ACTUATE THERAPEUTICS, INC.
For the period ended Sep 30, 2025. Filed Nov 13, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 13, 2025
ACTU$0.33+0.6%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-14.
0001683168-25-006159
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-13.
0001683168-25-008323
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 104 previous paragraphs and 84 current paragraphs.
56 unchanged; 21 reworded; 7 added; 24 removed; 3 previous and 0 current paragraphs rearranged.
Tables are not compared: 16 previous and 13 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 (7)
Current report
In addition, we recently amended our investigational new drug (“IND”) application with the FDA with updated topline clinical data covering our Actuate-1801 trial in addition to filing for Breakthrough Therapy Designation (“BTD”) shortly thereafter. In response to our submission, the FDA notified us that for a BTD, they will require that a new therapy demonstrate a substantial improvement in the treatment of mPDAC over all existing standard of care therapies, including irinotecan-containing regimens. Therefore, if clinical data are supportive from our ongoing or future trials in mPDAC evaluating the combination of elraglusib plus other combination agents, we will need to submit those data to the FDA to support a potential BTD. In addition, we plan to request meetings with the FDA to gain regulatory clarity on the design of a future clinical trial required to support potential product registration in the U.S. and with the European Medicines Agency (“EMA”) to discuss regulatory and clinical trial requirements for potential conditional approval in Europe (“EU”) for the treatment of first-line mPDAC.
Current report
Comparison of the Nine Months Ended September 30, 2025 and 2024:
Current report
On June 27, 2025, the Company closed the June 2025 Private Placement and received aggregate net proceeds of $4,592,462 in exchange for 666,497 shares of common stock (see Note 7 to the accompanying unaudited condensed consolidated financial statements).
Current report
On September 11, 2025, the Company closed the September 2025 Public Offering and received net proceeds of $15,573,966 in exchange for the issuance of 2,464,286 shares of common stock to the Underwriter, including shares issued under the over-allotment option (see Note 7 to the accompanying unaudited condensed consolidated financial statements).
Current report
During the nine months ended September 30, 2025, the Company received net proceeds of $3,800,465 in exchange for 539,967 shares of common stock sold under the Committed Equity Facility (see Note 7 to the accompanying unaudited condensed consolidated financial statements).
Current report
Based on the above matters, we have concluded that there is substantial doubt regarding the Company’s ability to continue as a going concern.
Current report
Critical Accounting Estimates
Removed paragraphs (24)
Previous report
Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If we do not become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and may be forced to reduce or terminate our operations.
Previous report
On March 27, 2025, the Company entered into a common stock purchase agreement (the “Committed Equity Facility”) with B. Riley Principal Capital II (“B. Riley”) giving the Company the right, but not the obligation, to sell to B. Riley over a 36-month period up to the lesser of (i) $50 million of newly issued shares of our common stock and (ii) 3,904,374 shares of the Company’s common stock (see Note 7 to the accompanying unaudited condensed consolidated financial statements). The price per share of common stock sold to B. Riley is determined by reference to the volume weighted average price of the Company’s common stock as defined within the Committed Equity Facility less a 3% discount, subject to certain limitations and conditions. The total net proceeds that the Company will receive under the Committed Equity Facility will depend on the frequency and prices at which the Company sells common stock to B. Riley. During the three months ended June 30, 2025, the Company received net proceeds of $2,148,506 in exchange for 256,429 shares of common stock sold under the Committed Equity Facility. However, there can be no assurance that the Company will be able to raise sufficient proceeds in the future under the Committed Equity Facility or any additional financing will be available to the Company on acceptable terms, if at all.
Previous report
On June 25, 2025, the Company entered into a securities purchase agreement for a private placement of common stock and warrants with certain institutional and accredited investors, which closed on June 27, 2025 (the “June 2025 Private Placement”). Upon closing, the Company received aggregate net proceeds of $4,621,546 (see Note 7 to the accompanying unaudited condensed consolidated financial statements).
Previous report
Comparison of the Six Months Ended June 30, 2025 and 2024:
Previous report
Sources of Liquidity
Previous report
On March 27, 2025, the Company entered into a common stock purchase agreement (the “Committed Equity Facility”) with B. Riley Principal Capital II (“B. Riley”) giving the Company the right, but not the obligation, to sell to B. Riley over a 36-month period up to the lesser of (i) $50 million of newly issued shares of our common stock and (ii) 3,904,374 shares of the Company’s common stock (see Note 7 to the accompanying unaudited condensed consolidated financial statements). The price per share of common stock sold to B. Riley is determined by reference to the volume weighted average price of the Company’s common stock as defined within the Committed Equity Facility less a 3% discount, subject to certain limitations and conditions. The total net proceeds that the Company will receive under the Committed Equity Facility will depend on the frequency and prices at which the Company sells common stock to B. Riley. During the three months ended June 30, 2025, the Company received net proceeds of $2,148,506 in exchange for 256,429 shares of common stock sold under the Committed Equity Facility. However, there can be no assurance that the Company will be able to raise sufficient proceeds in the future under the Committed Equity Facility or any additional financing will be available to the Company on acceptable terms, if at all.
Previous report
On June 25, 2025, the Company entered into a securities purchase agreement for a private placement of common stock and warrants with certain institutional and accredited investors, which closed on June 27, 2025, or the June 2025 Private Placement. Upon closing, the Company received aggregate net proceeds of $4,621,546 (see Note 7 to the accompanying unaudited condensed consolidated financial statements). As of June 30, 2025, we had cash and cash equivalents of $6,492,656.
Previous report
Future Funding Requirements
Previous report
Cash used to fund our operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding prepaid expenses, accounts payable, and other accrued expenses. The timing and amount of our funding requirements will depend on many factors, including:
Previous report
Critical Accounting Policies and Significant Judgments and Estimates
Previous report
While our significant accounting policies are described in more detail in Note 2 to the accompanying unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report, we believe the following accounting policies are those most critical to the judgments and estimates used in the preparation of our financial statements.
Previous report
Research and Development Expenses and Related Accrued Expenses
Previous report
In accordance with authoritative guidance, the Company charges research and development costs to operations as incurred. Research and development expenses consist primarily of personnel and related costs, external costs of outside vendors engaged in clinical trial activities, contract manufacturers, consultants and other third parties to conduct and support our clinical trials and preclinical studies.
Previous report
As part of the process of preparing our consolidated financial statements, we are required to estimate our research and development expenses as of each balance sheet date. This process involves reviewing open contracts, including clinical site contracts, and communicating with our personnel to identify services that have been performed on our behalf, and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of the actual cost. We make estimates of our research and development expenses as of each balance sheet date based on facts and circumstances known to us at that time. The significant estimates in our research and development expenses include the costs incurred for services performed by our vendors in connection with services for which we have not yet been invoiced. We base our expenses related to research and development activities on our estimates of the services received and efforts expended pursuant to quotes and contracts with contractors and vendors that conduct research and development on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract, and may result in uneven payment flows. Advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made.
Previous report
Although we do not expect our estimates to be materially different from amounts actually incurred, if our estimates of the status and timing of services performed differ from the actual status and timing of services performed, it could result in us reporting amounts that are too high or too low in any particular period. To date, there have been no material differences between our estimates of such expenses and the amounts actually incurred
Previous report
Stock-Based Compensation
Previous report
We periodically grant equity-based payment awards in the form of restricted common stock awards (“RSAs”), restricted stock units (“RSUs”), and stock options to employees, directors, consultants and non-employees and record stock-based compensation expense for awards of stock-based payments based on their estimated fair value at the grant date.
Previous report
The estimated fair value of service-based RSAs and RSUs are measured at the grant date based on the estimated fair market value of the Company’s common stock on the date of grant and is recognized as expense over the requisite service period, which is generally the awards’ vesting period. The estimated fair value of performance-based RSAs is measured at the grant date based on the estimated fair value of shares expected to be earned at the end of the performance period and is recognized as expense ratably over the performance period based upon the probable number of shares expected to vest.
Previous report
We account for the grant of stock options based on the estimated fair value of the underlying option using the Black-Scholes valuation model on the date of grant and recognized as expense in the consolidated statement of operations on a straight-line basis over the requisite service period, which is the vesting period. The Black-Scholes valuation model requires the input of subjective assumptions, including expected volatility, expected dividend yield, expected term, risk-free rate of return and the estimated fair value of the underlying common stock on the date of grant. Prior to the IPO, we regularly engaged a third-party valuation specialist to assist with estimates related to the valuation of the Company’s common stock. Post IPO, the fair value of our common stock is determined based on the closing price of our common stock as reported on the date of grant on the primary stock exchange on which our common stock is traded.
Previous report
We classify stock-based compensation expense in the unaudited condensed consolidated statements of operations in the same manner in which the award recipients’ payroll costs are classified or in which the award recipients’ service payments are classified. We recognize forfeitures related to stock-based compensation awards as they occur. We expect to continue to grant equity-based awards in the future, and to the extent that we do, our stock-based compensation expense recognized in future periods will likely increase.
Previous report
Off-Balance Sheet Arrangements
Previous report
We did not have, during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.
Previous report
Recent Accounting Pronouncements
Previous report
A description of recently issued accounting standards that may potentially impact our financial position, results of operations, and cash flows is included in Note 2 to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2024 as filed with the SEC on March 13, 2025, and in Note 2 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report.
Reworded paragraphs (21)
Previous wording
Our lead clinical program, referred to as Actuate-1801, is focused on evaluating the intravenous (“IV”) injection solution of elraglusib (“Elraglusib Injection”) for the treatment of first-line mPDAC. The Actuate-1801 trial is a randomized, controlled Phase 2 trial of elraglusib in combination with gemcitabine/nab-paclitaxel (“GnP”) versus GnP alone in first-line mPDAC. The trial enrolled 286 patients with mPDAC and no prior systemic treatment for metastatic disease, who were randomized 2:1 to the elraglusib/GnP combination arm or the GnP arm. The primary endpoint for this study was median overall survival (“mOS”), with overall survival (“OS”) summarized throughout the study by estimates of 1-year survival. Secondary endpoints were overall response rates (“ORR”), median progression-free survival (“PFS”) and disease control rate (“DCR”) and adverse events.
Current wording
Our lead clinical program, referred to as Actuate-1801, is focused on evaluating the intravenous (“IV”) injection solution of elraglusib (“Elraglusib Injection”) for the treatment of first-line mPDAC. The Actuate-1801 trial is a randomized, controlled Phase 2 trial of elraglusib in combination with gemcitabine/nab-paclitaxel (“GnP”) versus GnP alone in first-line mPDAC. The trial enrolled 286 patients with mPDAC and no prior systemic treatment for metastatic disease, who were randomized 2:1 to the elraglusib/GnP combination arm or the GnP arm. The primary endpoint for this study was median overall survival (“mOS”), with overall survival (“OS”) summarized throughout the study by estimates of 1-year survival. Secondary endpoints were overall response rates (“ORR”), median progression-free survival (“PFS”), disease control rate (“DCR”) and adverse events.
Previous wording
We have developed several oral dosage forms of elraglusib, which we believe will allow us to expand the number of cancer indications that we are able to target and allow us to further explore more convenient dose delivery options for patients. A clinical candidate tablet, the Elraglusib Oral Tablet, has been selected for further development and we are planning a Phase 1 study (Actuate-2401) to identify the maximum tolerated dose (“MTD”) and recommended Phase 2 dose (“RP2D”) for Elraglusib Oral Tablet in patients with advanced, refractory adult cancers, subject to future funding.
Current wording
We have developed several oral dosage forms of elraglusib, which we believe will allow us to expand the number of cancer indications that we are able to target and allow us to further explore more convenient dose delivery options for patients. A clinical candidate tablet (“Elraglusib Oral Tablet”) has been selected for further development, and we are planning a Phase 1 study (Actuate-2401) to identify the maximum tolerated dose (“MTD”) and recommended Phase 2 dose (“RP2D”) for Elraglusib Oral Tablet in patients with advanced, refractory adult cancers, subject to future funding.
Previous wording
Research and development expenses consist primarily of external and internal costs incurred in performing clinical and preclinical development activities. Our external research and development costs primarily consists of the cost incurred under agreements with hospitals to treat and monitor patients enrolled in our clinical trials, contract research organizations (“CRO”) and contract manufacturers, consultants and other third parties to conduct and support our clinical trials and preclinical studies. Our internal research and development costs primarily include research and development personnel-related expenses such as employee compensation, employer taxes, group insurance benefits, and stock-based compensation.
Current wording
Research and development expenses consist primarily of external and internal costs incurred in performing clinical and preclinical development activities. Our external research and development costs primarily consist of the cost incurred under agreements with hospitals to treat and monitor patients enrolled in our clinical trials, contract research organizations (“CROs”) and contract manufacturers, consultants and other third parties to conduct and support our clinical trials and preclinical studies. Our internal research and development costs primarily include research and development personnel-related expenses such as employee compensation, employer taxes, group insurance benefits, and stock-based compensation.
Previous wording
We expense research and development costs as incurred. We currently only have one product candidate, elraglusib. Therefore, since our inception, substantially all of our research and development costs were related to the development of elraglusib. We track research and development expenses on an aggregate basis and not on an indication-by-indication or treatment setting-by-treatment setting basis.
Current wording
We expense research and development costs as incurred. We have been developing our lead investigational product candidate, elraglusib, since inception, and therefore, substantially all of our research and development costs were related to the development of elraglusib. We track research and development expenses on an aggregate basis and not on an indication-by-indication or treatment setting-by-treatment setting basis.
Previous wording
The Company previously had outstanding warrants that required liability classification. The warrants were recorded at fair value upon issuance and were subject to remeasurement to fair value at each balance sheet date, with any changes in fair value recognized in other income (expense), net. The warrant liabilities were remeasured upon the closing of the Company’s initial public offering (“IPO”) and marked to market to its fair value before being reclassified to equity.
Current wording
We previously had outstanding warrants that required liability classification. The warrants were recorded at fair value upon issuance and were subject to remeasurement to fair value at each balance sheet date, with any changes in fair value recognized in other income (expense), net. The warrant liabilities were remeasured upon the closing of our initial public offering (“IPO”) and marked to market to its fair value before being reclassified to equity.
Previous wording
We have incurred significant operating losses and negative cash flows from operations since our inception. Our net losses were $27,285,328 and $24,744,620 for the years ended December 31, 2024 and 2023, respectively, and $12,266,429 and $14,868,278 for the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $144,646,278. Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations. We expect to continue to incur significant expenses and operating losses in the foreseeable future, and we anticipate these losses will increase substantially as we continue our development of, seek regulatory approval for, and potentially commercialize elraglusib, and potentially seek to discover and develop additional product candidates, utilize third parties to manufacture elraglusib, hire additional personnel, expand and protect our intellectual property, and incur additional costs associated with being a public company. If we obtain regulatory approval for elraglusib, we expect to incur significant expenses related to developing our commercialization capability to support product sales, marketing and distribution.
Current wording
** **We have incurred significant operating losses and negative cash flows from operations since our inception. Our net losses were $27,285,328 and $24,744,620 for the years ended December 31, 2024 and 2023, respectively, and $17,673,899 and $20,839,239 for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $150,053,748. Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations. We expect to continue to incur significant expenses and operating losses in the foreseeable future, and we anticipate these losses will increase substantially as we continue our development of, seek regulatory approval for, and potentially commercialize elraglusib, and potentially seek to discover, acquire and develop additional product candidates, utilize third parties to manufacture elraglusib, hire additional personnel, expand and protect our intellectual property, and incur additional costs associated with being a public company. If we obtain regulatory approval for elraglusib, we expect to incur significant expenses related to developing our commercialization capability to support product sales, marketing and distribution.
Previous wording
The decrease in research and development expenses of $1,608,000 for the three months ended June 30, 2025 compared to the same prior year period was primarily due to a (i) decrease in external clinical trial expenses of $1,976,217 mostly related to lower patient fees and CRO costs associated with fewer patients on study during the current period related to the randomized Phase 2 mPDAC trial (Actuate-1801 Part 3B) and (ii) a decrease in Chemistry Manufacturing & Control (“CMC”) related costs of $71,404 primarily due to the timing of drug product manufacturing and stability studies to support ongoing trials. These amounts were offset by a current period (i) increase in personnel and consulting expense of $226,669 primarily due to an increase in consulting expenses associated with the Company’s regulatory and clinical operations related to the Actuate-1801 Part 3B trial, an increase in non-cash stock-based compensation expense of $56,742 related to awards granted to employees and consultants of the Company, and an increase in bonus expense, and (ii) an increase in preclinical and biomarker studies in the current period of $212,952 primarily due to new biomarker studies completed in the current period.
Current wording
The decrease in research and development expenses of $1,579,180 for the three months ended September 30, 2025 compared to the same prior year period was primarily due to a (i) decrease in external clinical trial expenses of $1,573,794 mostly related to lower patient fees and CRO costs associated with fewer patients on study during the current period related to the randomized Phase 2 mPDAC trial (Actuate-1801 Part 3B) and (ii) a decrease in Chemistry Manufacturing & Control (“CMC”) related costs of $365,769 primarily due to the timing of drug product manufacturing and stability studies to support ongoing trials. These amounts were offset by a current period (i) increase in personnel and consulting expenses of $282,948 primarily due to an increase in consulting expenses associated with the Company’s regulatory and clinical operations related to the Actuate-1801 Part 3B trial, an increase in non-cash stock-based compensation expense of $77,030 related to awards granted to employees and consultants of the Company, and an increase in bonus expense, and (ii) an increase in preclinical and biomarker studies in the current period of $77,435 primarily due to new studies completed in the current period.
Previous wording
The increase in general and administrative expenses of $2,141,428 for the three months ended June 30, 2025 compared to the same prior year period was primarily due to (i) an increase in personnel-related expenses of $1,698,919 mostly due to an increase in non-cash stock-based compensation expense of $1,432,510 related to awards granted to employees, non-employee members of the board of directors, and consultants of the Company combined with an increase in payroll and related expenses primarily related to the hiring of the Company’s chief financial officer in June 2024 combined with a current period increase in base salaries for certain administrative employees and an increase in bonus expense, (ii) an increase in other expenses of $613,771 primarily due to an increase in the cost of directors and officer insurance, board fees, investor relation fees, and other public company expenses. These amounts were offset by a current period decrease in professional and consulting fees of $171,262 primarily related to lower legal and intellectual property fees and lower search firm related fees incurred in the same prior year period to identify and add three new board members to the Company’s Board of Directors, which amounts were offset by a current period increase in consulting fees associated with additional administrative support.
Current wording
The increase in general and administrative expenses of $1,658,655 for the three months ended September 30, 2025 compared to the same prior year period was primarily due to (i) an increase in personnel-related expenses of $1,388,065 mostly due to an increase in non-cash stock-based compensation expense of $1,157,603 related to awards granted to employees, non-employee members of the board of directors, and consultants of the Company combined with a current period increase in base salaries for certain administrative employees and an increase in bonus expense, (ii) an increase in professional and consulting fees of $187,166 primarily due to an increase in consulting fees associated with investor relations and administrative support, and (iii) an increase in other expenses of $83,424 primarily due to an increase in the cost of directors and officers insurance, board fees, and other public company expenses.
Previous wording
The following table summarizes our results of operations for the six months ended June 30, 2025 and 2024:
Current wording
The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024:
Previous wording
The following table summarizes our research and development expenses for the six months ended June 30, 2025 and 2024:
Current wording
The following table summarizes our research and development expenses for the nine months ended September 30, 2025 and 2024:
Previous wording
The decrease in research and development expenses of $5,248,111 for the six months ended June 30, 2025 compared to the same prior year period was primarily due to a (i) decrease in external clinical trial expenses of $5,228,941 mostly related to lower patient fees and CRO costs associated with fewer patients on study during the current period related to the randomized Phase 2 mPDAC trial (Actuate-1801 Part 3B) and (ii) a decrease in CMC related costs of $223,055 in the current period primarily due to the timing of drug product manufacturing and stability studies to support ongoing trials, which amounts were primarily offset by an increase in personnel and consulting expenses of $203,320 mostly due to an increase in non-cash stock-based compensation expense of $112,720 related to awards granted to employees and consultants of the Company combined with an increase in payroll and consulting expenses primarily related to increased clinical and regulatory activities, combined with an increase in bonus expense.
Current wording
The decrease in research and development expenses of $6,827,291 for the nine months ended September 30, 2025 compared to the same prior year period was primarily due to a (i) decrease in external clinical trial expenses of $6,802,734 mostly related to lower patient fees and CRO costs associated with fewer patients on study during the current period related to the randomized Phase 2 mPDAC trial (Actuate-1801 Part 3B) and (ii) a decrease in CMC related costs of $588,825 in the current period primarily due to the timing of drug product manufacturing and stability studies. These amounts were offset by (i) an increase in personnel and consulting expenses of $486,268 due to an increase in non-cash stock-based compensation expense of $189,750 related to awards granted to employees and consultants of the Company, an increase in payroll and consulting expenses primarily related to increased clinical and regulatory activities, and an increase in bonus expense, and (ii) an increase in preclinical and biomarker studies in the current period of $78,000 primarily due to new studies completed in the current period.
Previous wording
The following table summarizes our general and administrative expenses for the six months ended June 30, 2025 and 2024:
Current wording
The following table summarizes our general and administrative expenses for the nine months ended September 30, 2025 and 2024:
Previous wording
The increase in general and administrative expenses of $4,373,869 for the six months ended June 30, 2025 compared to the same prior year period was primarily due to (i) an increase in personnel-related expenses of $2,925,952 mostly due to an increase in non-cash stock-based compensation expense of $2,353,427 related to awards granted to employees, non-employee members of the board of directors, and consultants of the Company combined with an increase in payroll and related expenses primarily related to the hiring of the Company’s chief financial officer in June 2024 combined with a current period increase in base salaries for certain administrative employees and an increase in bonus expense, (ii) an increase in other expenses of $1,039,735 primarily due to an increase in the cost of directors and officer insurance, board fees, investor relation fees, and other public company expenses, and (iii) an increase in professional and consulting fees of $408,182 primarily due to increased legal fees related to routine corporate activities combined with an increase in consulting fees to support administrative functions.
Current wording
The increase in general and administrative expenses of $6,032,524 for the nine months ended September 30, 2025 compared to the same prior year period was primarily due to (i) an increase in personnel-related expenses of $4,337,493 mostly due to an increase in non-cash stock-based compensation expense of $3,511,030 related to awards granted to employees, non-employee members of the board of directors, and consultants of the Company combined with an increase in payroll and related expenses primarily related to the hiring of the Company’s chief financial officer in June 2024, a current period increase in base salaries for certain administrative employees and an increase in bonus expense, (ii) an increase in professional and consulting fees of $910,820 primarily due to increased legal fees related to routine corporate activities combined with an increase in consulting fees associated with investor relations and administrative support, which amounts were offset by a decrease in board member search fees and valuation services and (iii) an increase in other expenses of $784,211 primarily due to an increase in the cost of directors and officers insurance, board fees, listing fees, and other public company expenses.
Previous wording
Other income (expense), net, for the six months ended June 30, 2025 and 2024 is comprised of the following:
Current wording
Other income (expense), net, for the nine months ended September 30, 2025 and 2024 is comprised of the following:
Previous wording
As of June 30, 2025, we had cash and cash equivalents of $6,492,656. Based on our current operating plan, we estimate that our existing cash and cash equivalents as of the date of this Report will not satisfy the Company’s operational and capital requirements beyond October, 2025 without raising additional capital.
Current wording
As of September 30, 2025, we had cash and cash equivalents of $16,924,763 and working capital of $11,071,338. We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we continue our development of, seek regulatory approval for, and potentially commercialize elraglusib and potentially seek to discover and develop and/or license or acquire additional product candidates, conduct our ongoing and planned clinical trials and preclinical studies, continue our research and development activities, utilize third parties to manufacture elraglusib, hire additional personnel, expand and protect our intellectual property, and incur additional costs associated with being a public company. Based on our current operating plan, we estimate that our existing cash and cash equivalents as of the date of this Quarterly Report will not satisfy the Company’s operational and capital requirements beyond the second quarter of fiscal year 2026 without raising additional capital. There can be no assurance that the Company will be able to raise sufficient proceeds in the future under the Committed Equity Facility or any additional financing will be available to the Company on acceptable terms, if at all. Moreover, the Company agreed, subject to certain exceptions, not to sell any shares of its capital stock or any securities convertible into or exercisable or exchangeable for shares of capital stock for a period of seventy-five (75) days from the closing date of the September 2025 Public Offering.
Previous wording
The following table provides a summary of our cash flows for the six months ended June 30, 2025 and 2024:
Current wording
The following table provides a summary of our cash flows for the nine months ended September 30, 2025 and 2024:
Previous wording
Six Months Ended June 30, 2025 — Net cash used in operating activities for the six months ended June 30, 2025 consisted of our net loss of $12,266,429, which amount was offset by (i) non-cash stock-based compensation expense of $2,704,372, (ii) an increase in accrued interest on license payable of $10,125, and (iii) cash provided by a net change in operating assets and liabilities of $759,431.
Current wording
Nine Months Ended September 30, 2025 — Net cash used in operating activities for the nine months ended September 30, 2025 consisted of our net loss of $17,673,899 combined with cash used by a net change in operating assets and liabilities of $2,316,485, which amounts were offset by non-cash stock-based compensation expense of $4,504,986 and an increase in accrued interest on license payable of $15,188.
Previous wording
Six Months Ended June 30, 2024 — Net cash used in operating activities for the six months ended June 30, 2024 consisted of our net loss of $14,868,278, which amount was offset by (i) non-cash stock-based compensation expense of $238,225, (ii) a non-cash increase in the fair value of our warrant liability of $272,854, (iii) a loss on issuance of Related Party Convertible Notes Payable at fair value of $400,000, (iv) the change in estimated fair value of Related Party Convertible Notes Payable of $1,000,000 at June 30, 2024, (v) an increase in accrued interest on license payable of $10,152, and (vi) cash provided by a net change in operating assets and liabilities of $5,025,827.
Current wording
Nine Months Ended September 30, 2024 — Net cash used in operating activities for the nine months ended September 30, 2024 consisted of our net loss of $20,839,239 combined with the gain on settlement of the warrant liability of $343,240, which amounts were offset by (i) non-cash stock-based compensation expense of $804,206, (ii) a non-cash increase in the fair value of our warrant liability of $78,903, (iii) a loss on issuance of Related Party Convertible Notes Payable at fair value of $400,000, (iv) the change in estimated fair value of Related Party Convertible Notes Payable of $2,192,507, (v) an increase in accrued interest on license payable of $13,565, and (vi) cash provided by a net change in operating assets and liabilities of $623,065.
Previous wording
Six Months Ended June 30, 2025 — During the six months ended June 30, 2025, net cash provided by financing activities consisted of net proceeds received of (i) $4,621,546 under the June 2025 Private Placement, (ii), $2,163,100 from the sale of common stock to B. Riley under the Committed Equity Facility and (iii) $34,115 from the exercise of stock options, which amounts were offset by a change in deferred offering costs of $175,226.
Current wording
Nine Months Ended September 30, 2025 — During the nine months ended September 30, 2025, net cash provided by financing activities consisted of net proceeds received of (i) $15,573,966 under the September 2025 Public Offering, (ii) $4,592,462 under the June 2025 Private Placement, (iii), $3,826,336 from the sale of common stock to B. Riley under the Committed Equity Facility, and (iv) $34,115 from the exercise of stock options, which amounts were offset by the payment of deferred offering costs of $273,528.
Previous wording
Six Months Ended June 30, 2024 — During the six months ended June 30, 2024, net cash provided by financing activities consisted of net proceeds received from the issuance of the Related Party Convertible Notes Payable of $5,500,000, which amount was offset by deferred offering costs paid during the period in the amount of $185,730 associated with the IPO.
Current wording
Nine Months Ended September 30, 2024 — During the nine months ended September 30, 2024, net cash provided by financing activities primarily consisted of net proceeds received from the closing of the IPO and Overallotment Option of $22,135,023 (net of underwriting discounts and commissions and after payment of offering costs of $1,821,777) and proceeds of $5,500,000 from the issuance of the Related Party Convertible Notes Payable.
Previous wording
Our financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The preparation of our financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our financial statements. We base our estimates on historical experience, known trends and events, and various other factors we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.
Current wording
Our financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The preparation of our financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our financial statements. We base our estimates on historical experience, known trends and events, and various other factors we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions. There were no material changes to our critical accounting estimates as reported in our Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on March 13, 2025.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
Also, we will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for elraglusib or any future product candidates, which we expect will take a number of years and may never occur. As a result, we need substantial additional funding to support our continuing operations and pursue our business strategy. Until such time we can generate significant revenue from product sales, if ever, we expect to finance our operations through equity offerings, debt financings, or other capital sources, including potential future collaborations, licenses, and other similar arrangements. As we seek additional financing in the near term, we may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements or arrangements as, and when needed, we may delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves, or even cease operations.
Previous report — wording carried elsewhere
We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we continue our development of, seek regulatory approval for, and potentially commercialize elraglusib and potentially seek to discover and develop and/or license or acquire additional product candidates, conduct our ongoing and planned clinical trials and preclinical studies, continue our research and development activities, utilize third parties to manufacture elraglusib, hire additional personnel, expand and protect our intellectual property, and incur additional costs associated with being a public company.
Previous report — wording carried elsewhere
Based on our current operating plan, we estimate that our existing cash and cash equivalents as of the date of this Quarterly Report will not satisfy the Company’s operational and capital requirements beyond October, 2025.