PDS Biotechnology (PDSB) 10-Q 15 May 24 2024 Q1 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	3 Months Ended
	Mar. 31, 2024	May 08, 2024
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Quarterly Report	true
Document Period End Date	Mar. 31, 2024
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q1
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		36,679,275

Condensed Consolidated Balance

Condensed Consolidated Balance Sheets - USD ($)	Mar. 31, 2024	Dec. 31, 2023
Current assets:
Cash and cash equivalents	$ 66,634,417	$ 56,560,517
Prepaid expenses and other assets	2,051,348	2,494,558
Total current assets	68,685,765	59,055,075
Property and equipment, net	129,398	134,132
Financing lease right-to-use assets	191,203	200,873
Total assets	69,006,366	59,390,080
Current liabilities:
Accounts payable	6,000,831	6,982,824
Accrued expenses	1,714,111	2,424,692
Note payable - short term	7,291,667	4,166,667
Financing lease obligation-short term	57,081	55,794
Total current liabilities	15,063,690	13,629,977
Noncurrent liabilities:
Notes payable, net of debt discount	16,651,420	19,506,183
Financing lease obligation-long term	108,211	122,973
Total liabilities	31,823,321	33,259,133
STOCKHOLDERS' EQUITY
Common stock, $0.00033 par value, 75,000,000 shares authorized at March 31, 2024 and December 31, 2023, 36,679,275 shares and 33,094,521 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively	12,104	10,921
Additional paid-in capital	192,275,033	170,620,641
Accumulated deficit	(155,104,092)	(144,500,615)
Total stockholders' equity	37,183,045	26,130,947
Total liabilities and stockholders' equity	$ 69,006,366	$ 59,390,080

Condensed Consolidated Balanc_2

Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	Mar. 31, 2024	Dec. 31, 2023
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)	36,679,275	33,094,521
Common stock shares outstanding (in shares)	36,679,275	33,094,521

Condensed Consolidated Statemen

Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($)	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Operating expenses:
Research and development expenses	$ 6,704,164	$ 5,843,686
General and administrative expenses	3,393,463	3,578,728
Total operating expenses	10,097,627	9,422,414
Loss from operations	(10,097,627)	(9,422,414)
Interest income (expenses), net
Interest income	668,895	729,341
Interest expense	(1,174,745)	(966,845)
Interest income (expense), net	(505,850)	(237,504)
Net loss	(10,603,477)	(9,659,918)
Comprehensive loss	$ (10,603,477)	$ (9,659,918)
Per share information:
Net loss per share, basic (in dollars per share)	$ (0.3)	$ (0.32)
Net loss per share, diluted (in dollars per share)	$ (0.3)	$ (0.32)
Weighted average common shares outstanding, basic (in shares)	34,815,870	30,428,053
Weighted average common shares outstanding, diluted (in shares)	34,815,870	30,428,053

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, 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			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]
Issuances of common stock from the Sales Agreement, net (in shares)				2,642,269
Balance at Dec. 31, 2023	$ 10,921	170,620,641	(144,500,615)	$ 26,130,947
Balance (in shares) at Dec. 31, 2023	33,094,521
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Stock-based compensation expense	$ 0	1,630,011	0	1,630,011
Issuances of common stock from the Sales Agreement, net	$ 1,131	19,493,342	0	$ 19,494,473
Issuances of common stock from the Sales Agreement, net (in shares)	3,428,681			3,428,681
Issuances of common stock, from exercise of stock options	$ 52	531,039	0	$ 531,091
Issuances of common stock, from exercise of stock options (in shares)	156,073
Net loss	$ 0	0	(10,603,477)	(10,603,477)
Balance at Mar. 31, 2024	$ 12,104	$ 192,275,033	$ (155,104,092)	$ 37,183,045
Balance (in shares) at Mar. 31, 2024	36,679,275

Condensed Consolidated Statem_3

Condensed Consolidated Statements of Cash Flows - USD ($)	3 Months Ended		12 Months Ended
	Mar. 31, 2024	Mar. 31, 2023	Dec. 31, 2023
Cash flows from operating activities:
Net loss	$ (10,603,477)	$ (9,659,918)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense	1,630,011	2,080,319
Amortization of debt discount	270,236	121,997
Depreciation expense	4,735	3,155
Operating lease expense	0	60,257
Finance lease depreciation expense	9,670	10,957
Changes in assets and liabilities:
Prepaid expenses and other assets	443,210	(113,758)
Accounts payable	(981,993)	852,774
Accrued expenses	(710,581)	(6,455,317)
Operating lease liabilities	0	(89,102)
Net cash used in operating activities	(9,938,189)	(13,188,636)
Cash flows from financing activities:
Proceeds from exercise of stock options	531,091	0
Payments of finance lease obligations	(13,475)	(20,667)
Proceeds from issuance of common stock, net of issuance costs	19,494,473	4,588,522	$ 16,100,000
Net cash provided by financing activities	20,012,089	4,567,855
Net (decrease) increase in cash and cash equivalents	10,073,900	(8,620,781)
Cash and cash equivalents at beginning of period	56,560,517	73,820,160	73,820,160
Cash and cash equivalents at the end of period	66,634,417	65,199,379	$ 56,560,517
Supplemental information of cash and non-cash transactions:
Cash paid for interest	$ 1,174,745	$ 966,845

Nature of Operations

Nature of Operations	3 Months Ended
	Mar. 31, 2024
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 molecularly targeted immunotherapies designed to overcome the limitations of current immunotherapy and vaccine technologies. The Company develops proprietary platforms designed to train and enable the immune system to attack and destroy disease; Versamune®, and Versamune® in combination with PDS01ADC for treatments in oncology and Infectimune® for treatments in infectious diseases. 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. PDS01ADC is a novel investigational tumor-targeting fusion protein of Interleukin 12 that enhances the proliferation, potency, infiltration and longevity of T cells in the tumor microenvironment and is therefore designed to overcome the limitations of cytokine therapy which today has resulted in high toxicity and limited therapeutic potential. Infectimune® is also designed to promote the induction of disease-specific neutralizing antibodies. The Company’s immuno-oncology product candidates are of potential interest for use as a component of combination product candidates (for example, in combination with other leading technologies such as immune checkpoint inhibitors) to provide more effective treatments across a range of advanced and/or refractory cancers. The Company is also evaluating its immunotherapies as monotherapies in early-stage disease. The Company is developing targeted product candidates to treat several cancers, including Human Papillomavirus (HPV) associated cancers, melanoma, colorectal, lung, breast and prostate cancers. The Company’s infectious disease candidate is of potential interest for use in universal influenza vaccines.

Summary of Significant Accounti

Summary of Significant Accounting Policies	3 Months Ended
	Mar. 31, 2024
Summary of Significant Accounting Policies [Abstract]
Summary of Significant Accounting Policies	Note 2 – Summary of Significant Accounting Policies (A) Unaudited interim financial statements: The unaudited financial statements for all periods presented are referred to as “Condensed Consolidated Financial Statements”, and have been prepared by the Company in United States (“U.S.”) dollars and in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial reporting and pursuant to the rules and regulations for reporting on Form 10-Q, which do not conform in all respects to the requirements of U.S. GAAP for annual financial statements. Accordingly, certain information and disclosures required by U.S. GAAP for complete consolidated financial statements are not included herein. Accordingly, these notes to the unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements prepared in accordance with U.S. GAAP that are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission (“SEC”) on March 28, 2024. The unaudited condensed consolidated financial statements have been prepared using accounting policies that are consistent with the policies used in preparing the Company’s audited consolidated financial statements for the year ended December 31, 2023. The unaudited Condensed Consolidated Financial Statements reflect all normal and recurring adjustments necessary for a fair statement of the Company’s financial position and results of operations for the interim periods. The operating results for the interim periods presented are not necessarily indicative of the results expected for the full year. (B) Use of estimates: The preparation of the 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 condensed consolidated financial statements and during the reporting periods, and to disclose contingent assets and liabilities at the date of the condensed 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 Company’s ability to complete clinical trials necessary to obtain regulatory product licenses, the regulatory approvals needed to pursue products, the Company’s adherence to covenants under its debt agreement, the Company’s 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 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 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 condensed consolidated 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 condensed 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. While the risk-free interest rate and dividend yield are less subjective assumptions that are based on factual data derived from public sources, the expected stock-price volatility and option term assumptions require a greater level of judgment. (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 March 31, 2024 2023 Stock options to purchase Common Stock 5,314,661 5,295,911 Warrants to purchase Common Stock 466,112 506,229 Total 5,780,773 5,802,140 (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: FASB 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 condensed 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. (L) New accounting standards: Recently Adopted Accounting Pronouncements Recently issued accounting pronouncements did not, or are not believed by management to, have a material effect on our present or future condensed consolidated financial statements. Recent Accounting Pronouncements Not Yet Adopted In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which improves the disclosures required for reportable segments in the Company’s annual and interim financial statements, primarily through enhanced disclosures about significant segment expenses. ASU 2023-07 is effective for annual periods beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024. Adoption of this ASU should be applied retrospectively to all prior periods presented in the financial statements. Early adoption is permitted. The Company is currently evaluating the impact that adopting this standard will have on the consolidated financial statements and disclosures and given the Company has one reportable segment, this policy is not expected to have a material impact on the consolidated financial statements. In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, which requires public entities, on an annual basis, to provide disclosures of specific categories in the rate reconciliation, additional information for reconciling items that meet a quantitative threshold and income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for annual periods beginning after December 15, 2024. Early adoption is permitted. The Company is currently evaluating the impact that adopting this standard will have on the consolidated financial statements and disclosures.

Liquidity and Capital Resources

Liquidity and Capital Resources	3 Months Ended
	Mar. 31, 2024
Liquidity and Capital Resources [Abstract]
Liquidity and Capital Resources	Note 3 – Liquidity and Capital Resources As of March 31, 2024, the Company had $66.6 million of cash and cash equivalents. The Company’s primary use of cash is to fund operating expenses, primarily research and development expenditures. Cash used to fund operating expenses is impacted by the level of activities undertaken, as well as 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. In addition, the Loan and Security Agreement allows for the lenders to call the outstanding balance of the term loans if the minimum cash balances outlined in the Loans and Security Agreement are not maintained. The Company funds its operations through equity and/or debt financings such as the following: 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 Sh ares 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, 2023, the Company sold 2,642,269 shares of common stock for a net value of $16.1 million pursuant to the Sales Agreement. During the quarter ended March 31, 2024 and 2023, the Company sold 3,428,681 and 553,293 shares of common stock for a net value of $19.5 and $4.6 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. In total, the Company received $24.6 million in net proceeds. 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 maintenance of minimum cash balances as well as 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. In April 2024, the Company received approximately $0.9 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to its participation in the New Jersey Technology Business Tax Certificate Transfer of Net Operating Loss (NOL) program for tax year 2022. 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 Subtopic 205-40, Going Concern . 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. In addition, the Loan and Security Agreement allows for the lenders to call the outstanding balance of the term loans if the minimum cash balances outlined in the Loan and Security Agreement are not maintained. The Company’s budgeted cash requirements in 2024 and beyond include expenses related to continuing development and clinical trials as well as payments on its debt . 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	3 Months Ended
	Mar. 31, 2024
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 month ended March 31, 2024 or 2023. 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 March 31, 2024: (unaudited) Cash and cash equivalents $ 66,634,417 $ 66,634,417 $ – $ – As of December 31, 2023 Cash and cash equivalents $ 56,560,517 $ 56,560,517 $ – $ – The carrying value of the Loan and Security Agreement

Leases

Leases	3 Months Ended
	Mar. 31, 2024
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 with a term of forty (40) months with an option to renew through October 31, 2027. The sublease term expired on August 31, 2023, and was not renewed. Upon inception of the sublease, the Company recognized approximately $0.7 million of ROU assets 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 March 31, 2024 2023 Cash paid for operating lease liabilities $ – $ 89,102
Leases	Financing Lease: The Company has financed certain laboratory equipment as follows: As of March 31, 2024 2023 Cash paid for finance lease liabilities $ 17,463 $ 20,667 Maturity of the Company’s financing lease liabilities is as follows: Year ended December 31, 2024 $ 52,387 2025 69,850 2026 40,108 2027 26,721 2028 and after 1 Total future minimum lease payments 189,067 Less imputed interest (23,775 ) Remaining lease liability $ 165,292 The Company entered into four financing leases for laboratory equipment with a total cost of $251,959 with four

Accrued Expenses

Accrued Expenses	3 Months Ended
	Mar. 31, 2024
Accrued Expenses [Abstract]
Accrued Expenses	Note 6 – Accrued Expenses Accrued expenses consist of the following: As of March 31, 2024 As of December 31, 2023 Accrued research and development $ 457,229 $ - Accrued professional fees 531,294 827,863 Accrued compensation 418,449 1,289,690 Accrued interest on debt 306,771 306,771 Accrued rent 368 368 Total $ 1,714,111 $ 2,424,692

Stock-Based Compensation

Stock-Based Compensation	3 Months Ended
	Mar. 31, 2024
Stock-Based Compensation [Abstract]
Stock-Based Compensation	Note 7 – Stock-Based Compensation In 2014, the Company’s stockholders approved the 2014 Equity Incentive Plan (the “Original 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 Original 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 (“Board”) may determine in its discretion. In March 2019, the Board adopted and the Company’s stockholders approved the Amended and Restated PDS Biotechnology Corporation 2014 Equity Incentive Plan (the “Prior Plan”) which amended and restated the Original Plan in order to remove the annual increase component and was limited to 826,292 shares. On December 8, 2020, the Board adopted and on June 17, 2021, the stockholders approved, the Second Amended and Restated PDS Biotechnology Corporation 2014 Equity Incentive Plan (the “Restated Plan”), which amended and restated the Prior Plan. The Restated Plan is identical to the Prior Plan in all material respects, except (a) the number of shares of Common Stock authorized for issuance under the Restated Plan was increased from 826,292 shares to 4,165,535 shares, plus the total number of shares that remained available for issuance, that were not covered by outstanding awards issued under the Prior Plan, immediately prior to December 8, 2020; and (b) the Prior Plan was amended to terminate on December 7, 2030, unless earlier terminated. On May 19, 2023, the Board adopted, subject to stockholder approval, the Third Amended and Restated PDS Biotechnology Corporation 2014 Equity Incentive Plan (the “Third Restated Plan”). At the 2023 annual meeting of stockholders held on July 14, 2023, the stockholders approved the Third Restated Plan, which amended and restated the Restated Plan to increase the total amount of shares authorized for issuance thereunder. The Third Restated Plan is identical to the Restated Plan in all material respects, except, the number of shares of Common Stock authorized for issuance under the Third Restated Plan increased from 4,165,535 to 6,565,535. As of March 31, 2024, there were 2,645,723 shares available for grant under the Third Restated Plan. Pursuant to the terms of the Third Restated Plan, stock options 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. On June 17, 2019, the Board adopted the 2019 Inducement Plan (the “Inducement Plan”). 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. On May 17, 2022, the Company further amended the Inducement Plan solely to increase the total number of shares of Common Stock reserved for issuance under the Inducement Plan from 500,000 shares to 1,100,000 shares. On January 22, 2024, the Company further amended the Inducement Plan solely to increase the total number of shares of Common Stock reserved for issuance under the Inducement Plan from 1,100,000 shares to 2,100,000 shares. The Inducement Plan provides for the grant of non-qualified stock options. The Inducement Plan, and each amendment thereto, 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. The Inducement Plan is administered by the Compensation Committee of the Board. In accordance with Rule 5635(c)(4) of the Nasdaq Listing Rules, non-qualified stock options under the Inducement Plan may only be made to an employee who has not previously been an employee of the Company or member of the Board of Directors of the Company (or any parent or subsidiary of the Company), if he or she is granted such non-qualified stock options in connection with his or her commencement of employment with the Company or a subsidiary and such grant is an inducement material to his or her entering into employment with the Company or such subsidiary. As of March 31, 2024, there were 1,232,200 shares available for grant under the Inducement Plan. The following table summarizes the components of stock-based compensation expense in the condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2024 and 2023: Three Months Ended March 31, 2024 2023 (unaudited) Research and development $ 551,918 $ 800,764 General and administrative 1,078,093 1,279,555 Total $ 1,630,011 $ 2,080,319 There were 938,648 and 1,124,600 options granted during the three months ended March 31, 2024 and 2023, respectively. The fair value of options granted during the three months ended March 31, 2024 and 2023 was estimated using the Black-Scholes option valuation model utilizing the following assumptions: Three Months Ended March 31, 2024 2023 Weighted Average Weighted Average (unaudited) Volatility 145.41 % 142.02 % Risk-Free Interest Rate 3.98 % 4.06 % Expected Term in Years 6.08 6.08 Dividend Rate – – Fair Value of Option on Grant Date $ 5.22 $ 10.79 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, 2023 5,029,345 $ 6.43 7.42 $ 4,395,227 Granted 938,648 5.58 9.90 – Exercised (156,073 ) 3.40 Forfeited and expired (497,259 ) 8.64 Options outstanding at March 31, 2024 5,314,661 $ 6.16 7.60 $ 2,327,199 Vested and expected to vest at 5,314,661 $ 6.16 7.60 $ 2,327,199 Exercisable at March 31, 2024 2,858,485 $ 5.80 6.42 $ 1,971,346 As of March 31, 2024 there was approximately $15,111,713 of unamortized stock option compensation expense, which is expected to be recognized over a remaining average vesting period of 2.95 years.

Income Taxes

Income Taxes	3 Months Ended
	Mar. 31, 2024
Income Taxes [Abstract]
Income Taxes	Note 8 – Income Taxes The Company records a valuation allowance against its deferred tax assets to reduce the net carrying value to an amount that it believes is more likely than not to be realized 2024 no 31, 2024 2023 no The Company is subject to a U.S. federal statutory income tax rate of 21%. The primary factor impacting the effective tax rate for the three months ended March 31, 2024 Entities are 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 March 31, 2024 31, 2024 2023. In April 2024, the Company received approximately $0.9 million from the sale of its New Jersey state net operating losses

Commitments and Contingencies

Commitments and Contingencies	3 Months Ended
	Mar. 31, 2024
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 months ended March 31, 2024 and 2023 was $66,000 and $66,000, respectively. Exclusive License Agreement In January 2023, the Company entered into an exclusive global license agreement with Merck KGaA, Darmstadt, Germany for the tumor targeting IL 12 fused antibody drug conjugate, M9241 (the “Merck KGaA License Agreement”). Pursuant to the Merck KGaA License Agreement, the Company agreed to make (i) development and first commercial sales 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 the 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 which, but for 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	3 Months Ended
	Mar. 31, 2024
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 during 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 maintenance of minimum cash balances as well as 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. As of March 31, 2024, the Company is in compliance with all covenants in all material respects. 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 For the three months ended March 31, 2024 and 2023, the Company recognized interest expense of $1,170,758 and $961,753, respectively, of which $270,236 and $121,997, respectively, was related to the amortization of the debt discount.

Retirement Plan

Retirement Plan	3 Months Ended
	Mar. 31, 2024
Retirement Plan [Abstract]
Retirement Plan	Note 11 – Retirement Plan The Company has a 401(k) defined contribution plan for the benefit of all employees and permits voluntary contributions by employees, subject to IRS-imposed limitations. The 401(k) employer contributions were $66,488 and $94,907 for the three months ended March 31, 2024 and 2023, respectively .

Subsequent Events

Subsequent Events	3 Months Ended
	Mar. 31, 2024
Subsequent Events [Abstract]
Subsequent Events	Note 12– Subsequent Events In April 2024, the Company received approximately $0.9 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to its participation in the New Jersey Technology Business Tax Certificate Transfer of Net Operating Loss (NOL) program for tax year 2022.

Insider Trading Arrangements

Insider Trading Arrangements	3 Months Ended
	Mar. 31, 2024
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)	3 Months Ended
	Mar. 31, 2024
Summary of Significant Accounting Policies [Abstract]
Unaudited Interim Financial Statements	(A) Unaudited interim financial statements: The unaudited financial statements for all periods presented are referred to as “Condensed Consolidated Financial Statements”, and have been prepared by the Company in United States (“U.S.”) dollars and in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial reporting and pursuant to the rules and regulations for reporting on Form 10-Q, which do not conform in all respects to the requirements of U.S. GAAP for annual financial statements. Accordingly, certain information and disclosures required by U.S. GAAP for complete consolidated financial statements are not included herein. Accordingly, these notes to the unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements prepared in accordance with U.S. GAAP that are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission (“SEC”) on March 28, 2024. The unaudited condensed consolidated financial statements have been prepared using accounting policies that are consistent with the policies used in preparing the Company’s audited consolidated financial statements for the year ended December 31, 2023. The unaudited Condensed Consolidated Financial Statements reflect all normal and recurring adjustments necessary for a fair statement of the Company’s financial position and results of operations for the interim periods. The operating results for the interim periods presented are not necessarily indicative of the results expected for the full year.
Use of Estimates	(B) Use of estimates: The preparation of the 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 condensed consolidated financial statements and during the reporting periods, and to disclose contingent assets and liabilities at the date of the condensed 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 Company’s ability to complete clinical trials necessary to obtain regulatory product licenses, the regulatory approvals needed to pursue products, the Company’s adherence to covenants under its debt agreement, the Company’s 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 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 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 condensed consolidated 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 condensed 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. While the risk-free interest rate and dividend yield are less subjective assumptions that are based on factual data derived from public sources, the expected stock-price volatility and option term assumptions require a greater level of judgment.
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 March 31, 2024 2023 Stock options to purchase Common Stock 5,314,661 5,295,911 Warrants to purchase Common Stock 466,112 506,229 Total 5,780,773 5,802,140
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: FASB 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 condensed 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.
New Accounting Standards	(L) New accounting standards: Recently Adopted Accounting Pronouncements Recently issued accounting pronouncements did not, or are not believed by management to, have a material effect on our present or future condensed consolidated financial statements. Recent Accounting Pronouncements Not Yet Adopted In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which improves the disclosures required for reportable segments in the Company’s annual and interim financial statements, primarily through enhanced disclosures about significant segment expenses. ASU 2023-07 is effective for annual periods beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024. Adoption of this ASU should be applied retrospectively to all prior periods presented in the financial statements. Early adoption is permitted. The Company is currently evaluating the impact that adopting this standard will have on the consolidated financial statements and disclosures and given the Company has one reportable segment, this policy is not expected to have a material impact on the consolidated financial statements. In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, which requires public entities, on an annual basis, to provide disclosures of specific categories in the rate reconciliation, additional information for reconciling items that meet a quantitative threshold and income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for annual periods beginning after December 15, 2024. Early adoption is permitted. The Company is currently evaluating the impact that adopting this standard will have on the consolidated financial statements and disclosures.

Summary of Significant Accoun_3

Summary of Significant Accounting Policies (Tables)	3 Months Ended
	Mar. 31, 2024
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 March 31, 2024 2023 Stock options to purchase Common Stock 5,314,661 5,295,911 Warrants to purchase Common Stock 466,112 506,229 Total 5,780,773 5,802,140

Fair Value of Financial Instr_2

Fair Value of Financial Instruments (Tables)	3 Months Ended
	Mar. 31, 2024
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 March 31, 2024: (unaudited) Cash and cash equivalents $ 66,634,417 $ 66,634,417 $ – $ – As of December 31, 2023 Cash and cash equivalents $ 56,560,517 $ 56,560,517 $ – $ –

Leases (Tables)

Leases (Tables)	3 Months Ended
	Mar. 31, 2024
Leases [Abstract]
Supplemental Cash Flow Information Related to Operating Leases	Supplemental cash flow information related to operating leases is as follows: As of March 31, 2024 2023 Cash paid for operating lease liabilities $ – $ 89,102
Supplemental Cash Flow Information Related to Financing Lease	The Company has financed certain laboratory equipment as follows: As of March 31, 2024 2023 Cash paid for finance lease liabilities $ 17,463 $ 20,667
Future Payments for Financing Lease Liability	Maturity of the Company’s financing lease liabilities is as follows: Year ended December 31, 2024 $ 52,387 2025 69,850 2026 40,108 2027 26,721 2028 and after 1 Total future minimum lease payments 189,067 Less imputed interest (23,775 ) Remaining lease liability $ 165,292

Accrued Expenses (Tables)

Accrued Expenses (Tables)	3 Months Ended
	Mar. 31, 2024
Accrued Expenses [Abstract]
Accrued Expenses and Other Liabilities	Accrued expenses consist of the following: As of March 31, 2024 As of December 31, 2023 Accrued research and development $ 457,229 $ - Accrued professional fees 531,294 827,863 Accrued compensation 418,449 1,289,690 Accrued interest on debt 306,771 306,771 Accrued rent 368 368 Total $ 1,714,111 $ 2,424,692

Stock-Based Compensation (Table

Stock-Based Compensation (Tables)	3 Months Ended
	Mar. 31, 2024
Stock-Based Compensation [Abstract]
Stock-Based Compensation Expense	The following table summarizes the components of stock-based compensation expense in the condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2024 and 2023: Three Months Ended March 31, 2024 2023 (unaudited) Research and development $ 551,918 $ 800,764 General and administrative 1,078,093 1,279,555 Total $ 1,630,011 $ 2,080,319
Assumptions Used to Value Stock Options Granted	The fair value of options granted during the three months ended March 31, 2024 and 2023 was estimated using the Black-Scholes option valuation model utilizing the following assumptions: Three Months Ended March 31, 2024 2023 Weighted Average Weighted Average (unaudited) Volatility 145.41 % 142.02 % Risk-Free Interest Rate 3.98 % 4.06 % Expected Term in Years 6.08 6.08 Dividend Rate – – Fair Value of Option on Grant Date $ 5.22 $ 10.79
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, 2023 5,029,345 $ 6.43 7.42 $ 4,395,227 Granted 938,648 5.58 9.90 – Exercised (156,073 ) 3.40 Forfeited and expired (497,259 ) 8.64 Options outstanding at March 31, 2024 5,314,661 $ 6.16 7.60 $ 2,327,199 Vested and expected to vest at 5,314,661 $ 6.16 7.60 $ 2,327,199 Exercisable at March 31, 2024 2,858,485 $ 5.80 6.42 $ 1,971,346

Summary of Significant Accoun_4

Summary of Significant Accounting Policies (Details)	3 Months Ended
	Mar. 31, 2024 Segment shares	Mar. 31, 2023 shares
Net Loss per Common Share [Abstract]
Antidilutive impact to EPS (in shares)	5,780,773	5,802,140
New Accounting Standards [Abstract]
Number of reportable segments | Segment	1
Stock Options to Purchase Common Stock [Member]
Net Loss per Common Share [Abstract]
Antidilutive impact to EPS (in shares)	5,314,661	5,295,911
Warrants to Purchase Common Stock [Member]
Net Loss per Common Share [Abstract]
Antidilutive impact to EPS (in shares)	466,112	506,229

Liquidity and Capital Resourc_2

Liquidity and Capital Resources (Details)		1 Months Ended			3 Months Ended		12 Months Ended
	Aug. 24, 2022 USD ($)	Apr. 30, 2024 USD ($)	Apr. 30, 2023 USD ($)	Aug. 31, 2022 USD ($)	Mar. 31, 2024 USD ($) Loan shares	Mar. 31, 2023 USD ($) shares	Dec. 31, 2023 USD ($) shares
Liquidity [Abstract]
Cash and cash equivalents					$ 66,634,417		$ 56,560,517
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					3,428,681	553,293	2,642,269
Proceeds from issuance of common stock					$ 19,494,473	$ 4,588,522	$ 16,100,000
Proceeds from sale of tax benefits			$ 1,400,000
Subsequent Event [Member]
Liquidity [Abstract]
Proceeds from sale of tax benefits		$ 900,000
Term Loans [Member]
Liquidity [Abstract]
Number of independent term loans | Loan					6
Proceeds from issuance of secured loans	$ 24,600,000
Term					48 months
Period after October 1, 2024 for making monthly payments on principal balance					24 months
Minimum base rate used to compute floating interest rate					4%
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]
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
Loan F [Member]
Liquidity [Abstract]
Uncommitted loan					$ 5,000,000

Fair Value of Financial Instr_3

Fair Value of Financial Instruments (Details) - USD ($)	Mar. 31, 2024	Dec. 31, 2023
Fair Value of Financial Instruments [Abstract]
Cash and cash equivalents	$ 66,634,417	$ 56,560,517
Quoted Prices in Active Markets (Level 1) [Member]
Fair Value of Financial Instruments [Abstract]
Cash and cash equivalents	66,634,417	56,560,517
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)	3 Months Ended
	Mar. 31, 2024 USD ($) ft²	Mar. 31, 2023 USD ($)	May 01, 2020 USD ($)
Operating Lease [Abstract]
Area of office space under sublease | ft²	11,200
Term of sublease agreement	40 months
Operating lease right-of-use assets			$ 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	$ 0	$ 89,102

Leases, Financing Lease (Detail

Leases, Financing Lease (Details)	3 Months Ended		12 Months Ended
	Mar. 31, 2024 USD ($) Lease	Mar. 31, 2023 USD ($)	Dec. 31, 2023 USD ($)
Supplemental Cash Flow Information Related to Finance Lease [Abstract]
Cash paid for finance lease liabilities	$ 17,463	$ 20,667
Future Payments for Finance Lease Liabilities [Abstract]
2024	52,387
2025	69,850
2026	40,108
2027	26,721
2028 and after	1
Total future minimum lease payments	189,067
Less imputed interest	(23,775)
Remaining lease liability	$ 165,292
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 ($)	Mar. 31, 2024	Dec. 31, 2023
Accrued Expenses [Abstract]
Accrued research and development	$ 457,229	$ 0
Accrued professional fees	531,294	827,863
Accrued compensation	418,449	1,289,690
Accrued interest on debt	306,771	306,771
Accrued rent	368	368
Total	$ 1,714,111	$ 2,424,692

Stock-Based Compensation, Equit

Stock-Based Compensation, Equity Compensation Plans (Details) - shares	3 Months Ended	12 Months Ended
	Mar. 31, 2024	Dec. 31, 2014	Jan. 22, 2024	Jul. 14, 2023	May 17, 2022	Dec. 08, 2020	Jun. 17, 2019	Mar. 31, 2019
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		826,292
Percentage of Common Stock outstanding used to determine annual increase in the plan limit		4%
Shares available for grant (in shares)	2,645,723
2019 Inducement Plan [Member]
Stock Options [Abstract]
Shares available for grant (in shares)	1,232,200
Common stock reserved for issuance (in shares)			2,100,000		1,100,000	500,000	200,000

Stock-Based Compensation, Stock

Stock-Based Compensation, Stock-Based Compensation Expense (Details) - Stock Options [Member] - USD ($)	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Stock-Based Compensation [Abstract]
Stock-based compensation expense	$ 1,630,011	$ 2,080,319
Research and Development [Member]
Stock-Based Compensation [Abstract]
Stock-based compensation expense	551,918	800,764
General and Administrative [Member]
Stock-Based Compensation [Abstract]
Stock-based compensation expense	$ 1,078,093	$ 1,279,555

Stock-Based Compensation, Assum

Stock-Based Compensation, Assumptions Used to Value Stock Options and Warrants Granted (Details) - $ / shares	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Assumptions Used in Determining Fair Value of Stock Options and Warrants Granted [Abstract]
Volatility	145.41%	142.02%
Risk-free interest rate	3.98%	4.06%
Expected term	6 years 29 days	6 years 29 days
Dividend rate	0%	0%
Fair value of option on grant date (in dollars per share)	$ 5.22	$ 10.79
Stock Options [Member]
Stock-Based Compensation [Abstract]
Options granted (in shares)	938,648	1,124,600

Stock-Based Compensation, Sto_2

Stock-Based Compensation, Stock Option Activity (Details) - USD ($)	3 Months Ended		12 Months Ended
	Mar. 31, 2024	Mar. 31, 2023	Dec. 31, 2023
Common Stock [Member]
Number of Shares [Roll Forward]
Exercised (in shares)	(156,073)
Stock Options [Member]
Number of Shares [Roll Forward]
Options outstanding, beginning balance (in shares)	5,029,345
Granted (in shares)	938,648	1,124,600
Exercised (in shares)	(156,073)
Forfeited and expired (in shares)	(497,259)
Options outstanding, ending balance (in shares)	5,314,661		5,029,345
Vested and expected to vest (in shares)	5,314,661
Exercisable (in shares)	2,858,485
Weighted Average Exercise Price [Roll Forward]
Options outstanding, beginning balance (in dollars per share)	$ 6.43
Granted (in dollars per share)	5.58
Exercised (in dollars per share)	3.4
Forfeited and expired (in dollars per share)	8.64
Options outstanding, ending balance (in dollars per share)	6.16		$ 6.43
Vested and expected to vest (in dollars per share)	6.16
Exercisable (in dollars per share)	$ 5.8
Weighted Average Remaining Contractual Life and Aggregate Intrinsic Value [Abstract]
Options outstanding, weighted average remaining contractual life	7 years 7 months 6 days		7 years 5 months 1 day
Granted, weighted average remaining contractual life	9 years 10 months 24 days
Vested and expected to vest, weighted average remaining contractual life	7 years 7 months 6 days
Exercisable, weighted average remaining contractual life	6 years 5 months 1 day
Options outstanding, aggregate intrinsic value	$ 4,395,227
Granted, aggregate intrinsic value	0
Options outstanding, aggregate intrinsic value	2,327,199		$ 4,395,227
Vested and expected to vest, aggregate intrinsic value	2,327,199
Exercisable, aggregate intrinsic value	1,971,346
Unamortized Stock Compensation Expense [Abstract]
Unamortized stock compensation expense	$ 15,111,713
Period for recognition	2 years 11 months 12 days

Income Taxes (Details)

Income Taxes (Details) - USD ($)	1 Months Ended		3 Months Ended
	Apr. 30, 2024	Apr. 30, 2023	Mar. 31, 2024	Dec. 31, 2023
Income Taxes [Abstract]
Current income tax expense			$ 0
Income tax benefit due to realization uncertainties			$ 0
Federal statutory income tax rate			21%
Uncertain tax positions			$ 0
Unrecognized tax benefits			0	$ 0
Accrued interest and penalties			$ 0	$ 0
Income Taxes [Abstract]
Proceeds from sale of tax benefits		$ 1,400,000
Subsequent Event [Member]
Income Taxes [Abstract]
Proceeds from sale of tax benefits	$ 900,000

Commitments and Contingencies (

Commitments and Contingencies (Details) - USD ($)	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Commitments and Contingencies [Abstract]
Rent expense	$ 66,000	$ 66,000
Merck KGaA License Agreement [Member]
Commitments and Contingencies [Abstract]
Milestone payments for development and first commercial sales	$ 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

Venture Loan and Security Agr_2

Venture Loan and Security Agreement, Term Loans (Details)	3 Months Ended
	Mar. 31, 2024 USD ($) Loan	Aug. 31, 2022 USD ($)
Term Loans [Member]
Venture Loan and Security Agreement [Abstract]
Number of independent term loans | Loan	6
Term	48 months
Period after October 1, 2024 for making monthly payments on principal balance	24 months
Minimum base rate used to compute floating interest rate	4%
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]
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
Loan F [Member]
Venture Loan and Security Agreement [Abstract]
Uncommitted loan	$ 5,000,000

Venture Loan and Security Agr_3

Venture Loan and Security Agreement, Warrant and Debt Discount (Details) (Details)	3 Months Ended		9 Months Ended
	Mar. 31, 2024 USD ($)	Mar. 31, 2023 USD ($)	Sep. 30, 2022 USD ($)	Aug. 31, 2022 $ / 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
Debt issuance costs			$ 449,329
Unamortized debt discount	$ 1,994,412
Interest expense	1,170,758	$ 961,753
Amortization of debt discount	$ 270,236	$ 121,997
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
Risk-free Rate [Member]
Venture Loan and Security Agreement [Abstract]
Warrants measurement input	0.0311
Expected Volatility [Member]
Venture Loan and Security Agreement [Abstract]
Warrants measurement input	0.938
Estimated Dividend Yield [Member]
Venture Loan and Security Agreement [Abstract]
Warrants measurement input	0

Retirement Plan (Details)

Retirement Plan (Details) - USD ($)	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Retirement Plan [Abstract]
401(k) employer contributions	$ 66,488	$ 94,907

Subsequent Events (Details)

Subsequent Events (Details) - USD ($) $ in Millions	1 Months Ended
	Apr. 30, 2024	Apr. 30, 2023
Subsequent Events [Abstract]
Proceeds from sale of tax benefits		$ 1.4
Subsequent Event [Member]
Subsequent Events [Abstract]
Proceeds from sale of tax benefits	$ 0.9