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VYNE Therapeutics Inc.

For the period ended Sep 30, 2025. Filed Nov 6, 2025.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2025 · Filed Nov 6, 2025

YARW$15.60+14.7%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-06-30; filed 2025-08-14.

0001628280-25-040366

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2025-09-30; filed 2025-11-06.

0001566044-25-000010

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 108 previous paragraphs and 113 current paragraphs.

77 unchanged; 30 reworded; 6 added; 1 removed; 0 previous and 0 current paragraphs rearranged.

Tables are not compared: 3 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (6)

Current report

In August 2025, our board of directors initiated a strategic review to evaluate a range of options to maximize stockholder value, including the assessment of our internal pipeline, financing opportunities and strategic alternatives. These alternatives may include strategic partnerships, licensing opportunities, merger or acquisition transactions, asset sales or other potential paths. As part of this process, which remains ongoing, we will evaluate opportunities for VYN202, including as part of broader strategic alternatives. In conjunction, we have implemented cost reductions that are expected to extend our cash runway into the first half of 2027.

Current report

In August 2025, we initiated a strategic review to evaluate a range of options to maximize stockholder value, including the assessment of our internal pipeline, financing opportunities and strategic alternatives. These alternatives may include strategic partnerships, licensing opportunities, merger or acquisition transactions, asset sales or other potential paths. As part of this process, which remains ongoing, we are evaluating opportunities for VYN201 and VYN202, including as part of broader strategic alternatives.

Current report

Comparison of the Nine Months Ended September 30, 2025 and 2024

Current report

•the timing and costs of identifying, pursuing and completing a strategic transaction with a third-party partner, if at all, for repibresib and/or VYN202;
Removed paragraphs (1)
Reworded paragraphs (30)

Previous wording

We are a clinical-stage biopharmaceutical company focused on developing differentiated therapies to treat chronic inflammatory and immune-mediated conditions with high unmet need.

Current wording

We are a clinical-stage biopharmaceutical company focused on developing differentiated therapies to treat inflammatory and immune-mediated conditions with high unmet need.

Previous wording

In April 2025, the U.S. Food and Drug Administration ("FDA") verbally placed a clinical hold on our Phase 1b trial evaluating VYN202 in subjects with moderate-to-severe plaque psoriasis following an observation of testicular toxicity in dogs from a non-clinical toxicology study of VYN202. In June 2025, the FDA lifted the clinical hold for two doses of VYN202 for female subjects. Further, the FDA has indicated that sufficient data from a 12-week non-clinical toxicology study of VYN202 in dogs would be required in order to resume studies in male clinical subjects. The design of this toxicology study has been agreed upon with the FDA and we intend to initiate the repeat non-clinical toxicology study of VYN202 in dogs to remedy the partial hold in male clinical subjects. There were no serious adverse events observed in subjects that were enrolled in the Phase 1b trial. Following the clinical hold, we made the decision to unblind the clinical data from the seven subjects who were enrolled in the trial and announced promising preliminary results as described below.

Current wording

In April 2025, the U.S. Food and Drug Administration ("FDA") verbally placed a clinical hold on our Phase 1b trial evaluating VYN202 in subjects with moderate-to-severe plaque psoriasis following an observation of testicular toxicity in dogs from a non-clinical toxicology study of VYN202. In June 2025, the FDA lifted the clinical hold for two doses of VYN202 for female subjects. Further, the FDA has indicated that sufficient data from a 12-week non-clinical toxicology study of VYN202 in dogs would be required in order to resume studies in male clinical subjects. The design of this toxicology study has been agreed upon with the FDA and we have initiated the repeat non-clinical toxicology study of VYN202 in dogs to remedy the partial hold in male clinical subjects. There were no serious adverse events observed in subjects that were enrolled in the Phase 1b trial. Following the clinical hold, we made the decision to unblind the clinical data from the seven subjects who were enrolled in the trial and announced promising preliminary results as described below.

Previous wording

We have also evaluated VYN202 in preclinical studies in areas such as nephrology, pulmonology, rheumatology and myeloproliferative neoplasms, among others. The preclinical and translational data obtained support the potential of VYN202 as a potent, disease-modifying therapy for the treatment of serious, immune-mediated diseases and hematological cancers with limited effective treatment options. We are determining the best path forward for the VYN202 program. In conjunction, we have implemented cost reductions that are expected to extend its cash runway into the first half of 2027.

Current wording

We have also evaluated VYN202 in preclinical studies in areas such as nephrology, pulmonology, rheumatology and myeloproliferative neoplasms, among others. The preclinical and translational data obtained support the potential of VYN202 as a potent, disease-modifying therapy for the treatment of serious, immune-mediated diseases and hematological cancers with limited effective treatment options. We are determining the best path forward for the VYN202 program.

Previous wording

Until July 2025, our lead product was repibresib gel (also known as VYN201), a topically administered, small molecule pan-bromodomain (“BD”) BET inhibitor designed as a “soft” drug to address diseases involving multiple, diverse inflammatory cell signaling pathways while providing low systemic exposure. In preclinical testing, repibresib produced consistent reductions in pro-inflammatory and disease-related biomarkers and improvements in disease severity across a variety of inflammatory and fibrotic preclinical models. We announced positive results from a Phase 1b trial evaluating repibresib in nonsegmental vitiligo in October 2023 and initiated a Phase 2b trial in nonsegmental vitiligo in June 2024. The trial evaluated 177 subjects (mITT population). In July 2025, we announced that the trial did not meet its primary endpoint of the proportion of subjects achieving an improvement in Facial Vitiligo Area Scoring Index of at least 50% from baseline (“F-VASI50”) at week 24 compared to vehicle. The trial also missed a key secondary endpoint of F-VASI75. However, the trial showed a nominally statistically significant treatment effect for the highest dose cohort in a key secondary endpoint, percent change-from-baseline (“CFB”) in F-VASI score at week 24 compared to vehicle (Repibresib 3%: -43.6% vs. Vehicle: -25.6%), and an exploratory endpoint of percent CFB in Total Vitiligo Area Scoring Index score at week 24 compared to vehicle (Repibresib 3%: -28.3% vs. Vehicle: -16.2%). Based on these data, we discontinued the ongoing extension phase of the trial and has terminated the trial. Repibresib gel covered by patents providing composition of matter patent exclusivity into at least 2042 in the United States and into at least 2040 in Europe, Japan and other large global pharmaceutical markets. We are currently seeking an external partner for continued development of repibresib gel.

Current wording

Until July 2025, our lead product was repibresib gel (also known as VYN201), a topically administered, small molecule pan-bromodomain (“BD”) BET inhibitor designed as a “soft” drug to address diseases involving multiple, diverse inflammatory cell signaling pathways while providing low systemic exposure. In preclinical testing, repibresib produced consistent reductions in pro-inflammatory and disease-related biomarkers and improvements in disease severity across a variety of inflammatory and fibrotic preclinical models. We announced positive results from a Phase 1b trial evaluating repibresib in nonsegmental vitiligo in October 2023 and initiated a Phase 2b trial in nonsegmental vitiligo in June 2024. The trial evaluated 177 subjects (mITT population). In July 2025, we announced that the trial did not meet its primary endpoint of the proportion of subjects achieving an improvement in Facial Vitiligo Area Scoring Index of at least 50% from baseline (“F-VASI50”) at week 24 compared to vehicle. The trial also missed a key secondary endpoint of F-VASI75. However, the trial showed a nominally statistically significant treatment effect for the highest dose cohort in a key secondary endpoint, percent change-from-baseline (“CFB”) in F-VASI score at week 24 compared to vehicle (Repibresib 3%: -43.6% vs. Vehicle: -25.6%), and an exploratory endpoint of percent CFB in Total Vitiligo Area Scoring Index score at week 24 compared to vehicle (Repibresib 3%: -28.3% vs. Vehicle: -16.2%). Based on these data, we discontinued the ongoing extension phase of the trial and has terminated the trial. Repibresib gel covered by patents providing composition of matter patent exclusivity into at least 2042 in the United States and into at least 2040 in Europe, Japan and other large global pharmaceutical markets. We are currently seeking an external partner to continue development of repibresib gel.

Previous wording

We have incurred net losses since our inception. Except from the period from 2020 to 2022, when we conducted commercial operations, our business activities have been primarily limited to developing product candidates, raising capital and performing research and development activities. As of June 30, 2025, we had an accumulated deficit of $745.5 million. We recorded net losses of $14.4 million and $15.7 million for the six months ended June 30, 2025 and 2024, respectively.

Current wording

We have incurred net losses since our inception. Except from the period from 2020 to 2022, when we conducted commercial operations, our business activities have been primarily limited to developing product candidates, raising capital and performing research and development activities. As of September 30, 2025, we had an accumulated deficit of $752.8 million. We recorded net losses of $21.6 million and $27.8 million for the nine months ended September 30, 2025 and 2024, respectively.

Previous wording

We made a cash payment of $3.75 million to Tay in connection with entering into the VYN202 License Agreement. Pursuant to the terms of the VYN202 License Agreement, we agreed to make cash payments to Tay of up to $43.75 million upon the achievement of specified clinical development and regulatory approval milestones with respect to each licensed oral product in the United States for all indications, of which $1.3 million has been paid or accrued through June 30, 2025. Tay is entitled to additional milestone payments upon the achievement of regulatory approvals in certain non-U.S. jurisdictions. In addition, with respect to any products we commercialize under the VYN202 License Agreement, we will pay tiered royalties to Tay on net sales of such licensed products by us, our affiliates, or sublicensees, of 5%, 7.5% and 10% based on tiered annual net sales of licensed products under the VYN202 License Agreement and the Repibresib License Agreement, subject to specified reductions. We are obligated to pay royalties until the latest of (1) the tenth anniversary of the first commercial sale of the relevant licensed product, (2) the expiration of the last valid claim of the licensed patent rights covering such licensed product in such country and (3) the expiration of regulatory exclusivity for the relevant licensed product in the relevant country, on a licensed product-by-licensed product and country-by-country basis.

Current wording

We made a cash payment of $3.75 million to Tay in connection with entering into the VYN202 License Agreement. Pursuant to the terms of the VYN202 License Agreement, we agreed to make cash payments to Tay of up to $43.75 million upon the achievement of specified clinical development and regulatory approval milestones with respect to each licensed oral product in the United States for all indications, of which $2.3 million has been paid or accrued through September 30, 2025. In August 2025, we paid Tay $1,000,000 in partial satisfaction of the "Phase 2 Milestone" under the VYN202 License Agreement for the initiation of the Phase 1b trial in psoriasis and amended the VYN202 License Agreement to provide that upon initiation of a new clinical trial in a target patient population involving VYN202 for oral administration with an efficacy endpoint, regardless of the trial's phase designation or regulatory classification, we shall pay Tay the remaining $4,000,000 amount under the "Phase 2 Milestone." All other terms of the VYN202 License Agreement were unchanged. Tay is entitled to additional milestone payments upon the achievement of regulatory approvals in certain non-U.S. jurisdictions. In addition, with respect to any products we commercialize under the VYN202 License Agreement, we will pay tiered royalties to Tay on net sales of such licensed products by us, our affiliates, or sublicensees, of 5%, 7.5% and 10% based on tiered annual net sales of licensed products under the VYN202 License Agreement and the Repibresib License Agreement, subject to specified reductions. We are obligated to pay royalties until the latest of (1) the tenth anniversary of the first commercial sale of the relevant licensed product, (2) the expiration of the last valid claim of the licensed patent rights covering such licensed product in such country and (3) the expiration of regulatory exclusivity for the relevant licensed product in the relevant country, on a licensed product-by-licensed product and country-by-country basis.

Previous wording

Historically, we have generated revenues under development and license agreements, including royalty payments from sales of Finacea foam. We previously licensed the rights to Finacea to LEO Pharma A/S ("LEO Pharma"). This license was not part of the sale of our commercial business to Journey. For the three months ended June 30, 2025 and 2024, royalty revenues from LEO Pharma in connection with sales of Finacea were $0.1 million and $0.2 million, respectively. For both the six months ended June 30, 2025 and 2024, royalty revenues from LEO Pharma in connection with sales of Finacea were $0.3 million.

Current wording

Historically, we have generated revenues under development and license agreements, including royalty payments from sales of Finacea foam. We previously licensed the rights to Finacea to LEO Pharma A/S ("LEO Pharma"). This license was not part of the sale of our commercial business to Journey. For the three months ended September 30, 2025 and 2024, royalty revenues from LEO Pharma in connection with sales of Finacea were $0.2 million and $0.1 million, respectively. For both the nine months ended September 30, 2025 and 2024, royalty revenues from LEO Pharma in connection with sales of Finacea were $0.4 million.

Previous wording

Our research and development expenses for the three months ended June 30, 2025 and 2024 were $4.9 million and $7.3 million, respectively. Total research and development expenses for both the six months ended June 30, 2025 and 2024 were $11.0 million.

Current wording

Our research and development expenses for the three months ended September 30, 2025 and 2024 were $5.3 million and $10.2 million, respectively. Total research and development expenses for the nine months ended September 30, 2025 and 2024 were $16.3 million and $21.3 million, respectively.

Previous wording

Our general and administrative expenses for the three months ended June 30, 2025 and 2024 were $2.7 million and $3.3 million, respectively. Total general and administrative expenses for the six months ended June 30, 2025 and 2024 were $6.0 million and $7.1 million, respectively.

Current wording

Our general and administrative expenses for the three months ended September 30, 2025 and 2024 were $2.7 million and $3.0 million, respectively. Total general and administrative expenses for the nine months ended September 30, 2025 and 2024 were $8.7 million and $10.0 million, respectively.

Previous wording

Revenues totaled $0.1 million and $0.2 million for the three months ended June 30, 2025 and 2024, respectively, consisting of royalty revenue from our royalty agreement with LEO Pharma.

Current wording

Revenues totaled $0.2 million and $0.1 million for the three months ended September 30, 2025 and 2024, respectively, consisting of royalty revenue from our royalty agreement with LEO Pharma.

Previous wording

Our research and development expenses for the three months ended June 30, 2025 were $4.9 million, representing a decrease of $2.4 million, or 33.2%, compared to $7.3 million for the three months ended June 30, 2024. The decrease was primarily driven by decreased expenses for repibresib and VYN202 of $2.1 million and $0.2 million, respectively. The$2.1 million decrease in expenses for repibresib was primarily driven by the timing of expenses for the Phase 2b trial in nonsegmental vitiligo, including a $1.0 million milestone payment due to Tay under the License Agreement upon the initiation of the trial in June 2024. The $0.2 million decrease in expenses for VYN202 was primarily driven by the timing of expenses for Phase 1 trials evaluating VYN202, including a $1.0 million milestone payment due to Tay under the License Agreement upon the initiation of the Phase 1a healthy volunteer trial in June 2024, partially offset by increased expenses in the second quarter of 2025 for the Phase 1b trial evaluating VYN202 in moderate-to-severe plaque psoriasis subjects.

Current wording

Our research and development expenses for the three months ended September 30, 2025 were $5.3 million, representing a decrease of $5.0 million, or 48.7%, compared to $10.2 million for the three months ended September 30, 2024. The decrease was primarily driven by decreased expenses for repibresib and VYN202 of $3.9 million and $1.0 million, respectively. The $3.9 million decrease in expenses for repibresib was primarily driven by the timing of expenses for the Phase 2b trial in nonsegmental vitiligo, including our decision to terminate the trial following the announcement of topline results in July 2025. The $1.0 million decrease in expenses for VYN202 was primarily driven by decreased clinical expenses for the Phase 1 trials evaluating VYN202, partially offset by a $1.0 million milestone payment made to Tay in the third quarter of 2025 under an amendment to the VYN202 License Agreement.

Previous wording

Our general and administrative expenses for the three months ended June 30, 2025 were $2.7 million, representing a decrease of approximately $0.6 million, or 17.0%, compared to $3.3 million for the three months ended June 30, 2024. The decrease was primarily driven by a decrease in employee related expenses of $0.3 million and consulting and professional fees of $0.2 million.

Current wording

Our general and administrative expenses for the three months ended September 30, 2025 were $2.7 million, representing a decrease of approximately $0.3 million, or 8.7%, compared to $3.0 million for the three months ended September 30, 2024. The decrease was primarily driven by a decrease in employee related expenses of $0.2 million and consulting and professional fees of $0.1 million.

Previous wording

Other income, net for the three months ended June 30, 2025 was $1.8 million, representing an increase of approximately $0.8 million, or 79.3% compared to $1.0 million for the three months ended June 30, 2024. The increase was primarily due to the recognition of $1.3 million in income related to the closure of the IRS examination period of the Company's ERTC filings, offset by decreased interest income earned on cash, cash equivalents and marketable securities compared to prior year.

Current wording

Other income, net for the three months ended September 30, 2025 was $0.4 million, representing a decrease of approximately $0.6 million, or 60.8% compared to $0.9 million for the three months ended September 30, 2024. The decrease was primarily driven by lower interest income earned on cash, cash equivalents and marketable securities compared to prior year.

Previous wording

Revenues totaled $0.3 million for both the six months ended June 30, 2025 and 2024 consisting of royalty revenue from our royalty agreement with LEO Pharma.

Current wording

Revenues totaled $0.4 million for both the nine months ended September 30, 2025 and 2024 consisting of royalty revenue from our royalty agreement with LEO Pharma.

Previous wording

Our research and development expenses for both the six months ended June 30, 2025 and 2024 were $11.0 million, representing a decrease of $10.0 thousand, or 0.1%. The decrease was primarily driven by decreased expenses of $1.4 million for repibresib, partially offset by increased expenses of $1.3 million for VYN202. The decrease in expenses for repibresib was primarily driven by the timing of expenses for the Phase 2b trial in nonsegmental vitiligo, including a $1.0 million milestone payment due to Tay under the License Agreement upon the initiation of the trial in June 2024. The $1.3 million increase in expenses for VYN202 was primarily associated with costs incurred in connection with our Phase 1b trial evaluating VYN202 in moderate-to-severe plaque psoriasis subjects.

Current wording

Our research and development expenses for the nine months ended September 30, 2025 and 2024 were$16.3 million and $21.3 million, representing a decrease of $5.0 million, or 23.5%. The decrease was primarily driven by decreased expenses of $5.2 million for repibresib, partially offset by increased expenses of $0.3 million for VYN202. The decrease in expenses for repibresib was primarily driven by the timing of expenses for the Phase 2b trial in nonsegmental vitiligo, including our decision to terminate the trial following the announcement of topline results in July 2025, as well as a $1.0 million milestone payment due to Tay under the License Agreement upon the initiation of the trial in June 2024. The $0.3 million increase in expenses for VYN202 was primarily associated with costs incurred in connection with our Phase 1b trial evaluating VYN202 in moderate-to-severe plaque psoriasis subjects.

Previous wording

Our general and administrative expenses for the six months ended June 30, 2025 were $6.0 million, representing a decrease of approximately $1.1 million, or 17.0%, compared to $7.1 million for the six months ended June 30, 2024. The decrease was primarily driven byemployee related expenses of$0.6 million and consulting and professional fees of$0.5 million.

Current wording

Our general and administrative expenses for the nine months ended September 30, 2025 were $8.7 million, representing a decrease of approximately $1.3 million, or 8.7%, compared to $10.0 million for the nine months ended September 30, 2024. The decrease was primarily driven by a decrease inemployee related expenses of$0.8 million and consulting and professional fees of$0.5 million.

Previous wording

Other income, net for the six months ended June 30, 2025 was $2.4 million, representing an increase of approximately $0.2 million, or 11.6% compared to $2.1 million for the six months ended June 30, 2024. The increase was primarily due to the recognition of $1.3 million in income related to the closure of the IRS examination period of the Company's ERTC filings, offset by decreased interest income earned on cash, cash equivalents and marketable securities compared to the prior period.

Current wording

Other income, net for the nine months ended September 30, 2025 was $2.8 million, representing a decrease of approximately $0.3 million, or 10.4% compared to $3.1 million for the nine months ended September 30, 2024. The increase was primarily due to the recognition of $1.3 million in income related to the closure of the IRS examination period of the Company's ERTC filings, offset by decreased interest income earned on cash, cash equivalents and marketable securities compared to the prior period.

Previous wording

As of June 30, 2025, we had cash, cash equivalents and marketable securities of $39.6 million and an accumulated deficit of $745.5 million. We had no outstanding debt as of June 30, 2025. For the six months ended June 30, 2025, we incurred a net loss of $14.4 million and used $22.3 million of cash in operations. Based on our current operating plan, we believe our existing cash, cash equivalents and marketable securities are sufficient to fund our operating and capital expenditure requirements for a period of at least 12 months from the date of issuance of the unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.

Current wording

As of September 30, 2025, we had cash, cash equivalents and marketable securities of $32.7 million and an accumulated deficit of $752.8 million. We had no outstanding debt as of September 30, 2025. For the nine months ended September 30, 2025, we incurred a net loss of $21.6 million and used $29.4 million of cash in operations. Based on our current operating plan, we believe our existing cash, cash equivalents and marketable securities are sufficient to fund our operating and capital expenditure requirements for a period of at least 12 months from the date of issuance of the unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.

Previous wording

Our sources of funding for both the six months ended June 30, 2025 and 2024 are further evaluated in the cash flow section below. Other than our obligations pursuant to the Tay License Agreements, we have no ongoing material financial commitments that may affect our liquidity over the next five years. See the section titled “Development and License Agreements—Agreements with Tay Therapeutics” for additional discussion of our financial obligations under the Tay License Agreements.

Current wording

Our sources of funding for both the nine months ended September 30, 2025 and 2024 are further evaluated in the cash flow section below. Other than our obligations pursuant to the Tay License Agreements, we have no ongoing material financial commitments that may affect our liquidity over the next five years. See the section titled “Development and License Agreements—Agreements with Tay Therapeutics” for additional discussion of our financial obligations under the Tay License Agreements.

Previous wording

We do not expect to generate any product revenue unless and until we obtain regulatory approval of and commercialize any of our product candidates, and we do not know when, or if, that will occur. Until we can generate significant revenue from product sales, if ever, we will continue to require substantial additional capital to develop our current and future product candidates and fund operations for the foreseeable future. Our primary uses of capital are, and we expect will continue to be, compensation and related expenses, research and development costs to support our product candidate pipeline, legal and other regulatory expenses and general overhead costs. We are subject to all the risks incident to the development of new biopharmaceutical products, and we may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors that may harm our business.

Current wording

We do not expect to generate any product revenue unless and until we obtain regulatory approval of and commercialize any of our product candidates, and we do not know when, or if, that will occur. Until we can generate significant revenue from product sales, if ever, we will continue to require substantial additional capital to develop our current and future product candidates and fund operations for the foreseeable future. Our primary uses of capital are, and we expect will continue to be, compensation and related expenses, research and development costs to support our product candidate pipeline, legal and other regulatory expenses and general overhead costs as we conduct a strategic review to evaluate a range of options to maximize stockholder value. We are subject to all the risks incident to the development of new biopharmaceutical products, and we may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors that may harm our business.

Previous wording

In order to complete the development of VYN202 (including making milestone payments pursuant to the VYN202 License Agreement), or any future product candidates, we will require substantial additional capital. Accordingly, we expect to review our strategy and pipeline, seek to raise any necessary additional capital, through private or public equity or debt financings, loans or other capital sources, which could include income from collaborations, partnerships or other marketing, distribution, licensing or other strategic arrangements with third parties, or from grants. To the extent that we raise additional capital through equity financings or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation, voting or other preferences that adversely affect the rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, including restricting our operations and limiting our ability to incur liens, issue additional debt, pay dividends, repurchase our common stock, make certain investments or engage in merger, consolidation, licensing, or asset sale transactions. If we raise capital through collaborations, partnerships, and other similar arrangements with third parties, we may be required to grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. We may be unable to raise additional capital from these sources on favorable terms, or at all.

Current wording

In order to complete the development of VYN202 (including making milestone payments pursuant to the VYN202 License Agreement), or any future product candidates, we will require substantial additional capital. Accordingly, we expect to review our strategy and pipeline, including by exploring strategic alternatives in order to raise any necessary additional capital through private or public equity or debt financings, loans or other capital sources, income from collaborations, partnerships or other marketing, distribution, licensing or other strategic arrangements with third parties, or from grants. To the extent that we raise additional capital through equity financings or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation, voting or other preferences that adversely affect the rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, including restricting our operations and limiting our ability to incur liens, issue additional debt, pay dividends, repurchase our common stock, make certain investments or engage in merger, consolidation, licensing, or asset sale transactions. If we raise capital through collaborations, partnerships, and other similar arrangements with third parties, we may be required to grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. We may be unable to raise additional capital from these sources on favorable terms, or at all.

Previous wording

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

Current wording

The following table summarizes our cash flows for the nine months ended September 30, 2025 and 2024:

Previous wording

During the six months ended June 30, 2025, net cash used in operating activities was $22.3 million and primarily reflected our net loss of $14.4 million adjusted for non-cash stock-based compensation expense of $1.3 million, partially offset by the amortization of premium on marketable securities of $0.5 million. The remainder of the cash used in operations was driven by changes in operating assets and liabilities.

Current wording

During the nine months ended September 30, 2025, net cash used in operating activities was $29.4 million and primarily reflected our net loss of $21.6 million adjusted for non-cash stock-based compensation expense of $1.8 million, partially offset by the amortization of premium on marketable securities of $0.7 million. The remainder of the cash used in operations was driven by changes in operating assets and liabilities.

Previous wording

During the six months ended June 30, 2024, net cash used in operating activities was $16.5 million and primarily reflected our net loss of $15.7 million adjusted for non-cash stock-based compensation expense of $1.9 million, partially offset by the amortization of premium on marketable securities of $1.4 million. The remainder of the cash used in operations was driven by the changes in operating assets and liabilities.

Current wording

During the nine months ended September 30, 2024, net cash used in operating activities was $25.0 million and primarily reflected our net loss of $27.8 million adjusted for non-cash stock-based compensation expense of $2.6 million, partially offset by the amortization of premium on marketable securities of $1.9 million. The remainder of the cash used in operations was driven by the changes in operating assets and liabilities.

Previous wording

During the six months ended June 30, 2025, net cash provided by investing activities was $24.5 million and consisted of $47.9 million of proceeds received from the sale and maturity of marketable securities, partially offset by $23.3 million paid for the purchase of marketable securities.

Current wording

During the nine months ended September 30, 2025, net cash provided by investing activities was $28.9 million and consisted of $59.1 million of proceeds received from the sale and maturity of marketable securities, partially offset by $30.1 million paid for the purchase of marketable securities.

Previous wording

During the six months ended June 30, 2024, net cash provided by investing activities was $15.5 million and consisted of $37.5 million of proceeds received from the sale and maturity of marketable securities, partially offset by$22.0 million paid for the purchase of marketable securities.

Current wording

During the nine months ended September 30, 2024, net cash provided by investing activities was $10.6 million and consisted of $61.1 million of proceeds received from the sale and maturity of marketable securities, partially offset by$50.5 million paid for the purchase of marketable securities.

Previous wording

During the six months ended June 30, 2025, net cash used in financing activities was$0.1 million and consisted of withholdings related to the exercise of options and issuance of stock for stock-based compensation arrangements.

Current wording

During the nine months ended September 30, 2025, net cash used in financing activities was$0.1 million and consisted of withholdings related to the exercise of options and issuance of stock for stock-based compensation arrangements.

Previous wording

During the six months ended June 30, 2024, net cash used in financing activities was immaterial.

Current wording

During the nine months ended September 30, 2024, net cash used in financing activities was immaterial.

Previous wording

Our critical accounting policies are described in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 6, 2025. There have been no material changes to these policies for the six months ended June 30, 2025.

Current wording

Our critical accounting policies are described in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 6, 2025. There have been no material changes to these policies for the nine months ended September 30, 2025.