Genprex, Inc.
For the period ended Jun 30, 2025. Filed Aug 14, 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.
Jun 30, 2025 · Filed Aug 14, 2025
GNPX$2.07-1.4%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-12.
0001437749-25-016133
Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-14.
0001437749-25-026965
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 66 previous paragraphs and 74 current paragraphs.
42 unchanged; 24 reworded; 4 added; 0 removed; 0 previous and 4 current paragraphs rearranged.
Tables are not compared: 21 previous and 21 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 (4)
Current report
Recent Developments - Equity Line of Credit
Current report
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 report
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 report
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.
Reworded paragraphs (24)
Previous wording
The TUSC2 gene, which is the key component of REQORSA and plays a vital role in cancer suppression and normal cell metabolism, is one of a series of genes on the short arm of Chromosome 3 whose therapeutic use is covered by our exclusive worldwide licenses from The University of Texas MD Anderson Cancer Center (“MD Anderson”). We believe that our ONCOPREX Delivery System allows for the delivery of a number of cancer-fighting tumor suppressor genes, alone or in combination with other cancer therapies, to combat multiple types of cancer and we are in early stages of discovery programs to identify other cancer candidates. In August 2022, we entered into a sponsored research agreement with MD Anderson to support further preclinical studies of TUSC2 and other tumor suppressor genes. Additionally, we are collaborating with MD Anderson to discover, develop and utilize biomarkers to select the patient population most likely to respond to REQORSA and enable decisions on progression of our drug candidates to the next phase of development. MD Anderson is currently analyzing biomarkers that would indicate lack of response in lung cancer that could enrich our population of responders in our clinical trials and enhance patient screening and enrollment in order to increase the likelihood of potential success of the Acclaim studies for the Company.
Current wording
The TUSC2 gene, which is the key component of REQORSA and plays a vital role in cancer suppression and normal cell metabolism, is one of a series of genes on the short arm of Chromosome 3 whose therapeutic use is covered by our exclusive worldwide licenses from The University of Texas MD Anderson Cancer Center (“MD Anderson”). We believe that our ONCOPREX Delivery System allows for the delivery of a number of cancer-fighting tumor suppressor genes, alone or in combination with other cancer therapies, to combat multiple types of cancer and we are in early stages of discovery programs to identify other cancer candidates. In August 2022, we entered into a sponsored research agreement with MD Anderson to support further preclinical studies of TUSC2 and other tumor suppressor genes. Additionally, we are collaborating with MD Anderson to discover, develop and utilize biomarkers to select the patient population most likely to respond to REQORSA and enable decisions on progression of our drug candidates to the next phase of development. MD Anderson researchers currently are analyzing biomarkers that may indicate a strong positive or negative response to REQORSA in lung cancer that could be used to enrich our population of responders in our clinical trials.
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 49 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 recently had disease progression and is no longer receiving treatment. 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 both 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…
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 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.
Previous wording
The Phase 2a expansion portion of the Acclaim-1 study provides us the advantage of early insight into drug effectiveness in defined and distinct patient populations at the maximum tolerated dose (the “MTD”) or RP2D in order to better evaluate efficacy and increase the likelihood of a successful randomized Phase 2 trial which will follow the expansion portion of the study.
Current wording
The Phase 2a expansion portion of the Acclaim-1 study provides us the advantage of early insight into drug effectiveness in defined and distinct patient populations at the maximum tolerated dose or RP2D in order to better evaluate efficacy and increase the likelihood of a successful randomized Phase 2 trial which will follow the expansion portion of the study.
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 developed 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 (“Acclaim-3 SRC”) 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 second half of 2025.
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 quarter 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 (“AAV”) 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 above). 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. See also “Note 7 – Commitments and Contingencies” to our unaudited consolidated condensed financial statements included in this Quarterly Report on Form 10-Q. In February 2023, the Company’s rese…
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 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.
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.
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 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.
Previous wording
We recognize all research and development costs as they are incurred. Clinical trial costs, contract manufacturing and other development costs incurred by third-parties are expensed as the contracted work is performed.
Current wording
We recognize all research and development costs as they are incurred except those capitalized with alternative further use. Clinical trial costs, contract manufacturing and other development costs incurred by third-parties are expensed as the contracted work is performed.
Previous wording
Comparison of the Three Months Ended March 31, 2025 and 2024
Current wording
Comparison of the Three and Six Months Ended June 30, 2025 and 2024
Previous wording
The following summarizes our results of operations for the three months ended March 31, 2025 and 2024.
Current wording
The following summarizes our results of operations for the three and six months ended June 30, 2025 and 2024.
Previous wording
Research and development (“R&D”) expense for the three months ended March 31, 2025 was $2,539,993, compared to $3,274,380 for the three months ended March 31, 2024, a decrease of $734,387, or 22%. 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 (iii) reduction of R&D overheads and employee associated expenses with a reduction of R&D staff from 15 employees at March 31, 2024 to 9 employees at March 31, 2025.
Current 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.
Previous wording
General and administrative (“G&A”) expense for the three months ended March 31, 2025 was $1,429,299, compared to $2,719,667 for the three months ended March 31, 2024, a decrease of $1,290,368, or 47%. 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 11 employees at March 31, 2024 to 6 employees at March 31, 2025.
Current 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.
Previous wording
**Other Income.**Other income was $4,771 and $27,713 for the three months ended March 31, 2025, and 2024, respectively, representing a decrease of $22,942. The decrease was primarily due to lower cash balances held in interest bearing accounts for the three months ended March 31, 2025 compared to the three months ended March 31, 2024.
Current 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.
Previous wording
**Depreciation Expense.**There was no depreciation expense for the three months ended March 31, 2025, and $2,670 of depreciation expense for the three months ended March 31, 2024, representing a decrease of $2,670, or 100%. The change in depreciation expense for the three months ended March 31, 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 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.
Previous wording
Net Loss. We had a net loss of $3,964,601 and $5,968,869 for the three months ended March 31, 2025 and 2024, respectively, representing a decrease of $2,004,268, or 34%. 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 26 employees at March 31, 2024 to 15 employees at March 31, 2025.
Current 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.
Previous wording
From inception through March 31, 2025, we have never generated revenue from product sales and have incurred net losses in each year. As of March 31, 2025, we had an accumulated deficit of $158,764,044. We have funded our operations primarily through the sale and issuance of capital stock.
Current 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.
Previous wording
During the three months ended March 31, 2025, we sold 13,278,666 shares of common stock for aggregate gross proceeds of approximately $6.2 million (resulting in aggregate net proceeds of $6,028,103 after offering expenses), pursuant to our 2023 ATM Facility (defined below). From April 1, 2025 through the date of filing of this Quarterly Report on Form 10-Q we sold 3,661,788 shares of common stock for aggregate gross proceeds of approximately $0.9 million (resulting in aggregate net proceeds of $867,844 after offering expenses), pursuant to our 2023 ATM Facility. As of the filing date of this Quarterly Report on Form 10-Q, 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 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.
Previous wording
On December 13, 2023, we entered into an At The Market (“ATM”) Offering Agreement (the “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 Agreement, and also have provided the Agent with customary indemnification and contribution rights. See also “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 consolidated condensed financial statements included in this Quarterly Report on Form 10-Q.
Previous wording
As of March 31, 2025, we had $3,468,338 in cash and cash equivalents.
Current wording
As of June 30, 2025, we had $1,346,844 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 end of 2025. We expect interim enrollment in the Phase 2 dose expansion portion of the Acclaim-3 trial to be completed in the second half of 2025. 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, drawdowns on our ATM Facility pursuant to our 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 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.
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 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.
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 the second quarter of 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 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.
Previous wording
The following table sets forth the primary sources and uses of cash during the three months ended March 31, 2025, and 2024:
Current wording
The following table sets forth the primary sources and uses of cash during the six months ended June 30, 2025, and 2024:
Previous wording
Net cash used in operating activities was $4,161,425 and $5,297,891 for the three months ended March 31, 2025, and 2024, respectively, a decrease of $1,136,466, or 21%. 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 26 employees at March 31, 2024 to 15 employees at March 31, 2025.
Current 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.
Previous wording
The Company had no net cash provided by or used in investing activities for the three months ended March 31, 2025, compared to net cash used in investing activities of $15,822 for the three months ended March 31, 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 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.
Previous wording
Net cash provided by financing activities was $6,028,103 and $6,793,199 during the three months ended March 31, 2025, and 2024, respectively. This decrease of $765,096 was primarily due to differences in amounts raised by sales of our securities in capital raising activities conducted during the three months ended March 31, 2025, and 2024, respectively.
Current 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.
Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
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 report — wording carried from elsewhere
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 report — wording carried from elsewhere
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 report — wording carried from elsewhere
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.