ACTUATE THERAPEUTICS, INC.
For the period ended Sep 30, 2026. Filed Nov 13, 2026.
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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, 2026 · Filed Nov 13, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-14.
0001683168-26-006472
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-13.
0001683168-26-008697
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 72 previous paragraphs and 77 current paragraphs.
47 unchanged; 23 reworded; 7 added; 1 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 11 previous and 30 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
Comparison of the Nine Months Ended September 30, 2026 and 2025:
Current report
On October 26, 2026, the Company entered into an underwriting agreement with Newbridge Securities Corporation, acting as sole book-running manager, relating to the issuance and sale of up to 35,633,785 shares of the Company’s common stock and warrants to purchase up to an aggregate of 17,816,892 shares of common stock, including the 15% over-allotment option granted to the underwriter (“October 2026 Public Offering”). The combined public offering price for each set of two shares of common stock and one accompanying warrant to purchase one share of common stock was $0.71, before underwriting discounts and commissions. Under the October 2026 Public Offering, the Company received aggregate net proceeds of $11,764,494 in exchange for the issuance of an aggregate of 35,633,785 shares of common stock and warrants to purchase an aggregate of up to 17,816,892 shares of common stock, including the full exercise of the over-allotment option, after deducting underwriting discounts and commissions and before estimated offering expenses payable by the Company.
Current report
Pro Forma Impact of the October 2026 Public Offering
Current report
The following financial information has been developed by application of pro forma adjustments to the historical financial statements of the Company appearing elsewhere in this Report. The unaudited pro forma information gives effect to the October 2026 Public Offering.
Current report
The unaudited pro forma financial information is presented for informational purposes only and does not purport to represent what the results of operations or financial position of the Company would have been had the transactions described above actually occurred on the dates indicated, nor do they purport to project the financial condition of the Company for any future period or as of any future date. The unaudited pro forma financial information should be read in conjunction with the Company’s financial statements and notes thereto included elsewhere in this Report.
Current report
Unaudited Pro Forma Balance Sheet
Current report
The unaudited pro forma balance sheet as of September 30, 2026 gives effect to an assumed October 2026 Public Offering and net proceeds of $11,764,494 completed after September 30, 2026, after deducting underwriting discounts and commissions and before estimated offering expenses payable by the Company. Underwriting discounts and commissions are assumed to be $885,500 (representing 7% of gross proceeds) and are reflected as a reduction of additional paid-in capital in accordance with U.S. GAAP. No proceeds from the exercise of the issued warrants are reflected.
Removed paragraphs (1)
Previous report
Comparison of the Six Months Ended June 30, 2026 and 2025:
Reworded paragraphs (23)
Previous wording
To date, we have treated over 500 patients with elraglusib as an IV injection (“Elraglusib Injection”) in Phase 1 and Phase 2 studies. We have also developed an oral formulation of elraglusib (“Elraglusib Oral Tablet”), which we believe will allow us to pursue a number of cancer indications with a more convenient dose delivery option for patients with the ability to dose patients on a daily basis. We filed an Investigational New Drug (“IND”) application with the FDA in April 2026 to advance the Elraglusib Oral Tablet into a Phase 1/2 clinical study to identify the maximum tolerated dose and Recommended Phase 2 Dose (“RP2D”) in adult patients with advanced, refractory cancers, and we recently received FDA clearance to proceed with the Phase 1/2 clinical study. Once we have determined a RP2D, several Phase 2 or registrational studies have been identified for further clinical development of Elraglusib Oral Tablet, subject to additional funding, based on data from previous studies, including but not limited to, first-line metastatic pancreatic ductal adenocarcinoma (“mPDAC”), refractory, metastatic melanoma, refractory, metastatic colorectal cancer, and non-small cell lung cancer.
Current wording
To date, we have treated over 500 patients with elraglusib as an IV injection (“Elraglusib Injection”) in Phase 1 and Phase 2 studies. We have also developed an oral formulation of elraglusib (“Elraglusib Oral Tablet”), which we believe will allow us to pursue a number of cancer indications with a more convenient dose delivery option for patients with the ability to dose patients on a daily basis. We filed an Investigational New Drug (“IND”) application with the FDA in April 2026 to advance the Elraglusib Oral Tablet into a Phase 1/2 clinical study to identify the maximum tolerated dose and Recommended Phase 2 Dose (“RP2D”) in adult patients with advanced, refractory cancers, and we received FDA clearance to proceed with the Phase 1/2 clinical study, subject to additional funding. Once we have determined a RP2D, several Phase 2 or registrational studies have been identified for further clinical development of Elraglusib Oral Tablet, subject to additional funding, based on data from previous studies, including but not limited to, metastatic pancreatic ductal adenocarcinoma (“mPDAC”), refractory, metastatic melanoma, refractory, metastatic colorectal cancer, and non-small cell lung cancer.
Previous wording
While these data are impressive with once weekly dosing, we believe we can further improve the outcome of patients using the Elraglusib Oral Tablet at the RP2D, including a more frequent dosing regimen to be identified in the Phase 1/2 clinical study. We believe this strategy will further align with other new approaches to treating mPDAC with investigational products that are delivered orally to patients. In addition, the safety profile of elraglusib in over 500 patients to date shows the product is well tolerated as a monotherapy and in combination with chemotherapy. We believe this may allow the Elraglusib Oral Tablet to be combined with other investigational products, including but not limited to RAS and MEK inhibitors, where possible additive or synergistic mechanisms of action may potentiate better outcomes for patients treated with combination therapy including elraglusib.
Current wording
While these data are impressive with once weekly IV dosing, we believe we can further improve the outcome of patients using the Elraglusib Oral Tablet at the RP2D, including a more frequent dosing regimen to be identified in the Phase 1/2 clinical study. We believe this strategy will further align with other new approaches to treating patients with mPDAC and other oncology indications with investigational or approved products that are delivered orally to patients. In addition, the safety profile of elraglusib in over 500 patients to date shows the product is well tolerated as a monotherapy and in combination with chemotherapy. We believe this may allow the Elraglusib Oral Tablet to be combined with other investigational or approved products, including but not limited to RAS and MEK inhibitors, where possible additive or synergistic mechanisms of action may potentiate better outcomes for patients treated with combination therapy including elraglusib.
Previous wording
In addition to our development plans for the Elraglusib Oral Tablet, we have advanced the development of Elraglusib Injection in pediatric cancer patients with recurrent/refractory solid cancers. This clinical study, Actuate-1902, is a Phase 1/2 study that evaluated escalating doses of elraglusib as a single agent as well as in combination with irinotecan or cyclophosphamide/topotecan in the Phase 1 portion of the study. Patients in the Actuate-1902 study also experienced a number of objective responses in the combination chemotherapy arms, and based on these data, we identified neuroblastoma and Ewing sarcoma as possible new indications for further development of Elraglusib Injection, pending additional funding primarily focused on non-dilutive sources of capital, further expanding the potential use and positive therapeutic impact of elraglusib. In June 2026, we entered into an initial agreement with the University of Birmingham to evaluate elraglusib in the BEACON2 clinical study, an international, multi-arm, multi-stage platform clinical study designed to identify and advance promising treatment approaches for children with relapsed and refractory neuroblastoma. The planned clinical study is expected to enroll up to 20 patients with relapsed and refractory neuroblastoma in a dose confirmation cohort to evaluate safety and to determine the maximum tolerated dose (“MTD”), RP2D, and pharmacokinetics (“PK”) profile of the combination of elraglusib with dinutuximab beta plus chemotherapy. Following completion of the dose confirmation stage, the regimen may advance into a randomized portion of the study, where approximately 75 patients will be enrolled with a planned interim analysis.
Current wording
In addition to our development plans for the Elraglusib Oral Tablet, we have advanced the development of Elraglusib Injection in pediatric cancer patients with recurrent/refractory solid cancers. This clinical study, Actuate-1902, is a Phase 1/2 study that evaluated escalating doses of elraglusib as a single agent as well as in combination with irinotecan or cyclophosphamide/topotecan in the Phase 1 portion of the study. Patients in the Actuate-1902 study also experienced a number of objective responses in the combination chemotherapy arms. Based on these data, we identified neuroblastoma and Ewing sarcoma as possible new indications for further development of Elraglusib Injection, pending additional funding primarily focused on non-dilutive sources of capital, further expanding the potential use and positive therapeutic impact of elraglusib. In June 2026, we entered into an initial agreement with the University of Birmingham to evaluate elraglusib in the BEACON2 clinical study, an international, multi-arm, multi-stage platform clinical study designed to identify and advance promising treatment approaches for children with relapsed and refractory neuroblastoma. The planned clinical study is expected to enroll up to 20 patients with relapsed and refractory neuroblastoma in a dose confirmation cohort to evaluate safety and to determine the maximum tolerated dose (“MTD”), RP2D, and pharmacokinetics (“PK”) profile of the combination of elraglusib with dinutuximab beta plus chemotherapy, subject to additional funding. Following completion of the dose confirmation stage, the regimen may advance into a randomized portion of the study, where approximately 75 patients are expected to be enrolled with an interim analysis.
Previous wording
Although research and development activities are central to our business model, the successful development of elraglusib and any future product candidates is highly uncertain. There are numerous factors associated with the successful development of any product candidate such as elraglusib, including future study design and various regulatory requirements, many of which cannot be determined with accuracy at this time given our stage of development. In addition, future regulatory factors beyond our control may impact our clinical development programs. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased number of patients and longer duration of later-stage clinical studies. As a result, we expect our research and development expenses to increase substantially in connection with our ongoing and planned clinical and nonclinical development activities in the near term and in the future, provided we are able to raise additional capital. At this time, we cannot accurately estimate or know the nature, timing, and costs of the efforts that will be necessary to complete the nonclinical and clinical development of elraglusib and any future product candidates. Our future research and development expenses may vary significantly based on a wide variety of factors such as:
Current wording
Although research and development activities are central to our business model, the successful development of elraglusib and any future product candidates is highly uncertain. There are numerous factors associated with the successful development of any product candidate such as elraglusib, including future study design and various regulatory requirements, many of which cannot be determined with accuracy at this time given our stage of development. In addition, future regulatory factors beyond our control may impact our clinical development programs. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased number of patients and longer duration of later-stage clinical studies. As we advance the oral tablet formulation of elraglusib into a Phase 1/2 clinical trial in a smaller number of patients compared to the number of patients in our prior Actuate-1801 Phase 2 clinical trial, we expect our research and development expenses to decrease in the near term, provided we are able to raise additional capital to support these efforts. At this time, we cannot accurately estimate or know the nature, timing, and costs of the efforts that will be necessary to complete the nonclinical and clinical development of elraglusib and any future product candidates. Our future research and development expenses may vary significantly based on a wide variety of factors such as:
Previous wording
General and administrative expenses consist primarily of personnel-related expenses, such as employee compensation, benefits, and stock-based compensation, for our personnel in executive and other administrative functions. General and administrative expenses also include legal fees relating to patent and corporate matters and professional fees paid for accounting, auditing, consulting, and tax services, as well as other costs such as insurance costs, board of director fees, investor and public relations, and travel expenses.
Current wording
General and administrative expenses consist primarily of personnel-related expenses, such as employee compensation, benefits, and stock-based compensation, for our personnel in executive and other administrative functions. General and administrative expenses also include legal fees relating to patent and corporate matters and professional fees paid for accounting, auditing, consulting, and tax services, as well as other costs such as insurance costs, board of director fees, investor and public relations, and travel expenses. We anticipate our general and administrative expenses will remain steady or decrease in the near future based on available financial resources. However, pending the availability of additional capital, we anticipate our general and administrative expenses may increase in the future if we are able to expand our operations, including increasing our headcount to support our continued research and development activities and preparing for later-stage clinical studies and potential commercialization of elraglusib.
Previous wording
We have incurred significant operating losses and negative cash flows from operations since our inception. Our net losses were $22,227,852 and $27,285,328 for the years ended December 31, 2025 and 2024, respectively, and $10,492,384 and $12,266,429 for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $165,100,085. Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs and general and administrative costs associated with our operations. We expect to continue to incur significant expenses and operating losses for 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 operating as 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 $22,227,852 and $27,285,328 for the years ended December 31, 2025 and 2024, respectively, and $13,913,033 and $17,673,899 for the nine months ended September 30, 2026 and 2025, respectively. As of September 30, 2026, we had an accumulated deficit of $168,520,734. Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs and general and administrative costs associated with our operations. We expect to continue to incur significant expenses and operating losses for 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 operating as 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 $697,980 for the three months ended June 30, 2026 compared to the same prior year period was primarily due to (i) a decrease in external clinical study expenses of $749,598 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 clinical study (Actuate-1801 Part 3B), (ii) a decrease of $68,095 in CMC related costs primarily due to the timing of our stability studies, and (iii) a decrease of $53,488 in nonclinical and biomarker research costs primarily related to lower bioanalytical costs. These decreases were partially offset by an increase in personnel and consulting expenses of $173,201 primarily due to an increase in non-cash stock-based compensation expense of $106,685 related to awards granted to employees and consultants of the Company.
Current wording
The decrease in research and development expenses of $366,321 for the three months ended September 30, 2026 compared to the same prior year period was primarily due to (i) a decrease in external clinical study expenses of $525,543 mostly related to lower costs associated with the randomized Phase 2 mPDAC clinical study (Actuate-1801 Part 3B) as the study nears completion, (ii) a decrease in personnel and consulting expenses of $295,189 primarily due to lower consulting expenses due to the fewer activities associated with the randomized Phase 2 mPDAC clinical study combined with a decrease in bonus expense in the current period, which were offset by an increase in non-cash stock-based compensation expense of $130,845 related to awards granted to employees and consultants of the Company, and (iii) a decrease of $52,962 in CMC related costs primarily due to the timing of our stability studies. These amounts were offset by a current period increase in nonclinical and biomarker research costs of $507,373 mostly associated with nonclinical studies being conducted to evaluate the combination of elraglusib with various RAS inhibitors.
Previous wording
The decrease in general and administrative expenses of $364,309 for the three months ended June 30, 2026 compared to the same prior year period was primarily due to (i) a decrease in personnel-related expenses of $514,875 mostly due to a decrease in non-cash stock-based compensation expense of $345,187 resulting from the timing of amortization of awards granted to employees, non-employee members of the board of directors, and consultants of the Company and (ii) a decrease in other expenses of $68,626 primarily related to lower insurance costs and travel costs. These decreases were partially offset by a current period increase in professional and consulting fees of $219,192 mostly due to an increase in investor and public relations fees.
Current wording
The decrease in general and administrative expenses of $1,666,970 for the three months ended September 30, 2026 compared to the same prior year period was primarily due to (i) a decrease in personnel-related expenses of $1,392,649 mostly due to a decrease in non-cash stock-based compensation expense of $960,635 resulting from the timing of amortization of awards granted to employees, non-employee members of the board of directors, and consultants of the Company combined with a decrease in bonus expense and (ii) a decrease in professional and consulting fees of $274,348 mostly due to a decrease in investor and public relations fees combined with a decrease in legal expenses.
Previous wording
The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025:
Current wording
The following table summarizes our results of operations for the nine months ended September 30, 2026 and 2025:
Previous wording
The following table summarizes our research and development expenses for the six months ended June 30, 2026 and 2025:
Current wording
The following table summarizes our research and development expenses for the nine months ended September 30, 2026 and 2025:
Previous wording
The decrease in research and development expenses of $1,353,055 for the six months ended June 30, 2026 compared to the same prior year period was primarily due to a decrease in external clinical study expenses of $2,002,780 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 clinical study (Actuate-1801 Part 3B) combined with a decrease in CMC related costs of $268,182 in the current period primarily due to the timing of drug product manufacturing and stability studies to support ongoing and planned clinical studies. These decreases in expenses in the current period were partially offset by (i) an increase in personnel and consulting expenses of $525,719 primarily due to increased headcount, an increase in medical and regulatory consulting associated with ongoing regulatory filings, and an increase in non-cash stock-based compensation expense of $134,429 and (ii) an increase in nonclinical and biomarker research studies in the amount of $392,188 due to greater nonclinical studies and bioanalytical studies conducted in the current period to support advancing elraglusib and the oral tablet formulation.
Current wording
The decrease in research and development expenses of $1,719,376 for the nine months ended September 30, 2026 compared to the same prior year period was primarily related to lower external clinical study expenses of $2,532,668 mostly related to the randomized Phase 2 mPDAC clinical study (Actuate-1801 Part 3B) as the study nears completion combined with a decrease in CMC related costs of $321,143 primarily due to the timing of drug product manufacturing and stability studies. These decreases in expenses in the current period were partially offset by (i) an increase in nonclinical and biomarker research costs of $899,562 mostly associated with nonclinical studies being conducted to evaluate the combination of elraglusib with various RAS inhibitors and (ii) an increase in personnel and consulting expenses of $234,873 due to an increase in headcount compared to the same prior year period combined with an increase in non-cash stock-based compensation expense of $265,274 related to awards granted to employees and consultants of the Company, which amounts were offset by lower consulting expenses in the current period.
Previous wording
The following table summarizes our general and administrative expenses for the six months ended June 30, 2026 and 2025:
Current wording
The following table summarizes our general and administrative expenses for the nine months ended September 30, 2026 and 2025:
Previous wording
The decrease in general and administrative expenses of $368,862 for the six months ended June 30, 2026 compared to the same prior year period was primarily due to (i) a decrease in personnel-related expenses of $347,549 related to lower amounts accrued for annual bonuses in the current period combined with lower non-cash stock-based compensation expense of $141,643 related to the timing of amortization of awards granted to employees, non-employee members of the board of directors, and consultants of the Company and (ii) a decrease in other expenses of $72,588 primarily related to lower insurance costs and travel costs in the current period. These amounts were partially offset by a current period increase in professional and consulting fees of $51,275, mostly due to an increase in investor and public relations fees.
Current wording
The decrease in general and administrative expenses of $2,035,832 for the nine months ended September 30, 2026 compared to the same prior year period was primarily due to (i) a decrease in personnel-related expenses of $1,740,197 related to lower non-cash stock-based compensation expense of $1,102,278 related to the timing of amortization of awards granted to employees, non-employee members of the board of directors, and consultants of the Company combined with lower bonus expense in the current period, (ii) a decrease in professional and consulting fees of $223,074, mostly due to a decrease in investor and public relations fees, and (iii) a decrease in other expenses of $72,561 primarily related to lower insurance costs in the current period.
Previous wording
Other income (expense), net, for the six months ended June 30, 2026 and 2025 was comprised of the following:
Current wording
Other income (expense), net, for the nine months ended September 30, 2026 and 2025 was comprised of the following:
Previous wording
On November 28, 2025, the Company entered into an At Market Issuance Sales Agreement (the “ATM Agreement”) with B. Riley Securities, Inc. and Craig-Hallum Capital Group LLC (each a “Sales Agent” and collectively the “Sales Agents”) with respect to an “at the market” offering program (the “ATM Facility”), under which the Company may, from time to time, at its sole discretion, issue and sell through the Sales Agents, up to $100 million of shares of common stock. Pursuant to the ATM Agreement, the Company may sell the shares through the Sales Agents by any method permitted that is deemed an “at the market” offering as defined in Rule 415 under the Securities Act. The Sales Agents will use commercially reasonable efforts consistent with their normal trading and sales practices to sell the shares from time to time, based upon instructions from us, including any price or size limits or other customary parameters or conditions we may impose. The Company will pay the Sales Agents a commission of up to 3.0% of the gross sales proceeds of any common stock sold through the Sales Agents under the ATM Agreement and also has provided the Sales Agents with customary indemnification rights. During the six months ended June 30, 2026, the Company sold 498,193 shares of common stock at a weighted-average price of $2.66 per share for net proceeds of $1,249,591 under the ATM Facility. As of June 30, 2026, the Company had approximately $98.7 million in remaining capacity under its ATM Facility.
Current wording
On November 28, 2025, we entered into an At Market Issuance Sales Agreement (the “ATM Agreement”) with B. Riley Securities, Inc. and Craig-Hallum Capital Group LLC (each a “Sales Agent” and collectively the “Sales Agents”) with respect to an “at the market” offering program (the “ATM Facility”), under which we may, from time to time, at our sole discretion, issue and sell through the Sales Agents, up to $100 million of shares of our common stock. Pursuant to the ATM Agreement, we may sell the shares through the Sales Agents by any method permitted that is deemed an “at the market” offering as defined in Rule 415 under the Securities Act. The Sales Agents will use commercially reasonable efforts consistent with their normal trading and sales practices to sell the shares from time to time, based upon instructions from us, including any price or size limits or other customary parameters or conditions we may impose. We will pay the Sales Agents a commission of up to 3.0% of the gross sales proceeds of any common stock sold through the Sales Agents under the ATM Agreement and also has provided the Sales Agents with customary indemnification rights. During the nine months ended September 30, 2026, we sold 1,078,995 shares of common stock at a weighted-average price of $1.96 per share for net proceeds of $2,023,024 under the ATM Facility. As of September 30, 2026, we had approximately $97.9 million in remaining capacity under its ATM Facility.
Previous wording
On March 27, 2025, we 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. During the six months ended June 30, 2026, the Company did not issue any shares of common stock under the Committed Equity Facility. As of June 30, 2026, we had 3,364,407 shares of common stock in remaining capacity under our Committed Equity Facility.
Current wording
On March 27, 2025, we entered into a common stock purchase agreement (the “Committed Equity Facility”) with B. Riley Principal Capital II (“B. Riley”) giving us 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 our common stock. During the nine months ended September 30, 2026, we did not issue any shares of common stock under the Committed Equity Facility. As of September 30, 2026, we had 3,364,407 shares of common stock in remaining capacity under our Committed Equity Facility.
Previous wording
As of June 30, 2026, we had cash and cash equivalents of $4,425,841 and working capital of $942,745. 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 studies and nonclinical 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 operating as a public company. 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 September 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 ATM Facility or Committed Equity Facility or any additional financing will be available to the Company on acceptable terms, if at all.
Current wording
As of September 30, 2026, we had cash and cash equivalents of $2,101,816 and a working capital deficit of $974,694. 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 studies and nonclinical 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 operating as a public company. Based on our current operating plan, we estimate that our existing cash and cash equivalents as of the date of this Report, and after giving effect to our October 2026 Public Offering, will not be sufficient to fund our operational and capital requirements for at least one year after the date these financial statements are issued without raising additional capital. There can be no assurance that we will be able to raise sufficient proceeds in the future under the ATM Facility or Committed Equity Facility or any additional financing will be available to the us on acceptable terms, if at all.
Previous wording
Until such time, if ever, that we can generate substantial product revenue, we expect to finance our operations through equity offerings, debt financings, or other capital sources, including current or potential future collaborations, licenses, and other similar arrangements. As we seek additional financing in the near future, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our ability to raise additional funds may be adversely impacted by business conditions, global economic conditions, disruptions to, and volatility in, the credit and financial markets in the United States and worldwide, and diminished liquidity and credit availability. To the extent we raise additional capital through the sale of equity or convertible debt securities, stockholders’ ownership interest in our common stock will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions, engaging in acquisition, merger or collaboration transactions, selling or licensing our assets, making capital expenditures, redeeming our stock, making certain investments or declaring dividends. If we raise additional funds through collaborations or license agreements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity, debt, or other financings when needed, we may be required to 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.
Current wording
Until such time, if ever, that we can generate substantial product revenue, we expect to finance our operations through equity offerings, debt financings, or other capital sources, including current or potential future collaborations, licenses, and other similar arrangements. As we seek additional financing in the near future, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our ability to raise additional funds may be adversely impacted by business conditions, global economic conditions, disruptions to, and volatility in, the credit and financial markets in the United States and worldwide, and diminished liquidity and credit availability. In addition, we are not currently in compliance with the Nasdaq Global Market’s minimum market value of listed securities (“MVLS”) requirement of $50 million and $1.00 minimum bid price requirement. If our common stock is delisted from the Nasdaq Global Market, and our common stock is not accepted for listing on the Nasdaq Capital Market, or we are unable to meet the $1.00 minimum bid price requirement or fail to maintain compliance with other listing requirements, the market price and liquidity of our common stock and our ability to raise additional capital would be adversely impacted. To the extent we raise additional capital through the sale of equity or convertible debt securities, stockholders’ ownership interest in our common stock will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions, engaging in acquisition, merger or collaboration transactions, selling or licensing our assets, making capital expenditures, redeeming our stock, making certain investments or declaring dividends. If we raise additional funds through collaborations or license agreements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity, debt, or other financings when needed, we may be required to 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 wording
The following table provides a summary of our cash flows for the six months ended June 30, 2026 and 2025:
Current wording
The following table provides a summary of our cash flows for the nine months ended September 30, 2026 and 2025:
Previous wording
Six Months Ended June 30, 2026 — Net cash used in operating activities for the six months ended June 30, 2026 consisted of our net loss of $10,492,384 combined with cash used by a net change in operating assets and liabilities of $1,775,849, which amounts were partially offset by (i) non-cash stock-based compensation expense of $2,697,158, (ii) non-cash stock issued for services of $138,500, and (iii) an increase in accrued interest on license payable of $10,125.
Current wording
Nine Months Ended September 30, 2026 — Net cash used in operating activities for the nine months ended September 30, 2026 consisted of our net loss of $13,913,033 combined with cash used by a net change in operating assets and liabilities of $2,281,893, which amounts were partially offset by (i) non-cash stock-based compensation expense of $3,667,982, (ii) non-cash stock issued for services of $138,500, and (iii) an increase in accrued interest on license payable of $15,188.
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 partially offset by (i) non-cash stock-based compensation expense of $2,704,372, (ii) cash provided by a net change in operating assets and liabilities of $759,431, and (iii) an increase in accrued interest on license payable of $10,125.
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, 2026 — During the six months ended June 30, 2026, net cash provided by financing activities consisted of net proceeds received of $1,251,213 from the sale of shares of common stock under the ATM Facility, before the amortization of deferred offering costs of $1,622, which amount was partially offset by the payment of taxes from withholding of common stock on settlement of restricted stock units of $527,716 and the payment of deferred offering costs of $34,629.
Current wording
Nine Months Ended September 30, 2026 — During the nine months ended September 30, 2026, net cash provided by financing activities consisted of net proceeds received of $2,025,619 from the sale of shares of common stock under the ATM Facility, before the amortization of deferred offering costs of $2,595, which amount was partially offset by the payment of taxes from withholding of common stock on settlement of restricted stock units of $649,442 and the payment of deferred offering costs of $60,528.
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 partially offset by the payment of 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.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
We anticipate our general and administrative expenses will increase in the future as we expand our operations, including increasing our headcount to support our continued research and development activities and preparing for later-stage clinical studies and potential commercialization of elraglusib. We also anticipate we will continue to incur increased accounting, audit, legal, regulatory, compliance, director and officer insurance, and investor and public relations expenses associated with operating as a public company.