Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 10, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2022 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2022 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-39126 | |
Entity Registrant Name | CNS Pharmaceuticals, Inc. | |
Entity Central Index Key | 0001729427 | |
Entity Tax Identification Number | 82-2318545 | |
Entity Incorporation, State or Country Code | NV | |
Entity Address, Address Line One | 2100 West Loop South | |
Entity Address, Address Line Two | Suite 900 | |
Entity Address, City or Town | Houston | |
Entity Address, State or Province | TX | |
Entity Address, Postal Zip Code | 77027 | |
City Area Code | 800 | |
Local Phone Number | 946-9185 | |
Title of 12(b) Security | Common Stock | |
Trading Symbol | CNSP | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Elected Not To Use the Extended Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 40,032,481 |
Balance Sheets (Unaudited)
Balance Sheets (Unaudited) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Current Assets: | ||
Cash and cash equivalents | $ 7,027,470 | $ 5,004,517 |
Prepaid expenses | 1,672,899 | 2,472,933 |
Total current assets | 8,700,369 | 7,477,450 |
Noncurrent Assets: | ||
Prepaid expenses, net of current portion | 594,898 | 929,688 |
Property and equipment, net | 8,522 | 16,109 |
Deferred offering costs | 334,138 | 334,138 |
Total noncurrent assets | 937,558 | 1,279,935 |
Total Assets | 9,637,927 | 8,757,385 |
Current Liabilities: | ||
Accounts payable | 1,005,043 | 1,522,823 |
Accrued expenses | 200,000 | 224,949 |
Notes payable | 39,260 | 387,794 |
Total current liabilities | 1,244,303 | 2,135,566 |
Total Liabilities | 1,244,303 | 2,135,566 |
Commitments and contingencies | ||
Stockholders' Equity: | ||
Preferred stock, $0.001 par value, 5,000,000 shares authorized and 0 shares issued and outstanding | 0 | 0 |
Common stock, $0.001 par value, 75,000,000 shares authorized and 40,032,481 and 27,927,217 shares issued and outstanding, respectively | 40,032 | 27,927 |
Additional paid-in capital | 53,106,357 | 41,576,813 |
Accumulated deficit | (44,752,765) | (34,982,921) |
Total Stockholders' Equity | 8,393,624 | 6,621,819 |
Total Liabilities and Stockholders' Equity | $ 9,637,927 | $ 8,757,385 |
Balance Sheets (Unaudited) (Par
Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 |
Preferred stock shares authorized | 5,000,000 | 5,000,000 |
Preferred stock shares issued | 0 | 0 |
Preferred stock shares outstanding | 0 | 0 |
Common Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 |
Common Stock, Shares Authorized | 75,000,000 | 75,000,000 |
Common Stock, Shares, Issued | 40,032,481 | 27,927,217 |
Common Stock, Shares, Outstanding | 40,032,481 | 27,927,217 |
Statements of Operations (Unaud
Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Operating expenses: | ||||
General and administrative | $ 1,211,102 | $ 1,235,385 | $ 3,814,513 | $ 3,784,509 |
Research and development | 2,207,913 | 2,578,016 | 5,950,616 | 7,449,869 |
Total operating expenses | 3,419,015 | 3,813,401 | 9,765,129 | 11,234,378 |
Loss from operations | (3,419,015) | (3,813,401) | (9,765,129) | (11,234,378) |
Other expenses: | ||||
Interest expense | (538) | (947) | (4,715) | (7,047) |
Total other expenses | (538) | (947) | (4,715) | (7,047) |
Net loss | $ (3,419,553) | $ (3,814,348) | $ (9,769,844) | $ (11,241,425) |
Loss per share - basic | $ (0.09) | $ (0.14) | $ (0.25) | $ (0.43) |
Loss per share - diluted | $ (0.09) | $ (0.14) | $ (0.25) | $ (0.43) |
Weighted average shares outstanding - basic | 40,032,481 | 27,443,771 | 39,631,939 | 25,858,221 |
Weighted average shares outstanding - diluted | 40,032,481 | 27,443,771 | 39,631,939 | 25,858,221 |
Statements of Stockholder's Eq
Statements of Stockholder's Equity (Unaudited) - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Beginning balance, value at Dec. 31, 2020 | $ 23,856 | $ 34,870,471 | $ (20,946,343) | $ 13,947,984 |
Beginning balance, shares at Dec. 31, 2020 | 23,856,151 | |||
Common stock issued for cash, net | $ 43 | 144,800 | 144,843 | |
Common stock issued for cash, shares | 43,083 | |||
Exercise of warrants | $ 1,447 | 331,303 | 332,750 | |
Exercise of warrants, shares | 1,447,325 | |||
Stock-based compensation | $ 6 | 430,673 | 430,679 | |
Stock-based compensation, shares | 6,250 | |||
Net loss | (3,613,404) | (3,613,404) | ||
Ending balance, value at Mar. 31, 2021 | $ 25,352 | 35,777,247 | (24,559,747) | 11,242,852 |
Ending balance, shares at Mar. 31, 2021 | 25,352,809 | |||
Beginning balance, value at Dec. 31, 2020 | $ 23,856 | 34,870,471 | (20,946,343) | 13,947,984 |
Beginning balance, shares at Dec. 31, 2020 | 23,856,151 | |||
Net loss | (11,241,425) | |||
Ending balance, value at Sep. 30, 2021 | $ 27,460 | 41,260,374 | (32,187,768) | 9,100,066 |
Ending balance, shares at Sep. 30, 2021 | 27,460,735 | |||
Beginning balance, value at Mar. 31, 2021 | $ 25,352 | 35,777,247 | (24,559,747) | 11,242,852 |
Beginning balance, shares at Mar. 31, 2021 | 25,352,809 | |||
Common stock issued for cash and subscription receivable, net | $ 2,020 | 4,506,958 | 4,508,978 | |
Common stock issued for cash and subscription receivable, net ,shares | 2,020,426 | |||
Stock-based compensation | $ 7 | 469,603 | 469,610 | |
Stock-based compensation, shares | 6,250 | |||
Net loss | (3,813,673) | (3,813,673) | ||
Ending balance, value at Jun. 30, 2021 | $ 27,379 | 40,753,808 | (28,373,420) | 12,407,767 |
Ending balance, shares at Jun. 30, 2021 | 27,379,485 | |||
Stock-based compensation | $ 81 | 506,566 | 506,647 | |
Stock-based compensation, shares | 81,250 | |||
Net loss | (3,814,348) | (3,814,348) | ||
Ending balance, value at Sep. 30, 2021 | $ 27,460 | 41,260,374 | (32,187,768) | 9,100,066 |
Ending balance, shares at Sep. 30, 2021 | 27,460,735 | |||
Beginning balance, value at Dec. 31, 2021 | $ 27,927 | 41,576,813 | (34,982,921) | 6,621,819 |
Beginning balance, shares at Dec. 31, 2021 | 27,927,217 | |||
Common stock issued for cash, net | $ 9,489 | 10,616,297 | 10,625,786 | |
Common stock issued for cash, shares | 9,489,474 | |||
Exercise of warrants | $ 2,616 | 2,616 | ||
Exercise of warrants, shares | 2,615,790 | |||
Stock-based compensation | 336,685 | 336,685 | ||
Net loss | (2,784,339) | (2,784,339) | ||
Ending balance, value at Mar. 31, 2022 | $ 40,032 | 52,529,795 | (37,767,260) | 14,802,567 |
Ending balance, shares at Mar. 31, 2022 | 40,032,481 | |||
Beginning balance, value at Dec. 31, 2021 | $ 27,927 | 41,576,813 | (34,982,921) | 6,621,819 |
Beginning balance, shares at Dec. 31, 2021 | 27,927,217 | |||
Net loss | (9,769,844) | |||
Ending balance, value at Sep. 30, 2022 | $ 40,032 | 53,106,357 | (44,752,765) | 8,393,624 |
Ending balance, shares at Sep. 30, 2022 | 40,032,481 | |||
Beginning balance, value at Mar. 31, 2022 | $ 40,032 | 52,529,795 | (37,767,260) | 14,802,567 |
Beginning balance, shares at Mar. 31, 2022 | 40,032,481 | |||
Stock-based compensation | 286,841 | 286,841 | ||
Net loss | (3,565,952) | (3,565,952) | ||
Ending balance, value at Jun. 30, 2022 | $ 40,032 | 52,816,636 | (41,333,212) | 11,523,456 |
Ending balance, shares at Jun. 30, 2022 | 40,032,481 | |||
Stock-based compensation | 289,721 | 289,721 | ||
Net loss | (3,419,553) | (3,419,553) | ||
Ending balance, value at Sep. 30, 2022 | $ 40,032 | $ 53,106,357 | $ (44,752,765) | $ 8,393,624 |
Ending balance, shares at Sep. 30, 2022 | 40,032,481 |
Statements of Cash Flows (Unaud
Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash Flows from Operating Activities: | ||
Net loss | $ (9,769,844) | $ (11,241,425) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 913,247 | 1,406,936 |
Depreciation | 9,375 | 9,577 |
Loss on disposal of fixed assets | 2,635 | 0 |
Changes in operating assets and liabilities: | ||
Prepaid expenses | 1,134,824 | (1,373,257) |
Accounts payable | (517,780) | 515,244 |
Accrued expenses | (24,949) | 381,418 |
Net cash used in operating activities | (8,252,492) | (10,301,507) |
Cash Flows from Investing Activities: | ||
Purchase of property and equipment | (4,423) | (3,672) |
Net cash used in investing activities | (4,423) | (3,672) |
Cash Flows from Financing Activities: | ||
Payments on notes payable | (348,534) | (394,662) |
Proceeds from exercise of warrants | 2,616 | 332,750 |
Proceeds from sale of common stock | 10,625,786 | 4,653,821 |
Net cash provided by financing activities | 10,279,868 | 4,591,909 |
Net change in cash and cash equivalents | 2,022,953 | (5,713,270) |
Cash and cash equivalents, at beginning of period | 5,004,517 | 14,039,493 |
Cash and cash equivalents, at end of period | 7,027,470 | 8,326,223 |
Supplemental disclosures of cash flow information: | ||
Cash paid for interest | 5,782 | 7,207 |
Cash paid for income taxes | 0 | 0 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Cashless exercise of warrants | $ 0 | $ 1,296 |
Nature of Business
Nature of Business | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Business | Note 1 – Nature of Business CNS Pharmaceuticals, Inc. (“we”, “our”, the “Company”) is a clinical pharmaceutical company organized as a Nevada corporation on July 27, 2017 to focus on the development of anti-cancer drug candidates. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 2 – Summary of Significant Accounting Policies Basis of Presentation Liquidity and Going Concern Cash and Cash Equivalents 6,777,470 Stock-based Compensation Restricted Stock Units (“RSUs”) Performance Units (“PUs”) Loss Per Common Share 15,719,445 5,130,240 285,625 0 856,875 0 2,789,736 2,939,736 |
Note Payable
Note Payable | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
Note Payable | Note 3 – Note Payable On November 8, 2021, the Company entered into a short-term note payable for an aggregate of $ 425,990 3.3 September 30, 2022 39,260 387,794 |
Equity
Equity | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
Equity | Note 4 – Equity Common Stock The Company engaged H.C. Wainwright & Co., LLC (“Wainwright”), to act as placement agent related to the Securities Purchase Agreement described below. The Company agreed to pay Wainwright an aggregate fee equal to 7.0% of the gross proceeds received by the Company from the sale of the securities in the transaction. The Company also issued to Wainwright or its designees warrants to purchase up to 5.0% of the aggregate number of shares of Common Stock sold in the transactions (the “Placement Agent Warrants”), or 605,263 50,000 10,000 On January 5, 2022, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with several institutional investors for the sale by the Company of (i) 9,489,474 2,615,790 12,105,264 Subject to certain ownership limitations, the Warrants are exercisable upon issuance. Each Pre-Funded Warrant is exercisable into one share of common stock at a price per share of $ 0.001 0.82 11,497,385 10,625,786 Stock Options In 2017, the Board of Directors of the Company approved the CNS Pharmaceuticals, Inc. 2017 Stock Plan (the “2017 Plan”). The 2017 Plan allows for the Board of Directors to grant various forms of incentive awards for up to 2,000,000 In 2020, the Board of Directors of the Company approved the CNS Pharmaceuticals, Inc. 2020 Stock Plan (the “2020 Plan”). The 2020 Plan allows for the Board of Directors to grant various forms of incentive awards for up to 3,000,000 During the nine months ended September 30, 2022 and 2021, the Company recognized $ 877,510 1,228,811 1,583,144 The following table summarizes the stock option activity for the nine months ended September 30, 2022: Schedule of Stock Option Activity Options Weighted-Average Exercise Price Per Share Outstanding, December 31, 2021 2,864,736 $ 2.25 Granted – – Exercised – – Forfeited – – Expired (75,000 ) 2.35 Outstanding, September 30, 2022 2,789,736 $ 2.25 Exercisable, September 30, 2022 1,990,361 $ 1.93 As of September 30, 2022, the outstanding stock options have a weighted average remaining term of 6.98 36,850 1,067,764 Stock Warrants During the nine months ended September 30, 2022, the Company received $ 2,616 2,615,790 0.001 The following table summarizes the stock warrant activity for the nine months ended September 30, 2022: Schedule of warrants activity Warrants Weighted-Average Exercise Price Per Share Outstanding, December 31, 2021 4,214,977 $ 4.76 Granted 15,326,317 0.69 Exercised (2,615,790 ) 0.001 Forfeited – – Expired (1,206,059 ) 11.00 Outstanding, September 30, 2022 15,719,445 $ 1.11 Exercisable, September 30, 2022 15,719,445 $ 1.11 As of September 30, 2022, the outstanding and exercisable warrants have a weighted average remaining term of 4.06 no Restricted Stock Units On April 28, 2022, the Compensation Committee approved cash bonuses totaling $ 213,000 285,625 4 95,399 During the nine months ended September 30, 2022, the Company recognized $ 11,925 83,474 The following table summarizes the RSUs activity for the nine months ended September 30, 2022: Schedule of restricted stock units activity RSUs Weighted-Average Grant Date Fair Value Non-vested, December 31, 2021 – $ – Granted 285,625 0.33 Vested – – Forfeited – – Non-vested, September 30, 2022 285,625 $ 0.33 Performance Units On April 28, 2022, the Compensation Committee approved, the officers and employees were awarded a total of 856,875 169,663 The fair value of each performance unit with market conditions (vesting terms (i) and (ii)) is estimated at the date of grant using a Monte Carlo simulation with the following assumptions: underlying stock price $ 0.33 2.00 4.00 2 3 18.7 2.8 During the nine months ended September 30, 2022, the Company recognized $ 14,619 9,193 0 145,853 The following table summarizes the PUs activity for the nine months ended September 30, 2022: Schedule of performance units activity PUs Weighted-Average Grant Date Fair Value Non-vested, December 31, 2021 – $ – Granted 856,875 0.20 Vested – – Forfeited – – Non-vested, September 30, 2022 856,875 $ 0.20 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 5 – Commitments and Contingencies Executive Employment Agreements On September 1, 2017, the Company entered into an employment agreement with Mr. John Climaco pursuant to which Mr. Climaco agreed to serve as Chief Executive Officer and Director of the Company commencing on such date for an initial term of three years. On September 1, 2020, the Company entered into an amendment to the employment agreement with Mr. Climaco. The amendment extends the term of employment under the Employment Agreement, which was originally for a three-year period, for additional twelve-month periods, unless and until either the Company or Mr. Climaco provides written notice to the other party not less than sixty days before such anniversary date that such party is electing not to extend the term. If the Company provides notice of its election not to extend the term, Mr. Climaco may terminate his employment at any time prior to the expiration of the term by giving written notice to the Company at least thirty days prior to the effective date of termination, and upon the earlier of such effective date of termination or the expiration of the term, Mr. Climaco shall be entitled to receive the same severance benefits as are provided upon a termination of employment by the Company without cause. Pursuant to the Amendment, the severance benefits shall be twelve months of Mr. Climaco’s base salary. Such severance payment shall be made in a single lump sum sixty days following the termination, provided that Mr. Climaco has executed and delivered to the Company and has not revoked a general release of the Company. Pursuant to the employment agreement, the compensation committee of the board of directors reviews the base salary payable to Mr. Climaco annually during the term of the agreement. On February 6, 2021, the compensation committee of the board of directors set Mr. Climaco’s 2021 annual base salary to $ 525,000 On June 28, 2019, we entered into employment letters with Drs. Silberman and Picker pursuant to which Dr. Silberman agreed to commit 50% of her time to our matters; and Dr. Picker agreed to commit 25% of his time to our matters. On February 6, 2021, the compensation committee of the board of directors set Drs. Silberman and Picker 2021 annual base salaries to $ 200,000 115,000 On September 14, 2019, the Company, entered into an employment agreement with Christopher Downs to serve as its Chief Financial Officer commencing on the closing date of the Company’s IPO, which occurred on November 13, 2019. The initial term of the Employment Agreement will continue for a period of three years. Pursuant to the employment agreement, the compensation committee of the board of directors reviews the base salary payable to Mr. Downs annually during the term of the agreement. On February 6, 2021, the compensation committee of the board of directors set Mr. Downs’ 2021 annual base salary to $ 340,000 Scientific Advisory Board On July 15, 2021, our Board approved the following compensation policy for the Scientific Advisory Board members. The Scientific Advisory board consisted of Dr. Waldemar Priebe, a significant shareholder and related party, and Dr. Sigmond Hsu. Each scientific advisory board member shall receive annual cash compensation of $68,600. During the nine month months ended September 30, 2022, the Company paid $ 76,087 82,984 WP744 Portfolio (Berubicin) On November 21, 2017, the Company entered into a Collaboration and Asset Purchase Agreement with Reata Pharmaceuticals, Inc. (“Reata”). Through this agreement, the Company purchased all of Reata’s rights, title, interest and previously conducted research and development results in the chemical compound commonly known as Berubicin. In exchange for these rights, the Company agreed to pay Reata an amount equal to 2.25% of the net sales of Berubicin for a period of 10 years from the Company’s first commercial sale of Berubicin plus $10,000. Reata also agreed to collaborate with the Company on the development of Berubicin, from time to time. On December 28, 2017, the Company entered into a Technology Rights and Development Agreement with Houston Pharmaceuticals, Inc. (“HPI”). HPI is affiliated with Dr. Waldemar Priebe, our founder and significant shareholder. Pursuant to this agreement, the Company obtained a worldwide exclusive license to the chemical compound commonly known as WP744. In exchange for these rights, the Company agreed to pay consideration to HPI as follows: (i) a royalty of 2% of net sales of any product utilizing WP744 for a period of ten years after the first commercial sale of such; and (ii) $100,000 upon beginning Phase II clinical trials (paid in 2021); and (iii) $200,000 upon the approval by the FDA of a New Drug Application for any product utilizing WP744; and (iv) a series of quarterly development payments totaling $750,000 beginning immediately after the Company’s raise of $7,000,000 of investment capital. In addition, the Company issued 200,000 shares of the Company’s common stock valued at $0.045 per share to HPI upon execution of the agreement. On November 13, 2019, the Company closed its IPO, thereby fulfilling all conditions precedent and completing the acquisition of the intellectual property discussed in the HPI agreement. During the nine months ended September 30, 2022 and 2021, the Company recognized $ 262,500 41,075 385,000 On August 30, 2018, we entered into a sublicense agreement with WPD Pharmaceuticals, Inc. (“WPD”). Pursuant to the agreement, the Company granted WPD an exclusive sublicense, even as to us, for the patent rights we licensed pursuant to the HPI License within the following countries: Poland, Estonia, Latvia, Lithuania, Belarus, Ukraine, Moldova, Romania, Bulgaria, Serbia, Macedonia, Albania, Armenia, Azerbaijan, Georgia, Montenegro, Bosnia, Croatia, Slovenia, Slovakia, Czech Republic, Hungary, Chechnya, Uzbekistan, Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan, Greece, Austria, and Russia. The sublicense agreement provides that WPD must use commercially reasonable development efforts to attempt to develop and commercialize licensed products in the above-mentioned territories, which means the expenditure of at least $2.0 million on the development, testing, regulatory approval or commercialization of the licensed products during the three year period immediately following the date of the sublicense agreement. In consideration for the rights granted under the sublicense agreement, to the extent we are required to make any payments to HPI pursuant to the HPI License as a result of this sublicense agreement, WPD agreed to advance us such payments, and to pay us a royalty equal to 1% of such payments. WPD is a Polish corporation that is majority-owned by an entity controlled by Dr. Priebe, our founder and largest shareholder. On February 19, 2021, CNS entered into an Investigational Medicinal Product Supply Agreement with WPD, a related party. CNS agreed to sell the Berubicin drug product to WPD at historical cost of manufacturing without markup so that WPD may conduct the clinical trials contemplated by the sublicense agreement. WPD agreed to pay CNS the following payments: (i) an upfront payment of $ 131,073 262,145 655,000 393,182 On August 31, 2018, the Company entered into a sublicense agreement with Animal Life Sciences, LLC (“ALI”), a related party, pursuant to which we granted ALI an exclusive sublicense, even as to us, for the patent rights we licensed pursuant to the HPI License solely for the treatment of cancer in non-human animals through any type of administration. In consideration for the rights granted under the sublicense agreement, ALI agreed to issue us membership interests in ALI equal to 1.52% of the outstanding ALI membership interests. As additional consideration for the rights granted, to the extent we are required to make any payments to HPI pursuant to the HPI License as a result of this sublicense agreement, ALI agreed to advance us such payments, and to pay us a royalty equal to 1% of such payments. Dr. Waldemar Priebe, our founder and largest shareholder, is also the founder and a shareholder of ALI, holds 38% of the membership interests of ALI. On June 10, 2020, the FDA granted Orphan Drug Designation (“ODD”) for Berubicin for the treatment of malignant gliomas. ODD from the FDA is available for drugs targeting diseases with less than 200,000 cases per year. ODD may enable market exclusivity of 7 years from the date of approval of a New Drug Application (“NDA) in the United States. During that period the FDA generally could not approve another product containing the same drug for the same designated indication. Orphan drug exclusivity will not bar approval of another product under certain circumstances, including if a subsequent product with the same active ingredient for the same indication is shown to be clinically superior to the approved product on the basis of greater efficacy or safety, or providing a major contribution to patient care, or if the company with orphan drug exclusivity is not able to meet market demand. The ODD constitutes our primary intellectual property protections although the Company is exploring if there are other patents that could be filed related to Berubicin to extend additional protections. On July 24, 2021, the Company received Fast Track Designation from the FDA for Berubicin. Fast Track Designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. WP1244 Portfolio On January 10, 2020, Company entered into a Patent and Technology License Agreement (“Agreement”) with The Board of Regents of The University of Texas System, an agency of the State of Texas, on behalf of The University of Texas M. D. Anderson Cancer Center (“UTMDACC”). Pursuant to the Agreement, the Company obtained a royalty-bearing, worldwide, exclusive license to certain intellectual property rights, including patent rights, related to the Company’s recently announced WP1244 drug technology. In consideration, the Company must make payments to UTMDACC including an up-front license fee, annual maintenance fee, milestone payments and royalty payments (including minimum annual royalties) on sales of licensed products developed under the Agreement. The term of the Agreement expires on the last to occur of: (a) the expiration of all patents subject to the Agreement, or (b) fifteen years after execution; provided that UTMDACC has the right to terminate this Agreement in the event that the Company fails to meet certain commercial diligence milestones. The commercial diligence milestones are as follows (i) initiated PC toxicology to support filing of Investigational New Drug Application (“IND”) or New Drug Application (“NDA”) for the Licensed Product within the eighteen (18) month period following the Effective Date (ii) file and IND for the Licensed Product within three (3) year period following the Effective Date and (iii) Commencement of Phase I Study within the five (5) year period following the Effective Date. During the nine months ended September 30, 2022 and 2021, the Company paid $ 49,607 22,902 On May 7, 2020, pursuant to the WP1244 Portfolio license agreement described above, the Company entered into a Sponsored Research Agreement with UTMDACC to perform research relating to novel anticancer agents targeting CNS malignancies. The Company agreed to fund approximately $1,134,000 over a two-year period. During the year ended December 31, 2020, the Company paid $ 334,000 400,000 800,000 Anti-Viral Portfolio On March 20, 2020, the Company entered into a Development Agreement (“Agreement”) with WPD Pharmaceuticals (“WPD”), a company founded by Dr. Waldemar Priebe, the founder and largest shareholder of the Company. Pursuant to the Agreement, WPD agreed to use its commercially reasonable efforts in good faith to develop and commercialize certain products that WPD had previously sublicensed, solely in the field of pharmaceutical drug products for the treatment of any viral infection in humans, with a goal of eventual approval of in certain territories consisting of: Germany, Poland, Estonia, Latvia, Lithuania, Belarus, Ukraine, Romania, Armenia, Azerbaijan, Georgia, Slovakia, Czech Republic, Hungary, Uzbekistan, Kazakhstan, Greece, Austria, Russia, Netherlands, Turkey, Belgium, Switzerland, Sweden, Portugal, Norway, Denmark, Ireland, Finland, Luxembourg, Iceland. Pursuant to the Agreement, the Company agreed to pay WPD the following payments: (i) an upfront payment of $ 225,000 775,000 1.0 Nasdaq Capital Markets Listing Qualifications On February 18, 2022, the Company received a deficiency letter from the Listing Qualifications Department of the Nasdaq Stock Market (“Nasdaq”) notifying the Company that for the last 30 consecutive business days the bid price for the Company’s common stock had closed below the minimum $1.00 per share requirement for continued inclusion in Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”). The deficiency letter does not result in the immediate delisting of the Company’s common stock from Nasdaq. The Company was initially provided an initial period of 180 calendar days, or until August 17, 2022, to regain compliance with the Bid Price Rule. The Company was granted a second 180 calendar day period, or until February 13, 2023, to regain compliance since it met the continued listing requirement for market value of publicly held shares and all other initial listing standards required by Nasdaq, except for the minimum bid price requirement. On July 7, 2022, the Company filed a Definitive Proxy Statement on Form DEF 14A for its Annual Meeting of Stockholders to be held on July 27, 2022. The Annual Meeting of Stockholders was adjourned on July 27, 2022 until August 3, 2022, then adjourned again until August 16, 2022, and then adjourned again until August 25, 2022. In this Definitive Proxy Statement, the Company included a proposal to authorize an amendment to the Company’s amended and restated articles of incorporation to empower the Board of Directors to effect a reverse stock split of the outstanding shares of the Company’s common stock, at a split ratio of between 1-for-2 and 1-for-30 as determined by the Board of Directors in its sole discretion, prior to the one-year anniversary of this Annual Meeting. This proposal was approved by the Company’s stockholders when the Annual Meeting of Stockholders was reconvened on August 25, 2022. The Company intends to monitor the closing bid price of its common stock and, if appropriate, effect a reverse stock split of the Company’s common stock, to regain compliance with the Bid Price Rule in order to avoid being delisted from Nasdaq as well as to provide for additional shares available for issuance to continue to fund the Company’s clinical research programs. Notwithstanding the foregoing, there can be no assurance that the Company will be able to regain and maintain compliance with the Bid Price Rule if a reverse stock split is effected. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation |
Liquidity and Going Concern | Liquidity and Going Concern |
Cash and Cash Equivalents | Cash and Cash Equivalents 6,777,470 |
Stock-based Compensation | Stock-based Compensation |
Restricted Stock Units (“RSUs”) | Restricted Stock Units (“RSUs”) |
Performance Units (“PUs”) | Performance Units (“PUs”) |
Loss Per Common Share | Loss Per Common Share 15,719,445 5,130,240 285,625 0 856,875 0 2,789,736 2,939,736 |
Equity (Tables)
Equity (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Schedule of Stock Option Activity | Schedule of Stock Option Activity Options Weighted-Average Exercise Price Per Share Outstanding, December 31, 2021 2,864,736 $ 2.25 Granted – – Exercised – – Forfeited – – Expired (75,000 ) 2.35 Outstanding, September 30, 2022 2,789,736 $ 2.25 Exercisable, September 30, 2022 1,990,361 $ 1.93 |
Schedule of warrants activity | Schedule of warrants activity Warrants Weighted-Average Exercise Price Per Share Outstanding, December 31, 2021 4,214,977 $ 4.76 Granted 15,326,317 0.69 Exercised (2,615,790 ) 0.001 Forfeited – – Expired (1,206,059 ) 11.00 Outstanding, September 30, 2022 15,719,445 $ 1.11 Exercisable, September 30, 2022 15,719,445 $ 1.11 |
Restricted Stock Units (RSUs) [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Schedule of performance units activity | Schedule of restricted stock units activity RSUs Weighted-Average Grant Date Fair Value Non-vested, December 31, 2021 – $ – Granted 285,625 0.33 Vested – – Forfeited – – Non-vested, September 30, 2022 285,625 $ 0.33 |
Performance Units [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Schedule of performance units activity | Schedule of performance units activity PUs Weighted-Average Grant Date Fair Value Non-vested, December 31, 2021 – $ – Granted 856,875 0.20 Vested – – Forfeited – – Non-vested, September 30, 2022 856,875 $ 0.20 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details Narrative) - USD ($) | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Cash in excess of FDIC | $ 6,777,470 | |
Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive shares | 15,719,445 | 5,130,240 |
Unvested Restricted Stock Units R S U [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive shares | 285,625 | 0 |
Unvested Performance Units [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive shares | 856,875 | 0 |
Stock Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive shares | 2,789,736 | 2,939,736 |
Note Payable (Details Narrative
Note Payable (Details Narrative) - USD ($) | Nov. 08, 2021 | Sep. 30, 2022 | Dec. 31, 2021 |
Debt Disclosure [Abstract] | |||
Short-term note payable | $ 425,990 | ||
Interest rate | 3.30% | ||
Due date | Sep. 30, 2022 | ||
Notes payable | $ 39,260 | $ 387,794 |
Equity (Details - Option Activi
Equity (Details - Option Activity) - Stock Options [Member] | 9 Months Ended |
Sep. 30, 2022 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of Options Outstanding, Beginning | shares | 2,864,736 |
Weighted Average Exercise Price Outstanding, Beginning | $ / shares | $ 2.25 |
Number of Options Granted | shares | 0 |
Weighted Average Exercise Price Granted | $ / shares | $ 0 |
Number of Options Exercised | shares | 0 |
Weighted Average Exercise Price Exercised | $ / shares | $ 0 |
Number of Options Forfeited | shares | 0 |
Weighted Average Exercise Price Forfeited | $ / shares | $ 0 |
Number of Options Expired | shares | (75,000) |
Weighted Average Exercise Price Expired | $ / shares | $ 2.35 |
Number of Options Outstanding, Ending | shares | 2,789,736 |
Weighted Average Exercise Price Outstanding, Ending | $ / shares | $ 2.25 |
Number of Options Outstanding, Exercisable | shares | 1,990,361 |
Weighted Average Exercise Price Exercisable | $ / shares | $ 1.93 |
Equity (Details - Warrant Activ
Equity (Details - Warrant Activity) | 9 Months Ended |
Sep. 30, 2022 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Weighted Average Exercise Price Outstanding, Ending | $ 0.001 |
Warrants [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of Warrants Outstanding, Beginning | shares | 4,214,977 |
Weighted Average Exercise Price Outstanding, Beginning | $ 4.76 |
Number of Warrants Granted | shares | 15,326,317 |
Weighted Average Exercise Price Granted | $ 0.69 |
Number of Warrants Exercised | shares | (2,615,790) |
Weighted Average Exercise Price Exercised | $ 0.001 |
Number of Warrants Forfeited | shares | 0 |
Weighted Average Exercise Price Forfeited | $ 0 |
Number of Warrants Expired | shares | (1,206,059) |
Weighted Average Exercise Price Expired | $ 11 |
Number of Warrants Outstanding, Ending | shares | 15,719,445 |
Weighted Average Exercise Price Outstanding, Ending | $ 1.11 |
Number of Warrants Outstanding, Exercisable | shares | 15,719,445 |
Weighted Average Exercise Price Outstanding, Exercisable | $ 1.11 |
Equity (Details - Restricted St
Equity (Details - Restricted Stock Units Activity) | 9 Months Ended |
Sep. 30, 2022 $ / shares shares | |
Restricted Stock Units (RSUs) [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of nonvested Outstanding, Beginning | shares | 0 |
Weighted Average Exercise Price Outstanding, Beginning | $ / shares | $ 0 |
Granted | shares | 285,625 |
Weighted Average Exercise Price Granted | $ / shares | $ 0.33 |
Vested | shares | 0 |
Weighted Average Exercise Price Vested | $ / shares | $ 0 |
Forfeited | shares | 0 |
Weighted Average Exercise Price Forfeited | $ / shares | $ 0 |
Number of nonvested Outstanding, Ending | shares | 285,625 |
Weighted Average Exercise Price Outstanding, Ending | $ / shares | $ 0.33 |
Performance Units [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of nonvested Outstanding, Beginning | shares | 0 |
Weighted Average Exercise Price Outstanding, Beginning | $ / shares | $ 0 |
Granted | shares | 856,875 |
Weighted Average Exercise Price Granted | $ / shares | $ 0.20 |
Vested | shares | 0 |
Weighted Average Exercise Price Vested | $ / shares | $ 0 |
Forfeited | shares | 0 |
Weighted Average Exercise Price Forfeited | $ / shares | $ 0 |
Number of nonvested Outstanding, Ending | shares | 856,875 |
Weighted Average Exercise Price Outstanding, Ending | $ / shares | $ 0.20 |
Equity (Details Narrative)
Equity (Details Narrative) - USD ($) | 1 Months Ended | 9 Months Ended | |||
Jan. 05, 2022 | Apr. 28, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Class of Stock [Line Items] | |||||
Warrants exercise price | $ 0.001 | ||||
Share-based compensation expense | $ 913,247 | $ 1,406,936 | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term | 6 years 11 months 23 days | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Outstanding, Aggregate Intrinsic Value | $ 36,850 | ||||
Proceeds from exercise of warrants | 2,616 | 332,750 | |||
Vested term | 4 years | ||||
Officer [Member] | |||||
Class of Stock [Line Items] | |||||
Cash bonuses | $ 213,000 | ||||
Equity Option [Member] | |||||
Class of Stock [Line Items] | |||||
Share-based compensation expense | 877,510 | $ 1,228,811 | |||
Stock Options [Member] | |||||
Class of Stock [Line Items] | |||||
Unrecognized compensation expense | $ 1,583,144 | ||||
Warrants [Member] | |||||
Class of Stock [Line Items] | |||||
Warrants exercise price | $ 1.11 | $ 4.76 | |||
Weighted average remaining term | 4 years 21 days | ||||
Aggregate intrinsic value of warrants outstanding | $ 0 | ||||
Warrants [Member] | Price 2.20 [Member] | |||||
Class of Stock [Line Items] | |||||
Number of warrants exercised | 2,615,790 | ||||
Restricted Stock Units (RSUs) [Member] | |||||
Class of Stock [Line Items] | |||||
Share-based compensation expense | $ 11,925 | ||||
Unrecognized compensation expense | 83,474 | ||||
Employees were awarded shares | 285,625 | ||||
Stock price grant | 95,399 | ||||
Performance Units [Member] | |||||
Class of Stock [Line Items] | |||||
Unrecognized compensation expense | 145,853 | ||||
Stock price grant | 856,875 | ||||
Fair value at grant date | $ 169,663 | ||||
Stock price | $ 0.33 | ||||
Cost of equity | 18.70% | ||||
Risk-free rate | 2.80% | ||||
Vesting amount | $ 14,619 | ||||
Performance Units [Member] | Minimum [Member] | |||||
Class of Stock [Line Items] | |||||
Hurdle prices | $ 2 | ||||
Expected terms | 2 years | ||||
Performance Units [Member] | Maximum [Member] | |||||
Class of Stock [Line Items] | |||||
Hurdle prices | $ 4 | ||||
Expected terms | 3 years | ||||
Performance Units 1 [Member] | |||||
Class of Stock [Line Items] | |||||
Vesting amount | $ 9,193 | ||||
Performance Units 2 [Member] | |||||
Class of Stock [Line Items] | |||||
Vesting amount | $ 0 | ||||
2017 Stock Plan [Member] | |||||
Class of Stock [Line Items] | |||||
Shares authorized under plan | 2,000,000 | ||||
2020 Stock Plan [Member] | |||||
Class of Stock [Line Items] | |||||
Shares authorized under plan | 3,000,000 | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant | 1,067,764 | ||||
Securities Purchase Agreement [Member] | |||||
Class of Stock [Line Items] | |||||
Gross proceeds from issuance or sale of equity | $ 11,497,385 | ||||
Proceeds from Issuance or Sale of Equity | $ 10,625,786 | ||||
Securities Purchase Agreement [Member] | Wainwright [Member] | |||||
Class of Stock [Line Items] | |||||
Payments of Stock Issuance Costs | $ 50,000 | ||||
Legal Fees | $ 10,000 | ||||
Securities Purchase Agreement [Member] | Placement Agent Warrants [Member] | |||||
Class of Stock [Line Items] | |||||
Number of shares sold | 605,263 | ||||
Securities Purchase Agreement [Member] | Shares [Member] | |||||
Class of Stock [Line Items] | |||||
Stock Issued During Period, Shares, New Issues | 9,489,474 | ||||
Securities Purchase Agreement [Member] | Pre Funded Warrants [Member] | |||||
Class of Stock [Line Items] | |||||
Number of shares sold | 2,615,790 | ||||
Warrants exercise price | $ 0.001 | ||||
Securities Purchase Agreement [Member] | Common Warrants [Member] | |||||
Class of Stock [Line Items] | |||||
Number of shares sold | 12,105,264 | ||||
Warrants exercise price | $ 0.82 |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Apr. 30, 2020 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | |
Product Liability Contingency [Line Items] | |||||||
Labor and Related Expense | $ 76,087 | ||||||
Accrued expenses | $ 200,000 | 200,000 | $ 224,949 | ||||
Research and Development Expense | 2,207,913 | $ 2,578,016 | 5,950,616 | $ 7,449,869 | |||
Repayments of Related Party Debt | 800,000 | ||||||
Development fees | $ 1,000,000 | ||||||
Payment for fees | $ 775,000 | ||||||
Houston Pharmaceuticals [Member] | |||||||
Product Liability Contingency [Line Items] | |||||||
Cost of Goods and Services Sold | 41,075 | 385,000 | |||||
WPD Product Supply Agreement [Member] | |||||||
Product Liability Contingency [Line Items] | |||||||
Product held at third party depot | 655,000 | 655,000 | |||||
WPD Product Supply Agreement [Member] | Upfront Payment [Member] | |||||||
Product Liability Contingency [Line Items] | |||||||
Due from Other Related Parties, Current | 131,073 | 131,073 | |||||
WPD Product Supply Agreement [Member] | Pass Thru Costs [Member] | |||||||
Product Liability Contingency [Line Items] | |||||||
Due from Other Related Parties, Current | 262,145 | 262,145 | |||||
Mr Hsu Scientific Advisory Board [Member] | |||||||
Product Liability Contingency [Line Items] | |||||||
Accrued expenses | $ 82,984 | 82,984 | |||||
Houston Pharm [Member] | Technology Rights Agreement [Member] | |||||||
Product Liability Contingency [Line Items] | |||||||
Royalty Income, Nonoperating | 262,500 | 262,500 | |||||
WPD Pharmaceuticals [Member] | Upfront Payment [Member] | |||||||
Product Liability Contingency [Line Items] | |||||||
Other Nonoperating Income | 393,182 | ||||||
UTMDACC [Member] | Patent And Technology License Agr [Member] | |||||||
Product Liability Contingency [Line Items] | |||||||
License fee | 49,607 | $ 22,902 | |||||
UTMDACC [Member] | Sponsored Research Agreement [Member] | |||||||
Product Liability Contingency [Line Items] | |||||||
License fee | $ 334,000 | ||||||
Research and Development Expense | $ 400,000 | ||||||
WPD [Member] | Development Agreement [Member] | |||||||
Product Liability Contingency [Line Items] | |||||||
Development fees | $ 225,000 | ||||||
Climaco [Member] | |||||||
Product Liability Contingency [Line Items] | |||||||
Salary and wages | 525,000 | ||||||
Silberman [Member] | |||||||
Product Liability Contingency [Line Items] | |||||||
Salary and wages | 200,000 | ||||||
Picker [Member] | |||||||
Product Liability Contingency [Line Items] | |||||||
Salary and wages | 115,000 | ||||||
Downs [Member] | |||||||
Product Liability Contingency [Line Items] | |||||||
Salary and wages | $ 340,000 |