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Item 9A. Controls and Procedures

2024-03-28 compared with 2023-03-28 · 402 added, 347 removed, 574 unchanged (57% of the section changed)

1 unchanged sentence

Limitations of Internal Control System

Because of the inherent limitations in a cost-effective control system, no evaluation of internal control over financial reporting can provide absolute assurance that misstatements

due to error or fraud will not occur or that all control issues and instances of fraud, if any, within our company have been detected.

Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to

financial statement preparation and presentation.

Because of the inherent limitations in a cost-effective control system, no evaluation of internal control over financial reporting can provide absolute assurance that

misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, within our company have been detected.

Therefore, even those systems determined to be effective can provide only reasonable assurance

with respect to financial statement preparation and presentation.

Management does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent or detect all errors and all fraud.

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of the design and operation of our disclosure

controls and procedures, (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934 (the “Exchange Act”)), as of December 31, 2022.

Based on that evaluation, management has concluded that, as of such date,

our disclosure controls and procedures were effective at the reasonable assurance level.

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of the design and operation of our

disclosure controls and procedures, (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934 (the “Exchange Act”)), as of December 31, 2023.

Based on that evaluation, management has concluded that, as of

such date, our disclosure controls and procedures were effective at the reasonable assurance level.

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed by us in reports that we file or submit under the

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Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

In designing and evaluating our disclosure controls and procedures, management recognized that disclosure controls and procedures, no matter how well conceived and operated, can

provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met.

Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in

evaluating the cost-benefit relationship of possible disclosure controls and procedures.

The design of any disclosure controls and procedures also is based in part upon certain assumptions about the likelihood of future events, and there can be no

assurance that any design will succeed in achieving its stated goals under all potential future conditions

In designing and evaluating our disclosure controls and procedures, management recognized that disclosure controls and procedures, no matter how well conceived and operated,

can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met.

Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its

judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures.

The design of any disclosure controls and procedures also is based in part upon certain assumptions about the likelihood of future events, and

there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.

Management's Report on Internal Control over Financial Reporting

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Other Information

Not applicable.

During the three (3) months ended December 31, 2023, no director or officer adopted

or terminated any contract, instruction or written plan for the purchase or sale of company securities intended to satisfy the

affirmative defense conditions of Rule 10b5-1(c) of the Exchange Act and/or any non-Rule 10b5-1 trading arrangement.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.

Not applicable.

Certain information required by Part III is omitted from this Annual Report on Form 10-K because we will file a definitive Proxy Statement for the Annual Meeting of Stockholders

pursuant to Regulation 14A of the Securities Exchange Act of 1934 (the Proxy Statement), not later than 120 days after the end of the fiscal year covered by this Annual Report on Form 10-K, and the applicable information included in the Proxy

Statement is incorporated herein by reference.

Certain information required by Part III is omitted from this Annual Report on Form 10-K because we intend to file a definitive Proxy Statement for the Annual Meeting of

Stockholders pursuant to Regulation 14A of the Securities Exchange Act of 1934 (the Proxy Statement), not later than 120 days after the end of the fiscal year covered by this Annual Report on Form 10-K, and the applicable information included in

the Proxy Statement is incorporated herein by reference.

Directors, Executive Officers and Corporate Governance

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Exhibits, Financial Statement Schedules

The following documents are filed as part of this report:

(a) The following documents are filed as part of this report:

Financial Statements:

The information concerning our consolidated financial statements, and Report of Independent Registered Public Accounting Firm required by this Item is incorporated by reference

herein to the section of this Annual Report on Form 10-K in Item 8, entitled “(PCAOB ID 185 ) Financial Statements and Supplementary

The information concerning our consolidated financial statements, and Report of Independent Registered Public Accounting Firm (PCAOB ID 185 ) required by this Item is incorporated by reference herein to the section of this Annual Report on Form 10-K in Item 8, entitled “Financial

Statements and Supplementary Data”.

Financial Statement Schedules:

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information required is shown in the financial statements or the notes thereto.

The list of exhibits required by Item 601 of Regulation S-K is set forth in the Exhibit Index immediately preceding the signature page to this Annual Report on Form 10-K and is

incorporated herein by reference.

The list of exhibits required by Item 601 of Regulation S-K is set forth in the Exhibit Index immediately preceding the signature page to this Annual Report on Form 10-K and

is incorporated herein by reference.

Form 10-K Summary

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Agreement and Plan of Merger and Reorganization, dated November 23, 2018, by and among Edge Therapeutics, Inc., Echos Merger Sub, Inc.

and PDS Biotechnology Corporation (filed as Exhibit

2.1 to the Company’s Current Report on Form 8-K filed on November 26, 2018, and incorporated by reference herein).

Biotechnology Corporation (filed as Exhibit 2.1 to the Company’s Current Report on Form 8-K filed on November 26, 2018, and incorporated by reference herein).

Amendment No.

1 to Agreement and Plan of Merger and Reorganization, dated January 24, 2019, by and among Edge Therapeutics, Inc., Echos Merger Sub, Inc.

and PDS Biotechnology Corporation

(filed as Exhibit 2.1 to the Company’s Current Report on Form 8-K filed on January 30, 2019, and incorporated by reference herein).

1 to Agreement and Plan of Merger and Reorganization, dated January 24, 2019, by and among Edge Therapeutics, Inc., Echos Merger Sub,

and PDS Biotechnology Corporation (filed as Exhibit 2.1 to the Company’s Current Report on Form 8-K filed on January 30, 2019, and incorporated by reference herein).

Eighth Amended and Restated Certificate of Incorporation of Edge Therapeutics, Inc.

(filed as Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on October 6, 2015, and

incorporated by reference herein).

Third Amended and Restated Bylaws of PDS Biotechnology Corporation (filed as Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on March 15, 2022, and incorporated by reference

Certificate of Amendment to Amended and Restated Certificate of Incorporation (filed as Exhibit 3.1 to the Company’s Current Report on Form 8-K on March 18, 2019, and incorporated by

reference herein).

Certificate of Amendment to Amended and Restated Certificate of Incorporation (filed as Exhibit 3.2 to the Company’s Current Report on Form 8-K on March 18, 2019, and incorporated by

reference herein).

(filed as Exhibit 3.1 to the Company’s Current Report on Form 8-K

filed on October 6, 2015, and incorporated by reference herein).

Third Amended and Restated Bylaws of PDS Biotechnology Corporation (filed as Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on March

15, 2022, and incorporated by reference herein).

Certificate of Amendment to Amended and Restated Certificate of Incorporation (filed as Exhibit 3.1 to the Company’s Current Report on Form 8-K on

March 18, 2019, and incorporated by reference herein).

Certificate of Amendment to Amended and Restated Certificate of Incorporation (filed as Exhibit 3.2 to the Company’s Current Report on Form 8-K on

March 18, 2019, and incorporated by reference herein).

Form of Certificate of Common Stock (filed as Exhibit 4.1 to the Company’s Pre-Effective Amendment No.

1 to the registration statement on Form S-1 (File No.

333- 206416) filed on

September 21, 2015, and incorporated by reference herein).

Description of Securities (filed as Exhibit 4.10 to the Company’s Annual Report on Form 10-K filed on March 27, 2020, and incorporated by reference herein).

1 to the registration statement on Form S-1

333- 206416) filed on September 21, 2015, and incorporated by reference herein).

Description of Securities (filed as Exhibit 4.10 to the Company’s Annual Report on Form 10-K filed on March 27, 2020, and incorporated by reference

Form of Indenture (filed as Exhibit 4.3 to the Company’s registration statement on Form S-3 (File No.

333-267041) on August 24, 2022, and incorporated by reference herein).

Form of Warrant issued under the Venture Loan and Security Agreement, dated August 24, 2022 (filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q on November 14, 2022, and

333-267041) on August 24, 2022, and

incorporated by reference herein).

Venture Loan and Security Agreement, dated August 24, 2022, by and among Horizon Technology Finance Corporation, as a lender and collateral agent, Powerscourt Investments XXV, LP, as a

lender, PDS Operating Corporation, as a guarantor, and PDS Biotechnology Corporation, as borrower (filed as Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q on November 14, 2022, and incorporated by reference herein).

Clinical Trial Collaboration and Supply Agreement, dated May 19, 2017, by and between PDS Biotechnology Corporation and MSD International GmbH (filed as Exhibit 10.24 to the Company’s

Registration Statement on Form S-4/A on January 25, 2019, and incorporated by reference herein).

Patent License Agreement, dated January 5, 2015, by and between PDS Biotechnology Corporation and National Institutes of Health, as amended by First Amendment, dated August 5, 2015 (filed

as Exhibit 10.25 to the Company’s Registration Statement on Form S-4/A on January 25, 2019, and incorporated by reference herein).

Cost Reimbursement Agreement, dated November 1, 2015, by and between PDS Biotechnology Corporation and University of Kentucky Research Foundation (filed

Form of Warrant issued under the Venture Loan and Security Agreement, dated August 24, 2022 (filed as Exhibit 10.1 to the Company’s Quarterly Report

on Form 10-Q on November 14, 2022, and incorporated by reference herein).

Venture Loan and Security Agreement, dated August 24, 2022, by and among Horizon Technology Finance Corporation, as a lender and collateral agent,

Powerscourt Investments XXV, LP, as a lender, PDS Operating Corporation, as a guarantor, and PDS Biotechnology Corporation, as borrower (filed as Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q on November 14, 2022, and

incorporated by reference herein).

Clinical Trial Collaboration and Supply Agreement, dated May 19, 2017, by and between PDS Biotechnology Corporation and MSD International GmbH (filed

as Exhibit 10.24 to the Company’s Registration Statement on Form S-4/A on January 25, 2019, and incorporated by reference herein).

Cost Reimbursement Agreement, dated November 1, 2015, by and between PDS Biotechnology Corporation and University of Kentucky Research Foundation (filed as Exhibit 10.27 to the Company’s

Registration Statement on Form S-4/A on January 25, 2019, and incorporated by reference herein).

Public Health Service Cooperative Research & Development Agreement for Intramural-PHS Clinical Research, dated effective as of February 2, 2015, by and between the National Cancer

Institute and PDS Biotechnology Corporation (filed as Exhibit 10.28 to the Company’s Registration Statement on Form S-4/A on January 25, 2019, and incorporated by reference herein).

DOTAP Chloride Enantiomer License Agreement effective November 1, 2008, between Merck Eprova AG and PDS Biotechnology Corporation (filed as Exhibit 10.29 to the Company’s Registration

Statement on Form S-4/A on January 25, 2019, and incorporated by reference herein).

License Agreement dated as of December 30, 2022 by and between Merck KGaA, Darmstadt, Germany and PDS Biotechnology Corporation.

Patent License Agreement, dated January 5, 2015, by and between PDS Biotechnology Corporation and National Institutes of Health, as amended by First

Amendment, dated August 5, 2015 (filed as Exhibit 10.25 to the Company’s Registration Statement on Form S-4/A on January 25, 2019, and incorporated by reference herein).

Cost Reimbursement Agreement, dated November 1, 2015, by and between PDS Biotechnology Corporation and University of Kentucky Research Foundation

(filed as Exhibit 10.27 to the Company’s Registration Statement on Form S-4/A on January 25, 2019, and incorporated by reference herein).

Public Health Service Cooperative Research & Development Agreement for Intramural-PHS Clinical Research, dated effective as of February 2, 2015,

by and between the National Cancer Institute and PDS Biotechnology Corporation (filed as Exhibit 10.28 to the Company’s Registration Statement on Form S-4/A on January 25, 2019, and incorporated by reference herein).

DOTAP Chloride Enantiomer License Agreement effective November 1, 2008, between Merck Eprova AG and PDS Biotechnology Corporation (filed as Exhibit

10.29 to the Company’s Registration Statement on Form S-4/A on January 25, 2019, and incorporated by reference herein).

License Agreement dated as of December 30, 2022 by and between Merck KGaA, Darmstadt, Germany and PDS Biotechnology Corporation (filed as Exhibit

10.9 to the Company’s Annual Report on Form 10-K filed on March 28, 2023, and incorporated by reference herein).

Share Transfer Agreement by and between PDS Biotechnology Corporation and Merck KGaA, Darmstadt, Germany.

(filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K on January 3,

(filed as Exhibit 10.1 to the Company’s

Current Report on Form 8-K on January 3, 2023, and incorporated by reference herein).

PDS Biotechnology 2010 Equity Incentive Plan, and forms of agreement thereunder (filed as Exhibit 10.2 to the Company’s Registration Statement on

Form S-1/A on September 21, 2015, and incorporated by reference herein).

Third Amended and Restated PDS Biotechnology Corporation 2014 Equity Incentive Plan (filed as Exhibit 10.1 to the Company’s Current Report on Form

8-K on July 17, 2023, and incorporated by reference herein).

Employee Stock Option Agreement under the Second Amended and Restated PDS Biotechnology Corporation 2014 Equity Incentive Plan (filed as Exhibit 10.4

to the Company’s Current Report on Form 8-K filed on December 9, 2020, and incorporated by reference herein).

PDS Biotechnology Corporation 2009 Stock Option Plan, as amended (filed as Exhibit 99.1 to the Company’s Registration Statement on Form S-8 on June

4, 2019, and incorporated by reference herein).

PDS Biotechnology 2010 Equity Incentive Plan, and forms of agreement thereunder (filed as Exhibit 10.2 to the Company’s Registration Statement on Form S-1/A on September 21, 2015, and

incorporated by reference herein).

Second Amended and Restated PDS Biotechnology Corporation 2014 Equity Incentive Plan (filed as Exhibit 10.3 to the Company’s Current Report on Form 8-K on December 9, 2020, and

PDS Biotechnology Corporation 2018 Stock Option Plan (filed as Exhibit 99.2 to the Company’s Registration Statement on Form S-8 on June 4, 2019, and

incorporated by reference herein).

Employee Stock Option Agreement under the Second Amended and Restated PDS Biotechnology Corporation 2014 Equity Incentive Plan (filed as Exhibit 10.4 to the Company’s Current Report on

Form 8-K filed on December 9, 2020, and incorporated by reference herein).

PDS Biotechnology Corporation 2009 Stock Option Plan, as amended (filed as Exhibit 99.1 to the Company’s Registration Statement on Form S-8 on June 4, 2019, and incorporated by reference

PDS Biotechnology Corporation 2018 Stock Option Plan (filed as Exhibit 99.2 to the Company’s Registration Statement on Form S-8 on June 4, 2019, and incorporated by reference herein).

Form of PDS Biotechnology Corporation Option Agreement for 2009 Stock Option Plan, as amended (filed as Exhibit 99.3 to the Company’s Registration Statement on Form S-8 on June 4, 2019,

Form of PDS Biotechnology Corporation Option Agreement for 2009 Stock Option Plan, as amended (filed as Exhibit 99.3 to the Company’s Registration

Statement on Form S-8 on June 4, 2019, and incorporated by reference herein).

Form of PDS Biotechnology Corporation Option Agreement for 2018 Stock Incentive Plan (filed as Exhibit 99.4 to the Company’s Registration Statement

on Form S-8 on June 4, 2019, and incorporated by reference herein).

PDS Biotechnology Corporation 2019 Inducement Plan, as amended (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on January

22, 2024, and incorporated by reference herein).

Form of PDS Biotechnology Corporation Option Agreement for 2018 Stock Incentive Plan (filed as Exhibit 99.4 to the Company’s Registration Statement on Form S-8 on June 4, 2019, and

incorporated by reference herein).

PDS Biotechnology Corporation 2019 Inducement Plan, as amended (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on May 18, 2022, and incorporated by reference

Form of Stock Option Grant Notice and Stock Option Agreement under the 2019 Inducement Plan (filed as Exhibit 10.2 to the Company’s Current Report on Form 8-K on June 20, 2019, and

incorporated by reference herein).

Form of Indemnification Agreement for officers and directors (filed as Exhibit 10.9 to the Company’s Registration Statement on Form S-1 on August 14, 2015, and incorporated by reference

Common Stock Purchase Agreement, dated July 29, 2019, by and among the Company and Aspire Capital Fund, LLC (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K on July 30,

Form of Stock Option Grant Notice and Stock Option Agreement under the 2019 Inducement Plan (filed as Exhibit 10.2 to the Company’s Current Report on

Form 8-K on June 20, 2019, and incorporated by reference herein).

Form of Indemnification Agreement for officers and directors (filed as Exhibit 10.9 to the Company’s Registration Statement on Form S-1 on August 14,

2015, and incorporated by reference herein).

Sublease Agreement, effective as of March 5, 2020, by and between PDS Biotechnology Corporation and COWI North America, Inc.

(filed as Exhibit 10.37 to the Company’s Annual Report on Form

10-K filed on March 27, 2020, and incorporated by reference herein).

(filed as Exhibit 10.37

to the Company’s Annual Report on Form 10-K filed on March 27, 2020, and incorporated by reference herein).

Patent License Agreement dated as of November 5, 2021, by and between PDS Biotechnology Corporation and the U.S.

Department of Health and Human Services, as represented by the National

Cancer Institute (filed as Exhibit 10.19 to the Company’s Annual Report on Form 10-K filed on March 31, 2022, and incorporated by reference herein).

Department of Health and Human

Services, as represented by the National Cancer Institute (filed as Exhibit 10.19 to the Company’s Annual Report on Form 10-K filed on March 31, 2022, and incorporated by reference herein).

Option Agreement with University of Georgia Research Foundation, Inc.

effective as of October 25, 2021 (filed as Exhibit 10.20 to the Company’s Annual Report on Form 10-K filed on March 31, 2022, and

incorporated by reference herein).

PDS Biotechnology Corporation Change of Control Severance Plan effective as of March 14, 2022 (filed as Exhibit 10.21 to the Company’s Annual Report on Form 10-K filed on March 31, 2022, and incorporated by

reference herein)

Amended and Restated Executive Employment Agreement by and between Frank K.

Bedu-Addo and PDS Biotechnology Corporation, effective as of March 14, 2022 (filed as Exhibit 10.22 to the Company’s Annual Report

effective as of October 25, 2021 (filed as Exhibit 10.20 to the Company’s

Annual Report on Form 10-K filed on March 31, 2022, and incorporated by reference herein).

PDS Biotechnology Corporation Change of Control Severance Plan effective as of March 14, 2022 (filed as Exhibit 10.21 to the Company’s Annual Report

on Form 10-K filed on March 31, 2022, and incorporated by reference herein)

Amended and Restated Executive Employment Agreement by and between Frank K.

Bedu-Addo and PDS Biotechnology Corporation, effective as of March 14,

2022 (filed as Exhibit 10.22 to the Company’s Annual Report on Form 10-K filed on March 31, 2022, and incorporated by reference herein).

Executive Employment Agreement by and between Gregory Conn, Ph.D.

and PDS Biotechnology Corporation, effective as of March 14, 2022 (filed as Exhibit 10.23 to the Company’s Annual Report on Form 10-K filed on

March 31, 2022, and incorporated by reference herein).

Executive Employment Agreement by and between Matthew Hill and PDS Biotechnology Corporation, effective as of March 14, 2022(filed as Exhibit 10.24 to the Company’s Annual Report on Form 10-K filed on March

31, 2022, and incorporated by reference herein).

Executive Employment Agreement by and between Lauren V.

and PDS Biotechnology Corporation, effective as of March 14, 2022 (filed as Exhibit 10.25 to the Company’s Annual Report on Form 10-K filed

on March 31, 2022, and incorporated by reference herein).

Executive Employment Agreement by and between Spencer Brown and PDS Biotechnology Corporation, effective as of June 1, 2022 (filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed on

August 8, 2022, and incorporated herein by reference).

and PDS Biotechnology Corporation, effective as of March 14, 2022 (filed as

Exhibit 10.23 to the Company’s Annual Report on Form 10-K filed on March 31, 2022, and incorporated by reference herein).

Executive Employment Agreement by and between Lars Boesgaard and PDS Biotechnology Corporation, effective as of November 28, 2023

Executive Employment Agreement by and between Kirk V.

Shephard, M.D.

and PDS Biotechnology Corporation, effective as of January 22, 2024.

Executive Employment Agreement by and between Spencer Brown and PDS Biotechnology Corporation, effective as of June 1, 2022 (filed as Exhibit 10.1

to the Company’s Quarterly Report on Form 10-Q filed on August 8, 2022, and incorporated herein by reference).

PDS Biotechnology Corporation Policy on Insider Trading

Subsidiary of PDS Biotechnology Corporation.

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Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).

Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document)

PDS Biotechnology Corporation Policy for Recovery of Erroneously Awarded Incentive Compensation.

Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the

Inline XBRL document)

Inline XBRL Taxonomy Extension Schema Document

Inline XBRL Taxonomy Extension Calculation Linkbase Document

Inline XBRL Taxonomy Extension Definition Linkbase Document

Inline XBRL Taxonomy Extension Label Linkbase Document

Inline XBRL Taxonomy Extension Presentation Linkbase Document

Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101)

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Certain portions of this exhibit have been redacted pursuant to Item 601(b)(10)(iv) of Regulation S-K.

Pursuant to the requirements of the Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this Form 10-K to be signed on its behalf by the undersigned, thereunto

duly authorized.

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this Form 10-K to be signed on its behalf by the undersigned,

thereunto duly authorized.

PDS Biotechnology Corporation

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March 28, 2024

/s/ Matthew Hill

/s/ Lars Boesgaard

Lars Boesgaard

Chief Financial Officer

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(Principal Executive Officer)

/s/ Matthew Hill

/s/ Lars Boesgaard

Chief Financial Officer

March 28, 2024

Lars Boesgaard

(Principal Financial and Accounting Officer)

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Report of Independent Registered Public Accounting Firm

To the Stockholders and Board of Directors

To the Stockholders and Board of

PDS Biotechnology Corporation:

Opinion on the Consolidated Financial Statements

We have audited the accompanying consolidated balance sheets of PDS Biotechnology Corporation and subsidiary (the Company) as of December 31, 2022 and 2021, the related consolidated

statements of operations and comprehensive loss, changes in stockholders’ equity, and cash flows for the years then ended, and the related notes (collectively, the consolidated financial statements).

In our opinion, the consolidated financial

statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for the years then ended, in conformity with U.S.

accepted accounting principles.

We have audited the accompanying consolidated balance sheets of PDS Biotechnology Corporation and subsidiary (the Company) as

of December 31, 2023 and 2022, the related consolidated statements of operations and comprehensive loss, changes in stockholders’ equity, and cash flows for the years then ended, and the related notes

(collectively, the consolidated financial statements).

In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and 2022, and the results

of its operations and its cash flows for each of the years then ended, in conformity with U.S.

generally accepted accounting principles.

Going Concern

The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern.

As discussed in

Note 3 to the consolidated financial statements, the Company has experienced net losses and negative cash flows from operations that raise substantial doubt about its ability to continue as a going

Management’s plans in regard to these matters are also described in Note 3.

The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Basis for Opinion

These consolidated financial statements are the responsibility of the Company’s management.

Our responsibility is to express an opinion on these consolidated financial statements based on

We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S.

federal securities

laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB.

Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the

consolidated financial statements are free of material misstatement, whether due to error or fraud.

The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.

As part of our

audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting.

Accordingly, we

express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures

that respond to those risks.

Our responsibility is to express an opinion on these

consolidated financial statements based on our audit.

We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in

accordance with the U.S.

federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audit in accordance with the standards of the PCAOB.

Those standards require that we plan and perform the audit to obtain

reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.

The Company is not required to have, nor were we engaged to perform, an audit of its internal control

over financial reporting.

As part of our audit, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control

over financial reporting.

Accordingly, we express no such opinion.

Our audit included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to

error or fraud, and performing procedures that respond to those risks.

Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements.

Our audits also included evaluating the accounting principles used and

significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.

We believe that our audits provide a reasonable basis for our opinion.

Our audit also included

evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.

We believe that our audit provides a reasonable basis for our

Critical Audit Matters

Critical audit matters are matters arising from the current period audit

of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that:

(1) relate to accounts or disclosures that are material to the consolidated financial statements and (2) involved

our especially challenging, subjective, or complex judgments.

We determined that there are no critical audit matters.

Critical audit matters are matters arising from the current period audit of the consolidated financial statements that were communicated or

required to be communicated to the audit committee and that:

(1) relate to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments.

determined that there are no critical audit matters.

We have served as the Company’s auditor since 2019.

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Accrued expenses

Notes payable - short term

Financing lease obligation - short term

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Noncurrent liabilities:

Note payable, net of debt discount

Notes payable, net of debt discount

Financing lease obligation-long term

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( 144,500,615

( 101,558,417

Total stockholders’ equity

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Stock-based compensation expense

Issuance of common stock from 401K match

Issuances of common stock, from exercise of stock options

Balance - March 31, 2022

Stock-based compensation expense

Issuance of common stock from 401K match

Issuance of common stock, from exercise of stock options

Issuances of common stock, net of issuance costs

Issuances of common stock, from exercise of stock options

Balance - June 30 , 2022

Stock-based compensation expense

Issuance of common stock, from exercise of stock options

Issuance of warrants

Balance September 30, 2022

Stock-based compensation expense

Issuance of common stock, from exercise of stock options

Issuances of common stock, from exercise of stock options

Net shares for settlements of equity awards and taxes

Issuance of common stock for licensing agreement

Issuances of common stock from the Sales Agreement, net

Balance - December 31, 2022

( 101,558,417

Shares Issued

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January 1, 2023

( 101,558,417

Stock-based compensation expense

Issuances of common stock, from exercise of stock options

Issuances of common stock from the Sales Agreement, net

Balance - March 31, 2023

( 111,218,335

Stock-based compensation expense

Issuances of common stock, from exercise of stock options

Issuance of common stock for consulting agreement

Issuance of common stock from the Sales Agreement, net

Balance - June 30 , 2023

( 122,753,230

Stock-based compensation expense

Issuance of warrants

Issuance of common stock from the Sales Agreement, net

Balance - September 30, 2023

( 133,602,399

Stock-based compensation expense

Issuances of common stock, from exercise of stock options

Net shares for settlements of equity awards and taxes

Issuance of common stock for licensing agreement

Issuance of common stock from ATM

Issuance of common stock for consulting agreement

Issuance of common stock from the Sales Agreement, net

Balance - December 31, 2023

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Issuance of shares in licensing agreement

Stock-based 401K company common match

Issuance of shares in consulting agreement

Amortization of debt discount

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Proceeds from exercise of stock options

Payments of finance lease obligations

Payment of taxes in equity transaction

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Net cash provided by financing activities

Net increase in cash and cash equivalents

Net (decrease) increase in cash and cash equivalents

Cash and cash equivalents at beginning of period

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Note 1 – Nature of Operations

PDS Biotechnology Corporation, a Delaware

corporation (the “Company” or “PDS Biotech”), is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted immunotherapies designed to overcome the limitations of current immunotherapy and vaccine

technologies.

The Company’s proprietary T cell activating platforms designed to train the immune system to attack and destroy disease;

Versamune, and Versamune plus PDS0301 for treatments in oncology and Infectimune, for treatments in

infectious disease.

When paired with an antigen, which is a disease-related protein that is recognizable by the immune system, Versamune and Infectimune have both been shown to induce, in vivo, large quantities of high-quality, highly potent polyfunctional CD4 helper and CD8 killer T

cells, a specific sub-type of T cell that is more effective at killing infected or target cells.

PDS Biotechnology Corporation, a Delaware corporation (the “Company” or “PDS Biotech”), is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted

immunotherapies designed to overcome the limitations of current immunotherapy and vaccine technologies.

The Company develops proprietary platforms designed to train and enable the immune system to attack and destroy disease;

and Versamune® in combination with PDS01ADC for treatments in oncology and Infectimune® for treatments in infectious diseases.

When paired with an antigen, which is a disease-related protein that is recognizable by the immune system,

Versamune® and Infectimune® have both been shown to induce, in vivo, large quantities of high-quality, highly potent polyfunctional CD4

helper and CD8 killer T cells, a specific sub-type of T cell that is more effective at killing infected or target cells.

PDS01ADC is a novel investigational tumor-targeting fusion protein of Interleukin 12 that enhances the proliferation,

potency, infiltration and longevity of T cells in the tumor microenvironment and is therefore designed to overcome the limitations of cytokine therapy which today has resulted in high toxicity and limited therapeutic potential.

Infectimune® is also designed to promote the induction of disease-specific neutralizing antibodies.

The Company’s immuno-oncology product

candidates are of potential interest for use as a component of combination product candidates (for example, in combination with other leading technologies such as immune checkpoint inhibitors) to provide more effective treatments across a

range of advanced and/or refractory cancers.

The Company is also evaluating our immunotherapies as monotherapies in early-stage disease.

PDS is developing targeted product candidates to treat several cancers including Human

Papillomavirus (HPV)-associated cancers, melanoma, colorectal, lung, breast and prostate cancers.

The Company infectious disease candidates are of potential interest for use in COVID-19 and universal influenza vaccines.

PDS has developed numerous patents and patent applications and owns substantial know-how and trade secrets related to its

Versamune platform.

As of December 31, 2022, PDS holds seven ( 7 ) U.S.

patents with granted claims directed to its platform technology and nineteen

( 19 ) pending U.S.

The Company’s immuno-oncology product candidates are of potential interest for use as a component of combination product candidates (for

example, in combination with other leading technologies such as immune checkpoint inhibitors) to provide more effective treatments across a range of advanced and/or refractory cancers.

The Company is also evaluating its immunotherapies as

monotherapies in early-stage disease.

The Company is developing targeted product candidates to treat several cancers, including Human Papillomavirus (HPV) associated cancers, melanoma, colorectal, lung, breast and prostate cancers.

Company’s infectious disease candidate is of potential interest for use in universal influenza vaccines.

The Company has received numerous patents, submitted patent applications and owns substantial know-how and trade secrets

related to its Versamune® and PDS01ADC product platforms.

PDS Biotech holds thirteen ( 13 ) U.S.

granted claims directed to its platform technology and twenty-four ( 24 ) pending U.S.

patent applications.

These issued patents will expire in 2026, 2029, 2031 and 2033.

Should the more recently

submitted patent applications currently in prosecution be issued, these will expire in 2033 through 2043 assuming no patent term extensions are granted.

As of March 1, 2023, PDS holds seventy one ( 71 ) issued foreign patents and thirty-eight ( 38 ) pending or

published foreign patent applications.

Most of our international issued patents are issued in multiple countries including Europe, Japan and Australia, and all of which cover compositions of matter and methods of use related to its platform

These issued patents will expire in 2026 to 2037.

Should the more recently submitted patent applications currently in prosecution be issued, these

will expire in 2033 through 2043 assuming no patent term extensions are granted.

As of March 1, 2024, PDS Biotech holds seventy-four

( 74 ) issued foreign patents and forty-four

( 44 ) pending or published foreign patent applications.

Most of the Company’s international issued patents are issued in multiple

countries including Europe, Japan and Australia, and all of which cover compositions of matter and methods of use related to its platform technology.

These issued patents will expire in 2028-2037, or later if patent term extension applies.

Most recently, the USPTO allowed two

( 2 ) applications methods of use related to the platform technology which when granted will run until November 2036.

Included in the patents above is a patent protecting the use of Versamune® in combination

wit h PDS01ADC.

Licensed patents

The Company has licensed patented antigens

from the US government for use in our cationic lipid immunotherapies.

The Company has licensed T cell receptor gamma alternate reading frame protein (“TARP”) from the

National Cancer Institute (“NCI”) to develop and commercialize TARP peptide-based therapies in combination with the Company’s Versamune technology and any other of the Company’s proprietary technologies for prostate and breast cancers and

Acute Myeloid Leukemia.

These patents are directed to Immunogenic Peptides and Peptide Derivatives for The Treatment of Prostate and Breast Cancer Treatment and Multi-Epitope TARP Peptide Vaccine and Uses

These antigens are incorporated in PDS0102 with Versamune.

The Company has licensed patented antigens from the U.S.

government for use in its cationic lipid immunotherapies.

The Company has licensed T cell receptor gamma alternate reading frame protein (“TARP”)

from the National Cancer Institute (“NCI”) to develop and commercialize TARP peptide-based therapies in combination with the Company’s Versamune® technology and any other of the Company’s proprietary technologies for prostate and breast

cancers and acute myeloid leukemia.

These patents are directed to immunogenic peptides and peptide derivatives for the treatment of prostate and breast cancer treatment and multi-epitope TARP peptide vaccine and uses thereof.

These licensed

antigens are incorporated in PDS0102 with Versamune®.

The Company has licensed mucin-1 (“MUC1”) novel highly immunogenic agonist epitopes of MUC1 developed by the National Cancer Institute.

MUC1 is highly expressed in

multiple solid tumors and has been shown to be associated with drug resistance and poor disease prognosis in breast, colorectal, lung and ovarian cancers, for which PDS0103 is being developed.

The Company has been granted patents and are

pursuing additional patents that cover compositions and methods of use of cationic lipid immunotherapies with each of the licensed technologies .

MUC1 is highly expressed in multiple solid tumors

and has been shown to be associated with drug resistance and poor disease prognosis in breast, colorectal, lung and ovarian cancers, for which PDS0103 is being developed.

The Company has been granted patents and is pursuing additional

patents that cover compositions and methods of use of cationic lipid immunotherapies with each of the licensed technologies.

The Company entered into a non-exclusive agreement to license Computationally Optimized Broadly Reactive Antigen (COBRA) with

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Ted Ross at the University of Georgia.

Management believes that the combination of these antigens with our proprietary Versamune technology has potential to

induce a broad immune response as a universal flu vaccine.

The Company believes the combination of these antigens along with its proprietary Versamune® technology has the potential to induce a broad immune response as a universal

Exclusive License Agreement

On December 30, 2022, the Company entered into a License Agreement (the “License Agreement”) with Merck KGaA,

Darmstadt, Germany, pursuant to which Merck KGaA, Darmstadt, Germany has granted the Company an exclusive (even as to Merk KGaA), worldwide, sublicensable, milestone and royalty-bearing right and license to certain patent rights and certain

related data (the “Licensed Technology”) to develop, manufacture, use, commercialize and otherwise exploit any product containing NHS-IL12 fusion protein known as M9241, now PDS0301.

Darmstadt, Germany, pursuant to which Merck KGaA, Darmstadt, Germany has granted the Company an exclusive (even as to Merck KGaA), worldwide, sublicensable, milestone and royalty-bearing right and license to certain patent rights and

certain related data (the “Licensed Technology”) to develop, manufacture, use, commercialize and otherwise exploit any product containing NHS-IL12 fusion protein formerly known as M9241, now PDS01ADC.

In consideration for the rights granted by Merck KGaA, Darmstadt, Germany, the Company (i) agreed to make a one-time

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Pursuant to the License Agreement, the Company agreed to make certain

commercial sale milestone and royalty payments.

commercial sales milestone and royalty payments.

Note 2 – Summary of Significant Accounting Policies

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GAAP requires management to make estimates and

assumptions that affect the reported amounts of assets and liabilities and the reported amounts of revenues and expenses at the date of the consolidated financial statements and during the reporting periods, and to disclose contingent assets

and liabilities at the date of the consolidated financial statements.

assumptions that affect the reported amounts of assets and liabilities and the reported amounts of expenses at the date of the consolidated financial statements and during the reporting periods, and to disclose contingent assets and

liabilities at the date of the consolidated financial statements.

Actual results could differ from those estimates.

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the clinical and regulatory development of its products, the Company’s ability to preserve its cash resources, the Company’s ability to add product candidates to its pipeline, the Company’s

intellectual property, competition from products manufactured and sold or being developed by other companies, the price of, and demand for, Company products if approved for sale, the Company’s ability to negotiate favorable licensing or other

manufacturing and marketing agreements for its products, and the Company’s ability to raise capital.

intellectual property, the Company’s ability to complete clinical trials necessary to obtain regulatory product licenses, competition from products manufactured and sold or being developed by other companies, the price of, and demand for,

Company products if approved for sale, the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products, and the Company’s ability to raise capital.

The Company currently has no commercially approved products.

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Under the terms of the License Agreement,

the Company agreed to $ 5 million in an initial payment in cash and an additional $ 5 million in Company Stock, plus future milestone and royalty payments.

The Company accounts for milestone payments as expense in research and development and royalties

as a reduction in revenues.

the Company agreed to an initial payment of $ 5 million in cash and an additional $ 5 million in Company Stock, plus future milestone and royalty payments.

The Company accounts for milestone payments as expenses in research and development and royalties

are recorded as a reduction in revenues.

Patent costs:

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liabilities to be recognized for the future tax consequences attributable to net operating loss carryforwards and for differences between the financial statement carrying amounts and the respective tax bases of assets and liabilities.

Deferred tax assets are reduced if necessary, by a valuation allowance if it is more likely than not that some portion or all of the deferred tax assets will not be realized.

Valuation allowances are recorded to reduce deferred tax assets to the amount that will more likely than not be realized.

Fair value of financial instruments:

FASB ASC 820, Fair Value Measurement Disclosures, specifies a hierarchy of valuation techniques based on whether the inputs to

those valuation techniques are observable or unobservable.

ASC Topic 820, Fair Value Measurement Disclosures, specifies a hierarchy of valuation techniques based on whether the inputs

to those valuation techniques are observable or unobservable.

Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions.

The hierarchy gives the highest priority to unadjusted

quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement).

The hierarchy gives the highest priority to

unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement).

The three levels of the fair value hierarchy are as follows:

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and at least one significant model assumption or input is unobservable.

The Company determines if an arrangement is a lease at inception and recognizes the lease in accordance with ASC 842, Lease Accounting.

Operating leases are included in right-of-use ("ROU") assets, current portion, lease

liability and long-term lease liability in the Company's consolidated balance sheets.

ROU assets represent the right to use an underlying asset for the lease term and lease liabilities represent the Company's obligation to make lease

payments arising from the lease.

The Company determines if an arrangement is a lease at inception and recognizes the lease in accordance with ASC Topic 842, Leases.

Both financing and operating leases are included in right-of-use (ROU) assets, lease

obligations short-term and lease obligations long-term in the Company’s consolidated balance sheets.

ROU assets represent the right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation

to make lease payments arising from the lease.

Operating lease ROU assets and liabilities are recognized at the lease commencement date based on the present value of the lease payments over the lease term.

The Company determines the portion of the

lease liability that is current as the difference between the calculated lease liability at the end of the current period and the lease liability that is projected 12 months from the current period.

The Company determines the

portion of the lease liability that is current as the difference between the calculated lease liability at the end of the current period and the lease liability that is projected 12 months from the current period.

Subsequent events:

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Recent Accounting Pronouncements Not Yet Adopted

All recently issued accounting pronouncements are not expected to have a material effect on the consolidated financial statements.

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280):

Improvements to Reportable Segment Disclosures, which improves the disclosures required for reportable segments in the Company’s annual and interim

financial statements, primarily through enhanced disclosures about significant segment expenses.

ASU 2023-07 is effective for annual periods beginning after December 15, 2023 and interim periods within fiscal years beginning after

December 15, 2024.

Adoption of this ASU should be applied retrospectively to all prior periods presented in the financial statements.

Early adoption is permitted.

The Company is currently evaluating the impact that adopting this

standard will have on the consolidated financial statements and disclosures.

In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, which requires public entities, on an annual basis, to

provide disclosures of specific categories in the rate reconciliation, additional information for reconciling items that meet a quantitative threshold and income taxes paid disaggregated by jurisdiction.

ASU 2023-09 is effective

for annual periods beginning after December 15, 2024.

Early adoption is permitted.

The Company is currently evaluating the impact that adopting this standard will have on the consolidated financial statements and disclosures.

Note 3 – Liquidity and Capital Resources

As of December 31, 2023, the Company had $ 56.6 million of cash and cash equivalents.

The Company’s primary uses of cash are to fund operating expenses, primarily research and development expenditures.

to fund operating expenses is impacted by the timing of when the Company pays these expenses, as reflected in the change to the Company’s outstanding accounts payable and accrued expenses.

In May 2021, the Company received approximately $ 4.5 million from the net sale of tax benefits through 2019 to an unrelated, profitable New Jersey corporation pursuant the Company’s participation in the New Jersey Technology Business

Tax Certificate Transfer Net Operating Loss (NOL) program for State Fiscal Year 2020.

In June 2021, the Company completed an underwritten public offering in which it sold 6,088,235 shares of common stock at a public offering price of $ 8.50

per share pursuant to the 2020 Shelf Registration Statement, which includes 794,117 shares issued upon the exercise by the

underwriter of its option to purchase additional shares at the public offering price, minus underwriting discounts and commissions.

the Company received gross proceeds of approximately $ 51.7 million and net proceeds of approximately $ 48.5 million, after

deducting underwriting discounts and offering expenses.

Approximately $ 29,300,000 of Shelf Securities remain available for future

sale under the 2020 Shelf Registration Statement.

In April 2022, the Company received approximately $ 1.2 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant the Company’s participation in the New Jersey Technology Business Tax

Certificate Transfer NOL program for State Fiscal Year 2021.

The Company’s primary uses of cash are to fund operating expenses, primarily research

and development expenditures.

Cash used to fund operating expenses is impacted by the level of activities undertaken, as well as the timing of when the Company pays these expenses, as reflected in the change to the Company’s outstanding

accounts payable and accrued expenses.

Since inception, the Company has experienced net losses and negative cash flows from operations each fiscal year.

The Company has no revenues and expects to continue to incur operating losses for the

foreseeable future and may never become profitable.

In addition, the Loan and Security Agreement allows for the lenders to

call the outstanding balance of the term loans if the minimum cash balances outlined in the Loans and Security Agreement are not maintained.

The Company funds its operations through equity and/or debt financings such as the following:

Business Tax Certificate Transfer NOL program for tax year 2020.

In August 2022, the Company filed a shelf registration statement, or the 2022 Shelf Registration Statement, with the SEC for

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The 2022 Shelf Registration Statement was declared effective on September 2, 2022.

In August 2022, the Company entered into an At Market Issuance Sales Agreement, or the Sales Agreement, with B.

August 2022, the Company entered into an At Market Issuance Sales Agreement, or the Sales Agreement, with B.

Riley Securities, Inc.

and BTIG, LLC, each an Agent and

collectively the Agents, with respect to an at-the-market offering program under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, having an aggregate offering price of up to $ 50.0 million , or the Placement Shares, through or to the

Agents, as sales agents or principals.

Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, the Agents may sell the Placement Shares by any method permitted by law deemed to be an “at the

market” offering as defined in Rule 415 of the Securities Act of 1933, as amended, including, without limitation, sales made through The Nasdaq Capital Market or on any other existing trading market for the Company’s common stock.

The Agents will use commercially reasonable efforts to sell the

Placement Shares from time to time, based upon the Company’s instructions (including any price, time or size limits or other customary parameters or conditions the Company may impose).

The Company will pay the Agents a commission equal to three

percent ( 3 % ) of the gross sales proceeds of any Placement Shares sold through the Agents under the Sales Agreement, and the Company has also provided the Agents with customary indemnification and

contribution rights.

and BTIG, LLC, each an Agent and collectively the Agents, with respect to an at-the-market offering program

under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, having an aggregate offering price of up to $ 50.0 million, or the Placement Shares, through or to the Agents, as sales agents or principals.

Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, the Agents

may sell the Placement Shares by any method permitted by law deemed to be an “at the market” offering as defined in Rule 415 of the Securities Act of 1933, as amended, including, without limitation, sales made through The Nasdaq Capital

Market or on any other existing trading market for the Company’s common stock.

The Agents will use commercially reasonable efforts to sell the Placement Shares from time to time, based upon the Company’s instructions (including any price,

time or size limits or other customary parameters or conditions the Company may impose).

The Company will pay the Agents a commission equal to three percent ( 3 %) of the gross sales proceeds of any Placement Shares sold through the Agents under the Sales Agreement, and the Company has also provided the Agents with customary indemnification and contribution

The Company is not obligated to make any sales of its common stock under the Sales Agreement.

The offering of Placement Shares pursuant to the Sales Agreement will terminate upon the earlier of (i) the sale of all

Placement Shares subject to the Sales Agreement or (ii) termination of the Sales Agreement in accordance with its terms.

For the year ended December 31, 2022, we sold 1,238,491 shares of our common stock for a net value of $ 9.9

million pursuant to the Sales Agreement.

In the first quarter of 2023, we sold 553,293 shares of our common stock for a net

value of $ 4.6 million pursuant to the Sales Agreement.

The offering of Placement Shares pursuant to the Sales Agreement will terminate upon the earlier of (i) the sale of all Placement Shares

subject to the Sales Agreement or (ii) termination of the Sales Agreement in accordance with its terms.

For the year ended December 31, 2023, the Company sold 2,642,269 shares of common stock for a net value of $ 16.1 million pursuant to the Sales

For the year ended December 31, 2022, the Company sold 1,238,491 shares of our common stock for a net value of $ 9.9 million pursuant to the Sales Agreement.

As of the date of this Annual Report, in the first quarter of 2024, the Company sold 3,428,681 shares of common stock for a net value of $ 19.5 million pursuant to the Sales Agreement.

In August 2022, the Company entered into a venture loan and security agreement, or the Loan and Security Agreement, with Horizon

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The Loan and Security Agreement provides for the following 6 separate and independent term loans:

(a) a term loan in the amount of $ 7,500,000 ,

or Loan A, (b) a term loan in the amount of $ 10,000,000 , or Loan B, (c) a term loan in the amount of $ 3,750,000 , or Loan C, (d) a term loan in the amount of $ 3,750,000 ,

(a) a term loan in the amount of $ 7,500,000 , or Loan A, (b)

a term loan in the amount of $ 10,000,000 , or Loan B, (c) a term loan in the amount of $ 3,750,000 , or Loan C, (d) a term loan in the amount of $ 3,750,000 ,

or Loan D, (e) a term loan in the amount of $ 5,000,000 , or Loan E, and (f) a term loan in the amount of $ 5,000,000 , or Loan F, (with each of Loan A, Loan B, Loan C, Loan D, Loan E, and Loan F (individually a Loan and collectively the Loans).

Loan B, Loan C, and Loan D were delivered to the Company on August 24, 2022.

In total, we received $ 24.6 million in net proceeds.

Loan E and Loan F are uncommitted Loans that may be advanced by the lenders upon their discretion prior to July 31, 2023 upon the satisfaction of certain conditions.

The Company may only use the proceeds of the Loans for working capital or

general corporate purposes.

Each Loan matures on the 48 -month anniversary following the applicable funding date unless accelerated

pursuant to certain events of default.

The principal balance of each Loan bears a floating interest.

The interest rate is calculated initially and, thereafter, each calendar month as the sum of (a) the per annum rate of interest from time to

time published in The Wall Street Journal as contemplated by the Loan and Security Agreement, or any successor publication thereto, as the “prime rate” then in effect, plus (b) 5.75 %;

provided that, in the event such rate of interest is less than 4.00 %,

such rate shall be deemed to be 4.00 % for purposes of calculating the interest rate.

Interest is payable on a monthly basis based on

each Loan principal amount outstanding the preceding month.

The Company, at its option upon at least ten ( 10 ) business days’ written

notice to the lenders, may prepay all (and not less than all) of the outstanding Loan by simultaneously paying to each lender an amount equal to (i) any accrued and unpaid interest on the outstanding principal balance of the Loans;

amount equal to (A) if such Loan is prepaid on or before the Loan Amortization Date (as defined in the Loan and Security Agreement) applicable to such Loan, 3 % of the then outstanding principal balance of such Loan, (B) if such Loan is prepaid after the Loan Amortization Date applicable to such Loan, but on or before the date that is 12

months after such Loan Amortization Date, 2 % of the then outstanding principal balance of such Loan, or (C) if such Loan is prepaid

more than 12 months after the Loan Amortization Date but prior to the stated maturity date applicable to such Loan, 1 % of the then

outstanding principal balance of such Loan;

In total, the Company received $ 24.6 million in net

proceeds Loan E and Loan F were uncommitted Loans that could have been advanced by the lenders upon the parties agreement prior to July 31, 2023 upon the satisfaction of certain conditions.

At this time the option to advance Loan E and Loan F

has expired and Loan E and Loan F are no longer available to the Company under the Loan and Security Agreement.

The Company may only use the proceeds of the Loans for working capital or general corporate purposes.

Each Loan matures on the 48 -month anniversary following the applicable funding date unless accelerated pursuant to certain events of default.

Payments on the principal

balance begin on October 1, 2024 and are paid monthly in the succeeding 24 months.

The principal balance of each Loan bears a

floating interest.

The interest rate is calculated initially and, thereafter, each calendar month as the sum of (a) the per annum rate of interest from time to time published in The Wall Street Journal as contemplated by the Loan and Security

Agreement, or any successor publication thereto, as the “prime rate” then in effect, plus (b) 5.75 %;

provided that, in the event

such rate of interest is less than 4.00 %, such rate shall be deemed to be 4.00 % for purposes of calculating the interest rate.

Interest is payable on a monthly basis based on each Loan principal amount outstanding the preceding month.

Company, at its option upon at least ten ( 10 ) business days’ written notice to the lenders, may prepay all (and not less than all) of

the outstanding Loan by simultaneously paying to each lender an amount equal to (i) any accrued and unpaid interest on the outstanding principal balance of the Loans;

plus (ii) an amount equal to (A) if such Loan is prepaid on or before the

Loan Amortization Date (as defined in the Loan and Security Agreement) applicable to such Loan, 3 % of the then outstanding principal

balance of such Loan, (B) if such Loan is prepaid after the Loan Amortization Date applicable to such Loan, but on or before the date that is 12 months after such Loan Amortization Date, 2 % of the then outstanding principal balance of such Loan, or (C) if

such Loan is prepaid more than 12 months after the Loan Amortization Date but prior to the stated maturity date applicable to such

Loan, 1 % of the then outstanding principal balance of such Loan;

plus (iii) the outstanding principal balance of such Loan;

plus (iv) all other sums, if any, that shall have become due and payable thereunder.

No prepayment premium will be applied to any outstanding balance of any Loan paid on the stated maturity date.

The Loan and Security Agreement contains customary representations, warranties and covenants, including covenants by the

Company limiting additional indebtedness, liens, including on intellectual property, guaranties, mergers and consolidations, substantial asset sales, investments and loans, certain corporate changes, transactions with affiliates and

fundamental changes.

The Company evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial doubt

about its ability to continue as a going concern within one year beyond the filing of this Annual Report on Form 10-K.

The Company’s budgeted cash requirements in 2023 and beyond include expenses related to continuing development and

clinical studies.

Based on its available cash resources and cash flow projections as of the date the consolidated financial statements were available for issuance, management believes there are sufficient funds to continue operations and

research and development programs into the third quarter of 2024.

The Company plans to continue to fund its operations and capital funding needs through needs through existing cash and

additional equity and/or debt.

However, the Company cannot be certain that additional financing will be available when needed or that, if available, financing will be obtained on terms favorable to the Company or its existing stockholders.

The Company may also enter into government funding programs and consider selectively partnering for clinical development and commercialization.

(iv) all other sums, if any, that shall have become due and payable thereunder.

No prepayment premium will be applied to any

outstanding balance of any Loan paid on the stated maturity date.

The Loan and Security Agreement contains customary representations, warranties and covenants, including maintenance of

minimum cash balances as well as covenants by the Company limiting additional indebtedness, liens, including on intellectual property, guaranties, mergers and consolidations, substantial asset sales, investments and loans, certain corporate

changes, transactions with affiliates and fundamental changes.

In April 2023, the Company received approximately $ 1.4

million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to the Company’s participation in the New Jersey Technology Business Tax Certificate Transfer NOL program for tax year 2021.

Going Concern

The Company evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial

doubt about its ability to continue as a going concern within one year after the filing of this Annual Report on Form 10-K in accordance with ASC Subtopic 205-40, Going Concern.

Since inception, the Company has experienced net losses and

negative cash flows from operations each fiscal year.

The Company has no revenues and expects to continue to incur operating losses for the foreseeable future and may never become profitable.

In addition, the Loan and Security Agreement

allows for the lenders to call the outstanding balance of the term loans if the minimum cash balances outlined in the Loan and Security Agreement are not maintained.

The Company’s budgeted cash requirements in 2024 and beyond include expenses related to continuin g development and clinical trials as well as payments on our debt .

The Company plans to execute its operating plan by obtaining additional capital,

principally through entering into collaborations, strategic alliances, or license agreements with third parties and/or additional public or private debt and equity financing.

However, ther e is no assurance that additional capital

and/or financing will be available to the Company, and even if available, whether it will be on terms acceptable to the Company or its existing shareholders or in the amounts required.

The Company may also enter into government funding

programs and consider selectively partnering for clinical development and commercialization.

The sale of additional equity would result in additional dilution to the Company’s stockholders.

Incurring debt financing would result in debt service obligations, and the instruments governing such debt could provide for operating and financing covenants that would restrict its operations.

If the Company is unable to raise additional

capital in sufficient amounts or on acceptable terms, we may be required to delay, limit, reduce, or terminate its product development or future commercialization efforts or grant rights to develop and market immunotherapies that the Company

would otherwise prefer to develop and market itself.

Incurring debt financing would result in debt

service obligations, and the instruments governing such debt could provide for operating and financing covenants that would restrict its operations.

If the Company is unsuccessful in securing sufficient financing, it may need to delay,

reduce, or eliminate its research and development programs, which could adversely affect its business prospects, grant rights to third parties to develop and market immunotherapies that the Company would otherwise prefer to develop and

market itself or cease operations.

Any of these actions could harm its business, results of operations and prospects.

Failure to obtain adequate financing also may adversely affect the Company’s ability to operate as a going

Failure to obtain adequate financing also may adversely affect the Company’s ability to operate as a going concern.

As a result of these uncertainties, and as its plans are outside of management’s control, the Company has concluded that

substantial doubt exists about the Company’s ability to continue as a going concern for a period of at least 12 months from the date of the issuance of these audited consolidated financial statements.

The audited consolidated financial

statements do not include any adjustments to the carrying amounts and classifications of assets and liabilities that would result if the Company was unable to continue as a going concern.

Note 4 – Fair Value of Financial Instruments

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The carrying value of the Loan and Security Agreement approximated its fair value at December 31, 2023 due to its variable rate.

The FV of the Company ’ s long-term debt are based on Level 2 inputs.

The fair value of the Company ’ s long-term debt is based on Level 2 inputs.

Note 5 – Property and Equipment

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The sublease commenced on May 1, 2020 and will continue for a term of forty ( 40 ) months with an option to renew through October 31, 2027.

of December 31, 2022, there are eight ( 8 ) months remaining in the lease term.

Upon inception of the lease, the Company

recognized approximately $ 0.7 million of a ROU asset and operating lease liabilities.

The discount rate used to measure the

operating lease liability as of May 1, 2020, was 9.15 %.

Throughout the period described above the Company has maintained, and

continues to maintain, a month-to-month lease for its research facilities at the Princeton Innovation Center BioLabs located at 303A College Road E, Princeton NJ, 08540.

sublease term expired on August 31, 2023, and was not renewed.

Upon inception of the sublease, the Company recognized approximately $ 0.7

million of ROU assets and operating lease liabilities.

The discount rate used to measure the operating lease liability as of May 1, 2020 was 9.15 %.

Throughout the period described above, the Company has maintained, and continues to maintain, a month-to-month lease for its research facilities at the Princeton Innovation Center BioLabs located at 303A College Road E, Princeton NJ, 08540.

Supplemental cash flow information related to operating leases is as follows:

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Cash paid for operating lease liabilities

For the year ended December 31, 2022, the Company’s operating lease expense was $ 241,029 .

Year ended December 31,

2027 and after

Total future minimum lease payments

Less imputed interest

Financing Lease

The Company has financed certain laboratory equipment as follows:

The Company has financed certain

laboratory equipment as follows:

Year Ended December 31,

Cash paid for finance lease liabilities

Maturity of the Company’s

financing lease liabilities is as follows:

Year ended December 31,

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Remaining lease liability

The Company entered into four financing

leases for laboratory equipment with a total cost of $ 423,880 with two to four-year terms and a capitalized interest rate of 9.15 %.

The Company entered into four financing leases for laboratory equipment with a total cost of $ 251,959 with four to five-year terms and a capitalized interest rate of 9.15 %.

Each of the lease agreements include a bargain purchase option to acquire the equipment at the end of the lease term.

The aggregate

monthly payments are approximately $ 5,452 .

Finance lease depreciation expense for the years ended December 31, 2022 and 2021 was $ 48,992 and $ 0 , respectively.

The aggregate monthly payments are approximately $ 6,000 .

During the year ended December 31, 2023, the Company exercised a bargain purchase option, which resulted in recognition of property and equipment of $ 151,490 .

Finance lease amortization expense for the years ended December 31, 2023 and 2022 was $ 39,967 and $ 48,992 , respectively.

Note 7 – Accrued Expenses

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Note 8 – Stock-Based Compensation

In 2014, the Company’s stockholders approved the 2014 Equity Incentive Plan pursuant to which the Company may grant up to 91,367 shares as ISOs, NQs and restricted stock units (“RSUs”), subject to increases as hereafter described (the “Plan Limit”).

In addition, on

January 1, 2015, and each January 1 thereafter and prior to the termination of the 2014 Equity Incentive Plan, pursuant to the terms of the 2014 Equity Incentive Plan, the Plan Limit was and shall be increased by the lesser of (x) 4 % of the number of shares of Common Stock outstanding as of the immediately preceding December 31 and (y) such lesser number as the Board of

Directors may determine in its discretion.

In March 2019, the Plan was amended and restated which removed the annual increase component and was limited to 826,292 shares.

On December 8, 2020, the Company adopted the Second Amended and Restated PDS Biotechnology Corporation 2014 Equity Inventive

Plan (the “Restated Plan”), which amended and restated the Amended and Restated PDS Biotechnology Corporation 2014 Equity Incentive Plan (the “Current Plan”).

The Restated Plan is identical to the Current Plan in all material respects,

except as follows:

(a) the number of shares of Common Stock authorized for issuance under the Restated Plan will increase from 826,292

shares to 3,339,243 shares, plus the total number of shares that remained available for issuance, that are not covered by

outstanding awards issued under the Current Plan, immediately prior to December 8, 2020;

and (b) the Restated Plan will terminate on December 7, 2030, unless earlier terminated.

Company’s stockholders approved the 2014 Equity Incentive Plan (the “Original Plan”) pursuant to which the Company may grant up to 91,367

shares as ISOs, NQs and restricted stock units (“RSUs”), subject to increases as hereafter described (the “Plan Limit”).

In addition, on January 1, 2015, and each January 1 thereafter and prior to the termination of the 2014 Equity

Incentive Plan, pursuant to the terms of the Original Plan, the Plan Limit was and shall be increased by the lesser of (x) 4 %

of the number of shares of Common Stock outstanding as of the immediately preceding December 31 and (y) such lesser number as the Board of Directors may determine in its discretion.

In March 2019, the Board adopted and the Company’s

stockholders approved the Amended and Restated PDS Biotechnology Corporation 2014 Equity Incentive Plan (the “Prior Plan”) which amended and restated the Original Plan in order to remove the annual increase component and was limited to 826,292 shares.

On December 8, 2020, the Board adopted and on

June 17, 2021, the stockholders approved, the Second Amended and Restated PDS Biotechnology Corporation 2014 Equity Incentive Plan (the “Restated Plan”), which amended and restated the Prior Plan.

The Restated Plan is identical to the

Prior Plan in all material respects, except (a) the number of shares of Common Stock authorized for issuance under the Restated Plan was increased from 826,292 shares to 4,165,535 shares, plus the total number of shares

that remained available for issuance, that were not covered by outstanding awards issued under the Prior Plan, immediately prior to December 8, 2020;

and (b) the Restated Plan was amended to terminate on December 7, 2030, unless earlier

On July 14, 2023, the Company’s stockholders approved an amendment to the Restated Plan, increasing the number

of shares of common stock for issuance from 4,165,535 to 6,565,535 shares.

As of December 31, 2023 , there were 3,051,449 shares available for grant under the Restated Plan.

In 2018, the Company’s stockholders approved the 2018 Stock Incentive Plan pursuant to which the Company may grant up to 558,071 shares as (i) Stock Options, (ii) Stock Appreciation Rights, (iii) Restricted Stock, (iv) Preferred Stock, (v) Stock Reload Options and/or

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Incentive Plan.

Pursuant to the terms of the Plans, ISOs have a term of ten years from the date of grant or such shorter term as may be provided in the option agreement.

Unless specified otherwise in an individual option agreement, ISOs generally vest over a four-year period.

Unless terminated by the Board, the Plans shall continue to remain effective for a term of ten years or until such time as no further awards may be granted and all awards granted under the Plans are no longer outstanding.

On June 17, 2019, the Board adopted the 2019 Inducement Plan (the “Inducement

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On May 17, 2022, the Company further amended the Inducement Plan solely to increase the total number of shares of Common Stock reserved for issuance under the Inducement Plan from 500,000 shares to 1,100,000 shares.

On January 22, 2024,

the Company further amended the Inducement Plan solely to increase the total number of shares of Common Stock reserved for issuance under the Inducement Plan from 1,100,000 shares to 2,100,000 shares.

The Inducement Plan provides for the grant of non-qualified stock options.

The Inducement Plan, and each amendment thereto, was recommended for approval by the Compensation Committee of the Board and

subsequently approved and adopted by the Board without stockholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules .

The Inducement Plan, and each amendment thereto, was recommended for approval by the Compensation Committee of the Board and subsequently approved

and adopted by the Board without stockholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules .

The Inducement Plan is administered by the Compensation Committee of the Board.

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General and administrative

In lieu of higher cash compensation, the Company has granted non-employee options to consultants and expensed $ 1,383 and $ 1,389 during the years

ended December 31, 2022 and 2021, respectively.

The following table summarizes the stock option activity for the Company’ stock option plans for the year ended December 31, 2023:

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As of December 31, 2023 there was approximately $ 13,950,484 of unamortized stock compensation expense, which is expected to be recognized over a remaining average vesting period of 2.47 years.

The Company entered into an agreement with DC Consulting for certain consulting services and issued 200,000 shares in connection with the agreement.

The weighted-average grant date fair value of the stock options granted in 2023 was $ 9.59 per share.

The fair value of options granted during the year ended December 31, 2022 was estimated using the Black-Scholes option valuation

model utilizing the following assumptions:

The fair value of options granted during the year ended December 31, 2023 and 2022 were estimated using the Black-Scholes option

valuation model utilizing the following assumptions:

Year Ended December 31,

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Expected volatility .

The expected volatility assumption is based on volatilities of a

peer group of similar companies in the biotechnology industry whose share prices are publicly available.

The expected volatility assumption was changed on January 1,

2023 from using volatilities of a peer group of similar companies in the biotechnology industry whose share prices were publicly available, to using the volatility of the Company’s historical share price performance over the contractual term

of the options.

Risk-free interest rate .

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The expected term of the options is based on using the simplified method, which is the midpoint between the requisite service period and the contractual term of the option, since the Company has a limited history of being a

public company from March 15, 2019 (the date of the Merger) to develop reasonable expectations about future exercise patterns and employment duration for the stock options grants.

public company to develop reasonable expectations about future exercise patterns and employment duration for the stock options grants.

Expected dividend rate .

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Therefore, the capitalization of research and development costs in accordance

with IRC 174 resulted in a deferred tax asset of $ 4.5 million.

with IRC 174 resulted in a deferred tax asset of $ 10.0 million and $ 4.5 million as of December 31, 2023 and 2022, respectively.

At December 31, 2023, the Company had federal net operating loss (“NOL”) carryforwards of approximately $ 136.2 million.

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The Technology Business Tax Certificate Transfer Program enables qualified, unprofitable NJ-based technology or

biotechnology companies with fewer than 225 US employees (including parent company and all subsidiary) to sell a percentage of New Jersey NOLs and research and development (“R&D”) tax credits to unrelated profitable corporations.

biotechnology companies with fewer than 225 US employees (including the parent company and all subsidiaries) to sell a percentage of New Jersey NOLs and research and development (“R&D”) tax credits to unrelated profitable corporations.

In 2023, the Company sold

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Exclusive License Agreement

Pursuant to the Merck KGaA License Agreement, we agreed to make (i) development and first commercial sale milestone payments

Pursuant to the Merck KGaA License Agreement, we agreed to make (i) development and first commercial sales milestone payments

totaling up to $ 11 million upon the achievement of certain milestones, including the dosing of the fifth patient in a Phase3 trial

of the product and first commercial sale of the product for a first and second indications in a major market, and (ii) up to $ 105

of the clinical candidate and first commercial sale of the product for a first and second indication in a major market, and (ii) up to $ 105

million upon achieving certain aggregate sales levels of the product.

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and (ii) the expiration or invalidation of the licensed patents

covering the compound or product in such country (collectively, the “Royalty Term”).

The royalty rate is subject to reduction in that event that a product is not covered by a valid patent claim, a biosimilar to the compound or the product

comes on the market in a particular country, or if we obtain a license to any intellectual property owned or controlled by a third-party which but for such license would be infringed by making, using or selling the compound.

covering the compound or product in such country.

The royalty rate is subject to reduction in that event that a product is not covered by a valid patent claim, a biosimilar to the compound or the product comes on the market in a particular

country, or if we obtain a license to any intellectual property owned or controlled by a third-party which but for such license would be infringed by making, using or selling the compound.

Legal Proceedings

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Note 12 – Venture Loan and Security Agreement

August 2022, the Company entered into a Venture Loan and Security Agreement (the “Loan and Security Agreement”) with Horizon Technology Finance Corporation, as a lender and collateral agent for itself and the other Lenders (in such capacity, the

“Collateral Agent”), and the other persons party thereto from time to time as lenders (“Lenders”).

In August 2022, the Company entered into a Venture loan and security agreement (the “Loan and Security Agreement”) with Horizon

Technology Finance Corporation, as a lender and collateral agent for itself and the other Lenders (in such capacity, the “Collateral Agent”), and the other persons party thereto from time to time as lenders (“Lenders”).

Term loan Amounts .

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A, Loan B, Loan C, and Loan D were delivered to the Company on August 24, 2022.

Loan E and Loan F are uncommitted Loans that may be advanced by the Lenders upon their discretion prior to July 31, 2023 upon the satisfaction by the Company of

certain agreed upon conditions precedents.

The Company may only use the proceeds of the Loans for working capital or general corporate purposes.

Loan E and Loan F were uncommitted Loans that could have been advanced by the lenders upon the parties agreement prior to July 31, 2023 upon the satisfaction of

certain conditions.

At this time the option to advance Loan E and Loan F has expired and Loan E and Loan F are no longer available to the Company under the Loan and Security Agreement.

The Company may only use the proceeds of the Loans for

working capital or general corporate purposes.

Each Loan matures on the 48-month anniversary following the applicable date on which a Loan is made to or on account of the Company under the Loan and Security Agreement (the “Maturity Date”) unless accelerated

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All amounts outstanding under each Loan will be due and payable upon the earlier of the Maturity Date or the acceleration of the loans and commitments upon an event of default.

Payments on the principal

balance begin on October 1, 2024 and are paid monthly in the succeeding 24 months.

Interest Rate .

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Loan Amortization Date applicable to such Loan, three percent ( 3 %) of the then outstanding principal balance of such Loan, (B) if such Loan is prepaid after the Loan Amortization Date applicable to such Loan, but on or before the date that is twelve

(12) months after such Loan Amortization Date, two percent ( 2 %) of the then outstanding principal balance of such Loan, or (C) if such Loan is prepaid more than twelve (12) months after the Loan Amortization Date but prior to the stated Maturity

Date applicable to such Loan, one percent ( 1 %) of the then outstanding principal balance of such Loan;

( 12 ) months after such Loan Amortization Date, two percent ( 2 %) of the then outstanding principal balance of such Loan, or

(C) if such Loan is prepaid more than twelve ( 12 ) months after the Loan Amortization Date but prior to the stated Maturity Date

applicable to such Loan, one percent ( 1 %)

of the then outstanding principal balance of such Loan;

plus (iii) the outstanding principal balance of such Loan;

plus (iv) all other sums, if any, that shall have become due and payable hereunder.

No prepayment premium will be

applied to any outstanding balance of any Loan paid on the stated Maturity Date.

plus (iv) all other sums, if any, that shall

have become due and payable hereunder.

No prepayment premium will be applied to any outstanding balance of any Loan paid on the

stated Maturity Date.

Company’s obligations are secured by a security interest in all of the assets of the Company, subject to limited exceptions and excluding the Company’s intellectual property.

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Other Provisions .

The Loan and Security Agreement contains customary representations, warranties and covenants, including covenants by the Company limiting additional indebtedness, liens, including on intellectual

property, guaranties, mergers and consolidations, substantial asset sales, investments and loans, certain corporate changes, transactions with affiliates and fundamental changes.

As of December 31, 2022, the Company is in compliance with all

The Loan and Security Agreement contains customary representations, warranties and covenants, including maintenance of minimum cash balances as well as covenants by the Company limiting additional

indebtedness, liens, including on intellectual property, guaranties, mergers and consolidations, substantial asset sales, investments and loans, certain corporate changes, transactions with affiliates and fundamental changes.

As of December 31,

2023, the Company is in compliance with all covenants.

Default Provisions .

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unamortized debt discount was $ 2,264,650 as of December 31, 2023.

The Company recognized interest expense of $ 1,288,776 for the year ended December 31, 2022 and $ 183,914 was related to

the amortization of the debt discount for the year ended December 31, 2022.

For the year ended December 31, 2023 and 2022 the Company recognized interest expense of $ 4,187,075 and $ 1,288,776 ,

respectively, of which $ 652,006 and $ 183,914 ,

respectively was related to the amortization of the debt discount for each of the years.

Note 13 – Retirement Plan

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employees subject to IRS-imposed limitations.

In the first quarter of 2021, the company matched employee’s contributions with company stock valued at $ 35,747 .

The 401(k) employer cash contribution match for the year ended December 31, 2022 and the nine month period ended 2021 were $ 157,009 and $ 60,428 respectively.

The 401(k) employer cash contribution match for the years ended December 31, 2023 and December 31, 2022 $ 181,439 and $ 157,009 , respectively.

Note 14 – Subsequent Events

On January 5, 2023, the Company granted an option to purchase 1,124,600 shares of common stock to the management and employees of the Company with a strike price of $ 11.61 vesting 25 % on the first anniversary and the remaining vesting in equal monthly installments thereafter until fully vested.

Included in the above mentioned grant,

the Company granted an option to purchase 385,300 , 137,200 and 161,200 to its Chief Executive Officer,

Chief Scientific Officer and its Chief Medical Officer, respectively.

In the first quarter of 2023, the Company sold 553,293 shares of common stock for a value of $ 4.6 million pursuant to

its Sales Agreement .

On January 22, 2024, the Company amended the Inducement Plan solely to increase the total number of shares of common stock reserved for issuance under the Inducement

Plan from 1,100,000 shares to 2,100,000

As of the date of this Annual Report,in the first quarter of 2024, the Company sold 3,428,681 shares of common stock for net proceeds of $ 19.5 million pursuant to its Sales Agreement .

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures