (1) Includes Series CC and HH warrants for the three months ended December 31, 2021. In accordance with the contingently issuable shares guidance of ASC Topic 260, Earnings Per Share 2022 2021 Options and Warrants 13,917,352 10,477,966 Unvested Restricted Stock 149,250 151,250 Total 14,066,602 10,629,216 |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 3 Months Ended |
Dec. 31, 2022 | |
SUBSEQUENT EVENTS | |
SUBSEQUENT EVENTS | J. SUBSEQUENT EVENTS On January 11, 2023, the Company was required to deposit approximately $2.3 million to its landlord, equivalent to one year’s rent, for falling below the stipulated cash threshold in accordance with the San Tomas lease. The amount will be included in current assets on the balance sheet until the Company meets the minimum cash balance required and the deposit is returned. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Dec. 31, 2022 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | |
Cash and Cash Equivalents | Cash and Cash Equivalents |
U S Treasury Bills | U.S. Treasury Bills – |
Supplies used for R&D and manufacturing | Supplies used for R&D and manufacturing – |
Property and Equipment | Property and Equipment |
Patents | Patents |
Leases | Leases – |
Derivative Instruments | Derivative Instruments Accounting for Derivative Instruments and Hedging Activities The Company adopted Accounting Standards Update (ASU) 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in an Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity |
Stock-Based Compensation | Stock-Based Compensation Compensation – Stock Compensation The Company has Incentive Stock Option Plans, Non-Qualified Stock Option Plans, Stock Compensation Plans, Stock Bonus Plans and an Incentive Stock Bonus Plan. These Plans are collectively referred to as the “Plans”. All Plans have been approved by the Company’s stockholders. The Company’s stock options are not transferable, and the actual value of the stock options that an employee may realize, if any, will depend on the excess of the market price on the date of exercise over the exercise price. For options issued with service conditions only, the Company has based its assumption for stock price volatility on the variance of daily closing prices of the Company’s stock. The risk-free interest rate assumption is based on the U.S. Treasury rate at the date of grant with the term equal to the expected life of the option. Forfeitures are accounted for when they occur. The expected term of options represents the period that options granted are expected to be outstanding and has been determined based on an analysis of historical exercise behavior. If any of the assumptions used in the Black-Scholes model change significantly, stock-based compensation expense for new awards may differ materially in the future from that recorded in the current period. Restricted stock granted under the Incentive Stock Bonus Plan and options granted under the 2021 and 2020 Non-Qualified Stock Option Plan are subject to service, performance and market conditions and meet the classification of equity awards. These awards were measured at fair value on the grant dates using a Monte Carlo simulation for issuances where the attainment of performance criteria is uncertain. The total compensation cost will be expensed over the estimated requisite service period. |
Research and Development Costs | Research and Development Costs |
Net Loss Per Common Share | Net Loss Per Common Share Earnings Per Share |
Income Taxes | Income Taxes The Company adopted ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes |
Use of Estimates | Use of Estimates |
New Accounting Pronouncements | New Accounting Pronouncements The Company has considered all recently issued accounting pronouncements and does not believe the adoption of such pronouncements will have a material impact on its financial statements. |
STOCKHOLDERS EQUITY (Tables)
STOCKHOLDERS EQUITY (Tables) | 3 Months Ended |
Dec. 31, 2022 | |
STOCKHOLDERS EQUITY | |
Schedule of equity compensation plans | Name of Plan Total Shares Reserved Under Plans Incentive Stock Option Plans 138,400 Non-Qualified Stock Option Plans 13,787,200 Stock Bonus Plans 783,760 Stock Compensation Plans 634,000 Incentive Stock Bonus Plan 640,000 |
Schedule of Stock option activity | Three Months Ended December 31, 2022 2021 Options granted 2,500 251,000 Options exercised - 6,500 Options forfeited 96,832 13,000 Options expired 45,400 - |
Schedule of Stock-Based Compensation Expense | Three months Ended December 31, 2022 2021 Employees $ 1,692,831 $ 3,262,296 Non-employees $ 148,858 $ 218,318 |
Schedule of warrants and non-employee options outstanding | Warrant/Options Issue Date Shares Issuable upon Exercise of Warrants/ Options Exercise Price Expiration Date Reference Series N 8/18/2008 85,339 $ 3.00 8/18/2024 * Series UU 6/11/2018 93,603 $ 2.80 6/30/2024 * Series X 1/13/2016 120,000 $ 9.25 7/13/2024 * Series Y 2/15/2016 26,000 $ 12.00 8/15/2024 * Series MM 6/22/2017 333,432 $ 1.86 6/22/2024 * Series NN 7/24/2017 200,087 $ 2.52 7/24/2024 * Series RR 10/30/2017 234,009 $ 1.65 10/30/2024 2 Series SS 12/19/2017 - $ 2.09 12/18/2022 2 Series TT 2/5/2018 600 $ 2.24 2/5/2023 * Consultant Options 7/28/2017 10,000 $ 2.18 7/27/2027 3 |
Schedule of derivative liabilities | 2022 2021 Series Z warrants $ - $ 64,787 Series AA warrants - 274,635 Series CC warrants - 24,372 Series HH warrants - 802 Net gain on warrant liabilities $ - $ 364,596 |
Schedule of equity warrants | Warrants Warrants Exercised Exercise Price Proceeds Series RR 17,752 $ 1.65 $ 29,291 Series SS 200,000 $ 2.09 418,000 217,752 $ 447,291 Warrants Warrants Exercised Exercise Price Proceeds Series NN 4,500 $ 2.52 $ 11,340 Series TT 10,000 $ 2.24 22,400 14,500 $ 33,740 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 3 Months Ended |
Dec. 31, 2022 | |
FAIR VALUE MEASUREMENTS | |
Reconciliation of beginning and ending balances related to fair value measurements using significant unobservable inputs (Level 3) | 3 months ended December 31, 2022 3 months ended December 31, 2021 Beginning balance - $ 437,380 Issuances - - Exercises - (70,589 ) Realized and unrealized (gains) and losses - (364,596 ) Ending balance $ - $ 2,195 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 3 Months Ended |
Dec. 31, 2022 | |
Commitments and contingencies | |
Schedule of future minimum payments under finance leases | Nine months ending September 30, 2023 $ 1,937,000 Year ending September 30, 2024 2,655,000 2025 2,741,000 2026 2,832,000 2027 2,923,000 2028 3,015,000 Thereafter 252,000 Total future minimum lease obligation 16,355,000 Less imputed interest on finance lease obligations (3,446,000 ) Net present value of finance lease obligations $ 12,909,000 |
Schedule of future minimum payments under operating leases | Nine months ending September 30, 2023 262,000 Year ending September 30, 2024 357,000 2025 366,000 2026 287,000 2027 277,000 2028 285,000 Thereafter 1,040,000 Total future minimum lease obligation 2,874,000 Less imputed interest on operating lease obligation (893,000 ) Net present value of operating lease obligation $ 1,981,000 |
PATENTS (Tables)
PATENTS (Tables) | 3 Months Ended |
Dec. 31, 2022 | |
PATENTS | |
Schedule of total estimated future amortization | Nine months ending September 30, 2023 $ 28,000 Year ending September 30, 2024 30,000 2025 28,000 2026 24,000 2027 21,000 2028 17,000 Thereafter 54,000 Total $ 202,000 |
LOSS PER COMMON SHARE (Tables)
LOSS PER COMMON SHARE (Tables) | 3 Months Ended |
Dec. 31, 2022 | |
LOSS PER COMMON SHARE | |
Schedule of reconciliation of the numerators and denominators of the basic and diluted per-share computations | Three months ended December 31, 2022 2021 Loss per share – basic Net loss available to common shareholders - basic $ (8,025,061 ) $ (8,782,606 ) Weighted average shares outstanding - basic 43,440,387 43,077,961 Basic loss per common share $ (0.18 ) $ (0.20 ) Loss per share – diluted Net loss available to common shareholders - basic $ (8,025,061 ) $ (8,782,606 ) Gain on derivatives (1) - (25,114 ) Net loss available to common shareholders - diluted $ (8,025,061 ) $ (8,807,720 ) Weighted average shares outstanding - basic 43,440,387 43,077,961 Incremental shares underlying dilutive - warrants and options (1) - 5,459 Weighted average shares outstanding – diluted 43,440,387 43,083,420 Diluted loss earnings per common share $ (0.18 ) $ (0.20 ) |
Schedule of anti-dilutive securities | 2022 2021 Options and Warrants 13,917,352 10,477,966 Unvested Restricted Stock 149,250 151,250 Total 14,066,602 10,629,216 |
BASIS OF PRESENTATION AND SUM_2
BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) | 3 Months Ended |
Dec. 31, 2022 | |
BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Patent Useful Life | 17 years |
STOCKHOLDERS EQUITY (Details)
STOCKHOLDERS EQUITY (Details) | Dec. 31, 2022 shares |
Remaining Options/shares Under Plans | 138,400 |
Non-Qualified Stock Option Plans [Member] | |
Remaining Options/shares Under Plans | 13,787,200 |
Stock Bonus Plans [Member] | |
Remaining Options/shares Under Plans | 783,760 |
Stock Compensation Plan [Member] | |
Remaining Options/shares Under Plans | 634,000 |
Incentive Stock Bonus Plan [Member] | |
Remaining Options/shares Under Plans | 640,000 |
STOCKHOLDERS EQUITY (Details 1)
STOCKHOLDERS EQUITY (Details 1) - shares | 3 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
STOCKHOLDERS EQUITY | ||
Options Granted | 2,500 | 251,000 |
Options Exercised | 6,500 | |
Options Forfeited | 96,832 | 13,000 |
Options Expired | 45,400 |
STOCKHOLDERS EQUITY (Details 2)
STOCKHOLDERS EQUITY (Details 2) - USD ($) | 3 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
STOCKHOLDERS EQUITY | ||
Employees Stock Based Compensation Expense | $ 1,692,831 | $ 3,262,296 |
Non- Employees Stock Based Compensation Expense | $ 148,858 | $ 218,318 |
STOCKHOLDERS EQUITY (Details 3)
STOCKHOLDERS EQUITY (Details 3) | 3 Months Ended |
Dec. 31, 2022 $ / shares shares | |
Consultants [Member] | |
Shares Issuable Upon Exercise Of Warrant/options | shares | 10,000 |
Exercise Price | $ 2.18 |
Expiration Date | 7/27/2027 |
Issue Date | 7/28/2017 |
Series N [Member] | |
Shares Issuable Upon Exercise Of Warrant/options | shares | 85,339 |
Exercise Price | $ 3 |
Expiration Date | 8/18/2024 |
Issue Date | 8/18/2008 |
Series UU [Member] | |
Shares Issuable Upon Exercise Of Warrant/options | shares | 93,603 |
Exercise Price | $ 2.80 |
Expiration Date | 6/30/2024 |
Issue Date | 6/11/2018 |
Series X [Member] | |
Shares Issuable Upon Exercise Of Warrant/options | shares | 120,000 |
Exercise Price | $ 9.25 |
Expiration Date | 7/13/2024 |
Issue Date | 1/13/2016 |
Series Y [Member] | |
Shares Issuable Upon Exercise Of Warrant/options | shares | 26,000 |
Exercise Price | $ 12 |
Expiration Date | 8/15/2024 |
Issue Date | 2/15/2016 |
Series MM [Member] | |
Shares Issuable Upon Exercise Of Warrant/options | shares | 333,432 |
Exercise Price | $ 1.86 |
Expiration Date | 6/22/2024 |
Issue Date | 6/22/2017 |
Series NN [Member] | |
Shares Issuable Upon Exercise Of Warrant/options | shares | 200,087 |
Exercise Price | $ 2.52 |
Expiration Date | 7/24/2024 |
Issue Date | 7/24/2017 |
Series RR [Member] | |
Shares Issuable Upon Exercise Of Warrant/options | shares | 234,009 |
Exercise Price | $ 1.65 |
Expiration Date | 10/30/2024 |
Issue Date | 10/30/2017 |
Series SS [Member] | |
Exercise Price | $ 2.09 |
Expiration Date | 12/18/2022 |
Issue Date | 12/19/2017 |
Series TT [Member] | |
Shares Issuable Upon Exercise Of Warrant/options | shares | 600 |
Exercise Price | $ 2.24 |
Expiration Date | 2/5/2023 |
Issue Date | 2/5/2018 |
STOCKHOLDERS EQUITY (Details 4)
STOCKHOLDERS EQUITY (Details 4) - USD ($) | 3 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
STOCKHOLDERS EQUITY | ||
Series Z Warrants | $ 0 | $ 64,787 |
Series AA Warrants | 0 | 274,635 |
Series CC Warrants | 0 | 24,372 |
Series HH Warrants | 0 | 802 |
Net Gain On Warrant Liabilities | $ 0 | $ 364,596 |
STOCKHOLDERS EQUITY (Details 5)
STOCKHOLDERS EQUITY (Details 5) - USD ($) | 3 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Warrants Exercised | 217,752 | 14,500 |
Proceeds | $ 447,291 | $ 33,740 |
Series NN [Member] | ||
Warrants Exercised | 4,500 | |
Proceeds | $ 11,340 | |
Exercise Price | $ 2.52 | |
Series RR [Member] | ||
Warrants Exercised | 17,752 | |
Proceeds | $ 29,291 | |
Exercise Price | $ 1.65 | |
Series SS [Member] | ||
Warrants Exercised | 200,000 | |
Proceeds | $ 418,000 | |
Exercise Price | $ 2.09 | |
Series TT [Member] | ||
Warrants Exercised | 10,000 | |
Proceeds | $ 22,400 | |
Exercise Price | $ 2.24 |
STOCKHOLDERS EQUITY (Details Na
STOCKHOLDERS EQUITY (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | ||
Dec. 08, 2021 | Nov. 23, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | |
Incremental cost | $ 172,000 | |||
Consulting Agreements [Member] | ||||
Total expense | 149,000 | $ 218,000 | ||
Consulting fees inclued prepaid expenses | $ 183,000 | $ 295,000 | ||
Series CC [Member] | ||||
Warrants exercised | 640 | 15,205 | ||
Proceeds from warrants exercised | $ 76,000 | |||
Exercise price per share | $ 5 | $ 5 | ||
Series Z [Member] | ||||
Warrants exercised | 184,800 | |||
Exercise Price | $ 13.75 | |||
Consultants [Member] | ||||
Exercise price | $ 11.61 | |||
Options issued | 5,000 | |||
Consultants [Member] | Restricted Stock [Member] | ||||
Weighted average grant date fair value | $ 2.53 | $ 9.93 | ||
Common stock issued for service, shares | 40,236 | 18,020 | ||
Non-Qualified Stock Option Plans [Member] | ||||
Grant performance-based stock options | 250,000 | |||
Common stock price | $ 10.48 | |||
Stock options vest | 100% |
FAIR VALUE MEASUREMENTS (Detail
FAIR VALUE MEASUREMENTS (Details) - USD ($) | 3 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
FAIR VALUE MEASUREMENTS | ||
Beginning Balance | $ 0 | $ 437,380 |
Issuances | 0 | 0 |
Exercises | 0 | (70,589) |
Realized And Unrealized (gains) And Losses | 0 | (364,596) |
Ending Balance | $ 0 | $ 2,195 |
FAIR VALUE MEASUREMENTS (Deta_2
FAIR VALUE MEASUREMENTS (Details Narrative) | 3 Months Ended |
Dec. 31, 2022 | |
Fair Value Inputs Level 1 (Level 1) | |
Weighted Average Interest Rate | 0.10% |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details Narrative ) | 3 Months Ended |
Dec. 31, 2022 USD ($) | |
CEO, Geert Kersten [Member] | |
Modifications cost | $ 172,552 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES (Details) | Dec. 31, 2022 USD ($) |
Commitments and contingencies | |
Nine months ending September 30, 2023 | $ 1,937,000 |
2024 | 2,655,000 |
2025 | 2,741,000 |
2026 | 2,832,000 |
2027 | 2,923,000 |
2028 | 3,015,000 |
Thereafter | 252,000 |
Total Future Minimum Lease Obligation | 16,355,000 |
Less: Imputed Interest On Financing Lease Obligation | (3,446,000) |
Net Present Value Of Finance Lease Obligations | $ 12,909,000 |
COMMITMENTS AND CONTINGENCIES_3
COMMITMENTS AND CONTINGENCIES (Details 1) | Dec. 31, 2022 USD ($) |
Commitments and contingencies | |
Nine months ending September 30, 2023 | $ 262,000 |
2024 | 357,000 |
2025 | 366,000 |
2026 | 287,000 |
2027 | 277,000 |
2028 | 285,000 |
Thereafter | 1,040,000 |
Total Future Minimum Lease Obligation | 2,874,000 |
Less Imputed Interest On Operating Lease Obligation | (893,000) |
Net Present Value Of Operating Lease Obligation | $ 1,981,000 |
COMMITMENTS AND CONTINGENCIES_4
COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($) | 3 Months Ended | |||
Dec. 31, 2022 | Dec. 31, 2021 | Sep. 30, 2022 | Mar. 31, 2021 | |
Weighted Average Discount Rate Operating Lease | 9.10% | |||
Current portion of the operating lease obligation | $ 200,000 | |||
Increase In Right Of Use Asset And Liability | $ 1,100,000 | |||
Operating Lease Liabilities | 2,000,000 | |||
Research And Development Expenses | 35,600,000 | |||
Operating Lease Right Of Use Assets | 1,800,000 | $ 1,900,000 | ||
Current Balance | 200,000 | |||
Net Of Discount | 11,800,000 | |||
Operating Lease Expense | 91,000 | $ 91,000 | ||
Operating Lease Payment | $ 85,000 | 66,000 | ||
Weighted Average Time To Maturity | 5 years 29 days | |||
Landlord [Member] | ||||
Interest Rate | 8.45% | |||
Financing arrangement deposit base rent amount | $ 2,400,000 | |||
Financing arrangement deposit base rent percentage description | The repayment includes a base rent which escalates at 3% each year plus interest that accrues at 13.75% per year. | |||
Financing Arrangement | $ 11,100,000 | |||
Payments Made By Landlord | $ 2,400,000 | |||
Transaction One [Member] | ||||
Weighted average maturity date of operating leases | 7 years 7 months 6 days | |||
Weighted Average Discount Rate | 8.45% | |||
Net Book Value Of The Finance Lease Right Of Use Asset | $ 10,500,000 | $ 1,090,000 | ||
Balance Of The Finance Lease Liability | 12,900,000 | |||
Cash Paid Related To Finance Leases | 600,000 | |||
Cash Paid Related To Finance Leases Interest | 300,000 | |||
Ergomed [Member] | ||||
Research And Development Expenses | 10,000 | $ 200,000 | ||
Clinical Service Trial | $ 12,000,000 |
PATENTS (Details)
PATENTS (Details) | Dec. 31, 2022 USD ($) |
PATENTS | |
Nine months ending September 30, 2023 | $ 28,000 |
2024 | 30,000 |
2025 | 28,000 |
2026 | 24,000 |
2027 | 21,000 |
2028 | 17,000 |
Thereafter | 54,000 |
Total | $ 202,000 |
PATENTS (Details Narrative)
PATENTS (Details Narrative) - USD ($) | 3 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Patent Impairment Charges | $ 0 | $ 31,000 |
Amortization Of Patent Costs | 0 | 30,793 |
Amortization Of Patent Costs | ||
Amortization Of Patent Costs | $ 10,000 | $ 14,000 |
LOSS PER COMMON SHARE (Details)
LOSS PER COMMON SHARE (Details) - USD ($) | 3 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
LOSS PER COMMON SHARE | ||
Net loss available to common shareholders - basic | $ (8,025,061) | $ (8,782,606) |
Weighted average shares outstanding - basic | 43,440,387 | 43,077,961 |
Basic loss per common share | $ (0.18) | $ (0.20) |
Loss per share- diluted | ||
Net loss available to common shareholders -basic | $ (8,025,061) | $ (8,782,606) |
Gain on derivatives (1) | 0 | (25,114) |
Net loss available to common shareholders - diluted | $ (8,025,061) | $ (8,807,720) |
Weighted average shares outstanding - basic | 43,440,387 | 43,077,961 |
Incremental shares underlying dilutive - warrants and options (1) | 5,459 | |
Weighted average shares outstanding - diluted | 43,440,387 | 43,083,420 |
Diluted loss earnings per common share | $ (0.18) | $ (0.20) |
LOSS PER COMMON SHARE (Details
LOSS PER COMMON SHARE (Details 1) - shares | 3 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Antidilutive Securities | 14,066,602 | 10,629,216 |
Options and Warrants | ||
Antidilutive Securities | 13,917,352 | 10,477,966 |
Unvested Restricted Stock [Member] | ||
Antidilutive Securities | 149,250 | 151,250 |
SUBSEQUENT EVENTS (Details Narr
SUBSEQUENT EVENTS (Details Narrative) $ in Millions | Jan. 11, 2023 USD ($) |
Subsequent Events [Member] | |
Deposit to landlord | $ 2.3 |