PDS Biotechnology (PDSB) 10-K 28 Mar 24 2023 FY Annual report Financial data

Document and Entity Information

Document and Entity Information - USD ($)	12 Months Ended
	Dec. 31, 2023	Mar. 21, 2024	Jun. 30, 2023
Cover [Abstract]
Document Type	10-K
Amendment Flag	false
Document Annual Report	true
Document Period End Date	Dec. 31, 2023
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	FY
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 Well-known Seasoned Issuer	No
Entity Voluntary Filers	No
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
ICFR Auditor Attestation Flag	false
Document Financial Statement Error Correction [Flag]	false
Entity Shell Company	false
Entity Public Float			$ 148,298,700
Entity Common Stock, Shares Outstanding		36,679,275
Auditor Firm ID	185
Auditor Name	KPMG LLP
Auditor Location	Short Hills, New Jersey

Consolidated Balance Sheets

Consolidated Balance Sheets - USD ($)	Dec. 31, 2023	Dec. 31, 2022
Current assets:
Cash and cash equivalents	$ 56,560,517	$ 73,820,160
Prepaid expenses and other	2,494,558	2,660,230
Total current assets	59,055,075	76,480,390
Property and equipment, net	134,132	0
Financing lease right-to-use assets	200,873	374,888
Operating lease right-to-use asset	0	152,645
Total assets	59,390,080	77,007,923
Current liabilities:
Accounts payable	6,982,824	1,219,287
Accrued expenses	2,424,692	8,313,708
Notes payable - short term	4,166,667	0
Financing lease obligation - short term	55,794	56,612
Operating lease obligation - short term	0	231,429
Total current liabilities	13,629,977	9,821,036
Noncurrent liabilities:
Notes payable, net of debt discount	19,506,183	23,020,844
Financing lease obligation-long term	122,973	164,013
Operating lease obligation-long term	0	0
Total liabilities	33,259,133	33,005,893
STOCKHOLDERS' EQUITY
Common stock, $0.00033 par value, 75,000,000 shares authorized at December 31, 2023 and December 31, 2022, 33,094,521 shares and 30,170,317 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively	10,921	9,956
Additional paid-in capital	170,620,641	145,550,491
Accumulated deficit	(144,500,615)	(101,558,417)
Total stockholders' equity	26,130,947	44,002,030
Total liabilities and stockholders' equity	$ 59,390,080	$ 77,007,923

Consolidated Balance Sheets (Pa

Consolidated Balance Sheets (Parenthetical) - $ / shares	Dec. 31, 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)	33,094,521	30,170,317
Common stock, shares outstanding (in shares)	33,094,521	30,170,317

Consolidated Statements of Oper

Consolidated Statements of Operations and Comprehensive Loss - USD ($)	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Operating expenses:
Research and development expenses	$ 27,762,784	$ 29,431,027
General and administrative expenses	15,282,450	12,241,394
Total operating expenses	43,045,234	41,672,421
Loss from operations	(43,045,234)	(41,672,421)
Interest income (expense), net
Interest income	2,902,939	935,180
Interest expense	(4,205,922)	(1,316,519)
Interest income (expense), net	(1,302,983)	(381,339)
Loss before income taxes	(44,348,217)	(42,053,760)
Benefit from income taxes	1,406,019	1,198,905
Net loss	(42,942,198)	(40,854,855)
Comprehensive loss	$ (42,942,198)	$ (40,854,855)
Per share information:
Net loss per share, basic (in dollars per share)	$ (1.39)	$ (1.43)
Net loss per share, diluted (in dollars per share)	$ (1.39)	$ (1.43)
Weighted average common shares outstanding, basic (in shares)	30,952,060	28,599,221
Weighted average common shares outstanding, diluted (in shares)	30,952,060	28,599,221

Consolidated Statements of Chan

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]
Issuances of common stock from the Sales Agreement, net				$ 9,900,000
Issuances of common stock from the Sales Agreement, net (in shares)				1,238,491
Net loss				$ (40,854,855)
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		1,713,741	0	1,713,741
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
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Stock-based compensation expense	$ 0	1,374,233	0	1,374,233
Issuances of common stock, from exercise of stock options	$ 89	1,563,756	0	1,563,845
Issuances of common stock, from exercise of stock options (in shares)	269,535
Net shares for settlements of equity awards and taxes	$ (58)	(1,713,247)	0	(1,713,305)
Net shares for settlements of equity awards and taxes (in shares)	(175,184)
Issuance of common stock for consulting/licensing agreement	$ 125	4,999,863	0	4,999,988
Issuance of common stock for consulting/licensing agreement (in shares)	378,787
Issuances of common stock from the Sales Agreement, net	$ 409	9,855,707	0	9,856,116
Issuances of common stock from the Sales Agreement, net (in shares)	1,238,491
Net loss	$ 0	0	(19,137,683)	(19,137,683)
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/licensing agreement				5,000,000
Issuance of common stock for consulting/licensing agreement (in shares)	200,000
Issuances of common stock from the Sales Agreement, net				$ 16,100,000
Issuances of common stock from the Sales Agreement, net (in shares)				2,642,269
Net loss				$ (42,942,198)
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
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/licensing agreement	$ 33	609,967	0	610,000
Issuance of common stock for consulting/licensing 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
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
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Stock-based compensation expense	$ 0	1,354,857	0	1,354,857
Issuances of common stock, from exercise of stock options	$ 26	300,067	0	300,093
Issuances of common stock, from exercise of stock options (in shares)	80,526
Issuance of common stock for consulting/licensing agreement	$ 33	410,967	0	411,000
Issuance of common stock for consulting/licensing agreement (in shares)	100,000
Issuances of common stock from the Sales Agreement, net	$ 629	10,478,756	0	10,479,385
Issuances of common stock from the Sales Agreement, net (in shares)	1,906,232
Net loss	$ 0	0	(10,898,216)	(10,898,216)
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

Consolidated Statements of Cash

Consolidated Statements of Cash Flows - USD ($)	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Cash flows from operating activities:
Net loss	$ (42,942,198)	$ (40,854,855)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense	7,614,321	5,196,156
Issuance of shares in licensing agreement	0	4,999,988
Issuance of shares in consulting agreement	1,021,000	0
Amortization of debt discount	652,006	183,914
Depreciation expense	17,359	86
Operating lease expense	160,685	241,029
Finance lease amortization expense	39,967	48,992
Changes in operating assets and liabilities:
Prepaid expenses and other assets	165,672	(1,062,661)
Finance lease right-to-use asset	0	(423,880)
Accounts payable	5,763,537	(90,116)
Accrued expenses	(5,889,016)	6,126,004
Finance lease liabilities	0	220,625
Operating lease liabilities	(239,469)	(294,988)
Net cash used in operating activities	(33,636,136)	(25,709,706)
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	308,942	151,416
Payments of finance lease obligations	(59,300)	0
Payment of taxes in equity transaction	0	(270,959)
Proceeds from issuances of common stock, net of issuance costs	16,126,851	9,856,116
Net cash provided by financing activities	16,376,493	34,287,244
Net (decrease) increase in cash and cash equivalents	(17,259,643)	8,577,538
Cash and cash equivalents at beginning of period	73,820,160	65,242,622
Cash and cash equivalents at end of period	56,560,517	73,820,160
Supplemental information of cash and non-cash transactions:
Cash paid for interest	3,535,071	852,221
Fair value of warrants issued in connection with debt	$ 0	$ 1,713,741

Nature of Operations

Nature of Operations	12 Months Ended
	Dec. 31, 2023
Nature of Operations [Abstract]
Nature of Operations	Note 1 – Nature of Operations 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. The Company has received numerous patents, submitted patent applications and owns substantial know-how and trade secrets related to its Versamune® Included in the patents above is a patent protecting the use of Versamune® in combination wit h PDS01ADC. Licensed patents The Company has licensed patented antigens from the U.S. government for use in its cationic lipid immunotherapies. The Company has licensed T cell receptor gamma alternate reading frame protein (“TARP”) from the National Cancer Institute (“NCI”) to develop and commercialize TARP peptide-based therapies in combination with the Company’s Versamune® technology and any other of the Company’s proprietary technologies for prostate and breast cancers and acute myeloid leukemia. These patents are directed to immunogenic peptides and peptide derivatives for the treatment of prostate and breast cancer treatment and multi-epitope TARP peptide vaccine and uses thereof. These licensed antigens are incorporated in PDS0102 with Versamune®. The Company has licensed mucin-1 (“MUC1”) novel highly immunogenic agonist epitopes of MUC1 developed by the National Cancer Institute. MUC1 is highly expressed in multiple solid tumors and has been shown to be associated with drug resistance and poor disease prognosis in breast, colorectal, lung and ovarian cancers, for which PDS0103 is being developed. The Company has been granted patents and is pursuing additional patents that cover compositions and methods of use of cationic lipid immunotherapies with each of the licensed technologies. The Company entered into a non-exclusive agreement to license Computationally Optimized Broadly Reactive Antigen (COBRA) with the University of Georgia Research Foundation. These antigens are developed by Dr. Ted Ross at the University of Georgia. The Company believes the combination of these antigens along with its proprietary Versamune® Exclusive License Agreement On December 30, 2022, the Company entered into a License Agreement (the “License Agreement”) with Merck KGaA, Darmstadt, Germany, pursuant to which Merck KGaA, Darmstadt, Germany has granted the Company an exclusive (even as to Merck KGaA), worldwide, sublicensable, milestone and royalty-bearing right and license to certain patent rights and certain related data (the “Licensed Technology”) to develop, manufacture, use, commercialize and otherwise exploit any product containing NHS-IL12 fusion protein formerly known as M9241, now PDS01ADC. In consideration for the rights granted by Merck KGaA, Darmstadt, Germany, the Company (i) agreed to make a one-time up-front cash payment of $5.0 million to Merck KGaA, Darmstadt, Germany, and (ii) entered into a Share Transfer Agreement dated December 30, 2022 (the “Share Transfer Agreement”), pursuant to which the Company issued 378,787 shares of its common stock (the “Shares”) to Merck KGaA, Darmstadt, Germany in a private placement for an aggregate value of $5.0 million, as measured by the closing price of the Company’s common stock on the Nasdaq Capital Market as of December 30, 2022. Pursuant to the License Agreement, the Company agreed to make certain commercial sales milestone and royalty payments.

Summary of Significant Accounti

Summary of Significant Accounting Policies	12 Months Ended
	Dec. 31, 2023
Summary of Significant Accounting Policies [Abstract]
Summary of Significant Accounting Policies	Note 2 – Summary of Significant Accounting Policies (A) Use of estimates: The preparation of 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. (B) 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 products, the Company’s ability to preserve its cash resources, the Company’s ability to add product candidates to its pipeline, the Company’s intellectual property, the Company’s ability to complete clinical trials necessary to obtain regulatory product licenses, 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 Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products, and the Company’s ability to raise capital. 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. (C) 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. (D) Property and equipment: Property and equipment are recorded at cost. Depreciation is recorded for property and equipment using the straight-line method over the estimated useful life of five years. The Company reviews the recoverability of all long-lived assets, including the related useful lives, whenever events or changes in circumstances indicate that the carrying amount of a long-lived asset might not be recoverable. (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. Under the terms of the License Agreement, the Company agreed to an initial payment of $5 million in cash and an additional $5 million in Company Stock, plus future milestone and royalty payments. The Company accounts for milestone payments as expenses in research and development and royalties are recorded as a reduction in revenues. (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. (H) Net loss per common share: Basic net loss per common share is calculated by dividing the net loss by the weighted average number of common stock shares outstanding during the period. Diluted net loss per common share is the same as basic net loss per common share, because potentially dilutive securities would have an antidilutive effect as the Company incurred a net loss for the years ended December 31, 2023 and 2022. The potentially dilutive securities excluded from the determination of diluted loss per share as their effect is antidilutive, are as follows: Year Ended December 31, 2023 2022 Stock options to purchase common stock 5,029,345 4,171,311 Warrants to purchase common stock 466,112 506,229 Total 5,495,457 4,677,540 (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. Valuation allowances are recorded to reduce deferred tax assets to the amount that will more likely than not be realized. (J) Fair value of financial instruments: ASC Topic 820, Fair Value Measurement Disclosures, 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 Topic 842, Leases. Both financing and operating leases are included in right-of-use (ROU) assets, lease obligations short-term and lease obligations 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. Operating lease ROU assets and 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) Subsequent events: Subsequent events have been evaluated through the date these financial statements were issued. See Note 14. (M) New accounting standards adopted: 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 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. 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	12 Months Ended
	Dec. 31, 2023
Liquidity and Capital Resources [Abstract]
Liquidity and Capital Resources	Note 3 – Liquidity and Capital Resources As of December 31, 2023, the Company had $56.6 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 level of activities undertaken, as well as 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. 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 April 2022, the Company received approximately $1.2 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant 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, which the Company refers to collectively as the Shelf Securities, 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 $50.0 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, 2023, the Company sold 2,642,269 shares of common stock for a net value of $16.1 million pursuant to the Sales Agreement. For the year ended December 31, 2022, the Company sold 1,238,491 shares of our common stock for a net value of $9.9 million pursuant to the Sales Agreement. As of the date of this Annual Report, in the first quarter of 2024, the Company sold 3,428,681 shares of common stock for a net value of $19.5 million 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 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 of certain conditions. At this time the option to advance Loan E and Loan F has expired and Loan E and Loan F are no longer available to the Company under the Loan and Security Agreement. The Company may only use the proceeds 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. Payments on the principal balance begin on October 1, 2024 and are paid monthly in the succeeding 24 months. 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. The Company, at its option upon at least ten (10) business days’ written notice to the lenders, may prepay all (and not less than all) of the outstanding Loan by simultaneously paying to each lender an amount equal to (i) any accrued and unpaid interest on the outstanding principal balance of the Loans; plus (ii) an amount equal to (A) if such Loan is prepaid on or before the Loan Amortization Date (as defined in the Loan and Security Agreement) applicable to such Loan, 3% of the then outstanding principal balance of such Loan, (B) if such Loan is prepaid after the Loan Amortization Date applicable to such Loan, but on or before the date that is 12 months after such Loan Amortization Date, 2% of the then outstanding principal balance of such Loan, or (C) if such Loan is prepaid more than 12 months after the Loan Amortization Date but prior to the stated maturity date applicable to such Loan, 1% of the then outstanding principal balance of such Loan; plus (iii) the outstanding principal balance of such Loan; plus (iv) all other sums, if any, that shall have become due and payable thereunder. No prepayment premium will be applied to any outstanding balance of any Loan paid on the stated maturity date. 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. 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 Annual Report on Form 10-K 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 continuin g development and clinical trials as well as payments on our 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 audited consolidated financial statements. The audited 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	12 Months Ended
	Dec. 31, 2023
Fair Value of Financial Instruments [Abstract]
Fair Value of Financial Instruments	Note 4 – Fair Value of Financial Instruments There were no transfers between Levels 1, 2, or 3 during the years ended December 31, 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 December 31, 2023: Cash and cash equivalents $ 56,560,517 $ 56,560,517 $ – $ – As of December 31, 2022: Cash and cash equivalents $ 73,820,160 $ 73,820,160 $ – $ – The carrying value of the Loan and Security Agreement approximated its fair value at December 31, 2023 due to its variable rate. The fair value of the Company ’

Property and Equipment

Property and Equipment	12 Months Ended
	Dec. 31, 2023
Property and Equipment [Abstract]
Property and Equipment	Note 5 – Property and Equipment Property and equipment is summarized as follows: December 31, 2023 2022 Furniture and equipment $ 14,964 $ 14,964 Computer and Telephone equipment 13,545 13,545 Lab equipment 238,402 86,911 Total furniture and equipment 266,911 115,420 Less accumulated depreciation (132,779 ) (115,420 ) Property and equipment, net $ 134,132 $ 0 Depreciation expense for the years ended December 31, 2023 and 2022 was $17,359 and $86, respectively.

Leases

Leases	12 Months Ended
	Dec. 31, 2023
Leases [Abstract]
Leases	Note 6 – 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. The sublease term expired on August 31, 2023, and was not renewed. Supplemental cash flow information related to operating leases is as follows: Year Ended December 31, 2023 2022 Cash paid for operating lease liabilities $ 239,469 $ 294,987
Leases	Financing Lease The Company has financed certain laboratory equipment as follows: Year Ended December 31, 2023 2022 Cash paid for finance lease liabilities $ 78,146 $ 423,880 Maturity of the Company’s financing lease liabilities is as follows: Year ended December 31, 2024 $ 69,850 2025 69,850 2026 40,108 2027 26,721 2028 and after 1 Total future minimum lease payments 206,530 Less imputed interest (27,763 ) Remaining lease liability $ 178,767 The Company entered into four financing leases for laboratory equipment with a total cost of $251,959 with four

Accrued Expenses

Accrued Expenses	12 Months Ended
	Dec. 31, 2023
Accrued Expenses [Abstract]
Accrued Expenses	Note 7 – Accrued Expenses Accrued expenses consist of the following: December 31, 2023 2022 Accrued research and development costs $ – $ 5,645,737 Accrued professional fees 827,863 550,259 Accrued compensation 1,289,690 1,837,330 Accrued interest on debt 306,771 280,382 Accrued rent 368 – Total $ 2,424,692 $ 8,313,708

Stock-Based Compensation

Stock-Based Compensation	12 Months Ended
	Dec. 31, 2023
Stock-Based Compensation [Abstract]
Stock-Based Compensation	Note 8 – 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 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 Restated Plan was amended to terminate on December 7, 2030, unless earlier terminated. On July 14, 2023, the Company’s stockholders approved an amendment to the Restated Plan, increasing the number of shares of common stock for issuance from 4,165,535 to 6,565,535 shares. As of , there were 3,051,449 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 December 31, 2023, there were 190,799 shares available for grant under the 2018 Stock Incentive 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”). 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 December 31, 2023, there were 112,010 shares available for grant under the Inducement Plan. The following table summarizes the components of stock-based compensation expense in the consolidated statements of operations and comprehensive loss for the years ended December 31, 2023 and 2022: Year Ended December 31, 2023 2022 Research and development $ 3,013,326 $ 1,868,352 General and administrative 4,600,995 3,327,804 Total $ 7,614,321 $ 5,196,156 The following table summarizes the stock option activity for the Company’ stock option plans for the year ended December 31, 2023: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Aggregate Intrinsic Value Balance at January 1, 2023 4,171,311 $ 5.56 7.89 32,779,920 Granted 1,414,000 $ 10.31 9.18 290 Exercised (81,935 ) $ 3.77 – – Forfeited (456,405 ) $ 10.64 – – Expired (17,626 ) 16.17 Options outstanding at December 31, 2023 5,029,345 $ 6.43 7.42 $ 4,395,227 Vested and expected to vest at December 31, 2023 5,029,345 $ 6.43 7.42 $ 4,395,227 Exercisable at December 31, 2023 2,829,330 $ 5.60 6.53 $ 3,315,101 As of December 31, 2023 there was approximately $13,950,484 of unamortized stock compensation expense, which is expected to be recognized over a remaining average vesting period of 2.47 years. The Company entered into an agreement with DC Consulting for certain consulting services and issued 200,000 shares in connection with the agreement. The weighted-average grant date fair value of the stock options granted in 2023 was $9.59 per share. The fair value of options granted during the year ended December 31, 2023 and 2022 were estimated using the Black-Scholes option valuation model utilizing the following assumptions: Year Ended December 31, 2023 2022 Weighted Average Volatility 142.84 % 99.63 % Risk-Free Interest Rate 4.14 % 1.79 % Expected Term in Years 6.06 6.39 Dividend Rate – – Fair Value of Option on Grant Date $ 9.59 $ 4.40 Expected volatility Risk-free interest rate Expected term. Expected dividend rate

Stockholders' Equity

Stockholders' Equity	12 Months Ended
	Dec. 31, 2023
Stockholders' Equity [Abstract]
Stockholders' Equity	Note 9 – Stockholders’ Equity Preferred Stock The Company currently has 5,000,000 shares of preferred stock authorized. Voting Shares of preferred stock may be issued in one or more series, from time to time, with each such series to consist of such number of shares and to have such voting powers relative to other classes or series of preferred stock, if any, or common stock, full or limited or no voting powers, and such designations, preferences and relative, participating, optional or other special rights, and such qualifications, limitations or restrictions thereof, as shall be stated in the resolution or resolutions providing for the issuance of such series adopted by the Company’s Board of Directors. Common Stock The Company currently has 75,000,000 shares of common authorized. Voting Each holder of a share of common stock is entitled to one vote for each share of common stock. Dividends Dividends may be declared and paid as and when determined by the Board of Directors and subject to any preferential dividend rights of any then outstanding preferred stock. Preemptive Rights. The holders of common stock shall have no preemptive rights to subscribe for any shares of any class of stock of the Company whether now or hereafter authorized. Liquidation Rights Upon the dissolution or liquidation of the Company, whether voluntary or involuntary, holders of the common stock will be entitled to receive all assets of the Company available for distribution to its stockholders, subject to any preferential rights of any then outstanding preferred stock.

Income Taxes

Income Taxes	12 Months Ended
	Dec. 31, 2023
Income Taxes [Abstract]
Income Taxes	Note 10 – Income Taxes A reconciliation of the statutory U.S. federal income tax rate to the Company’s effective tax rate is as follows: December 31, 2023 2022 Federal statutory rate 21.0 % 21.0 % State taxes 7.9 % 4.8 % Extraordinary gain 0.0 % 0.0 % Permanent differences (0.9 )% (0.4 )% Research and development 4.1 % 2.9 % State Taxes/Sale of NOL 3.2 % 2.9 % Valuation Allowance (32.1 )% (28.3 )% Other 0.0 % 0.0 % Effective tax rate 3.2 % 2.9 % The tax effects of temporary differences that give rise to significant portions of the deferred tax assets were as follows: December 31, 2023 2022 Federal net operating losses $ 28,599,086 $ 25,063,210 State net operating losses 4,648,978 3,166,596 Stock options 4,668,417 2,696,879 Federal tax credit 4,730,921 2,893,412 State tax credits 582,605 511,557 Research and Development Capitalization (IRC 174) 10,017,958 4,506,729 License Agreement 2,639,961 2,811,000 Amortization 23,131 29,463 Accrued expense 104 – Depreciation 725,305 732,064 Lease liabilities 50,564 127,278 Other 15,374 15,278 Total gross deferred tax assets 56,702,404 42,553,261 Less valuation allowance (56,645,587 ) (42,404,971 ) Deferred tax assets, net $ 56,817 $ 148,290 Right of use asset $ (56,817 ) $ (148,290 ) Total gross deferred tax liabilities (56,817 ) (148,290 ) Deferred tax, net $ – $ – 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 of the deferred income tax 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. At December 31, 2023 and 2022, the Company has recorded a full valuation allowance against its net deferred tax assets of approximately $56.6 and $42.4 million, respectively. The change in the valuation allowance during the year ended 2023 was approximately $14.2 million. The Tax Cuts and Jobs Act of 2017 (TCJA) has modified the IRC 174 expenses related to research and development for the tax years beginning after December 31, 2021. Under the TCJA, the Company must now capitalize the expenditures related to research and development activities and amortize over five years for U.S. activities and 15 years for non-U.S. activities using a mid-year convention. Therefore, the capitalization of research and development costs in accordance with IRC 174 resulted in a deferred tax asset of $10.0 million and $4.5 million as of December 31, 2023 and 2022, respectively. At December 31, 2023, the Company had federal net operating loss (“NOL”) carryforwards of approximately $136.2 million. At December 31, 2023, the Company had federal research and development credit carryforwards of approximately $4.7 million. The federal net operating loss carryforwards begin to expire in 2028, losses generated in 2018 or later of $106.2 million will carry forward indefinitely. The federal credit carryforwards begin to expire in 2032 At December 31, 2023, the Company had approximately $65.5 million of State of New Jersey NOLs which expire between 2029 2043 In 2023, the Company sold New Jersey NOL carryforwards and R&D Credits, resulting in the recognition of $1.4 million of income tax benefit, net of transaction costs. There is no certainty as to whether this program will continue. Entities are also required to evaluate, measure, recognize and disclose any uncertain income tax provisions taken on their income tax returns. The Company has analyzed its tax positions and has concluded that as of December 31, 2023, there were no uncertain positions. The Company’s U.S. federal and state net operating losses have occurred since its inception in 2009 and as such, tax years subject to potential tax examination could apply from that date because the utilization of net operating losses from prior years opens the relevant year to audit by the IRS and/or state taxing authorities. Interest and penalties, if any, as they relate to income taxes assessed, are included in the income tax provision. The Company did not have any unrecognized tax benefits and has not accrued any interest or penalties for the years ended December 31, 2023 and 2022.

Commitments and Contingencies

Commitments and Contingencies	12 Months Ended
	Dec. 31, 2023
Commitments and Contingencies [Abstract]
Commitments and Contingencies	Note 11 – Commitments and Contingencies Rent For the years ended December 31, 2023 and 2022, rent was $264,000 and $232,500, respectively, for month-to-month arrangements not impacted by the adoption of ASC 842. Exclusive License Agreement Pursuant to the Merck KGaA License Agreement, we 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 Phase3 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. We 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 we obtain 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 may be involved, from time to time, in legal proceedings and claims arising in the ordinary course of its business. Such matters are subject to many uncertainties and outcomes are not predictable with assurance. While there can be no assurances as to the ultimate outcome of any legal proceeding or other loss contingency involving the Company, management does not believe any pending matter will be resolved in a manner that would have a material adverse effect on its financial position, results of operations or cash flows.

Venture Loan and Security Agree

Venture Loan and Security Agreement	12 Months Ended
	Dec. 31, 2023
Venture Loan and Security Agreement [Abstract]
Venture Loan and Security Agreement	Note 12 – 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 of certain conditions. At this time the option to advance Loan E and Loan F has expired and Loan E and Loan F are no longer available to the Company under the Loan and Security Agreement. The Company may only use the proceeds of the Loans for working capital or general corporate purposes. Maturity. Each Loan matures on the 48-month anniversary following the applicable date on which a Loan is made to or on account of the Company under the Loan and Security Agreement (the “Maturity Date”) unless accelerated pursuant to agreed upon events of default. All amounts outstanding under each Loan will be due and payable upon the earlier of the Maturity Date or the acceleration of the loans and commitments upon an event of default. Payments on the principal balance begin on October 1, 2024 and are paid monthly in the succeeding 24 months. 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 is required to commence making equal payments of principal plus accrued interest on the outstanding principal amount of the respect Loan (the “Loan Amortization Date”) and continuing thereafter on the first business day of each calendar month through the Maturity Date. Prepayment Premium. The Company may, at its option upon at least ten (10) business days’ written notice to the Lenders, prepay all (and not less than all) of the outstanding Loan by simultaneously paying to each Lender an amount equal to (i) any accrued and unpaid interest on the outstanding principal balance of the Loans; plus (ii) an amount equal to (A) if such Loan is prepaid on or before the Loan Amortization Date applicable to such Loan, three percent (3%) of the then outstanding principal balance of such Loan, (B) if such Loan is prepaid after the Loan Amortization Date applicable to such Loan, but on or before the date that is twelve (12) months after such Loan Amortization Date, two percent (2%) of the then outstanding principal balance of such Loan, or (C) if such Loan is prepaid more than twelve (12) months after the Loan Amortization Date but prior to the stated Maturity Date applicable to such Loan, one percent (1%) of the then outstanding principal balance of such Loan; 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 December 31, 2023, the Company is in compliance with all covenants. 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 Black-Scholes option pricing model were (i) expected term of 10 years, (ii) a risk-free rate of 3.11%, (iii) expected volatility of 93.8%, (iv) and no estimated dividend yield. In addition, the Company incurred third-party and lender fees of $449,329. These proceeds were allocated on a basis that approximates the relative fair value method. The fair value of the warrant and fees incurred were recorded as a debt discount and are being recognized as interest expense over the life of the Loan and Security Agreement using the effective interest method. The unamortized debt discount was $2,264,650 as of December 31, 2023. For the year ended December 31, 2023 and 2022 the Company recognized interest expense of $4,187,075 and $1,288,776, respectively, of which $652,006 and $183,914, respectively was related to the amortization of the debt discount for each of the years.

Retirement Plan

Retirement Plan	12 Months Ended
	Dec. 31, 2023
Retirement Plan [Abstract]
Retirement Plan	Note 13 – 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 cash contribution match for the years ended December 31, 2023 and December 31, 2022 $181,439 and $157,009, respectively.

Subsequent Events

Subsequent Events	12 Months Ended
	Dec. 31, 2023
Subsequent Events [Abstract]
Subsequent Events	Note 14 – Subsequent Events On January 22, 2024, 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 1,100,000 shares to 2,100,000 shares As of the date of this Annual Report,in the first quarter of 2024, the Company sold 3,428,681 shares of common stock for net proceeds of $19.5 million pursuant to its Sales Agreement .

Insider Trading Arrangements

Insider Trading Arrangements	3 Months Ended
	Dec. 31, 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)	12 Months Ended
	Dec. 31, 2023
Summary of Significant Accounting Policies [Abstract]
Use of Estimates	(A) Use of estimates: The preparation of 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	(B) 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 products, the Company’s ability to preserve its cash resources, the Company’s ability to add product candidates to its pipeline, the Company’s intellectual property, the Company’s ability to complete clinical trials necessary to obtain regulatory product licenses, 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 Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products, and the Company’s ability to raise capital. 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	(C) 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.
Property and Equipment	(D) Property and equipment: Property and equipment are recorded at cost. Depreciation is recorded for property and equipment using the straight-line method over the estimated useful life of five years. The Company reviews the recoverability of all long-lived assets, including the related useful lives, whenever events or changes in circumstances indicate that the carrying amount of a long-lived asset might not be recoverable.
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. Under the terms of the License Agreement, the Company agreed to an initial payment of $5 million in cash and an additional $5 million in Company Stock, plus future milestone and royalty payments. The Company accounts for milestone payments as expenses in research and development and royalties are recorded as a reduction in revenues.
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.
Net Loss per Common Share	(H) Net loss per common share: Basic net loss per common share is calculated by dividing the net loss by the weighted average number of common stock shares outstanding during the period. Diluted net loss per common share is the same as basic net loss per common share, because potentially dilutive securities would have an antidilutive effect as the Company incurred a net loss for the years ended December 31, 2023 and 2022. The potentially dilutive securities excluded from the determination of diluted loss per share as their effect is antidilutive, are as follows: Year Ended December 31, 2023 2022 Stock options to purchase common stock 5,029,345 4,171,311 Warrants to purchase common stock 466,112 506,229 Total 5,495,457 4,677,540
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. Valuation allowances are recorded to reduce deferred tax assets to the amount that will more likely than not be realized.
Fair Value of Financial Instruments	(J) Fair value of financial instruments: ASC Topic 820, Fair Value Measurement Disclosures, 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 Topic 842, Leases. Both financing and operating leases are included in right-of-use (ROU) assets, lease obligations short-term and lease obligations 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. Operating lease ROU assets and 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.
Subsequent Events	(L) Subsequent events: Subsequent events have been evaluated through the date these financial statements were issued. See Note 14.
New Accounting Standards Adopted	(M) New accounting standards adopted: 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 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. 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)	12 Months Ended
	Dec. 31, 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: Year Ended December 31, 2023 2022 Stock options to purchase common stock 5,029,345 4,171,311 Warrants to purchase common stock 466,112 506,229 Total 5,495,457 4,677,540

Fair Value of Financial Instr_2

Fair Value of Financial Instruments (Tables)	12 Months Ended
	Dec. 31, 2023
Fair Value of Financial Instruments [Abstract]
Fair Value of Financial Instruments	There were no transfers between Levels 1, 2, or 3 during the years ended December 31, 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 December 31, 2023: Cash and cash equivalents $ 56,560,517 $ 56,560,517 $ – $ – As of December 31, 2022: Cash and cash equivalents $ 73,820,160 $ 73,820,160 $ – $ –

Property and Equipment (Tables)

Property and Equipment (Tables)	12 Months Ended
	Dec. 31, 2023
Property and Equipment [Abstract]
Property and Equipment	Property and equipment is summarized as follows: December 31, 2023 2022 Furniture and equipment $ 14,964 $ 14,964 Computer and Telephone equipment 13,545 13,545 Lab equipment 238,402 86,911 Total furniture and equipment 266,911 115,420 Less accumulated depreciation (132,779 ) (115,420 ) Property and equipment, net $ 134,132 $ 0

Leases (Tables)

Leases (Tables)	12 Months Ended
	Dec. 31, 2023
Leases [Abstract]
Supplemental Cash Flow Information Related to Operating Leases	Supplemental cash flow information related to operating leases is as follows: Year Ended December 31, 2023 2022 Cash paid for operating lease liabilities $ 239,469 $ 294,987
Supplemental Cash Flow Information Related to Financing Lease	The Company has financed certain laboratory equipment as follows: Year Ended December 31, 2023 2022 Cash paid for finance lease liabilities $ 78,146 $ 423,880
Future Payments for Financing Lease Liability	Maturity of the Company’s financing lease liabilities is as follows: Year ended December 31, 2024 $ 69,850 2025 69,850 2026 40,108 2027 26,721 2028 and after 1 Total future minimum lease payments 206,530 Less imputed interest (27,763 ) Remaining lease liability $ 178,767

Accrued Expenses (Tables)

Accrued Expenses (Tables)	12 Months Ended
	Dec. 31, 2023
Accrued Expenses [Abstract]
Accrued Expenses	Accrued expenses consist of the following: December 31, 2023 2022 Accrued research and development costs $ – $ 5,645,737 Accrued professional fees 827,863 550,259 Accrued compensation 1,289,690 1,837,330 Accrued interest on debt 306,771 280,382 Accrued rent 368 – Total $ 2,424,692 $ 8,313,708

Stock-Based Compensation (Table

Stock-Based Compensation (Tables)	12 Months Ended
	Dec. 31, 2023
Stock-Based Compensation [Abstract]
Stock-Based Compensation Expense	The following table summarizes the components of stock-based compensation expense in the consolidated statements of operations and comprehensive loss for the years ended December 31, 2023 and 2022: Year Ended December 31, 2023 2022 Research and development $ 3,013,326 $ 1,868,352 General and administrative 4,600,995 3,327,804 Total $ 7,614,321 $ 5,196,156
Stock Option Activity	The following table summarizes the stock option activity for the Company’ stock option plans for the year ended December 31, 2023: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Aggregate Intrinsic Value Balance at January 1, 2023 4,171,311 $ 5.56 7.89 32,779,920 Granted 1,414,000 $ 10.31 9.18 290 Exercised (81,935 ) $ 3.77 – – Forfeited (456,405 ) $ 10.64 – – Expired (17,626 ) 16.17 Options outstanding at December 31, 2023 5,029,345 $ 6.43 7.42 $ 4,395,227 Vested and expected to vest at December 31, 2023 5,029,345 $ 6.43 7.42 $ 4,395,227 Exercisable at December 31, 2023 2,829,330 $ 5.60 6.53 $ 3,315,101
Assumptions Used to Value Options and Warrants Granted	The fair value of options granted during the year ended December 31, 2023 and 2022 were estimated using the Black-Scholes option valuation model utilizing the following assumptions: Year Ended December 31, 2023 2022 Weighted Average Volatility 142.84 % 99.63 % Risk-Free Interest Rate 4.14 % 1.79 % Expected Term in Years 6.06 6.39 Dividend Rate – – Fair Value of Option on Grant Date $ 9.59 $ 4.40

Income Taxes (Tables)

Income Taxes (Tables)	12 Months Ended
	Dec. 31, 2023
Income Taxes [Abstract]
Statutory to Effective Federal Income Tax Rate Reconciliation	A reconciliation of the statutory U.S. federal income tax rate to the Company’s effective tax rate is as follows: December 31, 2023 2022 Federal statutory rate 21.0 % 21.0 % State taxes 7.9 % 4.8 % Extraordinary gain 0.0 % 0.0 % Permanent differences (0.9 )% (0.4 )% Research and development 4.1 % 2.9 % State Taxes/Sale of NOL 3.2 % 2.9 % Valuation Allowance (32.1 )% (28.3 )% Other 0.0 % 0.0 % Effective tax rate 3.2 % 2.9 %
Deferred Tax Assets, Net	The tax effects of temporary differences that give rise to significant portions of the deferred tax assets were as follows: December 31, 2023 2022 Federal net operating losses $ 28,599,086 $ 25,063,210 State net operating losses 4,648,978 3,166,596 Stock options 4,668,417 2,696,879 Federal tax credit 4,730,921 2,893,412 State tax credits 582,605 511,557 Research and Development Capitalization (IRC 174) 10,017,958 4,506,729 License Agreement 2,639,961 2,811,000 Amortization 23,131 29,463 Accrued expense 104 – Depreciation 725,305 732,064 Lease liabilities 50,564 127,278 Other 15,374 15,278 Total gross deferred tax assets 56,702,404 42,553,261 Less valuation allowance (56,645,587 ) (42,404,971 ) Deferred tax assets, net $ 56,817 $ 148,290 Right of use asset $ (56,817 ) $ (148,290 ) Total gross deferred tax liabilities (56,817 ) (148,290 ) Deferred tax, net $ – $ –

Nature of Operations, Summary (

Nature of Operations, Summary (Details) - Patent	Mar. 01, 2024	Dec. 31, 2023
U.S. [Member]
Nature of Operations [Abstract]
Number of patents held		13
Number of pending patent applications		24
Foreign [Member] | Subsequent Event [Member]
Nature of Operations [Abstract]
Number of patents held	74
Number of pending patent applications	44

Nature of Operations, Exclusive

Nature of Operations, Exclusive License Agreement (Details) - USD ($)		3 Months Ended			12 Months Ended
	Dec. 30, 2022	Dec. 31, 2023	Jun. 30, 2023	Dec. 31, 2022	Dec. 31, 2023
Nature of Operations [Abstract]
Up-front cash payment for license agreement	$ 5,000,000				$ 5,000,000
Issuance of common stock for licensing agreement (in shares)	378,787
Issuance of common stock for licensing agreement	$ 5,000,000	$ 411,000	$ 610,000	$ 4,999,988	$ 5,000,000

Summary of Significant Accoun_4

Summary of Significant Accounting Policies (Details) - USD ($)		3 Months Ended			12 Months Ended
	Dec. 30, 2022	Dec. 31, 2023	Jun. 30, 2023	Dec. 31, 2022	Dec. 31, 2023	Dec. 31, 2022
Property and Equipment [Abstract]
Estimated useful lives of property and equipment		5 years			5 years
Research and Development [Abstract]
Up-front cash payment for license agreement	$ 5,000,000				$ 5,000,000
Issuance of common stock for licensing agreement	$ 5,000,000	$ 411,000	$ 610,000	$ 4,999,988	$ 5,000,000
Net Loss per Common Share [Abstract]
Antidilutive impact to EPS (in shares)					5,495,457	4,677,540
Stock Options to Purchase Common Stock [Member]
Net Loss per Common Share [Abstract]
Antidilutive impact to EPS (in shares)					5,029,345	4,171,311
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, 2023 USD ($)

Aug. 31, 2022 USD ($)

Apr. 30, 2022 USD ($)

Mar. 31, 2024 USD ($) shares

Mar. 28, 2024 USD ($) shares

Dec. 31, 2023 USD ($) Loan

Sep. 30, 2023 USD ($)

Jun. 30, 2023 USD ($)

Mar. 31, 2023 USD ($)

Dec. 31, 2022 USD ($)

Dec. 31, 2023 USD ($) Loan shares

Dec. 31, 2022 USD ($) shares

Liquidity [Abstract]

Cash and cash equivalents

$ 56,560,517

$ 73,820,160

$ 56,560,517

$ 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

2,642,269

1,238,491

Issuance of common stock

$ 10,479,385

$ 815,202

$ 243,743

$ 4,588,522

$ 9,856,116

$ 16,100,000

$ 9,900,000

Proceeds from issuance of secured loans

$ 0

$ 25,000,000

Threshold period after Loan Amortization Date used to determine prepayment premiums

12 months

Subsequent Event [Member]

Liquidity [Abstract]

Issuance of common stock (in shares) | shares

3,428,681

3,428,681

Issuance of common stock

$ 19,500,000

$ 19,500,000

Term Loans [Member]

Liquidity [Abstract]

Number of independent term loans | Loan

6

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

$ 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 ($)	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Fair Value Transfers Between Levels [Abstract]
Transfers into Level 3	$ 0	$ 0
Transfers out of Level 3	0	0
Fair Value of Financial Instruments [Abstract]
Cash and cash equivalents	56,560,517	73,820,160
Quoted Prices in Active Markets (Level 1) [Member]
Fair Value of Financial Instruments [Abstract]
Cash and cash equivalents	56,560,517	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

Property and Equipment (Details

Property and Equipment (Details) - USD ($)	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Property and Equipment [Abstract]
Property and equipment	$ 266,911	$ 115,420
Less accumulated depreciation	(132,779)	(115,420)
Property and equipment, net	134,132	0
Depreciation expense	17,359	86
Furniture and Equipment [Member]
Property and Equipment [Abstract]
Property and equipment	14,964	14,964
Computer and Telephone Equipment [Member]
Property and Equipment [Abstract]
Property and equipment	13,545	13,545
Lab Equipment [Member]
Property and Equipment [Abstract]
Property and equipment	$ 238,402	$ 86,911

Leases, Operating Lease (Detail

Leases, Operating Lease (Details)	12 Months Ended
	Dec. 31, 2023 USD ($) ft²	Dec. 31, 2022 USD ($)	May 01, 2020 USD ($)
Operating Leases [Abstract]
Area of office space under sublease | ft²	11,200
Term of sublease agreement	40 months
Operating lease right-of-use assets	$ 0	$ 152,645	$ 700,000
Operating leases liabilities			$ 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	$ 294,987

Leases, Financing Lease (Detail

Leases, Financing Lease (Details)	12 Months Ended
	Dec. 31, 2023 USD ($) Lease	Dec. 31, 2022 USD ($)
Supplemental Cash Flow Information Related to Finance Lease [Abstract]
Cash paid for finance lease liabilities	$ 78,146	$ 423,880
Future Payments for Finance Lease Liabilities [Abstract]
2024	69,850
2025	69,850
2026	40,108
2027	26,721
2028 and after	1
Total future minimum lease payments	206,530
Less imputed interest	(27,763)
Remaining lease liability	$ 178,767
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
Finance lease amortization expense	$ 39,967	$ 48,992
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 ($)	Dec. 31, 2023	Dec. 31, 2022
Accrued Expenses [Abstract]
Accrued research and development	$ 0	$ 5,645,737
Accrued professional fees	827,863	550,259
Accrued compensation	1,289,690	1,837,330
Accrued interest on debt	306,771	280,382
Accrued rent	368	0
Total	$ 2,424,692	$ 8,313,708

Stock-Based Compensation, Equit

Stock-Based Compensation, Equity Compensation Plans (Details) - shares	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2014	Jan. 22, 2024	Jul. 14, 2023	May 17, 2022	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		826,292
Percentage of Common Stock outstanding used to determine annual increase in the plan limit		4%
Shares available for grant (in shares)	3,051,449
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)	112,010
Common stock reserved for issuance (in shares)					1,100,000	500,000	200,000
2019 Inducement Plan [Member] | Subsequent Event [Member]
Stock Options [Abstract]
Common stock reserved for issuance (in shares)			2,100,000

Stock-Based Compensation, Stock

Stock-Based Compensation, Stock-Based Compensation Expense (Details) - USD ($)	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Stock-Based Compensation [Abstract]
Stock-based compensation expense	$ 7,614,321	$ 5,196,156
Research and Development [Member]
Stock-Based Compensation [Abstract]
Stock-based compensation expense	3,013,326	1,868,352
General and Administrative [Member]
Stock-Based Compensation [Abstract]
Stock-based compensation expense	$ 4,600,995	$ 3,327,804

Stock-Based Compensation, Sto_2

Stock-Based Compensation, Stock Option Activity (Details) - USD ($)		3 Months Ended					12 Months Ended
	Dec. 30, 2022	Dec. 31, 2023	Jun. 30, 2023	Dec. 31, 2022	Jun. 30, 2022	Mar. 31, 2022	Dec. 31, 2023	Dec. 31, 2022
Unamortized Stock Compensation Expense [Abstract]
Shares issued for consulting services (in shares)	378,787
Weighted-average grant date fair value, granted (in dollars per share)							$ 9.59	$ 4.4
Common Stock [Member]
Number of Shares [Roll Forward]
Exercised (in shares)		(80,526)	(1,409)	(269,535)	(7,794)	(2,282)
Unamortized Stock Compensation Expense [Abstract]
Shares issued for consulting services (in shares)		100,000	100,000	378,787			200,000
Stock Options [Member]
Number of Shares [Roll Forward]
Options outstanding, beginning balance (in shares)							4,171,311
Granted (in shares)							1,414,000
Exercised (in shares)							(81,935)
Forfeited (in shares)							(456,405)
Expired (in shares)							(17,626)
Options outstanding, ending balance (in shares)		5,029,345		4,171,311			5,029,345	4,171,311
Vested and expected to vest (in shares)		5,029,345					5,029,345
Exercisable (in shares)		2,829,330					2,829,330
Weighted Average Exercise Price [Roll Forward]
Options outstanding, beginning balance (in dollars per share)							$ 5.56
Granted (in dollars per share)							10.31
Exercised (in dollars per share)							3.77
Forfeited (in dollars per share)							10.64
Expired (in dollars per share)							16.17
Options outstanding, ending balance (in dollars per share)		$ 6.43		$ 5.56			6.43	$ 5.56
Vested and expected to vest (in dollars per share)		6.43					6.43
Exercisable (in dollars per share)		$ 5.6					$ 5.6
Weighted Average Remaining Contractual Life and Aggregate Intrinsic Value [Abstract]
Options outstanding, weighted average remaining contractual life							7 years 5 months 1 day	7 years 10 months 20 days
Granted, weighted average remaining contractual life							9 years 2 months 4 days
Vested and expected to vest, weighted average contractual life							7 years 5 months 1 day
Exercisable, weighted average contractual life							6 years 6 months 10 days
Options outstanding, aggregate intrinsic value							$ 32,779,920
Granted, aggregate intrinsic value							290
Exercised, aggregate intrinsic value							0
Forfeited, aggregate intrinsic value							0
Options outstanding, aggregate intrinsic value		$ 4,395,227		$ 32,779,920			4,395,227	$ 32,779,920
Vested and expected to vest, aggregate intrinsic value		4,395,227					4,395,227
Exercisable, aggregate intrinsic value		3,315,101					3,315,101
Unamortized Stock Compensation Expense [Abstract]
Unamortized stock compensation expense		$ 13,950,484					$ 13,950,484
Period for recognition							2 years 5 months 19 days
Weighted-average grant date fair value, granted (in dollars per share)							$ 9.59

Stock-Based Compensation, Assum

Stock-Based Compensation, Assumptions Used to Value Stock Options Granted (Details) - $ / shares	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Assumptions Used in Determining Fair Value of Stock Options and Warrants Granted [Abstract]
Volatility	142.84%	99.63%
Risk-free interest rate	4.14%	1.79%
Expected term	6 years 21 days	6 years 4 months 20 days
Dividend rate	0%	0%
Fair value of option on grant date (in dollars per share)	$ 9.59	$ 4.4

Stockholders' Equity (Details)

Stockholders' Equity (Details)	Dec. 31, 2023 Vote shares	Dec. 31, 2022 shares
Stockholders' Equity [Abstract]
Preferred stock, shares authorized (in shares)	5,000,000
Common stock, shares authorized (in shares)	75,000,000	75,000,000
Number of votes for each share of common stockholder | Vote	1

Income Taxes (Details)

Income Taxes (Details) - USD ($)	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Effective Federal Income Tax Rate Reconciliation [Abstract]
Federal statutory rate	21%	21%
State taxes	7.90%	4.80%
Extraordinary gain	0%	0%
Permanent differences	(0.90%)	(0.40%)
Research and development	4.10%	2.90%
State taxes/sale of NOL	3.20%	2.90%
Valuation Allowance	(32.10%)	(28.30%)
Other	0%	0%
Effective tax rate	3.20%	2.90%
Deferred Tax Assets, Net [Abstract]
Federal net operating losses	$ 28,599,086	$ 25,063,210
State net operating losses	4,648,978	3,166,596
Stock options	4,668,417	2,696,879
Research and Development Capitalization (IRC 174)	10,017,958	4,506,729
License Agreement	2,639,961	2,811,000
Amortization	23,131	29,463
Accrued expense	104	0
Depreciation	725,305	732,064
Lease liabilities	50,564	127,278
Other	15,374	15,278
Total gross deferred tax assets	56,702,404	42,553,261
Less valuation allowance	(56,645,587)	(42,404,971)
Deferred tax assets, net	56,817	148,290
Right of use asset	(56,817)	(148,290)
Total gross deferred tax liabilities	(56,817)	(148,290)
Deferred tax, net	0	0
Tax Carryforwards [Abstract]
Amount of change in valuation allowance	14,200,000
Benefit from income taxes	(1,406,019)	(1,198,905)
Income Tax Uncertainties [Abstract]
Uncertain tax positions	0
Unrecognized tax benefits	0	0
Accrued interest and penalties	0	0
Federal [Member]
Tax Carryforwards [Abstract]
Net operating loss carryforwards	136,200,000
Net operating loss carryforwards that will carry forward indefinitely	$ 106,200,000
Expiration date of net operating loss carryforwards	Dec. 31, 2032
New Jersey [Member]
Tax Carryforwards [Abstract]
Net operating loss carryforwards	$ 65,500,000
New Jersey [Member] | Minimum [Member]
Tax Carryforwards [Abstract]
Expiration date of net operating loss carryforwards	Dec. 31, 2029
New Jersey [Member] | Maximum [Member]
Tax Carryforwards [Abstract]
Expiration date of net operating loss carryforwards	Dec. 31, 2043
Research and Development Credit [Member] | Federal [Member]
Tax Carryforwards [Abstract]
Tax credit carryforwards	$ 700,000
Research and Development Credit [Member] | New Jersey [Member]
Tax Carryforwards [Abstract]
Tax credit carryforwards	4,700,000
Federal [Member]
Deferred Tax Assets, Net [Abstract]
Tax credits	4,730,921	2,893,412
State [Member]
Deferred Tax Assets, Net [Abstract]
Tax credits	$ 582,605	$ 511,557

Commitments and Contingencies (

Commitments and Contingencies (Details) - USD ($)	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Commitments and Contingencies [Abstract]
Rent expense	$ 264,000	$ 232,500
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)	12 Months Ended
	Dec. 31, 2023 USD ($) Loan	Aug. 31, 2022 USD ($)
Venture Loan and Security Agreement [Abstract]
Threshold period after Loan Amortization Date used to determine prepayment premiums	12 months
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)	12 Months Ended
	Dec. 31, 2023 USD ($)	Dec. 31, 2022 USD ($)	Aug. 31, 2022 $ / shares shares
Warrant and Debt Discount [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	$ 0	$ 449,329
Unamortized debt discount	2,264,650
Interest expense	4,187,075	1,288,776
Amortization of debt discount	$ 652,006	$ 183,914
Minimum [Member]
Warrant and Debt Discount [Abstract]
Percentage of voting power disposed off	50%
Expected Term [Member]
Warrant and Debt Discount [Abstract]
Term of warrants	10 years
Risk-free Rate [Member]
Warrant and Debt Discount [Abstract]
Warrants measurement input	0.0311
Expected Volatility [Member]
Warrant and Debt Discount [Abstract]
Warrants measurement input	0.938
Estimated Dividend Yield [Member]
Warrant and Debt Discount [Abstract]
Warrants measurement input	0

Retirement Plan (Details)

Retirement Plan (Details) - USD ($)	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Retirement Plan [Abstract]
401(k) employer contributions	$ 181,439	$ 157,009

Subsequent Events (Details)

Subsequent Events (Details) - USD ($)

3 Months Ended

12 Months Ended

Mar. 31, 2024

Mar. 28, 2024

Dec. 31, 2023

Sep. 30, 2023

Jun. 30, 2023

Mar. 31, 2023

Dec. 31, 2022

Dec. 31, 2023

Dec. 31, 2022

Jan. 22, 2024

May 17, 2022

Dec. 08, 2020

Dec. 07, 2020

Subsequent Events [Abstract]

Issuance of common stock (in shares)

2,642,269

1,238,491

Issuance of common stock

$ 10,479,385

$ 815,202

$ 243,743

$ 4,588,522

$ 9,856,116

$ 16,100,000

$ 9,900,000

Inducement Plan [Member]

Subsequent Events [Abstract]

Common stock reserved for issuance (in shares)

1,100,000

500,000

200,000

Subsequent Event [Member]

Subsequent Events [Abstract]

Issuance of common stock (in shares)

3,428,681

3,428,681

Issuance of common stock

$ 19,500,000

$ 19,500,000

Subsequent Event [Member] | Inducement Plan [Member]

Subsequent Events [Abstract]

Common stock reserved for issuance (in shares)

2,100,000