Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Mar. 31, 2021 | May 10, 2021 | |
Document and Entity Information [Abstract] | ||
Entity Registrant Name | Citius Pharmaceuticals, Inc. | |
Entity Central Index Key | 0001506251 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --09-30 | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2021 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2021 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Shell Company | false | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 135,473,947 | |
Entity File Number | 001-38174 | |
Entity Interactive Data Current | Yes | |
Entity Incorporation State Country Code | NV |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) | Mar. 31, 2021 | Sep. 30, 2020 |
Current Assets: | ||
Cash and cash equivalents | $ 103,697,162 | $ 13,859,748 |
Prepaid expenses | 1,277,029 | 122,237 |
Total Current Assets | 104,974,191 | 13,981,985 |
Property and equipment, net | 1,272 | 1,577 |
Operating lease right-of-use asset, net | 906,092 | 986,204 |
Other Assets: | ||
Deposits | 38,062 | 57,093 |
In-process research and development | 19,400,000 | 19,400,000 |
Goodwill | 9,346,796 | 9,346,796 |
Total Other Assets | 28,784,858 | 28,803,889 |
Total Assets | 134,666,413 | 43,773,655 |
Current Liabilities: | ||
Accounts payable | 1,132,877 | 1,856,235 |
Accrued expenses | 240,610 | 164,040 |
Accrued compensation | 1,172,375 | 1,654,919 |
Accrued interest | 97,877 | 89,970 |
Notes payable – related parties | 172,970 | 172,970 |
Operating lease liability | 167,937 | 158,999 |
Total Current Liabilities | 2,984,646 | 4,097,133 |
Note payable – paycheck protection program | 164,583 | 164,583 |
Deferred tax liability | 4,985,800 | 4,985,800 |
Operating lease liability – non current | 769,218 | 855,471 |
Total Liabilities | 8,904,247 | 10,102,987 |
Commitments and Contingencies | ||
Stockholders' Equity: | ||
Preferred stock – $0.001 par value; 10,000,000 shares authorized; no shares issued and outstanding | ||
Common stock – $0.001 par value; 200,000,000 shares authorized; 134,701,219 and 55,576,996 shares issued and outstanding at March 31, 2021 and September 30, 2020, respectively | 134,701 | 55,577 |
Additional paid-in capital | 210,289,813 | 104,208,958 |
Accumulated deficit | (85,262,728) | (70,593,867) |
Total Citius Pharmaceuticals, Inc. Stockholders' Equity | 125,161,786 | 33,670,668 |
Non-controlling interest | 600,380 | |
Total Equity | 125,762,166 | 33,670,668 |
Total Liabilities and Equity | $ 134,666,413 | $ 43,773,655 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Mar. 31, 2021 | Sep. 30, 2020 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | ||
Preferred stock, shares outstanding | ||
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 134,701,219 | 55,576,996 |
Common stock, shares outstanding | 134,701,219 | 55,576,996 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | Mar. 31, 2021 | Mar. 31, 2020 | |
Income Statement [Abstract] | ||||
Revenues | ||||
Operating Expenses | ||||
Research and development | 1,551,341 | 2,015,940 | 7,742,520 | 4,680,486 |
General and administrative | 2,293,517 | 2,258,322 | 3,982,181 | 3,821,317 |
Stock-based compensation – general and administrative | 342,962 | 158,833 | 619,544 | 379,217 |
Total Operating Expenses | 4,187,820 | 4,433,095 | 12,344,245 | 8,881,020 |
Operating Loss | (4,187,820) | (4,433,095) | (12,344,245) | (8,881,020) |
Other Income (Expense) | ||||
Other income | 110,207 | |||
Interest income | 69,327 | 12,106 | 82,811 | 31,445 |
Interest expense | (3,939) | (3,980) | (7,907) | (7,971) |
Total Other Income, Net | 65,388 | 8,126 | 74,904 | 133,681 |
Net Loss | $ (4,122,432) | $ (4,424,969) | $ (12,269,341) | $ (8,747,339) |
Net Loss Per Share - Basic and Diluted | $ (0.04) | $ (0.13) | $ (0.16) | $ (0.28) |
Weighted Average Common Shares Outstanding | ||||
Basic and diluted | 95,997,427 | 34,318,761 | 75,565,121 | 31,744,379 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - USD ($) | Preferred Stock | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total Citius Pharmaceuticals, Inc. Shareholder's Equity | Non-Controlling Interest | Total |
Balance at Sep. 30, 2019 | $ 28,930 | $ 80,169,724 | $ (53,045,782) | $ (27,152,872) | $ 27,152,872 | ||
Balance, shares at Sep. 30, 2019 | 28,930,493 | ||||||
Issuance of common stock upon exercise of warrants | $ 1,061 | (955) | 106 | 106 | |||
Issuance of common stock upon exercise of warrants, shares | 1,060,615 | ||||||
Issuance of common stock for services | $ 187 | 99,813 | 100,000 | 100,000 | |||
Issuance of common stock for services, shares | 186,566 | ||||||
Stock-based compensation expense | 220,384 | 220,384 | 220,384 | ||||
Net loss | (4,322,370) | (4,322,370) | (4,322,370) | ||||
Balance at Dec. 31, 2019 | $ 30,178 | 80,488,966 | (57,368,152) | 23,150,992 | 23,150,992 | ||
Balance, shares at Dec. 31, 2019 | 30,177,674 | ||||||
Issuance of common stock upon exercise of warrants | $ 7,614 | 6,019,417 | 6,027,031 | 6,027,031 | |||
Issuance of common stock upon exercise of warrants, shares | 7,614,388 | ||||||
Issuance of common stock for services | $ 286 | 305,734 | 306,020 | 306,020 | |||
Issuance of common stock for services, shares | 286,000 | ||||||
Stock-based compensation expense | 158,833 | 158,833 | 158,833 | ||||
Net loss | (4,424,969) | (4,424,969) | (4,424,969) | ||||
Balance at Mar. 31, 2020 | $ 38,078 | 86,972,950 | (61,793,121) | 25,217,907 | 25,217,907 | ||
Balance, shares at Mar. 31, 2020 | 38,078,062 | ||||||
Balance at Sep. 30, 2020 | $ 55,577 | 104,208,958 | (70,593,867) | 33,670,668 | 33,670,668 | ||
Balance, shares at Sep. 30, 2020 | 55,576,996 | ||||||
Issuance of NoveCite common stock | 1,799,640 | (2,399,520) | (599,880) | 600,380 | 500 | ||
Stock-based compensation expense | 276,582 | 276,582 | 276,582 | ||||
Net loss | (8,146,909) | (8,146,909) | (8,146,909) | ||||
Balance at Dec. 31, 2020 | $ 55,577 | 106,285,180 | (81,140,296) | 25,200,461 | 600,380 | 25,800,841 | |
Balance, shares at Dec. 31, 2020 | 55,576,996 | ||||||
Issuance of common stock in private placement offering | $ 15,456 | 18,434,954 | 18,450,410 | 18,450,410 | |||
Issuance of common stock in private placement offering, shares | 15,455,960 | ||||||
Issuance of common stock in registered direct offering | $ 50,830 | 70,929,012 | 70,979,842 | 70,979,842 | |||
Issuance of common stock in registered direct offering, shares | 50,830,566 | ||||||
Issuance of common stock upon exercise of warrants | $ 12,788 | 14,229,755 | 14,242,543 | 14,242,543 | |||
Issuance of common stock upon exercise of warrants, shares | 12,787,697 | ||||||
Issuance of common stock for services | $ 50 | 67,950 | 68,000 | 68,000 | |||
Issuance of common stock for services, shares | 50,000 | ||||||
Stock-based compensation expense | 342,962 | 342,962 | 342,962 | ||||
Net loss | (4,122,432) | (4,122,432) | (4,122,432) | ||||
Balance at Mar. 31, 2021 | $ 134,701 | $ 210,289,813 | $ (85,262,728) | $ 125,161,786 | $ 600,380 | $ 125,762,166 | |
Balance, shares at Mar. 31, 2021 | 134,701,219 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) (Parenthetical) | 3 Months Ended |
Mar. 31, 2021USD ($) | |
Condensed Consolidated Statements Of Changes In Stockholders Equity Unaudited | |
Issuance of common stock in private placement offering, net of costs | $ 1,549,602 |
Issuance of common stock in registered direct offering, net of costs | $ 5,520,160 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 6 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Cash Flows From Operating Activities: | ||
Net loss | $ (12,269,341) | $ (8,747,339) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 619,544 | 379,217 |
Issuance of common stock for services | 68,000 | 406,020 |
Amortization of operating lease right-of-use asset | 80,112 | 81,847 |
Depreciation | 305 | 354 |
Changes in operating assets and liabilities: | ||
Prepaid expenses | (1,154,792) | (5,553) |
Deposits | 19,031 | |
Accounts payable | (723,358) | (1,189,182) |
Accrued expenses | 76,570 | (96,234) |
Accrued compensation | (482,544) | (368,812) |
Accrued interest | 7,907 | 7,971 |
Operating lease liability | (77,315) | (50,158) |
Net Cash Used In Operating Activities | (13,835,881) | (9,581,869) |
Cash Flows From Financing Activities: | ||
Proceeds from sale of NoveCite, Inc. common stock | 500 | |
Net proceeds from private placement | 18,450,410 | |
Net proceeds from registered direct offering | 70,979,842 | |
Net proceeds from common stock warrant exercises | 14,242,543 | 6,027,137 |
Net Cash Provided By Financing Activities | 103,673,295 | 6,027,137 |
Net Change in Cash and Cash Equivalents | 89,837,414 | (3,554,732) |
Cash and Cash Equivalents - Beginning of Period | 13,859,748 | 7,893,804 |
Cash and Cash Equivalents - End of Period | 103,697,162 | 4,339,072 |
Supplemental Disclosures Of Cash Flow Information and Non-cash Activities: | ||
Operating lease right-of-use asset and liability recorded upon adoption of ASC 842 | $ 1,137,724 |
Nature of Operations, Basis of
Nature of Operations, Basis of Presentation and Summary of Significant Accounting Policies | 6 Months Ended |
Mar. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
NATURE OF OPERATIONS, BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 1. NATURE OF OPERATIONS, BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Business Citius Pharmaceuticals, Inc. ("Citius," the "Company," "we" or "us") is a specialty pharmaceutical company dedicated to the development and commercialization of critical care products with a focus on anti-infective products in adjunct cancer care, unique prescription products and stem cell therapy. On March 30, 2016, Citius acquired Leonard-Meron Biosciences, Inc. ("LMB") as a wholly-owned subsidiary. The Company acquired all of the outstanding stock of LMB by issuing shares of its common stock. The net assets acquired included identifiable intangible assets of $19,400,000 related to in-process research and development. The Company recorded goodwill of $9,346,796 for the excess of the purchase price over the net assets. In-process research and development represents the value of LMB's leading drug candidate, which is an antibiotic solution used to treat catheter-related bloodstream infections (Mino-Lok®) and is expected to be amortized on a straight-line basis over a period of eight years commencing upon revenue generation. Goodwill represents the value of LMB's industry relationships and its assembled workforce. Goodwill will not be amortized but will be tested at least annually for impairment. On September 11, 2020, we formed NoveCite, Inc. ("NoveCite"), a Delaware corporation, of which we own 75% (7,500,000 shares) of the issued and outstanding capital stock (see Note 3). Citius is subject to a number of risks common to companies in the pharmaceutical industry including, but not limited to, risks related to the development by Citius or its competitors of research and development stage product candidates, market acceptance of its product candidates that might be approved, competition from larger companies, dependence on key personnel, dependence on key suppliers and strategic partners, the Company's ability to obtain additional financing and the Company's compliance with governmental and other regulations. Basis of Presentation and Summary of Significant Accounting Policies Basis of Preparation The accompanying unaudited condensed consolidated financial statements of the Company have been prepared on the same basis as the annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to fairly state the condensed consolidated financial position of the Company as of March 31, 2021, and the results of its operations and cash flows for the three and six month periods ended March 31, 2021 and 2020. The operating results for the three and six month periods ended March 31, 2021 are not necessarily indicative of the results that may be expected for the year ending September 30, 2021. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company's Annual Report on Form 10-K for the year ended September 30, 2020 filed with the Securities and Exchange Commission. Use of Estimates Basic and Diluted Net Loss per Common Share Recently Issued Accounting Standards In December 2019, the FASB issued ASU No. 2019-12 Simplifications to Accounting for Income Taxes. ASU 2019-12 removes certain exceptions for recognizing deferred taxes for investments, performing intra-period allocation, and calculating income taxes in interim periods. The ASU also adds guidance to reduce complexity in certain areas, including deferred taxes for goodwill and allocating taxes for members of a consolidated group. ASU 2019-12 is effective for all entities for fiscal years beginning after December 15, 2020, and earlier adoption is permitted. The Company is currently evaluating the impact of adopting ASU 2019-12 on its consolidated financial statements. In August 2020, FASB issued ASU 2020-06, Debt — Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging — Contracts in Entity's Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity's Own Equity, which, among other things, provides guidance on how to account for contracts on an entity's own equity. This ASU eliminates the beneficial conversion and cash conversion accounting models for convertible instruments. It also amends the accounting for certain contracts in an entity's own equity that are currently accounted for as derivatives because of specific settlement provisions. In addition, this ASU modifies how particular convertible instruments and certain contracts that may be settled in cash or shares impact the diluted EPS computation. The amendments in this ASU are effective for the public companies for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020. The Company is currently evaluating the impact of ASU 2020-06 on its consolidated financial statements. |
Liquidity and Management's Plan
Liquidity and Management's Plan | 6 Months Ended |
Mar. 31, 2021 | |
Going Concern Uncertainty and Management's Plan [Abstract] | |
LIQUIDITY AND MANAGEMENT'S PLAN | 2. LIQUIDITY AND MANAGEMENT'S PLAN The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company experienced negative cash flows from operations of $13,835,881 for the six months ended March 31, 2021. As a result of the Company's recent common stock offerings and common stock warrant exercises in its second fiscal quarter of 2021, the Company had working capital of $101,989,545 at March 31, 2021. The Company estimates that its available cash resources will be sufficient to fund its operations through March 2023. The Company has generated no operating revenue to date and has principally raised capital through the issuance of debt and equity instruments to finance its operations. However, the Company's continued operations beyond March 2023, including its development plans for Mino-Lok, Mino-Wrap, Halo-Lido and Novecite, will depend on its ability to obtain regulatory approval to market Mino-Lok and generate substantial revenue from the sale of Mino-Lok and on its ability to raise additional capital through various potential sources, such as equity and/or debt financings, strategic relationships, or out-licensing of its products. However, the Company can provide no assurances on future sales of Mino-Lok or that financing or strategic relationships will be available on acceptable terms, or at all. If the Company is unable to raise sufficient capital, find strategic partners or generate substantial revenue from the sale of Mino-Lok, there would be a material adverse effect on its business. Further, the Company expects in the future to incur additional expenses as it continues to develop its product candidates, including regulatory approval, and protect its intellectual property. |
Patent and Technology License A
Patent and Technology License Agreements | 6 Months Ended |
Mar. 31, 2021 | |
Patent and Technology License Agreements [Abstract] | |
PATENT AND TECHNOLOGY LICENSE AGREEMENTS | 3. PATENT AND TECHNOLOGY LICENSE AGREEMENTS Patent and Technology License Agreement – Mino-Lok LMB has a patent and technology license agreement with Novel Anti-Infective Therapeutics, Inc. ("NAT") to develop and commercialize Mino-Lok® on an exclusive, worldwide sub licensable basis. LMB is required to pay an annual maintenance fee each June until commercial sales of a product subject to the license commence. The annual fee paid in June 2020 was $90,000 (at which level it will remain for as long as it is due). LMB will also pay annual royalties on net sales of licensed products, with royalties ranging from the mid-single digits to the low double digits or, in the event the licensed product is not subject to a valid patent claim, the royalty is reduced to mid- to lower-single digits. In limited circumstances in which the licensed product is not subject to a valid patent claim and a competitor is selling a competing product, the royalty rate is in the low single digits. After a commercial sale is obtained, LMB must pay minimum aggregate annual royalties of $100,000 in the first commercial year which is prorated for a less than 12-month period, increasing $25,000 per year to a maximum of $150,000 annually. LMB must also pay NAT up to $1,100,000 upon achieving specified regulatory and sales milestones. Finally, LMB must pay NAT a specified percentage of payments received from any sub licensees. Unless earlier terminated by NAT, based on the failure by the Company to achieve certain development and commercial milestones or for various breaches by the Company, the license agreement remains in effect until the date that all patents licensed under the agreement have expired and all patent applications within the licensed patent rights have been cancelled, withdrawn or expressly abandoned. Patent and Technology License Agreement – Mino-Wrap On January 2, 2019, we entered into a patent and technology license agreement with the Board of Regents of the University of Texas System on behalf of the University of Texas M. D. Anderson Cancer Center ("Licensor"), whereby we in-licensed exclusive worldwide rights to the patented technology for any and all uses relating to breast implants. We intend to develop a liquefying gel-based wrap containing minocycline and rifampin for the reduction of infections associated with breast implants following breast reconstructive surgeries ("Mino-Wrap"). We are required to use commercially reasonable efforts to commercialize Mino-Wrap under several regulatory scenarios and achieve milestones associated with these regulatory options leading to an approval from the U.S. Food and Drug Administration ("FDA"). Under the license agreement, the Company paid annual maintenance fees of $45,000 and $30,000 in January 2021 and 2020, respectively. The annual maintenance fee increases by $15,000 per year up to a maximum of $90,000. Annual maintenance fees cease on the first sale of product. We also must pay up to an aggregate of $2.1 million in milestone payments, contingent on the achievement of various regulatory and commercial milestones. Under the terms of the license agreement, we also must pay a royalty of mid- to upper-single digit percentages of net sales, depending on the amount of annual sales, and subject to downward adjustment to lower- to mid-single digit percentages in the event there is no valid patent for the product in the United States at the time of sale. After the first sale of product, we will owe an annual minimum royalty payment of $100,000 that will increase annually by $25,000 for the duration of the term. We will be responsible for all patent expenses incurred by Licensor for the term of the agreement although Licensor is responsible for filing, prosecution and maintenance of all patents. Unless earlier terminated by Licensor, based upon the failure by us to achieve certain development and commercial milestones or for various breaches by us, the agreement expires on the later of the expiration of the patents or January 2, 2034. License Agreement with Novellus On March 31, 2020, we entered into an option agreement with a subsidiary of Novellus, Inc. ("Novellus") whereby we had the opportunity to in-license from Novellus on a worldwide basis, a novel cellular therapy for acute respiratory distress syndrome ("ARDS"). The option exercise period ran for six months and the option agreement contained the agreed upon financial terms for the license. In April 2020 we paid Novellus $100,000 for the option and recorded it as a research and development expense. Our Board Chairman Leonard Mazur, who is also our largest stockholder, is a significant shareholder of Novellus and subsequent to the option agreement as well as the license agreement referred to below, became a director of Novellus. As required by our Code of Ethics, the Audit Committee of our Board of Directors approved the entry into the option agreement with Novellus, as did the disinterested members of our Board of Directors. On October 6, 2020, we, through NoveCite, our subsidiary that was established specifically for this purpose, exercised the option and signed an exclusive license agreement with Novellus. NoveCite is focused on developing cellular therapies. Upon execution of the agreement, we paid $5,000,000 to Novellus and issued to Novellus shares of NoveCite's common stock representing 25% of the outstanding equity. We own the other 75% of NoveCite's outstanding equity. Pursuant to the terms of the stock subscription agreement between Novellus and NoveCite, if NoveCite issues additional equity, subject to certain exceptions, NoveCite must maintain Novellus's ownership at 25% by issuing additional shares to Novellus. The $5,000,000 payment to Novellus was charged to research and development expense in the six months ended March 31, 2021. Citius is responsible for the operational activities of NoveCite, and bears all costs necessary to operate NoveCite. Citius's officers are also the officers of NoveCite and oversee the business strategy and operations of NoveCite. As such, NoveCite is accounted for as a consolidated subsidiary with a noncontrolling interest. Novellus has no contractual rights in the profits or obligations to share in the losses of NoveCite, and the Company has not allocated any losses to the noncontrolling interest. NoveCite is obligated to pay Novellus up to $51,000,000 upon the achievement of various regulatory and developmental milestones. NoveCite also must pay a royalty equal to low double-digit percentages of net sales, commencing upon the sale of a licensed product. This royalty is subject to downward adjustment to an upper-single digit percentage of net sales in any country in the event of the expiration of the last valid patent claim or if no valid patent claim exists in that country. The royalty will end on the earlier of (i) the date on which a biosimilar product is first marketed, sold, or distributed in the applicable country or (ii) the 10-year anniversary of the date of expiration of the last-to-expire valid patent claim in that country. In the case of a country where no licensed patent ever exists, the royalty will end on the later of (i) the date of expiry of such licensed product's regulatory exclusivity and (ii) the 10-year anniversary of the date of the first commercial sale of the licensed product in the applicable country. In addition, NoveCite will pay to Novellus an amount equal to a mid-twenties percentage of any sublicensee fees it receives. Under the terms of the license agreement, in the event that Novellus receives any revenue involving the original cell line included in the licensed technology, then Novellus shall remit to NoveCite 50% of such revenue. The term of the license agreement will continue on a country-by-country and licensed product-by-licensed product basis until the expiration of the last-to-expire royalty term. Either party may terminate the license agreement upon written notice if the other party is in material default. NoveCite may terminate the license agreement at any time without cause upon 90 days prior written notice. Novellus will be responsible for preparing, filing, prosecuting and maintaining all patent applications and patents included in the licensed patents in the territory. Provided however, that if Novellus decides that it is not interested in maintaining a particular licensed patent or in preparing, filing, or prosecuting a licensed patent, NoveCite will have the right, but not the obligation, to assume such responsibilities in the territory at NoveCite's sole cost and expense. |
Notes Payable
Notes Payable | 6 Months Ended |
Mar. 31, 2021 | |
Debt Disclosure [Abstract] | |
NOTES PAYABLE | 4. NOTES PAYABLE Notes Payable – Related Parties The aggregate principal balance as of March 31, 2021 consists of notes payable held by our Chairman, Leonard Mazur, in the amount of $160,470 and notes payable held by our Chief Executive Officer, Myron Holubiak, in the amount of $12,500. Notes with an aggregate principal balance of $104,000 accrue interest at the prime rate plus 1.0% per annum and notes with an aggregate principal balance of $68,970 accrue interest at 12% per annum. Interest expense on notes payable – related parties was $3,533 and $3,980, respectively, for the three months ended March 31, 2021 and 2020. Interest expense on notes payable – related parties was $7,096 and $7,971, respectively, for the six months ended March 31, 2021 and 2020. Paycheck Protection Program On April 12, 2020, due to the business disruption caused by the COVID-19 health crisis, the Company applied for a forgivable loan through the Small Business Association's Paycheck Protection Program (the "PPP"). In accordance with the provisions of the PPP, the loan accrues interest at a rate of 1% and a portion of the loan may be forgiven if it is used to pay qualifying costs such as payroll, rent and utilities. Amounts that are not forgiven will be repaid 2 years from the date of the loan. On April 15, 2020, the Company received funding in the amount of $164,583 from the Paycheck Protection Program through its bank. Interest expense was $406 and $811 for the three and six months ended March 31, 2021, respectively. |
Common Stock, Stock Options and
Common Stock, Stock Options and Warrants | 6 Months Ended |
Mar. 31, 2021 | |
Stockholders' Equity Note [Abstract] | |
COMMON STOCK, STOCK OPTIONS AND WARRANTS | 5. COMMON STOCK, STOCK OPTIONS AND WARRANTS Common Stock Offerings On May 18, 2020, the Company closed a registered direct offering with several institutional and accredited investors for the sale of 7,058,824 shares of common stock at $1.0625 per share for gross proceeds of $7,500,001. The Company also agreed to issue 3,529,412 unregistered immediately exercisable warrants to the investors with an exercise price of $1.00 per share and a term of five and one-half years. The Company paid the placement agent for the offering a fee of 7% of the gross proceeds totaling $525,000 and issued the placement agent 494,118 immediately exercisable warrants with an exercise price of $1.3281 per share and a term of five years. The Company also reimbursed the placement agent for $85,000 in expenses and incurred $12,901 in other expenses. Net proceeds from the offering were $6,877,100. The estimated fair value of the 3,529,412 warrants issued to the investors was $2,138,998 and the estimated fair value of the 494,118 warrants issued to the placement agent was $275,724. On August 10, 2020, the Company closed an underwritten public offering of 9,159,524 shares of common stock at a price of $1.05 per share for gross proceeds of $9,617,500. The Company paid the underwriter a fee of 7% of the gross proceeds totaling $673,225 and issued the underwriters 641,166 immediately exercisable warrants with an exercise price of $1.3125 per share and a term of five years. The Company also reimbursed the placement agent for $135,000 in expenses and incurred $109,074 in other expenses. Net proceeds from the offering were $8,700,201. The estimated fair value of the 641,166 warrants issued to the underwriter was $569,426. On January 27, 2021, the Company closed a private placement for 15,455,960 shares of its common stock and warrants to purchase up to 7,727,980 shares of common stock, at a purchase price of $1.294 per share of common stock and accompanying warrant, for gross proceeds of $20,000,012. The 7,727,980 warrants are immediately exercisable at $1.231 per share for a term of five and one-half years. The Company paid the placement agent a fee of 7% of the gross proceeds totaling $1,400,001 and issued the placement agent 1,081,917 warrants for common stock that are immediately exercisable at $1.6175 per share for a term of five and one-half years. The Company also reimbursed the placement agent for $85,000 in expenses and incurred $64,601 in other expenses. Net proceeds from the offering were $18,450,410. The estimated fair value of the 7,727,980 warrants issued to the investors was approximately $7,582,000 and the estimated fair value of the 1,081,917 warrants issued to the placement agent was approximately $1,025,000. On February 19, 2021, the Company closed a registered direct offering for 50,830,566 shares of its common stock and warrants to purchase up to 25,415,283 shares of common stock, at a purchase price of $1.505 per share of common stock and accompanying warrant, for gross proceeds of $76,500,002. The 25,415,283 warrants are immediately exercisable at $1.70 per share for a term of five years. The Company paid the placement agent a fee of 7% of the gross proceeds totaling $5,355,000 and issued the placement agent 3,558,140 warrants for common stock that are immediately exercisable at $1.881 per share for a term of five years. The Company also reimbursed the placement agent for $85,000 in expenses and incurred $80,160 in other expenses. Net proceeds from the offering were $70,979,842. The estimated fair value of the 25,415,283 warrants issued to the investors was approximately $42,322,000 and the estimated fair value of the 3,558,140 warrants issued to the placement agent was approximately $5,850,000. Common Stock Issued for Services On November 4, 2019, the Company issued 186,566 shares of common stock for strategic consulting and corporate development services and expensed the $100,000 fair value of the common stock issued. On February 10, 2020, the Company issued 150,000 shares of common stock for investor relations services and 136,000 shares of common stock for general advisory and business development advisory services. The Company expensed the $306,020 fair value of the common stock issued. On April 6, 2020, the Company issued 50,000 shares of common stock for strategic consulting and corporate development services and expensed the $22,750 fair value of the common stock issued. On September 8, 2020, the Company issued 101,174 shares of common stock for investor relations services and expensed the $100,000 fair value of the common stock issued. On February 12, 2021, the Company issued 50,000 shares of common stock for investor relations services and expensed the $68,000 fair value of the common stock issued. Stock Option Plans Pursuant to its 2014 Stock Incentive Plan (the "2014 Plan") the Company reserved 866,667 shares of common stock for issuance to employees, directors and consultants. As of March 31, 2021, there were options to purchase an aggregate of 855,171 shares of common stock outstanding under the 2014 Plan, options to purchase 4,829 shares were exercised, options to purchase 6,667 shares expired and no shares remain available for future grants. On February 7, 2018, our stockholders approved the 2018 Omnibus Stock Incentive Plan (the "2018 Plan") and the Company reserved 2,000,000 shares of common stock for issuance to employees, directors and consultants. As of March 31, 2021, there were options to purchase an aggregate of 1,890,000 shares of common stock outstanding under the 2018 Plan and no shares available for future grants. On February 10, 2020, the Company's stockholders approved the 2020 Omnibus Stock Incentive Plan ("2020 Stock Plan"). The 2020 Stock Plan authorizes a maximum of 3,110,000 shares. The 2020 Stock Plan provides incentives to employees, directors, and consultants of the Company in form of granting an option, SAR, dividend equivalent right, restricted stock, restricted stock unit, or other right or benefit under the 2020 Stock Plan. As of March 31, 2021, there were options to purchase 1,870,000 shares outstanding under the 2020 Plan and 1,240,000 shares available for future grants. The fair value of each stock option award is estimated on the date of grant using the Black-Scholes option pricing model. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant commensurate with the expected term assumption. The expected term of stock options granted, all of which qualify as "plain vanilla," is based on the average of the contractual term (generally 10 years) and the vesting period. For non-employee options, the expected term is the contractual term. A summary of option activity under the Company's stock option plans (excluding the NoveCite Stock Plan) is presented below: Option Weighted- Weighted- Aggregate Outstanding at October 1, 2020 3,390,171 $ 2.51 8.0 years $ 440,336 Granted 1,225,000 1.08 Exercised — — Forfeited or expired — — Outstanding at March 31, 2021 4,615,171 $ 2.13 8.1 years $ 2,659,010 Exercisable at March 31, 2021 1,968,804 $ 3.56 6.6 years $ 787,968 On October 6, 2020, the Board of Directors granted stock options to purchase 800,000 shares to employees, 175,000 shares to directors and 125,000 shares to consultants at $1.01 per share. On February 16, 2021, the Board of Directors granted stock options to purchase a total of 125,000 shares to directors at $1.69 per share. All of these options vest over terms of 12 to 36 months and have a term of 10 years. Stock-based compensation expense for the three months ended March 31, 2021 and 2020 was $342,962 (including $18,833 for the NoveCite Stock Plan) and $158,833, respectively. Stock-based compensation expense for the six months ended March 31, 2021 and 2020 was $619,544 (including $31,389 for the NoveCite Stock Plan) and $379,217, respectively. At March 31, 2021, unrecognized total compensation cost related to unvested awards under the 2014 Plan, 2018 Plan and 2020 Stock Plan of $1,669,737 is expected to be recognized over a weighted average period of 1.8 years. On November 5, 2020, the stockholders of our majority-owned subsidiary, NoveCite, Inc., approved NoveCite's 2020 Omnibus Stock Incentive Plan ("NoveCite Stock Plan"). The NoveCite Stock Plan authorizes a maximum of 2,000,000 shares of NoveCite common stock. The NoveCite Stock Plan provides incentives to employees, directors, and consultants of NoveCite through grants of options, SARs, dividend equivalent rights, restricted stock, restricted stock units, or other rights or benefits under the NoveCite Stock Plan. As of March 31, 2021, there were options outstanding to purchase 1,130,000 shares of NoveCite common stock under the NoveCite Stock Plan and 870,000 shares of NoveCite common stock available for future grants. On November 5, 2020, NoveCite granted stock options to purchase 1,130,000 shares of NoveCite common stock to employees at a weighted average exercise price of $0.24 per share, of which, none are exercisable as of March 31, 2021. The weighted average remaining contractual term of options outstanding under the NoveCite Stock Plan is 9.61 years. At March 31, 2021, unrecognized total compensation cost related to unvested awards under the NoveCite Stock Plan of $194,611 is expected to be recognized over a weighted average period of 2.6 years. Warrants As of March 31, 2021, the Company has reserved shares of common stock for the exercise of outstanding warrants. The following table summarizes the warrants outstanding: Exercise Number Expiration Dates Investor Warrants $ 9.00 126,669 April 15, 2021 – April 25, 2021 LMB Warrants 7.50 53,110 March 24, 2022 – April 29, 2022 Financial Advisor Warrants 3.00 25,833 August 15, 2021 2016 Offering Warrants 4.13 140,819 November 23, 2021 – February 27, 2022 2017 Public Offering Investors 4.13 1,622,989 August 2, 2022 2017 Public Offering Underwriter 4.54 65,940 February 2, 2023 December 2017 Registered Direct/Private Placement Offering Investors 4.63 640,180 June 19, 2023 December 2017 Registered Direct/Private Placement Offering Placement Agent 5.87 89,625 December 19, 2022 March 2018 Registered Direct/Private Placement Offering Investors 2.86 218,972 October 2, 2023 March 2018 Registered Direct/Private Placement Offering Placement Agent 3.73 46,866 March 28, 2023 August 2018 Offering Investors 1.15 3,921,569 August 14, 2023 August 2018 Offering Agent 1.59 549,020 August 8, 2023 April 2019 Registered Direct/Private Placement Offering Investors 1.42 1,294,498 April 5, 2021 April 2019 Registered Direct/Private Placement Offering Placement Agent 1.93 240,130 April 5, 2021 September 2019 Offering Investors 0.77 2,793,297 September 27, 2024 September 2019 Offering Underwriter 1.12 194,358 September 27, 2024 February 2020 Exercise Agreement Placement Agent 1.28 143,295 August 19, 2025 May 2020 Registered Direct Offering Investors 1.00 2,400,000 November 18, 2025 May 2020 Registered Direct Offering Placement Agent 1.33 494,118 May 14, 2025 August 2020 Underwriter 1.31 641,166 August 10, 2025 January 2021 Registered Direct Offering Investors 1.23 6,182,384 July 27, 2026 January 2021 Registered Direct Offering Agent 1.62 1,081,917 July 27, 2026 February 2021 Offering Investors 1.70 25,044,164 February 19, 2026 February 2021 Offering Agent 1.88 3,558,140 February 19, 2026 51,569,059 At March 31, 2021, the weighted average remaining life of the outstanding warrants is 4.3 years, all warrants are exercisable, and the aggregate intrinsic value of the warrants outstanding was $14,029,462. Common Stock Reserved A summary of common stock reserved for future issuances as of March 31, 2021 is as follows: Stock plan options outstanding 4,615,171 Stock plan shares available for future grants 1,240,000 Warrants outstanding 51,569,059 Total 57,424,230 |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Mar. 31, 2021 | |
Related Party Transactions [Abstract] | |
RELATED PARTY TRANSACTIONS | 6. RELATED PARTY TRANSACTIONS The Company has outstanding debt due to Leonard Mazur (Chairman of the Board) and Myron Holubiak (Chief Executive Officer) (see Note 4). Leonard Mazur is a director and significant shareholder of Novellus, Inc. On October 6, 2020, the Company, through its subsidiary NoveCite, entered into an exclusive agreement with Novellus to develop cellular therapies (see Note 3). |
Operating Lease
Operating Lease | 6 Months Ended |
Mar. 31, 2021 | |
Disclosure Text Block [Abstract] | |
OPERATING LEASE | 7. OPERATING LEASE Effective July 1, 2019, Citius entered into a 76-month lease for office space in Cranford, NJ. Citius will pay its proportionate share of real estate taxes and operating expenses in excess of the base year expenses. These costs are considered to be variable lease payments and are not included in the determination of the lease's right-of-use asset or lease liability. The Company identified and assessed the following significant assumptions in recognizing its right-of-use assets and corresponding lease liabilities: ● As the Company's current Cranford lease does not provide an implicit rate, the Company estimated the incremental borrowing rate in calculating the present value of the lease payments. The Company estimated its incremental borrowing rate based on the remaining lease term as of the adoption date. ● Since the Company elected to account for each lease component and its associated non-lease components as a single combined component, all contract consideration was allocated to the combined lease component. ● The expected lease terms include noncancelable lease periods. The elements of lease expense are as follows: Lease cost Six Months Ended Six Months Ended Operating lease cost $ 119,412 $ 126,844 Variable lease cost 194 — Total lease cost 119,606 $ 126,844 Other information Weighted-average remaining lease term - operating leases 4.6 Years 5.6 Years Weighted-average discount rate - operating leases 8.0 % 8.0 % Maturities of lease liabilities due under the Company's non-cancellable leases as of March 31, 2021 is as follows: Year Ending September 30, March 31, 2021 (excluding the 6 months ended March 31, 2021) $ 117,830 2022 239,306 2023 244,165 2024 249,024 2025 and thereafter 275,343 Total lease payments 1,125,668 Less: interest (188,513 ) Present value of lease liabilities $ 937,155 Leases Classification March 31, September 30, Assets Lease asset Operating $ 906,092 $ 986,204 Total lease assets $ 906,092 $ 986,204 Liabilities Current Operating $ 167,937 $ 158,999 Non-current Operating 769,218 855,471 Total lease liabilities $ 937,155 $ 1,014,470 Interest expense on the lease liability was $39,300 and $44,997 for the six months ended March 31, 2021 and 2020, respectively. |
FDA Refund
FDA Refund | 6 Months Ended |
Mar. 31, 2021 | |
FDA Refund [Abstract] | |
FDA REFUND | 8. FDA REFUND In November 2019, the Company received a $110,207 refund from the FDA for 2016 product and establishment fees because the fees paid by the Company exceeded the costs of the FDA's review of the associated applications. The Company recorded the $110,207 as other income during the six months ended March 31, 2020. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Mar. 31, 2021 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | 9. SUBSEQUENT EVENTS Special Meeting of Stockholders The Company plans to hold a special meeting of stockholders on May 24, 2021 at the Company's headquarters at 11 Commerce Drive, First Floor, Cranford, New Jersey 07016, to 1) approve an amendment to our Articles of Incorporation to increase the authorized number of shares from 210,000,000 to 410,000,000 and the authorized number of common shares from 200,000,000 to 400,000,000, and 2) approve the 2021 Omnibus Stock Incentive Plan. The record date for the Special Meeting is April 7, 2021. Only stockholders of record at the close of business on that date may vote at the meeting or any adjournment thereof. |
Nature of Operations, Basis o_2
Nature of Operations, Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Preparation | Basis of Preparation The accompanying unaudited condensed consolidated financial statements of the Company have been prepared on the same basis as the annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to fairly state the condensed consolidated financial position of the Company as of March 31, 2021, and the results of its operations and cash flows for the three and six month periods ended March 31, 2021 and 2020. The operating results for the three and six month periods ended March 31, 2021 are not necessarily indicative of the results that may be expected for the year ending September 30, 2021. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company's Annual Report on Form 10-K for the year ended September 30, 2020 filed with the Securities and Exchange Commission. |
Use of Estimates | Use of Estimates |
Basic and Diluted Net Loss per Common Share | Basic and Diluted Net Loss per Common Share |
Recently Issued Accounting Standards | Recently Issued Accounting Standards In December 2019, the FASB issued ASU No. 2019-12 Simplifications to Accounting for Income Taxes. ASU 2019-12 removes certain exceptions for recognizing deferred taxes for investments, performing intra-period allocation, and calculating income taxes in interim periods. The ASU also adds guidance to reduce complexity in certain areas, including deferred taxes for goodwill and allocating taxes for members of a consolidated group. ASU 2019-12 is effective for all entities for fiscal years beginning after December 15, 2020, and earlier adoption is permitted. The Company is currently evaluating the impact of adopting ASU 2019-12 on its consolidated financial statements. In August 2020, FASB issued ASU 2020-06, Debt — Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging — Contracts in Entity's Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity's Own Equity, which, among other things, provides guidance on how to account for contracts on an entity's own equity. This ASU eliminates the beneficial conversion and cash conversion accounting models for convertible instruments. It also amends the accounting for certain contracts in an entity's own equity that are currently accounted for as derivatives because of specific settlement provisions. In addition, this ASU modifies how particular convertible instruments and certain contracts that may be settled in cash or shares impact the diluted EPS computation. The amendments in this ASU are effective for the public companies for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020. The Company is currently evaluating the impact of ASU 2020-06 on its consolidated financial statements. |
Common Stock, Stock Options a_2
Common Stock, Stock Options and Warrants (Tables) | 6 Months Ended |
Mar. 31, 2021 | |
Stockholders' Equity Note [Abstract] | |
Schedule of stock option activity | Option Weighted- Weighted- Aggregate Outstanding at October 1, 2020 3,390,171 $ 2.51 8.0 years $ 440,336 Granted 1,225,000 1.08 Exercised — — Forfeited or expired — — Outstanding at March 31, 2021 4,615,171 $ 2.13 8.1 years $ 2,659,010 Exercisable at March 31, 2021 1,968,804 $ 3.56 6.6 years $ 787,968 |
Schedule of warrants outstanding | Exercise Number Expiration Dates Investor Warrants $ 9.00 126,669 April 15, 2021 – April 25, 2021 LMB Warrants 7.50 53,110 March 24, 2022 – April 29, 2022 Financial Advisor Warrants 3.00 25,833 August 15, 2021 2016 Offering Warrants 4.13 140,819 November 23, 2021 – February 27, 2022 2017 Public Offering Investors 4.13 1,622,989 August 2, 2022 2017 Public Offering Underwriter 4.54 65,940 February 2, 2023 December 2017 Registered Direct/Private Placement Offering Investors 4.63 640,180 June 19, 2023 December 2017 Registered Direct/Private Placement Offering Placement Agent 5.87 89,625 December 19, 2022 March 2018 Registered Direct/Private Placement Offering Investors 2.86 218,972 October 2, 2023 March 2018 Registered Direct/Private Placement Offering Placement Agent 3.73 46,866 March 28, 2023 August 2018 Offering Investors 1.15 3,921,569 August 14, 2023 August 2018 Offering Agent 1.59 549,020 August 8, 2023 April 2019 Registered Direct/Private Placement Offering Investors 1.42 1,294,498 April 5, 2021 April 2019 Registered Direct/Private Placement Offering Placement Agent 1.93 240,130 April 5, 2021 September 2019 Offering Investors 0.77 2,793,297 September 27, 2024 September 2019 Offering Underwriter 1.12 194,358 September 27, 2024 February 2020 Exercise Agreement Placement Agent 1.28 143,295 August 19, 2025 May 2020 Registered Direct Offering Investors 1.00 2,400,000 November 18, 2025 May 2020 Registered Direct Offering Placement Agent 1.33 494,118 May 14, 2025 August 2020 Underwriter 1.31 641,166 August 10, 2025 January 2021 Registered Direct Offering Investors 1.23 6,182,384 July 27, 2026 January 2021 Registered Direct Offering Agent 1.62 1,081,917 July 27, 2026 February 2021 Offering Investors 1.70 25,044,164 February 19, 2026 February 2021 Offering Agent 1.88 3,558,140 February 19, 2026 51,569,059 |
Summary of common stock reserved for future issuances | Stock plan options outstanding 4,615,171 Stock plan shares available for future grants 1,240,000 Warrants outstanding 51,569,059 Total 57,424,230 |
Operating Lease (Tables)
Operating Lease (Tables) | 6 Months Ended |
Mar. 31, 2021 | |
Disclosure Text Block [Abstract] | |
Schedule operating lease expense | Lease cost Six Months Ended Six Months Ended Operating lease cost $ 119,412 $ 126,844 Variable lease cost 194 — Total lease cost 119,606 $ 126,844 Other information Weighted-average remaining lease term - operating leases 4.6 Years 5.6 Years Weighted-average discount rate - operating leases 8.0 % 8.0 % |
Schedule of future minimum lease commitments under non-cancelable operating lease agreements | Year Ending September 30, March 31, 2021 (excluding the 6 months ended March 31, 2021) $ 117,830 2022 239,306 2023 244,165 2024 249,024 2025 and thereafter 275,343 Total lease payments 1,125,668 Less: interest (188,513 ) Present value of lease liabilities $ 937,155 |
Schedule operating leases assets and liabilities | Leases Classification March 31, September 30, Assets Lease asset Operating $ 906,092 $ 986,204 Total lease assets $ 906,092 $ 986,204 Liabilities Current Operating $ 167,937 $ 158,999 Non-current Operating 769,218 855,471 Total lease liabilities $ 937,155 $ 1,014,470 |
Nature of Operations, Basis o_3
Nature of Operations, Basis of Presentation and Summary of Significant Accounting Policies (Details) - USD ($) | 1 Months Ended | |
Mar. 30, 2016 | Sep. 11, 2020 | |
Delaware Corporation [Member] | ||
Nature of Operations, Basis of Presentation and Summary of Significant Accounting Policies (Textual) | ||
Ownership, percentage | 75.00% | |
Capital stock shares, issued | 7,500,000 | |
Capital stock shares, outstanding | 7,500,000 | |
Series of Individually Immaterial Business Acquisitions [Member] | ||
Nature of Operations, Basis of Presentation and Summary of Significant Accounting Policies (Textual) | ||
Intangible assets | $ 19,400,000 | |
Goodwill | $ 9,346,796 | |
Amortized on straight-line basis period | 8 years |
Liquidity and Management's Pl_2
Liquidity and Management's Plan (Details) - USD ($) | 6 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Liquidity and Management's Plan (Textual) | ||
Cash flows from operations | $ (13,835,881) | $ (9,581,869) |
Working capital | $ 101,989,545 |
Patent and Technology License_2
Patent and Technology License Agreements (Details) - USD ($) | Oct. 06, 2020 | Jun. 30, 2020 | Apr. 30, 2020 | Mar. 31, 2021 |
Patent and Technology License Agreements (Textual) | ||||
Annual fee paid | $ 90,000 | |||
Minimum aggregate annual royalties | $ 100,000 | |||
Increasing annual royalties | 25,000 | |||
Maximum aggregate annual royalties | 150,000 | |||
Payable amount to NAT | $ 1,100,000 | |||
Description of license agreement | The Company paid annual maintenance fees of $45,000 and $30,000 in January 2021 and 2020, respectively. The annual maintenance fee increases by $15,000 per year up to a maximum of $90,000. Annual maintenance fees cease on the first sale of product. We also must pay up to an aggregate of $2.1 million in milestone payments, contingent on the achievement of various regulatory and commercial milestones. Under the terms of the license agreement, we also must pay a royalty of mid- to upper-single digit percentages of net sales, depending on the amount of annual sales, and subject to downward adjustment to lower- to mid-single digit percentages in the event there is no valid patent for the product in the United States at the time of sale. After the first sale of product, we will owe an annual minimum royalty payment of $100,000 that will increase annually by $25,000 for the duration of the term. | |||
Annual minimum royalty payment | $ 100,000 | |||
Agreement expiration date | Jan. 2, 2034 | |||
Options paid | $ 100,000 | |||
Research and development expense | $ 5,000,000 | |||
Exclusive agreement, description | Through NoveCite, our subsidiary that was established specifically for this purpose, exercised the option and signed an exclusive license agreement with Novellus. NoveCite is focused on developing cellular therapies. Upon execution of the agreement, we paid $5,000,000 to Novellus and issued Novellus shares of NoveCite’s common stock representing 25% of the outstanding equity. We own the other 75% of NoveCite’s outstanding equity. Pursuant to the terms of the stock subscription agreement between Novellus and NoveCite, if NoveCite issues additional equity, subject to certain exceptions, NoveCite must maintain Novellus’s ownership at 25% by issuing additional shares to Novellus. | |||
Developmental milestone, description | NoveCite is obligated to pay Novellus up to $51,000,000 upon the achievement of various regulatory and developmental milestones. NoveCite also must pay a royalty equal to low double-digit percentages of net sales, commencing upon the sale of a licensed product. This royalty is subject to downward adjustment to an upper-single digit percentage of net sales in any country in the event of the expiration of the last valid patent claim or if no valid patent claim exists in that country. The royalty will end on the earlier of (i) date on which a biosimilar product is first marketed, sold, or distributed in the applicable country or (ii) the 10-year anniversary of the date of expiration of the last-to-expire valid patent claim in that country. In the case of a country where no licensed patent ever exists, the royalty will end on the later of (i) the date of expiry of such licensed product’s regulatory exclusivity and (ii) the 10-year anniversary of the date of the first commercial sale of the licensed product in the applicable country. In addition, NoveCite will pay to Novellus an amount equal to a mid-twenties percentage of any sublicensee fees it receives. |
Notes Payable (Details)
Notes Payable (Details) - USD ($) | Apr. 12, 2020 | Mar. 31, 2021 | Mar. 31, 2020 | Mar. 31, 2021 | Mar. 31, 2020 |
Notes Payable (Textual) | |||||
Interest expense on notes payable - related parties | $ 3,980 | $ 3,533 | $ 7,096 | $ 7,971 | |
Debt instrument, description | The Company applied for a forgivable loan through the Small Business Association’s Paycheck Protection Program (the “PPP”). In accordance with the provisions of the PPP, the loan accrues interest at a rate of 1% and a portion of the loan may be forgiven if it is used to pay qualifying costs such as payroll, rent and utilities. Amounts that are not forgiven will be repaid 2 years from the date of the loan. On April 15, 2020, the Company received funding in the amount of $164,583 from the Paycheck Protection Program through its bank. | Notes with an aggregate principal balance of $104,000 accrue interest at the prime rate plus 1.0% per annum and notes with an aggregate principal balance of $68,970 accrue interest at 12% per annum. | |||
Notes assumed | $ 160,470 | ||||
Interest expense | $ 406 | 811 | |||
Chief Executive Officer [Member] | |||||
Notes Payable (Textual) | |||||
Principal balance | $ 12,500 |
Common Stock, Stock Options a_3
Common Stock, Stock Options and Warrants (Details) - Stock Options [Member] | 6 Months Ended |
Mar. 31, 2021USD ($)$ / sharesshares | |
Option Shares | |
Outstanding, beginning balance | shares | 3,390,171 |
Granted | shares | 1,225,000 |
Exercised | shares | |
Forfeited or expired | shares | |
Outstanding, ending balance | shares | 4,615,171 |
Exercisable, ending balance | shares | 1,968,804 |
Weighted - Average Exercise Price | |
Outstanding, beginning balance | $ / shares | $ 2.51 |
Weighted - Average Exercise Price, Granted | $ / shares | 1.08 |
Weighted - Average Exercise Price, Exercised | $ / shares | |
Weighted - Average Exercise Price, Forfeited or expired | $ / shares | |
Weighted - Average Exercise Price, Outstanding, ending balance | $ / shares | 2.13 |
Weighted - Average Exercise Price, Exercisable, ending balance | $ / shares | $ 3.56 |
Weighted-Average Remaining Contractual Term | |
Weighted-Average Remaining Contractual Term, beginning | 8 years |
Weighted-Average Remaining Contractual Term, ending | 8 years 1 month 6 days |
Weighted-average remaining contractual term, exercisable | 6 years 7 months 6 days |
Aggregate Intrinsic Value | |
Aggregate Intrinsic Value, beginning balance | $ | $ 440,336 |
Aggregate Intrinsic Value, ending balance | $ | 2,659,010 |
Aggregate Intrinsic Value, Exercisable ending balance | $ | $ 787,968 |
Common Stock, Stock Options a_4
Common Stock, Stock Options and Warrants (Details 1) | 6 Months Ended |
Mar. 31, 2021$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number | 51,569,059 |
Investor Warrants [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price | $ / shares | $ 9 |
Number | 126,669 |
Expiration Dates | April 15, 2021 – April 25, 2021 |
LMB Warrants [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price | $ / shares | $ 7.50 |
Number | 53,110 |
Expiration Dates | March 24, 2022 – April 29, 2022 |
Financial Advisor Warrants [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price | $ / shares | $ 3 |
Number | 25,833 |
Expiration Dates | August 15, 2021 |
2016 Offering Warrants [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price | $ / shares | $ 4.13 |
Number | 140,819 |
Expiration Dates | November 23, 2021 – February 27, 2022 |
2017 Public Offering Investors [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price | $ / shares | $ 4.13 |
Number | 1,622,989 |
Expiration Dates | August 2, 2022 |
2017 Public Offering Underwriter Warrants [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price | $ / shares | $ 4.54 |
Number | 65,940 |
Expiration Dates | February 2, 2023 |
December 2017 Registered Direct/Private Placement Offering Investors [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price | $ / shares | $ 4.63 |
Number | 640,180 |
Expiration Dates | June 19, 2023 |
December 2017 Registered Direct/Private Placement Offering Placement Agent [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price | $ / shares | $ 5.87 |
Number | 89,625 |
Expiration Dates | December 19, 2022 |
March 2018 Registered Direct/Private Placement Offering Investors [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price | $ / shares | $ 2.86 |
Number | 218,972 |
Expiration Dates | October 2, 2023 |
March 2018 Registered Direct/Private Placement Offering Placement Agent [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price | $ / shares | $ 3.73 |
Number | 46,866 |
Expiration Dates | March 28, 2023 |
August 2018 Offering Investors [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price | $ / shares | $ 1.15 |
Number | 3,921,569 |
Expiration Dates | August 14, 2023 |
August 2018 Offering Agent [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price | $ / shares | $ 1.59 |
Number | 549,020 |
Expiration Dates | August 8, 2023 |
April 2019 Registered Direct/Private Placement Offering Investors [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price | $ / shares | $ 1.42 |
Number | 1,294,498 |
Expiration Dates | April 5, 2021 |
April 2019 Registered Direct/Private Placement Offering Placement Agent [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price | $ / shares | $ 1.93 |
Number | 240,130 |
Expiration Dates | April 5, 2021 |
September 2019 Offering Investors [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price | $ / shares | $ 0.77 |
Number | 2,793,297 |
Expiration Dates | September 27, 2024 |
September 2019 Offering Underwriter [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price | $ / shares | $ 1.12 |
Number | 194,358 |
Expiration Dates | September 27, 2024 |
February 2020 Exercise Agreement Placement Agent [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price | $ / shares | $ 1.28 |
Number | 143,295 |
Expiration Dates | August 19, 2025 |
May 2020 Registered Direct Offering Investors [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price | $ / shares | $ 1 |
Number | 2,400,000 |
Expiration Dates | November 18, 2025 |
May 2020 Registered Direct Offering Placement Agent [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price | $ / shares | $ 1.33 |
Number | 494,118 |
Expiration Dates | May 14, 2025 |
August 2020 Underwriter [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price | $ / shares | $ 1.31 |
Number | 641,166 |
Expiration Dates | August 10, 2025 |
January 2021 Registered Direct Offering Investors [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price | $ / shares | $ 1.23 |
Number | 6,182,384 |
Expiration Dates | July 27, 2026 |
January 2021 Registered Direct Offering Agent [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price | $ / shares | $ 1.62 |
Number | 1,081,917 |
Expiration Dates | July 27, 2026 |
February 2021 Offering Investors [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price | $ / shares | $ 1.70 |
Number | 25,044,164 |
Expiration Dates | February 19, 2026 |
February 2021 Offering Agent [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price | $ / shares | $ 1.88 |
Number | 3,558,140 |
Expiration Dates | February 19, 2026 |
Common Stock, Stock Options a_5
Common Stock, Stock Options and Warrants (Details 2) | 6 Months Ended |
Mar. 31, 2021shares | |
Stockholders' Equity Note [Abstract] | |
Stock plan options outstanding | 4,615,171 |
Stock plan shares available for future grants | 1,240,000 |
Warrants outstanding | 51,569,059 |
Total | 57,424,230 |
Common Stock, Stock Options a_6
Common Stock, Stock Options and Warrants (Details Textual) - USD ($) | Feb. 12, 2021 | Nov. 05, 2020 | Oct. 06, 2020 | Sep. 08, 2020 | Aug. 10, 2020 | Feb. 10, 2020 | Feb. 19, 2021 | Feb. 16, 2021 | Jan. 27, 2021 | May 18, 2020 | Apr. 06, 2020 | Nov. 04, 2019 | Mar. 31, 2021 | Mar. 31, 2020 | Mar. 31, 2021 | Mar. 31, 2020 | Sep. 30, 2020 | Feb. 07, 2018 |
Common Stock, Stock Options and Warrants (Textual) | ||||||||||||||||||
Proceeds from common stock warrant exercises | $ 14,242,543 | $ 6,027,137 | ||||||||||||||||
Common stock, shares issued | 1,669,737 | 1,669,737 | ||||||||||||||||
Stock option purchase grants | 1,130,000 | |||||||||||||||||
Stock-based compensation expense | $ 342,962 | $ 158,833 | $ 619,544 | 379,217 | ||||||||||||||
Recognized over weighted average period | 9 years 1 month 27 days | 2 years 1 month 6 days | ||||||||||||||||
Option shares available future grants | 870,000 | |||||||||||||||||
Stok plan authorizes maximum | 2,000,000 | |||||||||||||||||
Weighted average exercise price | $ 0.24 | |||||||||||||||||
Common stock offerings, description | The Company closed a registered direct offering for 50,830,566 shares of its common stock and warrants to purchase up to 25,415,283 shares of common stock, at a purchase price of $1.505 per share of common stock and accompanying warrant, for gross proceeds of $76,500,002. The 25,415,283 warrants are immediately exercisable at $1.70 per share for a term of five years. The Company paid the placement agent a fee of 7% of the gross proceeds totaling $5,355,000 and issued the placement agent 3,558,140 warrants for common stock that are immediately exercisable at $1.881 per share for a term of five years. The Company also reimbursed the placement agent for $85,000 in expenses and incurred $80,160 in other expenses. Net proceeds from the offering were $70,979,842. The estimated fair value of the 25,415,283 warrants issued to the investors was approximately $42,322,000 and the estimated fair value of the 3,558,140 warrants issued to the placement agent was approximately $5,850,000. | The Company closed a private placement for 15,455,960 shares of its common stock and warrants to purchase up to 7,727,980 shares of common stock, at a purchase price of $1.294 per share of common stock and accompanying warrant, for gross proceeds of $20,000,012. The 7,727,980 warrants are immediately exercisable at $1.231 per share for a term of five and one-half years. The Company paid the placement agent a fee of 7% of the gross proceeds totaling $1,400,001 and issued the placement agent 1,081,917 warrants for common stock that are immediately exercisable at $1.6175 per share for a term of five and one-half years. The Company also reimbursed the placement agent for $85,000 in expenses and incurred $64,601 in other expenses. Net proceeds from the offering were $18,450,410. The estimated fair value of the 7,727,980 warrants issued to the investors was approximately $7,582,000 and the estimated fair value of the 1,081,917 warrants issued to the placement agent was approximately $1,025,000. | ||||||||||||||||
Board of Directors [Member] | ||||||||||||||||||
Common Stock, Stock Options and Warrants (Textual) | ||||||||||||||||||
Options vest over terms, description | All of these options vest over terms of 12 to 36 months and have a term of 10 years. | |||||||||||||||||
Total Purchase | 800,000 | 125,000 | ||||||||||||||||
Shares of employees | 175,000 | |||||||||||||||||
Directors shares | 125,000 | |||||||||||||||||
Directors per shares | $ 1.69 | |||||||||||||||||
Common Stock [Member] | ||||||||||||||||||
Common Stock, Stock Options and Warrants (Textual) | ||||||||||||||||||
Number of common stock shares | 1,890,000 | 1,890,000 | ||||||||||||||||
Common stock issued for services | 50,000 | 101,174 | 150,000 | 50,000 | 186,566 | |||||||||||||
Common stock issued for services fair value | $ 68,000 | $ 100,000 | $ 306,020 | $ 22,750 | $ 100,000 | |||||||||||||
Common stock, shares issued | 136,000 | |||||||||||||||||
Warrant [Member] | ||||||||||||||||||
Common Stock, Stock Options and Warrants (Textual) | ||||||||||||||||||
Common stock outstanding warrants reserve | 14,029,462 | |||||||||||||||||
Aggregate intrinsic value for the warrants outstanding | $ 14,029,462 | $ 14,029,462 | ||||||||||||||||
Recognized over weighted average period | 4 years 3 months 19 days | |||||||||||||||||
Registered Direct and Private Placement Offerings [Member] | Investor [Member] | ||||||||||||||||||
Common Stock, Stock Options and Warrants (Textual) | ||||||||||||||||||
Other cash expenses related to placements | $ 135,000 | $ 85,000 | ||||||||||||||||
Sale of common stock | 9,159,524 | 7,058,824 | ||||||||||||||||
Warrants sold and issued to investors | $ 569,426 | $ 2,138,998 | ||||||||||||||||
Proceeds from common stock warrant exercises | 6,877,100 | |||||||||||||||||
Other expense | $ 109,074 | $ 12,901 | ||||||||||||||||
Warrants issued | 641,166 | 494,118 | ||||||||||||||||
Registered Direct and Private Placement Offerings [Member] | Placement Agent [Member] | ||||||||||||||||||
Common Stock, Stock Options and Warrants (Textual) | ||||||||||||||||||
Sale of common stock | 8,700,201 | 3,529,412 | ||||||||||||||||
Sale of stock price | $ 1.05 | $ 1.0625 | ||||||||||||||||
Warrants sold and issued to investors | $ 9,617,500 | $ 275,724 | ||||||||||||||||
Description of warrants | The Company paid the underwriter a fee of 7% of the gross proceeds totaling $673,225 and issued the underwriters 641,166 immediately exercisable warrants with an exercise price of $1.3125 per share and a term of five years. | The Company paid the placement agent for the offering a fee of 7% of the gross proceeds totaling $525,000 and issued the placement agent 494,118 immediately exercisable warrants with an exercise price of $1.3281 per share and a term of five years. | ||||||||||||||||
Registered Direct and Private Placement Offerings [Member] | Accredited Investors [Member] | ||||||||||||||||||
Common Stock, Stock Options and Warrants (Textual) | ||||||||||||||||||
Sale of stock price | $ 1 | |||||||||||||||||
Warrants sold and issued to investors | $ 7,500,001 | |||||||||||||||||
Stock Options [Member] | ||||||||||||||||||
Common Stock, Stock Options and Warrants (Textual) | ||||||||||||||||||
Warrants to purchase common stock | 855,171 | |||||||||||||||||
Weighted average period | 10 years | |||||||||||||||||
Common stock, shares issued | 866,667 | 866,667 | ||||||||||||||||
Common stock outstanding | 4,615,171 | 4,615,171 | 3,390,171 | |||||||||||||||
Stock options to purchase exercised | ||||||||||||||||||
Stock option purchase grants | 3,110,000 | |||||||||||||||||
Financial advisor warrants were exercised | 4,829 | 4,829 | ||||||||||||||||
Aggregate intrinsic value for the warrants outstanding | $ 787,968 | $ 787,968 | $ 440,336 | |||||||||||||||
Options to purchase shares expired | 6,667 | |||||||||||||||||
Option to purchase share outstanding | 1,870,000 | 1,870,000 | ||||||||||||||||
Option shares available future grants | 1,365,000 | |||||||||||||||||
Omnibus Stock Incentive Plan [Member] | ||||||||||||||||||
Common Stock, Stock Options and Warrants (Textual) | ||||||||||||||||||
Common stock, shares issued | 2,000,000 | |||||||||||||||||
NoveCite Stock Plan [Member] | ||||||||||||||||||
Common Stock, Stock Options and Warrants (Textual) | ||||||||||||||||||
Stock-based compensation expense | $ 18,833 | $ 18,833 | $ 31,389 | $ 31,389 | ||||||||||||||
Unrecognized total compensation cost related to unvested awards | $ 194,611 | |||||||||||||||||
Recognized over weighted average period | 2 years 9 months 18 days |
Operating Lease (Details)
Operating Lease (Details) - USD ($) | 6 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Lease cost | ||
Operating lease cost | $ 119,412 | $ 126,844 |
Variable lease cost | 194 | |
Total lease cost | $ 119,606 | $ 126,844 |
Other information | ||
Weighted-average remaining lease term - operating leases | 4 years 22 days | 5 years 22 days |
Weighted-average discount rate - operating leases | 8.00% | 8.00% |
Operating Lease (Details 1)
Operating Lease (Details 1) | Mar. 31, 2021USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2021 (excluding the 6 months ended March 31, 2021) | $ 117,830 |
2022 | 239,306 |
2023 | 244,165 |
2024 | 249,024 |
2025 and thereafter | 275,343 |
Total lease payments | 1,125,668 |
Less: interest | (188,513) |
Present value of lease liabilities | $ 937,155 |
Operating Lease (Details 2)
Operating Lease (Details 2) - USD ($) | Mar. 31, 2021 | Sep. 30, 2020 |
Assets | ||
Lease asset | $ 906,092 | $ 986,204 |
Total lease assets | 906,092 | 986,204 |
Liabilities | ||
Current | 167,937 | 158,999 |
Non-current | 769,218 | 855,471 |
Total lease liabilities | $ 937,155 | $ 1,014,470 |
Operating Lease (Details Textua
Operating Lease (Details Textual) - USD ($) | 6 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Commitments and Contingencies (Textual) | ||
Lease liability Interest expenses | $ 39,300 | $ 44,997 |
FDA Refund (Details)
FDA Refund (Details) - USD ($) | 1 Months Ended | 6 Months Ended |
Nov. 30, 2019 | Mar. 31, 2020 | |
Placement Agent Unit Warrants [Member] | ||
Additional refund amount | $ 110,207 | |
Other income | $ 110,207 |
Subsequent Events (Details)
Subsequent Events (Details) | 1 Months Ended |
May 24, 2021 | |
Subsequent Event [Member] | |
Subsequent Events (Textual) | |
Special meeting of stockholders, description | The Company's headquarters at 11 Commerce Drive, First Floor, Cranford, New Jersey 07016, to 1) approve an amendment to our Articles of Incorporation to increase the authorized number of shares from 210,000,000 to 410,000,000 and the authorized number of common shares from 200,000,000 to 400,000,000, and 2) approve the 2021 Omnibus Stock Incentive Plan. The record date for the Special Meeting is April 7, 2021. Only stockholders of record at the close of business on that date may vote at the meeting or any adjournment thereof. |