PDS Biotechnology (PDSB) 10-K 28 Mar 23 2022 FY Annual report Financial data

Document and Entity Information

Document and Entity Information - USD ($)	12 Months Ended
	Dec. 31, 2022	Mar. 21, 2023	Jun. 30, 2022
Cover [Abstract]
Document Type	10-K
Amendment Flag	false
Document Annual Report	true
Document Period End Date	Dec. 31, 2022
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2022
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	25B Vreeland Road
Entity Address, Address Line Two	Suite 300
Entity Address, City or Town	Florham Park
Entity Address, State or Province	NJ
Entity Address, Postal Zip Code	07932
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
Entity Shell Company	false
Entity Public Float			$ 98,323,054
Entity Common Stock, Shares Outstanding		30,723,610
Auditor Firm ID	185
Auditor Name	KPMG LLP
Auditor Location	Short Hills, New Jersey

Consolidated Balance Sheets

Consolidated Balance Sheets - USD ($)	Dec. 31, 2022	Dec. 31, 2021
Current assets:
Cash and cash equivalents	$ 73,820,160	$ 65,242,622
Prepaid expenses and other	2,660,230	1,597,569
Total current assets	76,480,390	66,840,191
Property and equipment, net	0	86
Financing lease right-to-use assets	374,888	0
Operating lease right-to-use asset	152,645	357,611
Total assets	77,007,923	67,197,888
Current liabilities:
Accounts payable	1,219,287	1,309,403
Accrued expenses	8,313,708	2,187,704
Financing lease obligation - short term	56,612	0
Operating lease obligation - short term	231,429	258,924
Total current liabilities	9,821,036	3,756,031
Noncurrent liabilities:
Note payable, net of debt discount	23,020,844	0
Financing lease obligation-long term	164,013	0
Operating lease obligation-long term	0	231,430
Total liabilities	33,005,893	3,987,461
STOCKHOLDERS' EQUITY
Common stock, $0.00033 par value, 75,000,000 shares authorized at December 31, 2022 and December 31, 2021, 30,170,317 shares and 28,448,612 shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively	9,956	9,387
Additional paid-in capital	145,550,491	123,904,602
Accumulated deficit	(101,558,417)	(60,703,562)
Total stockholders' equity	44,002,030	63,210,427
Total liabilities and stockholders' equity	$ 77,007,923	$ 67,197,888

Consolidated Balance Sheets (Pa

Consolidated Balance Sheets (Parenthetical) - $ / shares	Dec. 31, 2022	Dec. 31, 2021
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)	30,170,317	28,448,612
Common stock, shares outstanding (in shares)	30,170,317	28,448,612

Consolidated Statements of Oper

Consolidated Statements of Operations and Comprehensive Loss - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Operating expenses:
Research and development expenses	$ 29,431,027	$ 11,254,538
General and administrative expenses	12,241,394	10,184,773
Total operating expenses	41,672,421	21,439,311
Loss from operations	(41,672,421)	(21,439,311)
Interest income (expense), net
Interest income	935,180	4,346
Interest expense	(1,316,519)	0
Interest income (expense), net	(381,339)	4,346
Loss before income taxes	(42,053,760)	(21,434,965)
Benefit from income taxes	1,198,905	4,516,488
Net loss	(40,854,855)	(16,918,477)
Comprehensive loss	$ (40,854,855)	$ (16,918,477)
Per share information:
Net loss per share, basic (in dollars per share)	$ (1.43)	$ (0.66)
Net loss per share, diluted (in dollars per share)	$ (1.43)	$ (0.66)
Weighted average common shares outstanding, basic (in shares)	28,599,221	25,597,125
Weighted average common shares outstanding, diluted (in shares)	28,599,221	25,597,125

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, 2020	$ 7,346	$ 70,907,315	$ (43,785,085)	$ 27,129,576
Balance (in shares) at Dec. 31, 2020	22,261,619
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Stock-based compensation expense	$ 0	257,622	0	257,622
Issuance of common stock from 401K match	$ 0	35,747	0	35,747
Issuance of common stock from 401K match (in shares)	16,642
Net loss	$ 0	0	(3,048,618)	(3,048,618)
Balance at Mar. 31, 2021	$ 7,346	71,200,684	(46,833,703)	24,374,327
Balance (in shares) at Mar. 31, 2021	22,278,261
Balance at Dec. 31, 2020	$ 7,346	70,907,315	(43,785,085)	27,129,576
Balance (in shares) at Dec. 31, 2020	22,261,619
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss				(16,918,477)
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
Balance at Mar. 31, 2021	$ 7,346	71,200,684	(46,833,703)	24,374,327
Balance (in shares) at Mar. 31, 2021	22,278,261
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Stock-based compensation expense	$ 0	441,598	0	441,598
Issuance of common stock from 401K match	$ 5	(5)	0	0
Issuance of common stock from 401K match (in shares)	0
Issuances of common stock, from exercise of stock options	$ 17	220,586	0	220,603
Issuances of common stock, from exercise of stock options (in shares)	51,413
Issuances of common stock, net of issuance costs	$ 2,009	48,542,989	0	48,544,998
Issuances of common stock, net of issuance costs (in shares)	6,088,235
Net loss	$ 0	0	(588,931)	(588,931)
Balance at Jun. 30, 2021	$ 9,377	120,405,851	(47,422,634)	72,992,594
Balance (in shares) at Jun. 30, 2021	28,417,909
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Stock-based compensation expense	$ 0	1,701,763	0	1,701,763
Issuances of common stock, from exercise of stock options	$ 6	123,501	0	123,507
Issuances of common stock, from exercise of stock options (in shares)	17,158
Net loss	$ 0	0	(6,960,966)	(6,960,966)
Balance at Sep. 30, 2021	$ 9,383	122,231,115	(54,383,600)	67,856,898
Balance (in shares) at Sep. 30, 2021	28,435,067
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Stock-based compensation expense	$ 0	1,673,475	0	1,673,475
Issuance of common stock from 401K match	$ 4	12	0	16
Issuance of common stock from 401K match (in shares)	13,545
Net loss	$ 0	0	(6,319,962)	(6,319,962)
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, net of issuance costs				$ 9,900,000
Issuances of common stock, net of issuance costs (in shares)				1,238,491
Issuance of common stock for licensing agreement				$ 5,000,000
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	0	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
Issuances of common stock, net of issuance costs	$ 409	9,855,707	0	9,856,116
Issuances of common stock, net of issuance costs (in shares)	1,238,491
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 licensing agreement	$ 125	4,999,863	0	4,999,988
Issuance of common stock for licensing agreement (in shares)	378,787
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

Consolidated Statements of Cash

Consolidated Statements of Cash Flows - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Cash flows from operating activities:
Net loss	$ (40,854,855)	$ (16,918,477)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense	5,196,156	4,074,458
Issuance of shares in licensing agreement	4,999,988	0
Stock-based 401K company common match	0	35,747
Amortization of debt discount	183,914	0
Depreciation expense	86	5,357
Operating lease expense	241,029	241,031
Finance lease amortization expense	48,992	0
Changes in operating assets and liabilities:
Prepaid expenses and other assets	(1,062,661)	(99,904)
Finance lease right-to-use asset	(423,880)	0
Accounts payable	(90,116)	(105,821)
Accrued expenses	6,126,004	452,382
Finance lease liabilities	220,625	0
Operating lease liabilities	(294,988)	(170,839)
Net cash used in operating activities	(25,709,706)	(12,486,066)
Cash flows from financing activities:
Proceeds from issuance of note payable	25,000,000	0
Payment for debt issuance costs	(449,329)	0
Proceeds from exercise of stock options	151,416	344,125
Payment of taxes in equity transaction	(270,959)	0
Proceeds from issuances of common stock, net of issuance costs	9,856,116	48,544,998
Net cash provided by financing activities	34,287,244	48,889,123
Net increase in cash and cash equivalents	8,577,538	36,403,057
Cash and cash equivalents at beginning of period	65,242,622	28,839,565
Cash and cash equivalents at end of period	73,820,160	65,242,622
Supplemental Cash Flow Information [Abstract]
Cash paid for interest	852,221	0
Fair value of warrants issued in connection with debt	$ 1,713,741	$ 0

Nature of Operations

Nature of Operations	12 Months Ended
	Dec. 31, 2022
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’s proprietary T cell activating platforms designed to train the immune system to attack and destroy disease; Versamune, and Versamune plus PDS0301 for treatments in oncology and Infectimune, for treatments in infectious disease. When paired with an antigen, which is a disease-related protein that is recognizable by the immune system, Versamune and Infectimune have both been shown to induce, in vivo, large quantities of high-quality, highly potent polyfunctional CD4 helper and CD8 killer T cells, a specific sub-type of T cell that is more effective at killing infected or target cells. Infectimune is also designed to promote the induction of disease-specific neutralizing antibodies. 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 our immunotherapies as monotherapies in early-stage disease. PDS is developing targeted product candidates to treat several cancers including Human Papillomavirus (HPV)-associated cancers, melanoma, colorectal, lung, breast and prostate cancers. The Company infectious disease candidates are of potential interest for use in COVID-19 and universal influenza vaccines. PDS has developed numerous patents and patent applications and owns substantial know-how and trade secrets related to its Versamune platform. As of December 31, 2022, PDS holds seven (7) U.S. patents with granted claims directed to its platform technology and nineteen (19) pending U.S. patent applications. These issued patents will expire in 2026, 2029, 2031 and 2033. Should the more recently submitted patent applications currently in prosecution be issued, these will expire in 2033 through 2043 assuming no patent term extensions are granted. As of March 1, 2023, PDS holds seventy one (71) issued foreign patents and thirty-eight (38) pending or published foreign patent applications. Most of our international issued patents are issued in multiple countries including Europe, Japan and Australia, and all of which cover compositions of matter and methods of use related to its platform technology. These issued patents will expire in 2028-2037, or later if patent term extension applies. Most recently, the USPTO allowed two (2) applications methods of use related to the platform technology which when granted will run until November 2036. Licensed patents The Company has licensed patented antigens from the US government for use in our 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 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 are 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. Management believes that the combination of these antigens with our proprietary Versamune technology has potential to induce a broad immune response as a universal flu vaccine. 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 Merk 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 known as M9241, now PDS0301. 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 sale milestone and royalty payments.

Summary of Significant Accounti

Summary of Significant Accounting Policies	12 Months Ended
	Dec. 31, 2022
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 revenues and 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, 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 $5 million in an initial payment in cash and an additional $5 million in Company Stock, plus future milestone and royalty payments. The Company accounts for milestone payments as expense in research and development and royalties 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, 2022 and 2021. 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, 2022 2021 Stock options to purchase Common Stock 4,171,311 3,163,835 Warrants to purchase Common Stock 506,229 197,518 Total 4,677,540 3,361,353 (I) Income taxes: The Company provides for deferred income taxes under the asset and liability method, which requires deferred tax assets and liabilities to be recognized for the future tax consequences attributable to net operating loss carryforwards and for differences between the financial statement carrying amounts and the respective tax bases of assets and liabilities. Deferred tax assets are reduced if necessary, by a valuation allowance if it is more likely than not that some portion or all of the deferred tax assets will not be realized. (J) Fair value of financial instruments: FASB ASC 820, Fair Value Measurement 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 842, Lease Accounting. Operating leases are included in right-of-use ("ROU") assets, current portion, lease liability and long-term lease liability 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 All recently issued accounting pronouncements are not expected to have a material effect on the consolidated financial statements.

Liquidity and Capital Resources

Liquidity and Capital Resources	12 Months Ended
	Dec. 31, 2022
Liquidity and Capital Resources [Abstract]
Liquidity and Capital Resources	Note 3 – Liquidity and Capital Resources As of December 31, 2022, the Company had $73.8 million of cash and cash equivalents. The Company’s primary uses of cash are to fund operating expenses, primarily research and development expenditures. Cash used to fund operating expenses is impacted by the timing of when the Company pays these expenses, as reflected in the change to the Company’s outstanding accounts payable and accrued expenses. In May 2021, the Company received approximately $4.5 million from the net sale of tax benefits through 2019 to an unrelated, profitable New Jersey corporation pursuant the Company’s participation in the New Jersey Technology Business Tax Certificate Transfer Net Operating Loss (NOL) program for State Fiscal Year 2020. In June 2021, the Company completed an underwritten public offering in which it sold 6,088,235 shares of common stock at a public offering price of $8.50 per share pursuant to the 2020 Shelf Registration Statement, which includes 794,117 shares issued upon the exercise by the underwriter of its option to purchase additional shares at the public offering price, minus underwriting discounts and commissions. the Company received gross proceeds of approximately $51.7 million and net proceeds of approximately $48.5 million, after deducting underwriting discounts and offering expenses. Approximately $29,300,000 of Shelf Securities remain available for future sale under the 2020 Shelf Registration Statement. 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 State Fiscal Year 2021. 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 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 , 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 of the Securities Act of 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 ) 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 we sold shares of our common stock for a net value of $9.9 million pursuant to the Sales Agreement. In the first quarter of 2023, we sold 553,293 shares of our common stock for a net value of $4.6 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, we received $24.6 million in net proceeds. Loan E and Loan F are uncommitted Loans that may be advanced by the lenders upon their discretion prior to July 31, 2023 upon the satisfaction of certain conditions. 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. 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 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. 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 beyond the filing of this Annual Report on Form 10-K. The Company’s budgeted cash requirements in 2023 and beyond include expenses related to continuing development and clinical studies. Based on its available cash resources and cash flow projections as of the date the consolidated financial statements were available for issuance, management believes there are sufficient funds to continue operations and research and development programs into the third quarter of 2024. The Company plans to continue to fund its operations and capital funding needs through needs through existing cash and additional equity and/or debt. However, the Company cannot be certain that additional financing will be available when needed or that, if available, financing will be obtained on terms favorable to the Company or its existing stockholders. The Company may also enter into government funding programs and consider selectively partnering for clinical development and commercialization. The sale of additional equity would result in additional dilution to the Company’s stockholders. Incurring debt financing would result in debt service obligations, and the instruments governing such debt could provide for operating and financing covenants that would restrict its operations. If the Company is unable to raise additional capital in sufficient amounts or on acceptable terms, we may be required to delay, limit, reduce, or terminate its product development or future commercialization efforts or grant rights to develop and market immunotherapies that the Company would otherwise prefer to develop and market itself. Any of these actions could harm its business, results of operations and prospects. Failure to obtain adequate financing also may adversely affect the Company’s ability to operate as a going concern.

Fair Value of Financial Instrum

Fair Value of Financial Instruments	12 Months Ended
	Dec. 31, 2022
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, 2022 or 2021. 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, 2022: Cash and cash equivalents $ 73,820,160 $ 73,820,160 $ – $ – As of December 31, 2021: Cash and cash equivalents $ 65,242,622 $ 65,242,622 $ – $ – The carrying value of the Loan and Security Agreement approximated its fair value at December 31, 2022 due to its variable rate. The FV of the Company ’

Property and Equipment

Property and Equipment	12 Months Ended
	Dec. 31, 2022
Property and Equipment [Abstract]
Property and Equipment	Note 5 – Property and Equipment Property and equipment is summarized as follows: December 31, 2022 2021 Furniture and equipment $ 14,964 $ 14,964 Computer and Telephone equipment 13,545 13,545 Lab equipment 86,911 86,911 Total furniture and equipment 115,420 115,420 Less accumulated depreciation (115,420 ) (115,334 ) Property and equipment, net $ 0 $ 86 Depreciation expense for the years ended December 31, 2022 and 2021 was $86 and $5,357, respectively.

Leases

Leases	12 Months Ended
	Dec. 31, 2022
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. As of December 31, 2022, there are eight (8) months remaining in the lease term. Supplemental cash flow information related to operating leases is as follows: Year Ended December 31, 2022 2021 Cash paid for operating lease liabilities $ 294,987 $ 170,839 For the year ended December 31, 2022, the Company’s operating lease expense was $241,029. Year ended December 31, 2023 $ 239,470 2024 – 2025 – 2026 – 2027 – Total future minimum lease payments 239,470 Less imputed interest (8,041 ) $ 231,429 Financing Lease The Company has financed certain laboratory equipment as follows: Year Ended December 31, 2022 2021 Cash paid for finance lease liabilities $ 423,880 $ – Year ended December 31, 2023 $ 74,096 2024 65,432 2025 65,432 2026 35,690 2027 and after 22,305 Total future minimum lease payments 262,955 Less imputed interest (42,330 ) Remaining lease liability $ 220,625 The Company entered into four financing leases for laboratory equipment with a total cost of $423,880 with two Finance lease depreciation expense for the years ended December 31, 2022 and 2021 was $48,992 and $0, respectively.

Accrued Expenses

Accrued Expenses	12 Months Ended
	Dec. 31, 2022
Accrued Expenses [Abstract]
Accrued Expenses	Note 7 – Accrued Expenses Accrued expenses consist of the following: December 31, 2022 2021 Accrued research and development costs $ 5,645,737 $ 227,400 Accrued professional fees 550,259 485,400 Accrued compensation 1,837,330 1,458,310 Accrued interest on debt 280,382 – Accrued rent – 16,594 Total $ 8,313,708 $ 2,187,704

Stock-Based Compensation

Stock-Based Compensation	12 Months Ended
	Dec. 31, 2022
Stock-Based Compensation [Abstract]
Stock-Based Compensation	Note 8 – Stock-Based Compensation In 2014, the Company’s stockholders approved the 2014 Equity Incentive Plan pursuant to which the Company may grant up to 91,367 shares as ISOs, NQs and restricted stock units (“RSUs”), subject to increases as hereafter described (the “Plan Limit”). In addition, on January 1, 2015, and each January 1 thereafter and prior to the termination of the 2014 Equity Incentive Plan, pursuant to the terms of the 2014 Equity Incentive Plan, the Plan Limit was and shall be increased by the lesser of (x) 4% of the number of shares of Common Stock outstanding as of the immediately preceding December 31 and (y) such lesser number as the Board of Directors may determine in its discretion. In March 2019, the Plan was amended and restated which removed the annual increase component and was limited to 826,292 shares. On December 8, 2020, the Company adopted the Second Amended and Restated PDS Biotechnology Corporation 2014 Equity Inventive Plan (the “Restated Plan”), which amended and restated the Amended and Restated PDS Biotechnology Corporation 2014 Equity Incentive Plan (the “Current Plan”). The Restated Plan is identical to the Current Plan in all material respects, except as follows: (a) the number of shares of Common Stock authorized for issuance under the Restated Plan will increase from 826,292 shares to 3,339,243 shares, plus the total number of shares that remained available for issuance, that are not covered by outstanding awards issued under the Current Plan, immediately prior to December 8, 2020; and (b) the Restated Plan will terminate on December 7, 2030, unless earlier terminated. 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, 2022, there were 190,799 shares available for grant under the 2018 Stock Incentive Plan. 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. 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, 2022, there were 215,215 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, 2022 and 2021: Year Ended December 31, 2022 2021 Research and development $ 1,868,352 $ 1,395,957 General and administrative 3,327,804 2,678,500 Total $ 5,196,156 $ 4,074,457 In lieu of higher cash compensation, the Company has granted non-employee options to consultants and expensed $1,383 and $1,389 during the years ended December 31, 2022 and 2021, respectively. The following table summarizes the stock option activity for the Company’ stock option plans for the year ended December 31, 2022: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Aggregate Intrinsic Value Balance at January 1, 2022 3,163,835 $ 5.57 7.90 10,839,589 Granted 1,596,005 $ 5.50 9.14 560,930 Exercised (279,611 ) $ 5.68 – – Forfeited (308,918 ) $ 5.24 – – Options outstanding at December 31, 2022 4,171,311 $ 5.56 7.89 $ 32,779,920 Vested and expected to vest at December 31, 2022 4,171,311 $ 5.56 7.89 $ 32,779,920 Exercisable at December 31, 2022 1,819,185 $ 6.09 6.82 $ 13,785,526 As of December 31, 2022 there was approximately $12,257,982 of unamortized stock compensation expense, which is expected to be recognized over a remaining average vesting period of 2.63 years. The weighted-average grant date fair value of the stock options granted in 2022 was $4.40 per share. The fair value of options granted during the year ended December 31, 2022 was estimated using the Black-Scholes option valuation model utilizing the following assumptions: Year Ended December 31, 2022 2021 Weighted Average Volatility 99.63 % 100.53 % Risk-Free Interest Rate 1.79 % 0.49 % Expected Term in Years 6.39 6.06 Dividend Rate – – Fair Value of Option on Grant Date $ 4.40 $ 7.65 Expected volatility Risk-free interest rate Expected term. Expected dividend rate

Stockholders' Equity

Stockholders' Equity	12 Months Ended
	Dec. 31, 2022
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, 2022
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, 2022 2021 Federal statutory rate 21.0 % 21.0 % State taxes 4.8 % (13.0 )% Extraordinary gain 0.0 % 0.0 % Permanent differences (0.4 )% (8.9 )% Research and development 2.9 % 2.8 % State Taxes/Sale of NOL 2.9 % 21.0 % Valuation Allowance (28.3 )% (1.8 )% Other 0.0 % 0.0 % Effective tax rate 2.9 % 21.1 % The tax effects of temporary differences that give rise to significant portions of the deferred tax assets were as follows: December 31, 2022 2021 Federal net operating losses $ 25,063,210 $ 22,831,097 State net operating losses 3,166,596 3,426,561 Stock options 2,696,879 1,374,830 Federal tax credit 2,893,412 1,661,238 State tax credits 511,557 410,089 Research and Development Capitalization (IRC 174) 4,506,729 – License Agreement 2,811,000 – Amortization 29,463 35,579 Accrued expense – 4,665 Depreciation 732,064 719,666 Lease liabilities 127,278 137,838 Other 15,278 15,278 Total gross deferred tax assets 42,553,261 30,616,841 Less valuation allowance (42,404,971 ) (30,516,318 ) Deferred tax assets, net $ 148,290 $ 100,523 Right of use asset $ (148,290 ) $ (100,523 ) Total gross deferred tax liabilities (148,290 ) (100,523 ) 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, 2022 and 2021, the Company has recorded a full valuation allowance against its net deferred tax assets of approximately $42.4 and $30.5 million respectively. The change in the valuation allowance during the year ended 2022 was approximately $11.9 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 $4.5 million. At December 31, 2022, the Company had federal net operating loss (“NOL”) carryforwards of approximately $119.3 million. At December 31, 2022, the Company had federal research and development credit carryforwards of approximately $2.9 million. The federal net operating loss carryforwards begin to expire in 2028, losses generated in 2018 or later of $89.4 million will carry forward indefinitely. The federal credit carryforwards begin to expire in 2032 At December 31, 2022, the Company had approximately $44.5 million of State of New Jersey NOLs which expire between 2029 2041 In 2022, the company sold New Jersey NOL carryforwards and R&D Credits, resulting in the recognition of $1.2 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, 2022, 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, 2022 and 2021

Commitments and Contingencies

Commitments and Contingencies	12 Months Ended
	Dec. 31, 2022
Commitments and Contingencies [Abstract]
Commitments and Contingencies	Note 11 – Commitments and Contingencies Rent For the years ended December 31, 2022 and 2021, rent was $232,500 and $185,195, 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 sale milestone payments totaling up to $11 million upon the achievement of certain milestones, including the dosing of the fifth patient in a Phase 3 trial of the product and first commercial sale of the product for a first and second indications 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 (collectively, the “Royalty Term”). 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. 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, 2022
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 are uncommitted Loans that may be advanced by the Lenders upon their discretion prior to July 31, 2023 upon the satisfaction by the Company of certain agreed upon conditions precedents. 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. 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 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, 2022, 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 $2,916,655 as of December 31, 2022. The Company recognized interest expense of $1,288,776 for the year ended December 31, 2022 and $183,914 was related to the amortization of the debt discount for the year ended December 31, 2022.

Retirement Plan

Retirement Plan	12 Months Ended
	Dec. 31, 2022
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. In the first quarter of 2021, the company matched employee’s contributions with company stock valued at $35,747. The 401(k) employer cash contribution match for the year ended December 31, 2022 and the nine month period ended 2021 were $157,009 and $60,428 respectively.

Subsequent Events

Subsequent Events	12 Months Ended
	Dec. 31, 2022
Subsequent Events [Abstract]
Subsequent Events	Note 14 – Subsequent Events On January 5, 2023, the Company granted an option to purchase 1,124,600 shares of common stock to the management and employees of the Company with a strike price of $11.61 vesting 25% on the first In the first quarter of 2023, the Company sold 553,293 shares of common stock for a value of $4.6 million pursuant to its Sales Agreement .

Summary of Significant Accoun_2

Summary of Significant Accounting Policies (Policies)	12 Months Ended
	Dec. 31, 2022
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 revenues and 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, 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 $5 million in an initial payment in cash and an additional $5 million in Company Stock, plus future milestone and royalty payments. The Company accounts for milestone payments as expense in research and development and royalties 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, 2022 and 2021. 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, 2022 2021 Stock options to purchase Common Stock 4,171,311 3,163,835 Warrants to purchase Common Stock 506,229 197,518 Total 4,677,540 3,361,353
Income Taxes	(I) Income taxes: The Company provides for deferred income taxes under the asset and liability method, which requires deferred tax assets and liabilities to be recognized for the future tax consequences attributable to net operating loss carryforwards and for differences between the financial statement carrying amounts and the respective tax bases of assets and liabilities. Deferred tax assets are reduced if necessary, by a valuation allowance if it is more likely than not that some portion or all of the deferred tax assets will not be realized.
Fair Value of Financial Instruments	(J) Fair value of financial instruments: FASB ASC 820, Fair Value Measurement 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 842, Lease Accounting. Operating leases are included in right-of-use ("ROU") assets, current portion, lease liability and long-term lease liability 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 All recently issued accounting pronouncements are not expected to have a material effect on the consolidated financial statements.

Summary of Significant Accoun_3

Summary of Significant Accounting Policies (Tables)	12 Months Ended
	Dec. 31, 2022
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, 2022 2021 Stock options to purchase Common Stock 4,171,311 3,163,835 Warrants to purchase Common Stock 506,229 197,518 Total 4,677,540 3,361,353

Fair Value of Financial Instr_2

Fair Value of Financial Instruments (Tables)	12 Months Ended
	Dec. 31, 2022
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, 2022 or 2021. 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, 2022: Cash and cash equivalents $ 73,820,160 $ 73,820,160 $ – $ – As of December 31, 2021: Cash and cash equivalents $ 65,242,622 $ 65,242,622 $ – $ –

Property and Equipment (Tables)

Property and Equipment (Tables)	12 Months Ended
	Dec. 31, 2022
Property and Equipment [Abstract]
Property and Equipment	Property and equipment is summarized as follows: December 31, 2022 2021 Furniture and equipment $ 14,964 $ 14,964 Computer and Telephone equipment 13,545 13,545 Lab equipment 86,911 86,911 Total furniture and equipment 115,420 115,420 Less accumulated depreciation (115,420 ) (115,334 ) Property and equipment, net $ 0 $ 86

Leases (Tables)

Leases (Tables)	12 Months Ended
	Dec. 31, 2022
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, 2022 2021 Cash paid for operating lease liabilities $ 294,987 $ 170,839
Future Payments for Operating Lease Liabilities	For the year ended December 31, 2022, the Company’s operating lease expense was $241,029. Year ended December 31, 2023 $ 239,470 2024 – 2025 – 2026 – 2027 – Total future minimum lease payments 239,470 Less imputed interest (8,041 ) $ 231,429
Supplemental Cash Flow Information Related to Finance Lease	The Company has financed certain laboratory equipment as follows: Year Ended December 31, 2022 2021 Cash paid for finance lease liabilities $ 423,880 $ –
Future Payments for Finance Lease Liabilities	Year ended December 31, 2023 $ 74,096 2024 65,432 2025 65,432 2026 35,690 2027 and after 22,305 Total future minimum lease payments 262,955 Less imputed interest (42,330 ) Remaining lease liability $ 220,625

Accrued Expenses (Tables)

Accrued Expenses (Tables)	12 Months Ended
	Dec. 31, 2022
Accrued Expenses [Abstract]
Accrued Expenses	Accrued expenses consist of the following: December 31, 2022 2021 Accrued research and development costs $ 5,645,737 $ 227,400 Accrued professional fees 550,259 485,400 Accrued compensation 1,837,330 1,458,310 Accrued interest on debt 280,382 – Accrued rent – 16,594 Total $ 8,313,708 $ 2,187,704

Stock-Based Compensation (Table

Stock-Based Compensation (Tables)	12 Months Ended
	Dec. 31, 2022
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, 2022 and 2021: Year Ended December 31, 2022 2021 Research and development $ 1,868,352 $ 1,395,957 General and administrative 3,327,804 2,678,500 Total $ 5,196,156 $ 4,074,457
Stock Option Activity	The following table summarizes the stock option activity for the Company’ stock option plans for the year ended December 31, 2022: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Aggregate Intrinsic Value Balance at January 1, 2022 3,163,835 $ 5.57 7.90 10,839,589 Granted 1,596,005 $ 5.50 9.14 560,930 Exercised (279,611 ) $ 5.68 – – Forfeited (308,918 ) $ 5.24 – – Options outstanding at December 31, 2022 4,171,311 $ 5.56 7.89 $ 32,779,920 Vested and expected to vest at December 31, 2022 4,171,311 $ 5.56 7.89 $ 32,779,920 Exercisable at December 31, 2022 1,819,185 $ 6.09 6.82 $ 13,785,526
Assumptions Used to Value Options and Warrants Granted	The fair value of options granted during the year ended December 31, 2022 was estimated using the Black-Scholes option valuation model utilizing the following assumptions: Year Ended December 31, 2022 2021 Weighted Average Volatility 99.63 % 100.53 % Risk-Free Interest Rate 1.79 % 0.49 % Expected Term in Years 6.39 6.06 Dividend Rate – – Fair Value of Option on Grant Date $ 4.40 $ 7.65

Income Taxes (Tables)

Income Taxes (Tables)	12 Months Ended
	Dec. 31, 2022
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, 2022 2021 Federal statutory rate 21.0 % 21.0 % State taxes 4.8 % (13.0 )% Extraordinary gain 0.0 % 0.0 % Permanent differences (0.4 )% (8.9 )% Research and development 2.9 % 2.8 % State Taxes/Sale of NOL 2.9 % 21.0 % Valuation Allowance (28.3 )% (1.8 )% Other 0.0 % 0.0 % Effective tax rate 2.9 % 21.1 %
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, 2022 2021 Federal net operating losses $ 25,063,210 $ 22,831,097 State net operating losses 3,166,596 3,426,561 Stock options 2,696,879 1,374,830 Federal tax credit 2,893,412 1,661,238 State tax credits 511,557 410,089 Research and Development Capitalization (IRC 174) 4,506,729 – License Agreement 2,811,000 – Amortization 29,463 35,579 Accrued expense – 4,665 Depreciation 732,064 719,666 Lease liabilities 127,278 137,838 Other 15,278 15,278 Total gross deferred tax assets 42,553,261 30,616,841 Less valuation allowance (42,404,971 ) (30,516,318 ) Deferred tax assets, net $ 148,290 $ 100,523 Right of use asset $ (148,290 ) $ (100,523 ) Total gross deferred tax liabilities (148,290 ) (100,523 ) Deferred tax, net $ – $ –

Nature of Operations, Summary (

Nature of Operations, Summary (Details)	Mar. 01, 2023 Patent	Dec. 31, 2022 Patent Application
Nature of Operations [Abstract]
Number of applications methods of use allowed by USPTO | Application		2
U.S. [Member]
Nature of Operations [Abstract]
Number of patents held		7
Number of pending patent applications		19
Foreign [Member] | Subsequent Event [Member]
Nature of Operations [Abstract]
Number of patents held	71
Number of pending patent applications	38

Nature of Operations, Exclusive

Nature of Operations, Exclusive License Agreement (Details) - USD ($)		3 Months Ended	12 Months Ended
	Dec. 30, 2022	Dec. 31, 2022	Dec. 31, 2022
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	$ 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, 2022	Dec. 31, 2022	Dec. 31, 2021
Property and Equipment [Abstract]
Estimated useful lives of property and equipment			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	$ 4,999,988	$ 5,000,000
Net Loss per Common Share [Abstract]
Antidilutive impact to EPS (in shares)			4,677,540	3,361,353
Stock Options to Purchase Common Stock [Member]
Net Loss per Common Share [Abstract]
Antidilutive impact to EPS (in shares)			4,171,311	3,163,835
Warrants to Purchase Common Stock [Member]
Net Loss per Common Share [Abstract]
Antidilutive impact to EPS (in shares)			506,229	197,518

Liquidity and Capital Resourc_2

Liquidity and Capital Resources (Details)		1 Months Ended				3 Months Ended			12 Months Ended
	Aug. 24, 2022 USD ($)	Aug. 31, 2022 USD ($)	Apr. 30, 2022 USD ($)	Jun. 30, 2021 USD ($) $ / shares shares	May 31, 2021 USD ($)	Mar. 31, 2023 USD ($) shares	Dec. 31, 2022 USD ($) Loan	Jun. 30, 2021 USD ($) $ / shares	Dec. 31, 2022 USD ($) Loan shares	Dec. 31, 2021 USD ($)
Liquidity [Abstract]
Cash and cash equivalents							$ 73,820,160		$ 73,820,160	$ 65,242,622
Proceeds from sale of tax benefits			$ 1,200,000		$ 4,500,000
Issuance of common stock (in shares) | shares				6,088,235					1,238,491
Issuance of common stock							9,856,116	$ 48,544,998	$ 9,900,000
Sales price (in dollars per share) | $ / shares				$ 8.5				$ 8.5
Proceeds from issuance of shares				$ 51,700,000					9,856,116	48,544,998
Proceeds from issuance of shares, net of underwriting discounts and commissions				$ 48,500,000
Shelf securities available for sale							$ 29,300,000		29,300,000
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%
Proceeds from issuance of secured loans									$ 25,000,000	$ 0
Subsequent Event [Member]
Liquidity [Abstract]
Issuance of common stock (in shares) | shares						553,293
Issuance of common stock						$ 4,600,000
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
Prepayment premium paid if loan is prepaid on or before Loan Amortization date									3%
Prepayment premium paid if load is prepaid after Loan Amortization date, but on or before date that is 12 months after such Loan Amortization Date									2%
Prepayment premium paid if loan is prepaid more than 12 months after Loan Amortization Date but prior to stated Maturity Date.									1%
Prepayment premium paid if loan is paid on stated maturity date									0%
Term Loans [Member] | Minimum [Member]
Liquidity [Abstract]
Minimum base rate used to compute floating interest rate									4%
Written notice period for prepayment of outstanding loan									10 days
Term Loans [Member] | Prime Rate [Member]
Liquidity [Abstract]
Margin on variable rate									5.75%
Loan A [Member]
Liquidity [Abstract]
Face amount		$ 7,500,000
Loan B [Member]
Liquidity [Abstract]
Face amount		10,000,000
Loan C [Member]
Liquidity [Abstract]
Face amount		3,750,000
Loan D [Member]
Liquidity [Abstract]
Face amount		$ 3,750,000
Loan E [Member]
Liquidity [Abstract]
Uncommitted loan							$ 5,000,000		$ 5,000,000
Loan F [Member]
Liquidity [Abstract]
Uncommitted loan							$ 5,000,000		$ 5,000,000
Over-Allotment Option [Member]
Liquidity [Abstract]
Issuance of common stock (in shares) | shares				794,117

Fair Value of Financial Instr_3

Fair Value of Financial Instruments (Details) - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
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	73,820,160	65,242,622
Quoted Prices in Active Markets (Level 1) [Member]
Fair Value of Financial Instruments [Abstract]
Cash and cash equivalents	73,820,160	65,242,622
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, 2022	Dec. 31, 2021
Property and Equipment [Abstract]
Property and equipment	$ 115,420	$ 115,420
Less accumulated depreciation	(115,420)	(115,334)
Property and equipment, net	0	86
Depreciation expense	86	5,357
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	$ 86,911	$ 86,911

Leases, Operating Leases (Detai

Leases, Operating Leases (Details)	Dec. 31, 2022 USD ($) ft²	Dec. 31, 2021 USD ($)	May 01, 2020 USD ($)
Operating Leases [Abstract]
Area of office space under sub-lease | ft²	11,200
Term of sub-lease agreement	40 months
Remaining lease term	8 months
Operating right-of-use asset	$ 152,645	$ 357,611	$ 700,000
Operating leases liabilities	$ 231,429		$ 700,000
Discount rate used to measure operating lease liability			9.15%

Leases, Supplemental Cash Flow

Leases, Supplemental Cash Flow Information Related to Operating Leases (Details) - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Supplemental Cash Flow Information Related to Operating Leases [Abstract]
Cash paid for operating lease liabilities	$ 294,987	$ 170,839
Operating Lease Expense [Abstract]
Operating lease expense	$ 241,029

Leases, Future Payments for Ope

Leases, Future Payments for Operating Lease Liabilities (Details) - USD ($)	Dec. 31, 2022	May 01, 2020
Future Payments for Operating Lease Liabilities [Abstract]
2023	$ 239,470
2024	0
2025	0
2026	0
2027 and after	0
Total future minimum lease payments	239,470
Less imputed interest	(8,041)
Operating lease liability	$ 231,429	$ 700,000

Leases, Supplemental Cash Flo_2

Leases, Supplemental Cash Flow Information Related to Finance Lease (Details) - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Supplemental Cash Flow Information Related to Finance Lease [Abstract]
Cash paid for finance lease liabilities	$ 423,880	$ 0

Leases, Future Payments for Fin

Leases, Future Payments for Finance Lease Liabilities (Details)	Dec. 31, 2022 USD ($)
Future Payments for Finance Lease Liabilities [Abstract]
2023	$ 74,096
2024	65,432
2025	65,432
2026	35,690
2027 and after	22,305
Total future minimum lease payments	262,955
Less imputed interest	(42,330)
Remaining lease liability	$ 220,625

Leases, Financing Lease (Detail

Leases, Financing Lease (Details)	12 Months Ended
	Dec. 31, 2022 USD ($) Lease	Dec. 31, 2021 USD ($)
Financing Lease [Abstract]
Number of financing leases entered into | Lease	4
Total cost of financing leases	$ 423,880
Finance lease liability capitalized interest rate	9.15%
Aggregate monthly rental payments	$ 5,452
Finance lease amortization expense	$ 48,992	$ 0
Minimum [Member]
Financing Lease [Abstract]
Term of financing lease	2 years
Maximum [Member]
Financing Lease [Abstract]
Term of financing lease	4 years

Accrued Expenses (Details)

Accrued Expenses (Details) - USD ($)	Dec. 31, 2022	Dec. 31, 2021
Accrued Expenses [Abstract]
Accrued research and development	$ 5,645,737	$ 227,400
Accrued professional fees	550,259	485,400
Accrued compensation	1,837,330	1,458,310
Accrued interest on debt	280,382	0
Accrued rent	0	16,594
Total	$ 8,313,708	$ 2,187,704

Stock-Based Compensation, Equit

Stock-Based Compensation, Equity Compensation Plans (Details) - shares	12 Months Ended
	Dec. 31, 2014	Dec. 31, 2022	May 17, 2022	May 16, 2022	Dec. 08, 2020	Dec. 07, 2020	Mar. 31, 2019	Dec. 31, 2018
2014 Equity Incentive Plan [Member]
Stock Options [Abstract]
Number of shares authorized for issuance (in shares)	91,367				3,339,243		826,292
Percentage of Common Stock outstanding used to determine annual increase in the plan limit	4%
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
Inducement Plan [Member]
Stock Options [Abstract]
Shares available for grant (in shares)		215,215
Common stock reserved for issuance (in shares)			1,100,000	500,000	500,000	200,000

Stock-Based Compensation, Stock

Stock-Based Compensation, Stock-Based Compensation Expense (Details) - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Stock-Based Compensation [Abstract]
Stock-based compensation expense	$ 5,196,156	$ 4,074,457
Research and Development [Member]
Stock-Based Compensation [Abstract]
Stock-based compensation expense	1,868,352	1,395,957
General and Administrative [Member]
Stock-Based Compensation [Abstract]
Stock-based compensation expense	$ 3,327,804	$ 2,678,500

Stock-Based Compensation, Sto_2

Stock-Based Compensation, Stock Option Activity (Details)	12 Months Ended
	Dec. 31, 2022 USD ($) $ / shares shares	Dec. 31, 2021 USD ($) $ / shares shares
Unamortized Stock Compensation Expense [Abstract]
Weighted-average grant date fair value, granted (in dollars per share) | $ / shares	$ 4.4	$ 7.65
Nonemployee [Member]
Stock-Based Compensation [Abstract]
Options granted | $	$ 1,383	$ 1,389
Stock Options [Member]
Number of Shares [Roll Forward]
Options outstanding, beginning balance (in shares) | shares	3,163,835
Granted (in shares) | shares	1,596,005
Exercised (in shares) | shares	(279,611)
Forfeited (in shares) | shares	(308,918)
Options outstanding, ending balance (in shares) | shares	4,171,311	3,163,835
Vested and expected to vest (in shares) | shares	4,171,311
Exercisable (in shares) | shares	1,819,185
Weighted Average Exercise Price [Roll Forward]
Options outstanding, beginning balance (in dollars per share) | $ / shares	$ 5.57
Granted (in dollars per share) | $ / shares	5.5
Exercised (in dollars per share) | $ / shares	5.68
Forfeited (in dollars per share) | $ / shares	5.24
Options outstanding, ending balance (in dollars per share) | $ / shares	5.56	$ 5.57
Vested and expected to vest (in dollars per share) | $ / shares	5.56
Exercisable (in dollars per share) | $ / shares	$ 6.09
Weighted Average Remaining Contractual Life and Aggregate Intrinsic Value [Abstract]
Options outstanding, weighted average remaining contractual life	7 years 10 months 20 days	7 years 10 months 24 days
Granted, weighted average remaining contractual life	9 years 1 month 20 days
Vested and expected to vest, weighted average contractual life	7 years 10 months 20 days
Exercisable, weighted average contractual life	6 years 9 months 25 days
Options outstanding, aggregate intrinsic value | $	$ 10,839,589
Granted, aggregate intrinsic value | $	560,930
Exercised, aggregate intrinsic value | $	0
Forfeited, aggregate intrinsic value | $	0
Options outstanding, aggregate intrinsic value | $	32,779,920	$ 10,839,589
Vested and expected to vest, aggregate intrinsic value | $	32,779,920
Exercisable, aggregate intrinsic value | $	13,785,526
Unamortized Stock Compensation Expense [Abstract]
Unamortized stock compensation expense | $	$ 12,257,982
Period for recognition	2 years 7 months 17 days
Weighted-average grant date fair value, granted (in dollars per share) | $ / shares	$ 4.4

Stock-Based Compensation, Assum

Stock-Based Compensation, Assumptions Used to Value Stock Options Granted (Details) - $ / shares	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Assumptions Used in Determining Fair Value of Stock Options and Warrants Granted [Abstract]
Volatility	99.63%	100.53%
Risk-free interest rate	1.79%	0.49%
Expected term	6 years 4 months 20 days	6 years 21 days
Dividend rate	0%	0%
Fair value of option on grant date (in dollars per share)	$ 4.4	$ 7.65

Stockholders' Equity (Details)

Stockholders' Equity (Details)	Dec. 31, 2022 Vote shares	Dec. 31, 2021 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, 2022	Dec. 31, 2021
Effective Federal Income Tax Rate Reconciliation [Abstract]
Federal statutory rate	21%	21%
State taxes	4.80%	(13.00%)
Extraordinary gain	0%	0%
Permanent differences	(0.40%)	(8.90%)
Research and development	2.90%	2.80%
State taxes/sale of NOL	2.90%	21%
Valuation Allowance	(28.30%)	(1.80%)
Other	0%	0%
Effective tax rate	2.90%	21.10%
Deferred Tax Assets, Net [Abstract]
Federal net operating losses	$ 25,063,210	$ 22,831,097
State net operating losses	3,166,596	3,426,561
Stock options	2,696,879	1,374,830
Research and Development Capitalization (IRC 174)	4,506,729	0
License Agreement	2,811,000	0
Amortization	29,463	35,579
Accrued expense	0	4,665
Depreciation	732,064	719,666
Lease liabilities	127,278	137,838
Other	15,278	15,278
Total gross deferred tax assets	42,553,261	30,616,841
Less valuation allowance	(42,404,971)	(30,516,318)
Deferred tax assets, net	148,290	100,523
Right of use asset	(148,290)	(100,523)
Total gross deferred tax liabilities	(148,290)	(100,523)
Deferred tax, net	0	0
Tax Carryforwards [Abstract]
Amount of change in valuation allowance	11,900,000
Benefit from income taxes	(1,198,905)	(4,516,488)
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	119,300,000
Net operating loss carryforwards that will carry forward indefinitely	$ 89,400,000
Expiration date of net operating loss carryforwards	Dec. 31, 2032
New Jersey [Member]
Tax Carryforwards [Abstract]
Net operating loss carryforwards	$ 44,500,000
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, 2041
Research and Development Credit [Member] | Federal [Member]
Tax Carryforwards [Abstract]
Tax credit carryforwards	$ 600,000
Research and Development Credit [Member] | New Jersey [Member]
Tax Carryforwards [Abstract]
Tax credit carryforwards	2,900,000
Federal [Member]
Deferred Tax Assets, Net [Abstract]
Tax credits	2,893,412	1,661,238
State [Member]
Deferred Tax Assets, Net [Abstract]
Tax credits	$ 511,557	$ 410,089

Commitments and Contingencies (

Commitments and Contingencies (Details) - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Commitments and Contingencies [Abstract]
Rent expense	$ 232,500	$ 185,195
Merck KGaA License Agreement [Member]
Commitments and Contingencies [Abstract]
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 development and first commercial sales	$ 11,000,000
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, 2022 USD ($) Loan	Aug. 31, 2022 USD ($)
Term Loans [Member]
Venture Loan and Security Agreement [Abstract]
Number of independent term loans | Loan	6
Term	48 months
Prepayment premium paid if loan is prepaid on or before Loan Amortization date	3%
Prepayment premium paid if load is prepaid after Loan Amortization date, but on or before date that is 12 months after such Loan Amortization Date	2%
Prepayment premium paid if loan is prepaid more than 12 months after Loan Amortization Date but prior to stated Maturity Date.	1%
Prepayment premium paid if loan is paid on stated maturity date	0%
Term Loans [Member] | Minimum [Member]
Venture Loan and Security Agreement [Abstract]
Minimum base rate used to compute floating interest rate	4%
Written notice period for prepayment of outstanding loan	10 days
Term Loans [Member] | Prime Rate [Member]
Venture Loan and Security Agreement [Abstract]
Margin on variable rate	5.75%
Loan A [Member]
Venture Loan and Security Agreement [Abstract]
Face amount		$ 7,500,000
Loan B [Member]
Venture Loan and Security Agreement [Abstract]
Face amount		10,000,000
Loan C [Member]
Venture Loan and Security Agreement [Abstract]
Face amount		3,750,000
Loan D [Member]
Venture Loan and Security Agreement [Abstract]
Face amount		$ 3,750,000
Loan E [Member]
Venture Loan and Security Agreement [Abstract]
Uncommitted loan	$ 5,000,000
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, 2022 USD ($)	Dec. 31, 2021 USD ($)	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	$ 449,329	$ 0
Unamortized debt discount	2,916,655
Interest expense	1,288,776
Amortization of debt discount	$ 183,914	$ 0
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 ($)	3 Months Ended			9 Months Ended	12 Months Ended
	Dec. 31, 2021	Jun. 30, 2021	Mar. 31, 2021	Sep. 30, 2021	Dec. 31, 2022
Retirement Plan [Abstract]
401(k) employer stock contribution	$ 16	$ 0	$ 35,747
401(k) employer cash contributions				$ 60,428	$ 157,009

Subsequent Events (Details)

Subsequent Events (Details) - USD ($)		1 Months Ended	3 Months Ended			12 Months Ended
	Jan. 05, 2023	Jun. 30, 2021	Mar. 31, 2023	Dec. 31, 2022	Jun. 30, 2021	Dec. 31, 2022
Subsequent Events [Abstract]
Issuance of common stock (in shares)		6,088,235				1,238,491
Issuance of common stock				$ 9,856,116	$ 48,544,998	$ 9,900,000
Stock Options [Member]
Subsequent Events [Abstract]
Options granted (in shares)						1,596,005
Exercise price (in dollars per share)						$ 5.5
Subsequent Event [Member]
Subsequent Events [Abstract]
Issuance of common stock (in shares)			553,293
Issuance of common stock			$ 4,600,000
Subsequent Event [Member] | Management and Employees [Member]
Subsequent Events [Abstract]
Options granted (in shares)	1,124,600
Subsequent Event [Member] | Chief Executive Officer [Member]
Subsequent Events [Abstract]
Options granted (in shares)	385,300
Subsequent Event [Member] | Chief Scientific Officer [Member]
Subsequent Events [Abstract]
Options granted (in shares)	137,200
Subsequent Event [Member] | Chief Medical Officer [Member]
Subsequent Events [Abstract]
Options granted (in shares)	161,200
Subsequent Event [Member] | Stock Options [Member]
Subsequent Events [Abstract]
Exercise price (in dollars per share)	$ 11.61
Subsequent Event [Member] | Stock Options [Member] | First Anniversary of Options Granted [Member]
Subsequent Events [Abstract]
Vesting percentage	25%
Vesting period	1 year