Genprex, Inc.

Previous wording

You should read the following Management's Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) together with our interim consolidated condensed financial statements and the related notes appearing elsewhere in this Quarterly Report on Form 10-Q. In addition to historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below, and those discussed in the section titled“Risk Factors”* included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, in this filing, and in our other SEC filings, as may be amended, supplemented or superseded from time to time by other reports we file with the SEC. All amounts in this report are in United States (“U.S.”) dollars, unless otherwise noted.*

Current wording

You should read the following Management's Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) together with our interim condensed consolidated financial statements and the related notes appearing elsewhere in this Quarterly Report on Form 10-Q. In addition to historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below, and those discussed in the section titled“Risk Factors”* included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, in this filing, and in our other SEC filings, as may be amended, supplemented or superseded from time to time by other reports we file with the SEC. All amounts in this report are in United States (“U.S.”) dollars, unless otherwise noted.*

Previous wording

Acclaim – 1: We currently are enrolling and treating patients in the Phase 2a expansion portion of our Phase 1/2 Acclaim-1 clinical trial. The Acclaim-1 trial uses a combination of REQORSA and AstraZeneca’s Tagrisso® (osimertinib) in patients with late-stage NSCLC that has activating epidermal growth factor receptor (“EGFR”) mutations and progression on treatment with Tagrisso or Tagrisso-containing regimens. Following the May 2023 completion of the Phase 1 dose escalation portion of the study, the Acclaim-1 Safety Review Committee (“Acclaim-1 SRC”) approved advancement from the Phase 1 dose escalation portion to the Phase 2a expansion portion of the study. Based on a review of safety data which showed no dose limiting toxicities (“DLTs”), the Acclaim-1 SRC determined the recommended Phase 2 dose (“RP2D”) of REQORSA to be 0.12 mg/kg. This was the highest dose level delivered in the Phase 1 portion of the study and is twice the highest dose level delivered in our prior clinical trial combining REQORSA with Tarceva® (erlotinib) for the treatment of late-stage lung cancer. There were three patients originally enrolled in the Phase 1 dose escalation portion of the study who had prolonged progression-free survival (“PFS”). One patient attained a partial remission after the second course of REQORSA and Tagrisso and has maintained this response through 52 courses of treatment (approximately 36 months) and continues to receive REQORSA and Tagrisso treatment to date. A second patient had stable disease without disease progression through 32 courses of treatment (approximately 24 months) but then had disease progression and REQORSA treatment was stopped. A third patient had stable disease without disease progression through 14 courses of treatment (approximately 10 months) before disease progression and is no longer receiving treatment. We opened the Phase 2a expansion portion of the study and enrolled and dosed the first patient in January 2024. The initial trial design of the Phase 2a expansion portion of the study included two cohorts with half being patients who received only prior Tagrisso treatment and the other half being patients who received prior Tagrisso treatment and chemotherapy. However, as previously announced in August 2024, based on resource prioritization and to focus on the patients for whom REQORSA is most likely to show a benefit, we decided to limit our enrollment efforts moving forward to patients who received only prior Tagrisso treatment and cease enrollment of the second cohort (patients who received prior Tagrisso treatment and chemotherapy). However, noting that two of the patients with prolonged PFS in the Phase 1 portion of the study had previously received both chemotherapy and Tagrisso, in February 2025, we amended the protocol to allow entry of patients progressing on Tagrisso or Tagrisso-containing regimens. The Phase 2a expansion portion of the trial is now expected to enroll approximately 33 patients; all of whom have pr…

Excerpt shortened here; the source contains the full paragraph.

Current wording

Acclaim – 1: We currently are enrolling and treating patients in the Phase 2a expansion portion of our Phase 1/2 Acclaim-1 clinical trial. The Acclaim-1 trial uses a combination of REQORSA and AstraZeneca’s Tagrisso® (osimertinib) in patients with late-stage NSCLC that has activating epidermal growth factor receptor (“EGFR”) mutations and progression on treatment with Tagrisso or Tagrisso-containing regimens. Following the May 2023 completion of the Phase 1 dose escalation portion of the study, the Acclaim-1 Safety Review Committee (“Acclaim-1 SRC”) approved advancement from the Phase 1 dose escalation portion to the Phase 2a expansion portion of the study. Based on a review of safety data which showed no dose limiting toxicities (“DLTs”), the Acclaim-1 SRC determined the recommended Phase 2 dose (“RP2D”) of REQORSA to be 0.12 mg/kg. This was the highest dose level delivered in the Phase 1 portion of the study and is twice the highest dose level delivered in our prior clinical trial combining REQORSA with Tarceva® (erlotinib) for the treatment of late-stage lung cancer. There were three patients out of the twelve originally enrolled in the Phase 1 dose escalation portion of the study who had prolonged progression-free survival (“PFS”). One patient attained a partial remission after the second course of REQORSA and Tagrisso and has maintained this response through 56 courses of treatment (approximately 39 months) and continues to receive REQORSA and Tagrisso treatment to date. A second patient had stable disease without disease progression through 32 courses of treatment (approximately 24 months) but then had disease progression and REQORSA treatment was stopped. A third patient had stable disease without disease progression through 14 courses of treatment (approximately 10 months) before disease progression and is no longer receiving treatment. We opened the Phase 2a expansion portion of the study and enrolled and dosed the first patient in January 2024. The initial trial design of the Phase 2a expansion portion of the study included two cohorts with half being patients who received only prior Tagrisso treatment and the other half being patients who received prior Tagrisso treatment and chemotherapy. However, as previously announced in August 2024, based on resource prioritization and to focus on the patients for whom REQORSA is most likely to show a benefit, we decided to limit our enrollment efforts moving forward to patients who received only prior Tagrisso treatment and cease enrollment of the second cohort (patients who received prior Tagrisso treatment and chemotherapy). However, noting that two of the patients with prolonged PFS in the Phase 1 portion of the study had previously received both chemotherapy and Tagrisso, in February 2025, we amended the protocol to allow entry of patients progressing on Tagrisso or Tagrisso-containing regimens. The Phase 2a expansion portion of the trial is now expected to enroll approximately 33 patients; a…

Excerpt shortened here; the source contains the full paragraph.

Previous wording

Acclaim – 3: We are currently enrolling and treating patients in the Phase 2 expansion portion of our Phase 1/2 Acclaim-3 clinical trial. The Acclaim-3 clinical trial uses a combination of REQORSA and Genentech, Inc.’s Tecentriq® (atezolizumab) as maintenance therapy for patients with extensive stage small cell lung cancer (“ES-SCLC”) who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. Patients are treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. On December 16, 2024, we announced that we had completed the Phase 1 dose escalation portion of the Acclaim-3 clinical trial. Based on full safety data, which showed no DLTs, the Acclaim-3 Safety Review Committee determined that the RP2D of REQORSA will be 0.12 mg/kg, which was the highest dose level delivered in the Phase 1 portion of the trial, and approved the opening of the Phase 2 expansion portion of the trial. We anticipate that the Phase 2 expansion portion will enroll approximately 50 patients at approximately 10 to 15 U.S sites. Patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. The primary endpoint of the Phase 2 portion is to determine the 18-week progression-free survival rate from the time of the start of maintenance therapy with REQORSA and Tecentriq in patients with ES-SCLC. Patients will also be followed for survival. A Phase 2 futility analysis will be performed after the 25th patient enrolled and treated reaches 18 weeks of follow up. We expect to complete enrollment of the first 25 patients for interim analysis in the Phase 2 expansion portion of the study in the first quarter of 2026.

Current wording

Acclaim – 3: We are currently enrolling and treating patients in the Phase 2 expansion portion of our Phase 1/2 Acclaim-3 clinical trial. The Acclaim-3 clinical trial uses a combination of REQORSA and Genentech, Inc.’s Tecentriq® (atezolizumab) as maintenance therapy for patients with extensive stage small cell lung cancer (“ES-SCLC”) who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. Patients are treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. On December 16, 2024, we announced that we had completed the Phase 1 dose escalation portion of the Acclaim-3 clinical trial. Based on full safety data, which showed no DLTs, the Acclaim-3 Safety Review Committee determined that the RP2D of REQORSA will be 0.12 mg/kg, which was the highest dose level delivered in the Phase 1 portion of the trial, and approved the opening of the Phase 2 expansion portion of the trial. We anticipate that the Phase 2 expansion portion will enroll approximately 50 patients at approximately 10 to 15 U.S sites. Patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. The primary endpoint of the Phase 2 portion is to determine the 18-week progression-free survival rate from the time of the start of maintenance therapy with REQORSA and Tecentriq in patients with ES-SCLC. Patients will also be followed for survival. A Phase 2 futility analysis will be performed after the 25th patient enrolled and treated reaches 18 weeks of follow up. We expect to complete enrollment of the first 25 patients for interim analysis in the Phase 2 expansion portion of the study in the first half of 2026 and expect the interim analysis in the second half of 2026.

Previous wording

In diabetes, we have exclusively licensed from the University of Pittsburgh of the Commonwealth System of Higher Education (“University of Pittsburgh” or “UP”) multiple technologies relating to the development of a gene therapy product for each of Type 1 and Type 2 diabetes. The same general novel approach is used in each of Type 1 and Type 2 diabetes whereby an adeno-associated virus vector containing the Pdx1 and MafA genes is administered directly into the pancreatic duct. In humans, this can be done with a routine endoscopy procedure. Our diabetes product candidates are currently being evaluated and optimized in preclinical studies at the University of Pittsburgh. GPX-002 is being developed using the same construct for the treatment of both Type 1 diabetes and Type 2 diabetes. GPX-002 for Type 1 diabetes is designed to work by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body’s immune system. In a similar approach, GPX-002 for Type 2 diabetes (formerly known as GPX-003), where autoimmunity is not at play, is believed to work by replenishing and rejuvenating exhausted beta cells that make insulin. We finalized the components of the diabetes construct to take forward for nonclinical studies and in December 2023, we submitted a request to meet with the FDA to obtain their guidance on the nonclinical studies needed to file an Investigational New Drug (“IND”) application and initiate first-in-human studies. As a result of the FDA’s response, we decided to continue with our planned additional nonclinical studies before requesting regulatory guidance for the IND-enabling studies. We are currently working with the University of Pittsburgh on species analyses for the animal models as well as on other regulatory and clinical strategic planning, including the planned initiation of research in Type 2 diabetes animal models, following which we believe we would be poised to seek further regulatory guidance from the FDA on IND-enabling studies in the second half of 2025. In May 2025, following the recent completion of our August 2022 sponsored research agreement with UP, we entered into a new sponsored research agreement with UP to study Type 1 diabetes and Type 2 diabetes in animal models. The new sponsored research agreement also includes a revised research plan to encompass our most recent technologies to which we originally acquired exclusive rights from UP in July 2023 as amended and restated in the comprehensive New UP License Agreement in February 2025 (as defined and described below). These include a MafB promoter to drive expression of the Pdx1 and MafA transcription factors that can potentially be used for both Type 1 and Type 2 diabetes. In February 2023, the Company’s research collaborators at UP presented preclinical data in a non-human primate model of Type 1 diabetes highlighting the therapeutic potential of GPX-002 at the 16th Inter…

Excerpt shortened here; the source contains the full paragraph.

Current wording

In diabetes, we have exclusively licensed from the University of Pittsburgh of the Commonwealth System of Higher Education (“University of Pittsburgh” or “UP”) multiple technologies relating to the development of a gene therapy product for each of Type 1 and Type 2 diabetes. The same general novel approach is used in each of Type 1 and Type 2 diabetes whereby an adeno-associated virus vector containing the Pdx1 and MafA genes is administered directly into the pancreatic duct. In humans, this can be done with a routine endoscopy procedure. Our diabetes product candidates are currently being evaluated and optimized in preclinical studies at the University of Pittsburgh. GPX-002 is being developed using the same construct for the treatment of both Type 1 diabetes and Type 2 diabetes. GPX-002 for Type 1 diabetes is designed to work by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body’s immune system. In a similar approach, GPX-002 for Type 2 diabetes (formerly known as GPX-003), where autoimmunity is not at play, is believed to work by replenishing and rejuvenating exhausted beta cells that make insulin. We finalized the components of the diabetes construct to take forward for nonclinical studies and in December 2023, we submitted a request to meet with the FDA to obtain their guidance on the nonclinical studies needed to file an Investigational New Drug (“IND”) application and initiate first-in-human studies. As a result of the FDA’s response, we decided to continue with our planned additional nonclinical studies before requesting regulatory guidance for the IND-enabling studies. We are currently working with the University of Pittsburgh on species analyses for the animal models as well as on other regulatory and clinical strategic planning, including the planned initiation of research in Type 2 diabetes animal models, following which we plan to submit a request to the FDA to meet regarding IND-enabling studies by the end of 2025. In May 2025, following the recent completion of our August 2022 sponsored research agreement with UP, we entered into a new sponsored research agreement with UP to study Type 1 diabetes and Type 2 diabetes in animal models. The new sponsored research agreement also includes a revised research plan to encompass our most recent technologies to which we originally acquired exclusive rights from UP in July 2023 as amended and restated in the comprehensive New UP License Agreement in February 2025 (as defined and described below). These include a MafB promoter to drive expression of the Pdx1 and MafA transcription factors that can potentially be used for both Type 1 and Type 2 diabetes. On February 17, 2025, we and the University of Pittsburgh entered into an amended and restated Exclusive License Agreement (the “New UP License Agreement”), which updated and consolidated into a single agreement our prior license agreem…

Excerpt shortened here; the source contains the full paragraph.

Previous wording

On June 11, 2025, we entered into an equity line of credit (“ELOC”) purchase agreement (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park committed to purchase up to $12.5 million in shares of our common stock (subject to certain conditions and limitations contained in the Purchase Agreement) from time to time at our sole discretion over the 24-month term of the Purchase Agreement (the “2025 ELOC Facility”). Under applicable Nasdaq rules, the Company may not issue or sell to Lincoln Park under the Purchase Agreement more than 19.99% of the shares of our common stock outstanding immediately prior to the execution of the Purchase Agreement (the “Exchange Cap”), unless (i) we obtain stockholder approval to issue shares of common stock to Lincoln Park under the Purchase Agreement in excess of the Exchange Cap or (ii) the average price of all applicable sales of our common stock to Lincoln Park under the Purchase Agreement equals or exceeds the Base Price (as defined in the Purchase Agreement). The Company is seeking stockholder approval to approve the issuance of shares of common stock in excess of the Exchange Cap at its upcoming 2025 Annual Meeting of Stockholders. Sales of shares of our common stock to Lincoln Park under the Purchase Agreement will depend on a variety of factors to be determined by us from time to time, including, among others, market conditions, the trading price of our common stock and our determination as to the appropriate sources of funding for our operations.

Current wording

On June 11, 2025, we entered into an equity line of credit (“ELOC”) purchase agreement (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park committed to purchase up to $12.5 million in shares of our common stock (subject to certain conditions and limitations contained in the Purchase Agreement) from time to time at our sole discretion over the 24-month term of the Purchase Agreement (the “2025 ELOC Facility”). Sales of shares of common stock to Lincoln Park under the Purchase Agreement will depend on a variety of factors to be determined by us from time to time, including, among others, market conditions, the trading price of the common stock and our determination as to the appropriate sources of funding for our operations. Due to certain pricing and settlement provisions, the Purchase Agreement qualifies as a standby purchase equity agreement and includes an embedded putoption and an embedded forward contract. We will account for the Purchase Agreement as a derivative measured at fair value, with changes in fair value recognized in the consolidated statement of operations. The fair value of the ELOC derivative associated with the Purchase Agreement was $243,000 at September 30, 2025. The Company expenses the difference between the discounted purchase price of the settled forward and the fair value of the shares on the date of settlement as a non-cash financing cost. During the three months ended September 30, 2025, we sold 341,224 shares of common stock to Lincoln Park as purchase shares for aggregate net proceeds of $2,943,745 under the 2025 ELOC Facility. During thenine months ended September 30, 2025, we (i) issued 23,737 shares of common stock to Lincoln Park with a value of$365,550 as commitment shares pursuant to the 2025 ELOC Facility, which was expensed as incurred, and (ii) sold 422,380 shares of common stock to Lincoln Park as purchase shares for aggregate net proceeds of $3,818,631 under the 2025 ELOC Facility.

Previous wording

A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed below and in Note 2 to our unaudited consolidated condensed financial statements appearing in this Quarterly Report on Form 10-Q.

Current wording

A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed below and in Note 2 to our unaudited condensed consolidated financial statements appearing in this Quarterly Report on Form 10-Q.

Previous wording

Our unaudited consolidated condensed financial statements have been prepared in accordance with generally accepted accounting principles in the U.S. (“US GAAP”). The preparation of these unaudited consolidated condensed financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the unaudited consolidated condensed financial statements, and the reported amounts of expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

Current wording

Our unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the U.S. (“US GAAP”). The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements, and the reported amounts of expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

Previous wording

We record accrued expenses for costs invoiced from research and development activities conducted on our behalf by third-party service providers, which include the conduct of preclinical studies and clinical trials and contract research, manufacturing, and testing activities. We record the costs of research and development activities based upon the amount of services provided, and we include these costs in accrued liabilities in the unaudited consolidated condensed balance sheets and within research and development expense in the unaudited consolidated condensed statements of operations. These costs are a significant component of our research and development expenses. Purchased materials to be used in future research are valued at cost and capitalized and included in research and development supplies. The costs of materials that were acquired for a particular research and development activity and have no alternative future use are expensed in the period acquired.

Current wording

We record accrued expenses for costs invoiced from research and development activities conducted on our behalf by third-party service providers, which include the conduct of preclinical studies and clinical trials and contract research, manufacturing, and testing activities. We record the costs of research and development activities based upon the amount of services provided, and we include these costs in accrued liabilities in the unaudited condensed consolidated balance sheets and within research and development expense in the unaudited condensed consolidated statements of operations. These costs are a significant component of our research and development expenses. Purchased materials to be used in future research are valued at cost and capitalized and included in research and development supplies. The costs of materials that were acquired for a particular research and development activity and have no alternative future use are expensed in the period acquired.

Previous wording

Comparison of the Three and Six Months Ended June 30, 2025 and 2024

Current wording

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

Previous wording

The following summarizes our results of operations for the three and six months ended June 30, 2025 and 2024.

Current wording

The following summarizes our results of operations for the three and nine months ended September 30, 2025 and 2024.

Previous wording

Research and development (“R&D”) expense for the three months ended June 30, 2025 was $2,499,495, compared to $1,666,522 for the three months ended June 30, 2024, an increase of $832,973, or 50%. This increase was primarily due to (i) the reduction of approximately $1.165 million of R&D expense during the three months ended June 30, 2024 due to a one-time refund from a contract manufacturer, (ii) differences in enrollment of the Acclaim-1 and Acclaim-3 clinical trials during each of the periods, and (iii) reduction of R&D overheads and employee associated expenses with a reduction of R&D staff from thirteen employees at June 30, 2024 to nine employees at June 30, 2025.

Current wording

Research and development (“R&D”) expense for the three months ended September 30, 2025 was $2,192,881, compared to $2,756,081 for the three months ended September 30, 2024, a decrease of $563,200, or 20%. This decrease was primarily due to (i) differences in enrollment of the Acclaim-1 and Acclaim-3 clinical trials during each of the periods, and (ii) reduction of R&D overheads and employee associated expenses with a reduction of R&D staff from twelve employees at September 30, 2024 to seven employees at September 30, 2025.

Previous wording

Research and development expense for the six months ended June 30, 2025 was $5,039,489, compared to $4,940,902 for the six months ended June 30, 2024, an increase of $98,587, or 2%. This increase was primarily due to (i) the reduction of approximately $1.165 million of R&D expense during the three months ended June 30, 2024 due to a one-time refund from a contract manufacturer, (ii) reduction in clinical and manufacturing expenses due to closing of the Acclaim-2 clinical trial, (iii) differences in enrollment of the Acclaim-1 and Acclaim-3 clinical trials during each of the periods, and (iv) reduction of R&D overheads and employee associated expenses with a reduction of R&D staff from thirteen employees at June 30, 2024 to nine employees at June 30, 2025.

Current wording

Research and development expense for thenine months ended September 30, 2025 was $7,232,370, compared to $7,696,983 for thenine months ended September 30, 2024, a decrease of $464,613, or 6%. This decrease was primarily due to (i) reduction in clinical and manufacturing expenses due to closing of the Acclaim-2 clinical trial, (ii) differences in enrollment of the Acclaim-1 and Acclaim-3 clinical trials during each of the periods, and (iv) reduction of R&D overheads and employee associated expenses with a reduction of R&D staff from twelve employees at September 30, 2024 to seven employees at September 30, 2025.

Previous wording

General and administrative (“G&A”) expense for the three months ended June 30, 2025 was $2,182,289, compared to $4,849,472 for the three months ended June 30, 2024, a decrease of $2,667,183, or 55%. This decrease was primarily due to the implementation of expense reduction strategies by leadership which significantly reduced travel expenses, the number of professional service providers and associated expenses, and reduced headcount and associated overhead of G&A staff from eight employees at June 30, 2024 to six employees at June 30, 2025.

Current wording

General and administrative (“G&A”) expense for the three months ended September 30, 2025 was $1,153,032, compared to $1,566,085 for the three months ended September 30, 2024, a decrease of $413,053, or 26%. This decrease was primarily due to the implementation of expense reduction strategies by leadership which significantly reduced travel expenses, the number of professional service providers and associated expenses, and reduced headcount and associated overhead of G&A staff from seven employees at September 30, 2024 to six employees at September 30, 2025.

Previous wording

General and administrative expense for the six months ended June 30, 2025 was $3,611,587, compared to $7,569,140 for the six months ended June 30, 2024, a decrease of $3,957,553, or 52%. This decrease was primarily due to the implementation of expense reduction strategies by leadership which significantly reduced travel expenses, the number of professional service providers and associated expenses, and reduced headcount and associated overhead of G&A staff from eight employees at June 30, 2024 to six employees at June 30, 2025.

Current wording

General and administrative expense for thenine months ended September 30, 2025 was $4,764,617, compared to $9,135,225 for thenine months ended September 30, 2024, adecrease of $4,370,608, or 48%. This decrease was primarily due to the implementation of expense reduction strategies by leadership which significantly reduced travel expenses, the number of professional service providers and associated expenses, and reduced headcount and associated overhead of G&A staff from seven employees at September 30, 2024 to six employees at September 30, 2025.

Previous wording

**Other Income.**Other income was $6,881 and $23,057 for the three months ended June 30, 2025 and 2024, respectively, representing a decrease of $16,176. The decrease was primarily due to lower cash balances held in interest bearing accounts for the three months ended June 30, 2025 compared to the three months ended June 30, 2024.

Current wording

**Other Income.**Other income was $2,405 and $8,080 for the three months ended September 30, 2025 and 2024, respectively, representinga decrease of $5,675. The decrease was primarily due to lower cash balances held in interest bearing accounts for the three months ended September 30, 2025 compared to the three months ended September 30, 2024.

Previous wording

Other income was $11,652 and $50,771 for the six months ended June 30, 2025 and 2024, respectively, representing a decrease of $39,119. The decrease was primarily due to lower cash balances held in interest bearing accounts for the six months ended June 30, 2025 compared to the six months ended June 30, 2024.

Current wording

Other income was $14,056 and $58,851 for the nine months ended September 30, 2025 and 2024, respectively, representinga decrease of $44,795. The decrease was primarily due to lower cash balances held in interest bearing accounts for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024.

Previous wording

**Depreciation Expense.**There was no depreciation expense for the three months ended June 30, 2025, and $2,288 of depreciation expense for the three months ended June 30, 2024, representing a decrease of $2,288. The change in depreciation expense for the three months ended June 30, 2025 was primarily due to the timing of purchases of computer equipment for new employees and changes to accounting policies related to depreciation.

Current wording

**Depreciation Expense.**There was no depreciation expense for the three months ended September 30, 2025, and $1,272 of depreciation expense for the three months ended September 30, 2024, representing a decrease of $1,272. The change in depreciation expense for the three months ended September 30, 2025 was primarily due to the timing of purchases of computer equipment for new employees and changes to accounting policies related to depreciation.

Previous wording

There was no depreciation expense for the six months ended June 30, 2025, and $4,958 of depreciation expense for the six months ended June 30, 2024, representing a decrease of $4,958. The change in depreciation expense for the six months ended June 30, 2025 was primarily due to the timing of purchases of computer equipment for new employees and changes to accounting policies related to depreciation.

Current wording

There was no depreciation expense for the nine months ended September 30, 2025, and $6,230 of depreciation expense for the nine months ended September 30, 2024, representing a decrease of $6,230. The change in depreciation expense for the nine months ended September 30, 2025 was primarily due to the timing of purchases of computer equipment for new employees and changes to accounting policies related to depreciation.

Previous wording

Net Loss. We had a net loss of $4,674,901 and $6,495,845 for the three months ended June 30, 2025 and 2024, respectively, representing a decrease of $1,820,944, or 28%. The decrease in net loss between these periods was primarily due to (i) the closing of the Acclaim-2 clinical trial and associated reductions in clinical and manufacturing related expenses, and (ii) the implementation of expense reduction strategies by leadership, which reduced travel expenses, the number of professional service providers and associated expenses, and reduced headcount and associated overhead of overall Company staff from 21 employees at June 30, 2024 to 15 employees at June 30, 2025.

Current wording

Net Loss. We had a net loss of $3,799,240 and $4,315,987 for the three months ended September 30, 2025 and 2024, respectively, representinga decrease of $516,747, or 12%. Thedecrease in net loss between these periods was primarily due to (i) the closing of the Acclaim-2 clinical trial and associated reductions in clinical and manufacturing related expenses, and (ii) the implementation of expense reduction strategies by leadership, which reduced travel expenses, the number of professional service providers and associated expenses, and reduced headcount and associated overhead of overall Company staff from nineteen employees at September 30, 2024 to thirteen employees at September 30, 2025.

Previous wording

We had a net loss of $8,639,503 and $12,464,714 for the six months ended June 30, 2025 and 2024, respectively, representing a decrease of $3,825,211, or 31%. The decrease in net loss between these periods was primarily due to (i) the closing of the Acclaim-2 clinical trial and associated reductions in clinical and manufacturing related expenses, and (ii) the implementation of expense reduction strategies by leadership, which reduced travel expenses, the number of professional service providers and associated expenses, and reduced headcount and associated overhead of overall Company staff from 21 employees at June 30, 2024 to 15 employees at June 30, 2025.

Current wording

We had a net loss of $12,438,742 and $16,780,702 for thenine months ended September 30, 2025 and 2024, respectively, representinga decrease of $4,341,960, or 26%. Thedecrease in net loss between these periods was primarily due to (i) the closing of the Acclaim-2 clinical trial and associated reductions in clinical and manufacturing related expenses, and (ii) the implementation of expense reduction strategies by leadership, which reduced travel expenses, the number of professional service providers and associated expenses, and reduced headcount and associated overhead of overall Company staff from nineteen employees at September 30, 2024 to thirteen employees at September 30, 2025.

Previous wording

From inception through June 30, 2025, we have never generated revenue from product sales and have incurred net losses in each year. As of June 30, 2025, we had an accumulated deficit of $163,438,946. We have funded our operations primarily through the sale and issuance of capital stock.

Current wording

From inception through September 30, 2025, we have never generated revenue from product sales and have incurred net losses in each year. As of September 30, 2025, we had an accumulated deficit of $167,238,185. We have funded our operations primarily through the sale and issuance of capital stock.

Previous wording

For the year ended December 31, 2024, we (i) sold 5,366,503 shares of common stock for aggregate net proceeds of $6.3 million pursuant to our 2023 ATM Facility (defined below), and (ii) completed a registered direct offering in which we sold (x) 165,000 shares of our common stock, (y) pre-funded warrants exercisable for up to an aggregate of 1,377,112 shares of our common stock (“March 2024 Pre-Funded Warrants”), and (z) warrants exercisable for up to an aggregate of 1,542,112 shares of our common stock (“March 2024 Common Warrants”), for net proceeds of approximately $5.8 million. In connection with the March 2024 registered direct offering, we amended certain existing warrants to reduce the exercise price and extend the term thereof. See also “Note 4 - Equity - Registered Direct Offering” to our unaudited consolidated condensed financial statements included in this Quarterly Report on Form 10-Q. As of December 31, 2024, all of the 1,377,112 March 2024 Pre-Funded Warrants had been exercised for shares of common stock.

Current wording

For the year ended December 31, 2024, we (i) sold 153,701 shares of common stock for aggregate net proceeds of $6.10 million pursuant to our 2023 ATM Facility (defined below), and (ii) completed a registered direct offering in which we sold (x)3,300 shares of our common stock, (y) pre-funded warrants exercisable for up to an aggregate of 27,543 shares of our common stock (“March 2024 Pre-Funded Warrants”), and (z) warrants exercisable for up to an aggregate of 30,843 shares of our common stock (“March 2024 Common Warrants”), for net proceeds of approxi mately $5.8 million. In connection with the March 2024 registered direct offering, we amended certain existing warrants to reduce the exercise price and extend the term thereof. See also “Note 4 - Equity - Registered Direct Offering” to our unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q. As of December 31, 2024, all of the 27,543 March 2024 Pre-Funded Warrants had been exercised for shares of common stock.

Previous wording

During the six months ended June 30, 2025, we sold (i) 16,940,454 shares of common stock for aggregate gross proceeds of approximately $7.2 million (resulting in aggregate net proceeds of $6,895,947 after offering expenses), pursuant to our 2023 ATM Facility, and (ii) 5,244,709 shares of common stock (inclusive of the 1,186,859 commitment shares issued pursuant to the Purchase Agreement (as defined below)) for aggregate net proceeds of approximately $874,897, pursuant to our 2025 ELOC Facility (as defined below). From July 1, 2025 through the date of filing of this Quarterly Report on Form 10-Q, (i) there were no sales of common stock pursuant to our 2023 ATM Facility, and (ii) we sold 316,736 shares of common stock for aggregate net proceeds of approximately $70,315, pursuant to our 2025 ELOC Facility. As of the filing date of this Quarterly Report on Form 10-Q, (i) we have utilized the full 5,561,445 share capacity available under the Exchange Cap (as defined below) pursuant to our 2025 ELOC Facility (with any further sales thereunder requiring stockholder approval first be obtained or alternatively, satisfaction of the average price condition for all shares issued to Lincoln Park under the 2025 ELOC Facility as described below, in accordance with Nasdaq rules), and (ii) we do not have any remaining capacity under the current prospectus supplement covering the 2023 ATM Facility offering, as most recently updated by the Fourth Sticker Supplement filed on December 20, 2024 to reflect the amount of common stock we are eligible to sell under General Instruction I.B.6 to Form S-3.

Current wording

During thenine months ended September 30, 2025, we sold (i)338,811 shares of common stock for aggregate gross proceeds of approximately $7.2 million (resulting in aggregate net proceeds of$6,895,947 after offering expenses), pursuant to our 2023 ATM Facility, and (ii)446,117 shares of common stock (inclusive of the 23,737 commitment shares issued pursuant to the Purchase Agreement (as defined below)) for aggregate net proceeds of approximately$3,818,631, pursuant to our 2025 ELOC Facility (as defined below). From October 1, 2025 through the date of filing of this Quarterly Report on Form 10-Q, (i) we sold 242,537 shares of common stock for aggregate net proceeds of approximately $1,006,740 pursuant to our 2023 ATM Facility, and (ii) we sold 326,750 shares of common stock for aggregate net proceeds of approximately $1,434,139, pursuant to our 2025 ELOC Facility.

Previous wording

On June 11, 2025, we entered into an equity line of credit (“ELOC”) purchase agreement, dated June 11, 2025 (the “Purchase Agreement”), with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park committed to purchase from us up to $12.5 million in shares of our common stock (subject to certain conditions and limitations contained in the Purchase Agreement) from time to time at our sole discretion over the 24-month term of the Purchase Agreement (the “2025 ELOC Facility”). Under applicable Nasdaq rules, we may not issue or sell to Lincoln Park under the Purchase Agreement more than 19.99% of our shares of common stock outstanding immediately prior to the execution of the Purchase Agreement (which was 5,561,445 shares, including the commitment shares, based on 27,821,136 shares outstanding immediately prior to the execution of the Purchase Agreement) (the “Exchange Cap”), unless (i) we obtain stockholder approval to issue shares of common stock to Lincoln Park under the Purchase Agreement in excess of the Exchange Cap or (ii) the average price of all applicable sales of our common stock to Lincoln Park under the Purchase Agreement equals or exceeds the Base Price (as defined in the Purchase Agreement). The Company is seeking stockholder approval to approve the issuance of shares of common stock in excess of the Exchange Cap at its upcoming 2025 Annual Meeting of Stockholders. Sales of shares of common stock to Lincoln Park under the Purchase Agreement will depend on a variety of factors to be determined by us from time to time, including, among others, market conditions, the trading price of our common stock and our determination as to the appropriate sources of funding for our operations. See also “Note 1 – Description of Business and Basis of Presentation – Capital Requirements, Liquidity and Going Concern Considerations” and “Note 4 - Equity – Equity Line of Credit” to our unaudited consolidated condensed financial statements included in this Quarterly Report on Form 10-Q.

Current wording

On June 11, 2025, we entered into an equity line of credit (“ELOC”) purchase agreement, dated June 11, 2025 (the “Purchase Agreement”), with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park committed to purchase from us up to $12.5 million in shares of our common stock (subject to certain conditions and limitations contained in the Purchase Agreement) from time to time at our sole discretion over the 24-month term of the Purchase Agreement (the “2025 ELOC Facility”). Sales of shares of common stock to Lincoln Park under the Purchase Agreement will depend on a variety of factors to be determined by us from time to time, including, among others, market conditions, the trading price of our common stock and our determination as to the appropriate sources of funding for our operations. See also “Note 1 – Description of Business and Basis of Presentation – Capital Requirements, Liquidity and Going Concern Considerations” and “Note 4 - Equity – Equity Line of Credit” to our unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.

Previous wording

On December 13, 2023, we entered into an At The Market (“ATM”) Offering Agreement (the “Sales Agreement”) with H.C. Wainwright & Co., LLC, serving as agent (the “Agent”) with respect to an at-the-market offering program (our “2023 ATM Facility”) under which we may offer and sell through the Agent, from time to time at our sole discretion, up to such number or dollar amount of shares of our common stock (the “Shares”) as registered on the prospectus supplement covering the 2023 ATM Facility offering, as may be amended or supplemented from time to time. We have agreed to pay the Agent a commission equal to three percent (3%) of the gross sales proceeds of any Shares sold through the Agent under the Sales Agreement, and also have provided the Agent with customary indemnification and contribution rights. See also “Note 1 - Description of Business and Basis of Presentation - Capital Requirements, Liquidity and Going Concern Considerations” and “Note 4 - Equity - At-The-Market Offering” to our unaudited consolidated condensed financial statements included in this Quarterly Report on Form 10-Q.

Current wording

On December 13, 2023, we entered into an At The Market (“ATM”) Offering Agreement (the “Sales Agreement”) with H.C. Wainwright & Co., LLC, serving as agent (the “Agent”) with respect to an at-the-market offering program (our “2023 ATM Facility”) under which we may offer and sell through the Agent, from time to time at our sole discretion, up to such number or dollar amount of shares of our common stock (the “Shares”) as registered on the prospectus supplement covering the 2023 ATM Facility offering, as may be amended or supplemented from time to time. We have agreed to pay the Agent a commission equal to three percent (3%) of the gross sales proceeds of any Shares sold through the Agent under the Sales Agreement, and also have provided the Agent with customary indemnification and contribution rights. See also “Note 1 - Description of Business and Basis of Presentation - Capital Requirements, Liquidity and Going Concern Considerations” and “Note 4 - Equity - At-The-Market Offering” to our unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.

Previous wording

As of June 30, 2025, we had $1,346,844 in cash and cash equivalents.

Current wording

As of September 30, 2025, we had $1,103,315 in cash and cash equivalents.

Previous wording

We do not expect to generate revenue from product sales unless and until we successfully complete development of, obtain regulatory approval for and begin to commercialize one or more of our current or potential product candidates, which we expect will take a number of years and which is subject to significant uncertainty. Accordingly, we anticipate that we will need to raise additional capital to fund our future operations, which include conducting our Acclaim-1 and Acclaim-3 clinical trials (of which both are currently enrolling) and completing preclinical work for potential other oncology candidates and completing preclinical work and conducting clinical trials for our diabetes program. We expect interim enrollment of the Phase 2a expansion portion of the Acclaim-1 trial to be completed by the first quarter of 2026. We expect interim enrollment in the Phase 2 dose expansion portion of the Acclaim-3 trial to be completed in the first quarter of 2026. Until such time as we can generate substantial revenue from product sales, if ever, we expect to finance our operating activities through a combination of equity offerings, sales pursuant to our 2025 ELOC (to the extent we first obtain stockholder approval for further sales pursuant to our 2025 ELOC Facility (as is intended to be presented for the consideration and vote of the Company’s stockholders at the Company’s 2025 Annual Meeting to be held in August 2025, as described in the Company’s Definitive Proxy Statement for the 2025 Annual Meeting filed with the SEC), or alternatively, satisfaction of the above-described average price condition for all shares issued to Lincoln Park under the 2025 ELOC Facility in accordance with Nasdaq rules; as noted above, as of the filing date of this Quarterly Report on Form 10-Q, we have utilized the full Exchange Cap available under the 2025 ELOC Facility with further sales thereunder requiring stockholder approval or compliance with the average price condition), drawdowns on our 2023 ATM Facility pursuant to our Sales Agreement with the Agent (to the extent we have available capacity under General Instruction I.B.6 of Form S-3; as noted above the current prospectus supplement for the ATM Facility has utilized all available capacity as of the filing date of this Quarterly Report on Form 10-Q), and debt financings and we may seek to raise additional capital through strategic collaborations or transactions. However, we may be unable to raise additional funds or enter into such arrangements when needed on favorable terms, or at all, which would have a negative impact on our financial condition and could force us to delay, limit, reduce or terminate our research and development programs or commercialization efforts or grant rights to others to develop or market product candidates that we would otherwise prefer to develop and market ourselves. Failure to receive additional funding could cause us to curtail or cease our operations. Furthermore, even if we believe we …

Excerpt shortened here; the source contains the full paragraph.

Current wording

We do not expect to generate revenue from product sales unless and until we successfully complete development of, obtain regulatory approval for and begin to commercialize one or more of our current or potential product candidates, which we expect will take a number of years and which is subject to significant uncertainty. Accordingly, we anticipate that we will need to raise additional capital to fund our future operations, which include conducting our Acclaim-1 and Acclaim-3 clinical trials (of which both are currently enrolling) and completing preclinical work for potential other oncology candidates and completing preclinical work and conducting clinical trials for our diabetes program. We expect interim enrollment of the Phase 2a expansion portion of the Acclaim-1 trial to be completed in the first half of 2026. We expect interim enrollment in the Phase 2 dose expansion portion of the Acclaim-3 trial to be completed in the first half of 2026. Until such time as we can generate substantial revenue from product sales, if ever, we expect to finance our operating activities through a combination of equity offerings, sales pursuant to our 2025 ELOC Facility, drawdowns on our 2023 ATM Facility pursuant to our Sales Agreement with the Agent, and debt financings and we may seek to raise additional capital through strategic collaborations or transactions. However, we may be unable to raise additional funds or enter into such arrangements when needed on favorable terms, or at all, which would have a negative impact on our financial condition and could force us to delay, limit, reduce or terminate our research and development programs or commercialization efforts or grant rights to others to develop or market product candidates that we would otherwise prefer to develop and market ourselves. Failure to receive additional funding could cause us to curtail or cease our operations. Furthermore, even if we believe we have sufficient funds for our current or future operating plans, we may seek additional capital due to favorable market conditions or strategic considerations. As a result of the Company’s recurring losses from operations and the need for additional financing to fund its operating and capital requirements, there is uncertainty regarding the Company’s ability to maintain liquidity sufficient to operate its business effectively over the next 12 months, which raises substantial doubt as to the Company’s ability to continue as a going concern.

Previous wording

Based on our current cash, we estimate that we will be able to fund our expenditure requirements for our current operations and planned clinical trial activities through the end of August 2025. We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently plan due to incorrect assumptions or due to a decision to expand our activities beyond those currently planned. We previously have experienced delays in engaging clinical sites as a result of disruptions at these clinical sites caused by the COVID-19 pandemic. We also have experienced delays in clinical trial enrollment as a result of competition for patients and additional time required in connection with transitions to new third party CDMOs and the manufacture of final drug product. Delays in the conduct of our trials could result in utilizing our capital resources sooner without advancing our clinical trials as anticipated.

Current wording

Based on our current cash, we estimate that we will be able to fund our expenditure requirements for our current operations and planned clinical trial activities into March 2026. We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently plan due to incorrect assumptions or due to a decision to expand our activities beyond those currently planned. We previously have experienced delays in engaging clinical sites as a result of disruptions at these clinical sites caused by the COVID-19 pandemic. We also have experienced delays in clinical trial enrollment as a result of competition for patients and additional time required in connection with transitions to new third party CDMOs and the manufacture of final drug product. Delays in the conduct of our trials could result in utilizing our capital resources sooner without advancing our clinical trials as anticipated.

Previous wording

The following table sets forth the primary sources and uses of cash during the six months ended June 30, 2025, and 2024:

Current wording

The following table sets forth the primary sources and uses of cash during the nine months ended September 30, 2025, and 2024:

Previous wording

Net cash used in operating activities was $8,025,660 and $11,867,211 for the six months ended June 30, 2025, and 2024, respectively, a decrease of $3,841,551, or 32%. This decrease was primarily due to (i) the closing of the Acclaim-2 clinical trial and associated reductions in clinical and manufacturing related expenses, and (ii) the implementation of expense reduction strategies by leadership, which reduced travel expenses, the number of professional service providers and associated expenses, and reduced headcount and associated overhead of overall Company staff from 21 employees at June 30, 2024 to 15 employees at June 30, 2025.

Current wording

Net cash used in operating activities was $11,212,938 and $14,053,136 for thenine months ended September 30, 2025, and 2024, respectively, a decrease of $2,840,198, or 20%. This decrease was primarily due to (i) the closing of the Acclaim-2 clinical trial and associated reductions in clinical and manufacturing related expenses, and (ii) the implementation of expense reduction strategies by leadership, which reduced travel expenses, the number of professional service providers and associated expenses, and reduced headcount and associated overhead of overall Company staff from nineteen employees at September 30, 2024 to thirteen employees at September 30, 2025.

Previous wording

The Company had no net cash provided by or used in investing activities for the six months ended June 30, 2025, compared to net cash used in investing activities of $774,645 for the six months ended June 30, 2024. This difference in net cash used in investing activities was primarily due to timing associated with filing and patent prosecution costs of our intellectual property.

Current wording

The Company had no net cash provided by or used in investing activities for the nine months ended September 30, 2025, compared to net cash provided by investing activities of $774,645 for the nine months ended September 30, 2024. This difference in net cash provided by investing activities was primarily due to timing associated with filing and patent prosecution costs of our intellectual property.

Previous wording

Net cash provided by financing activities was $7,770,844 and $6,813,961 during the six months ended June 30, 2025, and 2024, respectively. This increase of $956,883 was primarily due to differences in amounts raised by sales of our securities in capital raising activities conducted during the six months ended June 30, 2025, and 2024, respectively.

Current wording

Net cash provided by financing activities was $10,714,593 and $8,029,143 during the nine months ended September 30, 2025, and 2024, respectively. This increase of $2,685,450 was primarily due to differences in amounts raised by sales of our securities in capital raising activities conducted during the nine months ended September 30, 2025, and 2024, respectively.