Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2024 | May 08, 2024 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2024 | |
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 $0.00001 | |
Trading Symbol | CLRB | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 35,848,924 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q1 | |
Entity Central Index Key | 0001279704 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 40,031,181 | $ 9,564,988 |
Prepaid expenses and other current assets | 1,337,184 | 888,225 |
Total current assets | 41,368,365 | 10,453,213 |
Fixed assets, net | 1,023,447 | 1,090,304 |
Right-of-use asset, net | 486,847 | 502,283 |
Long-term assets | 23,566 | 23,566 |
Other assets | 6,214 | 6,214 |
TOTAL ASSETS | 42,908,439 | 12,075,580 |
CURRENT LIABILITIES: | ||
Accounts payable and accrued liabilities | 7,393,950 | 9,178,645 |
Warrant liability | 8,800,000 | 3,700,000 |
Lease liability | 73,994 | 58,979 |
Total current liabilities | 16,267,944 | 12,937,624 |
Long-term lease liability, net of current portion | 474,349 | 494,003 |
TOTAL LIABILITIES | 16,742,293 | 13,431,627 |
COMMITMENTS AND CONTINGENCIES (Note 7) | ||
STOCKHOLDERS' EQUITY (DEFICIT): | ||
Common stock, $0.00001 par value; 170,000,000 shares authorized; 33,164,466 and 20,744,110 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively | 332 | 207 |
Additional paid-in capital | 248,151,681 | 210,066,630 |
Accumulated deficit | (239,064,176) | (217,482,539) |
Total stockholders' equity (deficit) | 26,166,146 | (1,356,047) |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | 42,908,439 | 12,075,580 |
Series D preferred stock | ||
STOCKHOLDERS' EQUITY (DEFICIT): | ||
Preferred stock | 1,382,023 | 1,382,023 |
Series E-2 Preferred Stock | ||
STOCKHOLDERS' EQUITY (DEFICIT): | ||
Preferred stock | 3,474,286 | $ 4,677,632 |
Series E-3 preferred stock | ||
STOCKHOLDERS' EQUITY (DEFICIT): | ||
Preferred stock | $ 12,222,000 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
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 | 33,164,466 | 20,744,110 |
Common stock, shares outstanding | 33,164,466 | 20,744,110 |
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 | 237.50 | 319.76 |
Preferred stock, share outstanding | 237.50 | 319.76 |
Series E-3 preferred stock | ||
Preferred stock, shares authorized | 2,205 | 2,205 |
Preferred stock, share issued | 630 | 0 |
Preferred stock, share outstanding | 630 | 0 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
COSTS AND EXPENSES: | ||
Research and development | $ 7,377,940 | $ 6,654,094 |
General and administrative | 4,623,546 | 2,051,207 |
Total costs and expenses | 12,001,486 | 8,705,301 |
LOSS FROM OPERATIONS | (12,001,486) | (8,705,301) |
OTHER (LOSS) INCOME: | ||
Loss on valuation of warrants | (9,900,000) | |
Interest income, net | 319,849 | 124,034 |
Total other (loss) income, net | (9,580,151) | 124,034 |
NET LOSS | $ (21,581,637) | $ (8,581,267) |
BASIC NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE | $ (0.74) | $ (0.76) |
DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE | $ (0.74) | $ (0.76) |
SHARES USED IN COMPUTING BASIC NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE | 29,346,679 | 11,261,217 |
SHARES USED IN COMPUTING DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE | 29,346,679 | 11,261,217 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) | Pre-funded warrants Common Stock | Pre-funded warrants Additional Paid-In Capital | Pre-funded warrants | Tranche A Warrants Preferred Stock | Tranche A Warrants | Preferred Stock Series E-2 Preferred Stock | Preferred Stock Series E-3 preferred stock | Preferred Stock | Common Stock Series E-2 Preferred Stock | Common Stock Series E-3 preferred stock | Common Stock | Additional Paid-In Capital Series E-2 Preferred Stock | Additional Paid-In Capital Series E-3 preferred stock | Additional Paid-In Capital | Accumulated Deficit | Total |
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 | 111.11 | 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 | 111.11 | 9,740,507 | ||||||||||||||
BALANCE BEGINNING at Dec. 31, 2023 | $ 6,059,655 | $ 207 | 210,066,630 | (217,482,539) | (1,356,047) | |||||||||||
BALANCE BEGINNING (in shares) at Dec. 31, 2023 | 430.87 | 20,744,110 | ||||||||||||||
Stock-based compensation | 454,363 | 454,363 | ||||||||||||||
Exercise of warrants into common shares | $ 11 | $ (11) | $ 42,777,000 | $ 42,777,000 | $ 5 | 1,072,462 | 1,072,467 | |||||||||
Exercise of warrants into common shares (in shares) | 1,079,132 | 2,205 | 547,177 | |||||||||||||
Conversion of pre-funded warrants into common shares | $ (1,203,346) | $ (30,555,000) | $ 9 | $ 100 | $ 1,203,337 | $ 30,554,900 | 31,758,346 | |||||||||
Conversion of pre-funded warrants into common shares (in shares) | (82.26) | (1,575) | 903,956 | 9,890,099 | ||||||||||||
Settlement of warrants to equity (Note 2) | 4,800,000 | 4,800,000 | ||||||||||||||
Retired shares (in shares) | (8) | |||||||||||||||
Net loss | (21,581,637) | (21,581,637) | ||||||||||||||
BALANCE ENDING at Mar. 31, 2024 | $ 17,078,309 | $ 332 | $ 248,151,681 | $ (239,064,176) | $ 26,166,146 | |||||||||||
BALANCE ENDING (in shares) at Mar. 31, 2024 | 978.61 | 33,164,466 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net Income (Loss) | $ (21,581,637) | $ (8,581,267) |
Adjustments to reconcile net loss to cash used in operating activities: | ||
Depreciation and amortization | 88,490 | 42,557 |
Stock-based compensation expense | 454,363 | 408,206 |
Loss on revaluation of warrants | 9,900,000 | |
Noncash lease expense | 15,436 | 13,829 |
Changes in: | ||
Prepaid expenses and other current assets | (448,959) | (488,719) |
Lease liability | (4,639) | (4,378) |
Accounts payable and accrued liabilities | (1,784,695) | 1,426,102 |
Cash used in operating activities | (13,361,641) | (7,183,670) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of fixed assets | (21,633) | |
Cash used in investing activities | (21,633) | |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from exercise of warrants, net of issuance costs (Note 2) | 43,849,467 | 3 |
Cash provided by financing activities | 43,849,467 | 3 |
NET DECREASE IN CASH AND CASH EQUIVALENTS | 30,466,193 | (7,183,667) |
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 9,564,988 | 19,866,358 |
CASH AND CASH EQUIVALENTS AT END OF PERIOD | 40,031,181 | $ 12,682,691 |
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION | ||
Settlement of warrants to equity | 4,800,000 | |
Conversion of pre-funded warrants into common shares | $ 31,758,346 |
NATURE OF BUSINESS AND ORGANIZA
NATURE OF BUSINESS AND ORGANIZATION | 3 Months Ended |
Mar. 31, 2024 | |
NATURE OF BUSINESS AND ORGANIZATION | |
NATURE OF BUSINESS AND ORGANIZATION | 1. NATURE OF BUSINESS AND ORGANIZATION Cellectar Biosciences, Inc. (the Company) is a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, leveraging the Company’s 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 its efforts toward research and development and has an accumulated deficit of approximately $239,064,000 as of March 31, 2024. During the three months ended March 31, 2024, the Company generated a net loss of approximately $21,582,000 and the Company expects that it will continue to generate operating losses for the foreseeable future. The Company believes its cash balance as of March 31, 2024, 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 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. The accompanying Condensed Consolidated Balance Sheet as of December 31, 2023 has been derived from the Company’s audited financial statements. The accompanying Condensed Consolidated Balance Sheet as of March 31, 2024, and the Condensed Consolidated Statements of Operations, Cash Flows, and the Consolidated Statements of Stockholders’ Equity for the three months ended March 31, 2024 and 2023, and the related interim information contained within the Notes to the Condensed Consolidated Financial Statements, have been prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) for interim financial information and with the instructions, rules and regulations of the Securities and Exchange Commission (SEC) for interim financial information. Accordingly, they do not include all the information and the notes required by U.S. GAAP for complete financial statements. In the opinion of management, the unaudited interim condensed consolidated financial statements reflect all adjustments which are of a nature necessary for the fair presentation of the Company’s consolidated financial position as of March 31, 2024 and consolidated results of its operations, cash flows, and stockholders’ equity for the three months ended March 31, 2024 and 2023. The results for the three months ended March 31, 2024, are not necessarily indicative of future results. 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, 2023, which was filed with the SEC on March 27, 2024. Principles of Consolidation Use of Estimates Fixed Assets Right-of-Use (ROU) Asset and Lease Liabilities Stock-Based Compensation Research and Development Income Taxes Fair Value of Financial Instruments Warrants Preferred Stock Concentration of Credit Risk Government Assistance During the three months ended March 31, 2024, the Company received approximately $324,000 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, 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. Recently Adopted Accounting Pronouncements The Company evaluates all ASUs issued by the FASB for consideration of their applicability to the financial statements. The Company has 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. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 3 Months Ended |
Mar. 31, 2024 | |
STOCKHOLDERS' EQUITY | |
STOCKHOLDERS' EQUITY | 2. 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. As of December 31, 2023, the Tranche A and Tranche B warrants did not qualify as derivatives; however, they did 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 were deemed to be liabilities. As of March 31, 2024, after the settlement of the Tranche A warrants, the Tranche B warrants do not qualify as derivatives and meet the requirements necessary to be considered indexable in the Company’s stock. However, due to a cash settlement feature that requires cash settlement in event of a fundamental transaction that is outside the Company’s control, resulting in a form of settlement inconsistent with that which would be received by other security holders, the warrants do not qualify under the equity classification guidance. As a result, and in accordance with the guidance in ASC 815, the Tranche B 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. See Note 3 for the related valuation. 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 ASC 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. The outstanding shares of Series E-2 preferred stock were classified as permanent equity upon issuance. 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, resulting in 319.76 shares of Series E-2 preferred stock outstanding as of December 31, 2023. During the quarter ended March 31, 2024, 82.26 shares of Series E-2 preferred stock were converted into 903,956 shares of common stock. There remain 237.50 shares of Series E-2 preferred stock outstanding as of March 31, 2024. In January 2024, the Company released topline data from its pivotal, Phase 2b CLOVER WaM trial. In accordance with the terms of the Tranche A warrant, the warants’ expiration accelerated to 10 During the quarter ended March 31, 2024, investors who held 1,575.00 shares of Series E-3 preferred stock converted them into 9,890,099 shares of common stock. There remain 630.00 shares of Series E-3 preferred stock outstanding as of March 31, 2024. 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 three months ended March 31, 2024, and 2023, 1,079,132 and 0 pre-funded warrants were converted into 1,079,132 shares of common stock, respectively. 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 Cellectar 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. During the quarter ended March 31, 2024 and 2023, 547,177 and 0 warrants issued in October 2022 were exercised, respectively. Net proceeds in the quarter ended March 31, 2024 were approximately $1.1 million. Common Stock Warrants The following table summarizes information regarding outstanding warrants to purchase common stock as of March 31, 2024: Number of Shares Issuable Upon Exercise of Outstanding Exercise Offering Warrants Price Expiration Date 2023 Tranche B Warrants 7,179,492 $ 4.7775 September 8, 2028 (1) 2022 Common Warrants 4,201,044 $ 1.96 October 25, 2027 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 12,529,916 (1) These warrants are described under the caption “September 2023 Private Placement” above. |
FAIR VALUE
FAIR VALUE | 3 Months Ended |
Mar. 31, 2024 | |
FAIR VALUE | |
FAIR VALUE | 3. FAIR VALUE In accordance with the Fair Value Measurements and Disclosures Topic of 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. As part of the September 2023 financing (see Note 2) the Company issued Tranche A and Tranche B warrants to purchase shares of preferred stock which, on an as-converted basis, represented an aggregate of 21,025,641 shares of common stock. The fair value of the Tranche A and B 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 Tranche A and B 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. The Tranche A and B warrants are classified within the Level 3 hierarchy because of the nature of these inputs and the valuation technique utilized. The warrant liability of $8,800,000 and $3,700,000 presented on the accompanying condensed consolidated balance sheets as of March 31, 2024 and December 31, 2023, respectively, consisted entirely of the estimated value of the 2023 Warrants. The following table summarizes the modified option-pricing assumptions used on December 31, 2023, and March 31, 2024: December 31 March 31 Volatility 82.0-83.0 % 84.0-85.0 % Risk-free interest rate 3.80-5.40 % 4.26 % Expected life (years) 0.3-4.7 1.0-4.4 Dividend 0 % 0 % At the time the Tranche A warrants were exercised, their fair value, calculated as the difference between the common stock conversion rate in the Series E-3 preferred stock and the trading price of the stock when the warrants were exercised, was determined to be $4,800,000, and was recorded as an expense and liability. Due to the settlement of the Tranche A warrants relieving the Company of any further related obligation, the liability was reclassified to equity in accordance with ASC 815. The Tranche B warrants continue to be classified in the Level 3 hierarchy due to a cash settlement feature in the agreement. The following table summarizes the changes in the fair value of the Tranche A and B warrants, which are classified within the Level 3 fair value hierarchy, from December 31, 2023, through March 31, 2024: Level 3 December 31, 2023, warrant fair value $ 3,700,000 Loss from change in Tranche A warrant fair value 4,800,000 Settlement of Tranche A warrants to equity (4,800,000) Loss from change in Tranche B warrant fair value 5,100,000 March 31, 2024, warrant fair value $ 8,800,000 |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 3 Months Ended |
Mar. 31, 2024 | |
STOCK-BASED COMPENSATION | |
STOCK-BASED COMPENSATION | 4. 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 the 2021 Stock Incentive Plan by 1,100,000 to 2,368,000. The following table summarizes amounts charged to expense for stock-based compensation related to employee and director stock option grants: Three Months Ended March 31, 2024 2023 Employee and director stock option grants: Research and development $ 68,776 $ 66,195 General and administrative 385,587 342,011 Total stock-based compensation $ 454,363 $ 408,206 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 employees and directors, and in March 2024 the Company granted 200,000 contingent, non-statutory stock option awards at an exercise price of $3.63 and $3.35 per share to our employees. 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. Assumptions Used in Determining Fair Value Valuation and amortization method Volatility. Risk-free interest rate. Expected term. Forfeitures. Dividends. Exercise prices for all grants made during the three months ended March 31, 2024 and March 31, 2023, were equal to the market value of the Company’s common stock on the date of grant. |
INCOME TAXES
INCOME TAXES | 3 Months Ended |
Mar. 31, 2024 | |
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 ended March 31, 2024 or 2023 because the Company has experienced losses on a tax basis since inception. Because of the 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 | 3 Months Ended |
Mar. 31, 2024 | |
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 three months ended March 31, 2024 and March 31, 2023, 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: Three Months Ended March 31, 2024 2023 Warrants 12,529,916 6,714,479 Preferred shares as convertible into common stock 6,677,045 111,111 Stock options 2,348,624 1,478,756 Total potentially dilutive shares 21,555,585 8,304,346 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 3 Months Ended |
Mar. 31, 2024 | |
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. It is not anticipated that the outcome of such matters and disputes will materially affect the Company’s financial statements. |
LEASES
LEASES | 3 Months Ended |
Mar. 31, 2024 | |
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, with CAMPUS 100 LLC (the “Landlord”). Under the Amended 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 Lease for one additional 60-month period. Under the terms of the Amended Lease, the Company’s previously paid security deposit of $75,000 will be 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 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 March 31, 2024: Years ending March 31, 2024 $ 108,000 2025 146,000 2026 150,000 2027 153,000 2028 155,000 Thereafter 53,000 Total undiscounted lease payments 765,000 Less: Imputed interest (217,000) Present value of lease liabilities $ 548,000 |
NATURE OF BUSINESS AND ORGANI_2
NATURE OF BUSINESS AND ORGANIZATION (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
NATURE OF BUSINESS AND ORGANIZATION | |
Principles of Consolidation | Principles of Consolidation |
Use of Estimates | Use of Estimates |
Fixed Assets | Fixed Assets |
Right-of-Use Asset and Lease Liability | Right-of-Use (ROU) Asset and Lease Liabilities |
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 |
Warrants | Warrants |
Preferred Stock | Preferred Stock |
Concentration of Credit Risk | Concentration of Credit Risk |
Government Assistance | Government Assistance During the three months ended March 31, 2024, the Company received approximately $324,000 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, 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. |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements The Company evaluates all ASUs issued by the FASB for consideration of their applicability to the financial statements. The Company has 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. |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
STOCKHOLDERS' EQUITY | |
Summary of outstanding warrants to purchase common stock | The following table summarizes information regarding outstanding warrants to purchase common stock as of March 31, 2024: Number of Shares Issuable Upon Exercise of Outstanding Exercise Offering Warrants Price Expiration Date 2023 Tranche B Warrants 7,179,492 $ 4.7775 September 8, 2028 (1) 2022 Common Warrants 4,201,044 $ 1.96 October 25, 2027 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 12,529,916 (1) These warrants are described under the caption “September 2023 Private Placement” above. |
FAIR VALUE (Tables)
FAIR VALUE (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
FAIR VALUE | |
Schedule of modified option pricing assumptions | December 31 March 31 Volatility 82.0-83.0 % 84.0-85.0 % Risk-free interest rate 3.80-5.40 % 4.26 % Expected life (years) 0.3-4.7 1.0-4.4 Dividend 0 % 0 % |
Schedule of changes in the fair market value of the warrants | Level 3 December 31, 2023, warrant fair value $ 3,700,000 Loss from change in Tranche A warrant fair value 4,800,000 Settlement of Tranche A warrants to equity (4,800,000) Loss from change in Tranche B warrant fair value 5,100,000 March 31, 2024, warrant fair value $ 8,800,000 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
STOCK-BASED COMPENSATION | |
Summary of the expense for stock-based compensation related to stock option grants | Three Months Ended March 31, 2024 2023 Employee and director stock option grants: Research and development $ 68,776 $ 66,195 General and administrative 385,587 342,011 Total stock-based compensation $ 454,363 $ 408,206 |
NET LOSS PER SHARE (Tables)
NET LOSS PER SHARE (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
NET LOSS PER SHARE | |
Schedule of dilutive securities have been excluded from the computation of diluted net loss per share | Three Months Ended March 31, 2024 2023 Warrants 12,529,916 6,714,479 Preferred shares as convertible into common stock 6,677,045 111,111 Stock options 2,348,624 1,478,756 Total potentially dilutive shares 21,555,585 8,304,346 |
LEASES (Tables)
LEASES (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
LEASES | |
Schedule of the company's undiscounted payments for its short-term leases and operating lease liabilities | Years ending March 31, 2024 $ 108,000 2025 146,000 2026 150,000 2027 153,000 2028 155,000 Thereafter 53,000 Total undiscounted lease payments 765,000 Less: Imputed interest (217,000) Present value of lease liabilities $ 548,000 |
NATURE OF BUSINESS AND ORGANI_3
NATURE OF BUSINESS AND ORGANIZATION (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |
Sep. 30, 2022 | Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Accumulated deficit | $ 239,064,176 | $ 217,482,539 | ||
Net Income (Loss) | (21,581,637) | $ (8,581,267) | ||
Long-lived fixed asset impairment charges | 0 | |||
Uninsured cash balances | 39,587,000 | 9,123,000 | ||
Cancer treatment research award through the National Cancer Institute (NCI) | ||||
Government Assistance Amount Cumulative | $ 2,000,000 | |||
Government Assistance Transaction Duration | 3 years | |||
Grant received | $ 1,980,000 | $ 324,000 | $ 1,759,000 | |
Leasehold improvements | ||||
Property and equipment useful lives | 64 months | |||
Minimum | ||||
Property and equipment useful lives | 3 years | |||
Share-based compensation expiration period | 12 months | |||
Maximum | ||||
Property and equipment useful lives | 10 years | |||
Share-based compensation expiration period | 3 years |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) | 1 Months Ended | 3 Months Ended | |||||
Sep. 08, 2023 USD ($) D $ / shares shares | Oct. 25, 2022 USD ($) $ / shares shares | Oct. 20, 2022 USD ($) | Jan. 31, 2024 USD ($) $ / shares shares | Mar. 31, 2024 USD ($) $ / shares shares | Mar. 31, 2023 USD ($) shares | Dec. 31, 2023 $ / shares shares | |
STOCKHOLDERS' EQUITY | |||||||
Warrants issued to purchase shares | 12,529,916 | ||||||
Proceeds from exercise of warrants, net of issuance costs (Note 2) | $ | $ 43,849,467 | $ 3 | |||||
Common stock, shares authorized | 170,000,000 | 170,000,000 | |||||
Common stock par value | $ / shares | $ 0.00001 | $ 0.00001 | |||||
Exercise of warrants into common shares | $ | $ 1,072,467 | ||||||
September 2023 Private Placement | |||||||
STOCKHOLDERS' EQUITY | |||||||
Gross proceeds | $ | $ 24,500,000 | ||||||
Net proceeds | $ | $ 22,200,000 | ||||||
Common Stock | |||||||
STOCKHOLDERS' EQUITY | |||||||
Exercise of warrants into common shares (in shares) | 547,177 | ||||||
Exercise of warrants into common shares | $ | $ 5 | ||||||
Common Stock | September 2023 Private Placement | |||||||
STOCKHOLDERS' EQUITY | |||||||
Conversion of pre-funded warrants into common shares (in shares) | 903,956 | ||||||
Preferred Stock | September 2023 Private Placement | |||||||
STOCKHOLDERS' EQUITY | |||||||
Number of shares converted | 905.24 | ||||||
Common Stock | September 2023 Private Placement | |||||||
STOCKHOLDERS' EQUITY | |||||||
Convertible preferred shares issued | 9,947,684 | ||||||
Series D preferred stock | |||||||
STOCKHOLDERS' EQUITY | |||||||
Preferred stock, share outstanding | 111.11 | 111.11 | |||||
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 | 1,225 | ||||||
Conversion price per share | $ / shares | $ 1.82 | ||||||
Convertible preferred shares issued | 13,461,538 | ||||||
Gross proceeds from stockholders' equity | $ | $ 17,920,000 | ||||||
Series E-2 Preferred Stock | |||||||
STOCKHOLDERS' EQUITY | |||||||
Preferred stock, share outstanding | 237.50 | 319.76 | |||||
Series E-2 Preferred Stock | September 2023 Private Placement | |||||||
STOCKHOLDERS' EQUITY | |||||||
Conversion of pre-funded warrants into common shares (in shares) | 82.26 | ||||||
Common stock par value | $ / shares | $ 1.82 | ||||||
Preferred stock, share outstanding | 237.50 | 319.76 | |||||
Series E-2 Preferred Stock | Common Stock | |||||||
STOCKHOLDERS' EQUITY | |||||||
Conversion of pre-funded warrants into common shares (in shares) | 903,956 | ||||||
Series E-3 preferred stock | |||||||
STOCKHOLDERS' EQUITY | |||||||
Preferred stock, share outstanding | 630 | 0 | |||||
Series E-3 preferred stock | September 2023 Private Placement | |||||||
STOCKHOLDERS' EQUITY | |||||||
Conversion price per share | $ / shares | $ 3.185 | $ 3.185 | |||||
Convertible preferred shares issued | 13,846,154 | ||||||
Conversion of pre-funded warrants into common shares (in shares) | 9,890,099 | ||||||
Preferred stock, share outstanding | 630 | ||||||
Number of shares converted | 1,575 | ||||||
Series E-3 preferred stock | Common Stock | |||||||
STOCKHOLDERS' EQUITY | |||||||
Conversion of pre-funded warrants into common shares (in shares) | 9,890,099 | ||||||
Series E-4 preferred stock | September 2023 Private Placement | |||||||
STOCKHOLDERS' EQUITY | |||||||
Conversion price per share | $ / shares | $ 4.7775 | ||||||
Convertible preferred shares issued | 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 | 3,275,153 | ||||||
Gross proceeds | $ | $ 10,700,000 | ||||||
Proceeds from exercise of warrants, net of issuance costs (Note 2) | $ | $ 1,100,000 | ||||||
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 | 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) | 1,079,132 | ||||||
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 | 1,079,132 | 0 | |||||
Gross proceeds from stockholders' equity | $ | $ 2,300,000 | ||||||
Warrants | October 2022 Public Offering and Private Placement | |||||||
STOCKHOLDERS' EQUITY | |||||||
Exercise of warrants into common shares (in shares) | 547,177 | 0 | |||||
Tranche A Warrants | |||||||
STOCKHOLDERS' EQUITY | |||||||
Exercise of warrants into common shares | $ | $ 42,777,000 | ||||||
Tranche A Warrants | September 2023 Private Placement | |||||||
STOCKHOLDERS' EQUITY | |||||||
Warrants term | 10 days | ||||||
Tranche A Warrants | Series E-3 preferred stock | September 2023 Private Placement | |||||||
STOCKHOLDERS' EQUITY | |||||||
Proceeds from exercise of warrants, net of issuance costs (Note 2) | $ | $ 44,100,000 | ||||||
Exercise of warrants into common shares (in shares) | 2,205 | ||||||
Exercise of warrants into common shares | $ | $ 42,800,000 | ||||||
2023 Tranche A Preferred Warrants | September 2023 Private Placement | |||||||
STOCKHOLDERS' EQUITY | |||||||
Proceeds from exercise of warrants, net of issuance costs (Note 2) | $ | $ 44,100,000 | ||||||
2023 Tranche A Preferred Warrants | Series E-3 preferred stock | September 2023 Private Placement | |||||||
STOCKHOLDERS' EQUITY | |||||||
Warrants issued to purchase shares | 2,205 | ||||||
Number of days | D | 10 | ||||||
2023 Tranche B Preferred Warrants | Series E-4 preferred stock | September 2023 Private Placement | |||||||
STOCKHOLDERS' EQUITY | |||||||
Warrants issued to purchase shares | 1,715 | ||||||
Proceeds from exercise of warrants, net of issuance costs (Note 2) | $ | $ 34,300,000 | ||||||
Number of days | D | 10 |
STOCKHOLDERS' EQUITY - Common S
STOCKHOLDERS' EQUITY - Common Stock Warrants (Details) | 3 Months Ended |
Mar. 31, 2024 $ / shares shares | |
STOCKHOLDERS' EQUITY | |
Number of shares issuable upon exercise of outstanding warrants (in shares) | 12,529,916 |
2023 Tranche A Preferred Warrants | |
STOCKHOLDERS' EQUITY | |
Number of shares issuable upon exercise of outstanding warrants (in shares) | 7,179,492 |
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) | 4,201,044 |
Exercise price of warrants (in dollars per share) | $ / shares | $ 1.96 |
Warrants expiration date | Oct. 25, 2027 |
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 |
FAIR VALUE - Narratives (Detail
FAIR VALUE - Narratives (Details) | 3 Months Ended | ||
Mar. 31, 2024 USD ($) shares | Dec. 31, 2023 USD ($) | Sep. 30, 2023 shares | |
FAIR VALUE | |||
Warrants issued to purchase shares | shares | 12,529,916 | ||
Warrant liability | $ 8,800,000 | $ 3,700,000 | |
Fair Value Adjustment of Warrants | 9,900,000 | ||
Tranche A Warrants | Series E-3 preferred stock | |||
FAIR VALUE | |||
Fair Value Adjustment of Warrants | $ 4,800,000 | ||
Dividend | |||
FAIR VALUE | |||
Warrants issued to purchase shares | shares | 21,025,641 | ||
Warrants | 0 | 0 | 0 |
Warrant liability | $ 8,800,000 | $ 3,700,000 |
FAIR VALUE - Option-pricing ass
FAIR VALUE - Option-pricing assumptions (Details) | Mar. 31, 2024 Y | Dec. 31, 2023 USD ($) | Sep. 30, 2023 |
Volatility | Maximum | |||
FAIR VALUE | |||
Warrants | 0.850 | 0.830 | |
Volatility | Minimum | |||
FAIR VALUE | |||
Warrants | 0.840 | 0.820 | |
Risk-free interest rate | |||
FAIR VALUE | |||
Warrants | 0.0426 | ||
Risk-free interest rate | Maximum | |||
FAIR VALUE | |||
Warrants | 0.0540 | ||
Risk-free interest rate | Minimum | |||
FAIR VALUE | |||
Warrants | 0.0380 | ||
Expected life (years) | Maximum | |||
FAIR VALUE | |||
Warrants | 4.4 | 4.7 | |
Expected life (years) | Minimum | |||
FAIR VALUE | |||
Warrants | 1 | 0.3 | |
Dividend | |||
FAIR VALUE | |||
Warrants | 0 | 0 | 0 |
FAIR VALUE - Changes in the fai
FAIR VALUE - Changes in the fair market value of the warrants (Details) - Level 3 | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
Warrants | |
Changes in the fair market value of the warrants | |
Beginning fair value of warrants | $ 3,700,000 |
March 31, 2024 fair value of warrants | 8,800,000 |
Tranche A Warrants | |
Changes in the fair market value of the warrants | |
Loss from change in warrant fair value | 4,800,000 |
Settlement of Tranche A warrants to equity | (4,800,000) |
Tranche B Warrants | |
Changes in the fair market value of the warrants | |
Loss from change in warrant fair value | $ 5,100,000 |
STOCK-BASED COMPENSATION (Detai
STOCK-BASED COMPENSATION (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
STOCK-BASED COMPENSATION | ||
Stock-based compensation expense | $ 454,363 | $ 408,206 |
Employee and director stock option grants | ||
STOCK-BASED COMPENSATION | ||
Stock-based compensation expense | 454,363 | 408,206 |
Employee and director stock option grants | Research and development | ||
STOCK-BASED COMPENSATION | ||
Stock-based compensation expense | 68,776 | 66,195 |
Employee and director stock option grants | General and administrative | ||
STOCK-BASED COMPENSATION | ||
Stock-based compensation expense | $ 385,587 | $ 342,011 |
STOCK-BASED COMPENSATION - Addi
STOCK-BASED COMPENSATION - Additional Information (Details) - $ / shares | 1 Months Ended | ||
Jun. 23, 2023 | Mar. 31, 2024 | Dec. 31, 2023 | |
Contingent non-statutory stock option awards | |||
STOCK-BASED COMPENSATION | |||
Options granted (in shares) | 200,000 | 2,776,000 | |
Weighted-average exercise price | $ 2.65 | ||
Minimum | Contingent non-statutory stock option awards | |||
STOCK-BASED COMPENSATION | |||
Weighted-average exercise price | $ 3.35 | ||
Maximum | Contingent non-statutory stock option awards | |||
STOCK-BASED COMPENSATION | |||
Weighted-average exercise price | $ 3.63 | ||
2021 Stock Incentive Plan | |||
STOCK-BASED COMPENSATION | |||
Increase in common stock available for issuance | 1,100,000 | ||
Shares issued | 2,368,000 |
NET LOSS PER SHARE (Details)
NET LOSS PER SHARE (Details) - shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
NET LOSS PER SHARE | ||
Total potentially dilutive shares | 21,555,585 | 8,304,346 |
Warrants | ||
NET LOSS PER SHARE | ||
Total potentially dilutive shares | 12,529,916 | 6,714,479 |
Preferred shares as convertible into common stock | ||
NET LOSS PER SHARE | ||
Total potentially dilutive shares | 6,677,045 | 111,111 |
Stock Option | ||
NET LOSS PER SHARE | ||
Total potentially dilutive shares | 2,348,624 | 1,478,756 |
LEASES - Additional Information
LEASES - Additional Information (Details) | Dec. 30, 2022 USD ($) ft² | Mar. 31, 2024 | Jun. 30, 2018 |
Leases | |||
Area of land | ft² | 3,983 | ||
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 | |||
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 |
LEASES - Short-term leases and
LEASES - Short-term leases and operating lease liabilities (Details) | Mar. 31, 2024 USD ($) |
LEASES | |
2024 | $ 108,000 |
2025 | 146,000 |
2026 | 150,000 |
2027 | 153,000 |
2028 | 155,000 |
Thereafter | 53,000 |
Total undiscounted lease payments | 765,000 |
Less: Imputed interest | (217,000) |
Present value of lease liabilities | $ 548,000 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (21,581,637) | $ (8,581,267) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Mar. 31, 2024 | |
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 |