INOVIO PHARMACEUTICALS, INC.
For the period ended Sep 30, 2025. Filed Nov 10, 2025.
View on SEC.govAbout 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 10, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-12.
0001055726-25-000055
Item 2. Managements Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-10.
0001055726-25-000063
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe 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 77 previous paragraphs and 93 current paragraphs.
39 unchanged; 32 reworded; 18 added; 5 removed; 1 previous and 4 current paragraphs rearranged.
Tables are not compared: 2 previous and 2 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 (18)
Current report
During 2025, we have presented key data regarding INO-3107 at several scientific conferences. Highlights from the data include:
Current report
•81% (26/32) of patients experienced a reduction of one or more surgeries at Year 1 post-treatment
Current report
•By the end of Year 2, 91% (21/23) of evaluable patients continued to experience a reduction of one or more surgeries. Only two patients had not yet responded to treatment with INO-3107
Current report
•INO-3107 demonstrated continued clinical benefit, with a persistent decline in the mean number of surgeries through Year 2 post-therapy: A 78% reduction in mean annual surgeries was seen at Year 2 compared to the 1 year pre-treatment period (0.9, n=28 vs 4.1, n=32)
Current report
•Clinical response was not dependent upon low viral loads, molecular subtype or other elements of the papilloma microenvironment
Current report
•$726,000 in lower employee and consultant compensation, including stock-based compensation;
Current report
•$548,000 in lower engineering professional and outside services related to our device development; and
Current report
•$535,000 in lower contract labor; offset by
Current report
•$1.5 million of lower contra-research and development expense recorded from grant agreements.
Current report
•$2.4 million in lower contract labor;
Current report
•$1.2 million in lower outside services related to the collaborative research agreements with Wistar; and
Current report
•$1.1 million of lower contra-research and development expense recorded from grant agreements.
Current report
•$741,000 in lower employee and consultant compensation, including stock-based compensation; and
Current report
•$170,000 in lower rent and facilities related expenses; offset by
Current report
•$376,000 in higher legal expenses.
Current report
•$1.5 million in lower employee and consultant compensation, including stock-based compensation;
Current report
•$535,000 in lower contract labor;
Current report
•$530,000 in lower rent and facilities related expenses; and
Removed paragraphs (5)
Previous report
•$973,000 and $1.9 million, respectively, in lower contract labor;
Previous report
•$377,000 and $588,000, respectively, in lower outside services primarily related to commercial development;
Previous report
•$270,000 and $497,000, respectively, in lower contract labor; and
Previous report
On November 9, 2021, we entered into an ATM Equity Offering SM Sales Agreement, or the 2021 Sales Agreement, with outside sales agents, under which we were able to offer and sell shares of our common stock with aggregate gross proceeds of up to $300.0 million.
Previous report
During thesix months ended June 30, 2024, we sold 543,620 shares of our common stock under the 2021 Sales Agreement at a weighted average price of $9.76 per share, resulting in aggregate net proceeds of $5.2 million. We terminated the 2021 Sales Agreement in August 2024 in connection with the entry into the 2024 Sales Agreement described above.
Reworded paragraphs (32)
Previous wording
In 2023, we received feedback from the U.S. Food and Drug Administration, or FDA, that the data from this completed trial could be used to support the submission of a Biologic License Application, or BLA, for review under the FDA’s accelerated approval program. As part of submitting our BLA under the accelerated program, we will need to satisfy all FDA filing requirements and initiate a confirmatory clinical trial prior to BLA submission. We previously expected to be able to submit our BLA by the end of 2024; however, during our device testing process we identified a manufacturing issue involving the single-use disposable administration component of the CELLECTRA 5PSP device that we plan to use in the confirmatory trial and that will be submitted for approval for commercial use. We resolved the manufacturing issue in the first quarter of 2025 and have recently completed Design Verification (DV) testing. Utilizing our breakthrough therapy designation, we requested rolling submission of our BLA in July 2025 and remain on track to complete the BLA submission in the second half of 2025 with the goal of receiving file acceptance by the FDA by the end of 2025. We plan to request a priority review from the FDA.
Current wording
In 2023, we received feedback from the U.S. Food and Drug Administration, or FDA, that the data from our completed trial of INO-3107 could be used to support the submission of a Biologic License Application, or BLA, for review under the FDA’s accelerated approval program. As part of submitting our BLA under the accelerated program, we will need to satisfy all FDA filing requirements and initiate a confirmatory clinical trial prior to BLA submission. We previously expected to be able to submit our BLA by the end of 2024; however, during our device testing process we identified a manufacturing issue involving the single-use disposable administration component of the CELLECTRA 5PSP device that we plan to use in the confirmatory trial and that will be submitted for approval for commercial use. We resolved the manufacturing issue in the first quarter of 2025 and completed Design Verification (DV) testing in August 2025. Utilizing our breakthrough therapy designation, we requested rolling submission of our BLA in July 2025 and reported in November 2025 that we had completed the BLA submission, with the goal of receiving file acceptance by the FDA by the end of 2025. We have requested a priority review from the FDA, which, if granted, is expected to be completed within six months following the 60-day filing period.
Previous wording
In addition to our development efforts with the product candidates described above, we are actively developing or planning to develop DNA medicines for other indications, including HPV-related anal dysplasia; cancers in people with certain gene mutations; and a potential vaccine booster to protect against the Ebola virus. We were previously conducting clinical trials of a DNA medicine candidate for the treatment of HPV-related cervical high-grade squamous intraepithelial lesions, or HSIL, but announced in 2023 that we were ceasing development for this indication in the United States. However, our collaborator ApolloBio Corporation continues to conduct a Phase 3 clinical trial of this candidate in China and plans to seek regulatory approval for and potentially commercialize the candidate in that jurisdiction.
Current wording
In addition to our development efforts with the product candidates described above, we are actively developing or planning to develop DNA medicines for other indications, including HPV-related anal dysplasia; cancers in people with certain gene mutations; and a potential vaccine booster to protect against the Ebola virus. We are also working to identify partnership opportunities for our DPROT/DMAb research. We were previously conducting clinical trials of a DNA medicine candidate for the treatment of HPV-related cervical high-grade squamous intraepithelial lesions, or HSIL, but announced in 2023 that we were ceasing development for this indication in the United States. However, our collaborator ApolloBio Corporation continues to conduct a Phase 3 clinical trial of this candidate in China and plans to seek regulatory approval for and potentially commercialize the candidate in that jurisdiction.
Previous wording
Revenue. Total revenue was $0 and $65,000 for the three and six months ended June 30, 2025, respectively, as compared to $101,000 for both the three and six months ended June 30, 2024, all of which was derived under the collaborative arrangement with ApolloBio.
Current wording
Revenue. Total revenue was $0 and $65,000 for the three and nine months ended September 30, 2025, respectively, as compared to $0 and $101,000 for the three and nine months ended September 30, 2024, all of which was derived under the collaborative arrangement with ApolloBio.
Previous wording
The following table summarizes our research and development expense by product candidate for the three and six months ended June 30, 2025 and 2024:
Current wording
The following table summarizes our research and development expense by product candidate for the three and nine months ended September 30, 2025 and 2024:
Previous wording
The decrease in research and development expenses for the three and six-month periods year over year was primarily the result of:
Current wording
The decrease in research and development expenses for the three-month period year over year was primarily the result of:
Previous wording
•$5.9 million and $9.1 million, respectively, in lower drug manufacturing, clinical study, immunology and other expenses related to INO-3107;
Current wording
•$3.6 million in lower drug manufacturing, clinical study and other expenses related to INO-3107;
Previous wording
•$287,000 and $1.0 million, respectively, of lower expensed inventory; and
Current wording
•$1.0 million of lower expensed inventory;
Previous wording
•$415,000 and $539,000, respectively, of lower clinical study and drug manufacturing expenses related to INO-5401;
Current wording
•$12.0 million in lower drug manufacturing, clinical study and other expenses related to INO-3107;
Previous wording
•$411,000 and $1.0 million, respectively, in lower employee and consultant stock-based compensation;
Current wording
•$1.1 million in lower employee and consultant stock-based compensation; offset by
Previous wording
Contributions received from current grant agreements and recorded as contra-research and development expense were $315,000 and $601,000 for the three and six months ended June 30, 2025, respectively, as compared to $9,000 and $188,000 for the three and six months ended June 30, 2024, respectively. The increase for the three and six-month periods year over year was due to the increase in expenses earned under the sub-grants through Wistar, among other variances.
Current wording
Contributions received from current grant agreements and recorded as contra-research and development expense were $256,000 and $856,000 for the three and nine months ended September 30, 2025, respectively, as compared to $1.8 million and $1.9 million for the three and nine months ended September 30, 2024, respectively. The decrease for the three and nine-month periods year over year was primarily due to funding received from the close-out of the CEPI grants in 2024; offset by the increase in expenses earned under the sub-grants through Wistar, among other variances.
Previous wording
General and administrative expenses. General and administrative expenses, which include commercial and business development expenses and patent expenses, were $8.6 million and $17.6 million for the three and six months ended June 30, 2025, respectively, as compared to $10.2 million and $20.8 million for the three and six months ended June 30, 2024, respectively. Decreases for the three and six-month periods year over year included:
Current wording
General and administrative expenses. General and administrative expenses, which include commercial, business development expenses and patent expenses, were $7.9 million and $25.5 million for the three and nine months ended September 30, 2025, respectively, as compared to $8.6 million and $29.4 million for the three and nine months ended September 30, 2024, respectively. Decreases for the three-month period year over year included:
Previous wording
•$525,000 and $505,000, respectively, in lower employee severance expenses;
Current wording
•$518,000 in lower employee severance expenses;
Previous wording
•$31,000 and $776,000, respectively, in lower legal expenses due a decrease in litigation activity.
Current wording
•$401,000 in lower legal expenses due to a decrease in litigation activity.
Previous wording
Stock-based compensation. Employee stock-based compensation expense is measured at the grant date, based on the fair value of the award, and is recognized as expense over the requisite vesting period. Total employee and director stock-based compensation expense recognized in the condensed consolidated statements of operations for the three and six months ended June 30, 2025 was $819,000 and $2.2 million, respectively, of which $319,000 and $866,000, respectively, was included in research and development expenses, and $500,000 and $1.3 million, respectively, was included in general and administrative expenses. Total employee and director stock-based compensation expense recognized in the condensed consolidated statements of operations for the three and six months ended June 30, 2024 was $1.5 million and $3.9 million, respectively, of which $581,000 and $1.6 million, respectively, was included in research and development expenses, and $890,000 and $2.3 million, respectively, was included in general and administrative expenses. The decrease was due to a lower weighted average grant date fair value for the awards granted during 2025.
Current wording
Stock-based compensation. Employee stock-based compensation expense is measured at the grant date, based on the fair value of the award, and is recognized as expense over the requisite vesting period. Total employee and director stock-based compensation expense recognized in the condensed consolidated statements of operations for the three and nine months ended September 30, 2025 was $742,000 and $2.9 million, respectively, of which $300,000 and $1,200,000, respectively, was included in research and development expenses, and $442,000 and $1.7 million, respectively, was included in general and administrative expenses. Total employee and director stock-based compensation expense recognized in the condensed consolidated statements of operations for the three and nine months ended September 30, 2024 was $1.2 million and $5.1 million, respectively, of which $581,000 and $2.2 million, respectively, was included in research and development expenses, and $619,000 and $2.9 million, respectively, was included in general and administrative expenses. The decrease was due to a lower weighted average grant date fair value for the awards granted during 2025.
Previous wording
Interest income. Interest income for the three and six months ended June 30, 2025 was $611,000 and $1.4 million, respectively, as compared to $1.3 million and $2.8 million for the three and six months ended June 30, 2024, respectively. The decrease for the three-month period year over year was primarily due to a lower short-term investment balance.
Current wording
Interest income. Interest income for the three and nine months ended September 30, 2025 was $552,000 and $2.0 million, respectively, as compared to $1.1 million and $3.9 million for the three and nine months ended September 30, 2024, respectively. The decrease for the three and nine-month periods year over year was primarily due to a lower short-term investment balance.
Previous wording
Interest expense. Interest expense for both the three and six months ended June 30, 2025 was $0, as compared to $0 and $178,000 for the three and six months ended June 30, 2024, respectively. The prior year interest expense related to our senior convertible promissory notes that were repaid in full on March 1, 2024.
Current wording
Interest expense. Interest expense for both the three and nine months ended September 30, 2025 was $0, as compared to $0 and $178,000 for the three and nine months ended September 30, 2024, respectively. The prior year interest expense related to our senior convertible promissory notes that were repaid in full on March 1, 2024.
Previous wording
Change in Fair Value of Common Stock Warrant Liability. The change in fair value of our common stock warrant liability is related to the revaluation of the liability associated with the 2024 Warrants, as defined below, we issued in December 2024. We record the fair value of these 2024 Warrants at each balance sheet date and will record gain or loss on the statement of operations for changes between balance sheet dates.
Current wording
Change in Fair Value of Common Stock Warrant Liabilities. The change in fair value of our common stock warrant liabilities of $(22.5) million and $(20.7) million for the three and nine months ended September 30, 2025, respectively, is related to the revaluation of the liability associated with the 2024 and 2025 Warrants, as defined below, which we issued in December 2024 and July 2025, respectively. We record the fair value of these 2024 and 2025 Warrants at each balance sheet date and will record gain or loss on the statement of operations for changes in fair value between balance sheet dates.
Previous wording
Gain (loss) on investment in affiliated entity. The gain (loss) resulted from the change in the fair market value of our investment in Plumbline Life Sciences, Inc. (PLS) of $776,000 and $1.5 million for the three and six months ended June 30, 2025, respectively, as compared to $(334,000) and $(460,000) for the three and six months ended June 30, 2024, respectively. We record our investment in PLS at its market value based on the closing price of the shares on the Korea New Exchange Market at each balance sheet date, with changes in fair value reflected in the condensed consolidated statements of operations.
Current wording
(Loss) gain on investment in affiliated entity. The (loss) gain resulted from the change in the fair market value of our investment in Plumbline Life Sciences, Inc. (PLS) of $(590,000) and $882,000 for the three and nine months ended September 30, 2025, respectively, as compared to $324,000 and $(136,000) for the three and nine months ended September 30, 2024, respectively. We record our investment in PLS at its market value based on the closing price of the shares on the Korea New Exchange Market at each balance sheet date, with changes in fair value reflected in the condensed consolidated statements of operations.
Previous wording
Net unrealized gain (loss) on available-for-sale equity securities. The net unrealized gain (loss) on available-for-sale equity securities for the three and six months ended June 30, 2025 of $759,000 and $900,000, respectively, as compared to $(21,000) and $480,000 for the three and six months ended June 30, 2024, respectively, resulted from a change in the fair market value of the investments.
Current wording
Net unrealized gain on available-for-sale equity securities. The net unrealized gain on available-for-sale equity securities for the three and nine months ended September 30, 2025 of $205,000 and $1.1 million, respectively, as compared to $1.3 million and $1.8 million for the three and nine months ended September 30, 2024, respectively, resulted from a change in the fair market value of the investments.
Previous wording
Other (expense) income, net. Other (expense) income, net, for the three and six months ended June 30, 2025 of $(703,000) and $(704,000), respectively, as compared to $8,000 and $(675,000) for the three and six months ended June 30, 2024, respectively, related primarily to the realized loss on short-term investments sold during the periods.
Current wording
Other expense, net. Other expense, net, for the three and nine months ended September 30, 2025 of $1.9 million and $2.6 million, respectively, as compared to $580,000 and $1.3 million for the three and nine months ended September 30, 2024, respectively, related primarily to financing costs incurred in connection with the issuance of the Common Stock Warrants in July 2025, as well as the realized loss on short-term investments sold during the periods.
Previous wording
As of June 30, 2025, we had cash, cash equivalents and short-term investments of $47.5 million and working capital of $21.0 million, as compared to $94.1 million and $62.5 million, respectively, as of December 31, 2024.
Current wording
As of September 30, 2025, we had cash, cash equivalents and short-term investments of $50.8 million and working capital of $(14.6) million, as compared to $94.1 million and $62.5 million, respectively, as of December 31, 2024.
Previous wording
Net cash used in operating activities was $47.7 million and $57.0 million for the six months ended June 30, 2025 and 2024, respectively. The variance was primarily due to the timing and changes in working capital balances, offset by decreased operating expenses.
Current wording
Net cash used in operating activities was $69.3 million and $84.4 million for the nine months ended September 30, 2025 and 2024, respectively. The variance was primarily due to the timing and changes in working capital balances, offset by decreased operating expenses.
Previous wording
Net cash provided by investing activities was $5.2 million and $55.3 million for the six months ended June 30, 2025 and 2024, respectively. The variance was primarily the result of timing differences and overall decrease in short-term investment purchases, sales and maturities.
Current wording
Net cash provided by investing activities was $14.1 million and $69.4 million for the nine months ended September 30, 2025 and 2024, respectively. The variance was primarily the result of timing differences and overall decrease in short-term investment purchases, sales and maturities.
Previous wording
Net cash provided by financing activities was $993,000 and $21.7 million for the six months ended June 30, 2025 and 2024, respectively. The variance was primarily due to the repayment of our convertible senior notes of $16.4 million in March 2024, offset by net proceeds from the April 2024 Offering (defined below) of $33.2 million and net proceeds of $5.2 million from the sale of common stock under the Sales Agreements (defined below) during the six months ended June 30, 2024, compared to $1.1 million received during the six months ended June 30, 2025.
Current wording
Net cash provided by financing activities was $25.9 million and $22.3 million for the nine months ended September 30, 2025 and 2024, respectively. The variance was primarily due to net proceeds from the July 2025 Offering (defined below) of $22.4 million and $1.1 million received from the sale of common stock under the Sales Agreements (defined below) during the nine months ended September 30, 2025, compared to net proceeds from the April 2024 Offering (defined below) of $33.2 million and net proceeds of $5.9 million from the sale of common stock under the Sales Agreements (defined below) during the nine months ended September 30, 2024, offset by the repayment of our convertible senior notes of $16.4 million in March 2024.
Previous wording
On July 7, 2025 , we closed an underwritten public offering, or the July 2025 Offering, relating to the issuance and sale of 14,285,715 shares of our common stock and accompanying Series A warrants to purchase up to 14,285,715 shares of our common stock (or pre-funded warrants, each representing the right to purchase one share of common stock at an exercise price of $0.001, or the Pre-Funded Warrants, in lieu thereof) at an exercise price of $1.75 per share of common stock (or $1.749 per Pre-Funded Warrant), or the Series A Warrants, and Series B warrants to purchase up to 14,285,715 shares of our common stock (or Pre-Funded Warrants in lieu thereof) at an exercise price of $1.75 per share of Common Stock (or $1.749 per Pre-Funded Warrant), or the Series B Warrants, and, together with the Series A Warrants, the 2025 Warrants, at a combined public offering price of $1.75 per share of common stock and accompanying 2025 Warrants. The net proceeds to us from the July 2025 Offering were $22.5 million, after deducting the underwriting discounts and commissions and offering expenses paid by us.
Current wording
14,285,715 shares of our common stock and accompanying Series A warrants to purchase up to 14,285,715 shares of our common stock (or pre-funded warrants, each representing the right to purchase one share of common stock at an exercise price of $0.001, or the Pre-Funded Warrants, in lieu thereof) at an exercise price of $1.75 per share of common stock (or $1.749 per Pre-Funded Warrant), or the Series A Warrants, and Series B warrants to purchase up to 14,285,715 shares of our common stock (or Pre-Funded Warrants in lieu thereof) at an exercise price of $1.75 per share of Common Stock (or $1.749 per Pre-Funded Warrant), or the Series B Warrants, and, together with the Series A Warrants, the 2025 Warrants, at a combined public offering price of $1.75 per share of common stock and accompanying 2025 Warrants. The net proceeds to us from the July 2025 Offering were $22.4 million, after deducting the underwriting discounts and commissions and offering expenses paid and payable by us.
Previous wording
On April 18, 2024, we closed an underwritten registered direct offering, or the April 2024 Offering, relating to the issuance and sale of 2,536,258 shares of common stock at a price of $7.693 per share and pre-funded warrants to purchase up to 2,135,477 shares of common stock, or the Pre-Funded Warrants, at a price of $7.692 per Pre-Funded Warrant, which represents the per share price for the shares less the $0.001 per share exercise price for each Pre-Funded Warrant. The net proceeds from the April 2024 Offering were $33.2 million, after deducting the underwriting discounts and commissions and offering expenses paid by us.
Current wording
On April 18, 2024, we closed an underwritten registered direct offering, or the April 2024 Offering, relating to the issuance and sale of 2,536,258 shares of common stock at a price of $7.693 per share and pre-funded warrants to purchase up to 2,135,477 shares of common stock, or the Pre-Funded Warrants, at a price of $7.692 per Pre-Funded Warrant, which represents the per share price for the shares less the $0.001 per share exercise price for each Pre-Funded Warrant. The net proceeds from the April 2024 Offering were $33.2 million, after deducting the underwriting discounts and commissions and offering expenses paid by us. In July 2025, all of the 2,135,477 Pre-Funded Warrants were exercised in full with proceeds to us of $2,000.
Previous wording
During the six months ended June 30, 2025, we sold 518,670 shares of common stock under the 2024
Current wording
During the nine months ended September 30, 2025, we sold 518,670 shares of common stock under the 2024
Previous wording
During the six months ended June 30, 2025, nostock options were exercised and tax payments of $109,000 were made related to net share settlement of RSU awards. During the six months ended June 30, 2024, stock options to purchase 8,159 shares of common stock were exercised for aggregate net proceeds to us of $68,000, which proceeds were offset by tax payments made related to net share settlement of RSU awards of $414,000.
Current wording
During the nine months ended September 30, 2025, warrants to purchase 428,571 shares of common stock were exercised for aggregate net proceeds to us of $750,000, nostock options were exercised and tax payments of$111,000 were made related to net share settlement of RSU awards. During the nine months ended September 30, 2024, stock options to purchase 8,159 shares of common stock were exercised for aggregate net proceeds to us of $68,000, which proceeds were offset by tax payments made related to net share settlement of RSU awards of $421,000.
Previous wording
As of June 30, 2025, we had an accumulated deficit of $1.8 billion, and we expect to continue to operate at a loss for the near term. The amount of our accumulated deficit will continue to increase, as it will be expensive to continue research and development efforts. Our current cash resources will not be sufficient to complete the clinical development of our product candidates beyond INO-3107, and we anticipate that additional financing will be required in order to complete the development of and to commercialize and generate revenues from the sale of INO-3107 or any other product candidates that may receive regulatory approval. If these activities are successful and if we receive approval from the FDA to market our DNA medicine candidates, then we will need to raise additional funding to market and sell the approved products and equipment. In addition to the potential issuance of equity or debt securities in order to raise capital, we are also evaluating potential collaborations as an additional way to fund our operations. We expect our cash runway, including the net proceeds from the July 2025 Offering, to extend into the second quarter of 2026, without giving effect to any further capital raising activities that we may undertake.
Current wording
As of September 30, 2025, we had an accumulated deficit of $1.8 billion, and we expect to continue to operate at a loss for the near term. The amount of our accumulated deficit will continue to increase, as it will be expensive to continue research and development efforts. Our current cash resources will not be sufficient to complete the clinical development of our product candidates beyond INO-3107, and we anticipate that additional financing will be required in order to complete the development of and to commercialize and generate revenues from the sale of INO-3107 or any other product candidates that may receive regulatory approval. If these activities are successful and if we receive approval from the FDA to market our DNA medicine candidates, then we will need to raise additional funding to market and sell the approved products and equipment. In addition to the potential issuance of equity or debt securities in order to raise capital, we are also evaluating potential collaborations as an additional way to fund our operations. We expect our cash runway to extend into the second quarter of 2026, without giving effect to any further capital raising activities that we may undertake.
Previous wording
Our ability to continue operations is dependent upon our ability to obtain additional capital in the future and achieve profitable operations. We expect to continue to rely on outside sources of financing to meet our capital needs and we may never achieve positive cash flow. In light of these factors, management believes that there is substantial doubt about our ability to continue as a going concern beyond the second quarter of 2026. The condensed consolidated financial statements as of and for the three and six months ended June 30, 2025 do not include any adjustments that might result from the outcome of this uncertainty.
Current wording
Our ability to continue operations is dependent upon our ability to obtain additional capital in the future and achieve profitable operations. We expect to continue to rely on outside sources of financing to meet our capital needs and we may never achieve positive cash flow. In light of these factors, management believes that there is substantial doubt about our ability to continue as a going concern beyond the second quarter of 2026. The condensed consolidated financial statements as of and for the three and nine months ended September 30, 2025 do not include any adjustments that might result from the outcome of this uncertainty.
Previous wording
We have existing supply agreements with contract manufacturers to manufacture drug substance. At June 30, 2025, we had approximately $476,000 inminimum purchase obligations in connection with these agreements. We expect to satisfy these obligations from existing cash over the next twelve months.
Current wording
We have existing supply agreements with contract manufacturers to manufacture drug substance. At September 30, 2025, we had approximately $355,000 in minimum purchase obligations in connection with these agreements. We expect to satisfy these obligations from existing cash over the next twelve months.
Previous wording
During the six months ended June 30, 2025, there have been no significant changes to our contractual obligations and commitments described under Management’s Discussion and Analysis of Financial Condition and Results of Operations in our 2024 Annual Report.
Current wording
During the nine months ended September 30, 2025, there have been no significant changes to our contractual obligations and commitments described under Management’s Discussion and Analysis of Financial Condition and Results of Operations in our 2024 Annual Report.
Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
The decrease in research and development expenses for the nine-month period year over year was primarily the result of:
Current report — wording carried from elsewhere
•$2.0 million of lower expensed inventory;
Current report — wording carried from elsewhere
Decreases for the nine-month period year over year included:
Current report — wording carried from elsewhere
On July 7, 2025, we closed an underwritten public offering, or the July 2025 Offering, relating to the issuance and sale of
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
•$268,000 and $776,000, respectively, in lower employee and consultant stock-based compensation, as a result of the lower weighted average grant date fair value for the awards granted during 2025.