Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 21, 2024 | Jun. 30, 2023 | |
Document and Entity Information | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2023 | ||
Entity File Number | 001-36598 | ||
Entity Registrant Name | CELLECTAR BIOSCIENCES, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 04-3321804 | ||
Entity Address, Address Line One | 100 Campus Drive | ||
Entity Address, City or Town | Florham Park | ||
Entity Address, State or Province | NJ | ||
Entity Address, Postal Zip Code | 07932 | ||
City Area Code | 608 | ||
Local Phone Number | 441-8120 | ||
Title of 12(b) Security | Common stock, par value $0.00001 | ||
Trading Symbol | CLRB | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Document Financial Statement Error Correction [Flag] | false | ||
Entity Common Stock, Shares Outstanding | 32,260,510 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001279704 | ||
Amendment Flag | false | ||
Entity Public Float | $ 18,922,339 | ||
ICFR Auditor Attestation Flag | false | ||
Auditor Name | Baker Tilly US, LLP | ||
Auditor Firm ID | 23 | ||
Auditor Location | Madison, Wisconsin |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 9,564,988 | $ 19,866,358 |
Prepaid expenses and other current assets | 888,225 | 663,243 |
Total current assets | 10,453,213 | 20,529,601 |
Fixed assets, net | 1,090,304 | 418,641 |
Right-of-use asset, net | 502,283 | 560,334 |
Long-term assets | 23,566 | 75,000 |
Other assets | 6,214 | 6,214 |
TOTAL ASSETS | 12,075,580 | 21,589,790 |
CURRENT LIABILITIES: | ||
Accounts payable and accrued liabilities | 9,178,645 | 5,478,443 |
Warrant liability | 3,700,000 | |
Lease liability | 58,979 | 50,847 |
Total current liabilities | 12,937,624 | 5,529,290 |
Lease liability, net of current portion | 494,003 | 552,981 |
TOTAL LIABILITIES | 13,431,627 | 6,082,271 |
COMMITMENTS AND CONTINGENCIES (Note 10) | ||
STOCKHOLDERS' (DEFICIT) EQUITY: | ||
Common stock, $0.00001 par value; 170,000,000 shares authorized; 20,744,110 and 9,385,272 shares issued and outstanding as of December 31, 2023 and 2022, respectively | 207 | 94 |
Additional paid-in capital | 210,066,630 | 193,624,445 |
Accumulated deficit | (217,482,539) | (179,499,043) |
Total stockholders' (deficit) equity | (1,356,047) | 15,507,519 |
TOTAL LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY | 12,075,580 | 21,589,790 |
Series D preferred stock | ||
STOCKHOLDERS' (DEFICIT) EQUITY: | ||
Preferred stock | 1,382,023 | $ 1,382,023 |
Series E-2 Preferred Stock | ||
STOCKHOLDERS' (DEFICIT) EQUITY: | ||
Preferred stock | $ 4,677,632 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Common stock, par value (in dollars per share) | $ 0.00001 | $ 0.00001 |
Common stock, shares authorized | 170,000,000 | 170,000,000 |
Common stock, shares issued | 20,744,110 | 9,385,272 |
Common stock, shares outstanding | 20,744,110 | 9,385,272 |
Series D preferred stock | ||
Preferred stock, shares authorized | 111.11 | 111.11 |
Preferred stock, share issued | 111.11 | 111.11 |
Preferred stock, share outstanding | 111.11 | 111.11 |
Series E-2 Preferred Stock | ||
Preferred stock, shares authorized | 1,225 | 1,225 |
Preferred stock, share issued | 319.76 | 319.76 |
Preferred stock, share outstanding | 0 | 0 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
COSTS AND EXPENSES: | ||
Research and development | $ 28,211,460 | $ 19,219,603 |
General and administrative | 10,749,183 | 9,594,170 |
Total costs and expenses | 38,960,643 | 28,813,773 |
LOSS FROM OPERATIONS | (38,960,643) | (28,813,773) |
OTHER INCOME (EXPENSE): | ||
Warrant issuance expense | (470,000) | |
Gain on valuation of warrants | 1,000,000 | |
Interest income, net | 387,147 | 152,519 |
Total other income, net | 917,147 | 152,519 |
LOSS BEFORE INCOME TAXES | (38,043,496) | (28,661,254) |
INCOME TAX BENEFIT | (60,000) | (60,000) |
NET LOSS | $ (37,983,496) | $ (28,601,254) |
BASIC NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE | $ (3.11) | $ (4.05) |
DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE | $ (3.11) | $ (4.05) |
SHARES USED IN COMPUTING BASIC NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE | 12,221,571 | 7,055,665 |
SHARES USED IN COMPUTING DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE | 12,221,571 | 7,055,665 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' (DEFICIT) EQUITY - USD ($) | Preferred Stock | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total |
BALANCE BEGINNING at Dec. 31, 2021 | $ 1,382,023 | $ 61 | $ 182,560,859 | $ (150,897,789) | $ 33,045,154 |
BALANCE BEGINNING (in shares) at Dec. 31, 2021 | 111.11 | 6,110,125 | |||
Issuance of common stock, pre-funded warrants and warrants, net of issuance costs | $ 33 | 9,610,622 | 9,610,655 | ||
Issuance of common stock, pre-funded warrants and warrants, net of issuance costs (in shares) | 3,275,153 | ||||
Stock-based compensation | 1,452,964 | $ 1,452,964 | |||
Retired Shares (in shares) | (6) | ||||
Stock awards (in shares) | 440,250 | ||||
Net loss | (28,601,254) | $ (28,601,254) | |||
BALANCE ENDING at Dec. 31, 2022 | $ 1,382,023 | $ 94 | 193,624,445 | (179,499,043) | 15,507,519 |
BALANCE ENDING (in shares) at Dec. 31, 2022 | 111.11 | 9,385,272 | |||
Stock-based compensation | 2,410,288 | 2,410,288 | |||
Exercise of warrants into common shares | $ 12 | 789,630 | 789,642 | ||
Exercise of warrants into common shares (in shares) | 1,197,622 | ||||
Issuance of preferred stock, net of issuance costs | $ 17,920,000 | 17,920,000 | |||
Issuance of preferred stock, net of issuance costs (in shares) | 1,225 | ||||
Conversion of preferred stock to common stock | $ (13,242,368) | $ 99 | 13,242,269 | $ 13,242,368 | |
Conversion of preferred stock to common stock(in shares) | (905.24) | 9,947,684 | |||
Stock awards | $ 2 | (2) | |||
Stock awards (in shares) | 213,532 | 1,617,000 | |||
Net loss | (37,983,496) | $ (37,983,496) | |||
BALANCE ENDING at Dec. 31, 2023 | $ 6,059,655 | $ 207 | $ 210,066,630 | $ (217,482,539) | $ (1,356,047) |
BALANCE ENDING (in shares) at Dec. 31, 2023 | 430.87 | 20,744,110 | |||
Conversion of pre-funded warrants into common shares (in shares) | (905.24) | 9,947,684 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net Income (Loss) | $ (37,983,496) | $ (28,601,254) |
Adjustments to reconcile net loss to cash used in operating activities: | ||
Depreciation and amortization | 192,375 | 148,435 |
Stock-based compensation | 2,410,288 | 1,452,964 |
Loss on disposal of fixed assets | 3,386 | |
Costs to issue warrants | 470,000 | |
Gain on valuation of warrants | (1,000,000) | |
Noncash lease expense | 58,051 | 90,432 |
Changes in: | ||
Prepaid expenses and other current assets | (173,548) | 204,242 |
Accounts payable and accrued liabilities | 3,700,202 | 1,623,529 |
Lease liability | (50,846) | (144,035) |
Cash used in operating activities | (32,376,974) | (25,222,301) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of fixed assets | (864,038) | (225,971) |
Cash used in investing activities | (864,038) | (225,971) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from issuance of preferred stock and warrants, net of issuance costs | 22,150,000 | 9,610,655 |
Proceeds from exercise of warrants | 789,642 | |
Cash provided by financing activities | 22,939,642 | 9,610,655 |
DECREASE IN CASH AND CASH EQUIVALENTS | (10,301,370) | (15,837,617) |
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 19,866,358 | 35,703,975 |
CASH AND CASH EQUIVALENTS AT END OF PERIOD | 9,564,988 | $ 19,866,358 |
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION | ||
Conversion of preferred stock to common stock | 13,242,368 | |
Conversion of mezzanine equity to permanent equity (Note 6) | $ 17,920,000 |
NATURE OF BUSINESS AND ORGANIZA
NATURE OF BUSINESS AND ORGANIZATION | 12 Months Ended |
Dec. 31, 2023 | |
NATURE OF BUSINESS AND ORGANIZATION | |
NATURE OF BUSINESS AND ORGANIZATION | 1. NATURE OF BUSINESS AND ORGANIZATION Cellectar Biosciences, Inc. (Cellectar or the Company) is a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, leveraging our proprietary phospholipid drug conjugate™ (PDC™) delivery platform that specifically targets cancer cells and delivers improved efficacy and better safety as a result of fewer off-target effects. The Company has incurred losses since inception in devoting substantially all of its efforts toward research and development and has an accumulated deficit of approximately $217,483,000 as of December 31, 2023. During the year ended December 31, 2023, the Company generated a net loss of approximately $37,983,000 and the Company expects that it will continue to generate operating losses for the foreseeable future. The Company believes that its cash balance as of December 31, 2023, when combined with funds generated by the exercise of warrants in January 2024 (see Note 13), is adequate to fund its basic budgeted operations into the fourth quarter of 2024. The Company’s ability to execute its current operating plan depends on its ability to obtain additional funding via the sale of equity and/or debt securities, a strategic transaction or other source of capital. The Company plans to continue actively pursuing financing alternatives, however, there can be no assurance that it will obtain the necessary funding, raising substantial doubt about the Company’s ability to continue as a going concern within one year of the date these financial statements are issued. The accompanying financial statements do not include any adjustments that might result from the outcome of this uncertainty. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2023 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES The accompanying consolidated financial statements reflect the application of certain accounting policies, as described in this note and elsewhere in the notes to the consolidated financial statements. Principles of Consolidation Use of Estimates Cash and Cash Equivalents Fixed Assets 10 years 64 months Right-of-Use Asset and Lease Liability Leases Stock-Based Compensation three years Research and Development Income Taxes Fair Value of Financial Instruments Financial Instruments Warrants Preferred Stock Concentration of Credit Risk Recently Adopted Accounting Pronouncements information about certain type of government assistance they receive in the notes to the financial statements. Reimbursements of eligible expenditures pursuant to government assistance programs are recorded as reductions of operating costs when there is reasonable assurance that the Company will comply with the conditions attached to the grant arrangement and when the reimbursement has been claimed. The determination of the amount of the claim, and accordingly the receivable amount, requires management to make calculations based on its interpretation of eligible expenditures in accordance with the terms of the programs. The reimbursement claims submitted by the Company are subject to review by the relevant government agencies During the twelve months ended December 31, 2023, the Company received approximately $1,759,000 in NCI grant funding under the grants described above, all of which was reported as a reduction of research and development (R&D) expenses. During the twelve months ended December 31, 2022, the Company received approximately $697,000 in NCI grant funding under the grants described above, all of which was reported as a reduction of research and development (R&D) expenses. In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740)—Improvements to Income Tax Disclosures (ASU 2023-09), which is intended to enhance the transparency and decision usefulness of income tax disclosures. Public business entities are required to adopt this standard for annual fiscal periods beginning after December 31, 2024, and early adoption is permitted. The Company is evaluating the impact the adoption of this guidance will have on its consolidated financial statements and related disclosures. The Company evaluates all Accounting Standards Updates (ASUs) issued by the FASB for consideration of their applicability to our consolidated financial statements. We have assessed all ASUs issued but not yet adopted and concluded that those not disclosed are not relevant to the Company or are not expected to have a material impact. |
FAIR VALUE
FAIR VALUE | 12 Months Ended |
Dec. 31, 2023 | |
FAIR VALUE | |
FAIR VALUE | 3. FAIR VALUE In accordance with Fair Value Measurements and Disclosures Topic of the FASB ASC 820, the Company groups its financial assets and financial liabilities generally measured at fair value in three levels, based on the markets in which the assets and liabilities are traded, and the reliability of the assumptions used to determine fair value. ● Level 1: Input prices quoted in an active market for identical financial assets or liabilities. ● Level 2: Inputs other than prices quoted in Level 1, such as prices quoted for similar financial assets and liabilities in active markets, prices for identical assets, and liabilities in markets that are not active or other inputs that are observable or can be corroborated by observable market data. ● Level 3: Input prices quoted that are significant to the fair value of the financial assets or liabilities which are not observable or supported by an active market. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The carrying value of cash and cash equivalents approximates fair value as maturities are less than three months. The carrying amounts reported for other current financial assets and liabilities approximate fair value because of their short-term nature. In September 2023 the Company issued warrants to purchase shares of preferred stock which, on an as-converted basis, represent an aggregate of 21,025,641 shares of common stock (the September 2023 Warrants) (see Note 6). The fair value of the September 2023 Warrants was determined using a probability-weighted expected return method (PWERM) with a scenario-based Monte Carlo simulation and Black-Scholes model. The PWERM is a scenario-based methodology that estimates the fair value of the Company’s different classes of equity based upon an analysis of future values for the Company, assuming various outcomes. Under both models, assumptions and estimates are used to value the preferred stock warrants. The Company assesses these assumptions and estimates on a quarterly basis as additional information that impacts the assumptions is obtained. The quantitative elements associated with the inputs impacting the fair value measurement of the September 2023 Warrants include the value per share of the underlying common stock, the timing, form and overall value of the expected exits for the stockholders, the risk-free interest rate, the expected dividend yield and the expected volatility of the Company’s shares. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve for time periods approximately equal to the remaining contractual term of the warrants. The Company estimated a 0% dividend yield based on the expected dividend yield and the fact that the Company has never paid or declared cash dividends. Expected volatility was determined based upon the historical volatility of the Company’s common stock. These warrants are classified within the Level 3 hierarchy because of the nature of these inputs and the valuation technique utilized. The Warrant Liability of $3,700,000 presented on the accompanying balance sheet as of December 31, 2023, consists entirely of the estimated value of the September 2023 Warrants. The following table summarizes the modified option-pricing assumptions used on September 8, 2023, which was the date of issuance, and December 31, 2023: September 8 December 31 Volatility 83.0-84.0 % 82.0-83.0 % Risk-free interest rate 4.39-5.53 % 3.80-5.40 % Expected life (years) 0.4-5.0 0.3-4.7 Dividend 0 % 0 % The following table summarizes the changes in the fair market value of the warrants which are classified within the Level 3 fair value hierarchy from September 8, 2023, which was the date of issuance, through December 31, 2023: Level 3 Beginning fair value of warrants $ 4,700,000 Gain from change in fair value (1,000,000) December 31, 2023 fair value of warrants $ 3,700,000 |
FIXED ASSETS
FIXED ASSETS | 12 Months Ended |
Dec. 31, 2023 | |
FIXED ASSETS | |
FIXED ASSETS | 4. FIXED ASSETS Fixed assets consisted of the following as of December 31: 2023 2022 Office and laboratory equipment $ 1,661,316 $ 797,278 Computer software 4,000 4,000 Leasehold improvements 309,897 309,897 Total fixed assets 1,975,213 1,111,175 Less– accumulated depreciation and amortization (884,909) (692,534) Fixed assets, net $ 1,090,304 $ 418,641 For the years ended December 31, 2023 and 2022, the Company recorded approximately $192,000 and $148,000 of fixed asset depreciation and amortization expense, respectively. |
ACCOUNTS PAYABLE AND ACCRUED LI
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES | 12 Months Ended |
Dec. 31, 2023 | |
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES | |
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES | 5. ACCOUNTS PAYABLE AND ACCRUED LIABILITIES Accounts payable and accrued liabilities consist of the following as of December 31: 2023 2022 Incentive compensation $ 2,069,000 $ 916,000 Accounts payable 5,620,000 2,558,000 Clinical project costs 1,252,000 1,637,000 Professional fees 153,000 359,000 Other 85,000 8,000 $ 9,179,000 $ 5,478,000 |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 12 Months Ended |
Dec. 31, 2023 | |
STOCKHOLDERS' EQUITY | |
STOCKHOLDERS' EQUITY | 6. STOCKHOLDERS’ EQUITY September 2023 Private Placement On September 8, 2023, in a private placement with certain institutional investors, the Company issued 1,225 shares of Series E-1 preferred stock, along with Tranche A warrants to purchase 2,205 shares of Series E-3 preferred stock and Tranche B warrants to purchase 1,715 shares of Series E-4 preferred stock. Shares of Series E preferred stock were issued at a fixed price of $20,000 per share, resulting in gross proceeds of $24.5 million and net proceeds of approximately $22.2 million after placement agent fees and other customary expenses. The conversion prices for the preferred stock are as follows: for the Series E-1 or E-2 preferred stock, $1.82 per share of common stock, or a total of 13,461,538 shares of common stock; for the Series E-3 preferred stock, $3.185 per share of common stock, or a total of 13,846,154 shares of common stock; and for the Series E-4 preferred stock, $4.7775 per share of common stock, or a total of 7,179,487 shares of common stock, in each case subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization. The warrants are exercisable as follows: ● Tranche A warrants, for an aggregate exercise price of $44.1 million, exercisable for Series E-3 preferred stock until the earlier of September 6, 2026, or 10 trading days after the Company's announcement of positive topline data from the Waldenstrom's macroglobulinemia CLOVER WaM pivotal trial; and, ● Tranche B warrants, for an aggregate exercise price of $34.3 million, exercisable for Series E-4 preferred stock until the earlier of September 6, 2028, or 10 days following the Company’s public announcement of its receipt of written approval from the FDA of its New Drug Application for iopofosine I 131. The Tranche A and Tranche B warrants do not qualify as derivatives; however, they do not meet the requirements necessary to be considered indexable in the Company’s stock. As a result, and in accordance with the guidance in FASB ASC 815, the warrants continue to be deemed liabilities. All such liabilities are required to be presented at fair value, with changes reflected in financial results for the period. When issued, the Series E-1 preferred stock had a redemption feature; therefore, it was classified as mezzanine equity as of September 30, 2023. The Series E-1 preferred stock also had a liquidation preference, which was calculated as an amount per share equal to the greater of (i) two times (2X) the Original Per Share Price, together with any declared, unpaid dividends, or (ii) such amount per share as would have been payable had all shares of Series E-1 preferred stock been converted into Common Stock immediately prior to such Liquidation. While the Series E-1 preferred was outstanding, this resulted in both the Tranche A and Tranche B warrants being considered puttable by virtue of the liquidation preference impacting the disposition of these warrants in the event of a liquidation. In accordance with the guidance in Accounting Standards Codification section 480, a puttable warrant is deemed to be a liability. These features only applied to the Series E-1 preferred stock when it was outstanding; upon stockholder approval of the transaction, which was obtained by the Company at a special meeting of stockholders held on October 25, 2023, the Series E-1 preferred stock immediately converted into either Series E-2 preferred stock and/or common stock, dependent upon the beneficial ownership position of the holder. The net proceeds from the September 2023 Private Placement were allocated first to the fair value of the Tranche A and Tranche B warrants, which had a fair value upon issuance of $4,700,000, with the remainder, or $17,920,000, allocated to the Series E-1 preferred stock. Upon stockholder approval of the transaction, the entire amount that had been assigned to mezzanine equity was reclassified to Series E-2 preferred stock and is a component of permanent equity, as is reflected in the financial statements. As a result of the stockholder approval, Series E-1 preferred stock was fully extinguished in accordance with the terms of the financing. Series E-2 preferred stock is convertible to common stock at the request of the holder, subject to the holder not exceeding certain beneficial ownership percentages as stipulated in the financing agreement. Subsequent to the issuance of the Series E-2 preferred stock and prior to December 31, 2023, preferred holders converted 905.24 shares of preferred stock into 9,947,684 shares of common stock at the stated rate of $1.82 per common share. October 2022 Public Offering and Private Placement On October 25, 2022, the Company completed a registered direct offering of 3,275,153 shares of the Company’s common stock at $2.085 per share and warrants to purchase up to an aggregate of 3,275,153 shares of common stock in a concurrent private placement priced at-the-market under Nasdaq rules. In a separate concurrent private placement transaction, the Company offered and sold pre-funded warrants to purchase an aggregate of 1,875,945 shares of common stock and warrants to purchase an aggregate of 1,875,945 shares of common stock. The warrants are immediately exercisable at an exercise price of $1.96 per share and will expire on the fifth anniversary of the closing date. Each pre-funded warrant had a purchase price of $2.08499, is immediately exercisable at an exercise price of $0.00001 per share and will not expire until exercised in full. The registered direct offering and private placements resulted in total gross proceeds of approximately $10.7 million with net proceeds to the Company of approximately $9.6 million after deducting estimated offering expenses. During the twelve months ended December 31, 2023, 355,235 pre-funded warrants were converted into 355,235 shares of common stock. During the twelve months ended December 31, 2023, 177,877 common warrants were exercised for proceeds of $348,638. There were no common warrants exercised during the twelve months ended December 31, 2022. In accordance with the concept of FASB ASC 820 regarding the October 2022 public offering, the Company allocated the value of the proceeds to the common stock, common warrants, and pre-funded warrants utilizing a relative fair value basis. Using the closing trading price for our stock on October 20, 2022, the Company computed the fair value of the shares sold. This valuation did not impact the total gross increase to Stockholders’ Equity of $10.7 million, but is an internal, proportionate calculation allocating gross proceeds of approximately $4.0 million to common stock, $4.4 million to common warrants and $2.3 million to pre-funded warrants. 2022 Reverse Stock Split At the annual stockholders’ meeting held on June 24, 2022, the Company’s stockholders approved an amendment to the Company’s certificate of incorporation to effect a reverse split of the Company’s common stock at a ratio between 1 1 1 1 Authorized Share Increase At a special meeting of stockholders held on October 25, 2023, the Company’s stockholders approved an amendment of the Company’s Second Amended and Restated Certificate of Incorporation, as amended, to increase the authorized common stock from 160,000,000 shares to 170,000,000 shares. Common Stock Warrants The following table summarizes the outstanding warrants to purchase common stock as of December 31, 2023: Number of Shares Issuable Upon Exercise of Outstanding Exercise Offering Warrants Price Expiration Date 2023 Tranche A Preferred Warrants 13,846,154 $ 3.185 September 8, 2026 (1) 2023 Tranche B Preferred Warrants 7,179,487 $ 4.7775 September 8, 2028 (1) 2022 Common Warrants 4,748,221 $ 1.96 October 25, 2027 2022 Pre-Funded Warrants 1,079,136 $ 0.00001 N/A June 2020 Series H Warrants 720,796 $ 12.075 June 5, 2025 May 2019 Series F Warrants 195,700 $ 24.00 May 20, 2024 May 2019 Series G Warrants 201,800 $ 24.00 May 20, 2024 October 2017 Series D Warrants 31,085 $ 178.00 October 14, 2024 Total 28,002,379 (1) These warrants are described further under the caption “September 2023 Private Placement” above. |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2023 | |
STOCK-BASED COMPENSATION | |
STOCK-BASED COMPENSATION | 7. STOCK-BASED COMPENSATION Accounting for Stock-Based Compensation 2021 Stock Incentive Plan The Company maintains the 2021 Stock Incentive Plan (the “2021 Plan”). The Company utilizes stock-based compensation incentives as a component of its employee and non-employee director and officer compensation philosophy. A committee of the Board of Directors determines the terms of the awards granted and may grant various forms of equity-based incentive compensation. Currently, these incentives consist principally of stock options and restricted shares. All outstanding awards under the 2015 Stock Incentive Plan (the “2015 Plan”) remained in effect according to the terms of the 2015 Plan. Any shares that are currently available under the 2015 Plan and any shares underlying 2015 Plan awards which are forfeited, cancelled, reacquired by the Company or otherwise terminated are added to the shares available for grant under the 2021 Plan. Under the current stock option award program, all options become exercisable between one and three years after issuance and expire after ten years. The fair value of each stock option award is estimated on the grant date using the Black-Scholes option-pricing model. Volatility is based on the Company’s historical common stock volatility. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time. The expected term of stock options granted is based on an estimate of when options will be exercised in the future. Forfeitures are recorded as they occur. No dividends have been recorded historically. At the annual meeting of stockholders held on June 23, 2023, the Company’s stockholders approved an increase in the number of shares of common stock available for issuance under our 2021 Stock Incentive Plan by 1,100,000 to 2,368,000. During the twelve-months ended December 31, 2023 and 2022, stock options granted were 1,617,000 and 440,250, respectively. The following table summarizes amounts charged to expense for stock-based compensation related to employee and director stock option grants: Twelve Months Ended December 31, 2023 2022 Employee and director stock option and stock grants: Research and development $ 505,155 $ 165,461 General and administrative 1,905,133 1,287,502 Total stock-based compensation $ 2,410,288 $ 1,452,964 In January 2023, the Company granted 609,000 non-statutory stock option awards at an exercise price of $1.68 per share to employees. These grants were contingent upon the approval of the increase in the number of shares available for issuance under the 2021 Plan that was approved by the stockholders at the Annual Meeting of Stockholders held on June 23, 2023. In accordance with the removal of the contingency, the Company began recognizing the expense for these awards beginning in June 2023. In December 2023, the Company granted 2,776,000 contingent, non-statutory stock option awards at an exercise price of $2.65 per share to our employees and our directors. Each of these grants is contingent on approval of an increase in the shares available in the 2021 Stock Incentive Plan that is to be voted on by the stockholders at the annual meeting of stockholders expected to be held in June 2024. Until such time that the contingent non-statutory stock option awards are approved by stockholders, no expense will be recognized by the Company. In December 2023, the Company awarded $434,132 in cash and 213,532 shares of stock, valued at $565,868, to certain employees as a result of the attainment of milestones established and approved by a committee of the Board of Directors. Due to the contingent nature of those awards, which were fully vested upon milestone attainment, the expense was recognized by the Company upon grant. Assumptions Used in Determining Fair Value Valuation and amortization method Volatility. Risk-free interest rate Expected term Forfeitures. Dividends. Summary. Year Ended December 31, 2023 2022 Volatility 82.02-83.28 % 82.47-100 % Risk-free interest rate 3.59-4.68 % 1.65-3.96 % Expected life (years) 6 6 Dividend 0 % 0 % Exercise prices for all grants made during the twelve months ended December 31, 2023 and 2022 were equal to the market value of the Company’s common stock on the date of grant. Stock Option Activity A summary of stock option activity is as follows: Number of Shares Issuable Weighted Upon Average Exercise Weighted Remaining of Average Contracted Aggregate Outstanding Exercise Term in Intrinsic Options Price Years Value Outstanding as of December 31, 2021 423,820 $ 22.70 Granted 440,250 $ 4.51 Expired (6) $ 15,000.00 Forfeited (117,807) $ 12.02 Outstanding as of December 31, 2022 746,257 $ 13.48 8.58 $ — Granted 1,617,000 $ 1.78 Expired (8) $ 8,325 Forfeited (11,346) $ 1.92 Outstanding as of December 31, 2023 2,351,903 $ 5.46 8.64 $ 1,682,667 Exercisable as of December 31, 2023 514,171 $ 15.68 $ 30,817 Unvested as of December 31, 2023 1,837,732 $ 2.58 $ 1,652,350 The aggregate intrinsic value of options outstanding is calculated based on the positive difference between the estimated per-share fair value of common stock at the end of the respective period and the exercise price of the underlying options. Shares of common stock issued upon the exercise of options are from authorized but unissued shares. At December 31, 2023, we had 116,579 shares available for grant under the 2021 Option Plan. The weighted-average grant-date fair value of options granted during the years ended December 31, 2023 and 2022 was $1.35 and $3.49, respectively. The total fair value of shares vested during the years ended December 31, 2023 and 2022 was $1,647,355 and $712,431, respectively. The weighted-average grant-date fair value of vested and unvested options outstanding at December 31, 2023 was $11.13 and $1.81, respectively. The weighted-average grant-date fair value of vested and unvested options outstanding at December 31, 2022 was $19.92 and $5.25, respectively. The weighted average grant date fair value of options forfeited during the years ended December 31, 2023 and 2022 was $1.41 and $7.33, respectively. The number of options vested during the years ended December 31, 2023 and December 31, 2022 was 308,144 and 135,986, respectively. The number of options unvested at January 1, 2023 and January 1, 2022 was 540,223 and 343,996, respectively. The weighted average grant date fair value of options unvested at January 1, 2023 and January 1, 2022 was $5.25 and $3.20, respectively. As of December 31, 2023, there was approximately $2,205,192 of total unrecognized compensation cost related to unvested stock-based compensation arrangements. Of this total amount, the Company expects to recognize approximately $1,330,233, $775,193, and $99,766 during 2024, 2025 and 2026, respectively. The Company’s expense estimates are based upon the expectation that all unvested options will vest in the future. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2023 | |
INCOME TAXES | |
INCOME TAXES | 8. INCOME TAXES 2023 2022 Tax provision (benefit) Current Federal $ — $ — State (60,000) (60,000) Total current (60,000) (60,000) Deferred Federal (12,233,641) (7,800,350) State (2,764,638) (2,633,146) Total deferred (14,998,279) (10,433,496) Change in valuation allowance 14,998,279 10,433,496 Total $ (60,000) $ (60,000) Deferred tax assets consisted of the following as of December 31: 2023 2022 Deferred tax assets Federal net operating loss $ 39,914,591 $ 35,958,687 Federal research and development tax credit carryforwards 15,868,907 11,484,209 State net operating losses and tax credit carryforwards 7,626,490 6,186,679 Capitalized research and development expenses 20,203,493 15,820,893 Stock-based compensation expense 3,710,609 3,186,702 Other 754,180 443,693 Total deferred tax assets 88,078,270 73,080,863 Deferred tax liabilities Depreciable assets (156,626) (157,498) Total deferred tax liabilities (156,626) (157,498) Net deferred tax assets 87,921,644 72,923,365 Less- valuation allowance (87,921,644) (72,923,365) Total deferred tax assets $ — $ — A reconciliation of income taxes computed using the U.S. federal statutory rate to that reflected in operations is as follows: Year ended December 31, 2023 2022 Income tax benefit using U.S. federal statutory rate 21.00 % 21.00 % State income taxes 7.81 % 9.35 % Permanent nondeductible items 0.20 % (0.01) % Federal tax credits 11.50 % 6.57 % Change in valuation allowance (40.01) % (36.40) % Other (0.32) % (0.31) % Total 0.18 % 0.20 % As of December 31, 2023, the Company had federal net operating loss (NOL) carryforwards of approximately $110,069,000 generated as of December 31, 2017, and NOL carryforwards of approximately $80,001,000 after December 31, 2017. Federal NOLs generated as of December 31, 2017, will expire in 2023 through 2037, while NOLs generated during 2018 and later will be carried forward indefinitely until utilized. As of December 31, 2023, the Company had state NOL carryforwards of approximately $97,080,000. State NOL carryforwards will expire in 2029 through 2043. As of December 31, 2023, the Company had federal research and development (R&D) and orphan drug credit carryforwards of approximately $15,869,000 which will expire in 2024 through 2042. As of December 31, 2023, the Company also had state credit carryforwards of approximately $1,045,000 which will expire in 2025 through 2038. The Company had federal NOLs and R&D credit carryforwards of $502,000 and $13,000, respectively, that expired in 2023. The NOL, R&D and orphan drug credit carryforwards may have, or may become subject to, an annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, as well as similar state tax provisions. This could limit the amount of NOLs that the Company can utilize annually to offset future taxable income or tax liabilities. The amount of the annual limitation, if any, will be determined based on the value of the Company immediately prior to an ownership change. Subsequent ownership changes may further affect the limitation in future years. If and when the Company utilizes the NOL carryforwards in a future period, it will perform an analysis to determine the effect, if any, of these loss limitation rules on the NOL carryforward balances. The Company has evaluated the available evidence supporting the realization of its deferred tax assets, including the amount and timing of future taxable income, and has determined that it is more likely than not that its net deferred tax assets will not be realized. As a result of uncertainties surrounding the realization of the deferred tax assets, the Company maintains a full valuation allowance against all of its net deferred tax assets. When the Company determines that it will be able to realize some portion or all of its deferred tax assets, an adjustment to the valuation allowance on its deferred tax assets would have the effect of increasing net income in the period such determination is made. The Company did not have unrecognized tax benefits or accrued interest and penalties at any time during the years ended December 31, 2023 or 2022, and does not anticipate having unrecognized tax benefits over the next twelve months. The Company is subject to audit by the Internal Revenue Service and state taxing authorities for tax periods commencing January 1, 2018, as a result of its NOLs. However, any adjustment related to these periods would be limited to the amount of the NOL generated in the year(s) under examination. |
NET LOSS PER SHARE
NET LOSS PER SHARE | 12 Months Ended |
Dec. 31, 2023 | |
NET LOSS PER SHARE | |
NET LOSS PER SHARE | 9. NET LOSS PER SHARE Basic net loss per share is computed by dividing net loss attributable to common stockholders by the weighted average number of shares of common stock and pre-funded warrants outstanding during the period. The pre-funded warrants are considered common shares outstanding for the purposes of the basic net loss per share calculation because of the nominal cash consideration and lack of other contingencies for issuance of the underlying common shares. Diluted net loss attributable to common stockholders per share is computed by dividing net loss attributable to common stockholders, as adjusted, by the sum of the weighted average number of shares of common stock and the dilutive potential common stock equivalents then outstanding. Potential common stock equivalents consist of stock options, warrants, and convertible preferred shares. Since there is a net loss attributable to common stockholders for the years ended December 31, 2023 and 2022, the inclusion of common stock equivalents in the computation for those periods would be antidilutive. Accordingly, basic and diluted net loss per share is the same for all periods presented. The following potentially dilutive securities have been excluded from the computation of diluted net loss per share since their inclusion would have been antidilutive: Year Ended December 31, 2023 2022 Warrants 28,002,379 6,714,479 Stock options 2,351,903 746,257 Convertible preferred shares 3,624,957 111,111 Total potentially dilutive shares 33,979,239 7,571,847 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2023 | |
COMMITMENTS AND CONTINGENCIES | |
COMMITMENTS AND CONTINGENCIES | 10. COMMITMENTS AND CONTINGENCIES Legal The Company may be involved in legal matters and disputes in the ordinary course of business. We do not anticipate that the outcome of such matters and disputes will materially affect the Company’s financial statements. |
LEASES
LEASES | 12 Months Ended |
Dec. 31, 2023 | |
LEASES | |
LEASES | 11. LEASES Operating Lease Liability In June 2018, the Company executed an agreement for office space in the Borough of Florham Park, Morris County, New Jersey to be used as its headquarters (HQ Lease). The HQ Lease commenced upon completion of certain improvements in October 2018 and terminates in February 2024 with an option to extend the term of the lease for one additional 60-month period. On December 30, 2022, the Company entered into an Amended Agreement of Lease, with CAMPUS 100 LLC (the “Landlord”). Under the Amended Lease, which was accounted for as a modification of the initial lease, as the Company will continue to lease 3,983 square feet of rentable area on the second floor of a building located at 100 Campus Drive in Florham Park, New Jersey, for the period commencing on March 1, 2023 and ending on April 30, 2029. The Company also has an option to extend the term of the Amended Lease for one additional 60-month period. Under the terms of the Amended Lease, the Company’s previously paid security deposit of $75,000 was reduced to $23,566 and the aggregate rent due over the term of the Amended Lease is approximately $918,000, which will be reduced to approximately $893,000 after certain rent abatements. The Company will also be required to pay its proportionate share of certain operating expenses and real estate taxes applicable to the leased premises. After certain rent abatements the rent is approximately $11,800 per month for the first year and then escalates thereafter by 2% per year for the duration of the term. The Company has not entered into any leases with related parties. Discount Rate The Company has determined an appropriate interest rate to be used in evaluating the present value of the Amended Lease liability considering factors such as the Company’s credit rating, borrowing terms offered by the U.S. Small Business Administration, amount of lease payments, quality of collateral and alignment of the borrowing term and lease term. The Company considers 14% per annum as reasonable to use as the incremental borrowing rate for the purpose of calculating the liability under the Amended Lease. In conjunction with the June 2018 lease, the Company had previously used a 10% per annum incremental borrowing rate. Maturity Analysis of Short-Term and Operating Leases The following table approximates the dollar maturity of the Company’s undiscounted payments for its short-term leases and operating lease liabilities as of December 31, 2023: Years ending December 31, 2024 $ 132,000 2025 146,000 2026 150,000 2027 153,000 2028 155,000 Thereafter 53,000 Total undiscounted lease payments 789,000 Less: Imputed interest (236,000) Present value of lease liabilities $ 553,000 |
EMPLOYEE RETIREMENT PLAN
EMPLOYEE RETIREMENT PLAN | 12 Months Ended |
Dec. 31, 2023 | |
EMPLOYEE RETIREMENT PLAN | |
EMPLOYEE RETIREMENT PLAN | 12. EMPLOYEE RETIREMENT PLAN The Company maintains a defined contribution plan under Section 401(k) of the Internal Revenue Code that allows eligible employees to contribute a portion of their annual compensation on a pre-tax basis. The Company has not made any matching contributions under this plan. |
SUBSEQUENT EVENT
SUBSEQUENT EVENT | 12 Months Ended |
Dec. 31, 2023 | |
SUBSEQUENT EVENT | |
SUBSEQUENT EVENT | 13. SUBSEQUENT EVENT In January 2024, the Company released topline data from its pivotal, Phase 2b CLOVER WaM trial. In accordance with the terms of the September 2023 financing, the Tranche A warrant expiration accelerated to 10 trading days after the topline data release. Warrant holders exercised the Tranche A warrants in their entirety, resulting in the Company issuing 2,205 shares of Series E-3 preferred stock, which are convertible to common stock at the stated rate of $3.185 per share, and receiving gross proceeds of $44.1 million and net proceeds of $42.8 million. Additionally, during January and February 2024, 547,177 warrants issued in October 2022 were exercised for net proceeds of approximately $1.1 million. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Principles of Consolidation | Principles of Consolidation |
Use of Estimates | Use of Estimates |
Cash and Cash Equivalents | Cash and Cash Equivalents |
Fixed Assets | Fixed Assets 10 years 64 months |
Right-of-Use Asset and Lease Liability | Right-of-Use Asset and Lease Liability Leases |
Stock-Based Compensation | Stock-Based Compensation three years |
Research and Development | Research and Development |
Income Taxes | Income Taxes |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Financial Instruments |
Warrants | Warrants |
Preferred Stock | Preferred Stock |
Concentration of Credit Risk | Concentration of Credit Risk |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements information about certain type of government assistance they receive in the notes to the financial statements. Reimbursements of eligible expenditures pursuant to government assistance programs are recorded as reductions of operating costs when there is reasonable assurance that the Company will comply with the conditions attached to the grant arrangement and when the reimbursement has been claimed. The determination of the amount of the claim, and accordingly the receivable amount, requires management to make calculations based on its interpretation of eligible expenditures in accordance with the terms of the programs. The reimbursement claims submitted by the Company are subject to review by the relevant government agencies During the twelve months ended December 31, 2023, the Company received approximately $1,759,000 in NCI grant funding under the grants described above, all of which was reported as a reduction of research and development (R&D) expenses. During the twelve months ended December 31, 2022, the Company received approximately $697,000 in NCI grant funding under the grants described above, all of which was reported as a reduction of research and development (R&D) expenses. In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740)—Improvements to Income Tax Disclosures (ASU 2023-09), which is intended to enhance the transparency and decision usefulness of income tax disclosures. Public business entities are required to adopt this standard for annual fiscal periods beginning after December 31, 2024, and early adoption is permitted. The Company is evaluating the impact the adoption of this guidance will have on its consolidated financial statements and related disclosures. The Company evaluates all Accounting Standards Updates (ASUs) issued by the FASB for consideration of their applicability to our consolidated financial statements. We have assessed all ASUs issued but not yet adopted and concluded that those not disclosed are not relevant to the Company or are not expected to have a material impact. |
FAIR VALUE (Tables)
FAIR VALUE (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
FAIR VALUE | |
Schedule of modified option pricing assumptions | September 8 December 31 Volatility 83.0-84.0 % 82.0-83.0 % Risk-free interest rate 4.39-5.53 % 3.80-5.40 % Expected life (years) 0.4-5.0 0.3-4.7 Dividend 0 % 0 % |
Schedule of changes in the fair market value of the warrants | Level 3 Beginning fair value of warrants $ 4,700,000 Gain from change in fair value (1,000,000) December 31, 2023 fair value of warrants $ 3,700,000 |
FIXED ASSETS (Tables)
FIXED ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
FIXED ASSETS | |
Schedule of Fixed assets | 2023 2022 Office and laboratory equipment $ 1,661,316 $ 797,278 Computer software 4,000 4,000 Leasehold improvements 309,897 309,897 Total fixed assets 1,975,213 1,111,175 Less– accumulated depreciation and amortization (884,909) (692,534) Fixed assets, net $ 1,090,304 $ 418,641 |
ACCOUNTS PAYABLE AND ACCRUED _2
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES | |
Schedule of accounts payable and accrued liabilities | 2023 2022 Incentive compensation $ 2,069,000 $ 916,000 Accounts payable 5,620,000 2,558,000 Clinical project costs 1,252,000 1,637,000 Professional fees 153,000 359,000 Other 85,000 8,000 $ 9,179,000 $ 5,478,000 |
NET LOSS PER SHARE (Tables)
NET LOSS PER SHARE (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
NET LOSS PER SHARE | |
Schedule of dilutive securities have been excluded from the computation of diluted net loss per share | Year Ended December 31, 2023 2022 Warrants 28,002,379 6,714,479 Stock options 2,351,903 746,257 Convertible preferred shares 3,624,957 111,111 Total potentially dilutive shares 33,979,239 7,571,847 |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
STOCKHOLDERS' EQUITY | |
Summary of outstanding warrants to purchase common stock | The following table summarizes the outstanding warrants to purchase common stock as of December 31, 2023: Number of Shares Issuable Upon Exercise of Outstanding Exercise Offering Warrants Price Expiration Date 2023 Tranche A Preferred Warrants 13,846,154 $ 3.185 September 8, 2026 (1) 2023 Tranche B Preferred Warrants 7,179,487 $ 4.7775 September 8, 2028 (1) 2022 Common Warrants 4,748,221 $ 1.96 October 25, 2027 2022 Pre-Funded Warrants 1,079,136 $ 0.00001 N/A June 2020 Series H Warrants 720,796 $ 12.075 June 5, 2025 May 2019 Series F Warrants 195,700 $ 24.00 May 20, 2024 May 2019 Series G Warrants 201,800 $ 24.00 May 20, 2024 October 2017 Series D Warrants 31,085 $ 178.00 October 14, 2024 Total 28,002,379 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
STOCK-BASED COMPENSATION | |
Summary of the expense for stock-based compensation related to stock option grants | Twelve Months Ended December 31, 2023 2022 Employee and director stock option and stock grants: Research and development $ 505,155 $ 165,461 General and administrative 1,905,133 1,287,502 Total stock-based compensation $ 2,410,288 $ 1,452,964 |
Schedule of assumptions used for stock | Year Ended December 31, 2023 2022 Volatility 82.02-83.28 % 82.47-100 % Risk-free interest rate 3.59-4.68 % 1.65-3.96 % Expected life (years) 6 6 Dividend 0 % 0 % |
Summary of stock options activity | Number of Shares Issuable Weighted Upon Average Exercise Weighted Remaining of Average Contracted Aggregate Outstanding Exercise Term in Intrinsic Options Price Years Value Outstanding as of December 31, 2021 423,820 $ 22.70 Granted 440,250 $ 4.51 Expired (6) $ 15,000.00 Forfeited (117,807) $ 12.02 Outstanding as of December 31, 2022 746,257 $ 13.48 8.58 $ — Granted 1,617,000 $ 1.78 Expired (8) $ 8,325 Forfeited (11,346) $ 1.92 Outstanding as of December 31, 2023 2,351,903 $ 5.46 8.64 $ 1,682,667 Exercisable as of December 31, 2023 514,171 $ 15.68 $ 30,817 Unvested as of December 31, 2023 1,837,732 $ 2.58 $ 1,652,350 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
INCOME TAXES | |
Schedule of components of tax provision (benefit) | 2023 2022 Tax provision (benefit) Current Federal $ — $ — State (60,000) (60,000) Total current (60,000) (60,000) Deferred Federal (12,233,641) (7,800,350) State (2,764,638) (2,633,146) Total deferred (14,998,279) (10,433,496) Change in valuation allowance 14,998,279 10,433,496 Total $ (60,000) $ (60,000) |
Schedule of deferred tax assets and liabilities | 2023 2022 Deferred tax assets Federal net operating loss $ 39,914,591 $ 35,958,687 Federal research and development tax credit carryforwards 15,868,907 11,484,209 State net operating losses and tax credit carryforwards 7,626,490 6,186,679 Capitalized research and development expenses 20,203,493 15,820,893 Stock-based compensation expense 3,710,609 3,186,702 Other 754,180 443,693 Total deferred tax assets 88,078,270 73,080,863 Deferred tax liabilities Depreciable assets (156,626) (157,498) Total deferred tax liabilities (156,626) (157,498) Net deferred tax assets 87,921,644 72,923,365 Less- valuation allowance (87,921,644) (72,923,365) Total deferred tax assets $ — $ — |
Schedule of reconciliation of income taxes | Year ended December 31, 2023 2022 Income tax benefit using U.S. federal statutory rate 21.00 % 21.00 % State income taxes 7.81 % 9.35 % Permanent nondeductible items 0.20 % (0.01) % Federal tax credits 11.50 % 6.57 % Change in valuation allowance (40.01) % (36.40) % Other (0.32) % (0.31) % Total 0.18 % 0.20 % |
LEASES (Tables)
LEASES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
LEASES | |
Schedule of the company's undiscounted payments for its short-term leases and operating lease liabilities | Years ending December 31, 2024 $ 132,000 2025 146,000 2026 150,000 2027 153,000 2028 155,000 Thereafter 53,000 Total undiscounted lease payments 789,000 Less: Imputed interest (236,000) Present value of lease liabilities $ 553,000 |
NATURE OF BUSINESS AND ORGANI_2
NATURE OF BUSINESS AND ORGANIZATION (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
NATURE OF BUSINESS AND ORGANIZATION | ||
Accumulated deficit | $ 217,482,539 | $ 179,499,043 |
Net loss | $ 37,983,496 | $ 28,601,254 |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |
Sep. 30, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |||
Fixed asset impairment charges | $ 0 | $ 0 | |
Uninsured cash balances | 9,123,000 | ||
Cancer treatment research award | 2,000,000 | ||
Reduction in research and development | $ 1,759,000 | ||
Government Assistance, Statement of Income or Comprehensive Income [Extensible Enumeration] | Costs and Expenses | ||
Cancer treatment research award through the National Cancer Institute (NCI) | |||
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |||
Reduction in research and development | $ 697,000 | ||
Grant received | $ 1,980,000 | ||
Minimum | |||
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |||
Property and equipment useful lives | 3 years | ||
Share-based compensation expiration period | 12 months | ||
Maximum | |||
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |||
Property and equipment useful lives | 10 years | ||
Share-based compensation expiration period | 3 years | ||
Leasehold improvements | |||
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |||
Property and equipment useful lives | 64 months |
FAIR VALUE - Narratives (Detail
FAIR VALUE - Narratives (Details) | Dec. 31, 2023 USD ($) shares | Sep. 30, 2023 shares |
FAIR VALUE | ||
Warrants issued to purchase shares | shares | 28,002,379 | |
Warrant liability | $ | $ 3,700,000 | |
Dividend | ||
FAIR VALUE | ||
Warrants issued to purchase shares | shares | 21,025,641 | |
Warrants | 0 | 0 |
Warrant liability | $ | $ 3,700,000 |
FAIR VALUE - Option-pricing ass
FAIR VALUE - Option-pricing assumptions (Details) | Dec. 31, 2023 Y | Sep. 30, 2023 | Sep. 08, 2023 Y |
Volatility | Maximum | |||
FAIR VALUE | |||
Warrants | 0.830 | 0.840 | |
Volatility | Minimum | |||
FAIR VALUE | |||
Warrants | 0.820 | 0.830 | |
Risk-free interest rate | Maximum | |||
FAIR VALUE | |||
Warrants | 0.0540 | 0.0553 | |
Risk-free interest rate | Minimum | |||
FAIR VALUE | |||
Warrants | 0.0380 | 0.0439 | |
Expected life (years) | Maximum | |||
FAIR VALUE | |||
Warrants | 4.7 | 5 | |
Expected life (years) | Minimum | |||
FAIR VALUE | |||
Warrants | 0.3 | 0.4 | |
Dividend | |||
FAIR VALUE | |||
Warrants | 0 | 0 |
FAIR VALUE - Changes in the fai
FAIR VALUE - Changes in the fair market value of the warrants (Details) | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Changes in the fair market value of the warrants | |
Fair Value, Liability, Recurring Basis, Unobservable Input Reconciliation, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration] | Fair Value Adjustment of Warrants |
Level 3 | Warrants | |
Changes in the fair market value of the warrants | |
Beginning fair value of warrants | $ 4,700,000 |
Gain from change in fair value | (1,000,000) |
December 31, 2023 fair value of warrants | $ 3,700,000 |
FIXED ASSETS (Details)
FIXED ASSETS (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
FIXED ASSETS | ||
Total fixed assets | $ 1,975,213 | $ 1,111,175 |
Less- accumulated depreciation and amortization | (884,909) | (692,534) |
Fixed assets, net | 1,090,304 | 418,641 |
Office and laboratory equipment | ||
FIXED ASSETS | ||
Total fixed assets | 1,661,316 | 797,278 |
Computer software | ||
FIXED ASSETS | ||
Total fixed assets | 4,000 | 4,000 |
Leasehold improvements | ||
FIXED ASSETS | ||
Total fixed assets | $ 309,897 | $ 309,897 |
FIXED ASSETS - Additional Infor
FIXED ASSETS - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
FIXED ASSETS | ||
Depreciation and amortization | $ 192,375 | $ 148,435 |
ACCOUNTS PAYABLE AND ACCRUED _3
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES | ||
Incentive compensation | $ 2,069,000 | $ 916,000 |
Accounts payable | 5,620,000 | 2,558,000 |
Clinical project costs | 1,252,000 | 1,637,000 |
Professional fees | 153,000 | 359,000 |
Other | 85,000 | 8,000 |
Accounts Payable and Accrued Liabilities, Current, Total | $ 9,178,645 | $ 5,478,443 |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) | 12 Months Ended | ||||||||
Sep. 08, 2023 USD ($) $ / shares shares | Oct. 25, 2022 USD ($) $ / shares shares | Oct. 20, 2022 USD ($) | Jun. 27, 2022 | Jun. 24, 2022 | Dec. 31, 2023 USD ($) $ / shares shares | Dec. 31, 2022 $ / shares shares | Oct. 25, 2023 shares | Oct. 24, 2023 shares | |
STOCKHOLDERS' EQUITY | |||||||||
Warrants issued to purchase shares | shares | 28,002,379 | ||||||||
Proceeds from exercise of warrants | $ | $ 789,642 | ||||||||
Number of warrants exercised | shares | 177,877 | 0 | |||||||
Reverse stock split | 0.10 | ||||||||
Common stock, shares authorized | shares | 170,000,000 | 170,000,000 | 170,000,000 | 160,000,000 | |||||
Aggregate value of shares issued | $ | $ 17,920,000 | ||||||||
Common stock par value | $ / shares | $ 0.00001 | $ 0.00001 | |||||||
September 2023 Private Placement | |||||||||
STOCKHOLDERS' EQUITY | |||||||||
Gross proceeds | $ | $ 24,500,000 | ||||||||
Net proceeds | $ | $ 22,200,000 | ||||||||
Common Stock | |||||||||
STOCKHOLDERS' EQUITY | |||||||||
Conversion of pre-funded warrants into common shares (in shares) | shares | 9,947,684 | ||||||||
Minimum | Common Stock | |||||||||
STOCKHOLDERS' EQUITY | |||||||||
Reverse stock split | 0.10 | ||||||||
Maximum | Common Stock | |||||||||
STOCKHOLDERS' EQUITY | |||||||||
Reverse stock split | 0.20 | ||||||||
Preferred Stock | September 2023 Private Placement | |||||||||
STOCKHOLDERS' EQUITY | |||||||||
Number of shares converted | shares | 905.24 | ||||||||
Common Stock | September 2023 Private Placement | |||||||||
STOCKHOLDERS' EQUITY | |||||||||
Convertible preferred shares issued | shares | 9,947,684 | ||||||||
Series E Warrants | September 2023 Private Placement | |||||||||
STOCKHOLDERS' EQUITY | |||||||||
Share price | $ / shares | $ 20,000 | ||||||||
Series E-1 preferred stock | September 2023 Private Placement | |||||||||
STOCKHOLDERS' EQUITY | |||||||||
Shares issued | shares | 1,225 | ||||||||
Conversion price per share | $ / shares | $ 1.82 | ||||||||
Convertible preferred shares issued | shares | 13,461,538 | ||||||||
Gross proceeds from stockholders' equity | $ | $ 17,920,000 | ||||||||
Series E-2 Preferred Stock | September 2023 Private Placement | |||||||||
STOCKHOLDERS' EQUITY | |||||||||
Common stock par value | $ / shares | $ 1.82 | ||||||||
Series E-3 preferred stock | September 2023 Private Placement | |||||||||
STOCKHOLDERS' EQUITY | |||||||||
Conversion price per share | $ / shares | $ 3.185 | ||||||||
Convertible preferred shares issued | shares | 13,846,154 | ||||||||
Series E-4 preferred stock | September 2023 Private Placement | |||||||||
STOCKHOLDERS' EQUITY | |||||||||
Conversion price per share | $ / shares | $ 4.7775 | ||||||||
Convertible preferred shares issued | shares | 7,179,487 | ||||||||
Tranche A and B Warrants | September 2023 Private Placement | |||||||||
STOCKHOLDERS' EQUITY | |||||||||
Gross proceeds from stockholders' equity | $ | $ 4,700,000 | ||||||||
October 2022 Public Offering and Private Placement | |||||||||
STOCKHOLDERS' EQUITY | |||||||||
Warrants issued to purchase shares | shares | 3,275,153 | ||||||||
Gross proceeds | $ | $ 10,700,000 | ||||||||
Proceeds from exercise of warrants | $ | $ 348,638 | ||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 2.085 | ||||||||
Class of warrant or rights from which warrants or rights exercisable. | $ / shares | $ 0.00001 | ||||||||
Estimated offering expenses | $ | $ 9,600,000 | ||||||||
Gross proceeds from stockholders' equity | $ | $ 10,700,000 | ||||||||
October 2022 Public Offering and Private Placement | Common Stock | |||||||||
STOCKHOLDERS' EQUITY | |||||||||
Warrants issued to purchase shares | shares | 1,875,945 | ||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 1.96 | ||||||||
Common Stock | October 2022 Public Offering and Private Placement | |||||||||
STOCKHOLDERS' EQUITY | |||||||||
Gross proceeds from stockholders' equity | $ | 4,000,000 | ||||||||
Common warrants | October 2022 Public Offering and Private Placement | |||||||||
STOCKHOLDERS' EQUITY | |||||||||
Conversion of pre-funded warrants into common shares (in shares) | shares | 355,235 | ||||||||
Gross proceeds from stockholders' equity | $ | 4,400,000 | ||||||||
Prefunded Warrant | October 2022 Public Offering and Private Placement | |||||||||
STOCKHOLDERS' EQUITY | |||||||||
Warrants issued to purchase shares | shares | 1,875,945 | ||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 2.08499 | ||||||||
pre-funded warrants | shares | 355,235 | ||||||||
Gross proceeds from stockholders' equity | $ | $ 2,300,000 | ||||||||
2023 Tranche A Preferred Warrants | September 2023 Private Placement | |||||||||
STOCKHOLDERS' EQUITY | |||||||||
Proceeds from exercise of warrants | $ | $ 44,100,000 | ||||||||
2023 Tranche A Preferred Warrants | Series E-3 preferred stock | September 2023 Private Placement | |||||||||
STOCKHOLDERS' EQUITY | |||||||||
Warrants issued to purchase shares | shares | 2,205 | ||||||||
Number of days | $ | 10 | ||||||||
2023 Tranche B Preferred Warrants | Series E-4 preferred stock | September 2023 Private Placement | |||||||||
STOCKHOLDERS' EQUITY | |||||||||
Warrants issued to purchase shares | shares | 1,715 | ||||||||
Proceeds from exercise of warrants | $ | $ 34,300,000 | ||||||||
Number of days | $ | 10 |
STOCKHOLDERS' EQUITY - Common S
STOCKHOLDERS' EQUITY - Common Stock Warrants (Details) | 12 Months Ended |
Dec. 31, 2023 $ / shares shares | |
STOCKHOLDERS' EQUITY | |
Number of shares issuable upon exercise of outstanding warrants (in shares) | 28,002,379 |
2023 Tranche A Preferred Warrants | |
STOCKHOLDERS' EQUITY | |
Number of shares issuable upon exercise of outstanding warrants (in shares) | 13,846,154 |
Exercise price of warrants (in dollars per share) | $ / shares | $ 3.185 |
Warrants expiration date | Sep. 08, 2026 |
2023 Tranche B Preferred Warrants | |
STOCKHOLDERS' EQUITY | |
Number of shares issuable upon exercise of outstanding warrants (in shares) | 7,179,487 |
Exercise price of warrants (in dollars per share) | $ / shares | $ 4.7775 |
Warrants expiration date | Sep. 08, 2028 |
2022 Common Warrants | |
STOCKHOLDERS' EQUITY | |
Number of shares issuable upon exercise of outstanding warrants (in shares) | 4,748,221 |
Exercise price of warrants (in dollars per share) | $ / shares | $ 1.96 |
Warrants expiration date | Oct. 25, 2027 |
2022 Pre-Funded Warrants | |
STOCKHOLDERS' EQUITY | |
Number of shares issuable upon exercise of outstanding warrants (in shares) | 1,079,136 |
Exercise price of warrants (in dollars per share) | $ / shares | $ 0.00001 |
June 2020 Series H Warrants | |
STOCKHOLDERS' EQUITY | |
Number of shares issuable upon exercise of outstanding warrants (in shares) | 720,796 |
Exercise price of warrants (in dollars per share) | $ / shares | $ 12.075 |
Warrants expiration date | Jun. 05, 2025 |
May 2019 Series F Warrants | |
STOCKHOLDERS' EQUITY | |
Number of shares issuable upon exercise of outstanding warrants (in shares) | 195,700 |
Exercise price of warrants (in dollars per share) | $ / shares | $ 24 |
Warrants expiration date | May 20, 2024 |
May 2019 Series G Warrants | |
STOCKHOLDERS' EQUITY | |
Number of shares issuable upon exercise of outstanding warrants (in shares) | 201,800 |
Exercise price of warrants (in dollars per share) | $ / shares | $ 24 |
Warrants expiration date | May 20, 2024 |
October 2017 Series D Warrants | |
STOCKHOLDERS' EQUITY | |
Number of shares issuable upon exercise of outstanding warrants (in shares) | 31,085 |
Exercise price of warrants (in dollars per share) | $ / shares | $ 178 |
Warrants expiration date | Oct. 14, 2024 |
STOCK-BASED COMPENSATION (Detai
STOCK-BASED COMPENSATION (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Employee and director stock option and stock grants: | ||
Stock-based compensation | $ 2,410,288 | $ 1,452,964 |
Employee and director stock option grants | ||
Employee and director stock option and stock grants: | ||
Stock-based compensation | 2,410,288 | 1,452,964 |
Employee and director stock option grants | Research and development | ||
Employee and director stock option and stock grants: | ||
Stock-based compensation | 505,155 | 165,461 |
Employee and director stock option grants | General and administrative | ||
Employee and director stock option and stock grants: | ||
Stock-based compensation | $ 1,905,133 | $ 1,287,502 |
STOCK-BASED COMPENSATION - Assu
STOCK-BASED COMPENSATION - Assumptions Used for Stock Options (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
STOCK-BASED COMPENSATION | ||
Expected life (years) | 6 years | 6 years |
Dividend | 0% | 0% |
Maximum | ||
STOCK-BASED COMPENSATION | ||
Volatility | 83.28% | 100% |
Risk-free interest rate | 4.68% | 3.96% |
Minimum | ||
STOCK-BASED COMPENSATION | ||
Volatility | 82.02% | 82.47% |
Risk-free interest rate | 3.59% | 1.65% |
STOCK-BASED COMPENSATION - Stoc
STOCK-BASED COMPENSATION - Stock Option Activity (Details) - Stock options | 12 Months Ended | |
Dec. 31, 2023 USD ($) $ / shares shares | Dec. 31, 2022 $ / shares shares | |
STOCK-BASED COMPENSATION | ||
Outstanding - Number of Shares Issuable Upon Exercise of Outstanding Options | shares | 746,257 | 423,820 |
Granted - Number of Shares Issuable Upon Exercise of Outstanding Options | shares | 1,617,000 | 440,250 |
Expired- Number of Shares Issuable Upon Exercise of Outstanding Options | shares | (8) | (6) |
Forfeited - Number of Shares Issuable Upon Exercise of Outstanding Options | shares | (11,346) | (117,807) |
Outstanding - Number of Shares Issuable Upon Exercise of Outstanding Options | shares | 2,351,903 | 746,257 |
Exercisable - Number of Shares Issuable Upon Exercise of Outstanding Options | shares | 514,171 | |
Unvested - Number of Shares Issuable Upon Exercise of Outstanding Options | shares | 1,837,732 | |
Outstanding - Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 13.48 | $ 22.70 |
Granted - Weighted Average Exercise Price (in dollars per share) | $ / shares | 1.78 | 4.51 |
Expired- Weighted Average Exercise Price (in dollars per share) | $ / shares | 8,325 | 15,000 |
Forfeited - Weighted Average Exercise Price (in dollars per share) | $ / shares | 1.92 | 12.02 |
Outstanding - Weighted Average Exercise Price (in dollars per share) | $ / shares | 5.46 | $ 13.48 |
Exercisable - Weighted Average Exercise Price (in dollars per share) | $ / shares | 15.68 | |
Unvested - Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 2.58 | |
Outstanding - Weighted Average Remaining Contracted Term in Years | 8 years 7 months 20 days | 8 years 6 months 29 days |
Outstanding - Aggregate Intrinsic Value | $ | $ 1,682,667 | |
Exercisable - Aggregate Intrinsic Value (in dollars) | $ | 30,817 | |
Unvested - Aggregate Intrinsic Value (in dollars) | $ | $ 1,652,350 |
STOCK-BASED COMPENSATION - Addi
STOCK-BASED COMPENSATION - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||||
Jun. 23, 2023 | Dec. 31, 2023 | Jan. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Jan. 01, 2023 | Jan. 01, 2022 | |
STOCK-BASED COMPENSATION | |||||||
Stock awards (in shares) | 1,617,000 | 440,250 | |||||
Weighted-average grant-date fair value | $ 1.35 | $ 3.49 | |||||
Total fair value of shares vested | $ 1,647,355 | $ 712,431 | |||||
Weighted-average grant-date fair value of vested options outstanding (in per shares) | $ 11.13 | $ 19.92 | |||||
Weighted-average grant-date fair value of unvested options outstanding (in per shares) | $ 1.81 | 1.81 | 5.25 | $ 5.25 | $ 3.20 | ||
Weighted average grant date fair value of options forfeited | $ 1.41 | $ 7.33 | |||||
Number of options vested | 308,144 | 135,986 | |||||
Number of options unvested | 540,223 | 343,996 | |||||
Total unrecognized compensation cost related to unvested stock-based compensation arrangements | $ 2,205,192 | $ 2,205,192 | |||||
Total amount the Company expects to recognize in 2024 | 1,330,233 | ||||||
Total amount the Company expects to recognize in 2025 | 775,193 | ||||||
Total amount the Company expects to recognize in 2026 | $ 99,766 | ||||||
Stock options | |||||||
STOCK-BASED COMPENSATION | |||||||
Weighted-average exercise price | $ 1.78 | $ 4.51 | |||||
Aggregate shares available for grants | 116,579 | 116,579 | |||||
Contingent non-statutory stock option awards | |||||||
STOCK-BASED COMPENSATION | |||||||
Stock awards (in shares) | 2,776,000 | 609,000 | |||||
Weighted-average exercise price | $ 2.65 | $ 1.68 | |||||
Employee | |||||||
STOCK-BASED COMPENSATION | |||||||
Stock awarded in cash | 434,132 | ||||||
Stock awarded (in shares) | 213,532 | ||||||
Stock awarded, valued | 565,868 | ||||||
2021 Stock Incentive Plan | |||||||
STOCK-BASED COMPENSATION | |||||||
Increase in common stock available for issuance | 1,100,000 | ||||||
Shares issued | 2,368,000 |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Current | ||
State | $ (60,000) | $ (60,000) |
Total current | (60,000) | (60,000) |
Deferred | ||
Federal | (12,233,641) | (7,800,350) |
State | (2,764,638) | (2,633,146) |
Total deferred | (14,998,279) | (10,433,496) |
Change in valuation allowance | 14,998,279 | 10,433,496 |
Total | $ (60,000) | $ (60,000) |
INCOME TAXES - Deferred tax ass
INCOME TAXES - Deferred tax assets (Details) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred tax assets | ||
Federal net operating loss | $ 39,914,591 | $ 35,958,687 |
Federal research and development tax credit carryforwards | 15,868,907 | 11,484,209 |
State net operating losses and tax credit carryforwards | 7,626,490 | 6,186,679 |
Capitalized research and development expenses | 20,203,493 | 15,820,893 |
Stock-based compensation expense | 3,710,609 | 3,186,702 |
Other | 754,180 | 443,693 |
Total deferred tax assets | 88,078,270 | 73,080,863 |
Deferred tax liabilities | ||
Depreciable assets | (156,626) | (157,498) |
Total deferred tax liabilities | (156,626) | (157,498) |
Net deferred tax assets | 87,921,644 | 72,923,365 |
Less- valuation allowance | $ (87,921,644) | $ (72,923,365) |
INCOME TAXES - Reconciliation o
INCOME TAXES - Reconciliation of income taxes (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
INCOME TAXES | ||
Income tax benefit using U.S. federal statutory rate | 21% | 21% |
State income taxes | 7.81% | 9.35% |
Permanent nondeductible items | 0.20% | (0.01%) |
Federal tax credits | 11.50% | 6.57% |
Change in valuation allowance | (40.01%) | (36.40%) |
Other | (0.32%) | (0.31%) |
Total | 0.18% | 0.20% |
INCOME TAXES - Additional Infor
INCOME TAXES - Additional Information (Details) | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
INCOME TAXES | |
Net operating loss carryforwards | $ 502,000 |
Net operating loss carryforwards expiration period | 80,001,000 |
Research and development credit carryforwards | $ 13,000 |
Research and development credit carryforwards expiration period | 2023 |
Federal | |
INCOME TAXES | |
Net operating loss carryforwards | $ 110,069,000 |
Net operating loss carryforwards expiration period | 2023 through 2037 |
Research and development credit carryforwards | $ 15,869,000 |
Research and development credit carryforwards expiration period | 2024 through 2042 |
State | |
INCOME TAXES | |
Net operating loss carryforwards | $ 97,080,000 |
Net operating loss carryforwards expiration period | 2029 through 2043 |
State credit carryforwards | $ 1,045,000 |
State credit carryforwards expiration period | 2025 through 2038 |
NET LOSS PER SHARE (Details)
NET LOSS PER SHARE (Details) - shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
NET LOSS PER SHARE | ||
Total potentially dilutive shares | 33,979,239 | 7,571,847 |
Warrants | ||
NET LOSS PER SHARE | ||
Total potentially dilutive shares | 28,002,379 | 6,714,479 |
Stock options | ||
NET LOSS PER SHARE | ||
Total potentially dilutive shares | 2,351,903 | 746,257 |
Convertible preferred shares | ||
NET LOSS PER SHARE | ||
Total potentially dilutive shares | 3,624,957 | 111,111 |
LEASES - Additional Information
LEASES - Additional Information (Details) | 12 Months Ended | |
Dec. 31, 2023 USD ($) ft² | Jun. 30, 2018 | |
Leases | ||
Area of land | ft² | 3,983 | |
Lessee, operating lease, term of contract | 60 months | |
Payments for rent | $ 11,800 | |
Increase In percentage of rent | 2% | |
Reasonable to use as the incremental borrowing rate (in percentage) | 14% | 10% |
Maximum | ||
Leases | ||
Security deposit paid | $ 75,000 | |
Operating leases rent expense net | 918,000 | |
Minimum | ||
Leases | ||
Security deposit paid | 23,566 | |
Operating leases rent expense net | $ 893,000 | |
Florham Park New Jersey | ||
Leases | ||
Lease option to extend the term | 60 months |
LEASES - Short-term leases and
LEASES - Short-term leases and operating lease liabilities (Details) | Dec. 31, 2023 USD ($) |
LEASES | |
2024 | $ 132,000 |
2025 | 146,000 |
2026 | 150,000 |
2027 | 153,000 |
2028 | 155,000 |
Thereafter | 53,000 |
Total undiscounted lease payments | 789,000 |
Less: Imputed interest | (236,000) |
Present value of lease liabilities | $ 553,000 |
SUBSEQUENT EVENT (Details)
SUBSEQUENT EVENT (Details) | 1 Months Ended | ||||
Sep. 08, 2023 USD ($) shares | Feb. 29, 2024 USD ($) shares | Jan. 31, 2024 USD ($) D $ / shares shares | Dec. 31, 2023 $ / shares shares | Dec. 31, 2022 $ / shares | |
Subsequent Event [Line Items] | |||||
Warrants issued to purchase shares | shares | 28,002,379 | ||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.00001 | $ 0.00001 | |||
September 2023 Private Placement | |||||
Subsequent Event [Line Items] | |||||
Gross proceeds | $ 24,500,000 | ||||
Net proceeds | $ 22,200,000 | ||||
Series E-3 preferred stock | September 2023 Private Placement | 2023 Tranche A Preferred Warrants | |||||
Subsequent Event [Line Items] | |||||
Number of days | 10 | ||||
Warrants issued to purchase shares | shares | 2,205 | ||||
Subsequent event | |||||
Subsequent Event [Line Items] | |||||
Warrants issued to purchase shares | shares | 547,177 | 547,177 | |||
Net proceeds | $ 1,100,000 | $ 1,100,000 | |||
Subsequent event | Series E-3 preferred stock | September 2023 Private Placement | |||||
Subsequent Event [Line Items] | |||||
Common stock, par value (in dollars per share) | $ / shares | $ 3.185 | ||||
Gross proceeds | $ 44,100,000 | ||||
Net proceeds | $ 42,800,000 | ||||
Subsequent event | Series E-3 preferred stock | September 2023 Private Placement | 2023 Tranche A Preferred Warrants | |||||
Subsequent Event [Line Items] | |||||
Number of days | D | 10 | ||||
Warrants issued to purchase shares | shares | 2,205 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (37,983,496) | $ (28,601,254) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |