Processa Pharmaceuticals (PCSA) 10-Q 8 Nov 22 2022 Q3 Quarterly report Financial data

Cover

Cover - shares	9 Months Ended
	Sep. 30, 2022	Nov. 01, 2022
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Sep. 30, 2022
Document Fiscal Period Focus	Q3
Document Fiscal Year Focus	2022
Current Fiscal Year End Date	--12-31
Entity File Number	001-39531
Entity Registrant Name	Processa Pharmaceuticals, Inc.
Entity Central Index Key	0001533743
Entity Tax Identification Number	45-1539785
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	7380 Coca Cola Drive
Entity Address, Address Line Two	Suite 106
Entity Address, City or Town	Hanover
Entity Address, State or Province	MD
Entity Address, Postal Zip Code	21076
City Area Code	(443)
Local Phone Number	776-3133
Title of 12(b) Security	Common Stock, $0.0001 par value per share
Trading Symbol	PCSA
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		15,990,924

Condensed Consolidated Balance

Condensed Consolidated Balance Sheets (Unaudited) - USD ($)	Sep. 30, 2022	Dec. 31, 2021
Current Assets
Cash and cash equivalents	$ 9,054,576	$ 16,497,581
Due from tax agencies		70,274
Prepaid expenses and other	1,832,109	1,759,296
Total Current Assets	10,886,685	18,327,151
Property and Equipment, net
Other Assets
Operating lease right-of-use assets, net of accumulated amortization	246,979	74,181
Intangible assets, net of accumulated amortization	7,465,266	8,056,638
Security deposit	5,535	5,535
Total Other Assets	7,717,780	8,136,354
Total Assets	18,604,465	26,463,505
Current Liabilities
Current maturities of operating lease liability	76,260	71,078
Accounts payable	311,066	218,905
Due to licensor	589,000	400,000
Due to related parties		1,772
Accrued expenses	216,407	279,265
Total Current Liabilities	1,192,733	971,020
Non-current Liabilities
Non-current operating lease liability	171,707	7,385
Total Liabilities	1,364,440	978,405
Commitments and Contingencies
Stockholders’ Equity
Common stock, par value $0.0001, 50,000,000 shares authorized: 15,995,087 issued and 15,895,087 outstanding at September 30, 2022, and 15,710,246 issued and outstanding at December 31, 2021	1,600	1,571
Additional paid-in capital	68,773,666	62,306,861
Treasury stock at cost — 100,000 shares at September 30, 2022	(300,000)
Accumulated deficit	(51,235,241)	(36,823,332)
Total Stockholders’ Equity	17,240,025	25,485,100
Total Liabilities and Stockholders’ Equity	$ 18,604,465	$ 26,463,505

Condensed Consolidated Balanc_2

Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares	Sep. 30, 2022	Dec. 31, 2021
Statement of Financial Position [Abstract]
Common stock, par value	$ 0.0001	$ 0.0001
Common stock, shares authorized	50,000,000	30,000,000
Common stock, shares issued	15,995,087	15,710,246
Common stock, shares outstanding	15,895,087	15,710,246
Treasury stock shares	100,000

Condensed Consolidated Statemen

Condensed Consolidated Statements of Operations (Unaudited) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Operating Expenses
Research and development expenses	$ 3,136,838	$ 1,722,364	$ 8,319,907	$ 4,806,845
Acquisition of in-process research and development		50,953		566,583
General and administrative expenses	2,920,280	1,338,113	6,137,674	3,391,105
Operating Loss	(6,057,118)	(3,111,430)	(14,457,581)	(8,764,533)
Other Income (Expense)
Forgiveness of PPP loan and related accrued interest				163,771
Interest income, net	36,708	1,771	45,672	8,163
Net Operating Loss Before Income Tax Benefit	(6,020,410)	(3,109,659)	(14,411,909)	(8,592,599)
Income Tax Benefit		122,442		348,859
Net Loss	$ (6,020,410)	$ (2,987,217)	$ (14,411,909)	$ (8,243,740)
Net Loss per Common Share - Basic and Diluted	$ (0.37)	$ (0.19)	$ (0.90)	$ (0.54)
Weighted Average Common Shares Used to Compute Net Loss Applicable to Common Shares - Basic and Diluted	16,200,222	15,531,442	15,991,653	15,177,306

Condensed Consolidated Statem_2

Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - USD ($)	Common Stock [Member]	Additional Paid-in Capital [Member]	Treasury Stock [Member]	Retained Earnings [Member]	Total
Beginning balance, value at Dec. 31, 2020	$ 1,419	$ 48,333,857		$ (25,395,798)	$ 22,939,478
Beginning balance, shares at Dec. 31, 2020	14,187,984
Stock-based compensation and forfeitures	$ 1	620,590			620,591
Stock- based compensation and forfeitures, shares	12,500
Shares issued in private placement, net of transaction costs	$ 132	9,875,418			9,875,550
Shares issued in private placement, net of transaction costs, shares	1,321,132
Net loss				(2,099,480)	(2,099,480)
Ending balance, value at Mar. 31, 2021	$ 1,552	58,829,865		(27,495,278)	31,336,139
Ending balance, shares at Mar. 31, 2021	15,521,616
Beginning balance, value at Dec. 31, 2020	$ 1,419	48,333,857		(25,395,798)	22,939,478
Beginning balance, shares at Dec. 31, 2020	14,187,984
Net loss					(8,243,740)
Ending balance, value at Sep. 30, 2021	$ 1,560	60,846,342		(33,639,538)	27,208,364
Ending balance, shares at Sep. 30, 2021	15,599,062
Beginning balance, value at Mar. 31, 2021	$ 1,552	58,829,865		(27,495,278)	31,336,139
Beginning balance, shares at Mar. 31, 2021	15,521,616
Stock-based compensation and forfeitures	$ 4	762,592			762,596
Stock- based compensation and forfeitures, shares	38,300
Net loss				(3,157,043)	(3,157,043)
Shares issued in connection with license agreement	$ 4	299,996			300,000
Shares issued in connection with license agreement, shares	44,689
Ending balance, value at Jun. 30, 2021	$ 1,560	59,892,453		(30,652,321)	29,241,692
Ending balance, shares at Jun. 30, 2021	15,604,605
Stock-based compensation and forfeitures		981,869			981,869
Stock- based compensation and forfeitures, shares	(1,030)
Net loss				(2,987,217)	(2,987,217)
Shares withheld to pay income taxes on stock-based compensation		(27,980)			(27,980)
Shares withheld to pay income taxes on stock-based compensation, shares	(4,513)
Ending balance, value at Sep. 30, 2021	$ 1,560	60,846,342		(33,639,538)	27,208,364
Ending balance, shares at Sep. 30, 2021	15,599,062
Beginning balance, value at Dec. 31, 2021	$ 1,571	62,306,861		(36,823,332)	25,485,100
Beginning balance, shares at Dec. 31, 2021	15,710,246
Stock-based compensation and forfeitures	$ 10	828,887			828,897
Stock- based compensation and forfeitures, shares	103,670
Net loss				(3,227,131)	(3,227,131)
Acquisition of treasury stock			$ (300,000)		(300,000)
Acquisition of treasury stock, shares			(100,000)
Shares issued in connection with the Purchase Agreement with Lincoln Park	$ 12	449,988			450,000
Shares issued in connection with the purchase agreement with lincoln park, shares	123,609
Ending balance, value at Mar. 31, 2022	$ 1,593	63,585,736	$ (300,000)	(40,050,463)	23,236,866
Ending balance, shares at Mar. 31, 2022	15,937,525		(100,000)
Beginning balance, value at Dec. 31, 2021	$ 1,571	62,306,861		(36,823,332)	25,485,100
Beginning balance, shares at Dec. 31, 2021	15,710,246
Net loss					(14,411,909)
Ending balance, value at Sep. 30, 2022	$ 1,600	68,773,666	$ (300,000)	(51,235,241)	17,240,025
Ending balance, shares at Sep. 30, 2022	15,995,087		(100,000)
Beginning balance, value at Mar. 31, 2022	$ 1,593	63,585,736	$ (300,000)	(40,050,463)	23,236,866
Beginning balance, shares at Mar. 31, 2022	15,937,525		(100,000)
Stock-based compensation and forfeitures	$ (1)	2,009,370			2,009,369
Stock- based compensation and forfeitures, shares	(18,208)
Net loss				(5,164,368)	(5,164,368)
Ending balance, value at Jun. 30, 2022	$ 1,592	65,595,106	$ (300,000)	(45,214,831)	20,081,867
Ending balance, shares at Jun. 30, 2022	15,919,317		(100,000)
Stock-based compensation and forfeitures	$ 9	3,213,806			3,213,815
Stock- based compensation and forfeitures, shares	86,888
Net loss				(6,020,410)	(6,020,410)
Shares withheld to pay income taxes on stock-based compensation	$ (1)	(35,246)			(35,247)
Shares withheld to pay income taxes on stock-based compensation, shares	(11,118)
Ending balance, value at Sep. 30, 2022	$ 1,600	$ 68,773,666	$ (300,000)	$ (51,235,241)	$ 17,240,025
Ending balance, shares at Sep. 30, 2022	15,995,087		(100,000)

Condensed Consolidated Statem_3

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Cash Flows From Operating Activities
Net loss	$ (14,411,909)	$ (8,243,740)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation		484
Lease expense for right-of-use assets	66,126	62,624
Milestone expense in connection with license agreement	189,000
Acquisition of in-process research and development		300,000
Amortization of issuance costs	78,113
Amortization of intangible asset	591,372	593,365
Deferred income tax benefit		(348,859)
Stock-based compensation	6,052,081	2,287,863
Forgiveness of PPP loan and related accrued interest		(163,771)
Net changes in operating assets and liabilities:
Prepaid expenses and other	299,074	(664,417)
Operating lease liability	(69,420)	(64,121)
Accrued interest		362
Accounts payable	92,161	34,283
Due (from) to related parties	(1,772)	84,872
Other receivables	70,274	6,750
Accrued expenses	(62,858)	123,984
Net Cash Used In Operating Activities	(7,107,758)	(5,990,321)
Cash Flows From Financing Activities
Net proceeds from issuance of common stock		9,875,550
Shares withheld to pay taxes on stock-based compensation	(35,247)	(27,980)
Acquisition of treasury stock	(300,000)
Other		(180,285)
Net Cash (Used In) Provided By Financing Activities	(335,247)	9,667,285
Net Increase (Decrease) in Cash	(7,443,005)	3,676,964
Cash and Cash Equivalents – Beginning of Period	16,497,581	15,416,224
Cash and Cash Equivalents – End of Period	9,054,576	19,093,188
Non-Cash Financing Activities
Issuance of 123,609 shares of common stock in connection with the Purchase Agreement with Lincoln Park	450,000
Right-of-use asset obtained in exchange for operating lease liability	(238,924)
Operating lease liability	238,924
Net

Condensed Consolidated Statem_4

Condensed Consolidated Statements of Cash Flows (Unaudited) (Parenthetical)	9 Months Ended
	Sep. 30, 2022 shares
Purchase Agreement [Member] | Lincoln Park Capital Fund LLC [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Issuance of common stock shares	123,609

Organization and Summary of Sig

Organization and Summary of Significant Accounting Policies	9 Months Ended
	Sep. 30, 2022
Accounting Policies [Abstract]
Organization and Summary of Significant Accounting Policies	Note 1 – Organization and Summary of Significant Accounting Policies Business Activities and Organization We are a diversified Next Generation Capecitabine previously identified as 12852 3117 ● Next Generation Capecitabine (NGC), previously identified as PCS6422, is a combination of PCS6422 and the FDA-approved cancer drug capecitabine. PCS6422 is an orally administered irreversible inhibitor of the enzyme dihydropyrimidine dehydrogenase (DPD). DPD metabolizes 5-Fluorouracil (5-FU), the major metabolite of capecitabine and widely used itself as an intravenous chemotherapeutic agent in many types of cancer, to multiple metabolites classified as catabolites. These catabolites do not have any cancer-killing properties but do cause dose-limiting side effects that may require dose adjustments or discontinuation of therapy. When combining capecitabine with PCS6422 in NGC, capecitabine becomes a more potent cancer chemotherapy agent than current FDA-approved capecitabine requiring significantly lower doses. On August 2, 2021, we enrolled the first patient in our Phase 1B dose-escalation maximum tolerated dose trial in patients with advanced refractory gastrointestinal (GI) tract tumors. Our interim analysis of Cohorts 1 and 2A found no dose-limiting toxicities (DLTs), no drug-related adverse events greater than Grade 1, and no hand-foot syndrome, a major side effect found with the catabolites of 5-FU. In this Phase 1B trial it was demonstrated that the irreversible inhibition of DPD by PCS6422 could alter the elimination of 5-FU making NGC significantly more potent (greater than 50 times more potent) and potentially lead to higher levels of the group of metabolites called anabolites which can kill replicating cancer and normal cells. By administering NGC to cancer patients, the balance between anabolites and catabolites changes depending on the dosage regimens of PCS6422 and capecitabine used, making the efficacy-safety profile of NGC different than that of FDA-approved capecitabine and requiring further evaluation of the PCS6422 and capecitabine regimens to determine the optimal NGC regimens for patients. In order for NGC to provide a safer and more efficacious profile for cancer patients compared to existing chemotherapy, understanding how the different regimens of PCS6422 and capecitabine may affect the systemic and tumor exposure to the anabolites, as well as the systemic exposure to the catabolites, is required. This can be achieved by following the timeline of DPD irreversible inhibition and the formation of new DPD using the plasma concentrations of 5-FU and its catabolites. In an effort to better estimate the timeline of DP inhibition and formation of new DPD, we modified the protocol for the Phase 1B trial and began enrolling patients in the amended Phase 1B trial in April 2022. On November 1, 2022, we announced that data from the Phase 1B trial identified multiple dosage regimens with potentially better safety and efficacy profiles than currently existing chemotherapy regimens. Since 5-FU exposure is dependent on both the PCS6422 regimen and the capecitabine regimen, safe regimens were identified as well as regimens that cause DLTs. One regimen in the Phase 1B trial did cause DLTs in 2 patients, one of whom died. The Phase 1B study is continuing to enroll patients and is expected to complete enrollment in the first half of 2023. The next study will be a Phase 2B trial to determine which regimens provide an improved efficacy-safety profile over present therapy using the principles of the FDA’s Oncology Project Optimus initiative to help guide the design of the trial. This FDA initiative requires us to consider NGC regimens that are not at the maximum tolerated dose or exposure level. In 2023, we plan to meet with FDA to discuss the design of our Phase 2B trial and initiate the trial. ● PCS12852 is a highly specific and potent 5HT4 agonist which has already been evaluated in clinical studies in South Korea for gastric emptying and gastrointestinal motility in healthy volunteers and volunteers with a history of constipation. In October 2021, the FDA cleared our IND application to proceed with a Phase 2A trial for the treatment of gastroparesis. We enrolled our first patient on April 5, 2022, and completed enrollment of the trial on September 2, 2022. Early results from this Phase 2A study which included 25 patients with moderate to severe gastroparesis, demonstrated improvements in gastric emptying in patients receiving 0.5 mg of PCS12852 as compared to placebo, and statistical significance was shown at p < 0.10 even though there were only a total of 14 patients in the 0.5 mg and placebo groups of this study. The mean (±SD) t 50 ● Our pipeline drug to treat unmet medical need conditions caused by multiple pathophysiological changes in a patient is PCS499. PCS499 is an oral tablet of the deuterated analog of one of the major metabolites of pentoxifylline (PTX or Trental®). We completed a Phase 2A trial for PCS499 in patients with ulcerative and non-ulcerative necrobiosis lipoidica (NL) in late 2020, and in May 2021 we enrolled the first patient in our Phase 2B trial for the treatment of ulcerative NL. Based on our current enrollment, we expect to complete our interim analysis and complete enrollment of the Phase 2B trial during the first half of 2023; and, depending on the results, begin a pivotal Phase 3 trial in late 2023 or 2024. We have experienced delays in the enrollment of patients for this trial due in part to COVID-19 and the ultra-rare nature of this disease. As a result, we have initiated a number of recruitment programs to increase the enrollment of patients in this study and continue to evaluate additional options to meet our overall trial enrollment goals. ● PCS3117 is a cytosine analog that is similar to gemcitabine (Gemzar®), but different enough in chemical structure that some patients are more likely to respond to PCS3117 than gemcitabine. The difference in response occurs because PCS3117 is metabolized to its active metabolite through a different enzyme system gemcitabine. We continue to evaluate the potential use of PCS3117 in patients with pancreatic cancer and to evaluate ways to identify patients who are more likely to respond to PCS3117 than gemcitabine. We anticipate initiating a Phase 2B trial or adaptive designed Phase 3 trial in 2023 subject to meeting with FDA and obtaining additional funding. ● PCS11T is an analog of SN38 (SN38 being the active metabolite of irinotecan) and a next generation irinotecan drug for multiple types of cancers. The manufacturing process and sites for drug substance and drug product are presently being evaluated. In addition, we are defining the potential paths to approval, which include defining the targeted patient population and the type of cancer. We hope to submit an IND in 2024, followed by a Phase 1B maximum tolerated dose trial. Impact of COVID-19 The COVID-19 pandemic continues to create uncertainties in expected timelines by causing delays in clinical trials and disruptions in the supply chain for raw materials used in clinical trial work. We have experienced delays in the enrollment of patients in our PCS499 Phase 2B trial due to COVID-19 and the rareness of the disease. Some potential patients died from COVID-19 prior to screening and others continue to be reluctant to travel to our testing sites for fear of contracting COVID-19. Delays in enrollment lengthen the time of studies and increase their costs, which could materially impact our business in future periods. For more information on the risks associated with COVID-19, refer to Part I, Item 1A, “Risk Factors” included in our Annual Report on Form 10-K for the year ended December 31, 2021. Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions of the Securities and Exchange Commission (“SEC”) on Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all the information and disclosures required by U.S. GAAP for complete financial statements. All material intercompany accounts and transactions have been eliminated in consolidation. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments necessary, which are of a normal and recurring nature, for the fair presentation of our financial position and of the results of operations and cash flows for the periods presented. These condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the SEC. The results of operations for the interim periods shown in this report are not necessarily indicative of the results that may be expected for any other interim period or for the full year. Liquidity We have incurred losses since inception, devoting substantially all of our efforts toward moving the drugs in our pipeline through the regulatory process and other research and development activities, and have an accumulated deficit of approximately $ 51.2 14.4 7.0 7.1 We had no On August 20, 2021, we entered into an equity distribution agreement (the “Sales Agreement”) with Oppenheimer & Co. Inc. under which we may issue and sell in a registered “at-the-market” offering shares of our common stock having an aggregate offering price of up to $ 30.0 On March 23, 2022, we entered into a Purchase Agreement (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”) under which we have the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $ 15.0 of our shares of common stock, subject to the terms and conditions in the Purchase Agreement. We expect to use the proceeds from this Purchase Agreement as the source for working capital and general corporate purposes. See Note 3 for additional details concerning the Purchase Agreement. Use of Estimates In preparing our condensed consolidated financial statements and related disclosures in conformity with GAAP and pursuant to the rules and regulations of the SEC, we make estimates and judgments that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Estimates are used for, but not limited to preclinical and clinical trial expenses, stock-based compensation, intangible assets, future milestone payments and income taxes. These estimates and assumptions are continuously evaluated and are based on management’s experience and knowledge of the relevant facts and circumstances. While we believe the estimates to be reasonable, actual results could differ materially from those estimates and could impact future results of operations and cash flows. Income Taxes We account for income taxes in accordance with ASC Topic 740, Income Taxes. 2 Under ACS 740-270 Income Taxes – Interim Reporting Concentration of Credit Risk Financial instruments that potentially subject us to significant concentration of credit risk consist primarily of our cash and cash equivalents. We utilize only well-established banks and financial institutions with high credit ratings. Balances on deposit are insured by the Federal Deposit Insurance Corporation (FDIC) up to specified limits. Total cash held by our banks at September 30, 2022 exceeded FDIC limits. Recent Accounting Pronouncements From time to time, the Financial Accounting Standards Board (“FASB”) or other standard setting bodies issue new accounting pronouncements. Updates to the FASB Accounting Standards Codification are communicated through issuance of an Accounting Standards Update (“ASU”). We have implemented all new accounting pronouncements that are in effect and that may impact our condensed consolidated financial statements. We have evaluated recently issued accounting pronouncements and determined that there is no material impact on our condensed consolidated financial position or results of operations.

Intangible Assets

Intangible Assets	9 Months Ended
	Sep. 30, 2022
Goodwill and Intangible Assets Disclosure [Abstract]
Intangible Assets	Note 2 – Intangible Assets Intangible assets at September 30, 2022 and December 31, 2021 consisted of the following: Summary of Intangible Assets September 30, 2022 December 31, 2021 Gross intangible assets $ 11,059,429 $ 11,059,429 Less: accumulated amortization (3,594,163 ) (3,002,791 ) Total intangible assets, net $ 7,465,266 $ 8,056,638 Gross intangible assets consist primarily of costs we capitalized when we acquired the license rights to PCS499 in 2018. Amortization expense was $ 197,124 195,700 591,372 593,365 788,000

Stockholders_ Equity

Stockholders’ Equity	9 Months Ended
	Sep. 30, 2022
Equity [Abstract]
Stockholders’ Equity	Note 3 – Stockholders’ Equity Preferred Stock There were no Common Stock Increase in Our Authorized Number of Shares On January 1, 2022, we amended our Certificate of Incorporation to increase the number of authorized shares of our common stock from 30,000,000 50,000,000 ATM Offering On August 20, 2021, we entered into the Sales Agreement with the Sales Agent under which we may issue and sell up to $ 30.0 Lincoln Park Capital Fund, LLC Purchase Agreement On March 23, 2022, we entered into the Purchase Agreement with Lincoln Park, pursuant to which Lincoln Park has committed to purchase up to $ 15.0 million of shares (the “Purchase Shares”) of our common stock, subject to the terms and conditions in the Purchase Agreement. We issued 123,609 shares of common stock (valued at $ 450,000 ) to Lincoln Park as a commitment fee in connection with entering into the Purchase Agreement and agreed to reimburse Lincoln Park $ 25,000 for fees incurred in connection with the Purchase Agreement. Concurrent with entering into the Purchase Agreement, we also entered into a registration rights agreement with Lincoln Park (the “Registration Rights Agreement”), pursuant to which we agreed to take certain actions relating to the registration under the Securities Act of 1933, as amended, of the offer and sale of the shares of common stock available for issuance under the Purchase Agreement. We have the right to present Lincoln Park with a purchase notice (a “Regular Purchase Notice”), directing Lincoln Park to purchase up to 25,000 75,000 1,250,000 The aggregate number of shares that we can issue to Lincoln Park under the Purchase Agreement may not exceed 3,142,430 19.99 9.99 We may terminate the Purchase Agreement at any time, at our sole discretion, without any cost or penalty, by giving one business day notice to Lincoln Park to terminate the Purchase Agreement. Lincoln Park has covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of the common stock. There are no limitations on use of proceeds, financial or business covenants, restrictions on future financings (other than restrictions on our ability to enter into variable rate transactions described in the Purchase Agreement), rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement. We may deliver Purchase Notices under the Purchase Agreement, subject to market conditions, and in light of our capital needs from time to time and under the limitations contained in the Purchase Agreement. Any proceeds that we receive under the Purchase Agreement are expected to be used for working capital and general corporate purposes. Repurchase of Shares from Aposense, Ltd. On March 29, 2022, we purchased 100,000 300,000 and are holding these shares as treasury stock until they are reissued or retired at the discretion of our Board of Directors.

Stock-based Compensation

Stock-based Compensation	9 Months Ended
	Sep. 30, 2022
Share-Based Payment Arrangement [Abstract]
Stock-based Compensation	Note 4 - Stock-based Compensation T he Processa Pharmaceuticals Inc. 2019 Omnibus Equity Incentive Plan (the “2019 Plan”) allows us to make grants of stock options, restricted and unrestricted stock and other stock-based awards to employees, including our executive officers, consultants and directors. The 2019 Plan originally provided for the aggregate issuance of 3,000,000 shares of our common stock. On July 11, 2022, our shareholders approved an increase in the aggregate number of shares of our common stock available for issuance under our 2019 plan by 3,000,000 shares to 6,000,000 shares in total. As of September 30, 2022, 2,430,146 shares were available for future grants. Stock Compensation Expense We recorded stock-based compensation expense for the three and nine month periods ended September 30, 2022 and 2021 as follows: Schedule of Stock-based Compensation Expense 2022 2021 2022 2021 Three Months Ended Nine Months Ended 2022 2021 2022 2021 Research and development $ 1,067,613 $ 274,146 $ 1,945,113 $ 519,284 General and administrative 2,146,202 840,095 4,106,968 1,768,579 Total $ 3,213,815 $ 1,114,241 $ 6,052,081 $ 2,287,863 No tax benefits were attributed to the stock-based compensation expense because a valuation allowance was maintained for all net deferred tax assets relating to this expense. Stock Options No s of 178,496 17.07 2.8 Restricted Stock Awards Activity in our Restricted Stock Awards (“RSAs”) during the nine months ended September 30, 2022 was as follows: Schedule of Information About RSA Outstanding Number of Weighted- Outstanding at January 1, 2022 91,109 $ 7.74 Awarded 187,058 3.71 Forfeited (29,326 ) 5.37 Issued (119,829 ) 5.66 Outstanding at September 30, 2022 129,012 $ 4.37 As of September 30, 2022, unrecognized stock-based compensation expense of approximately $ 296,000 0.92 During the nine months ended September 30, 2022, we granted and issued RSAs for 59,766 shares of our common stock to consultants for services to be provided in 2022. These RSAs had a cumulative fair market value of $ 196,500 on the dates of grant and were expensed as stock-based compensation. We also granted RSAs for 109,720 shares of our common stock to our directors for their 2022 service which had a fair market value of $ 378,000 on the dates of grant. Additionally, on March 31, 2022, we issued 17,572 shares of our common stock to our directors in satisfaction of the $ 120,000 of directors’ fees we had accrued at December 31, 2021. On May 31, 2022, a director did not seek reelection and forfeited the RSAs for 18,208 shares of our common stock related to their 2022 service. 53,609 42,491 11,118 We did not cancel any RSAs during the nine months ended September 30, 2022. Unvested RSAs representing 67,124 49,388 Restricted Stock Units Activity in our Restricted Stock Units (“RSUs”) during the nine months ended September 30, 2022 was as follows: Schedule of Information About RSU Outstanding Number of Weighted- Outstanding at January 1, 2022 439,593 $ 7.76 Awarded 2,343,575 3.11 Forfeited (42,875 ) 5.35 Issued (3,500 ) 6.65 Outstanding at September 30, 2022 2,736,793 3.82 Vested and unissued (569,392 ) 4.87 Unvested at September 30, 2022 2,167,401 $ 3.54 As of September 30, 2022, unrecognized stock-based compensation expense of approximately $ 4.7 0.35 343,000 During the nine months ended September 30, 2022, we granted RSUs related to the future issuance of 332,363 ursuant to agreements with our Executive team and certain other employees where a portion of their base compensation is paid in RSUs . The value of an RSU award is based on the average share price of the month services were provided. 5.00 On April 1, 2022, we also granted RSUs for 1,979,818 shares of our common stock, of which RSUs related to the future issuance of 879,819 shares were subject to shareholder approval, which was received on July 11, 2022. These RSUs vest on January 1, 2023 and are subject to distribution requirements before any shares of common stock are issued. The RSUs that were not subject to shareholder approval had a fair value on April 1, 2022 of $ 3.3 million and the RSUs that were subject to shareholder approval had a fair value on July 11, 2022 of $ 2.9 million. The $ 3.3 million is being recognized ratably over the period from April 1, 2022 through December 31, 2022 and the $ 2.9 million is being recognized ratably over the period from July 2022 through December 31, 2022 Holders of our vested RSUs will be issued shares of our common stock upon the satisfaction of the distribution restrictions contained in their Restricted Stock Unit Award Agreement. The distribution restrictions are typically different (longer) than the vesting schedule, imposing an additional restriction on the holder. Unlike RSAs, while employees may hold fully vested RSUs, the individual does not hold any shares or have any rights of a shareholder until the distribution restrictions are met. Upon distribution to the employee, each RSU converts into one share of our common stock. The RSUs contain dividend equivalent rights. Warrants No granted and 18,107 285,618 shares with a weighted average exercise price of $ 10.25 1.1 Effective May 3, 2022, we extended the expiration date of a warrant held by a consultant by one year in connection with the extension of their service agreement. No other terms of the warrant, including the exercise price of $ 7.18 are recognizing the 33,000

Net Loss per Share of Common St

Net Loss per Share of Common Stock	9 Months Ended
	Sep. 30, 2022
Earnings Per Share [Abstract]
Net Loss per Share of Common Stock	Note 5 – Net Loss per Share of Common Stock Net Loss Per Share Basic net loss per share is computed by dividing our net loss available to common shareholders by the weighted average number of shares of common stock outstanding (which excludes unvested RSAs and includes vested RSUs) during the period. Diluted loss per share is computed by dividing our net loss available to common shareholders by the diluted weighted average number of shares of common stock (which includes the potentially dilutive effect of stock options, unvested RSAs, unvested RSUs and warrants) during the period. Since we experienced a net loss for both periods presented, basic and diluted net loss per share are the same. As such, diluted loss per share for the three and nine month periods ended September 30, 2022 and 2021 excludes the impact of potentially dilutive common shares since those shares would have an anti-dilutive effect on net loss per share. The computation of net loss per share for the three and nine month periods ended September 30, 2022 and 2021 was as follows: Schedule of Net Loss Per Share Basic and Diluted 2022 2021 2022 2021 Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Basic and diluted net loss per share: Net loss available to common stockholders $ (6,020,410 ) $ (2,987,217 ) $ (14,411,909 ) $ (8,243,740 ) Weighted average number of common shares-basic and diluted 16,200,222 15,531,442 15,991,653 15,177,306 Basic and diluted net loss per share $ (0.37 ) $ (0.19 ) $ (0.90 ) $ (0.54 ) Our diluted net loss per share for the three and nine month periods ended September 30, 2022 and 2021 excluded 2,760,527 844,393

Operating Leases

Operating Leases	9 Months Ended
	Sep. 30, 2022
Operating Leases
Operating Leases	Note 6 – Operating Leases We lease our office space under an operating lease agreement, which was renewed on October 3, 2022 and its effects were recorded as of September 30, 2022. This lease does not have significant rent escalation, concessions, leasehold improvement incentives, or other build-out clauses. Further, the lease does not contain contingent rent provisions. Our office space lease includes both lease (e.g., fixed payments including rent, taxes, and insurance costs) and non-lease components (e.g., common-area or other maintenance costs), which are accounted for as a single lease component as we have elected the practical expedient to group lease and non-lease components for all leases. We also lease office equipment under an operating lease. Our leases do not provide an implicit rate and, as such, we have used our incremental borrowing rate of 8 Lease costs included in our condensed consolidated statements of operations totaled $ 23,681 24,198 72,209 70,029 Schedule of Weighted Average Remaining Lease Terms and Discount Rate for Operating Leases Remaining lease term (years) for our office lease 3.0 * Remaining lease term (years) for our equipment lease 1.5 Weighted average remaining lease term (years) for our facility and equipment leases 2.95 Weighted average discount rate for our facility and equipment leases 8.0 % * Includes term applicable to the lease renewal signed on October 3, 2022. Annual lease liabilities for all operating leases were as follows as of September 30, 2022, including the remaining costs associated with the office lease renewal executed on October 3, 2022: Schedule of Maturities of Lease Liabilities for all Operating Leases 2022 $ 23,192 2023 93,629 2024 92,302 2025 70,040 Total lease payments 279,163 Less: Interest (31,196 ) Present value of lease liabilities 247,967 Less: current maturities (76,260 ) Non-current lease liability $ 171,707

Related Party Transactions

Related Party Transactions	9 Months Ended
	Sep. 30, 2022
Related Party Transactions [Abstract]
Related Party Transactions	Note 7 – Related Party Transactions CorLyst, LLC (“CorLyst”) reimburses us for shared costs related to payroll, health insurance and rent based on actual costs incurred, which are recognized as a reduction of our general and administrative operating expenses in our condensed consolidated statement of operations. We recorded $ 94,642 92,419 No

Elion License Agreement

Elion License Agreement	9 Months Ended
	Sep. 30, 2022
Elion License Agreement
Elion License Agreement	Note 8 – Elion License Agreement On May 17, 2022, we amended the third Milestone Event of Section 6.4 of our License Agreement with Elion Oncology, Inc. changing the third Milestone Event from “1 st 189,000

Commitments and Contingencies

Commitments and Contingencies	9 Months Ended
	Sep. 30, 2022
Commitments and Contingencies Disclosure [Abstract]
Commitments and Contingencies	Note 9 – Commitments and Contingencies Purchase Obligations We enter into contracts in the normal course of business with contract research organizations and subcontractors to further develop our products. The contracts are cancellable, with varying provisions regarding termination. If we terminated a cancellable contract with a specific vendor, we would only be obligated for products or services that we received as of the effective date of the termination and any applicable cancellation fees. As of September 30, 2022, we are contractually obligated to pay up to approximately $4.4 million of future services under the agreements with the CROs, but our actual contractual obligations will vary depending on the progress and results of the clinical trials.

Organization and Summary of S_2

Organization and Summary of Significant Accounting Policies (Policies)	9 Months Ended
	Sep. 30, 2022
Accounting Policies [Abstract]
Business Activities and Organization	Business Activities and Organization We are a diversified Next Generation Capecitabine previously identified as 12852 3117 ● Next Generation Capecitabine (NGC), previously identified as PCS6422, is a combination of PCS6422 and the FDA-approved cancer drug capecitabine. PCS6422 is an orally administered irreversible inhibitor of the enzyme dihydropyrimidine dehydrogenase (DPD). DPD metabolizes 5-Fluorouracil (5-FU), the major metabolite of capecitabine and widely used itself as an intravenous chemotherapeutic agent in many types of cancer, to multiple metabolites classified as catabolites. These catabolites do not have any cancer-killing properties but do cause dose-limiting side effects that may require dose adjustments or discontinuation of therapy. When combining capecitabine with PCS6422 in NGC, capecitabine becomes a more potent cancer chemotherapy agent than current FDA-approved capecitabine requiring significantly lower doses. On August 2, 2021, we enrolled the first patient in our Phase 1B dose-escalation maximum tolerated dose trial in patients with advanced refractory gastrointestinal (GI) tract tumors. Our interim analysis of Cohorts 1 and 2A found no dose-limiting toxicities (DLTs), no drug-related adverse events greater than Grade 1, and no hand-foot syndrome, a major side effect found with the catabolites of 5-FU. In this Phase 1B trial it was demonstrated that the irreversible inhibition of DPD by PCS6422 could alter the elimination of 5-FU making NGC significantly more potent (greater than 50 times more potent) and potentially lead to higher levels of the group of metabolites called anabolites which can kill replicating cancer and normal cells. By administering NGC to cancer patients, the balance between anabolites and catabolites changes depending on the dosage regimens of PCS6422 and capecitabine used, making the efficacy-safety profile of NGC different than that of FDA-approved capecitabine and requiring further evaluation of the PCS6422 and capecitabine regimens to determine the optimal NGC regimens for patients. In order for NGC to provide a safer and more efficacious profile for cancer patients compared to existing chemotherapy, understanding how the different regimens of PCS6422 and capecitabine may affect the systemic and tumor exposure to the anabolites, as well as the systemic exposure to the catabolites, is required. This can be achieved by following the timeline of DPD irreversible inhibition and the formation of new DPD using the plasma concentrations of 5-FU and its catabolites. In an effort to better estimate the timeline of DP inhibition and formation of new DPD, we modified the protocol for the Phase 1B trial and began enrolling patients in the amended Phase 1B trial in April 2022. On November 1, 2022, we announced that data from the Phase 1B trial identified multiple dosage regimens with potentially better safety and efficacy profiles than currently existing chemotherapy regimens. Since 5-FU exposure is dependent on both the PCS6422 regimen and the capecitabine regimen, safe regimens were identified as well as regimens that cause DLTs. One regimen in the Phase 1B trial did cause DLTs in 2 patients, one of whom died. The Phase 1B study is continuing to enroll patients and is expected to complete enrollment in the first half of 2023. The next study will be a Phase 2B trial to determine which regimens provide an improved efficacy-safety profile over present therapy using the principles of the FDA’s Oncology Project Optimus initiative to help guide the design of the trial. This FDA initiative requires us to consider NGC regimens that are not at the maximum tolerated dose or exposure level. In 2023, we plan to meet with FDA to discuss the design of our Phase 2B trial and initiate the trial. ● PCS12852 is a highly specific and potent 5HT4 agonist which has already been evaluated in clinical studies in South Korea for gastric emptying and gastrointestinal motility in healthy volunteers and volunteers with a history of constipation. In October 2021, the FDA cleared our IND application to proceed with a Phase 2A trial for the treatment of gastroparesis. We enrolled our first patient on April 5, 2022, and completed enrollment of the trial on September 2, 2022. Early results from this Phase 2A study which included 25 patients with moderate to severe gastroparesis, demonstrated improvements in gastric emptying in patients receiving 0.5 mg of PCS12852 as compared to placebo, and statistical significance was shown at p < 0.10 even though there were only a total of 14 patients in the 0.5 mg and placebo groups of this study. The mean (±SD) t 50 ● Our pipeline drug to treat unmet medical need conditions caused by multiple pathophysiological changes in a patient is PCS499. PCS499 is an oral tablet of the deuterated analog of one of the major metabolites of pentoxifylline (PTX or Trental®). We completed a Phase 2A trial for PCS499 in patients with ulcerative and non-ulcerative necrobiosis lipoidica (NL) in late 2020, and in May 2021 we enrolled the first patient in our Phase 2B trial for the treatment of ulcerative NL. Based on our current enrollment, we expect to complete our interim analysis and complete enrollment of the Phase 2B trial during the first half of 2023; and, depending on the results, begin a pivotal Phase 3 trial in late 2023 or 2024. We have experienced delays in the enrollment of patients for this trial due in part to COVID-19 and the ultra-rare nature of this disease. As a result, we have initiated a number of recruitment programs to increase the enrollment of patients in this study and continue to evaluate additional options to meet our overall trial enrollment goals. ● PCS3117 is a cytosine analog that is similar to gemcitabine (Gemzar®), but different enough in chemical structure that some patients are more likely to respond to PCS3117 than gemcitabine. The difference in response occurs because PCS3117 is metabolized to its active metabolite through a different enzyme system gemcitabine. We continue to evaluate the potential use of PCS3117 in patients with pancreatic cancer and to evaluate ways to identify patients who are more likely to respond to PCS3117 than gemcitabine. We anticipate initiating a Phase 2B trial or adaptive designed Phase 3 trial in 2023 subject to meeting with FDA and obtaining additional funding. ● PCS11T is an analog of SN38 (SN38 being the active metabolite of irinotecan) and a next generation irinotecan drug for multiple types of cancers. The manufacturing process and sites for drug substance and drug product are presently being evaluated. In addition, we are defining the potential paths to approval, which include defining the targeted patient population and the type of cancer. We hope to submit an IND in 2024, followed by a Phase 1B maximum tolerated dose trial.
Impact of COVID-19	Impact of COVID-19 The COVID-19 pandemic continues to create uncertainties in expected timelines by causing delays in clinical trials and disruptions in the supply chain for raw materials used in clinical trial work. We have experienced delays in the enrollment of patients in our PCS499 Phase 2B trial due to COVID-19 and the rareness of the disease. Some potential patients died from COVID-19 prior to screening and others continue to be reluctant to travel to our testing sites for fear of contracting COVID-19. Delays in enrollment lengthen the time of studies and increase their costs, which could materially impact our business in future periods. For more information on the risks associated with COVID-19, refer to Part I, Item 1A, “Risk Factors” included in our Annual Report on Form 10-K for the year ended December 31, 2021.
Basis of Presentation	Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions of the Securities and Exchange Commission (“SEC”) on Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all the information and disclosures required by U.S. GAAP for complete financial statements. All material intercompany accounts and transactions have been eliminated in consolidation. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments necessary, which are of a normal and recurring nature, for the fair presentation of our financial position and of the results of operations and cash flows for the periods presented. These condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the SEC. The results of operations for the interim periods shown in this report are not necessarily indicative of the results that may be expected for any other interim period or for the full year.
Liquidity	Liquidity We have incurred losses since inception, devoting substantially all of our efforts toward moving the drugs in our pipeline through the regulatory process and other research and development activities, and have an accumulated deficit of approximately $ 51.2 14.4 7.0 7.1 We had no On August 20, 2021, we entered into an equity distribution agreement (the “Sales Agreement”) with Oppenheimer & Co. Inc. under which we may issue and sell in a registered “at-the-market” offering shares of our common stock having an aggregate offering price of up to $ 30.0 On March 23, 2022, we entered into a Purchase Agreement (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”) under which we have the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $ 15.0 of our shares of common stock, subject to the terms and conditions in the Purchase Agreement. We expect to use the proceeds from this Purchase Agreement as the source for working capital and general corporate purposes. See Note 3 for additional details concerning the Purchase Agreement.
Use of Estimates	Use of Estimates In preparing our condensed consolidated financial statements and related disclosures in conformity with GAAP and pursuant to the rules and regulations of the SEC, we make estimates and judgments that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Estimates are used for, but not limited to preclinical and clinical trial expenses, stock-based compensation, intangible assets, future milestone payments and income taxes. These estimates and assumptions are continuously evaluated and are based on management’s experience and knowledge of the relevant facts and circumstances. While we believe the estimates to be reasonable, actual results could differ materially from those estimates and could impact future results of operations and cash flows.
Income Taxes	Income Taxes We account for income taxes in accordance with ASC Topic 740, Income Taxes. 2 Under ACS 740-270 Income Taxes – Interim Reporting
Recent Accounting Pronouncements	Concentration of Credit Risk Financial instruments that potentially subject us to significant concentration of credit risk consist primarily of our cash and cash equivalents. We utilize only well-established banks and financial institutions with high credit ratings. Balances on deposit are insured by the Federal Deposit Insurance Corporation (FDIC) up to specified limits. Total cash held by our banks at September 30, 2022 exceeded FDIC limits. Recent Accounting Pronouncements From time to time, the Financial Accounting Standards Board (“FASB”) or other standard setting bodies issue new accounting pronouncements. Updates to the FASB Accounting Standards Codification are communicated through issuance of an Accounting Standards Update (“ASU”). We have implemented all new accounting pronouncements that are in effect and that may impact our condensed consolidated financial statements. We have evaluated recently issued accounting pronouncements and determined that there is no material impact on our condensed consolidated financial position or results of operations.

Intangible Assets (Tables)

Intangible Assets (Tables)	9 Months Ended
	Sep. 30, 2022
Goodwill and Intangible Assets Disclosure [Abstract]
Summary of Intangible Assets	Intangible assets at September 30, 2022 and December 31, 2021 consisted of the following: Summary of Intangible Assets September 30, 2022 December 31, 2021 Gross intangible assets $ 11,059,429 $ 11,059,429 Less: accumulated amortization (3,594,163 ) (3,002,791 ) Total intangible assets, net $ 7,465,266 $ 8,056,638

Stock-based Compensation (Table

Stock-based Compensation (Tables)	9 Months Ended
	Sep. 30, 2022
Share-Based Payment Arrangement [Abstract]
Schedule of Stock-based Compensation Expense	We recorded stock-based compensation expense for the three and nine month periods ended September 30, 2022 and 2021 as follows: Schedule of Stock-based Compensation Expense 2022 2021 2022 2021 Three Months Ended Nine Months Ended 2022 2021 2022 2021 Research and development $ 1,067,613 $ 274,146 $ 1,945,113 $ 519,284 General and administrative 2,146,202 840,095 4,106,968 1,768,579 Total $ 3,213,815 $ 1,114,241 $ 6,052,081 $ 2,287,863
Schedule of Information About RSA Outstanding	Activity in our Restricted Stock Awards (“RSAs”) during the nine months ended September 30, 2022 was as follows: Schedule of Information About RSA Outstanding Number of Weighted- Outstanding at January 1, 2022 91,109 $ 7.74 Awarded 187,058 3.71 Forfeited (29,326 ) 5.37 Issued (119,829 ) 5.66 Outstanding at September 30, 2022 129,012 $ 4.37
Schedule of Information About RSU Outstanding	Activity in our Restricted Stock Units (“RSUs”) during the nine months ended September 30, 2022 was as follows: Schedule of Information About RSU Outstanding Number of Weighted- Outstanding at January 1, 2022 439,593 $ 7.76 Awarded 2,343,575 3.11 Forfeited (42,875 ) 5.35 Issued (3,500 ) 6.65 Outstanding at September 30, 2022 2,736,793 3.82 Vested and unissued (569,392 ) 4.87 Unvested at September 30, 2022 2,167,401 $ 3.54

Net Loss per Share of Common _2

Net Loss per Share of Common Stock (Tables)	9 Months Ended
	Sep. 30, 2022
Earnings Per Share [Abstract]
Schedule of Net Loss Per Share Basic and Diluted	The computation of net loss per share for the three and nine month periods ended September 30, 2022 and 2021 was as follows: Schedule of Net Loss Per Share Basic and Diluted 2022 2021 2022 2021 Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Basic and diluted net loss per share: Net loss available to common stockholders $ (6,020,410 ) $ (2,987,217 ) $ (14,411,909 ) $ (8,243,740 ) Weighted average number of common shares-basic and diluted 16,200,222 15,531,442 15,991,653 15,177,306 Basic and diluted net loss per share $ (0.37 ) $ (0.19 ) $ (0.90 ) $ (0.54 )

Operating Leases (Tables)

Operating Leases (Tables)	9 Months Ended
	Sep. 30, 2022
Operating Leases
Schedule of Weighted Average Remaining Lease Terms and Discount Rate for Operating Leases	Schedule of Weighted Average Remaining Lease Terms and Discount Rate for Operating Leases Remaining lease term (years) for our office lease 3.0 * Remaining lease term (years) for our equipment lease 1.5 Weighted average remaining lease term (years) for our facility and equipment leases 2.95 Weighted average discount rate for our facility and equipment leases 8.0 % * Includes term applicable to the lease renewal signed on October 3, 2022.
Schedule of Maturities of Lease Liabilities for all Operating Leases	Annual lease liabilities for all operating leases were as follows as of September 30, 2022, including the remaining costs associated with the office lease renewal executed on October 3, 2022: Schedule of Maturities of Lease Liabilities for all Operating Leases 2022 $ 23,192 2023 93,629 2024 92,302 2025 70,040 Total lease payments 279,163 Less: Interest (31,196 ) Present value of lease liabilities 247,967 Less: current maturities (76,260 ) Non-current lease liability $ 171,707

Organization and Summary of S_3

Organization and Summary of Significant Accounting Policies (Details Narrative) - USD ($)			3 Months Ended						9 Months Ended
	Mar. 23, 2022	Aug. 20, 2021	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Sep. 30, 2021	Jun. 30, 2021	Mar. 31, 2021	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021
Accumulated deficit			$ 51,235,241						$ 51,235,241		$ 36,823,332
Net loss			6,020,410	$ 5,164,368	$ 3,227,131	$ 2,987,217	$ 3,157,043	$ 2,099,480	14,411,909	$ 8,243,740
Non cash expenditures									7,000,000
Net cash used in operating activities									7,107,758	$ 5,990,321
Revenue									0
Operating loss carry forwards			$ 2,000,000						$ 2,000,000		$ 2,000,000
Equity Distribution Agreement [Member]
Maximum number of shares to be sold at the market offering		$ 30,000,000
Purchase Agreement [Member] | Lincoln Park Capital Fund LLC [Member] | Maximum [Member]
Maximum commitment to purchase common stock value	$ 15,000,000

Summary of Intangible Assets (D

Summary of Intangible Assets (Details) - USD ($)	Sep. 30, 2022	Dec. 31, 2021
Goodwill and Intangible Assets Disclosure [Abstract]
Gross intangible assets	$ 11,059,429	$ 11,059,429
Less: accumulated amortization	(3,594,163)	(3,002,791)
Total intangible assets, net	$ 7,465,266	$ 8,056,638

Intangible Assets (Details Narr

Intangible Assets (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Goodwill and Intangible Assets Disclosure [Abstract]
Amortization expense	$ 197,124	$ 195,700	$ 591,372	$ 593,365
Future amortization expenses, annual periods thereafter	$ 788,000		$ 788,000

Stockholders_ Equity (Details N

Stockholders’ Equity (Details Narrative) - USD ($)				3 Months Ended
	Mar. 29, 2022	Mar. 23, 2022	Aug. 20, 2021	Mar. 31, 2022	Sep. 30, 2022	Dec. 31, 2021
Preferred stock, shares issued					0	0
Preferred stock, shares outstanding					0	0
Common stock, shares authorized					50,000,000	30,000,000
Repurchase of common stock value				$ 300,000
Aposense, Ltd. [Member]
Number of repurchase of common stock, shares	100,000
Repurchase of common stock value	$ 300,000
Equity Distribution Agreement [Member]
Maximum number of shares to be sold at the market offering			$ 30,000,000
Purchase Agreement [Member] | Lincoln Park Capital Fund LLC [Member]
Number of common stock issued on commitment fees, shares		123,609
Number of common stock issued on commitment fees, value		$ 450,000
Reimbursement fees		$ 25,000
Nasdaq's exchange cap percent		19.99%
Purchase Agreement [Member] | Lincoln Park Capital Fund LLC [Member] | Maximum [Member]
Commitment to purchase common stock		$ 15,000,000
Number of common stock shares in regular purchase		25,000
Number of common stock shares exceeding regular purchase		75,000
Daily maximum committed purchase obligations, value		$ 1,250,000
Maximum number of shares issued sold		3,142,430
Beneficial ownership limitation percentage		9.99%

Schedule of Stock-based Compens

Schedule of Stock-based Compensation Expense (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Total	$ 3,213,815	$ 1,114,241	$ 6,052,081	$ 2,287,863
Research and Development Expense [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Total	1,067,613	274,146	1,945,113	519,284
General and Administrative Expense [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Total	$ 2,146,202	$ 840,095	$ 4,106,968	$ 1,768,579

Schedule of Information About R

Schedule of Information About RSA Outstanding (Details) - Restricted Stock [Member]	9 Months Ended
	Sep. 30, 2022 $ / shares shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of shares, Beginning balance | shares	91,109
Weighted-average grant-date fair value per share, Beginning balance | $ / shares	$ 7.74
Number of shares, awarded | shares	187,058
Weighted-average grant-date fair value per share, awarded | $ / shares	$ 3.71
Number of shares, forfeited | shares	(29,326)
Weighted-average grant-date fair value per share, forfeited | $ / shares	$ 5.37
Number of shares, shares issued | shares	(119,829)
Weighted-average grant-date fair value per share, shares issued | $ / shares	$ 5.66
Number of shares, ending balance | shares	129,012
Weighted-average grant-date fair value per share, ending balance | $ / shares	$ 4.37

Schedule of Information About_2

Schedule of Information About RSU Outstanding (Details) - Restricted Stock Units (RSUs) [Member] - $ / shares			9 Months Ended
	Jul. 11, 2022	Apr. 01, 2022	Sep. 30, 2022
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of shares, Beginning balance			439,593
Weighted-average grant-date fair value per share, Beginning balance			$ 7.76
Number of shares, awarded	879,819	1,979,818	2,343,575
Weighted-average grant-date fair value per share, awarded			$ 3.11
Number of shares, forfeited			(42,875)
Weighted-average grant-date fair value per share, forfeited			$ 5.35
Number of shares, issued			(3,500)
Weighted-average grant-date fair value per share, shares issued			$ 6.65
Number of shares, ending balance			2,736,793
Weighted-average grant-date fair value per share, ending balance			$ 3.82
Number of shares, vested and unissued			(569,392)
Weighted-average grant-date fair value per share, vested and unissued			$ 4.87
Number of shares, unvested			2,167,401
Weighted-average grant-date fair value per share, unvested			$ 3.54

Stock-based Compensation (Detai

Stock-based Compensation (Details Narrative) - USD ($)

1 Months Ended

3 Months Ended

9 Months Ended

Aug. 05, 2022

Jul. 11, 2022

Jul. 11, 2022

May 31, 2022

May 02, 2022

Apr. 01, 2022

Mar. 31, 2022

Dec. 31, 2021

Sep. 30, 2022

Sep. 30, 2021

Sep. 30, 2022

Sep. 30, 2021

Jul. 10, 2022

May 03, 2022

Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]

Share-Based Payment Arrangement, Noncash Expense

$ 3,213,815

$ 1,114,241

$ 6,052,081

$ 2,287,863

2022 [Member]

Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]

Number of restricted stock expected to vest, shares

67,124

2023 [Member]

Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]

Number of restricted stock expected to vest, shares

49,388

Equity Option [Member]

Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]

Stock option granted

0

Stock option cancelled or forfeited

0

Outstanding options for the purchase shares

178,496

178,496

Weighted average exercise price of stock option outstanding

$ 17.07

$ 17.07

Stock options outstanding, weighted average remaining contractual term

2 years 9 months 18 days

Restricted Stock [Member]

Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]

Unrecognized share based compensation expense

$ 296,000

$ 296,000

Weighted average period

11 months 1 day

Share based compensation arrangement by share based payment award options grants issued in period

59,766

Share-Based Payment Arrangement, Noncash Expense

$ 196,500

Share based compensation granted in period

187,058

Share based compensation forfeited in period

29,326

Restricted Stock [Member] | Common Stock [Member]

Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]

Number of stock options vested

53,609

Number of shares issued

42,491

Shares paid for tax withholding for share based compensation

11,118

Restricted Stock [Member] | Directors [Member]

Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]

Share based compensation granted in period

109,720

Share based compensation granted in period, fair value

$ 378,000

Stock Issued During Period, Shares, Restricted Stock Award, Gross

17,572

Directors' fees

$ 120,000

Share based compensation forfeited in period

18,208

Restricted Stock Units (RSUs) [Member]

Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]

Unrecognized share based compensation expense

$ 4,700,000

$ 4,700,000

Weighted average period

4 months 6 days

Share based compensation granted in period

879,819

1,979,818

2,343,575

Share based compensation granted in period, fair value

$ 2,900,000

$ 3,300,000

Share based compensation forfeited in period

42,875

Unrecognized restricted stock expense

$ 343,000

Minimum price per share of equity compensation

$ 5

$ 5

Restricted Stock Units (RSUs) [Member] | Base Compensation [Member]

Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]

Share based compensation granted in period

332,363

Warrant [Member]

Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]

Warrant cancelled or forfeited

0

Share based compensation arrangement by share based payment award, expirations

18,107

Warrants to purchase shares

285,618

285,618

Exercise price of warrants

$ 10.25

$ 10.25

Weighted average remaining contractual life

1 year 1 month 6 days

Warrant [Member] | Consultant [Member]

Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]

Exercise price of warrants

$ 7.18

Warrants modification expense recognized

$ 33,000

2019 Plan [Member]

Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]

Maximum equity available for issuance under the plan

6,000,000

6,000,000

Shares available for future grants

2,430,146

2,430,146

2019 Plan [Member] | Original [Member]

Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]

Maximum equity available for issuance under the plan

3,000,000

Schedule of Net Loss Per Share

Schedule of Net Loss Per Share Basic and Diluted (Details) - USD ($)	3 Months Ended						9 Months Ended
	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Sep. 30, 2021	Jun. 30, 2021	Mar. 31, 2021	Sep. 30, 2022	Sep. 30, 2021
Earnings Per Share [Abstract]
Net loss available to common stockholders	$ (6,020,410)	$ (5,164,368)	$ (3,227,131)	$ (2,987,217)	$ (3,157,043)	$ (2,099,480)	$ (14,411,909)	$ (8,243,740)
Weighted average number of common shares-basic and diluted	16,200,222			15,531,442			15,991,653	15,177,306
Basic and diluted net loss per share	$ (0.37)			$ (0.19)			$ (0.90)	$ (0.54)

Net Loss per Share of Common _3

Net Loss per Share of Common Stock (Details Narrative) - shares	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Earnings Per Share [Abstract]
Antidilutive securities excluded from computation of earnings per share, amount	2,760,527	844,393

Schedule of Weighted Average Re

Schedule of Weighted Average Remaining Lease Terms and Discount Rate for Operating Leases (Details)	Sep. 30, 2022
Lessee, Lease, Description [Line Items]
Operating lease, weighted average remaining lease term	2 years 11 months 12 days
Weighted average discount rate for our facility and equipment leases	8%
Office Lease [Member]
Lessee, Lease, Description [Line Items]
Operating lease, weighted average remaining lease term	3 years	[1]
Equipment Lease [Member]
Lessee, Lease, Description [Line Items]
Operating lease, weighted average remaining lease term	1 year 6 months
[1]Includes term applicable to the lease renewal signed on October 3, 2022.

Schedule of Maturities of Lease

Schedule of Maturities of Lease Liabilities for all Operating Leases (Details) - USD ($)	Sep. 30, 2022	Dec. 31, 2021
Operating Leases
2022	$ 23,192
2023	93,629
2024	92,302
2025	70,040
Total lease payments	279,163
Less: Interest	(31,196)
Present value of lease liabilities	247,967
Less: current maturities	(76,260)	$ (71,078)
Non-current lease liability	$ 171,707	$ 7,385

Operating Leases (Details Narra

Operating Leases (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Operating Leases
Operating lease borrowing rate	8%		8%
Lease cost	$ 23,681	$ 24,198	$ 72,209	$ 70,029

Related Party Transactions (Det

Related Party Transactions (Details Narrative) - CorLyst, LLC [Member] - USD ($)	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Rent and other costs reimbursements received	$ 94,642	$ 92,419
Due from related parties	$ 0	$ 0

Elion License Agreement (Detail

Elion License Agreement (Details Narrative)	May 17, 2022 USD ($)
License Agreement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Expense and related liability	$ 189,000