Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 07, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2023 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Document Transition Report | false | |
Entity File Number | 001-37568 | |
Entity Registrant Name | PDS Biotechnology Corp | |
Entity Central Index Key | 0001472091 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 26-4231384 | |
Entity Address, Address Line One | 303A College Road East | |
Entity Address, City or Town | Princeton | |
Entity Address, State or Province | NJ | |
Entity Address, Postal Zip Code | 08540 | |
City Area Code | 800 | |
Local Phone Number | 208-3343 | |
Title of 12(b) Security | Common Stock, par value $0.00033 per share | |
Trading Symbol | PDSB | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 31,107,763 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 54,251,387 | $ 73,820,160 |
Prepaid expenses and other assets | 2,587,025 | 2,660,230 |
Total current assets | 56,838,412 | 76,480,390 |
Property and equipment, net | 138,866 | 0 |
Financing lease right-of-use assets | 210,543 | 374,888 |
Operating lease right-of-use asset | 0 | 152,645 |
Total assets | 57,187,821 | 77,007,923 |
Current liabilities: | ||
Accounts payable | 5,366,564 | 1,219,287 |
Accrued expenses | 3,732,727 | 8,313,708 |
Financing lease obligation-short term | 54,537 | 56,612 |
Operating lease obligation-short term | 0 | 231,429 |
Total current liabilities | 9,153,828 | 9,821,036 |
Noncurrent liabilities: | ||
Note payable, net of debt discount | 23,412,764 | 23,020,844 |
Financing lease obligation-long term | 137,401 | 164,013 |
Total liabilities | 32,703,993 | 33,005,893 |
STOCKHOLDERS' EQUITY | ||
Common stock, $0.00033 par value, 75,000,000 shares authorized at September 30, 2023 and December 31, 2022, 31,007,763 shares and 30,170,317 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively | 10,233 | 9,956 |
Additional paid-in capital | 158,075,994 | 145,550,491 |
Accumulated deficit | (133,602,399) | (101,558,417) |
Total stockholders' equity | 24,483,828 | 44,002,030 |
Total liabilities and stockholders' equity | $ 57,187,821 | $ 77,007,923 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
STOCKHOLDERS' EQUITY | ||
Common stock, par value (in dollars per share) | $ 0.00033 | $ 0.00033 |
Common stock, shares authorized (in shares) | 75,000,000 | 75,000,000 |
Common stock, shares issued (in shares) | 31,007,763 | 30,170,317 |
Common stock shares outstanding (in shares) | 31,007,763 | 30,170,317 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Operating expenses: | ||||
Research and development expenses | $ 6,448,528 | $ 4,352,987 | $ 20,297,066 | $ 13,275,947 |
General and administrative expenses | 4,071,158 | 2,926,209 | 12,341,207 | 9,575,122 |
Total operating expenses | 10,519,686 | 7,279,196 | 32,638,273 | 22,851,069 |
Loss from operations | (10,519,686) | (7,279,196) | (32,638,273) | (22,851,069) |
Interest income (expenses), net | ||||
Interest income | 739,404 | 252,073 | 2,219,399 | 332,318 |
Interest expense | (1,068,887) | (397,327) | (3,031,129) | (397,326) |
Interest income (expenses), net | (329,483) | (145,254) | (811,730) | (65,008) |
Loss before income taxes | (10,849,169) | (7,424,450) | (33,450,003) | (22,916,077) |
Benefit for income taxes | 0 | 0 | 1,406,021 | 1,198,905 |
Net loss | (10,849,169) | (7,424,450) | (32,043,982) | (21,717,172) |
Comprehensive loss | $ (10,849,169) | $ (7,424,450) | $ (32,043,982) | $ (21,717,172) |
Per share information: | ||||
Net loss per share, basic (in dollars per share) | $ (0.35) | $ (0.26) | $ (1.04) | $ (0.76) |
Net loss per share, diluted (in dollars per share) | $ (0.35) | $ (0.26) | $ (1.04) | $ (0.76) |
Weighted average common shares outstanding, basic (in shares) | 30,910,520 | 28,458,688 | 30,715,458 | 28,452,997 |
Weighted average common shares outstanding, diluted (in shares) | 30,910,520 | 28,458,688 | 30,715,458 | 28,452,997 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Stockholders' Equity - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2021 | $ 9,387 | $ 123,904,602 | $ (60,703,562) | $ 63,210,427 |
Balance (in shares) at Dec. 31, 2021 | 28,448,612 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Stock based compensation expense | $ 0 | 1,128,973 | 0 | 1,128,973 |
Issuances of common stock, from exercise of stock options | $ 1 | 7,487 | 0 | 7,488 |
Issuances of common stock, from exercise of stock options (in shares) | 2,282 | |||
Net loss | $ 0 | 0 | (8,473,522) | (8,473,522) |
Balance at Mar. 31, 2022 | $ 9,388 | 125,041,062 | (69,177,084) | 55,873,366 |
Balance (in shares) at Mar. 31, 2022 | 28,450,894 | |||
Balance at Dec. 31, 2021 | $ 9,387 | 123,904,602 | (60,703,562) | 63,210,427 |
Balance (in shares) at Dec. 31, 2021 | 28,448,612 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Net loss | (21,717,172) | |||
Balance at Sep. 30, 2022 | $ 9,391 | 129,470,179 | (82,420,734) | 47,058,836 |
Balance (in shares) at Sep. 30, 2022 | 28,458,688 | |||
Balance at Dec. 31, 2021 | $ 9,387 | 123,904,602 | (60,703,562) | $ 63,210,427 |
Balance (in shares) at Dec. 31, 2021 | 28,448,612 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Issuances of common stock from the Sales Agreement, net (in shares) | 1,238,491 | |||
Balance at Dec. 31, 2022 | $ 9,956 | 145,550,491 | (101,558,417) | $ 44,002,030 |
Balance (in shares) at Dec. 31, 2022 | 30,170,317 | |||
Balance at Mar. 31, 2022 | $ 9,388 | 125,041,062 | (69,177,084) | 55,873,366 |
Balance (in shares) at Mar. 31, 2022 | 28,450,894 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Stock based compensation expense | $ 0 | 1,348,601 | 0 | 1,348,601 |
Issuances of common stock, from exercise of stock options | $ 3 | 22,426 | 0 | 22,429 |
Issuances of common stock, from exercise of stock options (in shares) | 7,794 | |||
Net loss | $ 0 | 0 | (5,819,200) | (5,819,200) |
Balance at Jun. 30, 2022 | $ 9,391 | 126,412,089 | (74,996,284) | 51,425,196 |
Balance (in shares) at Jun. 30, 2022 | 28,458,688 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Stock based compensation expense | $ 0 | 1,344,349 | 0 | 1,344,349 |
Issuance of warrants | 0 | 1,713,714 | 0 | 1,713,714 |
Net loss | 0 | 0 | (7,424,450) | (7,424,450) |
Balance at Sep. 30, 2022 | $ 9,391 | 129,470,179 | (82,420,734) | 47,058,836 |
Balance (in shares) at Sep. 30, 2022 | 28,458,688 | |||
Balance at Dec. 31, 2022 | $ 9,956 | 145,550,491 | (101,558,417) | 44,002,030 |
Balance (in shares) at Dec. 31, 2022 | 30,170,317 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Stock based compensation expense | $ 0 | 2,080,319 | 0 | 2,080,319 |
Issuances of common stock from the Sales Agreement, net | $ 183 | 4,588,339 | 0 | 4,588,522 |
Issuances of common stock from the Sales Agreement, net (in shares) | 553,293 | |||
Net loss | $ 0 | 0 | (9,659,918) | (9,659,918) |
Balance at Mar. 31, 2023 | $ 10,139 | 152,219,149 | (111,218,335) | 41,010,953 |
Balance (in shares) at Mar. 31, 2023 | 30,723,610 | |||
Balance at Dec. 31, 2022 | $ 9,956 | 145,550,491 | (101,558,417) | $ 44,002,030 |
Balance (in shares) at Dec. 31, 2022 | 30,170,317 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Issuance of common stock for consulting agreement (in shares) | 100,000 | |||
Issuances of common stock from the Sales Agreement, net (in shares) | 736,037 | |||
Net loss | $ (32,043,982) | |||
Balance at Sep. 30, 2023 | $ 10,233 | 158,075,994 | (133,602,399) | 24,483,828 |
Balance (in shares) at Sep. 30, 2023 | 31,007,763 | |||
Balance at Mar. 31, 2023 | $ 10,139 | 152,219,149 | (111,218,335) | 41,010,953 |
Balance (in shares) at Mar. 31, 2023 | 30,723,610 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Stock based compensation expense | $ 0 | 2,105,538 | 0 | 2,105,538 |
Issuances of common stock, from exercise of stock options | $ 1 | 8,848 | 0 | 8,849 |
Issuances of common stock, from exercise of stock options (in shares) | 1,409 | |||
Issuance of common stock for consulting agreement | $ 33 | 609,967 | 0 | 610,000 |
Issuance of common stock for consulting agreement (in shares) | 100,000 | |||
Issuances of common stock from the Sales Agreement, net | $ 14 | 243,729 | 0 | 243,743 |
Issuances of common stock from the Sales Agreement, net (in shares) | 43,169 | |||
Net loss | $ 0 | 0 | (11,534,895) | (11,534,895) |
Balance at Jun. 30, 2023 | $ 10,187 | 155,187,231 | (122,753,230) | 32,444,188 |
Balance (in shares) at Jun. 30, 2023 | 30,868,188 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Stock based compensation expense | $ 0 | 2,073,607 | 0 | 2,073,607 |
Issuances of common stock from the Sales Agreement, net | $ 46 | 815,156 | 0 | $ 815,202 |
Issuances of common stock from the Sales Agreement, net (in shares) | 139,575 | 139,575 | ||
Net loss | $ 0 | 0 | (10,849,169) | $ (10,849,169) |
Balance at Sep. 30, 2023 | $ 10,233 | $ 158,075,994 | $ (133,602,399) | $ 24,483,828 |
Balance (in shares) at Sep. 30, 2023 | 31,007,763 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Cash flows from operating activities: | |||||||
Net loss | $ (10,849,169) | $ (9,659,918) | $ (7,424,450) | $ (8,473,522) | $ (32,043,982) | $ (21,717,172) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Stock-based compensation expense | 6,259,464 | 3,821,923 | |||||
Issuance of shares in consulting agreement | 610,000 | 0 | |||||
Amortization of debt discount | 158,397 | 391,920 | 72,722 | ||||
Depreciation expense | 12,624 | 86 | |||||
Operating lease expense | 160,685 | 180,772 | |||||
Finance lease depreciation expense | 30,297 | 37,417 | |||||
Changes in assets and liabilities: | |||||||
Prepaid expenses and other assets | 73,205 | (1,171,337) | |||||
Finance lease right-of-use asset | 0 | (306,487) | |||||
Accounts payable | 4,147,277 | 727,987 | |||||
Accrued expenses | (4,580,981) | 240,799 | |||||
Finance lease liabilities | 0 | 138,402 | |||||
Operating lease liabilities | (239,469) | (205,885) | |||||
Net cash used in operating activities | (25,178,960) | (18,180,773) | |||||
Cash flows from financing activities: | |||||||
Proceeds from issuance of note payable | 0 | 25,000,000 | |||||
Payment for debt issuance costs | 0 | (449,329) | |||||
Proceeds from exercise of stock options | 8,849 | 29,917 | |||||
Payments of finance lease obligations | (46,129) | 0 | |||||
Proceeds from issuance of common stock, net of issuance costs | 800,000 | 5,647,467 | 0 | $ 9,900,000 | |||
Net cash provided by financing activities | 5,610,187 | 24,580,588 | |||||
Net increase in cash and cash equivalents | (19,568,773) | 6,399,815 | |||||
Cash and cash equivalents at beginning of period | $ 73,820,160 | $ 65,242,622 | 73,820,160 | 65,242,622 | 65,242,622 | ||
Cash and cash equivalents at the end of period | $ 54,251,387 | $ 71,642,437 | 54,251,387 | 71,642,437 | $ 73,820,160 | ||
Supplemental information of cash and non-cash transactions: | |||||||
Cash paid for interest | 3,031,129 | 62,500 | |||||
Fair value of warrants issued in connection with debt | $ 0 | $ 1,713,741 |
Nature of Operations
Nature of Operations | 9 Months Ended |
Sep. 30, 2023 | |
Nature of Operations [Abstract] | |
Nature of Operations | Note 1 – PDS Biotechnology Corporation, a Delaware corporation (the “Company” or “PDS Biotech”), is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on its Versamune ® , Versamune ® plus our IL12 fused antibody-drug conjugate (ADC) PDS01ADC (formerly PDS0301/M9241) and Infectimune ® T cell-activating platforms and PDS01ADC tumor targeting immunocytokine. The Company believes its targeted immunotherapies have potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. Versamune, and Versamune plus PDS01ADC is for treatments in oncology and Infectimune, for treatments in infectious disease. When paired with an antigen, which is a disease-related protein that is recognizable by the immune system, Versamune and Infectimune have both been shown to induce, in vivo, large quantities of high-quality, highly potent polyfunctional CD4 helper and CD8 killer T cells, a specific sub-type of T cell that is more effective at killing infected or target cells. Infectimune is also designed to promote the induction of disease-specific neutralizing antibodies. PDS01ADC is an investigational tumor targeting IL-12 that enhances the proliferation, potency and longevity of T cells in the tumor microenvironment. Versamune plus PDS01ADC enhances the proliferation, potency and longevity of antigen specific multifunctional CD8 T cells in the tumor microenvironment and works synergistically to overcome tumor immune suppression. The Company’s immuno-oncology clinical candidates are of potential interest for use as a component of combination clinical candidates (for example, in combination with other leading technologies such as immune checkpoint inhibitors) to provide more effective treatments across a range of advanced cancers. The Company is also evaluating our immunotherapies as monotherapies in early-stage disease. PDS Biotech is developing targeted clinical candidates to treat several cancers including Human Papillomavirus (HPV)-positive cancers, melanoma, colorectal, lung, breast and prostate cancers. The Company’s infectious disease candidates are of potential interest for use in universal influenza vaccines. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Summary of Significant Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 2 – Summary of Significant Accounting Policies (A) Unaudited interim financial statements: The interim balance sheet at September 30, 2023, the statements of operations and comprehensive loss and changes in stockholders’ equity and cash flows for the three and nine months ended September 30, 2023 and 2022 are unaudited. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. GAAP, in accordance with the requirements of the Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted. These condensed consolidated financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments that are necessary for a fair statement of its financial information. The results of operations for the three and nine months ended September 30, 2023 are not necessarily indicative of the results to be expected for the year ending December 31, 2023 or for any other future annual or interim period. The balance sheet as of December 31, 2022 included herein was derived from the audited consolidated financial statements as of that date. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and notes thereto as of and for the year ended December 31, 2022, filed by the Company with the SEC in its Annual Report on Form 10-K on March 28, 2023. (B) Use of estimates: The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of expenses at the date of the consolidated financial statements and during the reporting periods, and to disclose contingent assets and liabilities at the date of the consolidated financial statements. Actual results could differ from those estimates. The most significant estimate relates to the fair value of securities underlying stock-based compensation. (C) Significant risks and uncertainties: The Company’s operations are subject to a number of factors that may affect its operating results and financial condition. Such factors include, but are not limited to: the clinical and regulatory development of its clinical candidates, the ability to preserve its cash resources, the Company’s review of strategic alternatives, the ability to add clinical candidates to its pipeline, the Company’s intellectual property, the ability to efficiently and effectively conduct its clinical trials, competition from products manufactured and sold or being developed by other companies, the price of, and demand for, Company products if approved for sale, the ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products, the ability to raise capital, and the effects of health epidemics, pandemics, or outbreaks of infectious diseases. The Company currently has no commercially approved products. As such, there can be no assurance that the Company’s future research and development programs will be successfully commercialized. Developing and commercializing a product requires significant time and capital and is subject to regulatory review and approval as well as competition from other biotechnology and pharmaceutical companies. The Company operates in an environment of rapid change and is dependent upon the continued services of its employees and consultants and obtaining and protecting its intellectual property. (D) Cash equivalents and concentration of cash balance: The Company considers all highly liquid securities with a maturity weighted average of less than three months to be cash equivalents. The Company’s cash and cash equivalents in bank deposit accounts, at times, may exceed federally insured limits. (E) Research and development: Costs incurred in connection with research and development activities are expensed as incurred. These costs include licensing fees to use certain technology in the Company’s research and development projects as well as fees paid to consultants and entities that perform certain research and testing on behalf of the Company. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data, such as patient enrollment, clinical trial site activations or information provided by vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred. (F) Patent costs: The Company expenses patent costs as incurred and classifies such costs as general and administrative expenses in the accompanying statements of operations and comprehensive loss. (G) Stock-based compensation: The Company accounts for its stock-based compensation in accordance with ASC Topic 718, Compensation—Stock Compensation (“ASC 718”). ASC 718 requires all stock-based payments to employees, directors and non-employees to be recognized as expense in the consolidated statements of operations and comprehensive loss based on their grant date fair values. In order to determine the fair value of stock options on the date of grant, the Company uses the Black-Scholes option-pricing model. Inherent in this model are assumptions related to expected stock-price volatility, option term, risk-free interest rate and dividend yield. The Company expenses the fair value of its stock-based compensation awards to employees and directors on a straight-line basis over the requisite service period, which is generally the vesting period. The Company recognizes forfeitures as they occur. (H) Net loss per common share: Basic and diluted net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted average common shares outstanding during the period. For all periods presented, the common shares underlying the stock options and warrants have been excluded from the calculation because their effect would be anti-dilutive. Therefore, the weighted average shares outstanding used to calculate both basic and diluted loss per common share is the same. The potentially dilutive securities excluded from the determination of diluted loss per share as their effect is antidilutive, are as follows: As of September 30, 2023 2022 Stock options to purchase Common Stock 5,383,902 4,370,846 Warrants to purchase Common Stock 506,229 506,229 Total 5,890,131 4,877,075 (I) Income taxes: The Company provides for deferred income taxes under the asset and liability method, which requires deferred tax assets and liabilities to be recognized for the future tax consequences attributable to net operating loss carryforwards and for differences between the financial statement carrying amounts and the respective tax bases of assets and liabilities. Deferred tax assets are reduced if necessary, by a valuation allowance if it is more likely than not that some portion or all of the deferred tax assets will not be realized. (J) Fair value of financial instruments: ASC 820, Fair Value Measurement, specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The three levels of the fair value hierarchy are as follows: ● Level 1 — Unadjusted quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities. ● Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly (e.g., quoted prices of similar assets or liabilities in active markets, or quoted prices for identical or similar assets or liabilities in markets that are not active). Level 2 includes financial instruments that are valued using models or other valuation methodologies. ● Level 3 — Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable. (K) Leases: The Company determines if an arrangement is a lease at inception and recognizes the lease in accordance with ASC 842, Leases (“ASC 842”). Both financing and operating leases are included in right-of-use (“ROU”) assets, lease obligation-short term and lease obligation-long term in the Company’s consolidated balance sheets. ROU assets represent the right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. The ROU assets and lease liabilities are recognized at the lease commencement date based on the present value of the lease payments over the lease term. The Company determines the portion of the lease liability that is current as the difference between the calculated lease liability at the end of the current period and the lease liability that is projected 12 months from the current period. |
Liquidity
Liquidity | 9 Months Ended |
Sep. 30, 2023 | |
Liquidity [Abstract] | |
Liquidity | Note 3 – Liquidity As of September 30, 2023, the Company had $54.3 million of cash and cash equivalents. The Company’s primary uses of cash are to fund operating expenses, primarily research and development expenditures. Cash used to fund operating expenses is impacted by the timing of when the Company pays these expenses, as reflected in the change to the Company’s outstanding accounts payable and accrued expenses. Since inception, the Company has experienced net losses and negative cash flows from operations each fiscal year. The Company has no revenues and expects to continue to incur operating losses for the foreseeable future and may never become profitable. The Company funds its operations through equity and/or debt financings such as the following: In April 2022, the Company received approximately $1.2 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to the Company’s participation in the New Jersey Technology Business Tax Certificate Transfer NOL program for tax year 2020. In August 2022, the Company filed a shelf registration statement, or the 2022 Shelf Registration Statement, with the SEC for the issuance of common stock, preferred stock, warrants, rights, debt securities, and units, up to an aggregate amount of $150 million, $50 million of which covers the offer, issuance and sale by the Company of its common stock under the Sales Agreement (as discussed below). The 2022 Shelf Registration Statement was declared effective on September 2, 2022. In August 2022, the Company entered into an At Market Issuance Sales Agreement, or the Sales Agreement, with B. Riley Securities, Inc. and BTIG, LLC, each an Agent and collectively the Agents, with respect to an at-the-market offering program under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, having an aggregate offering price of up to $50 million, or the Placement Shares, through or to the Agents, as sales agents or principals. Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, the Agents may sell the Placement Shares by any method permitted by law deemed to be an “at the market” offering as defined in Rule 415 of the Securities Act of 1933, as amended, including, without limitation, sales made through The Nasdaq Capital Market or on any other existing trading market for the Company’s common stock. The Agents will use commercially reasonable efforts to sell the Placement Shares from time to time, based upon the Company’s instructions (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company will pay the Agents a commission equal to three percent (3%) of the gross sales proceeds of any Placement Shares sold through the Agents under the Sales Agreement, and the Company has also provided the Agents with customary indemnification and contribution rights. The Company is not obligated to make any sales of its common stock under the Sales Agreement. The offering of Placement Shares pursuant to the Sales Agreement will terminate upon the earlier of (i) the sale of all Placement Shares subject to the Sales Agreement or (ii) termination of the Sales Agreement in accordance with its terms. For the year ended December 31, 2022, the Company sold 1,238,491 shares of common stock with a net value of $9.9 million pursuant to the Sales Agreement. During the three and nine months ended September 30, 2023, the Company sold 139,575 and 736,037 shares, respectively, of its common stock with a net value of $0.8 million and $5.6 million, respectively, pursuant to the Sales Agreement. In August 2022, the Company entered into a venture loan and security agreement, or the Loan and Security Agreement, with Horizon Technology Finance Corporation, as lender and collateral agent for itself and the other lenders. The Loan and Security Agreement provides for the following 6 separate and independent term loans: (a) a term loan in the amount of $7,500,000, or Loan A, (b) a term loan in the amount of $10,000,000, or Loan B, (c) a term loan in the amount of $3,750,000, or Loan C, (d) a term loan in the amount of $3,750,000, or Loan D, (e) a term loan in the amount of $5,000,000, or Loan E, and (f) a term loan in the amount of $5,000,000, or Loan F, (with each of Loan A, Loan B, Loan C, Loan D, Loan E, and Loan F, individually a Loan and, collectively, the Loans). Loan A, Loan B, Loan C , and Loan D were delivered to the Company on August 24, 2022. were At time the to advance Loan E and Loan F has expired and Loan E and Loan F are longer available under the Loan and Security Agreement of the Loans for working capital or general corporate purposes. Each Loan matures on the 48-month anniversary following the applicable funding date unless accelerated pursuant to certain events of default. The principal balance of each Loan bears a floating interest. The interest rate is calculated initially and, thereafter, each calendar month as the sum of (a) The Loan and Security Agreement contains customary representations, warranties and covenants, including covenants by the Company limiting additional indebtedness, liens, including on intellectual property, guaranties, mergers and consolidations, substantial asset sales, investments and loans, certain corporate changes, transactions with affiliates, and fundamental changes. In April 2023, the Company received approximately $1.4 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to the Company’s participation in the New Jersey Technology Business Tax Certificate Transfer NOL program for tax year 2021. Going Concern The Company evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern within one year after the filing of this Quarterly Report on Form 10-Q in accordance with ASC 205-40. Since inception, the Company has experienced net losses and negative cash flows from operations each fiscal year. The Company has no revenues and expects to continue to incur operating losses for the foreseeable future and may never become profitable. The Company’s budgeted cash requirements in 2023 and beyond include expenses related to continuing development and clinical trials. The Company plans to execute its operating plan by obtaining additional capital, principally through entering into collaborations, strategic alliances, or license agreements with third parties and/or additional public or private debt and equity financing. However, there is no assurance that additional capital and/or financing will be available to the Company, and even if available, whether it will be on terms acceptable to the Company or its existing shareholders or in the amounts required. The Company may also enter into government funding programs and consider selectively partnering for clinical development and commercialization. The sale of additional equity would result in additional dilution to the Company’s stockholders. Incurring debt financing would result in debt service obligations, and the instruments governing such debt could provide for operating and financing covenants that would restrict its operations. If the Company is unsuccessful in securing sufficient financing, it may need to delay, reduce, or eliminate its research and development programs, which could adversely affect its business prospects, grant rights to third parties to develop and market immunotherapies that the Company would otherwise prefer to develop and market itself or cease operations. Any of these actions could harm its business, results of operations and prospects. Failure to obtain adequate financing also may adversely affect the Company’s ability to operate as a going concern. As a result of these uncertainties, and as its plans are outside of management’s control, the Company has concluded that substantial doubt exists about the Company’s ability to continue as a going concern for a period of at least 12 months from the date of the issuance of these unaudited condensed consolidated financial statements. The unaudited condensed consolidated financial statements do not include any adjustments to the carrying amounts and classifications of assets and liabilities that would result if the Company was unable to continue as a going concern. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value of Financial Instruments [Abstract] | |
Fair Value of Financial Instruments | Note 4 – Fair Value of Financial Instruments There were no transfers among Levels 1, 2, or 3 during the three and nine months ended September 30, 2023 or 2022. Fair Value Measurements at Reporting Date Using Total Quoted Prices in Active Markets (Level 1) Quoted Prices in Inactive Markets (Level 2) Significant Unobservable Inputs (Level 3) As of September 30 2023 Cash and cash equivalents $ 54,251,387 $ 54,251,387 $ – $ – As of December 31, 2022 Cash and cash equivalents $ 73,820,160 $ 73,820,160 $ – $ – The carrying value of the Note Payable approximated its fair value at September 30, 2023 due to its variable rate. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Leases | Note 5 – Leases Operating Lease: Effective March 5, 2020, the Company entered into a sublease for approximately 11,200 square feet of office space located at 25B Vreeland Road, Suite 300, Florham Park, NJ. The sublease commenced on May 1, 2020 and will continue for a term of forty (40) months with an option to renew through October 31, 2027. As of August 31, 2023 the lease term has expired and was not renewed. Upon inception of the sublease, the Company recognized approximately $0.7 million of a ROU asset and operating lease liabilities. The discount rate used to measure the operating lease liability as of May 1, 2020 was 9.15%. Throughout the period described above, the Company has maintained, and continues to maintain, a month-to-month lease for its research facilities at the Princeton Innovation Center BioLabs located at 303A College Road E, Princeton NJ, 08540. Supplemental cash flow information related to operating leases is as follows: As of September 30, 2023 2022 Cash paid for operating lease liabilities $ 239,469 $ 205,885 |
Leases | Financing Lease: The Company has financed certain laboratory equipment as follows: As of September 30, 2023 2022 Cash paid for finance lease liabilities $ 60,684 $ 306,487 Maturity of the Company’s financing lease liability is as follows: Year ended September 30, 2023 $ 17,464 2024 $ 69,850 2025 $ 69,850 2026 $ 40,108 2027 and after $ 26,724 Total future minimum lease payments 223,996 Less imputed interest (32,058 ) Remaining lease liability $ 191,938 The Company entered into four financing leases for laboratory equipment with a total cost of $251,959 with four |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Expenses [Abstract] | |
Accrued Expenses | Note 6 – Accrued Expenses Accrued expenses and other liabilities consist of the following: As of September 30, 2023 As of December 31, 2022 Accrued research and development $ 79,910 $ 5,645,737 Accrued professional fees 1,570,401 550,259 Accrued compensation 1,785,173 1,837,330 Accrued interest on debt 296,875 280,382 Accrued rent 368 - Total $ 3,732,727 $ 8,313,708 |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2023 | |
Stock-Based Compensation [Abstract] | |
Stock-Based Compensation | Note 7 – Stock-Based Compensation In 2014, the Company’s stockholders approved the 2014 Equity Incentive Plan pursuant to which the Company may grant up to 91,367 shares as ISOs, NQs and restricted stock units (“RSUs”), subject to increases as hereafter described (the “Plan Limit”). In addition, on January 1, 2015 and each January 1 thereafter and prior to the termination of the 2014 Equity Incentive Plan, pursuant to the terms of the 2014 Equity Incentive Plan, the Plan Limit was and shall be increased by the lesser of (x) 4% of the number of shares of Common Stock outstanding as of the immediately preceding December 31 and (y) such lesser number as the Board of Directors may determine in its discretion. In March 2019, the Plan was amended and restated which removed the annual increase component and was limited to 826,292 shares. As previously disclosed, on December 8, 2020, the Board of Directors of the Company adopted, subject to stockholder approval, the Second Amended and Restated PDS Biotechnology Corporation 2014 Equity Inventive Plan (the “Restated Plan”), which amended and restated the Amended and Restated PDS Biotechnology Corporation 2014 Equity Incentive Plan (the “Current Plan”). At the annual meeting of stockholders on June 17, 2021 the stockholders voted to approve the Restated Plan at the Annual Meeting. The Restated Plan is identical to the Current Plan in all material respects, except as follows: (a) the number of shares of Common Stock authorized for issuance under the Restated Plan will increase from 826,292 shares to 3,339,243 shares, plus the total number of shares that remained available for issuance, that are not covered by outstanding awards issued under the Current Plan, immediately prior to December 8, 2020; and (b) the Restated Plan will terminate on December 7, 2030, unless earlier terminated. On July 14, 2023, the Company’s stockholders approved an amendment to the Current Plan increasing the number of shares of common stock for issuance from 4,165,535 to 6,565,535 shares. As of September 30, 2023, there were 119,013 shares available for grant under the Restated Plan. In 2018, the Company’s stockholders approved the 2018 Stock Incentive Plan pursuant to which the Company may grant up to 558,071 shares as (i) Stock Options, (ii) Stock Appreciation Rights, (iii) Restricted Stock, (iv) Preferred Stock, (v) Stock Reload Options and/or (vi) Other Stock-Based Awards. As of September 30, 2023, there were 190,799 shares available for grant under the Restated Plan. Pursuant to the terms of the Plans, ISOs have a term of ten years from the date of grant or such shorter term as may be provided in the option agreement. Unless specified otherwise in an individual option agreement, ISOs generally vest over a four-year period. Unless terminated by the Board, the Plans shall continue to remain effective for a term of ten years or until such time as no further awards may be granted and all awards granted under the Plans are no longer outstanding. On June 17, 2019, the Board adopted the 2019 Inducement Plan (the “Inducement Plan”). The Inducement Plan provides for the grant of non-qualified stock options. The Inducement Plan was recommended for approval by the Compensation Committee of the Board and subsequently approved and adopted by the Board without stockholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules. On December 8, 2020, the Company amended the Inducement Plan solely to increase the total number of shares of Common Stock reserved for issuance under the Inducement Plan from 200,000 shares to 500,000 shares. The Company’s stock-based compensation expense related to stock options was recognized in operating expense as follows: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (unaudited) (unaudited) Stock-Based Compensation Research and development $ 782,249 $ 493,083 $ 2,389,561 $ 1,349,664 General and administrative 1,291,358 851,267 3,869,903 2,472,259 Total $ 2,073,607 $ 1,344,350 $ 6,259,464 $ 3,821,923 There were 59,500 and 1,214,000 of options granted during the three and nine month periods ended September 30, 2023, respectively and 87,000 and 1,526,005 of options granted during the three and nine month period ended September 30, 2022, respectively. The fair value of options granted during the three and nine months ended September 30, 2023 and 2022 was estimated using the Black-Scholes option valuation model utilizing the following assumptions. Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Weighted Average Weighted Average Weighted Average Weighted Average (unaudited) (unaudited) Volatility 150.26 % 101.43 % 142.47 % 99.56 % Risk-Free Interest Rate 3.92 % 3.03 % 4.04 % 1.70 % Expected Term in Years 5.59 6.08 6.06 6.41 Dividend Rate – – – – Fair Value of Option on Grant Date $ 4.77 $ 2.58 $ 10.35 $ 4.80 The following table summarizes the number of options outstanding and the weighted average exercise price: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Aggregate Intrinsic Value Options outstanding at December 31, 2022 4,171,311 $ 5.56 7.89 $ 32,779,920 Granted 1,214,000 11.14 Exercised (1,409 ) - Forfeited and expired - - Options outstanding at September 30, 2023 5,383,902 $ 6.82 7.63 $ 4,685,828 Vested and expected to vest at September 30, 2023 5,383,902 $ 6.82 7.63 $ 4,685,828 Exercisable at September 30, 2023 2,722,797 $ 5.72 6.67 $ 3,225,309 At September 30, 2023 there was approximately $18,568,032 of unamortized stock option compensation expense, which is expected to be recognized over a remaining average vesting period of 2.51 years. The Company entered into an agreement with DC Consulting for certain consulting services and issued 100,000 shares in connection with the agreement. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2023 | |
Income Taxes [Abstract] | |
Income Taxes | Note 8 – Income Taxes In assessing the realizability of the net deferred tax assets, the Company considers all relevant positive and negative evidence to determine whether it is more likely than not that some portion or all of the deferred income tax assets will not be realized. The realization of the gross deferred tax assets is dependent on several factors, including the generation of sufficient taxable income prior to the expiration of the net operating loss carryforwards. The Company expects to have a loss for 2023 no 30, 2023 2022 no The Company’s U.S. statutory rate is 21%. The primary factor impacting the effective tax rate for the three and nine months ended September 30, 2023 Entities are also required to evaluate, measure, recognize and disclose any uncertain income tax positions taken on their income tax returns. The Company has analyzed its tax positions and has concluded that as of September 30, 2023 30, 2023 2022. In accordance with the State of New Jersey’s Technology Business Tax Certificate Program, which allows certain high technology and biotechnology companies to sell unused NOL carryforwards to other New Jersey-based corporate taxpayers, the Company sold New Jersey NOL carryforwards, resulting in the recognition of $1.4 million and $1.2 million of income tax benefit, net of transaction costs in the nine months ended September 30, 2023 and 2022, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | Note 9 – Commitments and Contingencies Rent For month-to-month arrangements not impacted by the adoption of ASC 842, rent for the three and nine months ended September 30, 2023 was $106,171 and $359,373 respectively, compared to the three and nine months ended September 30, 2022 of $55,500 and $165,500. Exclusive License Agreement In January 2023, we entered into an exclusive global license agreement with Merck KGaA, Darmstadt, Germany for the tumor targeting IL 12 fused drug conjugate (i) development and first commercial sale milestone payments totaling up to $11 million upon the achievement of certain milestones, including the dosing of the fifth patient in a Phase 3 trial of the clinical candidate and first commercial sale of the product for a first and second indication in a major market, and (ii) up to $105 million upon achieving certain aggregate sales levels of the product. The Company also agreed to pay Merck KGaA, Darmstadt, Germany a royalty of 10% on aggregate net sales of product as specified in the Merck KGaA License Agreement on a product-by-product and country-by-country basis until the later of: (i) ten years after the first commercial sale of a product in a given country; and (ii) the expiration or invalidation of the licensed patents covering the compound or product in such country. The royalty rate is subject to reduction in that event that a product is not covered by a valid patent claim, a biosimilar to the compound or the product comes on the market in a particular country, or if the Company obtains a license to any intellectual property owned or controlled by a third-party, but for which such license would be infringed by making, using or selling the compound. Legal Proceedings The Company is currently not a party to, and the Company’s property is not currently the subject of, any material legal proceedings. |
Venture Loan and Security Agree
Venture Loan and Security Agreement | 9 Months Ended |
Sep. 30, 2023 | |
Venture Loan and Security Agreement [Abstract] | |
Venture Loan and Security Agreement | Note 10 – Venture Loan and Security Agreement In August 2022, the Company entered into a Venture Loan and Security Agreement (the “Loan and Security Agreement”) with Horizon Technology Finance Corporation, as a lender and collateral agent for itself and the other Lenders (in such capacity, the “Collateral Agent”), and the other persons party thereto from time to time as lenders (“Lenders”). Term loan Amounts . The Loan and Security Agreement provides for the following six (6) separate and independent term loans: (a) a term loan in the amount of $7,500,000 (“Loan A”), (b) a term loan in the amount of $10,000,000 (“Loan B”), (c) a term loan in the amount of $3,750,000 (“Loan C”), (d) a term loan in the amount of $3,750,000 (“Loan D”), (e) a term loan in the amount of $5,000,000 (“Loan E”), and (f) a term loan in the amount of $5,000,000 (“Loan F”) (with each of Loan A, Loan B, Loan C, Loan D, Loan E, and Loan F, individually a “Loan” and, collectively, the “Loans”). Loan A, Loan B, Loan C, and Loan D were delivered to the Company on August 24, 2022. Loan E and Loan F were uncommitted Loans that could have been advanced by the Lenders upon the parties agreement prior to July 31, 2023 upon the satisfaction by the Company of certain agreed upon conditions. At time the has expired and Loan E and Loan F are longer available under the Loan and Security Agreement The Company may only use the proceeds of the Loans for working capital or general corporate purposes. Maturity Company Interest Rate . The principal balance of each Loan bears a floating interest. The interest rate is calculated initially and, thereafter, each calendar month as the sum of (a) the per annum rate of interest from time to time published in The Wall Street Journal as contemplated by the Loan and Security Agreement, or any successor publication thereto, as the “prime rate” then in effect, plus (b) 5.75%; provided that, in the event such rate of interest is less than 4.00%, such rate shall be deemed to be 4.00% for purposes of calculating the interest rate. Interest is payable on a monthly basis based on each Loan principal amount outstanding the preceding month. Amortization. Each Loan shall commence amortization upon the date set forth on the promissory note executed in connection with the respective Loan, upon which the Company Prepayment Premium. The Company plus plus Security . The Company’s obligations are secured by a security interest in all of the assets of the Company, subject to limited exceptions and excluding the Company’s intellectual property. Covenants; Representations and Warranties; Other Provisions . The Loan and Security Agreement contains customary representations, warranties and covenants, including covenants by the Company limiting additional indebtedness, liens, including on intellectual property, guaranties, mergers and consolidations, substantial asset sales, investments and loans, certain corporate changes, transactions with affiliates, and fundamental changes. Default Provisions . The Loan and Security Agreement provides for events of default customary for term loans of this type, including but not limited to non-payment, breaches or defaults in the performance of covenants, insolvency, and bankruptcy by and/or of the Company. Warrant and Debt Discount. In connection with the Loan and Security Agreement, the Company issued Horizon Technology Finance Corporation and Powerscourt Investments XXV, LP warrants to purchase an aggregate total of 381,625 shares of the Company’s common stock at an initial exercise price of $3.6685 per share. Each warrant is classified as equity and is exercisable at any time for a period beginning on the date of grant and ending on the earlier of (A) 10 years from the date of grant, and (B) the closing of (A) (i) the sale, lease, exchange, conveyance or other disposition of all or substantially all of the Company’s property or business, or (ii) its merger into or consolidation with any other corporation (other than a wholly-owned subsidiary of the Company), or any transaction (including a merger or other reorganization) or series of related transactions, in which more than 50% of the voting power of the Company is disposed of, in each case, for cash or for marketable securities meeting certain requirements as described in the applicable warrants. The key assumptions used in the Black-Scholes option pricing model were (i) expected term of 10 3.11% 93.8% no |
Retirement Plan
Retirement Plan | 9 Months Ended |
Sep. 30, 2023 | |
Retirement Plan [Abstract] | |
Retirement Plan | Note 11 – Retirement Plan The Company has a 401(k) defined contribution plan for the benefit for all employees and permits voluntary contributions by employees subject to IRS-imposed limitations. The 401(k) employer contributions were $32,861 and $164,631 for the three and nine months ended September 30, 2023, respectively, compared to the three and nine months ended September 30, 2022 of $31,515 and $119,232 respectively . |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Sep. 30, 2023 | |
Insider Trading Arrangements [Line Items] | |
Rule 10b5-1 Arrangement Adopted [Flag] | false |
Non-Rule 10b5-1 Arrangement Adopted [Flag] | false |
Rule 10b5-1 Arrangement Terminated [Flag] | false |
Non-Rule 10b5-1 Arrangement Terminated [Flag] | false |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Summary of Significant Accounting Policies [Abstract] | |
Unaudited Interim Financial Statements | (A) Unaudited interim financial statements: The interim balance sheet at September 30, 2023, the statements of operations and comprehensive loss and changes in stockholders’ equity and cash flows for the three and nine months ended September 30, 2023 and 2022 are unaudited. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. GAAP, in accordance with the requirements of the Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted. These condensed consolidated financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments that are necessary for a fair statement of its financial information. The results of operations for the three and nine months ended September 30, 2023 are not necessarily indicative of the results to be expected for the year ending December 31, 2023 or for any other future annual or interim period. The balance sheet as of December 31, 2022 included herein was derived from the audited consolidated financial statements as of that date. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and notes thereto as of and for the year ended December 31, 2022, filed by the Company with the SEC in its Annual Report on Form 10-K on March 28, 2023. |
Use of Estimates | (B) Use of estimates: The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of expenses at the date of the consolidated financial statements and during the reporting periods, and to disclose contingent assets and liabilities at the date of the consolidated financial statements. Actual results could differ from those estimates. The most significant estimate relates to the fair value of securities underlying stock-based compensation. |
Significant Risks and Uncertainties | (C) Significant risks and uncertainties: The Company’s operations are subject to a number of factors that may affect its operating results and financial condition. Such factors include, but are not limited to: the clinical and regulatory development of its clinical candidates, the ability to preserve its cash resources, the Company’s review of strategic alternatives, the ability to add clinical candidates to its pipeline, the Company’s intellectual property, the ability to efficiently and effectively conduct its clinical trials, competition from products manufactured and sold or being developed by other companies, the price of, and demand for, Company products if approved for sale, the ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products, the ability to raise capital, and the effects of health epidemics, pandemics, or outbreaks of infectious diseases. The Company currently has no commercially approved products. As such, there can be no assurance that the Company’s future research and development programs will be successfully commercialized. Developing and commercializing a product requires significant time and capital and is subject to regulatory review and approval as well as competition from other biotechnology and pharmaceutical companies. The Company operates in an environment of rapid change and is dependent upon the continued services of its employees and consultants and obtaining and protecting its intellectual property. |
Cash Equivalents and Concentration of Cash Balance | (D) Cash equivalents and concentration of cash balance: The Company considers all highly liquid securities with a maturity weighted average of less than three months to be cash equivalents. The Company’s cash and cash equivalents in bank deposit accounts, at times, may exceed federally insured limits. |
Research and Development | (E) Research and development: Costs incurred in connection with research and development activities are expensed as incurred. These costs include licensing fees to use certain technology in the Company’s research and development projects as well as fees paid to consultants and entities that perform certain research and testing on behalf of the Company. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data, such as patient enrollment, clinical trial site activations or information provided by vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred. |
Patent Costs | (F) Patent costs: The Company expenses patent costs as incurred and classifies such costs as general and administrative expenses in the accompanying statements of operations and comprehensive loss. |
Stock-Based Compensation | (G) Stock-based compensation: The Company accounts for its stock-based compensation in accordance with ASC Topic 718, Compensation—Stock Compensation (“ASC 718”). ASC 718 requires all stock-based payments to employees, directors and non-employees to be recognized as expense in the consolidated statements of operations and comprehensive loss based on their grant date fair values. In order to determine the fair value of stock options on the date of grant, the Company uses the Black-Scholes option-pricing model. Inherent in this model are assumptions related to expected stock-price volatility, option term, risk-free interest rate and dividend yield. The Company expenses the fair value of its stock-based compensation awards to employees and directors on a straight-line basis over the requisite service period, which is generally the vesting period. The Company recognizes forfeitures as they occur. |
Net Loss per Common Share | (H) Net loss per common share: Basic and diluted net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted average common shares outstanding during the period. For all periods presented, the common shares underlying the stock options and warrants have been excluded from the calculation because their effect would be anti-dilutive. Therefore, the weighted average shares outstanding used to calculate both basic and diluted loss per common share is the same. The potentially dilutive securities excluded from the determination of diluted loss per share as their effect is antidilutive, are as follows: As of September 30, 2023 2022 Stock options to purchase Common Stock 5,383,902 4,370,846 Warrants to purchase Common Stock 506,229 506,229 Total 5,890,131 4,877,075 |
Income Taxes | (I) Income taxes: The Company provides for deferred income taxes under the asset and liability method, which requires deferred tax assets and liabilities to be recognized for the future tax consequences attributable to net operating loss carryforwards and for differences between the financial statement carrying amounts and the respective tax bases of assets and liabilities. Deferred tax assets are reduced if necessary, by a valuation allowance if it is more likely than not that some portion or all of the deferred tax assets will not be realized. |
Fair Value of Financial Instruments | (J) Fair value of financial instruments: ASC 820, Fair Value Measurement, specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The three levels of the fair value hierarchy are as follows: ● Level 1 — Unadjusted quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities. ● Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly (e.g., quoted prices of similar assets or liabilities in active markets, or quoted prices for identical or similar assets or liabilities in markets that are not active). Level 2 includes financial instruments that are valued using models or other valuation methodologies. ● Level 3 — Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable. |
Leases | (K) Leases: The Company determines if an arrangement is a lease at inception and recognizes the lease in accordance with ASC 842, Leases (“ASC 842”). Both financing and operating leases are included in right-of-use (“ROU”) assets, lease obligation-short term and lease obligation-long term in the Company’s consolidated balance sheets. ROU assets represent the right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. The ROU assets and lease liabilities are recognized at the lease commencement date based on the present value of the lease payments over the lease term. The Company determines the portion of the lease liability that is current as the difference between the calculated lease liability at the end of the current period and the lease liability that is projected 12 months from the current period. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Summary of Significant Accounting Policies [Abstract] | |
Antidilutive Securities | The potentially dilutive securities excluded from the determination of diluted loss per share as their effect is antidilutive, are as follows: As of September 30, 2023 2022 Stock options to purchase Common Stock 5,383,902 4,370,846 Warrants to purchase Common Stock 506,229 506,229 Total 5,890,131 4,877,075 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value of Financial Instruments [Abstract] | |
Fair Value of Financial Instruments | Fair Value Measurements at Reporting Date Using Total Quoted Prices in Active Markets (Level 1) Quoted Prices in Inactive Markets (Level 2) Significant Unobservable Inputs (Level 3) As of September 30 2023 Cash and cash equivalents $ 54,251,387 $ 54,251,387 $ – $ – As of December 31, 2022 Cash and cash equivalents $ 73,820,160 $ 73,820,160 $ – $ – |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Supplemental Cash Flow Information Related to Operating Leases | Supplemental cash flow information related to operating leases is as follows: As of September 30, 2023 2022 Cash paid for operating lease liabilities $ 239,469 $ 205,885 |
Supplemental Cash Flow Information Related to Financing Lease | The Company has financed certain laboratory equipment as follows: As of September 30, 2023 2022 Cash paid for finance lease liabilities $ 60,684 $ 306,487 |
Future Payments for Financing Lease Liability | Maturity of the Company’s financing lease liability is as follows: Year ended September 30, 2023 $ 17,464 2024 $ 69,850 2025 $ 69,850 2026 $ 40,108 2027 and after $ 26,724 Total future minimum lease payments 223,996 Less imputed interest (32,058 ) Remaining lease liability $ 191,938 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Expenses [Abstract] | |
Accrued Expenses and Other Liabilities | Accrued expenses and other liabilities consist of the following: As of September 30, 2023 As of December 31, 2022 Accrued research and development $ 79,910 $ 5,645,737 Accrued professional fees 1,570,401 550,259 Accrued compensation 1,785,173 1,837,330 Accrued interest on debt 296,875 280,382 Accrued rent 368 - Total $ 3,732,727 $ 8,313,708 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Stock-Based Compensation [Abstract] | |
Stock-Based Compensation Expense | The Company’s stock-based compensation expense related to stock options was recognized in operating expense as follows: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (unaudited) (unaudited) Stock-Based Compensation Research and development $ 782,249 $ 493,083 $ 2,389,561 $ 1,349,664 General and administrative 1,291,358 851,267 3,869,903 2,472,259 Total $ 2,073,607 $ 1,344,350 $ 6,259,464 $ 3,821,923 |
Assumptions Used to Value Stock Options Granted | There were 59,500 and 1,214,000 of options granted during the three and nine month periods ended September 30, 2023, respectively and 87,000 and 1,526,005 of options granted during the three and nine month period ended September 30, 2022, respectively. The fair value of options granted during the three and nine months ended September 30, 2023 and 2022 was estimated using the Black-Scholes option valuation model utilizing the following assumptions. Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Weighted Average Weighted Average Weighted Average Weighted Average (unaudited) (unaudited) Volatility 150.26 % 101.43 % 142.47 % 99.56 % Risk-Free Interest Rate 3.92 % 3.03 % 4.04 % 1.70 % Expected Term in Years 5.59 6.08 6.06 6.41 Dividend Rate – – – – Fair Value of Option on Grant Date $ 4.77 $ 2.58 $ 10.35 $ 4.80 |
Stock Option Activity | The following table summarizes the number of options outstanding and the weighted average exercise price: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Aggregate Intrinsic Value Options outstanding at December 31, 2022 4,171,311 $ 5.56 7.89 $ 32,779,920 Granted 1,214,000 11.14 Exercised (1,409 ) - Forfeited and expired - - Options outstanding at September 30, 2023 5,383,902 $ 6.82 7.63 $ 4,685,828 Vested and expected to vest at September 30, 2023 5,383,902 $ 6.82 7.63 $ 4,685,828 Exercisable at September 30, 2023 2,722,797 $ 5.72 6.67 $ 3,225,309 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) - shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Net Loss per Common Share [Abstract] | ||
Antidilutive impact to EPS (in shares) | 5,890,131 | 4,877,075 |
Stock Options to Purchase Common Stock [Member] | ||
Net Loss per Common Share [Abstract] | ||
Antidilutive impact to EPS (in shares) | 5,383,902 | 4,370,846 |
Warrants to Purchase Common Stock [Member] | ||
Net Loss per Common Share [Abstract] | ||
Antidilutive impact to EPS (in shares) | 506,229 | 506,229 |
Liquidity (Details)
Liquidity (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Apr. 30, 2023 USD ($) | Aug. 31, 2022 USD ($) | Apr. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) Loan shares | Sep. 30, 2023 USD ($) Loan shares | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) shares | |
Liquidity [Abstract] | |||||||
Cash and cash equivalents | $ 54,251,387 | $ 54,251,387 | $ 73,820,160 | ||||
Proceeds from sale of tax benefits | $ 1,400,000 | $ 1,200,000 | |||||
Registered securities in Shelf Registration Statement available for future sale | $ 150,000,000 | ||||||
Placement Shares included in at-the-market offering program | $ 50,000,000 | ||||||
Commission paid on Placement Shares sold | 3% | ||||||
Issuance of common stock (in shares) | shares | 139,575 | 736,037 | 1,238,491 | ||||
Proceeds from issuance of shares | $ 800,000 | $ 5,647,467 | $ 0 | $ 9,900,000 | |||
Term Loans [Member] | |||||||
Liquidity [Abstract] | |||||||
Number of independent term loans | Loan | 6 | 6 | |||||
Term | 48 months | ||||||
Period after October 1, 2024 for making monthly payments on principal balance | 24 months | ||||||
Prepayment premium paid if loan is prepaid on or before Loan Amortization date | 3% | ||||||
Threshold period after Loan Amortization Date used to determine prepayment premiums | 12 months | ||||||
Prepayment premium paid if load is prepaid after Loan Amortization date, but on or before date that is 12 months after such Loan Amortization Date | 2% | ||||||
Prepayment premium paid if loan is prepaid more than 12 months after Loan Amortization Date but prior to stated Maturity Date. | 1% | ||||||
Prepayment premium paid if loan is paid on stated maturity date | 0% | ||||||
Term Loans [Member] | Minimum [Member] | |||||||
Liquidity [Abstract] | |||||||
Minimum base rate used to compute floating interest rate | 4% | ||||||
Written notice period for prepayment of outstanding loan | 10 days | ||||||
Term Loans [Member] | Prime Rate [Member] | |||||||
Liquidity [Abstract] | |||||||
Margin on variable rate | 5.75% | ||||||
Loan A [Member] | |||||||
Liquidity [Abstract] | |||||||
Face amount | $ 7,500,000 | ||||||
Loan B [Member] | |||||||
Liquidity [Abstract] | |||||||
Face amount | 10,000,000 | ||||||
Loan C [Member] | |||||||
Liquidity [Abstract] | |||||||
Face amount | 3,750,000 | ||||||
Loan D [Member] | |||||||
Liquidity [Abstract] | |||||||
Face amount | $ 3,750,000 | ||||||
Loan E [Member] | |||||||
Liquidity [Abstract] | |||||||
Uncommitted loan | $ 5,000,000 | $ 5,000,000 | |||||
Loan F [Member] | |||||||
Liquidity [Abstract] | |||||||
Uncommitted loan | $ 5,000,000 | $ 5,000,000 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Fair Value of Financial Instruments [Abstract] | ||
Cash and cash equivalents | $ 54,251,387 | $ 73,820,160 |
Quoted Prices in Active Markets (Level 1) [Member] | ||
Fair Value of Financial Instruments [Abstract] | ||
Cash and cash equivalents | 54,251,387 | 73,820,160 |
Quoted Prices in Inactive Markets (Level 2) [Member] | ||
Fair Value of Financial Instruments [Abstract] | ||
Cash and cash equivalents | 0 | 0 |
Significant Unobservable Inputs (Level 3) [Member] | ||
Fair Value of Financial Instruments [Abstract] | ||
Cash and cash equivalents | $ 0 | $ 0 |
Leases, Operating Lease (Detail
Leases, Operating Lease (Details) | 9 Months Ended | |||
Sep. 30, 2023 USD ($) ft² | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | May 01, 2020 USD ($) | |
Operating Lease [Abstract] | ||||
Area of office space under sublease | ft² | 11,200 | |||
Term of sublease agreement | 40 months | |||
Right-of-use asset | $ 0 | $ 152,645 | $ 700,000 | |
Operating lease liability | $ 700,000 | |||
Discount rate used to measure operating lease liability | 9.15% | |||
Supplemental Cash Flow Information Related to Operating Leases [Abstract] | ||||
Cash paid for operating lease liabilities | $ 239,469 | $ 205,885 |
Leases, Financing Lease (Detail
Leases, Financing Lease (Details) | 9 Months Ended | |
Sep. 30, 2023 USD ($) Lease | Sep. 30, 2022 USD ($) | |
Supplemental Cash Flow Information Related to Finance Lease [Abstract] | ||
Cash paid for finance lease liabilities | $ 60,684 | $ 306,487 |
Future Payments for Finance Lease Liabilities [Abstract] | ||
2023 | 17,464 | |
2024 | 69,850 | |
2025 | 69,850 | |
2026 | 40,108 | |
2027 and after | 26,724 | |
Total future minimum lease payments | 223,996 | |
Less imputed interest | (32,058) | |
Remaining lease liability | $ 191,938 | |
Financing Lease [Abstract] | ||
Number of financing leases entered into | Lease | 4 | |
Total cost of financing leases | $ 251,959 | |
Finance lease liability capitalized interest rate | 9.15% | |
Aggregate monthly rental payments | $ 6,000 | |
Recognition of property and equipment from bargain purchase option | $ 151,490 | |
Minimum [Member] | ||
Financing Lease [Abstract] | ||
Term of financing lease | 4 years | |
Maximum [Member] | ||
Financing Lease [Abstract] | ||
Term of financing lease | 5 years |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Accrued Expenses [Abstract] | ||
Accrued research and development | $ 79,910 | $ 5,645,737 |
Accrued professional fees | 1,570,401 | 550,259 |
Accrued compensation | 1,785,173 | 1,837,330 |
Accrued interest on debt | 296,875 | 280,382 |
Accrued rent | 368 | 0 |
Total | $ 3,732,727 | $ 8,313,708 |
Stock-Based Compensation, Equit
Stock-Based Compensation, Equity Compensation Plans (Details) - shares | 9 Months Ended | 12 Months Ended | |||||||||
Sep. 30, 2023 | Dec. 31, 2014 | Jul. 14, 2023 | Jul. 13, 2023 | May 17, 2022 | May 16, 2022 | Jun. 17, 2021 | Dec. 08, 2020 | Dec. 07, 2020 | Mar. 31, 2019 | Dec. 31, 2018 | |
The Plans [Member] | |||||||||||
Stock Options [Abstract] | |||||||||||
Term of plan | 10 years | ||||||||||
The Plans [Member] | Incentive Stock Options [Member] | |||||||||||
Stock Options [Abstract] | |||||||||||
Vesting period | 4 years | ||||||||||
The Plans [Member] | Incentive Stock Options [Member] | Maximum [Member] | |||||||||||
Stock Options [Abstract] | |||||||||||
Term of option | 10 years | ||||||||||
2014 Equity Incentive Plan [Member] | |||||||||||
Stock Options [Abstract] | |||||||||||
Number of shares authorized for issuance (in shares) | 91,367 | 6,565,535 | 4,165,535 | 3,339,243 | 826,292 | ||||||
Percentage of Common Stock outstanding used to determine annual increase in the plan limit | 4% | ||||||||||
Shares available for grant (in shares) | 119,013 | ||||||||||
2018 Equity Incentive Plan [Member] | |||||||||||
Stock Options [Abstract] | |||||||||||
Number of shares authorized for issuance (in shares) | 558,071 | ||||||||||
Shares available for grant (in shares) | 190,799 | ||||||||||
2019 Inducement Plan [Member] | |||||||||||
Stock Options [Abstract] | |||||||||||
Shares available for grant (in shares) | 185,315 | ||||||||||
Common stock reserved for issuance (in shares) | 1,100,000 | 500,000 | 500,000 | 200,000 |
Stock-Based Compensation, Stock
Stock-Based Compensation, Stock-Based Compensation Expense (Details) - Stock Options [Member] - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Stock-Based Compensation [Abstract] | ||||
Stock-based compensation expense | $ 2,073,607 | $ 1,344,350 | $ 6,259,464 | $ 3,821,923 |
Research and Development [Member] | ||||
Stock-Based Compensation [Abstract] | ||||
Stock-based compensation expense | 782,249 | 493,083 | 2,389,561 | 1,349,664 |
General and Administrative [Member] | ||||
Stock-Based Compensation [Abstract] | ||||
Stock-based compensation expense | $ 1,291,358 | $ 851,267 | $ 3,869,903 | $ 2,472,259 |
Stock-Based Compensation, Assum
Stock-Based Compensation, Assumptions Used to Value Stock Options and Warrants Granted (Details) - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Assumptions Used in Determining Fair Value of Stock Options and Warrants Granted [Abstract] | ||||
Volatility | 150.26% | 101.43% | 142.47% | 99.56% |
Risk-free interest rate | 3.92% | 3.03% | 4.04% | 1.70% |
Expected term | 5 years 7 months 2 days | 6 years 29 days | 6 years 21 days | 6 years 4 months 28 days |
Dividend rate | 0% | 0% | 0% | 0% |
Fair value of option on grant date (in dollars per share) | $ 4.77 | $ 2.58 | $ 10.35 | $ 4.8 |
Stock Options [Member] | ||||
Stock-Based Compensation [Abstract] | ||||
Options granted (in shares) | 59,500 | 87,000 | 1,214,000 | 1,526,005 |
Stock-Based Compensation, Sto_2
Stock-Based Compensation, Stock Option Activity (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||
Sep. 30, 2023 | Jun. 30, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Common Stock [Member] | ||||||||
Number of Shares [Roll Forward] | ||||||||
Exercised (in shares) | (1,409) | (7,794) | (2,282) | |||||
Unamortized Stock Compensation Expense [Abstract] | ||||||||
Shares issued for consulting services (in shares) | 100,000 | 100,000 | ||||||
Stock Options [Member] | ||||||||
Number of Shares [Roll Forward] | ||||||||
Options outstanding, beginning balance (in shares) | 4,171,311 | |||||||
Granted (in shares) | 59,500 | 87,000 | 1,214,000 | 1,526,005 | ||||
Exercised (in shares) | (1,409) | |||||||
Forfeited and expired (in shares) | 0 | |||||||
Options outstanding, ending balance (in shares) | 5,383,902 | 5,383,902 | 4,171,311 | |||||
Vested and expected to vest (in shares) | 5,383,902 | 5,383,902 | ||||||
Exercisable (in shares) | 2,722,797 | 2,722,797 | ||||||
Weighted Average Exercise Price [Roll Forward] | ||||||||
Options outstanding, beginning balance (in dollars per share) | $ 5.56 | |||||||
Granted (in dollars per share) | 11.14 | |||||||
Exercised (in dollars per share) | 0 | |||||||
Forfeited and expired (in dollars per share) | 0 | |||||||
Options outstanding, ending balance (in dollars per share) | $ 6.82 | 6.82 | $ 5.56 | |||||
Vested and expected to vest (in dollars per share) | 6.82 | 6.82 | ||||||
Exercisable (in dollars per share) | $ 5.72 | $ 5.72 | ||||||
Weighted Average Remaining Contractual Life and Aggregate Intrinsic Value [Abstract] | ||||||||
Options outstanding, weighted average remaining contractual life | 7 years 7 months 17 days | 7 years 10 months 20 days | ||||||
Vested and expected to vest, weighted average remaining contractual life | 7 years 7 months 17 days | |||||||
Exercisable, weighted average remaining contractual life | 6 years 8 months 1 day | |||||||
Options outstanding, aggregate intrinsic value | $ 32,779,920 | |||||||
Options outstanding, aggregate intrinsic value | $ 4,685,828 | 4,685,828 | $ 32,779,920 | |||||
Vested and expected to vest, aggregate intrinsic value | 4,685,828 | 4,685,828 | ||||||
Exercisable, aggregate intrinsic value | 3,225,309 | 3,225,309 | ||||||
Unamortized Stock Compensation Expense [Abstract] | ||||||||
Unamortized stock compensation expense | $ 18,568,032 | $ 18,568,032 | ||||||
Period for recognition | 2 years 6 months 3 days |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Income Taxes [Abstract] | |||||
Current income tax expense | $ 0 | ||||
Income tax benefit due to realization uncertainties | $ 0 | ||||
Federal statutory rate | 21% | 21% | |||
Uncertain tax positions | $ 0 | $ 0 | |||
Unrecognized tax benefits | 0 | 0 | $ 0 | ||
Accrued interest and penalties | 0 | 0 | $ 0 | ||
Benefit from income taxes | $ 0 | $ 0 | $ (1,406,021) | $ (1,198,905) |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Commitments and Contingencies [Abstract] | ||||
Rent expense | $ 106,171 | $ 55,500 | $ 359,373 | $ 165,500 |
Merck KGaA License Agreement [Member] | ||||
Commitments and Contingencies [Abstract] | ||||
Milestone payments for development and first commercial sales | 11,000,000 | $ 11,000,000 | ||
Royalty percentage paid on net sales of product | 10% | |||
Term of royalty payment | 10 years | |||
Merck KGaA License Agreement [Member] | Maximum [Member] | ||||
Commitments and Contingencies [Abstract] | ||||
Milestone payments for aggregate sales levels of product | $ 105,000,000 | $ 105,000,000 |
Venture Loan and Security Agr_2
Venture Loan and Security Agreement (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 USD ($) Loan | Sep. 30, 2023 USD ($) Loan | Sep. 30, 2022 USD ($) | Aug. 31, 2022 USD ($) $ / shares shares | |
Venture Loan and Security Agreement [Abstract] | ||||
Number of shares of common stock that can be purchased with warrants (in shares) | shares | 381,625 | |||
Exercise price of warrants (in dollars per share) | $ / shares | $ 3.6685 | |||
Term of warrants | 10 years | 10 years | ||
Debt issuance costs | $ 0 | $ 449,329 | ||
Unamortized debt discount | $ 2,524,736 | 2,524,736 | ||
Interest expense | 1,064,300 | 3,016,572 | ||
Amortization of debt discount | $ 158,397 | $ 391,920 | $ 72,722 | |
Minimum [Member] | ||||
Venture Loan and Security Agreement [Abstract] | ||||
Percentage of voting power disposed off | 50% | |||
Expected Term [Member] | ||||
Venture Loan and Security Agreement [Abstract] | ||||
Term of warrants | 10 years | 10 years | ||
Risk-free Rate [Member] | ||||
Venture Loan and Security Agreement [Abstract] | ||||
Warrants measurement input | 0.0311 | 0.0311 | ||
Expected Volatility [Member] | ||||
Venture Loan and Security Agreement [Abstract] | ||||
Warrants measurement input | 0.938 | 0.938 | ||
Estimated Dividend Yield [Member] | ||||
Venture Loan and Security Agreement [Abstract] | ||||
Warrants measurement input | 0 | 0 | ||
Term Loans [Member] | ||||
Venture Loan and Security Agreement [Abstract] | ||||
Number of independent term loans | Loan | 6 | 6 | ||
Term | 48 months | |||
Prepayment premium paid if loan is prepaid on or before Loan Amortization date | 3% | |||
Threshold period after Loan Amortization Date used to determine prepayment premiums | 12 months | |||
Prepayment premium paid if load is prepaid after Loan Amortization date, but on or before date that is 12 months after such Loan Amortization Date | 2% | |||
Prepayment premium paid if loan is prepaid more than 12 months after Loan Amortization Date but prior to stated Maturity Date. | 1% | |||
Prepayment premium paid if loan is paid on stated maturity date | 0% | |||
Term Loans [Member] | Minimum [Member] | ||||
Venture Loan and Security Agreement [Abstract] | ||||
Minimum base rate used to compute floating interest rate | 4% | |||
Written notice period for prepayment of outstanding loan | 10 days | |||
Term Loans [Member] | Prime Rate [Member] | ||||
Venture Loan and Security Agreement [Abstract] | ||||
Margin on variable rate | 5.75% | |||
Loan A [Member] | ||||
Venture Loan and Security Agreement [Abstract] | ||||
Face amount | $ 7,500,000 | |||
Loan B [Member] | ||||
Venture Loan and Security Agreement [Abstract] | ||||
Face amount | 10,000,000 | |||
Loan C [Member] | ||||
Venture Loan and Security Agreement [Abstract] | ||||
Face amount | 3,750,000 | |||
Loan D [Member] | ||||
Venture Loan and Security Agreement [Abstract] | ||||
Face amount | $ 3,750,000 | |||
Loan E [Member] | ||||
Venture Loan and Security Agreement [Abstract] | ||||
Uncommitted loan | $ 5,000,000 | $ 5,000,000 | ||
Loan F [Member] | ||||
Venture Loan and Security Agreement [Abstract] | ||||
Uncommitted loan | $ 5,000,000 | $ 5,000,000 |
Retirement Plan (Details)
Retirement Plan (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Retirement Plan [Abstract] | ||||
401(k) employer contributions | $ 32,861 | $ 31,515 | $ 164,631 | $ 119,232 |