Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 10, 2023 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2023 | |
Entity File Number | 1-36598 | |
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 $0.00001 | |
Trading Symbol | CLRB | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 12,288,325 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0001279704 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 18,986,443 | $ 19,866,358 |
Prepaid expenses and other current assets | 1,123,467 | 663,243 |
Total current assets | 20,109,910 | 20,529,601 |
Fixed assets, net | 893,509 | 418,641 |
Right-of-use asset, net | 517,566 | 560,334 |
Long-term assets | 23,566 | 75,000 |
Other assets | 6,214 | 6,214 |
TOTAL ASSETS | 21,550,765 | 21,589,790 |
CURRENT LIABILITIES: | ||
Accounts payable and accrued liabilities | 7,814,590 | 5,478,443 |
Warrant liability | 8,600,000 | |
Lease liability | 56,263 | 50,847 |
Total current liabilities | 16,470,853 | 5,529,290 |
Long-term lease liability, net of current portion | 512,750 | 552,981 |
TOTAL LIABILITIES | 16,983,603 | 6,082,271 |
COMMITMENTS AND CONTINGENCIES | ||
MEZZANINE EQUITY: | ||
Preferred stock, $0.00001 par value; 7,000 shares authorized; Series E-1 preferred stock: 1,225 issued and outstanding as of September 30, 2023 and none as of December 31, 2022 (Note 3) | 17,920,000 | |
STOCKHOLDERS' (DEFICIT) EQUITY: | ||
Preferred stock, $0.00001 par value; 7,000 shares authorized; Series D preferred stock: 111 issued and outstanding as of September 30, 2023 and December 31, 2022 | 1,382,023 | 1,382,023 |
Common stock, $0.00001 par value; 160,000,000 shares authorized; 9,918,384 and 9,385,272 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively | 99 | 94 |
Additional paid-in capital | 195,298,922 | 193,624,445 |
Accumulated deficit | (210,033,882) | (179,499,043) |
Total stockholders' (deficit) equity | (13,352,838) | 15,507,519 |
TOTAL LIABILITIES, MEZZANINE EQUITY AND STOCKHOLDERS' (DEFICIT) EQUITY | $ 21,550,765 | $ 21,589,790 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) | ||
Temporary equity, preferred stock par value (in dollars per share) | $ 0.00001 | $ 0.00001 |
Temporary equity, preferred stock, shares authorized | 7,000 | 7,000 |
Temporary equity, preferred stock, shares issued | 1,225 | 0 |
Temporary equity, preferred stock, shares outstanding | 1,225 | 0 |
Preferred stock, par value (in dollars per share) | $ 0.00001 | $ 0.00001 |
Preferred stock, shares authorized | 7,000 | 7,000 |
Preferred stock, share issued | 111 | 111 |
Preferred stock, share outstanding | 111 | 111 |
Common stock, par value (in dollars per share) | $ 0.00001 | $ 0.00001 |
Common stock, shares authorized | 160,000,000 | 160,000,000 |
Common stock, shares issued | 9,918,384 | 9,385,272 |
Common stock, shares outstanding | 9,918,384 | 9,385,272 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
COSTS AND EXPENSES: | ||||
Research and development | $ 7,312,504 | $ 5,380,190 | $ 20,275,004 | $ 13,765,846 |
General and administrative | 2,100,956 | 2,435,296 | 6,137,760 | 7,625,391 |
Total costs and expenses | 9,413,460 | 7,815,486 | 26,412,764 | 21,391,237 |
LOSS FROM OPERATIONS | (9,413,460) | (7,815,486) | (26,412,764) | (21,391,237) |
OTHER (EXPENSE) INCOME: | ||||
Warrant issuance expense | (470,000) | (470,000) | ||
Loss on revaluation of warrants | (3,900,000) | (3,900,000) | ||
Interest income, net | 51,110 | 4,164 | 247,925 | 5,075 |
Total other income | (4,318,890) | 4,164 | (4,122,075) | 5,075 |
NET LOSS | $ (13,732,350) | $ (7,811,322) | $ (30,534,839) | $ (21,386,162) |
BASIC NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE | $ (1.21) | $ (1.28) | $ (2.71) | $ (3.50) |
DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE | $ (1.21) | $ (1.28) | $ (2.71) | $ (3.50) |
SHARES USED IN COMPUTING BASIC NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE | 11,308,738 | 6,110,119 | 11,277,231 | 6,110,123 |
SHARES USED IN COMPUTING DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE | 11,308,738 | 6,110,119 | 11,277,231 | 6,110,123 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' (DEFICIT) EQUITY (Unaudited) - 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 | 6,110,126 | |||
Stock-based compensation | 303,805 | 303,805 | |||
Net loss | $ (1) | (6,139,797) | (6,139,797) | ||
BALANCE ENDING at Mar. 31, 2022 | $ 1,382,023 | $ 61 | 182,864,664 | (157,037,586) | 27,209,162 |
BALANCE ENDING (in shares) at Mar. 31, 2022 | 111 | 6,110,125 | |||
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 | 6,110,126 | |||
Net loss | (21,386,162) | ||||
BALANCE ENDING at Sep. 30, 2022 | $ 1,382,023 | $ 61 | 183,652,376 | (172,283,951) | 12,750,509 |
BALANCE ENDING (in shares) at Sep. 30, 2022 | 111 | 6,110,119 | |||
BALANCE BEGINNING at Mar. 31, 2022 | $ 1,382,023 | $ 61 | 182,864,664 | (157,037,586) | 27,209,162 |
BALANCE BEGINNING (in shares) at Mar. 31, 2022 | 111 | 6,110,125 | |||
Stock-based compensation | 419,953 | 419,953 | |||
Retired Shares (in shares) | (2) | ||||
Net loss | (7,435,043) | (7,435,043) | |||
BALANCE ENDING at Jun. 30, 2022 | $ 1,382,023 | $ 61 | 183,284,617 | (164,472,629) | 20,194,072 |
BALANCE ENDING (in shares) at Jun. 30, 2022 | 111 | 6,110,123 | |||
Stock-based compensation | 367,759 | 367,759 | |||
Retired Shares (in shares) | (4) | ||||
Net loss | (7,811,322) | (7,811,322) | |||
BALANCE ENDING at Sep. 30, 2022 | $ 1,382,023 | $ 61 | 183,652,376 | (172,283,951) | 12,750,509 |
BALANCE ENDING (in shares) at Sep. 30, 2022 | 111 | 6,110,119 | |||
BALANCE BEGINNING at Dec. 31, 2022 | $ 1,382,023 | $ 94 | 193,624,445 | (179,499,043) | 15,507,519 |
BALANCE BEGINNING (in shares) at Dec. 31, 2022 | 111 | 9,385,272 | |||
Stock-based compensation | 408,206 | 408,206 | |||
Conversion of pre-funded warrants into common shares | $ 3 | 3 | |||
Conversion of pre-funded warrants into common shares (in shares) | 355,235 | ||||
Net loss | (8,581,267) | (8,581,267) | |||
BALANCE ENDING at Mar. 31, 2023 | $ 1,382,023 | $ 97 | 194,032,651 | (188,080,310) | 7,334,461 |
BALANCE ENDING (in shares) at Mar. 31, 2023 | 111 | 9,740,507 | |||
BALANCE BEGINNING at Dec. 31, 2022 | $ 1,382,023 | $ 94 | 193,624,445 | (179,499,043) | 15,507,519 |
BALANCE BEGINNING (in shares) at Dec. 31, 2022 | 111 | 9,385,272 | |||
Net loss | (30,534,839) | ||||
BALANCE ENDING at Sep. 30, 2023 | $ 1,382,023 | $ 99 | 195,298,922 | (210,033,882) | (13,352,838) |
BALANCE ENDING (in shares) at Sep. 30, 2023 | 111 | 9,918,384 | |||
BALANCE BEGINNING at Mar. 31, 2023 | $ 1,382,023 | $ 97 | 194,032,651 | (188,080,310) | 7,334,461 |
BALANCE BEGINNING (in shares) at Mar. 31, 2023 | 111 | 9,740,507 | |||
Stock-based compensation | 419,757 | 419,757 | |||
Net loss | (8,221,222) | (8,221,222) | |||
BALANCE ENDING at Jun. 30, 2023 | $ 1,382,023 | $ 97 | 194,452,408 | (196,301,532) | (467,004) |
BALANCE ENDING (in shares) at Jun. 30, 2023 | 111 | 9,740,507 | |||
Stock-based compensation | 497,878 | 497,878 | |||
Exercise of warrants into common shares | $ 2 | 348,636 | 348,638 | ||
Exercise of warrants into common shares (in shares) | 177,877 | ||||
Net loss | (13,732,350) | (13,732,350) | |||
BALANCE ENDING at Sep. 30, 2023 | $ 1,382,023 | $ 99 | $ 195,298,922 | $ (210,033,882) | $ (13,352,838) |
BALANCE ENDING (in shares) at Sep. 30, 2023 | 111 | 9,918,384 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) - USD ($) | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Net loss | $ (13,732,350) | $ (30,534,839) | $ (21,386,162) |
Adjustments to reconcile net loss to cash used in operating activities: | |||
Depreciation and amortization | 122,415 | 110,276 | |
Stock-based compensation expense | 1,325,841 | 1,091,517 | |
Noncash lease expense | 42,768 | 66,547 | |
Loss on disposal of fixed assets | 3,386 | ||
Warrant issuance expense | 470,000 | ||
Loss on revaluation of warrants | 3,900,000 | 3,900,000 | |
Changes in: | |||
Prepaid expenses and other current assets | (408,790) | (108,451) | |
Lease liability | (34,815) | (99,772) | |
Accounts payable and accrued liabilities | 2,336,146 | 2,512,121 | |
Cash used in operating activities | (22,781,274) | (17,810,538) | |
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Purchases of fixed assets | (597,282) | (108,115) | |
Cash used in investing activities | (597,282) | (108,115) | |
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from exercise of warrants | 348,641 | ||
Proceeds from issuance of preferred stock and warrants, net of issuance costs | 22,150,000 | ||
Cash provided by financing activities | 22,498,641 | ||
NET DECREASE IN CASH AND CASH EQUIVALENTS | (879,915) | (17,918,653) | |
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 19,866,358 | 35,703,975 | |
CASH AND CASH EQUIVALENTS AT END OF PERIOD | $ 18,986,443 | $ 18,986,443 | $ 17,785,322 |
NATURE OF BUSINESS AND ORGANIZA
NATURE OF BUSINESS AND ORGANIZATION | 9 Months Ended |
Sep. 30, 2023 | |
NATURE OF BUSINESS AND ORGANIZATION | |
NATURE OF BUSINESS AND ORGANIZATION | 1. NATURE OF BUSINESS AND ORGANIZATION Cellectar Biosciences, Inc. (the Company, our, we) is a late-stage clinical biopharmaceutical company focused on the discovery and development 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 $210,034,000 as of September 30, 2023. During the nine months ended September 30, 2023, the Company generated a net loss of approximately $30,535,000, 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 September 30, 2023, is adequate to fund its basic budgeted operations into the second 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 otherwise. The Company plans to continue to actively pursue financing alternatives, but 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. The condensed consolidated financial statements have been prepared by Cellectar Biosciences, Inc. in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. Management believes the disclosures made in this document are adequate with respect to interim reporting requirements. The accompanying unaudited condensed consolidated financial statements, taken as a whole, contain all adjustments that are of a normal recurring nature necessary to present fairly the operating results, cash flows, and financial position of the Company as of and for the period ended September 30, 2023. The accompanying condensed consolidated balance sheet as of December 31, 2022 has been derived from our audited financial statements. Operating results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results that may be expected for the year ending December 31, 2023. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and related notes thereto included in the Company’s Form 10-K for the fiscal year ended December 31, 2022, which was filed with the SEC on March 9, 2023. Principles of Consolidation Use of Estimates Fixed Assets 3 generated by the applicable asset exceed its net book value as of the assessment date. There were no long-lived fixed asset impairment charges recorded during the nine months ended September 30, 2023. Right-of-Use (ROU) Asset and Lease Liabilities Leases Stock-Based Compensation Research and Development Income Taxes Fair Value of Financial Instruments Financial Instruments Warrants Preferred Stock Concentration of Credit Risk Recently Adopted Accounting Pronouncements During the three months ended September 30, 2023, the Company received approximately $667,000 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 nine months ended September 30, 2023, the Company received approximately $1,314,000 in NCI grants, all of which was reported as a reduction of research and development expenses. 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 | 9 Months Ended |
Sep. 30, 2023 | |
FAIR VALUE | |
FAIR VALUE | 2. FAIR VALUE In accordance with the 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 in the Condensed Consolidated Balance sheets 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 3). 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. Due to the nature of these inputs and the valuation technique utilized, these warrants are classified within the Level 3 hierarchy. The Warrant Liability of $8,600,000 presented on the accompanying Condensed Consolidated Balance Sheet as of September 30, 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 September 30, 2023: September 8 September 30 Volatility 83.0-84.0 % 83.0-84.0 % Risk-free interest rate 4.39-5.53 % 4.61-5.55 % Expected life (years) 0.4-5.0 0.3-5.0 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 September 30, 2023: Level 3 Beginning fair value of warrants $ 4,700,000 Loss from change in fair value 3,900,000 September 30, 2023 fair value of warrants $ 8,600,000 |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 9 Months Ended |
Sep. 30, 2023 | |
STOCKHOLDERS' EQUITY | |
STOCKHOLDERS' EQUITY | 3. 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 $22.1 million after placement agent fees and other customary expenses. The private placement is subject to approval by the Company’s stockholders. Upon approval (Note 9), the Series E-1 preferred stock will convert into either Series E-2 preferred stock and/or common stock. 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 two tranches of warrants are exercisable as follows: ● Tranche A warrants, for an aggregate exercise price of approximately $44.1 million, that are exercisable for Series E-3 preferred stock until the earlier of September 6, 2026, or 10 days following the Company's announcement of positive top-line data from the WM CLOVER-WaM pivotal trial; and, ● Tranche B warrants, for an aggregate exercise price of approximately $34.3 million, that are 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 Series E-1 preferred stock has a redemption feature; therefore, it has been classified as mezzanine equity in the accompanying Condensed Consolidated Balance Sheets as of September 30, 2023. This feature only applies to the Series E-1 preferred stock; upon stockholder approval of the transaction the redemption feature will no longer exist (Note 9). The Series E-1 preferred stock is considered a freestanding instrument, as are the Tranche A and Tranche B warrants, however the warrants are not freestanding from each other and are considered one unit for accounting purposes. The Series E-1 preferred stock also has a liquidation preference, which is 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 stock is outstanding, both the Tranche A and Tranche B warrants are 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. All such liabilities are required to be presented at fair value, with changes being reflected in financial results for the period. As a result, the net proceeds, as reduced by the direct costs of the financing, are allocated first to the warrant liability at fair value, with the residual amount presented in mezzanine equity in the accompanying Condensed Consolidated Balance Sheets, and the change in the value of the warrants from the date of issuance to the end of the fiscal period is reflected in the accompanying Condensed Consolidated Statements of Operations. 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 common 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 common warrants to purchase an aggregate of 1,875,945 shares of common stock. The common 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 has a purchase price of $2.08499, is immediately exercisable at an exercise price of $0.00001 per share and will not expire until exercised. 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 nine months ended September 30, 2023, 355,235 pre-funded warrants were converted into 355,235 shares of common stock. There were no pre-funded warrants exercised during the three months ended September 30, 2023. During the three months and nine months ended September 30, 2023, 177,877 common warrants were exercised for proceeds of $348,638. In accordance with the concept of 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 Nasdaq 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 Equity Distribution Agreement On August 11, 2020, the Company entered into an equity distribution agreement (the Sales Agreement) with Oppenheimer & Co. Inc. (the Sales Agent). Pursuant to the Sales Agreement, the Company may offer and sell from time-to-time through the Sales Agent, up to $14.5 million shares of the Company’s common stock, par value $0.00001 per share (the ATM Shares). The Sales Agent will receive from the Company a commission of 3.0% of the gross proceeds from the sales of the ATM Shares pursuant to the terms of the Sales Agreement. The offering of the ATM Shares pursuant to the Sales Agreement will terminate upon the earliest of (i) the sale of all ATM Shares subject to the Sales Agreement, and (ii) the termination of the Sales Agreement by the Company or the Sales Agent. Net proceeds from the sale of the ATM Shares will be used for general corporate purposes, including working capital. In conjunction with the October 2022 offering, the Company filed a prospectus supplement suspending the ATM program. The Company will not make any sales of its common stock pursuant to the Equity Distribution Agreement unless and until a new registration statement of Form S-3 and a new prospectus supplement are filed with the SEC; however, the Equity Distribution Agreement remains in effect. Common Stock Warrants The following table summarizes information with regard to outstanding warrants to purchase common stock as of September 30, 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 4,973,221 $ 1.96 October 25, 2027 2022 Pre-Funded Warrants 1,520,710 $ 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 28,668,953 (1) These warrants are described further under the caption “September 2023 Private Placement” above. |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 9 Months Ended |
Sep. 30, 2023 | |
STOCK-BASED COMPENSATION | |
STOCK-BASED COMPENSATION | 4. STOCK-BASED COMPENSATION Accounting for Stock-Based Compensation Stock Incentive Plans The Company maintains the 2021 Stock Incentive Plan (the “2021 Plan”). 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 number of shares available for grant under the 2021 Plan. The fair value of each stock 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. As of September 30, 2023, there were an aggregate of 351,254 shares available for future grants under the 2021 Plan. During the nine months ended September 30, 2023 and 2022, options granted were 1,542,000 and 340,250, respectively. The following table summarizes the expense for stock-based compensation related to stock option grants: Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Employee and director stock option grants: Research and development $ 89,172 $ 37,211 $ 227,896 $ 123,638 General and administrative 408,706 330,548 1,097,945 967,879 Total stock-based compensation $ 497,878 $ 367,759 $ 1,325,841 $ 1,091,517 On January 17, 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. |
INCOME TAXES
INCOME TAXES | 9 Months Ended |
Sep. 30, 2023 | |
INCOME TAXES | |
INCOME TAXES | 5. INCOME TAXES The Company accounts for income taxes in accordance with the liability method of accounting. Deferred tax assets or liabilities are computed based on the difference between the financial statement and income tax basis of assets and liabilities, and net operating loss carryforwards (“NOLs”), using the enacted tax rates. Deferred income tax expense or benefit is based on changes in the asset or liability from period to period. The Company did not record a provision or benefit for federal, state or foreign income taxes for the three months or nine months ended September 30, 2023 or 2022 because the Company has experienced losses on a tax basis since inception. Because of the limited operating history, continuing losses and uncertainty associated with the utilization of the NOLs in the future, management has provided a full allowance against the value of its gross deferred tax assets. The Company also accounts for the uncertainty in income taxes related to the recognition and measurement of a tax position taken or expected to be taken in an income tax return. The Company follows the applicable accounting guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition related to the uncertainty in income tax positions. No uncertain tax positions have been identified. |
NET LOSS PER SHARE
NET LOSS PER SHARE | 9 Months Ended |
Sep. 30, 2023 | |
NET LOSS PER SHARE | |
NET LOSS PER SHARE | 6. 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 due to 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 nine months ended September 30, 2023 and September 30, 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 be antidilutive: Nine Months Ended September 30, 2023 2022 Warrants 27,148,243 (1) 1,563,381 Preferred shares as convertible into common stock 111,111 111,111 Stock options 2,280,756 654,263 Total potentially dilutive shares 29,540,110 2,328,755 (1) As of September 30, 2023 the Convertible Preferred Series E-1 Shares were not convertible, pending stockholder approval of the transaction and are therefore excluded from this table. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 9 Months Ended |
Sep. 30, 2023 | |
COMMITMENTS AND CONTINGENCIES | |
COMMITMENTS AND CONTINGENCIES | 7. 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 | 9 Months Ended |
Sep. 30, 2023 | |
LEASES | |
LEASES | 8. 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. On December 30, 2022, the Company entered into an Amended Agreement of Lease of the HQ Lease (Amended HQ Lease), with CAMPUS 100 LLC (the “Landlord”). Under the Amended HQ Lease, which was accounted for as a modification of the initial lease, 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, commencing on March 1, 2023 until April 30, 2029. The Company also has an option to extend the term of the Amended HQ Lease for one additional 60 Under the terms of the Amended HQ Lease, the Company paid a security deposit of $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 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 September 30, 2023: Years ending September 30, 2023 $ 35,000 2024 132,000 2025 147,000 2026 150,000 2027 153,000 Thereafter 207,000 Total undiscounted lease payments 824,000 Less: Imputed interest (255,000) Present value of lease liabilities $ 569,000 |
SUBSEQUENT EVENT
SUBSEQUENT EVENT | 9 Months Ended |
Sep. 30, 2023 | |
SUBSEQUENT EVENT | |
SUBSEQUENT EVENT | 9. SUBSEQUENT EVENT September 2023 Private Placement Approval The Company held a Special Meeting of Stockholders on October 25, 2023, for the purpose of presenting three proposals to the stockholders for approval. The first proposal was to request the stockholders approve the potential issuance in excess of 19.99% of currently outstanding common stock upon the conversion of the Series E preferred stock at less than the “minimum price” under Nasdaq Listing Rule 5635(d), and which may be deemed a “change of control” under Nasdaq Listing Rule 5635(b). The second proposal was to request the stockholders approve an increase in the Company’s authorized common stock from 160,000,000 to 170,000,000. The third proposal was to support the adjournment of the meeting in the event additional votes needed to be solicited. The stockholders approved all three proposals at the meeting. Stockholder approval for the September 2023 Private Placement automatically causes the Series E-1 preferred stock to convert into either Series E-2 preferred stock or common stock. This eliminates the liquidation preference and redemption rights associated with the Series E-1 preferred stock. |
NATURE OF BUSINESS AND ORGANI_2
NATURE OF BUSINESS AND ORGANIZATION (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
NATURE OF BUSINESS AND ORGANIZATION | |
Principles of Consolidation | Principles of Consolidation |
Use of Estimates | Use of Estimates |
Fixed Assets | Fixed Assets 3 generated by the applicable asset exceed its net book value as of the assessment date. There were no long-lived fixed asset impairment charges recorded during the nine months ended September 30, 2023. |
Right-of-Use (ROU) Asset and Lease Liabilities | Right-of-Use (ROU) Asset and Lease Liabilities Leases |
Stock-Based Compensation | Stock-Based Compensation |
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 During the three months ended September 30, 2023, the Company received approximately $667,000 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 nine months ended September 30, 2023, the Company received approximately $1,314,000 in NCI grants, all of which was reported as a reduction of research and development expenses. 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) | 9 Months Ended |
Sep. 30, 2023 | |
FAIR VALUE | |
Schedule of modified option pricing assumptions | The following table summarizes the modified option-pricing assumptions used on September 8, 2023, which was the date of issuance, and September 30, 2023: September 8 September 30 Volatility 83.0-84.0 % 83.0-84.0 % Risk-free interest rate 4.39-5.53 % 4.61-5.55 % Expected life (years) 0.4-5.0 0.3-5.0 Dividend 0 % 0 % |
Schedule of changes in the fair market value of the warrants | 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 September 30, 2023: Level 3 Beginning fair value of warrants $ 4,700,000 Loss from change in fair value 3,900,000 September 30, 2023 fair value of warrants $ 8,600,000 |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
STOCKHOLDERS' EQUITY | |
Summary of outstanding warrants to purchase common stock | The following table summarizes information with regard to outstanding warrants to purchase common stock as of September 30, 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 4,973,221 $ 1.96 October 25, 2027 2022 Pre-Funded Warrants 1,520,710 $ 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 28,668,953 (1) These warrants are described further under the caption “September 2023 Private Placement” above. |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
STOCK-BASED COMPENSATION | |
Summary of the expense for stock-based compensation related to stock option grants | Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Employee and director stock option grants: Research and development $ 89,172 $ 37,211 $ 227,896 $ 123,638 General and administrative 408,706 330,548 1,097,945 967,879 Total stock-based compensation $ 497,878 $ 367,759 $ 1,325,841 $ 1,091,517 |
NET LOSS PER SHARE (Tables)
NET LOSS PER SHARE (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
NET LOSS PER SHARE | |
Schedule of dilutive securities have been excluded from the computation of diluted net loss per share | Nine Months Ended September 30, 2023 2022 Warrants 27,148,243 (1) 1,563,381 Preferred shares as convertible into common stock 111,111 111,111 Stock options 2,280,756 654,263 Total potentially dilutive shares 29,540,110 2,328,755 (1) As of September 30, 2023 the Convertible Preferred Series E-1 Shares were not convertible, pending stockholder approval of the transaction and are therefore excluded from this table. |
LEASES (Tables)
LEASES (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
LEASES | |
Schedule of the company's undiscounted payments for its short-term leases and operating lease liabilities | Years ending September 30, 2023 $ 35,000 2024 132,000 2025 147,000 2026 150,000 2027 153,000 Thereafter 207,000 Total undiscounted lease payments 824,000 Less: Imputed interest (255,000) Present value of lease liabilities $ 569,000 |
NATURE OF BUSINESS AND ORGANI_3
NATURE OF BUSINESS AND ORGANIZATION (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||
Sep. 30, 2022 | Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Accumulated deficit | $ 210,033,882 | $ 210,033,882 | $ 179,499,043 | |||||||
Net loss | 13,732,350 | $ 8,221,222 | $ 8,581,267 | $ 7,811,322 | $ 7,435,043 | $ 6,139,797 | 30,534,839 | $ 21,386,162 | ||
Fixed asset impairment charges | 0 | |||||||||
Uninsured cash balances | 18,486,000 | 18,486,000 | $ 19,400,000 | |||||||
Cancer treatment research award through the National Cancer Institute (NCI) | ||||||||||
Grant amount | 2,000,000 | $ 2,000,000 | ||||||||
Grant period | 3 years | |||||||||
Grant received | $ 1,980,000 | $ 667,000 | $ 1,314,000 | |||||||
Leasehold improvements | ||||||||||
Property and equipment useful lives | 64 months | 64 months | ||||||||
Minimum | ||||||||||
Property and equipment useful lives | 3 years | 3 years | ||||||||
Share-based compensation expiration period | 1 year | |||||||||
Maximum | ||||||||||
Property and equipment useful lives | 10 years | 10 years | ||||||||
Share-based compensation expiration period | 3 years |
FAIR VALUE - Narratives (Detail
FAIR VALUE - Narratives (Details) | Sep. 30, 2023 USD ($) shares | Sep. 08, 2023 |
FAIR VALUE | ||
Warrants issued to purchase shares | shares | 28,668,953 | |
Warrant liability | $ | $ 8,600,000 | |
Dividend | ||
FAIR VALUE | ||
Warrants issued to purchase shares | shares | 21,025,641 | |
Warrants | 0 | 0 |
Warrant liability | $ | $ 8,600,000 |
FAIR VALUE - Option-pricing ass
FAIR VALUE - Option-pricing assumptions (Details) | Sep. 30, 2023 Y | Sep. 08, 2023 Y |
Volatility | Maximum | ||
FAIR VALUE | ||
Warrants | 0.840 | 0.840 |
Volatility | Minimum | ||
FAIR VALUE | ||
Warrants | 0.830 | 0.830 |
Risk-free interest rate | Maximum | ||
FAIR VALUE | ||
Warrants | 0.0555 | 0.0553 |
Risk-free interest rate | Minimum | ||
FAIR VALUE | ||
Warrants | 0.0461 | 0.0439 |
Expected life (years) | Maximum | ||
FAIR VALUE | ||
Warrants | 5 | 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) - Level 3 - Warrants | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Changes in the fair market value of the warrants | |
Beginning fair value of warrants | $ 4,700,000 |
Loss from change in fair value | 3,900,000 |
September 30, 2023 fair value of warrants | $ 8,600,000 |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) | 3 Months Ended | 9 Months Ended | ||||||||
Sep. 08, 2023 USD ($) D tranche $ / shares shares | Oct. 25, 2022 USD ($) $ / shares shares | Oct. 20, 2022 USD ($) | Jun. 27, 2022 | Jun. 24, 2022 | Aug. 11, 2020 USD ($) $ / shares | Sep. 30, 2023 USD ($) $ / shares shares | Mar. 31, 2023 shares | Sep. 30, 2023 USD ($) $ / shares shares | Dec. 31, 2022 $ / shares | |
STOCKHOLDERS' EQUITY | ||||||||||
Warrants issued to purchase shares | 28,668,953 | 28,668,953 | ||||||||
Number of warrants exercised | 177,877 | 177,877 | ||||||||
Common stock par value | $ / shares | $ 0.00001 | $ 0.00001 | $ 0.00001 | |||||||
Proceeds from exercise of warrants | $ | $ 348,638 | $ 348,638 | ||||||||
Reverse stock split ratio | 0.10 | |||||||||
Sales Agent | Equity Distribution Agreement | ||||||||||
STOCKHOLDERS' EQUITY | ||||||||||
Aggregate value of shares issued | $ | $ 14,500,000 | |||||||||
Common stock par value | $ / shares | $ 0.00001 | |||||||||
Commission paid on sale of shares (in percentage) | 3% | |||||||||
Common Stock | ||||||||||
STOCKHOLDERS' EQUITY | ||||||||||
Conversion of pre-funded warrants into common shares (in shares) | 355,235 | |||||||||
Minimum | ||||||||||
STOCKHOLDERS' EQUITY | ||||||||||
Reverse stock split ratio | 0.10 | |||||||||
Maximum | ||||||||||
STOCKHOLDERS' EQUITY | ||||||||||
Reverse stock split ratio | 0.20 | |||||||||
October 2022 Public Offering and Private Placement | ||||||||||
STOCKHOLDERS' EQUITY | ||||||||||
Warrants issued to purchase shares | 3,275,153 | |||||||||
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 | |||||||||
Gross proceeds | $ | $ 10,700,000 | |||||||||
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 | 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 | ||||||||||
Conversion of pre-funded warrants into common shares (in shares) | 355,235 | |||||||||
Gross proceeds from stockholders' equity | $ | 4,000,000 | |||||||||
Common warrants | October 2022 Public Offering and Private Placement | ||||||||||
STOCKHOLDERS' EQUITY | ||||||||||
Gross proceeds from stockholders' equity | $ | 4,400,000 | |||||||||
Prefunded Warrant | October 2022 Public Offering and Private Placement | ||||||||||
STOCKHOLDERS' EQUITY | ||||||||||
Warrants issued to purchase shares | 1,875,945 | |||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 2.08499 | |||||||||
pre-funded warrants | 355,235 | |||||||||
Number of warrants exercised | 0 | |||||||||
Gross proceeds from stockholders' equity | $ | $ 2,300,000 | |||||||||
September 2023 Private Placement | ||||||||||
STOCKHOLDERS' EQUITY | ||||||||||
Gross proceeds | $ | $ 24,500,000 | |||||||||
Net proceeds | $ | $ 22,100,000 | |||||||||
Number of tranches | tranche | 2 | |||||||||
September 2023 Private Placement | Series E Warrants | ||||||||||
STOCKHOLDERS' EQUITY | ||||||||||
Share price | $ / shares | $ 20,000 | |||||||||
September 2023 Private Placement | Series E-1 preferred stock | ||||||||||
STOCKHOLDERS' EQUITY | ||||||||||
Shares issued | 1,225 | |||||||||
Conversion price per share | $ / shares | $ 1.82 | |||||||||
Convertible preferred shares issued | 13,461,538 | |||||||||
September 2023 Private Placement | Series E-3 preferred stock | ||||||||||
STOCKHOLDERS' EQUITY | ||||||||||
Conversion price per share | $ / shares | $ 3.185 | |||||||||
Convertible preferred shares issued | 13,846,154 | |||||||||
September 2023 Private Placement | Series E-4 preferred stock | ||||||||||
STOCKHOLDERS' EQUITY | ||||||||||
Conversion price per share | $ / shares | $ 4.7775 | |||||||||
Convertible preferred shares issued | 7,179,487 | |||||||||
September 2023 Private Placement | 2023 Tranche A Preferred Warrants | ||||||||||
STOCKHOLDERS' EQUITY | ||||||||||
Proceeds from exercise of warrants | $ | $ 44,100,000 | |||||||||
September 2023 Private Placement | 2023 Tranche A Preferred Warrants | Series E-3 preferred stock | ||||||||||
STOCKHOLDERS' EQUITY | ||||||||||
Warrants issued to purchase shares | 2,205 | |||||||||
Number of days | D | 10 | |||||||||
September 2023 Private Placement | 2023 Tranche B Preferred Warrants | Series E-4 preferred stock | ||||||||||
STOCKHOLDERS' EQUITY | ||||||||||
Warrants issued to purchase shares | 1,715 | |||||||||
Number of days | D | 10 | |||||||||
Proceeds from exercise of warrants | $ | $ 34,300,000 |
STOCKHOLDERS' EQUITY - Common S
STOCKHOLDERS' EQUITY - Common Stock Warrants (Details) | 9 Months Ended |
Sep. 30, 2023 $ / shares shares | |
STOCKHOLDERS' EQUITY | |
Number of shares issuable upon exercise of outstanding warrants (in shares) | 28,668,953 |
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) | 4,973,221 |
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) | 1,520,710 |
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 ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
STOCK-BASED COMPENSATION | ||||
Total stock-based compensation | $ 1,325,841 | $ 1,091,517 | ||
Employee and director stock option grants | ||||
STOCK-BASED COMPENSATION | ||||
Total stock-based compensation | $ 497,878 | $ 367,759 | 1,325,841 | 1,091,517 |
Employee and director stock option grants | Research and development | ||||
STOCK-BASED COMPENSATION | ||||
Total stock-based compensation | 89,172 | 37,211 | 227,896 | 123,638 |
Employee and director stock option grants | General and administrative | ||||
STOCK-BASED COMPENSATION | ||||
Total stock-based compensation | $ 408,706 | $ 330,548 | $ 1,097,945 | $ 967,879 |
STOCK-BASED COMPENSATION - Addi
STOCK-BASED COMPENSATION - Additional Information (Details) - $ / shares | 9 Months Ended | ||
Jan. 17, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | |
STOCK-BASED COMPENSATION | |||
Options granted (in shares) | 1,542,000 | 340,250 | |
Contingent non-statutory stock option awards | |||
STOCK-BASED COMPENSATION | |||
Options granted (in shares) | 609,000 | ||
Weighted-average exercise price | $ 1.68 | ||
2021 Stock Incentive Plan | |||
STOCK-BASED COMPENSATION | |||
Aggregate shares available for future grants | 351,254 |
NET LOSS PER SHARE (Details)
NET LOSS PER SHARE (Details) - shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
NET LOSS PER SHARE | ||
Total potentially dilutive shares | 29,540,110 | 2,328,755 |
Warrants | ||
NET LOSS PER SHARE | ||
Total potentially dilutive shares | 27,148,243 | 1,563,381 |
Preferred shares as convertible into common stock | ||
NET LOSS PER SHARE | ||
Total potentially dilutive shares | 111,111 | 111,111 |
Stock Option | ||
NET LOSS PER SHARE | ||
Total potentially dilutive shares | 2,280,756 | 654,263 |
LEASES - Short-term leases and
LEASES - Short-term leases and operating lease liabilities (Details) | Sep. 30, 2023 USD ($) |
LEASES | |
2023 | $ 35,000 |
2024 | 132,000 |
2025 | 147,000 |
2026 | 150,000 |
2027 | 153,000 |
Thereafter | 207,000 |
Total undiscounted lease payments | 824,000 |
Less: Imputed interest | (255,000) |
Present value of lease liabilities | $ 569,000 |
LEASES - Additional Information
LEASES - Additional Information (Details) | 9 Months Ended | |
Sep. 30, 2023 USD ($) ft² | Jun. 30, 2018 | |
Leases | ||
Area of land | ft² | 3,983 | |
Security deposit paid | $ 23,566 | |
Reasonable to use as the incremental borrowing rate (in percentage) | 14% | 10% |
Lessee, operating lease, term of contract | 60 months | |
Payments for rent | $ 11,800 | |
Increase In percentage of rent | 2% | |
Maximum | ||
Leases | ||
Operating leases rent expense net | $ 918,000 | |
Minimum | ||
Leases | ||
Operating leases rent expense net | $ 893,000 |
SUBSEQUENT EVENT (Details)
SUBSEQUENT EVENT (Details) | Oct. 25, 2023 USD ($) shares | Sep. 30, 2023 shares | Dec. 31, 2022 shares |
SUBSEQUENT EVENT | |||
Common stock, shares authorized | 160,000,000 | 160,000,000 | |
SUBSEQUENT EVENTS | September 2023 Private Placement Approval | |||
SUBSEQUENT EVENT | |||
Number of proposals | $ | 3 | ||
Outstanding common stock upon conversion of preferred stock (as a percent) | 19.99% | ||
Common stock, shares authorized | 170,000,000 | ||
Number of proposals approved | $ | 3 | ||
SUBSEQUENT EVENTS | September 2023 Private Placement Approval | Minimum | |||
SUBSEQUENT EVENT | |||
Common stock, shares authorized | 160,000,000 |