ZyVersa Therapeutics, Inc.

Previous wording

The following discussion and analysis of the results of operations and financial condition of ZyVersa Therapeutics, Inc. (the “Company,” “we,” “us” or “our”) as of March 31, 2025 and for the three months ended March 31, 2025 and 2024 should be read in conjunction with our unaudited condensed consolidated financial statements and the notes to those financial statements that are included elsewhere in this Quarterly Report on Form 10-Q. This discussion and analysis should be read in conjunction with the Company’s audited financial statements and related disclosures as of December 31, 2024 and for the year then ended, which are included in the Form 10-K (the “Annual Report”) filed with the Securities and Exchange Commission (“SEC”) on March 27, 2025. This Management’s Discussion and Analysis of Financial Condition and Results of Operations contains statements that are forward-looking. These statements are based on current expectations and assumptions that are subject to risk, uncertainties and other factors. These statements are often identified by the use of words such as “may,” “will,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate,” or “continue,” and similar expressions or variations. Actual results could differ materially because of the factors discussed in “Risk Factors” in our Annual Report, and other factors that we may not know. Except as otherwise required by applicable law, we disclaim any duty to update any forward-looking statements, all of which are expressly qualified by the statements above, to reflect events or circumstances after the date of this Quarterly Report on Form 10-Q.

Current wording

The following discussion and analysis of the results of operations and financial condition of ZyVersa Therapeutics, Inc. (the “Company,” “we,” “us” or “our”) as of June 30, 2025 and for the three and six months ended June 30, 2025 and 2024 should be read together with our unaudited condensed consolidated financial statements and the notes to those financial statements that are included elsewhere in this Quarterly Report on Form 10-Q. Additionally this discussion and analysis should be read together with the Company’s audited financial statements and related disclosures as of December 31, 2024 and for the year then ended, which are included in the Form 10-K (the “Annual Report”) filed with the Securities and Exchange Commission (“SEC”) on March 27, 2025. This Management’s Discussion and Analysis of Financial Condition and Results of Operations contains statements that are forward-looking. These statements are based on current expectations and assumptions that are subject to risk, uncertainties and other factors. These statements are often identified by the use of words such as “may,” “will,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate,” or “continue,” and similar expressions or variations. Actual results could differ materially because of the factors discussed in “Risk Factors” in our Annual Report, and other factors that we may not know. Except as otherwise required by applicable law, we disclaim any duty to update any forward-looking statements, all of which are expressly qualified by the statements above, to reflect events or circumstances after the date of this Quarterly Report on Form 10-Q.

Previous wording

Our lead renal drug candidate, which we refer to as Cholesterol Efflux Mediator TM VAR 200 (2-hydroxypropyl-beta-cyclodextrin or “2HβCD”), is in development to treat multiple renal indications. Our lead anti-inflammatory drug candidate, which we refer to as Inflammasome ASC Inhibitor IC 100, is a humanized monoclonal IgG4 antibody targeting ASC in development to treat multiple inflammatory diseases.

Current wording

Our renal drug candidate, which we refer to as Cholesterol Efflux Mediator TM VAR 200 (2-hydroxypropyl-beta-cyclodextrin or “2HβCD”), is in development to treat multiple renal indications. The lead indication is focal segmental glomerulosclerosis (FSGS). Our anti-inflammatory drug candidate, which we refer to as Inflammasome ASC Inhibitor IC 100, is a humanized monoclonal IgG4 antibody targeting ASC in development to treat multiple inflammatory diseases. The lead indication is obesity with cardiometabolic comorbidities.

Previous wording

We have not generated any revenue to date and have incurred significant operating losses. Our net losses were $2.3 million for the period from January 1, 2025 through March 31, 2025, compared to $2.8 million for the period from January 1, 2024 through March 31, 2024. As of March 31, 2025, we had an accumulated deficit of approximately $114.9 million and cash of $1.6 million. We expect to continue to incur significant expenses for the foreseeable future and to incur operating losses. We expect our expenses will increase in connection with our ongoing activities as we:

Current wording

We have not generated any revenue to date and have incurred significant operating losses. Our net losses were $4.5 million for the period from January 1, 2025 through June 30, 2025, compared to $5.6 million for the period from January 1, 2024 through June 30, 2024. As of June 30, 2025, we had an accumulated deficit of approximately $117.1 million and cash of $0.1 million. We expect to continue to incur significant expenses for the foreseeable future and to incur operating losses. We expect our expenses will increase in connection with our ongoing activities as we:

Previous wording

Research and development activities are central to our business model. We expect that our research and development expenses will continue to increase for the foreseeable future as we continue clinical development for our product candidates. As products enter later stages of clinical development, they will generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. Historically, our research and development costs have primarily related to the development of VAR 200 and IC 100. As we advance VAR 200 and IC 100, as well as identify any other potential product candidates, we will continue to allocate our direct external research and development costs to the products. We expect to fund our research and development expenses from our current cash and cash equivalents and any future equity or debt financings, or other capital sources, including potential collaborations with other companies or other strategic transactions.

Current wording

Research and development activities are central to our business model. We expect that our research and development expenses will continue to increase for the foreseeable future as we continue preclinical and clinical development for our product candidates. As products enter later stages of clinical development, they will generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. Historically, our research and development costs have primarily related to the development of VAR 200 and IC 100. As we advance VAR 200 and IC 100, as well as identify other potential product candidates, we will continue to allocate our direct external research and development costs to the products. We expect to fund our research and development expenses from our current cash and cash equivalents and any future equity or debt financings, or other capital sources, including potential collaborations with other companies or other strategic transactions.

Previous wording

The successful development of our product candidates is highly uncertain. At this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the remainder of the development of, or when, if ever, material net cash inflows may commence from our product candidates. This uncertainty is due to the numerous risks and uncertainties associated with the duration and cost of clinical trials, which vary significantly over the life of a project as a result of many factors, including:

Current wording

The successful development of our product candidates is highly uncertain. At this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the remainder of the development of, or when, if ever, material net cash inflows may commence from our product candidates. This uncertainty is due to the numerous risks and uncertainties associated with the duration and cost of clinical trials, which vary significantly over the life of a project resulting from many factors, including:

Previous wording

General and administrative expenses consist primarily of salaries, stock-based compensation and related costs for our employees in administrative, executive and finance functions. General and administrative expenses also include professional fees for legal, accounting, audit, tax and consulting services, insurance, human resource, information technology, office, and travel expenses.

Current wording

General and administrative expenses consist primarily of salaries, stock-based compensation and related costs for our employees in administrative, executive and finance functions. General and administrative expenses also include professional fees for legal, accounting, audit, tax and consulting services, insurance, human resources, information technology, office, and travel expenses.

Previous wording

Research and development expenses were $259 thousand for the three months ended March 31, 2025, a decrease of $254 thousand or 49.5% from the three months ended March 31, 2024. The decrease is attributable to lower manufacturing costs of IC100 of $62 thousand, lower CRO fees of $106 thousand for VAR200 and lower research and development consultant costs of $95 thousand due to fewer consultants.

Current wording

Research and development expenses were $0.4 million for the three months ended June 30, 2025, a decrease of $0.3 million or 42.2% from the three months ended June 30, 2024. The decrease is attributable to lower CRO fees of $0.1 million for VAR 200 and lower research and development consultant costs of $0.1 million due to fewer consultants, lower pre-clinical costs of IC 100 of $0.1 million, partially offset by an increase in VAR 200 manufacturing stability testing.

Previous wording

General and administrative expenses were $1.9 million for the three months ended March 31, 2025, a decrease of $428 thousand or 18.5% from the three months ended March 31, 2024. The decrease is primarily attributable to a decrease of $156 thousand in stock-based compensation expense due to options becoming fully amortized in January 2025, a decrease of $143 thousand due to lower director and officer insurance, and a $119 thousand decrease in investor and public relations marketing expense due to fewer firms hired.

Current wording

General and administrative expenses were $1.6 million for the three months ended June 30, 2025, a decrease of $0.4 million or 20.1% from the three months ended June 30, 2024. The decrease is primarily attributable to a decrease of $0.1 million due to lower director and officer insurance premiums, a $0.1 million decrease in investor relations marketing expense, a $0.1 million decrease in professional fees due to lower accounting and legal expense, and a decrease of $0.1 million in stock-based compensation expense due to options becoming fully amortized in 2025, offset by a $0.1 million increase in public company costs due to additional costs for our annual shareholder meeting and Nasdaq hearings.

Previous wording

Other (income) expense, net was $112 thousand for the three months ended March 31, 2025, an increase of $112 thousand from the three months ended March 31, 2024. The increase in expense is attributable to interest charged by a vendor for outstanding amounts owed.

Current wording

Other (income) expense, net was $0.2 million for the three months ended June 30, 2025, an increase of $0.2 million from the three months ended June 30, 2024. The increase in expense is primarily attributable to interest charged by a vendor for outstanding amounts owed.

Previous wording

The following table summarizes our cash flows from operating and financing activities for the three months ended March 31, 2025 and for the three months ended March 31, 2024:

Current wording

The following table summarizes our cash flows from operating and financing activities for the six months ended June 30, 2025 and for the six months ended June 30, 2024:

Previous wording

Net cash used in operating activities was $1.8 million and $3.8 million for the three months ended March 31, 2025 and 2024, respectively. For the three months ended March 31, 2025 and for the three months ended March 31, 2024, the net cash used in operating activities was primarily attributable to the net loss of approximately $2.3 million and $2.8 million, respectively, offset by $0.2 million and $0.3 million, respectively, of net non-cash expenses, and approximately $0.3 million and ($1.3) million, respectively, of cash generated from (used for) changes in the levels of operating assets and liabilities, respectively.

Current wording

Net cash used in operating activities was approximately $3.3 million and approximately $5.7 million for the six months ended June 30, 2025 and 2024, respectively. For the six months ended June 30, 2025 and for the six months ended June 30, 2024, the net cash used in operating activities was primarily attributable to the net loss of approximately $4.5 million and $5.6 million, respectively, offset by $0.3 million and $0.5 million, respectively, of net non-cash expenses, and approximately $0.8 million and ($0.6) million, respectively, of cash generated by (used in) the levels of operating assets and liabilities, respectively.

Previous wording

Net Cash Provided By Financing Activities

Current wording

Net Cash Provided By (Used In) Financing Activities

Previous wording

Net cash provided by financing activities was $1.9 million and $2.7 million for the three months ended March 31, 2025 and 2024, respectively. Cash provided by financing activities during the three months ended March 31, 2025 represented proceeds of $2.0 million from the private placement of pre-funded warrants and warrants offset by $0.1 million of cash registration and issuance costs associated with the warrant issuance.

Current wording

Net cash provided by financing activities was $1.8 million and $2.7 million for the six months ended June 30, 2025 and 2024, respectively. Cash provided by financing activities during the six months ended June 30, 2025 represented $2.0 million of proceeds from the private placement of warrants. This was partially offset by ($0.2) million in registration and issuance costs associated with warrant issuance. Cash provided by financing activities during the six months ended June 30, 2024 represented proceeds from the exercise of warrants

Previous wording

Since our inception in 2014 through March 31, 2025, we have not generated any revenue and have incurred significant operating losses and negative cash flows from our operations. Based on our current operating plan, we expect our cash of $1.6 million as of March 31, 2025 will only be sufficient to fund our operating expenses and capital expenditure requirements on a month-to-month basis. However, it is difficult to predict our spending for our product candidates prior to obtaining FDA approval. Moreover, changing circumstances may cause us to expend cash significantly faster than we currently anticipate, and we may need to spend more cash than currently expected because of circumstances beyond our control.

Current wording

Since our inception in 2014 through June 30, 2025, we have not generated any revenue and have incurred significant operating losses and negative cash flows from our operations. Based on our current operating plan, we expect our cash of $0.1 million as of June 30, 2025 will only be sufficient to fund our operating expenses and capital expenditure requirements on a month-to-month basis. It is difficult to predict our spending for our product candidates prior to obtaining FDA approval. Moreover, changing circumstances may cause us to expend cash significantly faster than we currently anticipate, and we may need to spend more cash than currently expected because of circumstances beyond our control.

Previous wording

Since inception we have been engaged in organizational activities, including raising capital and research and development activities. We have not generated revenues and have not yet achieved profitable operations, nor have we ever generated positive cash flow from operations. There is no assurance that profitable operations, if achieved, could be sustained on a continuing basis. We are subject to those risks associated with any pre-clinical stage pharmaceutical company that has substantial expenditures for research and development. There can be no assurance that our research and development projects will be successful, that products developed will obtain necessary regulatory approval, or that any approved product will be commercially viable. In addition, we operate in an environment of rapid technological change and are largely dependent on the services of our employees and consultants. Further, our future operations are dependent on the success of our efforts to raise additional capital. These uncertainties raise substantial doubt about our ability to continue as a going concern for 12 months after the issuance date of our financial statements. The accompanying financial statements have been prepared on a going concern basis. The financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the possible inability of us to continue as a going concern, which contemplates the continuation of operations, realization of assets and liquidation of liabilities in the ordinary course of business. We incurred a net loss of $2.3 million for the three months ended March 31, 2025 and had an accumulated deficit of $114.9 million on March 31, 2025. We anticipate incurring additional losses until such time, if ever, that we can generate significant revenue from our product candidates currently in development. Our primary source of capital has been the issuance of debt and equity securities. We believe that current cash is only sufficient to fund operations and capital requirements on a month-to-month basis. Additional financing will be needed by us to fund our operations, to complete development of and to commercially develop our product candidates. There is no assurance that such financing will be available when needed or on acceptable terms.

Current wording

Since inception we have been engaged in organizational activities, including raising capital and research and development activities. We have not generated revenues and have not yet achieved profitable operations, nor have we ever generated positive cash flow from operations. There is no assurance that profitable operations, if achieved, could be sustained on a continuing basis. We are subject to those risks associated with any pre-clinical stage pharmaceutical company that has substantial expenditures for research and development. There can be no assurance that our research and development projects will be successful, that products developed will obtain necessary regulatory approval, or that any approved product will be commercially viable. In addition, we operate in an environment of rapid technological change and are largely dependent on the services of our employees and consultants. Further, our future operations are dependent on the success of our efforts to raise additional capital. These uncertainties raise substantial doubt about our ability to continue as a going concern for 12 months after the issuance date of our financial statements. The accompanying financial statements have been prepared on a going concern basis. The financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the possible inability of us to continue as a going concern, which contemplates the continuation of operations, realization of assets and liquidation of liabilities in the ordinary course of business. We incurred a net loss of $4.5 million for the six months ended June 30, 2025 and had an accumulated deficit of $117.1 million on June 30, 2025. We anticipate incurring additional losses until such time, if ever, that we can generate significant revenue from our product candidates currently in development. Our primary source of capital has been the issuance of debt and equity securities. We believe that current cash is only sufficient to fund operations and capital requirements on a month-to-month basis. Additional financing will be needed by us to fund our operations, and to complete development of and to commercially develop our product candidates. There is no assurance that such financing will be available when needed or on acceptable terms.

Previous wording

The following summarizes our contractual obligations as of March 31, 2025 that will affect our future liquidity. Based on our current operating plan, we plan to satisfy the obligations identified below from our current cash balance and future financing.

Current wording

Cash requirements for our current liabilities as of June 30, 2025 include approximately $12.7 million for accounts payable and accrued expenses. Based on our current operating plan, we plan to satisfy the obligations identified below from our current cash balance and future financing. See Note 4,Accrued Expenses and Other Current Liabilities and Note 6,Commitments and Contingencies—Operating Leases of the accompanying notes to the unaudited condensed consolidated financial statements included elsewhere in this report for more information regarding our contractual obligations relating to our current liabilities and lease agreements, respectively.

Previous wording

Our policy is to invest any cash in excess of our immediate requirements in investments designed to preserve the principal balance and provide liquidity while producing a modest return on investment. Accordingly, our excess cash equivalents will be invested primarily in money market funds.

Current wording

Our policy is to invest any cash exceeding our immediate requirements in investments designed to preserve the principal balance and provide liquidity while producing a modest return on investment. Accordingly, our excess cash equivalents will be invested primarily in money market funds.

Previous wording

We expect to continue to incur substantial additional operating losses for at least the next several years as we continue to develop our product candidates and seek marketing approval and, subject to obtaining such approval, the eventual commercialization of our product candidates. If we obtain marketing approval for our product candidates, we will incur significant sales, marketing and outsourced manufacturing expenses. In addition, we expect to incur additional expenses to add operational, financial and information systems and personnel, including personnel to support our planned product commercialization efforts. We also expect to incur significant costs to comply with corporate governance, internal controls and similar requirements applicable to us as a public company.

Current wording

We expect to continue to incur substantial additional operating losses for at least the next several years as we continue to develop our product candidates and seek marketing approval and, subject to obtaining such approval, the eventual commercialization of our product candidates. If we obtain marketing approval for our product candidates, we will incur significant sales, marketing and outsourced manufacturing expenses. In addition, we expect to incur additional expenses to add operational, financial, and information systems and personnel, to support our planned product development efforts, among other initiatives. We also expect to incur significant costs to comply with corporate governance, internal controls, and similar requirements applicable to public companies.