0001213900-23-088387 | 10-Q | XBRL Viewer

Net Loss Per Share (Tables)

9 Months Ended

Sep. 30, 2023

The following securities were excluded from the computation of diluted shares outstanding due to the losses incurred in the periods presented, as they would have had an anti-dilutive impact on the Company’s net loss

	Three and Nine Months Ended September 30,
	2023		2022
Unvested shares of restricted stock		344,080		—
Options to purchase shares of common stock		1,378,855		1,383,801
Warrants		7,899,661		5,375,385
Total		9,622,596		6,759,186

Going Concern and Management’s Plans	9 Months Ended
Sep. 30, 2023
Going Concern and Management’s Plans [Abstract]
Going Concern and Management’s Plans	Note 2 — Going Concern and Management’s Plans The Company’s operating activities to date have been devoted to seeking licenses, engaging in research and development activities, and potential asset and business acquisitions. The Company’s product candidates currently under development will require significant additional research and development efforts prior to commercialization. The Company has financed its operations since inception primarily using proceeds received from seed investors, and proceeds received from its IPO and private placement issuances in April and August 2022 (the “Private Placements”, see Note 8). During 2022, the Company completed its IPO and the Private Placements in which the Company received an aggregate of approximately $33.1 million in net cash proceeds, after deducting placement agent fees and other offering expenses. During the three and nine months ended September 30, 2023, the Company received net proceeds of approximately $2.3 million in connection with the exercise of preferred investment options by an investor (see Note 8). The Company has incurred substantial operating losses since inception and expects to continue to incur significant operating losses for the foreseeable future. As of September 30, 2023, the Company had cash of approximately $7.7 million, a working capital deficit of approximately $8.1 million and an accumulated deficit of approximately $34.4 million. During June 2023, the Company entered into an asset purchase agreement with WraSer (the “WraSer APA”) for the acquisition of a significant portion of other assets that requires the Company to pay consideration of $8.5 million and one million shares of common stock, of which $3.5 million was paid upon execution of the agreement, $4.5 million of the remainder and common stock was to be paid at closing, and the remaining $500,000 was to be due June 13, 2024. On September 26, 2023, WraSer and its affiliates filed for relief under chapter 11 of the U.S. Bankruptcy Code in the Bankruptcy Court. On October 4, 2023, the parties agreed to amend the WraSer APA. The amendment, which is subject to court approval, seeks, among other things, to eliminate the $500,000 post-closing payment due June 13, 2024 and stagger the $4.5 million cash payment that the Company would otherwise have to pay at closing to: (i) $2.2 million to be paid at closing, (ii) $2.3 million, to be paid in monthly installments of $150,000 commencing January 2024 and (iii) 789 shares of Series A Preferred Stock to be paid at closing. On October 6, 2023, the Company was alerted to certain developments in WraSer’s operations relating to WraSer’s inability to manufacture the active pharmaceutical ingredient for one of the key WraSer Assets, which development the Company believes constitutes a Material Adverse Effect (as such term is defined in the WraSer APA) that will prevent the Company from closing the transaction. On October 20, 2023, the Company filed a motion for relief from the automatic stay in the Bankruptcy Court so that the Company can exercise the termination rights under the WraSer APA, as amended. WraSer has advised the Company that it does not believe that a Material Adverse Event occurred. If the Bankruptcy Court does not grant the Company’s motion and requires it to complete the transaction, the Company will not be able to execute its commercialization strategy for the WraSer Assets because there is no manufacturer for the active pharmaceutical ingredient for Zontivity, the key driver for the WraSer acquisition. Due to the WraSer bankruptcy filing and the Company’s status as an unsecured creditor of WraSer, it is also unlikely that the Company will recover the $3.5 million initial payment made or any costs and resources in connection with services provided by the Company under the WraSer Management Services Agreement. In addition, if the WraSer APA is terminated, the Company will not be able to recover any such costs. These factors, along with the Company’s forecasted future cash flows, indicate that the Company will be unable to meet its contractual commitments and obligations as they come due in the ordinary course of business within one year following the issuance of these condensed financial statements. The Company will require significant additional capital in the short-term to fund its continuing operations, satisfy existing and future obligations and liabilities, including the remaining payments due for the acquisition of assets described in Note 5 and other contracts entered into in support of the Company’s commercialization plans, in addition to funds needed to support the Company’s working capital needs and business activities. These business activities include the commercialization of ENTADFI®, and the development and commercialization of the Company’s current product candidates and future product candidates. Management’s plans include generating product revenue from sales of ENTADFI®, which has not yet been successfully commercialized, a process that will require significant amounts of additional capital to complete. In addition, certain of the commercialization activities are outside of the Company’s control, including but not limited to, securing contracts with wholesalers and third party payers, securing contracts with third-party logistics providers, and obtaining required licensure in various jurisdictions, as well as attempting to secure additional required funding through equity or debt financings if available; however, there are currently no commitments in place for further financing nor is there any assurance that such financing will be available to the Company on favorable terms, if at all, which creates significant uncertainty that the Company will be able to successfully launch ENTADFI®. If the Company is unable to secure additional capital, it may be required to defer any future clinical trials, should the Company decide to resume these activities, development and/or commercialization of products and product candidates, and it may take additional measures to reduce expenses in order to conserve its cash in amounts sufficient to sustain operations and meet its obligations. Because of historical and expected operating losses and net operating cash flow deficits, there is substantial doubt about the Company’s ability to continue as a going concern for one year from the issuance of the condensed financial statements, which is not alleviated by management’s plans. The condensed financial statements have been prepared assuming the Company will continue as a going concern. These condensed financial statements do not include any adjustments that might be necessary from the outcome of this uncertainty.

Going Concern and Management’s Plans

9 Months Ended

Sep. 30, 2023

Going Concern and Management’s Plans [Abstract]

Going Concern and Management’s Plans

Note 2 — Going Concern and Management’s Plans

The Company’s operating activities to date have been devoted to seeking licenses, engaging in research and development activities, and potential asset and business acquisitions. The Company’s product candidates currently under development will require significant additional research and development efforts prior to commercialization. The Company has financed its operations since inception primarily using proceeds received from seed investors, and proceeds received from its IPO and private placement issuances in April and August 2022 (the “Private Placements”, see Note 8). During 2022, the Company completed its IPO and the Private Placements in which the Company received an aggregate of approximately $33.1 million in net cash proceeds, after deducting placement agent fees and other offering expenses. During the three and nine months ended September 30, 2023, the Company received net proceeds of approximately $2.3 million in connection with the exercise of preferred investment options by an investor (see Note 8).

The Company has incurred substantial operating losses since inception and expects to continue to incur significant operating losses for the foreseeable future. As of September 30, 2023, the Company had cash of approximately $7.7 million, a working capital deficit of approximately $8.1 million and an accumulated deficit of approximately $34.4 million.

During June 2023, the Company entered into an asset purchase agreement with WraSer (the “WraSer APA”) for the acquisition of a significant portion of other assets that requires the Company to pay consideration of $8.5 million and one million shares of common stock, of which $3.5 million was paid upon execution of the agreement, $4.5 million of the remainder and common stock was to be paid at closing, and the remaining $500,000 was to be due June 13, 2024. On September 26, 2023, WraSer and its affiliates filed for relief under chapter 11 of the U.S. Bankruptcy Code in the Bankruptcy Court. On October 4, 2023, the parties agreed to amend the WraSer APA. The amendment, which is subject to court approval, seeks, among other things, to eliminate the $500,000 post-closing payment due June 13, 2024 and stagger the $4.5 million cash payment that the Company would otherwise have to pay at closing to: (i) $2.2 million to be paid at closing, (ii) $2.3 million, to be paid in monthly installments of $150,000 commencing January 2024 and (iii) 789 shares of Series A Preferred Stock to be paid at closing. On October 6, 2023, the Company was alerted to certain developments in WraSer’s operations relating to WraSer’s inability to manufacture the active pharmaceutical ingredient for one of the key WraSer Assets, which development the Company believes constitutes a Material Adverse Effect (as such term is defined in the WraSer APA) that will prevent the Company from closing the transaction. On October 20, 2023, the Company filed a motion for relief from the automatic stay in the Bankruptcy Court so that the Company can exercise the termination rights under the WraSer APA, as amended. WraSer has advised the Company that it does not believe that a Material Adverse Event occurred. If the Bankruptcy Court does not grant the Company’s motion and requires it to complete the transaction, the Company will not be able to execute its commercialization strategy for the WraSer Assets because there is no manufacturer for the active pharmaceutical ingredient for Zontivity, the key driver for the WraSer acquisition. Due to the WraSer bankruptcy filing and the Company’s status as an unsecured creditor of WraSer, it is also unlikely that the Company will recover the $3.5 million initial payment made or any costs and resources in connection with services provided by the Company under the WraSer Management Services Agreement. In addition, if the WraSer APA is terminated, the Company will not be able to recover any such costs.

These factors, along with the Company’s forecasted future cash flows, indicate that the Company will be unable to meet its contractual commitments and obligations as they come due in the ordinary course of business within one year following the issuance of these condensed financial statements. The Company will require significant additional capital in the short-term to fund its continuing operations, satisfy existing and future obligations and liabilities, including the remaining payments due for the acquisition of assets described in Note 5 and other contracts entered into in support of the Company’s commercialization plans, in addition to funds needed to support the Company’s working capital needs and business activities. These business activities include the commercialization of ENTADFI®, and the development and commercialization of the Company’s current product candidates and future product candidates. Management’s plans include generating product revenue from sales of ENTADFI®, which has not yet been successfully commercialized, a process that will require significant amounts of additional capital to complete. In addition, certain of the commercialization activities are outside of the Company’s control, including but not limited to, securing contracts with wholesalers and third party payers, securing contracts with third-party logistics providers, and obtaining required licensure in various jurisdictions, as well as attempting to secure additional required funding through equity or debt financings if available; however, there are currently no commitments in place for further financing nor is there any assurance that such financing will be available to the Company on favorable terms, if at all, which creates significant uncertainty that the Company will be able to successfully launch ENTADFI®. If the Company is unable to secure additional capital, it may be required to defer any future clinical trials, should the Company decide to resume these activities, development and/or commercialization of products and product candidates, and it may take additional measures to reduce expenses in order to conserve its cash in amounts sufficient to sustain operations and meet its obligations.

Because of historical and expected operating losses and net operating cash flow deficits, there is substantial doubt about the Company’s ability to continue as a going concern for one year from the issuance of the condensed financial statements, which is not alleviated by management’s plans. The condensed financial statements have been prepared assuming the Company will continue as a going concern. These condensed financial statements do not include any adjustments that might be necessary from the outcome of this uncertainty.

Document And Entity Information - shares	9 Months Ended
Document And Entity Information - shares	Sep. 30, 2023	Nov. 17, 2023
Document Information Line Items
Entity Registrant Name	Blue Water Biotech, Inc.
Trading Symbol	BWV
Document Type	10-Q
Current Fiscal Year End Date	--12-31
Entity Common Stock, Shares Outstanding		18,655,412
Amendment Flag	false
Entity Central Index Key	0001782107
Entity Current Reporting Status	Yes
Entity Filer Category	Non-accelerated Filer
Document Period End Date	Sep. 30, 2023
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q3
Entity Small Business	true
Entity Emerging Growth Company	true
Entity Shell Company	false
Entity Ex Transition Period	false
Document Quarterly Report	true
Document Transition Report	false
Entity File Number	001-41294
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	83-2262816
Entity Address, Address Line One	201 E. Fifth Street
Entity Address, Address Line Two	Suite 1900
Entity Address, City or Town	Cincinnati
Entity Address, State or Province	OH
Entity Address, Postal Zip Code	45202
City Area Code	(513)
Local Phone Number	620-4101
Title of 12(b) Security	Common stock, $0.00001 par value
Security Exchange Name	NASDAQ
Entity Interactive Data Current	Yes

Stockholders’ Equity (Details) - Schedule of Stock Options - Stock Options [Member]	9 Months Ended
	Sep. 30, 2023 USD ($) $ / shares shares
Stockholders’ Equity [Line Items]
Number of Shares, beginning \| shares	1,392,654
Weighted Average Exercise Price, beginning \| $ / shares	$ 3.3
Total Intrinsic Value, beginning \| $	$ 670,161
Weighted Average Remaining Contractual Life, beginning	8 years 2 months 12 days
Number of Shares, Granted \| shares	102,386
Weighted Average Exercise Price, Granted \| $ / shares	$ 1.19
Total Intrinsic Value, Granted \| $
Weighted Average Remaining Contractual Life, Granted
Number of Shares, Forfeited / cancelled \| shares	(70,265)
Weighted Average Exercise Price, Forfeited / cancelled \| $ / shares	$ 3.35
Total Intrinsic Value, Forfeited / cancelled \| $
Weighted Average Remaining Contractual Life, Forfeited / cancelled
Number of Shares, Exercised \| shares	(45,920)
Weighted Average Exercise Price, Exercised \| $ / shares	$ 0.01
Total Intrinsic Value, Exercised \| $	$ 45,920
Weighted Average Remaining Contractual Life, Exercised
Number of Shares, ending \| shares	1,378,855
Weighted Average Exercise Price, ending \| $ / shares	$ 3.25
Total Intrinsic Value, ending \| $	$ 274,299
Weighted Average Remaining Contractual Life, ending	7 years 9 months 18 days
Number of Shares, Options vested and exercisable \| shares	1,094,563
Weighted Average Exercise Price, Options vested and exercisable \| $ / shares	$ 2.95
Total Intrinsic Value, Options vested and exercisable \| $	$ 269,994
Weighted Average Remaining Contractual Life, Options vested and exercisable	7 years 6 months

Stockholders’ Equity (Details) - Schedule of Outstanding Warrants - Warrant [Member]	9 Months Ended
	Sep. 30, 2023 $ / shares shares
Stockholders’ Equity [Line Items]
Number of Shares, beginning \| shares	5,910,914
Weighted Average Exercise Price, beginning \| $ / shares	$ 2.37
Weighted Average Remaining Contractual Life, beginning	4 years 8 months 12 days
Number of Shares, Granted \| shares	5,121,601
Weighted Average Exercise Price, Granted \| $ / shares	$ 1.1
Number of Shares, Exercised \| shares	(3,132,854)
Weighted Average Exercise Price, Exercised \| $ / shares	$ 0.865
Number of Shares, Cancelled \| shares
Weighted Average Exercise Price, Cancelled \| $ / shares
Number of Shares, ending \| shares	7,899,661
Weighted Average Exercise Price, ending \| $ / shares	$ 1.68
Weighted Average Remaining Contractual Life, ending	4 years 7 months 6 days
Number of Shares, Warrants vested and exercisable \| shares	7,899,661
Weighted Average Exercise Price, Warrants vested and exercisable \| $ / shares	$ 1.68
Weighted Average Remaining Contractual Life, Warrants vested and exercisable	4 years 7 months 6 days

Balance Sheet Details

9 Months Ended

Sep. 30, 2023

Balance Sheet Details [Abstract]

Balance Sheet Details

Note 4 — Balance Sheet Details

Inventories

Inventories relate to ENTADFI® product and consisted of the following as of September 30, 2023, and December 31, 2022:

	September 30, 2023		December 31, 2022
Raw materials	$	329,780	$	-
Work-in-process		1,089,492		-
Total	$	1,419,272	$	-

Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following as of September 30, 2023, and December 31, 2022:

	September 30, 2023		December 31, 2022
Prepaid insurance	$	277,058	$	148,789
Prepaid research and development		89,195		231,981
Prepaid other		101,485		88,462
Total	$	467,738	$	469,232

Accrued Expenses

Accrued expenses consisted of the following as of September 30, 2023, and December 31, 2022:

	September 30, 2023		December 31, 2022
Accrued research and development	$	548,287	$	847,747
Accrued compensation		386,087		1,132,859
Accrued deferred offering costs		125,000		125,000
Accrued professional fees		216,000		—
Accrued implementation fees		106,287		—
Other accrued expenses		156,883		125,922
Accrued franchise taxes		—		177,600
Total	$	1,538,544	$	2,409,128

Notes Payable

9 Months Ended

Sep. 30, 2023

Notes Payable [Abstract]

Notes Payable

Note 7 — Notes Payable

In connection with the ENTADFI® APA (see Note 5), the Company executed three non-interest bearing notes payable (the “Notes”) in the principal amounts of $4.0 million, $5.0 million and $5.0 million with maturity dates of September 30, 2023, April 19, 2024, and September 30, 2024, respectively. No principal payments are due until maturity; however, the Company may voluntarily prepay the Notes with no penalty. Additionally, in an Event of Default, as defined in the Notes, the unpaid principal amount of the Notes will accrue interest at a rate of 10.0% per annum.

On September 29, 2023, the Company and the note holder entered into an amendment to the ENTADFI® APA, which provided that the $4.0 million note payable originally due on September 30, 2023, was deemed paid and fully satisfied upon (1) the payment to the Seller of $1.0 million in cash on September 29, 2023, and (2) the issuance to the Seller by October 3, 2023 of 3,000 shares of Series A Preferred Stock of the Company (see Notes 5 and 14). In connection with the ENTADFI® APA Amendment, the Company recorded an extinguishment loss on the note payable of approximately $490,000, which represents the difference between the fair value of the Series A Preferred Stock that will be issued to settle the debt and the carrying value of the note payable as of September 29, 2023. The balance of the note payable included in the accompanying condensed balance sheet at September 30, 2023, has been adjusted to the fair value of the Series A Preferred Stock that was issued and relieved the obligation on October 3, 2023. The extinguishment loss is recognized in other income (expense) in the accompanying condensed statements of operations for the three and nine months ended September 30, 2023.

To determine the fair value of the Series A Preferred Stock, the Company first derived the business enterprise value (“BEV”) using a discounted cash flow method. The BEV was adjusted to an equity value assuming $3.0 million of debt converted to Series A Preferred Stock, which was then allocated across the Company’s securities. The concluded value for the Series A Preferred Stock utilized the Black-Scholes option pricing model, which was classified as level 3 in the valuation hierarchy due to the presence of significant unobservable inputs. The following key assumptions were used in the model: volatility rate of 100%, risk free interest rate of 4.6%, 5.0 year expected term, and the Company’s aggregate equity value. The volatility was based on the historical and implied volatility of a peer group and the risk-free interest rate was based on the implied yield available on U.S. Treasury securities with a term commensurate with the estimated expected term.

The Company imputed interest on the Notes using an average discount rate of 8.2% and recorded a debt discount of approximately $1.1 million at the issuance date. The debt discount is reflected as a reduction in the carrying amount of the Notes and amortized to interest expense through the respective maturity dates, using the effective interest method. The Company recorded approximately $0.3 million and $0.5 million of associated interest expense during the three and nine months ended September 30, 2023, respectively. The unamortized debt discount as of September 30, 2023 was approximately $0.6 million.

Future minimum principal payments on the Notes as of September 30, 2023 includes $3.0 million in principal that was settled through issuance of Series A Preferred Stock in October 2023 and $10 million in principal payments that are due in 2024.

Organization and Basis of Presentation

9 Months Ended

Sep. 30, 2023

Organization and Basis of Presentation [Abstract]

Organization and Basis of Presentation

Note 1 — Organization and Basis of Presentation

Organization and Nature of Operations

Blue Water Biotech, Inc. (formerly known as Blue Water Vaccines Inc.) (the “Company”) was formed on October 26, 2018. Historically, the Company’s focus was on the research and development of transformational vaccines to prevent infectious diseases worldwide. In April 2023, the Company acquired ENTADFI®, with plans to commercialize it. ENTADFI® is a Food and Drug Administration (“FDA”)-approved, once daily pill that combines finasteride and tadalafil for the treatment of benign prostatic hyperplasia. This combination allows men to receive treatment for their symptoms of benign prostatic hyperplasia without the negative sexual side effects typically seen in patients on finasteride alone. During the third quarter of 2023, the Company deprioritized its efforts on vaccine development activities to pursue and focus on commercialization activities for ENTADFI®. On October 30, 2023, the Company announced a new business strategy of focusing its efforts on building a foundation of therapeutic, diagnostic, and service products in the field of oncology that will bolster and enrich the practice of medicine for clinicians. ENTADFI® will become the inaugural therapeutic drug in the Company’s expanding portfolio of oncology therapeutics once launched.

On April 21, 2023, the Company filed an amendment to its Articles of Incorporation with the Secretary of State of Delaware to change its corporate name from “Blue Water Vaccines Inc.” to “Blue Water Biotech, Inc.”. The name change was effective as of April 21, 2023. In connection with the name change, the Company amended the Company’s bylaws to reflect the corporate name Blue Water Biotech, Inc., also effective on April 21, 2023. No other changes were made to the bylaws.

On May 31, 2023, the board of directors of the Company (the “Board”) amended the Company’s bylaws to reduce the quorum requirement at meetings of the Company’s stockholders from a majority of the voting power of the outstanding shares of stock of the Company entitled to vote, to one-third of the voting power of the outstanding shares of stock of the Company entitled to vote, effective immediately. No other changes were made to the bylaws.

Initial Public Offering

On February 23, 2022, the Company completed its initial public offering (“IPO”) in which the Company issued and sold 2,222,222 shares of its common stock, par value $0.00001 per share (“common stock”), at a price to the public of $9.00 per share. Proceeds from the IPO, net of underwriting discounts, commissions, and offering costs of $2.9 million, were $17.1 million. In connection with the completion of the IPO, all outstanding shares of the Company’s convertible preferred stock were converted into 5,626,365 shares of common stock.

Basis of Presentation

The Company’s unaudited condensed financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”).

Unaudited Interim Financial Statements

The accompanying condensed balance sheet as of September 30, 2023, and the condensed statements of operations and the condensed statements of changes in stockholders’ equity for the three and nine months ended September 30, 2023 and 2022, and the condensed statements of cash flows for the nine months ended September 30, 2023 and 2022 are unaudited. These unaudited interim financial statements have been prepared on the same basis as the audited financial statements, and in management’s opinion, include all adjustments, consisting of only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of September 30, 2023 and its results of operations for the three and nine months ended September 30, 2023 and 2022, and its cash flows for the nine months ended September 30, 2023 and 2022. The financial data and the other financial information disclosed in the notes to these condensed financial statements related to the three and nine-month periods are also unaudited. Operating results for the three and nine months ended September 30, 2023, are not necessarily indicative of the results that may be expected for the year ending December 31, 2023, any other interim periods, or any future year or period. The unaudited condensed financial statements included in this Report should be read in conjunction with the audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, which includes a broader discussion of the Company’s business and the risks inherent therein.

Subsequent Events

9 Months Ended

Sep. 30, 2023

Subsequent Events [Abstract]

Subsequent Events

Note 14 — Subsequent Events

Veru APA Amendment

On October 3, 2023, in accordance with the terms of the Veru APA Amendment, the Company issued 3,000 shares of Series A Preferred Stock to Veru as settlement for the $3,000,000 note payable that had an original maturity date of September 30, 2023 (see Note 5).

WraSer APA Amendment

On October 4, 2023, the parties agreed to amend the WraSer APA, which is subject to court approval. Shortly after its bankruptcy filing, WraSer filed a motion seeking approval of the WraSer APA as amended. The amendment, among other things, eliminates the $500,000 post-closing payment due June 13, 2024 and staggers the $4.5 million cash payment that the Company would otherwise have to pay at closing to: (i) $2.2 million to be paid at closing, (ii) $2.3 million, to be paid in monthly installments of $150,000 commencing January 2024 and (iii) 789 shares of Series A Preferred Stock to be paid at closing. The amendment also reduced the number of products we were acquiring by excluding pain medications and including only (i) Ciprofloxacin 0.3% and Fluocinolone 0.025% Otic Solution, under the trademark OTOVEL and its Authorized Generic Version approved under US FDA NDA No. 208251, (ii) Ciprofloxacin 0.2% Otic solution, under the trademark CETRAXAL, and (iii) Vorapaxar Sulfate tablets under the trademark Zontivity approved under US FDA NDA N204886.

On October 6, 2023, the Company was alerted to certain issues in WraSer’s operations relating to WraSer’s inability to manufacture the active pharmaceutical ingredient for one of the key WraSer Assets, which development, the Company believes, constitutes a Material Adverse Effect (as such term is defined in the WraSer APA) that will prevent the Company from closing the transaction. On October 20, 2023, the Company filed a motion for relief from the automatic stay in the Bankruptcy Court so that we can exercise our termination rights under the WraSer APA, as amended. WraSer has advised the Company that it does not believe that a Material Adverse Event occurred. If the Bankruptcy Court does not grant the Company’s motion and requires it to complete the transaction, the Company will not be able to execute its commercialization strategy for the WraSer Assets because there is no manufacturer for the active pharmaceutical ingredient for Zontivity, the key driver for the WraSer acquisition. Due to the WraSer bankruptcy filing and the Company’s status as an unsecured creditor of WraSer, it is unlikely that the Company will recover the $3.5 million initial payment made or any costs and resources in connection with services provided by the Company under the WraSer MSA. If the Company does not complete the purchase of the WraSer Assets and the WraSer APA is terminated, the Company will not be able to recover any such costs. Any claims the Company makes for such payment will be general unsecured claims (see Note 5).

Chief Financial Officer Separation Agreement

Effective as of October 4, 2023, Jon Garfield resigned as Chief Financial Officer of the Company. The Company and Mr. Garfield entered into a separation agreement, which provides for a two-month severance payment.

Equity Incentive Plan Activity

On October 4, 2023, the Company’s Board granted stock options to the Company’s newly hired Chief Executive Officer and Chief Financial Officer. The options granted to the Chief Executive Officer and Chief Financial Officer totaled 532,326 and 177,442, respectively, have an exercise price of $0.4305 per share, and vest quarterly over a three-year period.

On October 4, 2023, upon his resignation, the Company’s former Chief Financial Officer forfeited 75,000 shares of unvested restricted stock, and 50,000 stock options.

Services Agreement

On October 12, 2023, the Company terminated a Master Services Agreement and statements of work with a vendor, resulting in early termination fees of approximately $2.3 million. The Company will record these fees during the quarter ending December 31, 2023 (see Note 6).

License Terminations

On November 15, 2023, the Company informed Oxford University Innovation and St. Jude of its termination of the respective license agreements (see Note 6). The amounts due upon termination of these license agreements were not significant.

Notes Payable (Details) - USD ($)			1 Months Ended		3 Months Ended		6 Months Ended	9 Months Ended
Notes Payable (Details) - USD ($)	Sep. 30, 2024	Apr. 19, 2024	Sep. 30, 2023	Sep. 29, 2023	Sep. 30, 2023	Sep. 30, 2022	Jun. 30, 2023	Sep. 30, 2023	Sep. 30, 2022
Debt Instrument [Line Items]
Principal amounts			$ 4,000,000
Interest rate percentage			10.00%		10.00%			10.00%
Note payable			$ 4,000,000		$ 4,000,000			$ 4,000,000
Issuance shares (in Shares)				3,000
Loss on extinguishment of note payable					$ (490,000)			$ (490,000)
Volatility rate								100.00%
Risk free interest rate								3.50%
Expected term								5 years
Average discount rate, percentage			8.20%		8.20%			8.20%
Interest expense							$ 300,000
Unamortized debt discount			$ 600,000		$ 600,000			$ 600,000
Series A Preferred Stock [Member]
Debt Instrument [Line Items]
Conversion of debt								$ 3,000,000
Risk free interest rate								4.60%
ENTADFI [Member]
Debt Instrument [Line Items]
Payment				$ 1,000,000
Debt discount			1,100,000		1,100,000			$ 1,100,000
Principal payment			$ 3,000,000		$ 3,000,000			$ 3,000,000
Forecast [Member]
Debt Instrument [Line Items]
Principal amounts	$ 5,000,000	$ 5,000,000
Forecast [Member] \| ENTADFI [Member]
Debt Instrument [Line Items]
Principal payment	$ 10,000,000

Condensed Statements of Operations (Unaudited) (Parentheticals) - $ / shares	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Income Statement [Abstract]
Net loss per share attributable to common stockholders, diluted	$ (0.31)	$ (0.27)	$ (0.92)	$ (0.94)
Weighted average number of common shares outstanding, diluted	17,521,562	14,338,379	16,452,136	10,949,265

- Definition

The amount of net income (loss) for the period available to each share of common stock or common unit outstanding during the reporting period and to each share or unit that would have been outstanding assuming the issuance of common shares or units for all dilutive potential common shares or units outstanding during the reporting period.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 3
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147483443/250-10-50-3

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 260
-SubTopic 10
-Name Accounting Standards Codification
-Section 55
-Paragraph 15
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482635/260-10-55-15

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 40
-Name Accounting Standards Codification
-Section 65
-Paragraph 1
-Subparagraph (e)(4)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480175/815-40-65-1

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 40
-Name Accounting Standards Codification
-Section 65
-Paragraph 1
-Subparagraph (f)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480175/815-40-65-1

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 11
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147483443/250-10-50-11

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 11
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147483443/250-10-50-11

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 7
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147483443/250-10-50-7

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 260
-SubTopic 10
-Name Accounting Standards Codification
-Section 45
-Paragraph 2
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482689/260-10-45-2

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 260
-SubTopic 10
-Name Accounting Standards Codification
-Section 45
-Paragraph 60B
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482689/260-10-45-60B

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 4
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147483443/250-10-50-4

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 260
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482662/260-10-50-1

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 220
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 2
-Subparagraph (SX 210.5-03(25))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147483621/220-10-S99-2

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 942
-SubTopic 220
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-04(27))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147483589/942-220-S99-1

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 944
-SubTopic 220
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.7-04(23))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147483586/944-220-S99-1

Reference 15: http://www.xbrl.org/2003/role/exampleRef
-Topic 260
-SubTopic 10
-Name Accounting Standards Codification
-Section 55
-Paragraph 52
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482635/260-10-55-52

Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Topic 260
-SubTopic 10
-Name Accounting Standards Codification
-Section 45
-Paragraph 7
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482689/260-10-45-7

+ Details

Balance Sheet Details (Details) - Schedule of Inventories - USD ($)	Sep. 30, 2023	Dec. 31, 2022
Inventory, Net [Abstract]
Raw materials	$ 329,780
Work-in-process	1,089,492
Total	$ 1,419,272

Stockholders’ Equity (Details) - USD ($)						1 Months Ended							3 Months Ended			9 Months Ended		12 Months Ended
Stockholders’ Equity (Details) - USD ($)	May 31, 2023	May 09, 2023	Mar. 29, 2023	Nov. 10, 2022	Aug. 11, 2022	Aug. 16, 2023	Jul. 31, 2023	Apr. 30, 2023	Apr. 30, 2022	Apr. 19, 2022	Feb. 23, 2022	Feb. 17, 2022	Sep. 30, 2023	Jun. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022	Nov. 18, 2022	Aug. 31, 2022	May 24, 2022
Stockholders’ Equity [Line Items]
Common stock, shares authorized											250,000,000		250,000,000			250,000,000		250,000,000
Preferred stock, shares authorized											10,000,000		10,000,000			10,000,000		10,000,000
Preferred stock, par value (in Dollars per share)											$ 0.00001		$ 0.00001			$ 0.00001		$ 0.00001
Shares designated as convertible preferred stock													10,000			10,000		0
Common stock price per share (in Dollars per share)												$ 9	$ 0.5254			$ 0.5254
Preferred Stock, Liquidation Preference, Value (in Dollars)													$ 1,000			$ 1,000
Common stock, shares issued													18,336,597			18,336,597		15,724,957
Common stock, shares outstanding													17,819,198			17,819,198		15,265,228
Common stock, voting rights																one
Aggregate shares												2,222,222				5,709,935
Underwriting discount percentage											8.00%
Net proceeds (in Dollars)											$ 17,100,000
Shares of common stock				5,000,000
Maximum price per (in Dollars per share)				$ 1															$ 2
Repurchased shares																57,670
Aggregate amount (in Dollars)																$ 59,000
Average price per share (in Dollars per share)																$ 1.02
Remaining shares																4,500,000
Shares of common stock											1,600,000
Aggregate shares of common stock							4,972,428		1,180,812
Agent fees and other offering expenses (in Dollars)										$ 6,900,000
Warrants exercise price (in Dollars per share)													$ 1.09			$ 1.09					$ 0.001
Exercise price (in Dollars per share)							$ 1.09			$ 6.65
Agent fee percentage																7.50%
Management fee percentage																1.00%
Out of pocket expenses (in Dollars)																$ 85,000
Purchase of common stock																220,997
Percentage of purchase warrants																6.00%
Exercise price, per share (in Dollars per share)													$ 8.46875			$ 8.46875				$ 2.546
Fair value of contingent warrant liability													646,640			646,640		1,686,640
Preferred investment options													2,486,214			2,486,214
Percentage of common stock shares																6.00%
Exercise price (in Dollars)														$ 459	$ 1,655
Contingent warrants issuable																298,346
Warrants issuable shares																70,849
Contingent warrants exchanged																70,849
Description of contingent warrant liability																The remaining 227,497 August Contingent Warrants were measured as a liability upon the close of the August 2022 Private Placement.
Issuance of warrants to Wainwright as settlement													149,173			149,173
Restricted shares of common stock			3,900,000
Original exercise price (in Dollars)							$ 2.546
Unissued shares of warrant													911,214			911,214
Fees and expenses of legal counsel (in Dollars)																$ 50,000
Non-accountable expenses (in Dollars)																35,000
Equity issuance cost (in Dollars)																2,600,000
Reduction of additional paid in capital (in Dollars)													$ 26,000			$ 26,000
Shares of common stock per value (in Dollars per share)													$ 0.51			$ 0.51
Contingent warrants (in Dollars)																$ 10,000
Common stock reserved for issuance	3,150,000																			2,600,000
Issuance options																1,146,878
Weighted average grant date fair value (in Dollars per share)																$ 1.08
Aggregate fair value of stock options vested (in Dollars)													$ 137,000			$ 616,000
Restricted stock granted		487,500
Description of restricted stock																All of the restricted shares granted vest as follows: 50% in January 2024, 25% in August 2024, and 25% in August 2025.
Outstanding stock options (in Dollars)																$ 394,000
Unvested restricted stock (in Dollars)																	$ 143,000
Common Stock [Member]
Stockholders’ Equity [Line Items]
Common stock, shares issued														18,336,597				15,724,957
Common stock, shares outstanding														17,819,198				15,265,228
Preferred investment options							2,486,214
Exercise price (in Dollars)															$ 2
Issuance of common stock from exercise of preferred investment options													1,575,000
Pre-Funded Warrants [Member]
Stockholders’ Equity [Line Items]
Aggregate shares of common stock					2,333,280					590,406
Purchase price per share (in Dollars per share)										$ 6.774
Warrants exercise price (in Dollars per share)														$ 0.001
2019 Equity Incentive Plan [Member]
Stockholders’ Equity [Line Items]
Shares of common stock													1,400,000			1,400,000
Minimum [Member]
Stockholders’ Equity [Line Items]
Issuance of common stock from exercise of preferred investment options																1,575,000
Weighted-average period term																	1 year 5 months 26 days
Maximum [Member]
Stockholders’ Equity [Line Items]
Issuance of common stock from exercise of preferred investment options																2,486,214
Weighted-average period term																1 year 8 months 1 day
Preferred Investment Options [Member]
Stockholders’ Equity [Line Items]
Aggregate shares of common stock					4,972,428					1,180,812
Purchase price per share (in Dollars per share)					$ 2.715					$ 6.775
Preferred investment options exercise price (in Dollars per share)								$ 8.46875
Exercise price (in Dollars)																$ 3.3938
Market Offering Agreement [Member]
Stockholders’ Equity [Line Items]
Commission fixed rate, percentage			3.00%
Contingent Warrant Liability [Member]
Stockholders’ Equity [Line Items]
Percentage of exercise of PIO																1.00%
Contingent Warrant Liability [Member]
Stockholders’ Equity [Line Items]
Issuance of warrants to Wainwright as settlement													149,173			149,173
Net proceeds of warrant (in Dollars)							$ 2,300,000
Percentage of preferred investment option																7.50%
Fair value of warrant liability (in Dollars)													$ 129,000			$ 129,000
Warrant [Member]
Stockholders’ Equity [Line Items]
Warrants exercise price (in Dollars per share)													$ 1.3625			$ 1.3625
Issuance of warrants to Wainwright as settlement													447,519			447,519		298,346
Inducement Contingent Warrants [Member]
Stockholders’ Equity [Line Items]
Exercise price (in Dollars per share)																$ 1.3625
Warrants issuable shares										298,346
Warrant, Down Round Feature, Decrease in Net Income to Common Shareholder, Amount (in Dollars)																$ 2,300,000
August Contingent Warrants [Member]
Stockholders’ Equity [Line Items]
Fair value of contingent warrant liability													149,173			149,173
Wainwright Inducement Warrants [Member]
Stockholders’ Equity [Line Items]
Other income (expense) (in Dollars)																$ 122,000
April Private Placement Warrants [Member]
Stockholders’ Equity [Line Items]
Fair value of contingent warrant liability													70,849			70,849
Private Placement Warrants [Member]
Stockholders’ Equity [Line Items]
Shares of common stock										590,406
Warrants exercise price (in Dollars per share)													$ 7,899,661			$ 7,899,661
Issuance of contingent warrants													70,849			70,849
Preferred stock, shares issued					1,350,000
Net cash proceeds (in Dollars)					$ 8,700,000
Exercise price (in Dollars)																$ 3.3938
Exchanged preferred investment options																1,289,148
Exercisable shares of common stock													5,121,601			5,121,601
Private Placement Warrants [Member] \| Preferred Investment Options [Member]
Stockholders’ Equity [Line Items]
Aggregate shares of common stock																1,180,812
Purchase price per share (in Dollars per share)					$ 2.714
Contingent Warrants [Member]
Stockholders’ Equity [Line Items]
Contingent warrants																70,849
August Private Placement Warrant [Member]
Stockholders’ Equity [Line Items]
Fair value of contingent warrant liability													2,707,211			2,707,211
Series A Preferred Stock [Member]
Stockholders’ Equity [Line Items]
Shares designated as convertible preferred stock													10,000			10,000
Convertible Preferred Stock [Member]
Stockholders’ Equity [Line Items]
Conversion price (in Dollars)																$ 1,000
Common Stock [Member]
Stockholders’ Equity [Line Items]
Percentage of preferred investment option																6.00%
Options [Member]
Stockholders’ Equity [Line Items]
Preferred investment options													2,486,214			2,486,214
Chief Executive Officer [Member]
Stockholders’ Equity [Line Items]
Restricted stock granted		150,000
Forfeited shares of unvested restricted stock						150,000
Chief Financial Officer [Member]
Stockholders’ Equity [Line Items]
Restricted stock granted		75,000
Chief Business Officer [Member]
Stockholders’ Equity [Line Items]
Restricted stock granted		150,000
Non-executive Board [Member]
Stockholders’ Equity [Line Items]
Restricted stock granted	25,440
H.C. Wainwright & Co., LLC [Member]
Stockholders’ Equity [Line Items]
Agent fee percentage								7.50%
Management fee percentage								1.00%
Out of pocket expenses (in Dollars)								$ 85,000
Purchase of common stock								70,849

Net Loss Per Share (Details) - Schedule of diluted shares outstanding - shares	3 Months Ended	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2023
Dilutive Securities, Effect on Basic Earnings Per Share [Abstract]
Unvested shares of restricted stock	344,080
Options to purchase shares of common stock	1,378,855	1,383,801
Warrants	7,899,661	5,375,385
Total	9,622,596	6,759,186

Condensed Statements of Cash Flows (Unaudited) - USD ($)	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Cash flows from operating activities
Net loss	$ (15,058,822)	$ (10,201,905)
Adjustments to reconcile net loss to net cash used in operating activities:
Impairment of deposit on asset purchase agreement	3,500,000
Stock-based compensation	563,761	1,796,268
Amortization of debt discount	483,093
Loss on extinguishment of note payable	490,000
Loss on impairment of other long-lived assets	267,019
Loss on related party receivable	265,648
Depreciation expense	4,886	4,906
Change in fair value of contingent warrant liability	99,787	(33,375)
Changes in assets and liabilities:
Inventories	(299,272)
Prepaid expenses and other current assets	(9,526)	(469,278)
Prepaid expenses, long-term	(16,882)	(66,357)
Deposit		(27,588)
Accounts payable	1,418,048	361,103
Accrued expenses	(976,871)	2,760,734
Net cash used in operating activities	(9,269,131)	(5,875,492)
Cash flows from investing activities
Acquisition of assets, including transaction costs of $79,771	(6,079,771)
Deposit made in connection with asset purchase agreement	(3,500,000)
Purchases of other long-lived assets	(51,744)
Net advances to related parties	(229,798)	(22,149)
Purchases of property and equipment	(3,300)	(9,339)
Net cash used in investing activities	(9,864,613)	(31,488)
Cash flows from financing activities
Purchase of treasury shares	(58,981)
Payment of deferred offering costs	(205,093)	(51,304)
Principal payment of note payable	(1,000,000)
Proceeds from exercise of preferred investment options, net	2,298,675
Proceeds from exercise of stock options	459	1,655
Proceeds from issuance of common stock in initial public offering, net of underwriting discount		18,400,000
Payments of initial public offering costs		(926,972)
Proceeds from issuance of common stock and warrants in private placements, net of placement agent discount		16,468,123
Payment of private placement issuance costs		(777,225)
Proceeds from exercise of pre-funded warrants		945
Net cash provided by financing activities	1,035,060	33,115,222
Net increase (decrease) in cash	(18,098,684)	27,208,242
Cash, beginning of period	25,752,659	1,928,474
Cash, end of period	7,653,975	29,136,716
Noncash investing and financing activities:
Inventory and intangible assets acquired through issuance of notes payable	12,947,000
Incremental fair value of exchanged preferred investment options	2,613,011	860,204
Deferred offering costs included in accounts payable and accrued expenses	150,000	125,000
Recognition of contingent warrant liability	25,837	75,431
Warrants issued for settlement of contingent warrants	129,184
Deferred offering costs previously included in prepaid expenses	(11,020)
Exercise of pre-funded warrants	7	6
Issuance of restricted stock	5
Restricted stock forfeitures	(2)
Payment of accrued bonus through related party receivable		140,000
Private placement offering costs included in accounts payable		67,823
Conversion of convertible preferred stock to common stock upon initial public offering		$ 45

Commitments and Contingencies

9 Months Ended

Sep. 30, 2023

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies

Note 9 — Commitments and Contingencies

Office Leases

The Company entered into a short-term lease in Palm Beach, Florida with an unrelated party, with a commencement date of May 1, 2022, for approximately $14,000 per month. The lease, which was personally guaranteed by the Company’s former CEO, ended on April 30, 2023. During the nine months ended September 30, 2023, the Company incurred rent expense on this lease of approximately $51,000, and variable lease expense of approximately $4,000. The Company incurred rent expense for the three and nine months ended September 30, 2022 of approximately $53,000 and $89,000, respectively.

Litigation

From time to time, the Company may be subject to various legal proceedings and claims that arise in the ordinary course of its business activities. As of September 30, 2023, the Company is not a party to any material legal proceedings and is not aware of any pending or threatened claims.

Registration Rights Agreements

In connection with the April 2022 Private Placement (see Note 8), the Company entered into a Registration Rights Agreement with the purchasers, dated as of April 13, 2022 (the “April Registration Rights Agreement”). The April Registration Rights Agreement provides that the Company shall file a registration statement covering the resale of all of the registrable securities (as defined in the April Registration Rights Agreement) with the SEC. The registration statement on Form S-1 required under the April Registration Rights Agreement was filed with the SEC on May 3, 2022, and became effective on May 20, 2022. A post-effective amendment to the Form S-1 on Form S-3 relating to such registration statement was filed with the SEC on April 28, 2023.

In connection with the August 2022 Private Placement (see Note 8), the Company entered into a Registration Rights Agreement with the purchasers, dated as of August 9, 2022 (the “August Registration Rights Agreement”). The August Registration Rights Agreement provides that the Company shall file a registration statement covering the resale of all of the registrable securities (as defined in the August Registration Rights Agreement) with the SEC. The registration statement on Form S-1 required under the August Registration Rights Agreement was filed with the SEC on August 29, 2022, and became effective on September 19, 2022. A post-effective amendment to the Form S-1 on Form S-3 relating to such registration statement was filed with the SEC on April 28, 2023.

Upon the occurrence of any Event (as defined in the April Registration Rights Agreement and the August Registration Rights Agreement), which, among others, prohibits the purchasers from reselling the securities for more than ten consecutive calendar days or more than an aggregate of fifteen calendar days during any 12-month period, and should the registration statement cease to remain continuously effective, the Company would be obligated to pay to each purchaser, on each monthly anniversary of each such Event, an amount in cash, as partial liquidated damages and not as a penalty, equal to the product of 2.0% multiplied by the aggregate subscription amount paid by such purchaser in the Private Placement. As of September 30, 2023, the Company determined that the likelihood of the Company incurring liquidated damages pursuant to the April Registration Rights Agreement and the August Registration Rights Agreement is remote, and as such, no accrual of these payments is required as of September 30, 2023.

Milestone and Royalty Obligations

The Company has entered into various license agreements with third parties that obligate the Company to pay certain development, regulatory, and commercial milestones, which aggregate to $115.1 million, as well as royalties based on product sales (see Note 6). As of September 30, 2023, the Company evaluated the likelihood of the Company achieving the specified milestones and generating product sales and determined that the likelihood is not yet probable and as such no accrual of these payments is required as of September 30, 2023. Subsequent to the balance sheet date, the Company terminated two of these license agreements (see Note 14).

Indemnification

In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnifications. The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the future but have not yet been made. To date, the Company has not paid any claims related to its indemnification obligations. However, during the third quarter of 2023, the Company received a claim from its former CEO and a former accounting employee requesting advancement of certain expenses, which may result in related expenses in the future. As of September 30, 2023, the Company recorded a related accrual of approximately $91,000, which is included in accrued expenses in the accompanying condensed balance sheet. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is not estimable at this time.

Condensed Statements of Operations (Unaudited) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Income Statement [Abstract]
Selling, general and administrative	$ 4,268,845	$ 2,694,254	$ 8,337,615	$ 7,311,243
Research and development	219,238	1,175,480	2,148,327	2,924,037
Impairment of deposit on asset purchase agreement			3,500,000
Total operating expenses	4,488,083	3,869,734	13,985,942	10,235,280
Loss from operations	(4,488,083)	(3,869,734)	(13,985,942)	(10,235,280)
Loss on extinguishment of note payable	(490,000)		(490,000)
Interest expense	(269,097)		(483,093)
Change in fair value of contingent warrant liability	(99,728)	3,072	(99,787)	33,375
Total other income (expense)	(858,825)	3,072	(1,072,880)	33,375
Net loss	(5,346,908)	(3,866,662)	(15,058,822)	(10,201,905)
Cumulative preferred stock dividends				96,359
Net loss applicable to common stockholders	$ (5,346,908)	$ (3,866,662)	$ (15,058,822)	$ (10,298,264)
Net loss per share attributable to common stockholders, basic (in Dollars per share)	$ (0.31)	$ (0.27)	$ (0.92)	$ (0.94)
Weighted average number of common shares outstanding, basic (in Shares)	17,521,562	14,338,379	16,452,136	10,949,265

Acquisitions (Details) - USD ($) $ in Millions		1 Months Ended		3 Months Ended	9 Months Ended
Acquisitions (Details) - USD ($) $ in Millions	Jul. 13, 2023	Apr. 19, 2023	Feb. 17, 2022	Sep. 30, 2023	Sep. 30, 2023
Business Acquisition [Line Items]
Consideration amount		$ 20.0
Business acquisition, description					(i) $6.0 million paid upon the closing of the Transaction on April 19, 2023, (ii) an additional $4.0 million in the form of a non-interest bearing note payable due on September 30, 2023, and (iii) an additional $10.0 million in the form of two $5.0 million non-interest bearing notes payable, each due on April 19, 2024 and September 30, 2024.
Net sales amount		$ 80.0
Royalty sales percentage		6.00%
Sales payments amount		$ 22.5
Aggregate shares (in Shares)			2,222,222		5,709,935
Business transaction years		5 years
Estimated useful life				5 years	5 years
Inventory fair value		$ 0.3
Cash payment amount	$ 4.5
Initial payment amount	3.5
Company payments	3.5
Payment as deposit	3.5
Cash target amount	$ 1.1
Initial payment					$ 3.5
Loss on impairment				$ 3.5	$ 3.5
ENTADFI [Member]
Business Acquisition [Line Items]
Description of company achievement					(i) $10.0 million is payable upon the first time the Company achieves net sales from ENTADFI® of $100.0 million during a calendar year, (ii) $20.0 million is payable upon the first time the Company achieves net sales from ENTADFI® of $200.0 million during a calendar year, and (3) $50.0 million is payable upon the first time the Company achieves net sales from ENTADFI® of $500.0 million during a calendar year.
Estimated using discount percentage		8.20%
Asset Purchase Agreement [Member]
Business Acquisition [Line Items]
Consideration amount		$ 100.0
Pharmaceutical Services, LLC [Member] \| ENTADFI [Member]
Business Acquisition [Line Items]
Business acquisition, description					(i) $5.0 million is payable upon the first time the Company achieves net sales from ENTADFI® of $100.0 million during a calendar year, (ii) $7.5 million is payable upon the first time the Company achieves net sales from ENTADFI® of $200.0 million during a calendar year, and (3) $10.0 million is payable upon the first time the Company achieves net sales from ENTADFI® of $300.0 million during a calendar year.
ENTADFI [Member]
Business Acquisition [Line Items]
Business acquisition, description					$4.0 million note payable originally due on September 30, 2023, was deemed paid and fully satisfied upon (1) the payment to the Seller of $1.0 million in cash on September 29, 2023, and (2) the issuance to the Seller by October 3, 2023 of 3,000 shares of Series A Convertible Preferred Stock (the “Series A Preferred Stock”) of the Company (see Note 8)
WraSer APA [Member]
Business Acquisition [Line Items]
Business acquisition, description					(i) $3.5 million in cash at signing of the WraSer APA; (ii) $4.5 million in cash on the later of (x) 90 days after the signing of the WraSer APA or (y) the date that all closing conditions under the WraSer APA are met or otherwise waived (the “Closing Date”); (iii) 1.0 million shares of the Company’s common stock (the “Closing Shares”) issuable on the Closing Date, and (iv) $500,000 in cash one year from the Closing Date.

Acquisitions

9 Months Ended

Sep. 30, 2023

Business Combinations [Abstract]

Acquisitions

Note 5 — Acquisitions

ENTADFI®

On April 19, 2023, the Company entered into an Asset Purchase Agreement (the “ENTADFI® APA”) with Veru Inc. (“Veru”), the seller of the assets. Pursuant to, and subject to the terms and conditions of, the ENTADFI® APA, the Company purchased substantially all of the assets related to Veru’s ENTADFI® product (“ENTADFI®”) and assumed certain liabilities of Veru of a trivial amount, (the “Transaction”) for a total possible consideration of $100 million.

In accordance with the ENTADFI® APA, the Company agreed to provide Veru with initial consideration totaling $20.0 million, consisting of (i) $6.0 million paid upon the closing of the Transaction on April 19, 2023, (ii) an additional $4.0 million in the form of a non-interest bearing note payable due on September 30, 2023, and (iii) an additional $10.0 million in the form of two $5.0 million non-interest bearing notes payable, each due on April 19, 2024 and September 30, 2024.

Additionally, the terms of the ENTADFI® APA require the Company to pay Veru up to an additional $80.0 million based on the Company’s net sales of ENTADFI® after closing (the “Milestone Payments”). The Milestone Payments are payable as follows: (i) $10.0 million is payable upon the first time the Company achieves net sales from ENTADFI® of $100.0 million during a calendar year, (ii) $20.0 million is payable upon the first time the Company achieves net sales from ENTADFI® of $200.0 million during a calendar year, and (3) $50.0 million is payable upon the first time the Company achieves net sales from ENTADFI® of $500.0 million during a calendar year.

In connection with the Transaction, the Company also assumed royalty and milestone obligations under an asset purchase agreement for tadalafil-finasteride combination entered into by Veru and Camargo Pharmaceutical Services, LLC on December 11, 2017 (the “Camargo Obligations”). The Camargo Obligations assumed by the Company include a 6% royalty on all sales of tadalafil-finasteride and sales milestone payments of up to $22.5 million, payable to Camargo as follows: (i) $5.0 million is payable upon the first time the Company achieves net sales from ENTADFI® of $100.0 million during a calendar year, (ii) $7.5 million is payable upon the first time the Company achieves net sales from ENTADFI® of $200.0 million during a calendar year, and (3) $10.0 million is payable upon the first time the Company achieves net sales from ENTADFI® of $300.0 million during a calendar year.

On September 29, 2023, the Company entered into an amendment to the ENTADFI® APA (the “ENTADFI® APA Amendment”), which provides that the $4.0 million note payable originally due on September 30, 2023, was deemed paid and fully satisfied upon (1) the payment to the Seller of $1.0 million in cash on September 29, 2023, and (2) the issuance to the Seller by October 3, 2023 of 3,000 shares of Series A Convertible Preferred Stock (the “Series A Preferred Stock”) of the Company (see Note 8). Pursuant to the ENTADFI®APA Amendment, the Series A Preferred Stock will convert to common stock of the Company one year from the date of issuance, if the required stockholder approval is obtained. The Series A Preferred Stock, which was issued to the Seller subsequent to September 30, 2023, is initially convertible, in the aggregate, into 5,709,935 shares of the Company’s common stock, subject to adjustment and certain shareholder approval limitations specified in the Certificate of Designations. Pursuant to the ENTADFI® APA Amendment, the Company agreed to use commercially reasonable efforts to obtain such shareholder approval by December 31, 2023. The Company also agreed to include the shares of common stock issuable upon conversion of the Series A Preferred Stock in the next resale registration statement filed with the SEC.

Also, in connection with the Transaction, and pursuant to the ENTADFI® APA, the Company entered into non-competition and non-solicitation agreements (the “Non-Competition Agreements”) with two of Veru’s key stockholders and employees (the “Restricted Parties”). The Non-Competition Agreements generally prohibit the Restricted Parties from either directly or indirectly engaging in the Restricted Business (as such term is defined in the ENTADFI® APA) for a period of five years from the closing of the Transaction.

The acquisition of ENTADFI® has been accounted for as an asset acquisition in accordance with ASC 805-50 because substantially all of the fair value of the assets acquired is concentrated in a single asset, the ENTADFI® product rights. The ENTADFI® products rights consist of trademarks, regulatory approvals, and other records, and are considered a single asset as they are inextricably linked.

The following table summarizes the aggregate consideration transferred for the assets acquired by the Company in connection with the ENTADFI® APA:

	Consideration Transferred
Consideration transferred at closing	$	6,000,000
Fair value of notes payable issued		12,947,000
Transaction costs		79,771
Total consideration transferred	$	19,026,771

The fair value of the non-interest bearing notes payable was estimated using a net present value model using discount rates averaging 8.2%. The resulting fair value is being accreted to the face value of the notes, through the respective maturity dates. Management evaluated the Milestone Payments and determined that at the close of the Transaction, they are not considered probable, and as such, the Company did not recognize any amount related to the Milestone Payments in the consideration transferred.

The following table summarizes the assets acquired with the ENTADFI® APA:

	Assets Recognized
Inventory	$	1,120,000
ENTADFI® Intangible		17,906,771
Total fair value of identifiable assets acquired	$	19,026,771

In accordance with ASC 805-50, the acquired inventory was recorded at fair value. The remaining consideration transferred was allocated to the ENTADFI® intangible asset, which will be amortized over its estimated useful life, starting when ENTADFI® sales begin. The Company originally estimated the useful life to be five years, but during the three months ended September 30, 2023, the useful life was reevaluated and changed to seven years. This change in estimate has no accounting impact as the amortization period has not yet begun. Acquired inventory is comprised of work-in-process and raw materials. The fair value of work-in-process inventory was determined based on an estimated sales price of the finished goods, adjusted for costs to complete the manufacturing process, costs of the selling effort, a reasonable profit allowance for the remaining manufacturing and selling effort, and an estimate of holding costs. The fair value of raw materials was determined to approximate replacement cost. The inventory fair value adjustment was approximately $0.3 million and will be amortized as inventory turns over, which is expected to approximate 1.5 years.

Management evaluated the Camargo Obligations and determined that at the close of the Transaction, the related sales milestone payments are not considered probable, and as such, the Company did not recognize any related liability at the date of the Transaction. In addition, royalties under the Camargo Obligations will be recorded as cost of sales, as the related sales are generated and recognized.

WraSer:

On June 13, 2023 (the “Execution Date”), the Company entered into an asset purchase agreement with WraSer, LLC, and affiliates (the “Seller”) (the “WraSer APA”). Pursuant to, and subject to the terms and conditions of, the WraSer APA, on the Closing Date (as defined below) the Company was to purchase six FDA-approved pharmaceutical assets across several indications, including cardiology, otic infections, and pain management (the “WraSer Assets”).

Under the terms of the WraSer APA, the Company was to purchase the WraSer Assets for (i) $3.5 million in cash at signing of the WraSer APA; (ii) $4.5 million in cash on the later of (x) 90 days after the signing of the WraSer APA or (y) the date that all closing conditions under the WraSer APA are met or otherwise waived (the “Closing Date”); (iii) 1.0 million shares of the Company’s common stock (the “Closing Shares”) issuable on the Closing Date, and (iv) $500,000 in cash one year from the Closing Date. On October 4, 2023, the Company and WraSer agreed to amend the WraSer APA (“WraSer APA Amendment”), to modify the payment terms of the transaction, which amendment is currently pending court approval (see Note 14).

Within 90 days of the Closing Date, the Company will use its best efforts to file with the SEC, (at its sole cost and expense,) a registration statement to register, on Form S-3 registering under the Securities Act of 1933, as amended (the “Securities Act”), the resale of the Closing Shares and will use its best efforts to have the registration statement declared effective as soon as practicable after filing.

In conjunction with the WraSer APA, the Company and the Seller entered into a Management Services Agreement (the “MSA”) on the Execution Date. Pursuant to the terms of the MSA, the Company will act as the manager of the Seller’s business during the period between the Execution Date and Closing Date. During this period, the Company will make advances to WraSer, if needed. If, on the Closing Date, the Seller’s cash balance is in excess of the target amount (“Cash Target”) specified in the MSA, the Company will apply that excess to the $4.5 million cash payment due upon closing. Conversely, if there is a shortfall, the Company will be required to remit the difference to the Seller over time.

The WraSer APA can be terminated prior to closing as follows (i) upon agreement with all parties; (ii) upon breach of contract of either party, uncured within 20 days of notice. If the WraSer APA is terminated upon agreement with all parties or upon uncured breach of contract by the Company, the initial $3.5 million payment is retained by the Sellers. If it is determined that there is an uncured breach of contract by the Seller, and the WraSer APA is terminated, the Company will have an unsecured claim against WraSer for the $3.5 million payment made by the Company upon execution of the WraSer APA. The closing of the transaction is subject to certain customary closing conditions, including submission of the FDA transfer documentation to transfer ownership of the acquired product regulatory approvals to the Company.

Management evaluated the terms of the WraSer APA and MSA, and determined that, at the Execution Date, control under the provisions of ASC 805, Business Combinations, did not transfer to the Company; if the transaction closes, control will transfer then, and the acquisition date will be the closing date. Management further evaluated the requirements pursuant to ASC 810, Consolidations, and determined based on the terms of the MSA, and the Company’s involvement in the Seller’s business, that the Seller is a variable interest entity (“VIE”) to the Company. Management determined that the Company is not the primary beneficiary of the VIE as the WraSer APA and MSA do not provide the Company with the power to direct the activities of the VIE that most significantly impact the VIE’s economic performance. While the Company was involved in the day-to-day business activities of the VIE until WraSer filed for relief under Chapter 11 of the U.S. Bankruptcy Court (see below), the Seller had to approve substantially all business activities and transactions that significantly impact the economic performance of WraSer during the term of the MSA. Additionally, the Company is not required to absorb the losses of WraSer if the WraSer APA does not close. As such, the Company is not required to consolidate WraSer in the Company’s financial statements as of September 30, 2023. The Company recorded the initial $3.5 million payment as a deposit. The Company does not have any liabilities recorded as of September 30, 2023 associated with its variable interest in the Seller, and its exposure to the Seller’s losses is limited to no more than the shortfall, if any, of the Cash Target amount of approximately $1.1 million compared to the Seller’s cash balance on the Closing Date.

On September 26, 2023, WraSer and its affiliates filed for relief under chapter 11 of the U.S. Bankruptcy Code in the United States Bankruptcy Court for the Middle District of Florida (the “Bankruptcy Court”), and on October 6, 2023, the Company was alerted to certain issues in WraSer’s operations that the Company believes constitutes a Material Adverse Effect (as such term is defined in the WraSer APA) that will prevent the Company from closing the transaction. On October 20, 2023, the Company filed a motion for relief from the automatic stay in the Bankruptcy Court so that the Company can exercise the termination rights under the WraSer APA, as amended. WraSer has advised the Company that it does not believe that a Material Adverse Event occurred. If the Bankruptcy Court does not grant the Company’s motion and requires it to complete the transaction, the Company will not be able to execute its commercialization strategy for the WraSer Assets because there is no manufacturer for the active pharmaceutical ingredient for Zontivity, the key driver for the WraSer acquisition. Due to the Company’s status as an unsecured creditor of WraSer, it is unlikely that the Company will recover the $3.5 million initial payment made or any costs and resources in connection with services provided by the Company under the WraSer MSA and therefore the deposit recorded is impaired. Management determined that the conditions resulting in impairment existed at September 30, 2023, and accordingly, the Company recorded a loss on impairment for the $3.5 million deposit during the nine months ended September 30, 2023.

Stockholders’ Equity

9 Months Ended

Sep. 30, 2023

Stockholders’ Equity [Abstract]

Stockholders’ Equity

Note 8 — Stockholders’ Equity

Authorized Capital

On February 23, 2022, in connection with the closing of the IPO, the Company filed with the Secretary of State of the State of Delaware its second amended and restated certificate of incorporation (the “A&R COI”), which became effective immediately. There was no change to the Company’s authorized shares of common stock and preferred stock of 250,000,000 shares and 10,000,000 shares, respectively, or the par value, which is $0.00001 for both common and preferred stock.

Preferred Stock

On September 29, 2023, the Company filed a Certificate of Designations of Rights and Preferences of Series A Convertible Preferred Stock of the Company (the “Certificate of Designations”) with the State of Delaware to designate and authorize the issuance of up to 10,000 shares of Series A Preferred Stock. Pursuant to the Certificate of Designations, each share of Series A Preferred Stock is convertible into that number of shares of the Company’s common stock determined by dividing the Stated Value (as defined in the Certificate of Designations) of $1,000 per share by the Conversion Price (as defined in the Certificate of Designations) of $0.5254 per share, subject to adjustment as provided in the Certificate of Designations, subject to certain shareholder approval limitations. The Series A Preferred Stock is entitled to share ratably in any dividends paid on the Company’s common stock (on an as-if-converted-to-common-stock basis), has no voting rights except as to certain significant matters specified in the Certificate of Designations, and has a liquidation preference equal to the Stated Value of $1,000 per share plus any accrued but unpaid dividends thereon. The Series A Preferred Stock is redeemable in whole or in part at the Company’s option at any time. The Certificate of Designations authorized the issuance of up to 10,000 shares of Series A Preferred Stock. As of September 30, 2023, there were no shares of Series A Convertible Preferred Stock outstanding (see Notes 5 and 14).

Common Stock

As of September 30, 2023, and December 31, 2022, there were 18,336,597 and 15,724,957 shares of common stock issued, respectively, and 17,819,198 and 15,265,228 shares of common stock outstanding, respectively.

Holders of the Company’s common stock are entitled to one vote for each share held of record and are entitled upon liquidation of the Company to share ratably in the net assets of the Company available for distribution after payment of all obligations of the Company and after provision has been made with respect to each class of stock, if any, having preference over the common stock. The shares of common stock are not redeemable and have no preemptive or similar rights.

On February 17, 2022, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Boustead Securities, LLC, acting as representative of the underwriters (“Boustead”), in relation to the Company’s IPO, pursuant to which the Company agreed to sell to the underwriters an aggregate of 2,222,222 shares of the Company’s common stock, at a price of $9.00 per share. The IPO closed on February 23, 2022 and resulted in net proceeds to the Company, after deducting the 8% underwriting discount, and other offering costs, of approximately $17.1 million.

Treasury Stock

On November 10, 2022, the Board approved a stock repurchase program (the “Repurchase Program”) to allow the Company to repurchase up to 5.0 million shares of common stock with a maximum price of $1.00 per share, with discretion to management to make purchases subject to market conditions. On November 18, 2022, the Board approved an increase to the maximum price to $2.00 per share. There is no expiration date for this program.

During the nine months ended September 30, 2023, the Company repurchased 57,670 shares of common stock, for an aggregate of approximately $59,000, at an average price of $1.02 per share. There were no repurchases of common stock during the three months ended September 30, 2023. Shares that are repurchased are classified as treasury stock pending future use and reduce the number of shares outstanding used in calculating earnings per share. As of September 30, 2023, there are approximately 4.5 million shares remaining, that can be repurchased under the Repurchase Program.

Private Investments in Public Equity

April 2022 Private Placement

On April 19, 2022, the Company consummated the closing of a private placement (the “April 2022 Private Placement”), pursuant to the terms and conditions of a securities purchase agreement, dated as of April 13, 2022. At the closing of the April 2022 Private Placement, the Company issued 590,406 shares of common stock, pre-funded warrants to purchase an aggregate of 590,406 shares of common stock and preferred investment options to purchase up to an aggregate of 1,180,812 shares of common stock. The purchase price of each share of common stock together with the associated preferred investment option was $6.775, and the purchase price of each pre-funded warrant together with the associated preferred investment option was $6.774. The aggregate net cash proceeds to the Company from the April 2022 Private Placement were approximately $6.9 million, after deducting placement agent fees and other offering expenses. The pre-funded warrants had an exercise price of $0.001 per share and were exercised in full on May 24, 2022. The preferred investment options, which had an exercise price of $6.65 per share, were exchanged in connection with the August 2022 Private Placement, as discussed below.

H.C. Wainwright & Co., LLC (“Wainwright”) acted as the exclusive placement agent for the April 2022 Private Placement. The Company agreed to pay Wainwright a placement agent fee and management fee equal to 7.5% and 1.0%, respectively, of the aggregate gross proceeds from the April 2022 Private Placement and reimburse certain out-of-pocket expenses up to an aggregate of $85,000. In addition, the Company issued warrants to Wainwright (the “April Wainwright Warrants”) to purchase up to 70,849 shares of common stock. The Wainwright Warrants are in substantially the same form as the preferred investment options, except that the exercise price is $8.46875. The form of the preferred investment options is a warrant, and as such the preferred investment options, the pre-funded warrants, and the Wainwright Warrants are collectively referred to as the “April 2022 Private Placement Warrants”. Further, upon any exercise for cash of any preferred investment options, the Company agreed to issue to Wainwright additional warrants to purchase the number of shares of common stock equal to 6.0% of the aggregate number of shares of common stock underlying the preferred investment options that have been exercised, also with an exercise price of $8.46875 (the “April Contingent Warrants”). The maximum number of April Contingent Warrants issuable under this provision of 70,849 were exchanged in connection with the August 2022 Private Placement, as discussed below.

The Company evaluated the terms of the April 2022 Private Placement Warrants and determined that they should be classified as equity instruments based upon accounting guidance provided in ASC 480, Distinguishing Liabilities from Equity (“ASC 480”) and ASC 815-40, Derivatives and Hedging – Contracts in Entity’s Own Equity (“ASC 815-40”). Since the Company determined that the April 2022 Private Placement Warrants were equity-classified, the Company recorded the proceeds from the April 2022 Private Placement, net of issuance costs, within common stock at par value and the balance of the net proceeds to additional paid in capital.

The Company evaluated the terms of the April Contingent Warrants and determined that they should be classified as a liability based upon accounting guidance provided in ASC 815-40. Since the April Contingent Warrants are a form of compensation to Wainwright, the Company recorded the value of the liability as a reduction of additional paid in capital, with subsequent changes in the value of the liability recorded in other income (expense) in the accompanying condensed statements of operations.

August 2022 Private Placement

On August 11, 2022, the Company consummated the closing of a private placement (the “August 2022 Private Placement”), pursuant to the terms and conditions of a securities purchase agreement, dated as of August 9, 2022. At the closing of the August 2022 Private Placement, the Company issued 1,350,000 shares of common stock, pre-funded warrants to purchase an aggregate of 2,333,280 shares of common stock and preferred investment options to purchase up to an aggregate of 4,972,428 shares of common stock. The purchase price of each share of common stock together with the associated preferred investment option was $2.715, and the purchase price of each pre-funded warrant together with the associated preferred investment option was $2.714. The aggregate net cash proceeds to the Company from the August 2022 Private Placement were approximately $8.7 million, after deducting placement agent fees and other offering expenses. In addition, the investors in the August 2022 Private Placement, who are the same investors from the April 2022 Private Placement, agreed to cancel preferred investment options to purchase up to an aggregate of 1,180,812 shares of the Company’s common stock issued in April 2022. The pre-funded warrants had an exercise price of $0.001 per share. During 2022, an aggregate of 1,686,640 of the pre-funded warrants were exercised. The remaining 646,640 of pre-funded warrants were exercised during the nine months ended September 30, 2023. The preferred investment options are exercisable at any time on or after August 11, 2022 through August 12, 2027, at an exercise price of $2.546 per share, subject to certain adjustments as defined in the agreement. During the three and nine months ended September 30, 2023, 2,486,214 of these preferred investment options were exercised at a reduced exercise price of $1.09, in connection with the warrant inducement transaction discussed below. As of September 30, 2023, 2,486,214 preferred investment options are outstanding.

Wainwright acted as the exclusive placement agent for the August 2022 Private Placement. The Company agreed to pay Wainwright a placement agent fee and management fee equal to 7.5% and 1.0%, respectively, of the aggregate gross proceeds from the August 2022 Private Placement and reimburse certain out-of-pocket expenses up to an aggregate of $85,000. In addition, the Company issued warrants to Wainwright (the “August Wainwright Warrants”) to purchase up to 220,997 shares of common stock. The August Wainwright Warrants are in substantially the same form as the preferred investment options, except that the exercise price is $3.3938. The form of the preferred investment options is a warrant, and as such the preferred investment options, the pre-funded warrants, and the August Wainwright Warrants are collectively referred to as the “August 2022 Private Placement Warrants”. Further, upon any exercise for cash of any preferred investment options, the Company agreed to issue to Wainwright additional warrants to purchase the number of shares of common stock equal to 6.0% of the aggregate number of shares of common stock underlying the preferred investment options that have been exercised, also with an exercise price of $3.3938 (the “August Contingent Warrants”). The maximum number of August Contingent Warrants issuable under this provision is 298,346, which includes 70,849 of April Contingent Warrants that were modified in connection with the August 2022 Private Placement.

The Company evaluated the terms of the August 2022 Private Placement Warrants and determined that they should be classified as equity instruments based upon accounting guidance provided in ASC 480 and ASC 815-40. Since the Company determined that the August 2022 Private Placement Warrants were equity-classified, the Company recorded the proceeds from the August 2022 Private Placement, net of issuance costs, within common stock at par value and the balance of the net proceeds to additional paid in capital.

The investors in the April 2022 Private Placement agreed to cancel the aggregate of 1,180,812 preferred investment options issued in the April 2022 Private Placement, as part of their participation in the August 2022 Private Placement. The preferred investment options that were cancelled were effectively exchanged for 1,289,148 new preferred investment options in the August 2022 Private Placement, and accordingly have been accounted for as a modification or exchange of equity-linked instruments. In accordance with ASC 815-40, as the preferred investment options were classified as equity instruments before and after the exchange, and as the exchange is directly attributable to an equity offering, the Company recognized the effect of the exchange as an equity issuance cost.

The Company evaluated the terms of the August Contingent Warrants and determined that they should be classified as a liability based upon accounting guidance provided in ASC 815-40. As a result of the exchange of the preferred investment options issued in the April 2022 Private Placement, the underlying equity-linked instruments that would trigger issuance of the April Contingent Warrants was replaced, and therefore the 70,849 of April Contingent Warrants were exchanged for 70,849 of the August Contingent Warrants. The value of the April Contingent Warrant liability was adjusted to fair value on the date of modification, using a Monte Carlo simulation, with the change in fair value recognized in the accompanying condensed statements of operations. The remaining 227,497 August Contingent Warrants were measured as a liability upon the close of the August 2022 Private Placement. Since the Contingent Warrants are a form of compensation to the placement agent, the Company recorded the value of the liability as a reduction of additional paid in capital.

During the three and nine months ended September 30, 2023, in connection with the warrant inducement transaction, the Company issued to Wainwright as settlement of the contingent warrant liability associated with 149,173 of the August Contingent Warrants, which was triggered upon exercise of the underlying preferred investment options. See Warrant Inducement below for further discussion.

At the Market Offering Agreement

On March 29, 2023, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC, as sales agent (the “Agent”), to create an at-the-market equity program under which it may sell up to $3,900,000 of shares of the Company’s common stock (the “Shares”) from time to time through the Agent (the “ATM Offering”). Under the ATM Agreement, the Agent will be entitled to a commission at a fixed rate of 3.0% of the gross proceeds from each sale of Shares under the ATM Agreement. The Company has no obligation to sell, and the Agent is not obligated to buy or sell, any of the Shares under the Agreement and may at any time suspend offers under the Agreement or terminate the Agreement. The ATM Offering will terminate upon the termination of the ATM Agreement as permitted therein.

Deferred offering costs associated with the ATM Agreement are reclassified to additional paid in capital on a pro-rata basis when the Company completes offerings under the ATM Agreement. Any remaining deferred costs will be expensed to the statements of operations should the planned offering be abandoned.

As of September 30, 2023, no shares have been sold under the ATM Offering.

Warrant Inducement

On July 31, 2023, the Company entered into a common stock preferred investment options exercise inducement offer letter (the “Inducement Letter”) with a certain holder (the “Holder”) of existing preferred investment options (“PIOs”) to purchase shares of the Company’s common stock at the original exercise price of $2.546 per share, issued on August 11, 2022 (the “Existing PIOs”). Pursuant to the Inducement Letter, the Holder agreed to exercise for cash its Existing PIOs to purchase an aggregate of 2,486,214 shares of the Company’s common stock (the “Inducement PIO Shares”), at a reduced exercised price of $1.09 per share, in exchange for the Company’s agreement to issue new preferred investment options (the “Inducement PIOs”) to purchase up to 4,972,428 shares of the Company’s common stock. The Inducement PIOs have substantially the same terms as the Existing PIOs.

On August 2, 2023, the Company consummated the transactions contemplated by the Inducement Letter (the “Warrant Inducement”). The Company received aggregate net proceeds of approximately $2.3 million from the Warrant Inducement, after deducting placement agent fees and other offering expenses payable by the Company.

Upon the close of the transaction, the Company issued the Holder 1,575,000 of the 2,486,214 shares of common stock that were issuable upon exercise of the Existing PIOs. Due to the beneficial ownership limitation provisions in the Inducement Letter, the remaining 911,214 shares were initially unissued, and held in abeyance for the benefit of the Holder until notice from the Holder that the shares may be issued in compliance with such limitation is received. These shares were issued to the Holder in October 2023.

The Company agreed to file a registration statement covering the resale of the Inducement PIO Shares issued or issuable upon the exercise of the Inducement PIOs (the “Resale Registration Statement”), as soon as practicable, and to use commercially reasonable efforts to have such Resale Registration Statement declared effective by the SEC within 90 days following the date of the Inducement Letter, and to keep the Resale Registration Statement effective at all times until there are no Inducement PIO Shares. The provision to register the underlying shares in the Warrant Inducement does not require payment related to the registration rights provided. As such, while the shares were not registered within 90 days of the date of the Inducement Letter, there is no accounting impact for this provision.

The Company engaged Wainwright to act as its placement agent in connection with the Warrant Inducement and paid Wainwright a cash fee equal to 7.5% of the gross proceeds received from the exercise of the Existing PIOs as well as a management fee equal to 1.0% of the gross proceeds from the exercise of the Existing PIOs. The Company also agreed to reimburse Wainwright for its expenses in connection with the exercise of the Existing PIOs and the issuance of the Inducement PIOs, up to $50,000 for fees and expenses of legal counsel and other out-of-pocket expenses and agreed to pay Wainwright for non-accountable expenses in the amount of $35,000. In addition, the exercise for cash of the Existing PIOs triggered the issuance to Wainwright or its designees, warrants to purchase 149,173 shares of common stock (“Wainwright Inducement Warrants”), which were issuable in accordance with the terms of the August Contingent Warrants, and have the same terms as the Inducement PIOs except for an exercise price equal to $1.3625 per share. The Company also agreed to issue warrants to Wainwright upon any exercise for cash of the Inducement PIOs, that number of shares of common stock equal to 6.0% of the aggregate number of such shares of common stock underlying the Inducement PIOs that have been exercised, also with an exercise price of $1.3625 (the “Inducement Contingent Warrants”). The maximum number of Inducement Contingent Warrants issuable under this provision is 298,346.

The Company evaluated the terms of the Inducement PIOs and the Wainwright Inducement Warrants (collectively, the “August 2023 Inducement Warrants”), and determined that they should be classified as equity instruments based upon accounting guidance provided in ASC 480 and ASC 815-40. The Company also evaluated the unissued shares held in abeyance, which represent a prepaid forward contract, and determined that it is an equity instrument based on the guidance provided in ASC 480 and ASC 815-40.

The Warrant Inducement, which resulted in the lowering of the exercise price of the Existing PIOs and the issuance of the Inducement PIOs, is considered a modification of the Existing PIOs under the guidance of Accounting Standards Update (“ASU”) No. 2021-04, Issuer’s Accounting for Certain Modifications or Exchanges of Equity Classified Written Call Options. The modification is consistent with the “Equity Issuance” classification under that guidance as the reason for the modification was to induce the holders of the Existing PIOs to cash exercise their warrants, resulting in the imminent exercise of the Existing PIOs, which raised equity capital and generated net proceeds for the Company of approximately $2.3 million. As the Existing PIOs and the Inducement PIOs were classified as equity instruments before and after the exchange, and as the exchange is directly attributable to an equity offering, the Company recognized the effect of the modification of approximately $2.6 million as an equity issuance cost.

In addition, the change in fair value of the contingent warrant liability associated with 149,173 of the August Contingent Warrants that were settled through issuance of the Wainwright Inducement Warrants, of approximately $122,000, was recognized in other income (expense) in the accompanying condensed statements of operations, and the fair value of the contingent warrant liability of approximately $129,000 was derecognized as of the settlement date. The corresponding amount, representing the fair value of the Wainwright Inducement Warrants, was recognized as additional paid in capital.

The Company evaluated the terms of the Inducement Contingent Warrants and determined that they should be classified as a liability based upon accounting guidance provided in ASC 815-40. Since the Inducement Contingent Warrants are a form of compensation to Wainwright, the Company recorded the value of the liability of approximately $26,000 as a reduction of additional paid in capital, with subsequent changes in the value of the liability recorded in other income (expense) in the accompanying condensed statements of operations.

Warrants

The following summarizes activity related to the Company’s outstanding warrants, excluding contingent warrants issuable upon exercise of the preferred investment options, for the nine months ended September 30, 2023:

						Weighted
						Average
				Weighted		Remaining
				Average		Contractual
	Number of			Exercise		Life
	Shares			Price		(in years)
Outstanding as of December 31, 2022		5,910,914		$	2.37		4.7
Granted		5,121,601			1.10
Exercised		(3,132,854	)		0.865
Cancelled		—			—
Outstanding as of September 30, 2023		7,899,661			1.68		4.6
Warrants vested and exercisable as of September 30, 2023		7,899,661		$	1.68		4.6

As of September 30, 2023, the outstanding warrants include 70,849 April 2022 Private Placement Warrants, 2,707,211 August 2022 Private Placement Warrants, and 5,121,601 August 2023 Inducement Warrants, which are exercisable into 7,899,661 shares of common stock which had a fair value of $0.51 per share, based on the closing trading price on that day.

Additionally, as of September 30, 2023, and December 31, 2022, the value of the August Contingent Warrants and the Inducement Contingent Warrants (collectively the “Contingent Warrants”) was approximately $10,000 and $14,000, respectively. The maximum number of warrants issuable upon settlement of the Contingent Warrants as of September 30, 2023 and December 31, 2023 was 447,519 and 298,346, respectively.

Equity Incentive Plans

The Company’s 2019 Equity Incentive Plan (the “2019 Plan”) was adopted by the Board and by its stockholders on July 1, 2019. The Company has reserved 1,400,000 shares of common stock for issuance pursuant to the 2019 Plan.

On February 23, 2022, and in connection with the closing of the IPO, the Board adopted the Company’s 2022 Equity Incentive Plan (the “2022 Plan”), which is the successor and continuation of the Company’s 2019 Plan. Under the 2022 Plan, the Company may grant stock options, restricted stock, restricted stock units, stock appreciation rights, and other forms of awards to employees, directors and consultants of the Company. Upon its effectiveness, a total of 1,600,000 shares of common stock were reserved for issuance under the 2022 Plan. In August 2022, the number of shares of common stock reserved for issuance under the 2022 Plan was increased to 2,600,000 and in May 2023, the number of shares of common stock reserved for issuance under the 2022 Plan was increased to 3,150,000. The stock options and restricted stock granted during the nine months ended September 30, 2023 were all granted under the 2022 Plan. As of September 30, 2023, there are 1,146,878 shares available for issuance under the 2022 Plan.

Stock Options

The following summarizes activity related to the Company’s stock options under the 2019 Plan and the 2022 Plan for the nine months ended September 30, 2023:

								Weighted
								Average
				Weighted				Remaining
				Average		Total		Contractual
	Number of			Exercise		Intrinsic		Life
	Shares			Price		Value		(in years)
Outstanding as of December 31, 2022		1,392,654		$	3.30	$	670,161		8.2
Granted		102,386			1.19		—		—
Forfeited / cancelled		(70,265	)		3.35		—		—
Exercised		(45,920	)		0.01		45,920		—
Outstanding as of September 30, 2023		1,378,855			3.25		274,299		7.8
Options vested and exercisable as of September 30, 2023		1,094,563		$	2.95	$	269,994		7.5

The fair value of options granted in 2023 was estimated using the following assumptions:

	For the Nine Months Ended September 30,
	2023
Exercise price	$	1.05 – 1.29
Term (years)		5.00 – 10.00
Expected stock price volatility		113.1% – 119.5	%
Risk-free rate of interest		3.5% – 3.6	%

The weighted average grant date fair value of stock options granted during the nine months ended September 30, 2023 was $1.08. The aggregate fair value of stock options that vested during the three and nine months ended September 30, 2023 was approximately $137,000 and $616,000, respectively.

Restricted Stock

On May 9, 2023, the Board’s Compensation Committee approved the issuance of restricted stock, granted under the Company’s 2022 Plan, to the Company’s executive officers, employees, and certain of the Company’s consultants. The restricted shares granted totaled 487,500, of which 150,000, 75,000, and 150,000 were granted to the Company’s Chief Executive Officer (“CEO”), Chief Financial Officer, and Chief Business Officer, respectively. All of the restricted shares granted vest as follows: 50% in January 2024, 25% in August 2024, and 25% in August 2025. In addition, on May 31, 2023, the Board’s Compensation Committee approved the issuance of 25,440 shares of restricted stock, granted to the Company’s non-executive Board members, with full vesting on May 31, 2024.

On August 16, 2023, upon his resignation, the Company’s former Chief Executive Officer forfeited 150,000 shares of unvested restricted stock.

				Weighted
				Average
				Weighted
				Average
	Number of			Grant Date
	Shares			Fair Value
Nonvested as of December 31, 2022		—		$	—
Granted		512,940			1.01
Forfeited / cancelled		(168,860	)		1.02
Vested		—			—
Nonvested as of September 30, 2023		344,080		$	1.01

Stock-Based Compensation

Stock-based compensation expense related to stock options and restricted stock, for the three and nine months ended September 30, 2023, and 2022 was as follows:

	For the Three Months Ended September 30,				For the Nine Months Ended September 30,
	2023		2022		2023		2022
Selling, general and administrative	$	89,832	$	255,115	$	362,191	$	1,193,743
Research and development		15,570		74,694		201,570		602,525
Total	$	105,402	$	329,809	$	563,761	$	1,796,268

As of September 30, 2023, unrecognized stock-based compensation expense relating to outstanding stock options and unvested restricted stock is approximately $394,000 and $143,000, respectively, which is expected to be recognized over a weighted-average period of 1.67 years and 1.49 years, respectively.

- Definition

The entire disclosure for equity.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (h)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 14
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-14

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 235
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481062/946-235-50-2

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 235
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481062/946-235-50-2

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 505
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481004/946-505-50-6

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480237/815-40-50-6

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.3-04)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480008/505-10-S99-1

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(e)(1))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480678/235-10-S99-1

Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 505
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org//505/tableOfContent

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (g)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (i)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 14
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-14

Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 14
-Subparagraph (c)
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-URI https://asc.fasb.org//1943274/2147481112/505-10-50-14

Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
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Reference 17: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 18
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-18

Reference 18: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 18
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-18

Reference 19: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
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-Paragraph 18
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-18

+ Details

Going Concern and Management’s Plans (Details) - USD ($)		9 Months Ended	12 Months Ended
	Jun. 30, 2023	Sep. 30, 2023	Dec. 31, 2022
Going Concern and Management's Plan [Line Items]
Net proceeds			$ 33,100,000
Proceeds from preferred investment		$ 2,300,000
Company cash		7,700,000
Working capital deficit		8,100,000
Accumulated deficit		$ 34,400,000
Consideration to pay	$ 8,500,000
Common stock paid	3,500,000
Agreement remainder common stock	4,500,000
Common stock remaining amount	$ 500,000
Post closing payment description		The amendment, which is subject to court approval, seeks, among other things, to eliminate the $500,000 post-closing payment due June 13, 2024 and stagger the $4.5 million cash payment that the Company would otherwise have to pay at closing to: (i) $2.2 million to be paid at closing, (ii) $2.3 million, to be paid in monthly installments of $150,000 commencing January 2024 and (iii) 789 shares of Series A Preferred Stock to be paid at closing.
Initial payment		$ 3.5

Balance Sheet Details (Tables)

9 Months Ended

Sep. 30, 2023

Balance Sheet Related Disclosures [Abstract]

Schedule of Inventories

Inventories relate to ENTADFI® product and consisted of the following as of September 30, 2023, and December 31, 2022:

	September 30, 2023		December 31, 2022
Raw materials	$	329,780	$	-
Work-in-process		1,089,492		-
Total	$	1,419,272	$	-

Schedule of Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following as of September 30, 2023, and December 31, 2022:

	September 30, 2023		December 31, 2022
Prepaid insurance	$	277,058	$	148,789
Prepaid research and development		89,195		231,981
Prepaid other		101,485		88,462
Total	$	467,738	$	469,232

Schedule of Accrued Expenses

Accrued expenses consisted of the following as of September 30, 2023, and December 31, 2022:

	September 30, 2023		December 31, 2022
Accrued research and development	$	548,287	$	847,747
Accrued compensation		386,087		1,132,859
Accrued deferred offering costs		125,000		125,000
Accrued professional fees		216,000		—
Accrued implementation fees		106,287		—
Other accrued expenses		156,883		125,922
Accrued franchise taxes		—		177,600
Total	$	1,538,544	$	2,409,128

Stockholders’ Equity (Details) - Schedule of Fair Value of Options Granted	9 Months Ended
	Sep. 30, 2023 $ / shares
Stockholders’ Equity [Line Items]
Exercise price (in Dollars per share)	$ 1.05
Term (years)	5 years
Expected stock price volatility	113.10%
Risk-free rate of interest	3.50%
Maximum [Member]
Stockholders’ Equity [Line Items]
Exercise price (in Dollars per share)	$ 1.29
Term (years)	10 years
Expected stock price volatility	119.50%
Risk-free rate of interest	3.60%

Acquisitions (Details) - Schedule of Assets Acquired	Sep. 30, 2023 USD ($)
Business Combinations [Abstract]
Inventory	$ 1,120,000
ENTADFI® Intangible	17,906,771
Total fair value of identifiable assets acquired	$ 19,026,771

Acquisitions (Tables)

9 Months Ended

Sep. 30, 2023

Business Combinations [Abstract]

Schedule of Aggregate Consideration Transferred Assets Acquired

The following table summarizes the aggregate consideration transferred for the assets acquired by the Company in connection with the ENTADFI® APA:

	Consideration Transferred
Consideration transferred at closing	$	6,000,000
Fair value of notes payable issued		12,947,000
Transaction costs		79,771
Total consideration transferred	$	19,026,771

Schedule of Assets Acquired

The following table summarizes the assets acquired with the ENTADFI® APA:

	Assets Recognized
Inventory	$	1,120,000
ENTADFI® Intangible		17,906,771
Total fair value of identifiable assets acquired	$	19,026,771

Retirement Plan (Details)	9 Months Ended
Retirement Plan (Details)	Sep. 30, 2023
Retirement Benefits [Abstract]
Percentage of gross pay	3.00%

Organization and Basis of Presentation (Details) - USD ($)		9 Months Ended
	Feb. 23, 2022	Sep. 30, 2023	Sep. 30, 2022
Organization and Basis of Presentation [Line Items]
Initial public offering	2,222,222
Initial public offering price per share	$ 0.00001
Public of per share	$ 9
Offering costs			$ (926,972)
Convertible preferred stock shares	5,626,365
Minimum [Member] \| IPO [Member]
Organization and Basis of Presentation [Line Items]
Offering costs	$ 2,900,000
Maximum [Member] \| IPO [Member]
Organization and Basis of Presentation [Line Items]
Offering costs	$ 17,100,000

Balance Sheet Details (Details) - Schedule of Prepaid Expenses and Other Current Assets - USD ($)	Sep. 30, 2023	Dec. 31, 2022
Payables and Accruals [Abstract]
Prepaid insurance	$ 277,058	$ 148,789
Prepaid research and development	89,195	231,981
Prepaid other	101,485	88,462
Total	$ 467,738	$ 469,232

Stockholders’ Equity (Tables)

9 Months Ended

Sep. 30, 2023

Stockholders’ Equity [Abstract]

Schedule of Outstanding Warrants

						Weighted
						Average
				Weighted		Remaining
				Average		Contractual
	Number of			Exercise		Life
	Shares			Price		(in years)
Outstanding as of December 31, 2022		5,910,914		$	2.37		4.7
Granted		5,121,601			1.10
Exercised		(3,132,854	)		0.865
Cancelled		—			—
Outstanding as of September 30, 2023		7,899,661			1.68		4.6
Warrants vested and exercisable as of September 30, 2023		7,899,661		$	1.68		4.6

Schedule of Stock Options

The following summarizes activity related to the Company’s stock options under the 2019 Plan and the 2022 Plan for the nine months ended September 30, 2023:

								Weighted
								Average
				Weighted				Remaining
				Average		Total		Contractual
	Number of			Exercise		Intrinsic		Life
	Shares			Price		Value		(in years)
Outstanding as of December 31, 2022		1,392,654		$	3.30	$	670,161		8.2
Granted		102,386			1.19		—		—
Forfeited / cancelled		(70,265	)		3.35		—		—
Exercised		(45,920	)		0.01		45,920		—
Outstanding as of September 30, 2023		1,378,855			3.25		274,299		7.8
Options vested and exercisable as of September 30, 2023		1,094,563		$	2.95	$	269,994		7.5

Schedule of Fair Value of Options Granted

The fair value of options granted in 2023 was estimated using the following assumptions:

	For the Nine Months Ended September 30,
	2023
Exercise price	$	1.05 – 1.29
Term (years)		5.00 – 10.00
Expected stock price volatility		113.1% – 119.5	%
Risk-free rate of interest		3.5% – 3.6	%

Schedule of Restricted Stock

On August 16, 2023, upon his resignation, the Company’s former Chief Executive Officer forfeited 150,000 shares of unvested restricted stock.

				Weighted
				Average
				Weighted
				Average
	Number of			Grant Date
	Shares			Fair Value
Nonvested as of December 31, 2022		—		$	—
Granted		512,940			1.01
Forfeited / cancelled		(168,860	)		1.02
Vested		—			—
Nonvested as of September 30, 2023		344,080		$	1.01

Schedule of Stock-Based Compensation Expense

Stock-based compensation expense related to stock options and restricted stock, for the three and nine months ended September 30, 2023, and 2022 was as follows:

	For the Three Months Ended September 30,				For the Nine Months Ended September 30,
	2023		2022		2023		2022
Selling, general and administrative	$	89,832	$	255,115	$	362,191	$	1,193,743
Research and development		15,570		74,694		201,570		602,525
Total	$	105,402	$	329,809	$	563,761	$	1,796,268

Retirement Plan

9 Months Ended

Sep. 30, 2023

Retirement Plan [Abstract]

Retirement Plan

Note 13 — Retirement Plan

On May 31, 2023, the Board voted to adopt a 401(k) Safe Harbor Non-Elective Plan (the “401(k) Plan”). The 401(k) Plan was an employee savings and retirement plan to which substantially all employees could have contributed, including the Company’s named executive officers, effective July 1, 2023. Pursuant to the 401(k) Plan, employee and Company contributions would vest immediately, subject to a three-month waiting period for new hires. The Company was required to contribute 3% of gross pay to eligible employees’ 401(k) Plans. On November 16, 2023, the 401(k) Plan was terminated.

- Definition

The entire disclosure for retirement benefits.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 715
-SubTopic 70
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480794/715-70-50-1

Reference 2: http://www.xbrl.org/2003/role/exampleRef
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org//1943274/2147480506/715-20-50-1

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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-SubTopic 20
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-Section 50
-Paragraph 1
-Subparagraph (p)
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-URI https://asc.fasb.org//1943274/2147480506/715-20-50-1

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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-Paragraph 1
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Reference 12: http://www.xbrl.org/2003/role/disclosureRef
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 715
-SubTopic 20
-Name Accounting Standards Codification
-Section S99
-Paragraph 2
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480126/715-20-S99-2

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 715
-SubTopic 60
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-Section 50
-Paragraph 3
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480266/715-60-50-3

+ Details

Accounting Policies, by Policy (Policies)	9 Months Ended
Accounting Policies, by Policy (Policies)	Sep. 30, 2023
Accounting Policies [Abstract]
Use of Estimates	*Use of Estimates* The preparation of 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 disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting periods. The most significant estimates in the Company’s financial statements relate to valuation of inventory, useful life of the amortizable intangible assets, estimates of future cash flows used to evaluate impairment, accrued research and development expenses, stock-based compensation, the valuation of preferred stock, and the valuation allowance of deferred tax assets resulting from net operating losses. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected.
Segment Information	*Segment Information* Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker (“CODM”), or decision-making group, in deciding how to allocate resources and in assessing performance. Prior to the acquisition of ENTADFI® during the quarter ended June 30, 2023, the Company managed one distinct business segment, which was vaccine discovery and development. During the second quarter of 2023, as a result of the acquisition of ENTADFI® for which the Company is working towards commercial launch, the Company operated in two business segments: research and development and commercial. During the third quarter of 2023, the Company deprioritized its vaccine discovery and development programs, and accordingly, as of September 30, 2023, the Company was operating in one segment: commercial. Management’s determination that the Company operated as two segments during the second quarter of 2023 and one segment during the third quarter of 2023, was consistent with the financial information regularly reviewed by the CODM for purposes of evaluating performance, allocating resources, setting incentive compensation targets, and planning and forecasting for future periods.
Inventories	*Inventories* Inventories consist of raw materials, packaging materials, and work-in-process. Inventories are stated at the lower of cost or net realizable value, with cost determined on a first-in, first-out basis, aside from inventory acquired in an asset acquisition, which is recorded at fair value. The Company periodically reviews the composition of inventory in order to identify excess, obsolete, slow-moving or otherwise non-saleable items taking into account anticipated future sales compared with quantities on hand, and the remaining shelf life of goods on hand. If non-saleable items are observed and there are no alternate uses for the inventory, the Company records a write-down to net realizable value in the period that the decline in value is first recognized. The Company had no inventory reserves at September 30, 2023 and December 31, 2022.
Acquisitions	*Acquisitions* The Company evaluates acquisitions to first determine whether a set of assets acquired constitutes a business and should be accounted for as a business combination. If the assets acquired are not a business, the transaction is accounted as an asset acquisition in accordance with Accounting Standards Codification (“ASC”) 805-50, Asset Acquisitions (“ASC 805-50”), which requires the acquiring entity to recognize assets acquired and liabilities assumed based on the cost to the acquiring entity on a relative fair value basis, except for non-qualifying assets including financial assets such as inventory. Further, the cost of the acquisition includes the fair value of consideration transferred and direct transaction costs attributable to the acquisition. Goodwill is not recognized in an asset acquisition and any excess consideration transferred over the fair value of the net assets acquired is allocated to the identifiable assets based on relative fair values. Contingent consideration payments in asset acquisitions are recognized when the contingency is determined to be probable and reasonably estimable. If the assets acquired are a business, the Company accounts for the transaction as a business combination. Business combinations are accounted for by using the acquisition method of accounting. Under the acquisition method, assets acquired, and liabilities assumed are recorded at their respective fair values. The excess of the fair value of consideration transferred over the fair value of the net assets acquired is recorded as goodwill. Contingent consideration obligations are recorded at their fair values on the acquisition date and remeasured at their fair values each subsequent reporting period until the related contingencies are resolved. The resulting changes in fair values are recorded in earnings.
Intangible Assets	*Intangible Assets* Intangible assets are reported at cost, less accumulated amortization. Intangible assets with finite lives are amortized over their estimated useful lives, starting when sales for the related product begin. Amortization is calculated using the straight-line method. During the ordinary course of business, the Company has entered into certain license and asset purchase agreements. Potential milestone payments for development, regulatory, and commercial milestones are recorded when the milestone is probable of achievement. Upon a milestone being achieved, the associated milestone payment is capitalized and amortized over the remaining useful life for approved products, or expensed as research and development expense for milestones relating to products whose FDA approval has not yet been obtained.
Impairment of Long-Lived Assets	*Impairment of Long-Lived Assets* The Company reviews long-lived assets, including intangible assets with finite useful lives, for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable (a “triggering event”). Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the long-lived asset in relation to expectations, significant negative industry or economic trends, and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset to its carrying value. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of an asset are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset over its fair value, determined based on discounted cash flows. During the three and nine months ended September 30, 2023, the Company recorded an impairment loss of approximately $267,000 related to $267,000 of implementation costs incurred under cloud computing hosting arrangements that were capitalized during the three and nine months ended September 30, 2023. There were no other impairment losses on long-lived assets.
New Accounting Pronouncements	New Accounting Pronouncements The Company’s management does not believe that any recently issued, but not yet effective, accounting standards if currently adopted would have a material effect on the accompanying condensed financial statements.

- Definition

Disclosure of inventory accounting policy for inventory classes, including, but not limited to, basis for determining inventory amounts, methods by which amounts are added and removed from inventory classes, loss recognition on impairment of inventories, and situations in which inventories are stated above cost.

+ References + Details

- Definition

Disclosure of accounting policy for segment reporting.

+ References + Details

Condensed Statements of Stockholders’ Equity (Unaudited) - USD ($)	Preferred Stock	Common Stock	Additional Paid-in Capital	Treasury Stock	Accumulated Deficit	Total
Balance at Dec. 31, 2021	$ 11	$ 32	$ 7,403,204		$ (5,956,670)	$ 1,446,577
Balance (in Shares) at Dec. 31, 2021	1,146,138	3,200,000
Issuance of common stock		$ 22	17,138,818			17,138,840
Issuance of common stock (in Shares)		2,222,222
Conversion of convertible preferred stock to common stock upon initial public offering	$ (11)	$ 56	(45)
Conversion of convertible preferred stock to common stock upon initial public offering (in Shares)	(1,146,138)	5,626,365
Stock-based compensation			19,332			19,332
Net loss					(2,070,661)	(2,070,661)
Balance at Mar. 31, 2022		$ 110	24,561,309		(8,027,331)	16,534,088
Balance (in Shares) at Mar. 31, 2022		11,048,587
Balance at Dec. 31, 2021	$ 11	$ 32	7,403,204		(5,956,670)	1,446,577
Balance (in Shares) at Dec. 31, 2021	1,146,138	3,200,000
Net loss						(10,201,905)
Balance at Sep. 30, 2022		$ 147	41,888,452		(16,158,575)	25,730,024
Balance (in Shares) at Sep. 30, 2022		14,689,851
Balance at Mar. 31, 2022		$ 110	24,561,309		(8,027,331)	16,534,088
Balance (in Shares) at Mar. 31, 2022		11,048,587
Exercise of pre-funded warrants		$ 6	(6)
Exercise of pre-funded warrants (in Shares)		590,406
Issuance of common stock		$ 6	6,858,322			6,858,328
Issuance of common stock (in Shares)		590,406
Stock-based compensation			1,447,127			1,447,127
Net loss					(4,264,582)	(4,264,582)
Balance at Jun. 30, 2022		$ 122	32,866,752		(12,291,913)	20,574,961
Balance (in Shares) at Jun. 30, 2022		12,229,399
Exercise of stock options		$ 2	1,653			1,655
Exercise of stock options (in Shares)		165,452
Exercise of pre-funded warrants		$ 9	936			945
Exercise of pre-funded warrants (in Shares)		945,000
Issuance of common stock		$ 14	8,689,302			8,689,316
Issuance of common stock (in Shares)		1,350,000
Stock-based compensation			329,809			329,809
Net loss					(3,866,662)	(3,866,662)
Balance at Sep. 30, 2022		$ 147	41,888,452		(16,158,575)	25,730,024
Balance (in Shares) at Sep. 30, 2022		14,689,851
Balance at Dec. 31, 2022		$ 157	42,331,155	$ (566,810)	(19,376,500)	22,388,002
Balance (in Shares) at Dec. 31, 2022		15,724,957		(459,729)
Exercise of pre-funded warrants		$ 7	(7)
Exercise of pre-funded warrants (in Shares)		646,640
Stock-based compensation			185,578			185,578
Purchase of treasury shares				$ (33,454)		(33,454)
Purchase of treasury shares (in Shares)				(32,638)
Net loss					(2,846,644)	(2,846,644)
Balance at Mar. 31, 2023		$ 164	42,516,726	$ (600,264)	(22,223,144)	19,693,482
Balance (in Shares) at Mar. 31, 2023		16,371,597		(492,367)
Balance at Dec. 31, 2022		$ 157	42,331,155	$ (566,810)	(19,376,500)	$ 22,388,002
Balance (in Shares) at Dec. 31, 2022		15,724,957		(459,729)
Restricted stock forfeitures (in Shares)						6,759,186
Net loss						$ (15,058,822)
Balance at Sep. 30, 2023		$ 183	45,297,371	$ (625,791)	(34,435,322)	10,236,441
Balance (in Shares) at Sep. 30, 2023		18,336,597		(517,399)
Balance at Mar. 31, 2023		$ 164	42,516,726	$ (600,264)	(22,223,144)	19,693,482
Balance (in Shares) at Mar. 31, 2023		16,371,597		(492,367)
Exercise of stock options			459			459
Exercise of stock options (in Shares)		45,920
Issuance of restricted stock		$ 5	(5)
Issuance of restricted stock (in Shares)		512,940
Stock-based compensation			272,781			272,781
Purchase of treasury shares				$ (25,527)		(25,527)
Purchase of treasury shares (in Shares)				(25,032)
Net loss					(6,865,270)	(6,865,270)
Balance at Jun. 30, 2023		$ 169	42,789,961	$ (625,791)	(29,088,414)	13,075,925
Balance (in Shares) at Jun. 30, 2023		16,930,457		(517,399)
Issuance of common stock from exercise of preferred investment options		$ 16	2,272,822			2,272,838
Issuance of common stock from exercise of preferred investment options (in Shares)		1,575,000
Issuance of warrants for settlement of contingent warrants			129,184			129,184
Restricted stock forfeitures		$ (2)	2
Restricted stock forfeitures (in Shares)		(168,860)				9,622,596
Stock-based compensation			105,402			$ 105,402
Net loss					(5,346,908)	(5,346,908)
Balance at Sep. 30, 2023		$ 183	$ 45,297,371	$ (625,791)	$ (34,435,322)	$ 10,236,441
Balance (in Shares) at Sep. 30, 2023		18,336,597		(517,399)

Condensed Balance Sheets (Parentheticals) - USD ($)	Sep. 30, 2023	Dec. 31, 2022
Statement of Financial Position [Abstract]
Notes payable, net of debt discount (in Dollars)	$ 569,907	$ 569,907
Preferred stock, par value (in Dollars per share)	$ 0.00001	$ 0.00001
Preferred stock, shares authorized	10,000,000	10,000,000
Series A convertible preferred stock shares designated	10,000	0
Preferred stock, shares issued	0	0
Preferred stock shares outstanding	0	0
Common stock, par value (in Dollars per share)	$ 0.00001	$ 0.00001
Common stock, shares authorized	250,000,000	250,000,000
Common stock, shares issued	18,336,597	15,724,957
Common stock, shares outstanding	17,819,198	15,265,228
Treasury stock, shares of common stock	517,399	459,729

Related Party Transactions

9 Months Ended

Sep. 30, 2023

Related Party Transactions

Note 10 — Related Party Transactions

The Company originally engaged the former CEO, who was also the Board Chairman and prior to the close of the IPO, sole common stockholder of the Company, pursuant to a consulting agreement commencing October 22, 2018, which called for the Company to pay for consulting services performed on a monthly basis. Upon the close of the Company’s IPO, the consulting agreement was terminated, and the former CEO’s employment agreement became effective. During the nine months ended September 30, 2022, the Company incurred approximately $63,000 in fees under the consulting agreement, which is recognized in general and administrative expenses in the accompanying condensed statement of operations.

During 2022 the Company entered into a lease agreement that was personally guaranteed by the Company’s former CEO. The lease expired on April 30, 2023 (see Note 9).

During the year ended December 31, 2022, the Company’s compensation committee approved one-time bonus awards of $140,000 and $100,000 to the Company’s former CEO and Chief Business Officer (“CBO”), respectively, in recognition of their efforts in connection with the Company’s IPO. These bonuses were recognized during the nine months ended September 30, 2022, as selling, general and administrative expenses in the accompanying condensed statement of operations.

During the three and nine months ended September 30, 2023, the Company’s Audit Committee completed a review of the Company’s expenses due to certain irregularities identified with regards to the related party balance. Based on the results of the review, it was determined that the Company paid and recorded within selling, general and administrative expense personal expenditures of the Company’s former CEO and an accounting employee who was also the former CEO’s assistant, during 2022 and during the first three quarters of 2023. The Company evaluated the receivable, which aggregates to approximately $522,000 as of September 30, 2023, and which represents the total of the items identified as personal in nature for which the Company does not anticipate recovery from the related party. The Company recorded a corresponding reserve for the full amount, resulting in a net related party receivable balance of $0 as of September 30, 2023. As the Company concluded that the amounts are not likely to be recovered, this would not cause an adjustment to previously issued financial statements.

Further, the credit card misuse described above resulted in a loss on related party receivable of approximately $100,000 and $266,000 during the three and nine months ended September 30, 2023, respectively, which was recorded in selling, general, and administrative expenses in the accompanying statements of operations.

As of December 31, 2022, the Company had a receivable from related party of approximately $36,000, consisting of miscellaneous payments made by the Company on the behalf of the Company’s former CEO, and which was paid in full during the first quarter of 2023.

A former director of the Company, who currently serves on the Company’s Scientific Advisory Board, serves on the Advisory Board for the Cincinnati Children’s Hospital Medical Center Innovation Fund, which is affiliated with CHMC. The Company has an exclusive license agreement with CHMC as disclosed in Note 6. This director resigned from the Board upon the close of the IPO, and also resigned from the Scientific Advisory Board on August 28, 2023.

- Definition

The entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480990/946-20-50-2

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 20
-Name Accounting Standards Codification
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-Paragraph 5
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-URI https://asc.fasb.org//1943274/2147480990/946-20-50-5

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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-Paragraph 2
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
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-Paragraph 2
-Subparagraph (e)
-Publisher FASB
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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-Paragraph 1
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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-SubTopic 220
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-Paragraph 1
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
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-Section 50
-Paragraph 1
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147483326/850-10-50-1

+ Details

Significant Agreements

9 Months Ended

Sep. 30, 2023

Significant Agreements [Abstract]

Significant Agreements

Note 6 — Significant Agreements

Oxford University Innovation Limited

In December 2018, the Company entered into an option agreement with Oxford University Innovation (“OUI”), which was a precursor to a license agreement (the “OUI Agreement”), dated July 16, 2019. Under the terms of the OUI Agreement, the Company holds an exclusive, worldwide license to certain specified patent rights and biological materials relating to the use of epitopes of limited variability and virus-like particle products and practice processes that are covered by the licensed patent rights and biological materials for the purpose of developing and commercializing a vaccine product candidate for influenza. The Company is obligated to use its best efforts to develop and market Licensed Products, as defined in the OUI Agreement, in accordance with its development plan, report to OUI on progress, achieve the following milestones and must pay OUI nonrefundable milestone fees when it achieves them: initiation of first Phase I study; initiation of first Phase II study; initiation of first Phase III/pivotal registration studies; first submission of application for regulatory approval (BLA/NDA); marketing authorization in the United States; marketing authorization in any EU country; marketing authorization in Japan; first marketing authorization in any other country; first commercial sale in Japan; first commercial sale in any ROW country; first year that annual sales equal or exceed certain thresholds. The OUI Agreement also requires the Company to pay certain milestone and royalty payments in the future, as the related contingent events occur. See Note 9. The OUI Agreement will expire upon ten (10) years from the expiration of the last patent contained in the licensed patent rights, unless terminated earlier. During the year ended December 31, 2021, the U.S. Patent related to immunogenic composition was issued to OUI. This patent expires in August 2037. No additional patents have been issued during the three and nine months ended September 30, 2023. Either party may terminate the OUI Agreement for an uncured material breach. The Company was able to terminate the OUI Agreement for any reason at any time upon six months’ written notice until July 16, 2022, which was the third anniversary of the OUI Agreement. OUI may terminate immediately if the Company has a petition presented for its winding-up or passes a resolution for winding up other than for a bona fide amalgamation or reconstruction or compounds with its creditors or has a receiver or administrator appointed. OUI may also terminate if the Company opposes or challenges the validity of any of the patents or applications in the Licensed Technology, as defined in the OUI Agreement; raises the claim that the know-how of the Licensed Technology is not necessary to develop and market Licensed Products; or in OUI’s reasonable opinion, is taking inadequate or insufficient steps to develop or market Licensed Products and does not take any further steps that OUI requests by written notice within a reasonable time. Subsequent to September 30, 2023, the Company terminated the license agreement with Oxford University Innovation (see Note 14). The amounts due upon termination of the license agreement were not significant.

St. Jude Children’s Hospital

The Company entered into a license agreement (the “St. Jude Agreement”), dated January 27, 2020, with St. Jude Children’s Research Hospital (“St. Jude”). Under the terms of the St. Jude Agreement, the Company holds an exclusive, worldwide license to certain specified patent rights and biological materials relating to the use of live attenuated streptococcus pneumoniae and practice processes that are covered by the licensed patent rights and biological materials for the purpose of developing and commercializing a vaccine product candidate for streptococcus pneumoniae. The St. Jude Agreement requires the Company to pay certain milestone and royalty payments in the future, as the related contingent events occur. See Note 9. The St. Jude Agreement will expire upon the expiration of the last valid claim contained in the licensed patent rights, unless terminated earlier. The Company is obligated to use commercially reasonable efforts to develop and commercialize the licensed product(s). The milestones include the following events: (i) complete IND enabling study; (ii) initiate animal toxicology study; (iii) file IND; (iv) complete Phase I Clinical Trial; (v) commence Phase II Clinical Trial; (vi) commence Phase III Clinical Trial; and (vii) regulatory approval, U.S. or foreign equivalent. If the Company fails to achieve the development milestones contained in the St. Jude Agreement, and if the Company and St. Jude fail to agree upon a mutually satisfactory revised timeline, St. Jude will have the right to terminate the St. Jude Agreement. Either party may terminate the St. Jude Agreement in the event the other party (a) files or has filed against it a petition under the Bankruptcy Act (among other things) or (b) fails to perform or otherwise breaches its obligations under the St. Jude Agreement and has not cured such failure or breach within sixty (60) days. The Company may terminate for any reason on thirty (30) days written notice. On May 11, 2022, the Company entered into an amendment to the St. Jude Agreement, whereby the royalty terms, milestone payments and licensing fees were amended, and a revised development milestone timeline was agreed to. On March 22, 2023, the Company entered into another amendment to the St. Jude Agreement, whereby the development milestone timeline was further revised, and which had no financial impact. Subsequent to September 30, 2023, the Company terminated the license agreement with St. Jude (see Note 14). The amounts due upon termination of the license agreement were not significant.

Cincinnati Children’s Hospital Medical Center

The Company entered into a license agreement (the “CHMC Agreement”), dated June 1, 2021, with Children’s Hospital Medical Center, d/b/a Cincinnati Children’s Hospital Medical Center (“CHMC”). Under the terms of the CHMC Agreement, the Company holds an exclusive, worldwide license (other than the excluded field of immunization against, and prevention, control, or reduction in the severity of gastroenteritis caused by rotavirus and norovirus in China and Hong Kong) to certain specified patent and biological materials relating to the use of norovirus nanoparticles and practice processes that are covered by the licensed patent rights and biological materials for the purpose of developing and commercializing CHMC patents and related technology directed to a virus-like particle vaccine platform that utilizes nanoparticle delivery technology that may have potential broad application to develop vaccines for multiple infectious diseases. The term of the CHMC Agreement begins on the effective date and extends on a jurisdiction by jurisdiction and product by product basis until the later of: (i) the last to expire licensed patent; (ii) ten (10) years after the first commercial sale; or (iii) entrance onto the market of a biosimilar or interchangeable product. The Company is obligated to use commercially reasonable efforts to bring licensed products to market through diligent research and development, testing, manufacturing and commercialization, to use best efforts to make all necessary regulatory filings and obtain all necessary regulatory approvals, to achieve milestones relating to development and sales, and report to CHMC on progress. See Note 9. The Company will also be obligated to pay agreed upon development milestone payments and royalty payment to CHMC, as the related contingent events occur. The Company may terminate the CHMC Agreement for convenience at any time prior to first commercial sale of a product or process by providing one hundred and eighty (180) days’ written notice to CHMC. It may also terminate for a CHMC uncured material breach. CHMC may terminate the CHMC Agreement for an uncured Company material breach or insolvency or bankruptcy. Pursuant to the terms of the CHMC Agreement, if the Company fails to achieve the milestones, and cannot mutually agree with CHMC on an amendment to the milestones, then CHMC will have the option of converting any and all of such exclusive licenses to nonexclusive licenses, to continue developing indications that have already entered development at any stage or in which the Company has invested in developing. CHMC may also terminate the CHMC Agreement to the fullest extent permitted by law in the countries of the worldwide territory, in the event the Company or its affiliates challenge or induce others set up challenges to the validity or enforceability of any of the Licensed Patents, as defined in the CHMC Agreement, and the Company will be obligated to reimburse CHMC for its costs, including reasonable attorneys’ fees.

Ology Bioservices, Inc. (which was later acquired by National Resilience, Inc.)

The Company entered into a Master Services Agreement (“Ology MSA”), dated July 19, 2019, with Ology, Inc. (“Ology”) to provide services from time to time, including but not limited to technology transfer, process development, analytical method optimization, current good manufacturing practice (“cGMP”) manufacture, regulatory affairs, and stability studies of biologic products. Pursuant to the Ology MSA, the Company and Ology shall enter into a Project Addendum for each project to be governed by the terms and conditions of the Ology MSA.

The Company has entered into two Project Addendums as of December 31, 2022. The initial Project Addendum was executed on October 18, 2019 and the Company was required to pay Ology an aggregate of approximately $4 million. Due to unforeseen delays associated with COVID-19, the Company and Ology entered into a letter agreement dated January 9, 2020 to stop work on the project, at which point the Company had paid Ology $100,000 for services to be provided. The second Project Addendum was executed on May 21, 2021 and the Company is obligated to pay Ology an aggregate amount of approximately $2.8 million, plus reimbursement for materials and outsourced testing, which will be billed at cost plus 15%.

During 2022, the Company entered into three amendments to the Ology MSA to adjust the scope of work defined in the second Project Addendum. The amendments resulted in a net increase to the Company’s obligations under the second Project Addendum of $154,000. On March 27, 2023, the second Project Addendum to the Ology MSA was further amended to increase the scope of the project, resulting in an increase to the Company’s obligations of $180,000 under the Ology MSA.

During the three and nine months ended September 30, 2023, the Company incurred related research and development expense (net gain) of approximately ($56,000) and $231,000, respectively, and at September 30, 2023, the Company had approximately $900,000 recorded as related accounts payable and accrued expenses. During the three and nine months ended September 30, 2022, the Company incurred related research and development expenses of approximately $496,000 and $988,000, respectively.

University of Texas Health Science Center at San Antonio

The Company entered into a patent and technology license agreement (the “UT Health Agreement”), dated November 18, 2022, with the University of Texas Health Science Center at San Antonio (“UT Health”). Under the terms of the UT Health Agreement, the Company holds an exclusive, worldwide license (other than the excluded field of vectors, as defined in the UT Health Agreement) to certain specified patent rights relating to the development of a live attenuated, oral Chlamydia vaccine candidate. An initial non-refundable license fee of $100,000 was due upon execution of the agreement and subsequent annual license fees are due as follows: $20,000 per year for each of the four years ending on December 31, 2026; $40,000 per year for each of the two years ending on December 31, 2028, and $60,000 per year for the year ending December 31, 2029 and each year thereafter until expiration or termination of the UT Health agreement. The UT Health Agreement also requires the Company to pay certain milestone and royalty payments in the future, as the related contingent events occur. The UT Health Agreement will expire upon the expiration of the last date of expiration or termination of the patent rights, unless terminated earlier. The Company may terminate the UT Health Agreement for convenience, by providing 90 days’ written notice to UT Health. UT Health may terminate the UT Health Agreement in the event the Company (a) becomes arrears in payment due and does not make payment within 30 days after notification from UT Health or (b) is in breach of any non-payment provision and does not cure such breach within 60 days after notification from UT Health or (c) UT Health delivers notice to the Company of three or more actual material breaches of the UT Health Agreement in any 12-month period or (d) in the event the Company or its affiliates initiates any proceeding or action to challenge the validity, enforceability, or scope of any of the licensed patents.

Co-development Agreement with AbVacc, Inc.

On February 1, 2023, the Company entered into a co-development agreement (the “Co-Development Agreement”) with AbVacc, Inc. (“AbVacc”), for the purpose of conducting research aimed at co-development of specific vaccine candidates, including monkeypox and Marburg virus disease with the potential to expand to others using the Norovirus nanoparticle platform (“Co-Development Project”), and to govern the sharing of materials and information, as defined in the Co-Development Agreement, for the Co-Development Project. Under the Co-Development Agreement, AbVacc and the Company will collaborate, through a joint development committee, to establish and implement a development plan or statement of work for each Co-Development Project targeted product. Under the Co-Development Agreement, either the Company or AbVacc, whichever party is the primary sponsor of any resulting product (as defined in the Co-Development Agreement), will be obligated to compensate the other party for certain milestone payments that would range between $2.1 million and $4.75 million, plus royalties of between 2% to 4%. There is no fixed obligation for either party, and each party will be responsible for their own costs. The term of the Co-Development Agreement is three years from the effective date, unless previously terminated by either party, in accordance with the Co-Development Agreement. During the three and nine months ended September 30, 2023, the Company incurred approximately $2,000 and $21,000, respectively, in costs for research and development related to the Co-Development Agreement. As of September 30, 2023, the Company evaluated the likelihood of the Company achieving the specified milestones and generating product sales and determined that the likelihood is not yet probable and as such no accrual of these payments is required as of September 30, 2023.

Services Agreement

On July 21, 2023, the Company, entered into a Licensing and Services Master Agreement (“Master Services Agreement”) and a related statement of work with a vendor, pursuant to which the vendor will provide to the Company commercialization services for the Company’s products, including recruiting, managing, supervising and evaluating sales personnel and providing sales-related services for such products, for fees totaling up to $29.1 million over the term of the statement of work. The statement of work had a term through September 6, 2026, unless earlier terminated in accordance with the Master Services Agreement and the statement of work. On July 29, 2023, a second statement of work was entered into with the same vendor for certain subscription services providing prescription market data access to the Company. The fees under this statement of work totaled approximately $800,000, and the term was through July 14, 2025. As of September 30, 2023, the Company prepaid approximately $865,000 for commercialization services under the first statement of work. The Company also had approximately $898,000 recorded in related accounts payable as of September 30, 2023. As the prepayment can be applied against amounts invoiced from the vendor, the prepayment of approximately $865,000 has been offset against accounts payable in the accompanying condensed balance sheet. On October 12, 2023, the Company terminated the Master Services Agreement and statements of work (see Note 14).

Condensed Balance Sheets - USD ($)	Sep. 30, 2023	Dec. 31, 2022
Current assets
Cash	$ 7,653,975	$ 25,752,659
Inventories	1,419,272
Prepaid expenses and other current assets	467,738	469,232
Receivable from related parties, net		35,850
Total current assets	9,540,985	26,257,741
Prepaid expenses, long-term	55,499	38,617
Property and equipment, net	12,503	14,089
Deferred offering costs	366,113
Intangible asset	17,906,771
Total assets	27,881,871	26,310,447
Current liabilities
Accounts payable	3,176,332	1,499,296
Accrued expenses	1,538,544	2,409,128
Notes payable, net of debt discount of $569,907	12,920,093
Contingent warrant liability	10,461	14,021
Total current liabilities	17,645,430	3,922,445
Commitments and Contingencies (see Note 9)
Stockholders’ equity
Preferred stock, $0.00001 par value, 10,000,000 shares authorized at September 30, 2023 and December 31, 2022; 10,000 and 0 shares designated as Series A convertible preferred stock at September 30, 2023 and December 31, 2022, respectively; 0 shares issued and outstanding at September 30, 2023 and December 31, 2022
Common stock, $0.00001 par value, 250,000,000 shares authorized at September 30, 2023 and December 31, 2022; 18,336,597 and 15,724,957 shares issued at September 30, 2023 and December 31, 2022, respectively; 17,819,198 and 15,265,228 shares outstanding at September 30, 2023 and December 31, 2022, respectively	183	157
Additional paid-in-capital	45,297,371	42,331,155
Treasury stock, at cost; 517,399 and 459,729 shares of common stock at September 30, 2023 and December 31, 2022, respectively	(625,791)	(566,810)
Accumulated deficit	(34,435,322)	(19,376,500)
Total stockholders’ equity	10,236,441	22,388,002
Total liabilities and stockholders’ equity	$ 27,881,871	$ 26,310,447

Subsequent Events (Details) - USD ($)			1 Months Ended	9 Months Ended
Subsequent Events (Details) - USD ($)	Oct. 04, 2023	Oct. 03, 2023	Feb. 17, 2022	Sep. 30, 2023	Sep. 30, 2022	Oct. 12, 2023	Oct. 06, 2023
Subsequent Event [Line Items]
Purchase shares			2,222,222	5,709,935
WraSer bankruptcy and wraSer APA amendment description				The amendment, among other things, eliminates the $500,000 post-closing payment due June 13, 2024 and staggers the $4.5 million cash payment that the Company would otherwise have to pay at closing to: (i) $2.2 million to be paid at closing, (ii) $2.3 million, to be paid in monthly installments of $150,000 commencing January 2024 and (iii) 789 shares of Series A Preferred Stock to be paid at closing. The amendment also reduced the number of products we were acquiring by excluding pain medications and including only (i) Ciprofloxacin 0.3% and Fluocinolone 0.025% Otic Solution, under the trademark OTOVEL and its Authorized Generic Version approved under US FDA NDA No. 208251, (ii) Ciprofloxacin 0.2% Otic solution, under the trademark CETRAXAL, and (iii) Vorapaxar Sulfate tablets under the trademark Zontivity approved under US FDA NDA N204886.
Unvested restricted stock forfeited				168,860
Stock options (in Dollars)				$ 459	$ 1,655
Subsequent Event [Member]
Subsequent Event [Line Items]
Exercise price (in Dollars per share)		$ 3,000
Purchase shares		3,000,000
Bankruptcy recovering initial payament (in Dollars)							$ 3,500,000
Stock options (in Dollars)	$ 50,000
Termination fees (in Dollars)						$ 2,300,000
Chief Executive Officer [Member] \| Subsequent Event [Member]
Subsequent Event [Line Items]
Options granted	532,326
Chief Financial Officer [Member] \| Subsequent Event [Member]
Subsequent Event [Line Items]
Options granted	177,442
Unvested restricted stock forfeited	75,000

Commitments and Contingencies (Details) - USD ($)		3 Months Ended	9 Months Ended
Commitments and Contingencies (Details) - USD ($)	May 01, 2022	Sep. 30, 2023	Sep. 30, 2023
Commitments and Contingencies [Line Items]
Short-term lease	$ 14,000
Rent expenses			$ 51,000
Lease expense			4,000
Incurred rent expense.		$ 53,000	$ 89,000
Percentage of subscription			2.00%
Aggregate royalties amount			$ 115,100,000
Accured expenses			$ 91,000

Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2023

Accounting Policies [Abstract]

Summary of Significant Accounting Policies

Note 3 — Summary of Significant Accounting Policies

During the nine months ended September 30, 2023, there were changes to the Company’s significant accounting policies described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, as follows:

Use of Estimates

The preparation of 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 disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting periods. The most significant estimates in the Company’s financial statements relate to valuation of inventory, useful life of the amortizable intangible assets, estimates of future cash flows used to evaluate impairment, accrued research and development expenses, stock-based compensation, the valuation of preferred stock, and the valuation allowance of deferred tax assets resulting from net operating losses. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected.

Segment Information

Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker (“CODM”), or decision-making group, in deciding how to allocate resources and in assessing performance. Prior to the acquisition of ENTADFI® during the quarter ended June 30, 2023, the Company managed one distinct business segment, which was vaccine discovery and development. During the second quarter of 2023, as a result of the acquisition of ENTADFI® for which the Company is working towards commercial launch, the Company operated in two business segments: research and development and commercial. During the third quarter of 2023, the Company deprioritized its vaccine discovery and development programs, and accordingly, as of September 30, 2023, the Company was operating in one segment: commercial. Management’s determination that the Company operated as two segments during the second quarter of 2023 and one segment during the third quarter of 2023, was consistent with the financial information regularly reviewed by the CODM for purposes of evaluating performance, allocating resources, setting incentive compensation targets, and planning and forecasting for future periods.

Inventories

Inventories consist of raw materials, packaging materials, and work-in-process. Inventories are stated at the lower of cost or net realizable value, with cost determined on a first-in, first-out basis, aside from inventory acquired in an asset acquisition, which is recorded at fair value. The Company periodically reviews the composition of inventory in order to identify excess, obsolete, slow-moving or otherwise non-saleable items taking into account anticipated future sales compared with quantities on hand, and the remaining shelf life of goods on hand. If non-saleable items are observed and there are no alternate uses for the inventory, the Company records a write-down to net realizable value in the period that the decline in value is first recognized. The Company had no inventory reserves at September 30, 2023 and December 31, 2022.

Acquisitions

The Company evaluates acquisitions to first determine whether a set of assets acquired constitutes a business and should be accounted for as a business combination. If the assets acquired are not a business, the transaction is accounted as an asset acquisition in accordance with Accounting Standards Codification (“ASC”) 805-50, Asset Acquisitions (“ASC 805-50”), which requires the acquiring entity to recognize assets acquired and liabilities assumed based on the cost to the acquiring entity on a relative fair value basis, except for non-qualifying assets including financial assets such as inventory. Further, the cost of the acquisition includes the fair value of consideration transferred and direct transaction costs attributable to the acquisition. Goodwill is not recognized in an asset acquisition and any excess consideration transferred over the fair value of the net assets acquired is allocated to the identifiable assets based on relative fair values. Contingent consideration payments in asset acquisitions are recognized when the contingency is determined to be probable and reasonably estimable. If the assets acquired are a business, the Company accounts for the transaction as a business combination. Business combinations are accounted for by using the acquisition method of accounting. Under the acquisition method, assets acquired, and liabilities assumed are recorded at their respective fair values. The excess of the fair value of consideration transferred over the fair value of the net assets acquired is recorded as goodwill. Contingent consideration obligations are recorded at their fair values on the acquisition date and remeasured at their fair values each subsequent reporting period until the related contingencies are resolved. The resulting changes in fair values are recorded in earnings.

Intangible Assets

Intangible assets are reported at cost, less accumulated amortization. Intangible assets with finite lives are amortized over their estimated useful lives, starting when sales for the related product begin. Amortization is calculated using the straight-line method.

During the ordinary course of business, the Company has entered into certain license and asset purchase agreements. Potential milestone payments for development, regulatory, and commercial milestones are recorded when the milestone is probable of achievement. Upon a milestone being achieved, the associated milestone payment is capitalized and amortized over the remaining useful life for approved products, or expensed as research and development expense for milestones relating to products whose FDA approval has not yet been obtained.

Impairment of Long-Lived Assets

The Company reviews long-lived assets, including intangible assets with finite useful lives, for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable (a “triggering event”). Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the long-lived asset in relation to expectations, significant negative industry or economic trends, and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset to its carrying value. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of an asset are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset over its fair value, determined based on discounted cash flows. During the three and nine months ended September 30, 2023, the Company recorded an impairment loss of approximately $267,000 related to $267,000 of implementation costs incurred under cloud computing hosting arrangements that were capitalized during the three and nine months ended September 30, 2023. There were no other impairment losses on long-lived assets.

New Accounting Pronouncements

The Company’s management does not believe that any recently issued, but not yet effective, accounting standards if currently adopted would have a material effect on the accompanying condensed financial statements.

Condensed Statements of Cash Flows (Unaudited) (Parentheticals) - USD ($)	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Statement of Cash Flows [Abstract]
Acquisition of assets, including transaction costs	$ 79,771	$ 79,771

Net Loss Per Share

9 Months Ended

Sep. 30, 2023

Net Loss Per Share [Abstract]

Net Loss Per Share

Note 12 — Net Loss Per Share

Basic net loss per share is computed by dividing the net income or loss applicable to common shares by the weighted average number of common shares outstanding during the period. The weighted average number of shares of common stock outstanding includes (i) pre-funded warrants because their exercise requires only nominal consideration for delivery of shares, and (ii) the shares held in abeyance because there is no consideration required for delivery of the shares; it does not include any potentially dilutive securities or any unvested restricted shares of common stock. Certain restricted shares, although classified as issued and outstanding at September 30, 2023, are considered contingently returnable until the restrictions lapse and will not be included in the basic net loss per share calculation until the shares are vested. Unvested shares of the Company’s restricted stock do not contain non-forfeitable rights to dividends and dividend equivalents. Diluted earnings per share is computed using the weighted average number of common shares and, if dilutive, potential common shares outstanding during the period. Potential common shares consist of the Company’s warrants, options, and restricted shares. Diluted net loss per share is computed by giving effect to all potential shares of common stock, including warrants, stock options, and unvested restricted shares, to the extent they are dilutive.

The two-class method is used to determine earnings per share based on participation rights of participating securities in any undistributed earnings. Each share of preferred stock that includes rights to participate in distributed earnings is considered a participating security and the Company uses the two-class method to calculate net income available to the Company’s common stockholders per common share — basic and diluted.

	Three and Nine Months Ended September 30,
	2023		2022
Unvested shares of restricted stock		344,080		—
Options to purchase shares of common stock		1,378,855		1,383,801
Warrants		7,899,661		5,375,385
Total		9,622,596		6,759,186

Stockholders’ Equity (Details) - Schedule of Restricted Stock	9 Months Ended
	Sep. 30, 2023 $ / shares shares
Shares Granted or Issued, Share-Based Payment Arrangement [Abstract]
Number of Shares, Outstanding at beginning \| shares
Weighted Average Grant Date Fair Value, Outstanding at beginning \| $ / shares
Number of Shares, Granted \| shares	512,940
Weighted Average Grant Date Fair Value, Granted \| $ / shares	$ 1.01
Number of Shares, Forfeited / cancelled \| shares	(168,860)
Weighted Average Grant Date Fair Value, Forfeited / cancelled \| $ / shares	$ 1.02
Number of Shares, Vested \| shares
Weighted Average Grant Date Fair Value, Vested \| $ / shares
Number of Shares, Outstanding at ending \| shares	344,080
Weighted Average Grant Date Fair Value, Outstanding at ending \| $ / shares	$ 1.01

Related Party Transactions (Details) - USD ($)	3 Months Ended		9 Months Ended		12 Months Ended
Related Party Transactions (Details) - USD ($)	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022
Related Party Transaction [Line Items]
Fees under consulting agreement			$ 3,500,000
Repaid amount	$ 4,000,000		4,000,000
Selling, general, and administrative expenses	4,268,845	$ 2,694,254	8,337,615	$ 7,311,243
Miscellaneous payments					$ 36,000
CEO [Member]
Related Party Transaction [Line Items]
Related party transactions amounts					140,000
Receivable from related party	522,000		522,000
Repaid amount	0		0
CBO [Member]
Related Party Transaction [Line Items]
Related party transactions amounts					$ 100,000
Related Party [Member]
Related Party Transaction [Line Items]
Fees under consulting agreement			63,000
Selling, general, and administrative expenses	$ 100,000		$ 266,000

Condensed Statements of Stockholders’ Equity (Unaudited) (Parentheticals) - USD ($)	3 Months Ended
	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022
Statement of Stockholders' Equity [Abstract]
Issuance of common stock , net offering costs	$ 2.2	$ 1.1	$ 2.9

Summary of Significant Accounting Policies (Details) - USD ($)	3 Months Ended	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2023
Summary of Significant Accounting Policies [Line Items]
impairment loss of long lived assets	$ 267,000	$ 267,000

Income Taxes

9 Months Ended

Sep. 30, 2023

Income Taxes [Abstract]

Income Taxes

Note 11 — Income Taxes

No provision for federal, state or foreign income taxes has been recorded for the three and nine months ended September 30, 2023, and 2022. The Company has incurred net operating losses for all of the periods presented and has not reflected any benefit of such net operating loss carryforwards in the accompanying condensed financial statements due to uncertainty around utilizing these tax attributes within their respective carryforward periods. The Company has recorded a full valuation allowance against all of its deferred tax assets as it is not more likely than not that such assets will be realized in the near future. The Company’s policy is to recognize interest expense and penalties related to income tax matters as income tax expense. For the three and nine months ended September 30, 2023, and 2022, the Company has not recognized any interest or penalties related to income taxes.

- Definition

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480990/946-20-50-13

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(h)(2))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480678/235-10-S99-1

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org//740/tableOfContent

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 14
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482685/740-10-50-14

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 21
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482685/740-10-50-21

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 270
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482526/740-270-50-1

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 17
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482685/740-10-50-17

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SAB TOPIC 6.I.5.Q1)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147479360/740-10-S99-1

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 2
-Subparagraph (SAB Topic 11.C)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147479360/740-10-S99-2

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 30
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482603/740-30-50-2

+ Details

Significant Agreements (Details) - USD ($)			1 Months Ended			3 Months Ended	6 Months Ended	9 Months Ended
Significant Agreements (Details) - USD ($)	Mar. 27, 2023	Feb. 01, 2023	Jul. 31, 2023	May 21, 2021	Oct. 18, 2019	Sep. 30, 2023	Jun. 30, 2023	Sep. 30, 2023	Jul. 21, 2023	Jan. 09, 2020
Significant Agreements [Line Items]
Increase in investment project							$ 154,000
Research and development expenses						$ (56,000)		$ 231,000
Accounts payable and accrued expenses						900,000		900,000
Accrued expenses						496,000		988,000
Incurred amount						2,000		21,000
Total amount of fee expenses			$ 800,000
Maturity term			Jul. 14, 2025
prepayment of accrued expenses			$ 865,000
Accounts payable						$ 898,000		898,000
Minimum [Member]
Significant Agreements [Line Items]
Other party payments		$ 2,100,000
Royalties percentage		2.00%
Maximum [Member]
Significant Agreements [Line Items]
Other party payments		$ 4,750,000
Royalties percentage		4.00%
Vendor Agreement [Member]
Significant Agreements [Line Items]
Sales-related services fee									$ 29.1
prepayment of accrued expenses								$ 865,000
Oxford University Innovation Limited [Member]
Significant Agreements [Line Items]
OUI agreement expiration								10 years
Cincinnati Children’s Hospital Medical Center [Member]
Significant Agreements [Line Items]
Commercial sale term								10 years
Ology MSA. [Member]
Significant Agreements [Line Items]
Aggregate agreement amount initial agreement					$ 4,000,000
Payment for service										$ 100,000
Aggregate amount				$ 2,800,000
Cost plus, percentage				15.00%
Increase in investment project	$ 180,000
University of Texas Health Science Center at San Antonio [Member]
Significant Agreements [Line Items]
License fee, description								An initial non-refundable license fee of $100,000 was due upon execution of the agreement and subsequent annual license fees are due as follows: $20,000 per year for each of the four years ending on December 31, 2026; $40,000 per year for each of the two years ending on December 31, 2028, and $60,000 per year for the year ending December 31, 2029 and each year thereafter until expiration or termination of the UT Health agreement.

Acquisitions (Details) - Schedule of Aggregate Consideration Transferred Assets Acquired	9 Months Ended
	Sep. 30, 2023 USD ($)
Business Combinations [Abstract]
Consideration transferred at closing	$ 6,000,000
Fair value of notes payable issued	12,947,000
Transaction costs	79,771
Total consideration transferred	$ 19,026,771

Balance Sheet Details (Details) - Schedule of Accrued Expenses - USD ($)	Sep. 30, 2023	Dec. 31, 2022
Accrued Liabilities, Current [Abstract]
Accrued research and development	$ 548,287	$ 847,747
Accrued compensation	386,087	1,132,859
Accrued deferred offering costs	125,000	125,000
Accrued professional fees	216,000
Accrued implementation fees	106,287
Other accrued expenses	156,883	125,922
Accrued franchise taxes		177,600
Total	$ 1,538,544	$ 2,409,128

Stockholders’ Equity (Details) - Schedule of Stock-Based Compensation Expense - Stock Options [Member] - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Stockholders’ Equity [Line Items]
Total stock-based compensation expenses	$ 105,402	$ 329,809	$ 563,761	$ 1,796,268
Selling, general and administrative [Member]
Stockholders’ Equity [Line Items]
Total stock-based compensation expenses	89,832	255,115	362,191	1,193,743
Research and development [Member]
Stockholders’ Equity [Line Items]
Total stock-based compensation expenses	$ 15,570	$ 74,694	$ 201,570	$ 602,525