Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2023 | May 02, 2023 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 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 $0.00001 | |
Trading Symbol | CLRB | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 9,740,507 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Entity Central Index Key | 0001279704 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 12,682,691 | $ 19,866,358 |
Prepaid expenses and other current assets | 1,163,745 | 663,243 |
Total current assets | 13,846,436 | 20,529,601 |
Fixed assets, net | 376,084 | 418,641 |
Right-of-use asset, net | 546,505 | 560,334 |
Long-term and other assets | 63,217 | 75,000 |
Other assets | 6,214 | 6,214 |
TOTAL ASSETS | 14,838,456 | 21,589,790 |
CURRENT LIABILITIES: | ||
Accounts payable and accrued liabilities | 6,904,545 | 5,478,443 |
Lease liability | 51,106 | 50,847 |
Total current liabilities | 6,955,651 | 5,529,290 |
Long-term lease liability, net of current portion | 548,344 | 552,981 |
TOTAL LIABILITIES | 7,503,995 | 6,082,271 |
COMMITMENTS AND CONTINGENCIES | ||
STOCKHOLDERS' EQUITY: | ||
Preferred stock, $0.00001 par value; 7,000 shares authorized; Series D preferred stock: 111 issued and outstanding as of March 31, 2023 and December 31, 2022 | 1,382,023 | 1,382,023 |
Common stock, $0.00001 par value; 160,000,000 shares authorized; 9,740,507 and 9,385,272 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively | 97 | 94 |
Additional paid-in capital | 194,032,651 | 193,624,445 |
Accumulated deficit | (179,499,043) | |
Total stockholders' equity | 7,334,461 | 15,507,519 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ 14,838,456 | $ 21,589,790 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
CONDENSED CONSOLIDATED BALANCE SHEETS | ||
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 | 9,740,507 | 9,385,272 |
Common stock, shares outstanding | 9,740,507 | 9,385,272 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
COSTS AND EXPENSES: | ||
Research and development | $ 6,654,094 | $ 3,887,039 |
General and administrative | 2,051,207 | 2,253,188 |
Total costs and expenses | 8,705,301 | 6,140,227 |
LOSS FROM OPERATIONS | (8,705,301) | (6,140,227) |
OTHER INCOME: | ||
Interest income, net | 124,034 | 430 |
Total other income, net | $ 124,034 | 430 |
NET LOSS | $ (6,139,797) | |
BASIC NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE | $ (0.76) | $ (1) |
DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE | $ (0.76) | $ (1) |
SHARES USED IN COMPUTING BASIC NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE | 11,261,217 | 6,110,125 |
SHARES USED IN COMPUTING DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE | 11,261,217 | 6,110,125 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) | Preferred Stock | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total |
BALANCE BEGINNING at Dec. 31, 2021 | $ 1,382,023 | $ 61 | $ 182,560,859 | $ (150,897,789) | $ 33,045,154 |
BALANCE BEGINNING (in shares) at Dec. 31, 2021 | 111 | 6,110,125 | |||
Stock-based compensation | 303,805 | 303,805 | |||
Net loss | (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, 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 stock | 355,235 | ||||
Net loss | (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 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (6,139,797) | |
Adjustments to reconcile net loss to cash used in operating activities: | ||
Depreciation and amortization | $ 42,557 | 43,417 |
Stock-based compensation expense | 408,206 | 303,805 |
Noncash lease expense | 13,829 | 21,358 |
Changes in: | ||
Prepaid expenses and other current assets | (488,719) | 107,065 |
Lease liability | (4,378) | (32,433) |
Accounts payable and accrued liabilities | 1,426,102 | 656,802 |
Cash used in operating activities | (7,183,670) | (5,039,783) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of fixed assets | (30,070) | |
Cash used in investing activities | (30,070) | |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from exercise of pre-funded warrants | 3 | |
Cash provided by financing activities | 3 | |
NET DECREASE IN CASH AND CASH EQUIVALENTS | (7,183,667) | (5,069,853) |
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 19,866,358 | 35,703,975 |
CASH AND CASH EQUIVALENTS AT END OF PERIOD | $ 12,682,691 | $ 30,634,122 |
NATURE OF BUSINESS AND ORGANIZA
NATURE OF BUSINESS AND ORGANIZATION | 3 Months Ended |
Mar. 31, 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 $188,080,000 as of March 31, 2023. During the three months ended March 31, 2023, the Company generated a net loss of approximately $8,581,000 and the Company expects that it will continue to generate operating losses for the foreseeable future. However, the Company believes that its cash balance as of March 31, 2023 is adequate to fund its basic budgeted operations into the fourth quarter of 2023. 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 accompanying Condensed Consolidated Balance Sheet as of December 31, 2022 has been derived from our audited financial statements. The accompanying Condensed Consolidated Balance Sheet as of March 31, 2023, and the Condensed Consolidated Statements of Operations, the Condensed Consolidated Statements of Cash Flows, and the Consolidated Statements of Stockholders’ Equity for the three months ended March 31, 2023 and 2022, 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 at March 31, 2023 and consolidated results of its operations, cash flows, and stockholders’ equity for the three months ended March 31, 2023 and 2022. The results for the three months ended March 31, 2023 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, 2022, which was filed with the SEC on March 9, 2023. Principles of Consolidation Fixed Assets 3 Right-of-Use (ROU) Asset and Lease Liabilities Leases Stock-Based Compensation Research and Development Income Taxes Fair Value of Financial Instruments Financial Instruments Concentration of Credit Risk Recently Adopted Accounting Pronouncements During the three months ended March 31, 2023, the Company received approximately $406,000 in NCI grants, all of which was reported as a reduction of research and development (R&D) expenses. |
FAIR VALUE
FAIR VALUE | 3 Months Ended |
Mar. 31, 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. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 3 Months Ended |
Mar. 31, 2023 | |
STOCKHOLDERS' EQUITY | |
STOCKHOLDERS' EQUITY | 3. STOCKHOLDERS’ EQUITY October 2022 Public Offering and Private Placement On October 25, 2022, we 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, 2023, 355,235 shares of our pre-funded warrants were converted into 355,235 shares of our common stock. 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. The ATM Shares issued under the Sales Agreement are offered pursuant to a registration statement on Form S-3, which was declared effective by the U.S. Securities and Exchange Commission (SEC) on August 20, 2020. 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 prospectus supplement is filed with the SEC; however, the Equity Distribution Agreement remains in full force and effect. Common Stock Warrants The following table summarizes information with regard to outstanding warrants to purchase common stock as of March 31, 2023: Number of Shares Issuable Upon Exercise of Outstanding Exercise Offering Warrants Price Expiration Date 2022 Common Warrants 5,151,098 $ 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 July 2018 Series E Warrants 414,000 $ 40.00 July 31, 2023 October 2017 Series D Warrants 31,085 $ 178.00 October 14, 2024 Total 8,235,189 |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 3 Months Ended |
Mar. 31, 2023 | |
STOCK-BASED COMPENSATION | |
STOCK-BASED COMPENSATION | Accounting for Stock-Based Compensation 2021 Stock Incentive Plan The 2021 Stock Incentive Plan (the “2021 Plan”) was adopted on June 23, 2021 authorizing an aggregate of 600,000 shares of common stock for grants of incentive or nonqualified stock options, rights to purchase restricted and unrestricted shares of common stock, stock appreciation rights and performance share grants. The Compensation Committee determines exercise prices, vesting periods and any performance requirements on the date of grant, subject to the provisions of the 2021 Plan. Options are granted at or above the fair market value of the common stock at the grant date and expire on the tenth anniversary of the grant date. Vesting periods are generally between one At the 2022 annual meeting of stockholders held on June 24, 2022, the Company’s stockholders approved an increase in the number of shares of common stock available for issuance under our 2021 Stock Incentive Plan by 500,000 shares. During the three-month period ended March 31, 2023 and 2022, options granted were 732,500 and 277,850, respectively. Additionally, during the three-month period ended March 31, 2023, the Company granted 609,000 contingent non-statutory stock option awards at an exercise price of $1.68 per share to our employees. These contingent grants require approval of an amendment to the 2021 Plan that is to be voted upon at the Annual Meeting of Stockholders to be held on June 14, 2023. Until such time that the contingent non-statutory stock option awards are approved by stockholders, no expense will be accrued by the Company. 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, 2023 2022 Employee and director stock option grants: Research and development $ 66,195 $ 41,928 General and administrative 342,011 261,877 Total stock-based compensation $ 408,206 $ 303,805 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, 2023 and March 31, 2022 were equal to the market value of the Company’s common stock on the date of grant. Stock Option Activity A summary of stock option activity is as follows: Weighted Number of Average Shares Issuable Remaining Upon Exercise Weighted Contracted Aggregate of Outstanding Average Term in Intrinsic Options Exercise Price Years Value Outstanding at December 31, 2022 746,257 $ 13.48 $ — Granted 732,500 $ 1.68 Forfeited (1) $ 14,800 Outstanding at March 31, 2023 1,478,756 $ 7.59 9.06 $ — Exercisable March 31, 2023 370,959 $ 20.06 7.74 $ — Unvested, March 31, 2023 1,107,797 $ 3.42 9.51 $ — The aggregate intrinsic value of options outstanding is calculated based on the positive difference between the estimated per-share fair value of common stock at the end of the respective period and the exercise price of the underlying options. There have been no option exercises to date. Shares of common stock issued upon the exercise of options are from authorized but unissued shares. As of March 31, 2023, there was approximately $2,366,000 of total unrecognized compensation cost related to unvested stock-based compensation arrangements. Of this total amount, the Company expects to recognize approximately $1,152,000, $832,000, $365,000, and $17,000 during 2023, 2024, 2025 and 2026 respectively. The Company’s expense estimates are based upon the expectation that all unvested options will vest in the future. The weighted-average grant-date fair value of vested and unvested options outstanding at March 31, 2023 was $14.16 and $2.31, respectively. As of March 31, 2022, vested and unvested options were $2.43 and $0.68, respectively. |
INCOME TAXES
INCOME TAXES | 3 Months Ended |
Mar. 31, 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 ended March 31, 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 | 3 Months Ended |
Mar. 31, 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 three months ended March 31, 2023 and March 31, 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: Three Months Ended March 31, 2023 2022 Warrants 6,714,479 1,563,381 Preferred shares as convertible into common stock 111,111 111,111 Stock options 1,478,756 606,470 Total potentially dilutive shares 8,304,346 2,280,962 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 3 Months Ended |
Mar. 31, 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 | 3 Months Ended |
Mar. 31, 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, 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 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, 2023: Years ending March 31, 2023 $ 106,000 2024 132,000 2025 147,000 2026 150,000 2027 153,000 Thereafter 207,000 Total undiscounted lease payments 895,000 Less: Imputed interest (295,000) Present value of lease liabilities $ 600,000 |
NATURE OF BUSINESS AND ORGANI_2
NATURE OF BUSINESS AND ORGANIZATION (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
NATURE OF BUSINESS AND ORGANIZATION | |
Principles of Consolidation | Principles of Consolidation |
Fixed Assets | Fixed Assets 3 |
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 |
Concentration of Credit Risk | Concentration of Credit Risk |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements During the three months ended March 31, 2023, the Company received approximately $406,000 in NCI grants, all of which was reported as a reduction of research and development (R&D) expenses. |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 3 Months Ended |
Mar. 31, 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 March 31, 2023: Number of Shares Issuable Upon Exercise of Outstanding Exercise Offering Warrants Price Expiration Date 2022 Common Warrants 5,151,098 $ 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 July 2018 Series E Warrants 414,000 $ 40.00 July 31, 2023 October 2017 Series D Warrants 31,085 $ 178.00 October 14, 2024 Total 8,235,189 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
STOCK-BASED COMPENSATION | |
Summary of amounts charged to expense for stock-based compensation related to employee and director stock option grants | Three Months Ended March 31, 2023 2022 Employee and director stock option grants: Research and development $ 66,195 $ 41,928 General and administrative 342,011 261,877 Total stock-based compensation $ 408,206 $ 303,805 |
Summary of stock options activity | Weighted Number of Average Shares Issuable Remaining Upon Exercise Weighted Contracted Aggregate of Outstanding Average Term in Intrinsic Options Exercise Price Years Value Outstanding at December 31, 2022 746,257 $ 13.48 $ — Granted 732,500 $ 1.68 Forfeited (1) $ 14,800 Outstanding at March 31, 2023 1,478,756 $ 7.59 9.06 $ — Exercisable March 31, 2023 370,959 $ 20.06 7.74 $ — Unvested, March 31, 2023 1,107,797 $ 3.42 9.51 $ — |
NET LOSS PER SHARE (Tables)
NET LOSS PER SHARE (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
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, 2023 2022 Warrants 6,714,479 1,563,381 Preferred shares as convertible into common stock 111,111 111,111 Stock options 1,478,756 606,470 Total potentially dilutive shares 8,304,346 2,280,962 |
LEASES (Tables)
LEASES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
LEASES | |
Schedule of maturity analysis of short-term and operating leases | Years ending March 31, 2023 $ 106,000 2024 132,000 2025 147,000 2026 150,000 2027 153,000 Thereafter 207,000 Total undiscounted lease payments 895,000 Less: Imputed interest (295,000) Present value of lease liabilities $ 600,000 |
NATURE OF BUSINESS AND ORGANI_3
NATURE OF BUSINESS AND ORGANIZATION (Details) - USD ($) | 1 Months Ended | 3 Months Ended | ||
Sep. 30, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Accumulated deficit | $ 179,499,043 | |||
Net loss | $ 6,139,797 | |||
Fixed asset impairment charges | $ 0 | |||
Uninsured cash balances | 12,200,000 | $ 19,400,000 | ||
Cancer treatment research award through the National Cancer Institute (NCI) | ||||
Grant amount | $ 2,000,000 | |||
Grant period | 3 years | |||
Grant received | $ 1,980,000 | $ 406,000 | ||
Leasehold Improvements [Member] | ||||
Property and equipment useful lives | 64 months | |||
Minimum [Member] | ||||
Share-based compensation expiration period | 1 year | |||
Property and equipment useful lives | 3 years | |||
Maximum [Member] | ||||
Share-based compensation expiration period | 3 years | |||
Property and equipment useful lives | 10 years |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) | 3 Months Ended | ||||||||
Oct. 25, 2022 USD ($) $ / shares shares | Oct. 20, 2022 USD ($) | Jun. 27, 2022 | Jun. 24, 2022 | Aug. 11, 2020 USD ($) $ / shares | Mar. 31, 2023 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | Mar. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
STOCKHOLDERS' EQUITY | |||||||||
Common stock, shares authorized | shares | 160,000,000 | 160,000,000 | |||||||
Common stock par value | $ / shares | $ 0.00001 | $ 0.00001 | |||||||
Warrants issued to purchase shares | shares | 8,235,189 | ||||||||
Proceeds from exercise of pre-funded warrants | $ 3 | ||||||||
Stockholders' Equity Attributable to Parent | $ 7,334,461 | $ 15,507,519 | $ 27,209,162 | $ 33,045,154 | |||||
Preferred Stock, Shares Outstanding | shares | 111 | 111 | |||||||
Stockholders' Equity Note, Stock Split, Conversion Ratio | 0.10 | ||||||||
Sales Agent | Equity Distribution Agreement | |||||||||
STOCKHOLDERS' EQUITY | |||||||||
Common stock par value | $ / shares | $ 0.00001 | ||||||||
Commission paid on sale of shares (in percentage) | 3% | ||||||||
Aggregate value of shares issued | $ 14,500,000 | ||||||||
Common Stock | |||||||||
STOCKHOLDERS' EQUITY | |||||||||
Stockholders' Equity Attributable to Parent | $ 97 | $ 94 | $ 61 | $ 61 | |||||
Conversion of pre-funded warrants into common stock | shares | 355,235 | ||||||||
Minimum | |||||||||
STOCKHOLDERS' EQUITY | |||||||||
Stockholders' Equity Note, Stock Split, Conversion Ratio | 0.10 | ||||||||
Maximum | |||||||||
STOCKHOLDERS' EQUITY | |||||||||
Stockholders' Equity Note, Stock Split, Conversion Ratio | 0.20 | ||||||||
October 2022 Public Offering and Private Placement | |||||||||
STOCKHOLDERS' EQUITY | |||||||||
class of warrant or rights from which warrants or rights exercisable. | $ / shares | $ 0.00001 | ||||||||
Gross proceeds from stockholders' equity | $ 10,700,000 | ||||||||
Warrants issued to purchase shares | shares | 3,275,153 | ||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 2.085 | ||||||||
proceeds from issuance of private placement | $ 10,700,000 | ||||||||
Estimated offering expenses | $ 9,600,000 | ||||||||
October 2022 Public Offering and Private Placement | Common Stock | |||||||||
STOCKHOLDERS' EQUITY | |||||||||
Warrants issued to purchase shares | shares | 1,875,945 | ||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 1.96 | ||||||||
Common Stock | October 2022 Public Offering and Private Placement | |||||||||
STOCKHOLDERS' EQUITY | |||||||||
Gross proceeds from stockholders' equity | 4,000,000 | ||||||||
Conversion of pre-funded warrants into common stock | shares | 355,235 | ||||||||
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 | |||||||||
Gross proceeds from stockholders' equity | $ 2,300,000 | ||||||||
Warrants issued to purchase shares | shares | 1,875,945 | ||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 2.08499 | ||||||||
pre-funded warrants | shares | 355,235 |
STOCKHOLDERS' EQUITY - Common S
STOCKHOLDERS' EQUITY - Common Stock Warrants (Details) | 3 Months Ended |
Mar. 31, 2023 $ / shares shares | |
STOCKHOLDERS' EQUITY | |
Number of shares issuable upon exercise of outstanding warrants (in shares) | 8,235,189 |
2022 Common Warrants | |
STOCKHOLDERS' EQUITY | |
Number of shares issuable upon exercise of outstanding warrants (in shares) | 5,151,098 |
Exercise price of warrants (in dollars per share) | $ / shares | $ 1.96 |
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 |
July 2018 Series E Warrants | |
STOCKHOLDERS' EQUITY | |
Number of shares issuable upon exercise of outstanding warrants (in shares) | 414,000 |
Exercise price of warrants (in dollars per share) | $ / shares | $ 40 |
Warrants expiration date | Jul. 31, 2023 |
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 | |
Mar. 31, 2023 | Mar. 31, 2022 | |
STOCK-BASED COMPENSATION | ||
Total stock-based compensation | $ 408,206 | $ 303,805 |
Employee and director stock option grants | ||
STOCK-BASED COMPENSATION | ||
Total stock-based compensation | 408,206 | 303,805 |
Employee and director stock option grants | Research and development | ||
STOCK-BASED COMPENSATION | ||
Total stock-based compensation | 66,195 | 41,928 |
Employee and director stock option grants | General and administrative | ||
STOCK-BASED COMPENSATION | ||
Total stock-based compensation | $ 342,011 | $ 261,877 |
STOCK-BASED COMPENSATION - Stoc
STOCK-BASED COMPENSATION - Stock Option Activity (Details) - Stock options - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Dec. 31, 2022 | |
STOCK-BASED COMPENSATION | ||
Outstanding - Number of Shares Issuable Upon Exercise of Outstanding Options | 746,257 | |
Granted - Number of Shares Issuable Upon Exercise of Outstanding Options | 732,500 | |
Forfeited - Number of Shares Issuable Upon Exercise of Outstanding Options | (1) | |
Outstanding - Number of Shares Issuable Upon Exercise of Outstanding Options | 1,478,756 | |
Exercisable - Number of Shares Issuable Upon Exercise of Outstanding Options | 370,959 | |
Unvested - Number of Shares Issuable Upon Exercise of Outstanding Options | 1,107,797 | |
Outstanding - Weighted Average Exercise Price (in dollars per share) | $ 13.48 | |
Granted - Weighted Average Exercise Price (in dollars per share) | 1.68 | |
Forfeited - Weighted Average Exercise Price (in dollars per share) | 14,800 | |
Outstanding - Weighted Average Exercise Price (in dollars per share) | 7.59 | |
Exercisable - Weighted Average Exercise Price (in dollars per share) | 20.06 | |
Unvested - Weighted Average Exercise Price (in dollars per share) | $ 3.42 | |
Outstanding - Weighted Average Remaining Contracted Term in Years | 9 years 21 days | |
Exercisable - Weighted Average Remaining Contracted Term in Years | 7 years 8 months 26 days | |
Unvested - Weighted Average Remaining Contracted Term in Years | 9 years 6 months 3 days | |
Outstanding - Aggregate Intrinsic Value | $ 0 | $ 0 |
Exercisable - Aggregate Intrinsic Value (in dollars) | 0 | |
Unvested - Aggregate Intrinsic Value (in dollars) | $ 0 |
STOCK-BASED COMPENSATION - Addi
STOCK-BASED COMPENSATION - Additional Information (Details) - USD ($) | 3 Months Ended | |||
Jun. 24, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | Jun. 23, 2021 | |
STOCK-BASED COMPENSATION | ||||
Options granted (in shares) | 732,500 | 277,850 | ||
Total unrecognized compensation cost related to unvested stock-based compensation arrangements | $ 2,366,000 | |||
Total amount the Company expects to recognize in 2022 | 1,152,000 | |||
Total amount the Company expects to recognize in 2022 | 832,000 | |||
Total amount the Company expects to recognize in 2022 | 365,000 | |||
2025 | $ 17,000 | |||
Weighted-average grant-date fair value of vested options outstanding (in per shares) | $ 14.16 | $ 2.43 | ||
Weighted-average grant-date fair value of unvested options outstanding (in per shares) | $ 2.31 | $ 0.68 | ||
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 | ||||
Increase in common stock available for issuance | 500,000 | |||
Aggregate of shares of common stock for grants of incentive or nonqualified stock options | 600,000 | |||
Aggregate shares available for future grants | 3,254 | |||
2021 Stock Incentive Plan | Minimum | ||||
STOCK-BASED COMPENSATION | ||||
Vesting period (in years) | 1 year | |||
2021 Stock Incentive Plan | Maximum | ||||
STOCK-BASED COMPENSATION | ||||
Vesting period (in years) | 3 years |
NET LOSS PER SHARE (Details)
NET LOSS PER SHARE (Details) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
NET LOSS PER SHARE | ||
Total potentially dilutive shares | 8,304,346 | 2,280,962 |
Warrants | ||
NET LOSS PER SHARE | ||
Total potentially dilutive shares | 6,714,479 | 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 | 1,478,756 | 606,470 |
LEASES - Short-term Leases and
LEASES - Short-term Leases and Operating Lease Liabilities (Details) | Mar. 31, 2023 USD ($) |
LEASES | |
2023 | $ 106,000 |
2024 | 132,000 |
2025 | 147,000 |
2026 | 150,000 |
2027 | 153,000 |
Thereafter | 207,000 |
Total undiscounted lease payments | 895,000 |
Less: Imputed interest | (295,000) |
Present value of lease liabilities | $ 600,000 |
LEASES - Additional Information
LEASES - Additional Information (Details) | 3 Months Ended | |
Mar. 31, 2023 USD ($) ft² | 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 |