MAIA Biotechnology Inc

Previous wording

Management’s Discussion and Analysis of Financial Condition and Results of Operations.

Current wording

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

Previous wording

In November 2018, we in-licensed THIO from UTSW, in Dallas. The patent license is global and exclusive for the duration of the patients’ lives.

Current wording

In November 2018, we in-licensed THIO from the University of Texas Southwestern (“UTSW”), in Dallas. The patent license is global and exclusive for the duration of the patients’ lives.

Previous wording

In the first quarter 2021, we entered into the Drug Supply Agreement with Regeneron. Under the Drug Supply Agreement, Regeneron will provide cemiplimab (Libtayo Ò; anti-PD-1 checkpoint inhibitor) at no charge for the THIO-101 trials, testing THIO administration for immune activation followed by cemiplimab in NSCLC. The Drug Supply Agreement replaces direct drug purchase expense that we would be otherwise required to incur. In exchange, Regeneron received development exclusivity in NSCLC for the duration of the trial meaning we cannot conduct trials in NSCLC with another checkpoint inhibitor during the time of the trial. All other areas of study and development in any other tumor types remain open.

Current wording

In the first quarter 2021, we entered into a Drug Supply Agreement with Regeneron. Under the Drug Supply Agreement, Regeneron will provide cemiplimab (Libtayo Ò; anti-PD-1 checkpoint inhibitor) at no charge for the THIO-101 trials, testing THIO administration for immune activation followed by cemiplimab in NSCLC. The Drug Supply Agreement replaces direct drug purchase expense that we would be otherwise required to incur. In exchange, Regeneron received development exclusivity in NSCLC for the duration of the trial meaning we cannot conduct trials in NSCLC with another checkpoint inhibitor during the time of the trial. All other areas of study and development in any other tumor types remain open.

Previous wording

In the first half of 2022, we completed a crossover round consisting of sales of 274,840 shares of our Common Stock at a price of $9.00 per shares for gross proceeds of approximately $2.5 million.

Current wording

In the first half of 2022, we completed a crossover round consisting of sales of 274,840 shares of our common stock, par value $0.0001 per share (the “Common Stock”), at a price of $9.00 per shares for gross proceeds of approximately $2.5 million.

Previous wording

Development may grant orphan designation status to drugs and biologics that are intended for the treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S. ODD provides certain benefits, including financial incentives, to support clinical development and the potential for up to seven years of market exclusivity for the drug for the designated orphan indication in the U.S. if the drug is ultimately approved for its designated indication.

Current wording

In March 2022, the U.S. Food and Drug Administration (the “FDA”) granted Orphan Drug Designation (“ODD”) to THIO for the treatment of Hepatocellular Carcinoma (“HCC”) (liver cancer), and in May 2022, the FDA granted ODD to THIO for the treatment of small-cell lung cancer. The FDA’s Office of Orphan Products Development may grant orphan designation status to drugs and biologics that are intended for the treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S. ODD provides certain benefits, including financial incentives, to support clinical development and the potential for up to seven years of market exclusivity for the drug for the designated orphan indication in the U.S. if the drug is ultimately approved for its designated indication.

Previous wording

On February 7, 2024, we announced publication of international Patent Cooperation Treat (PCT) application titled “Dinucleotides and Their Use in Treating Cancer.” The new dinucleotides disclosed in the patent application are telomere-targeting molecules, such as THIO fragments or other THIO analogues. These compounds are key next-generation telomere-targeting agents, an important extension of MAIA’s innovative cancer treatment platform. The PCT system streamlines the process for obtaining patent protection globally. Under the PCT, applicants can seek patent protection in a large number of countries.

Current wording

On February 7, 2024, we announced publication of international Patent Cooperation Treaty (“PCT”) application titled “Dinucleotides and Their Use in Treating Cancer.” The new dinucleotides disclosed in the patent application are telomere-targeting molecules, such as THIO fragments or other THIO analogues. These compounds are key next-generation telomere-targeting agents, an important extension of MAIA’s innovative cancer treatment platform. The PCT system streamlines the process for obtaining patent protection globally. Under the PCT, applicants can seek patent protection in a large number of countries.

Previous wording

On February 14, 2024, we entered into the ATM Agreement with Wainwright, to sell Shares having an aggregate sales price of up to $1,445,000, from time to time, through an “at-the-market offering” program under which Wainwright will act as sales agent. Effective March 25, 2024, the Company filed a prospectus supplement to amend, supplement and supersede certain information contained in the earlier prospectus and prospectus supplement, which increased the number of shares of Common Stock the Company may offer and sell under the ATM Agreement to an aggregate offering price of up to $4,950,000 from time to time. Effective May 15, 2024, the Company filed a prospectus supplement to amend, supplement and supersede certain information contained in the earlier prospectus and prospectus supplement, which increased the number of Shares the Company may offer and sell under the ATM Agreement to an aggregate offering price of up to $11,280,000 from time to time. As of the date of this Quarterly Report, we have sold 2,675,482 shares of our Common Stock under the ATM Agreement at an average price of $3.15 per share, resulting in aggregate gross proceeds of approximately $8,439,224, for which we paid Wainwright approximately $253,177 in commissions.

Current wording

On February 14, 2024, we entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”), to sell shares of our Common Stock having an aggregate sales price of up to $1,445,000, from time to time, through an “at-the-market offering” program under which Wainwright will act as sales agent. Effective March 25, 2024, the Company filed a prospectus supplement to amend, supplement and supersede certain information contained in the earlier prospectus and prospectus supplement, which increased the number of shares of Common Stock the Company may offer and sell under the ATM Agreement to an aggregate offering price of up to $4,950,000 from time to time. Effective May 15, 2024, the Company filed a prospectus supplement to amend, supplement and supersede certain information contained in the earlier prospectus and prospectus supplement, which increased the number of Shares the Company may offer and sell under the ATM Agreement to an aggregate offering price of up to $11,280,000 from time to time. As of the date of this Quarterly Report, we have sold 2,985,953 shares of our Common Stock under the ATM Agreement at an average price of $3.16 per share, resulting in aggregate gross proceeds of approximately $9,440,950, for which we paid Wainwright $283,228 in commissions resulting in net proceeds to us of approximately $9,157,722.

Previous wording

On March 6, 2024, we announced interim efficacy data for THIO-101 Phase 2 trial in NSCLC. In the latest data available (as of January 8, 2024), the ORR, characterized as partial or complete response to therapy, was 38% (3 out of 8 patients) in the efficacy evaluable population for combination THIO 180mg + cemiplimab in third-line treatment for NSCLC patients who failed treatment with immune checkpoint inhibitors in prior lines of therapy, with or without chemotherapy.

Current wording

On March 6, 2024, we announced interim efficacy data for THIO-101 Phase 2 trial in NSCLC. In the latest data available (as of January 8, 2024), the ORR, characterized as partial or complete response to therapy, was 38% (3 out of 8 patients) in the efficacy evaluable population for combination THIO 180mg + cemiplimab (Libtayo®) in third-line treatment for NSCLC patients who failed treatment with immune checkpoint inhibitors in prior lines of therapy, with or without chemotherapy.

Previous wording

On March 14, 2024, we issued and sold 2,496,318 shares of our Common Stock and warrants to purchase 2,496,318 shares of our Common Stock in a private placement to certain accredited investors and certain of our directors pursuant to securities purchase agreements dated March 11, 2024 at a price per share of $1.17 for which we received gross proceeds of approximately $2.92 million. The securities sold to our directors participating in the March 14, 2024 private placement were issued pursuant to the MAIA 2021 Plan.

Current wording

On March 14, 2024, we issued and sold 2,496,318 shares of our Common Stock and warrants to purchase 2,496,318 shares of our Common Stock in a private placement to certain accredited investors and certain of our directors pursuant to securities purchase agreements dated March 11, 2024 at a price per share of $1.17 for which we received gross proceeds of approximately $2.92 million. The warrants issued in the private placement have an exercise price of $1.30, are exercisable six months after issuance and expire 5-years after the initial exercise date. The securities sold to our directors participating in the March 14, 2024 private placement were issued pursuant to the MAIA Biotechnology, Inc. 2021 Equity Incentive Plan (the “MAIA 2021 Plan”).

Previous wording

On March 28, 2024, we issued and sold 578,643 shares of our Common Stock and warrants to purchase 578,643 shares of our Common Stock in a private placement to certain accredited investors pursuant to securities purchase agreements dated March 25, 2024 at a price per share of $2.295 for which we received gross proceeds of approximately $1.33 million.

Current wording

On March 28, 2024, we issued and sold 578,643 shares of our Common Stock and warrants to purchase 578,643 shares of our Common Stock in a private placement to certain accredited investors pursuant to securities purchase agreements dated March 25, 2024 at a price per share of $2.295 for which we received gross proceeds of approximately $1.33 million. The warrants issued in the private placement have an exercise price of $2.55, are exercisable six months after issuance and expire 5-years after the initial exercise date.

Previous wording

On April 25, 2024, we issued and sold 494,096 shares of our Common Stock and warrants to purchase 494,096 shares of our Common Stock in a private placement to certain accredited investors and Company directors pursuant to securities purchase agreements dated April 22, 2024 at a price per share of $2.034, for which we received gross proceeds of approximately $1.0 million. The securities sold to our directors participating in the April 25, 2024 private placement were issued pursuant to the MAIA 2021 Plan.

Current wording

On April 25, 2024, we issued and sold 494,096 shares of our Common Stock and warrants to purchase 494,096 shares of our Common Stock in a private placement to certain accredited investors and Company directors pursuant to securities purchase agreements dated April 22, 2024 at a price per share of $2.034, for which we received gross proceeds of approximately $1.0 million. The warrants issued in the private placement have an exercise price of $2.26, are exercisable six months after issuance and expire 5-years after the initial exercise date. The securities sold to our directors participating in the April 25, 2024 private placement were issued pursuant to the MAIA 2021 Plan.

Previous wording

On June 4, 2024, we announced new preliminary efficacy data from the Phase 2 THIO-101 clinical trial. The latest data available (April 30, 2024) was presented in a poster session at the ASCO 2024 Annual Meeting on June 3, 2024, and included: (i) all evaluable patients had completed ≥1 post-baseline assessment; (ii) third-line treatment across all doses had shown DCR of 85% for THIO, 65% of patients crossed the 5.8-month OS threshold identified in literature, 85% of patients crossed the 2.5-month PFS threshold, median survival follow-up time was 9.1 months; and (iii) third-line treatment with THIO 180mg had shown median PFS of 5.5 months, 78% OS rate at 6 months, 38% ORR, 75% of patients crossed the 5.8-month OS threshold, 88% of patients crossed the 2.5-month PFS threshold and median survival follow-up time observed was 9.1 months.

Current wording

On June 4, 2024, we announced new preliminary efficacy data from the Phase 2 THIO-101 clinical trial. The updated included that as of April 30, 2024: (i) all evaluable patients had completed ≥1 post-baseline assessment; (ii) third-line treatment across all doses had shown DCR of 85% for THIO, 65% of patients crossed the 5.8-month OS threshold identified in literature, 85% of patients crossed the 2.5-month PFS threshold, median survival follow-up time was 9.1 months; and (iii) third-line treatment with THIO 180mg had shown median PFS of 5.5 months, 78% OS rate at 6 months, 38% ORR, 75% of patients crossed the 5.8-month OS threshold, 88% of patients crossed the 2.5-month PFS threshold and median survival follow-up time observed was 9.1 months.

Previous wording

On June 7, 2024, MAIA announced the validation of clinical and regulatory pathways for viable therapies leveraging the cell’s telomeric functions as evidenced by the FDA approval of imetelstat, a treatment for low- to intermediate-risk hematologic malignancies (myelodysplastic syndromes) from Geron Corporation, illuminating the role of telomere targeting as a viable therapeutic strategy for cancer treatment.

Current wording

On June 7, 2024, we announced the validation of clinical and regulatory pathways for viable therapies leveraging the cell’s telomeric functions as evidenced by the FDA approval of imetelstat, a treatment for low- to intermediate-risk hematologic malignancies (myelodysplastic syndromes) from Geron Corporation, illuminating the role of telomere targeting as a viable therapeutic strategy for cancer treatment.

Previous wording

On July 23, 2024, MAIA announced treatment updates from its Phase 2 clinical trial of THIO as of June 12, the latest clinical cut-off date: (i) 6 patients remain on treatment following at least 12 months of therapy; (ii) treatment with THIO followed by cemiplimab has been well tolerated throughout the trial, with lower toxicity compared to standard-of-care treatments; and (iii) the longest-treated patients have completed 21 cycles of THIO sequenced with cemiplimab.

Current wording

On July 23, 2024, we announced treatment updates from our Phase 2 clinical trial of THIO. As of June 12, the latest clinical cut-off date: (i) 6 patients remain on treatment following at least 12 months of therapy; (ii) treatment with THIO followed by cemiplimab has been well tolerated throughout the trial, with lower toxicity compared to standard-of-care treatments; and (iii) the longest-treated patients have completed 21 cycles of THIO sequenced with cemiplimab.

Previous wording

In addition to NSCLC, MAIA plans to conduct clinical trials evaluating THIO in sequential combination with an immune checkpoint inhibitor in several other cancer indications. THIO-102 is a Phase 2 clinical trial planned to target: (i) colorectal cancer (CRC), in which THIO demonstrated 100% complete response in pre-clinical setting, with no tumor recurrence after long-term follow-up; (ii) HCC (90% of primary liver cancers), a deadly cancer indication to which MAIA holds an ODD awarded by the FDA in April 2022; (iii) SCLC, the deadliest type of lung cancer, MAIA was also awarded ODD for this indication in August 2022; and (iv) solid tumors, such as breast, prostate, gastric, pancreatic and ovarian cancers. THIO-103 is a Phase 2 clinical trial planned to evaluate treatment with THIO in first-line patients for both NSCLC and SCLC.

Current wording

In addition to NSCLC, we plan to conduct clinical trials evaluating THIO in sequential combination with an immune checkpoint inhibitor in several other cancer indications. THIO-102 is a Phase 2 clinical trial planned to target: (i) colorectal cancer, in which THIO demonstrated 100% complete response in pre-clinical setting, with no tumor recurrence after long-term follow-up; (ii) HCC (90% of primary liver cancers), a deadly cancer indication to which MAIA holds an ODD awarded by the FDA in April 2022; (iii) SCLC, the deadliest type of lung cancer, MAIA was also awarded ODD for this indication in August 2022; and (iv) solid tumors, such as breast, prostate, gastric, pancreatic and ovarian cancers. THIO-103 is a Phase 2 clinical trial planned to evaluate treatment with THIO in first-line patients for both NSCLC and SCLC.

Previous wording

Results of Operations for the Three and Six Months Ended June 30, 2024 and 2023

Current wording

Results of Operations for the Three and Nine Months Ended September 30, 2024 and 2023

Previous wording

Research and development expenses decreased by approximately $547,000 (or approximately 21%), from approximately $2,599,000 for the three months ended June 30, 2023 compared to approximately $2,052,000 for the three months ended June 30, 2024. The decrease was primarily related to a decrease in payroll and bonus expenses of approximately $634,000 related to the decreased headcount of research and development employees and the reversal of the accrued bonus, a decrease in stock-based compensation costs of approximately $128,000, and decrease in other expenses of approximately $33,000, offset by an increase in scientific research and clinical research of approximately $248,000.

Current wording

Research and development expenses increased by approximately $67,000 (or approximately 3%), from approximately $2,600,000 for the three months ended September 30, 2023 to approximately $2,667,000 for the three months ended September 30, 2024. The increase was primarily related to an increase in scientific research and clinical research of approximately $293,000, offset by a decrease in payroll expense of approximately $171,000 and a decrease in stock-based compensation costs of approximately $55,000.

Previous wording

General and administrative expenses decreased by approximately $302,000 (or approximately 15%) from approximately $2,065,000 for the three months ended June 30, 2023 compared to approximately $1,763,000 for the three months ended June 30, 2024. The decrease was primarily related to a decrease in payroll expense of approximately $413,000 relating to the reversal of the accrued bonus and a decrease in stock-based compensation of approximately $77,000, offset by an increase in professional fees of approximately $139,000 and an increase in other expenses of approximately $49,000.

Current wording

General and administrative expenses decreased by approximately $835,000 (or approximately 35%) from approximately $2,356,000 for the three months ended September 30, 2023, to approximately $1,521,000 for the three months ended September 30, 2024. The decrease was primarily related to a decrease in professional fees of approximately $507,000, a decrease in other expenses of approximately $258,000, a decrease in stock-based compensation of approximately $60,000, and a decrease of approximately $10,000 payroll expense.

Previous wording

Other expense, net increased by approximately $5,205,000 (or approximately 3691%) from other income of approximately $141,000 for the three months ended June 30, 2023 compared to other expense of approximately $5,064,000 for the three months ended June 30, 2024. The increase was primarily related to the change in the fair value of the warrant liability of approximately $5,260,000, a loss on the fair value of warrants over proceeds of approximately $13,000, a reduction in the Australian research and development incentives of approximately $22,000 and a net increase of interest income of approximately $90,000.

Current wording

Other income, net increased by approximately $1,373,000 (or approximately 1718%) from other income of approximately $80,000 for the three months ended September 30, 2023, to other income of approximately $1,452,000 for the three months ended September 30, 2024. The increase was primarily related to the change in the fair value of the warrant liability of approximately $1,313,000, a net increase in interest income of approximately $103,000, and a reduction in the Australian research and development incentives of approximately $43,000.

Previous wording

Research and development expenses decreased by approximately $422,000 (or approximately 9%) from approximately $4,795,000 for the six months ended June 30, 2023 compared to approximately $4,373,000 for the six months ended June 30, 2024. The decrease was primarily related to a decrease in payroll expense of approximately $949,000 related to the decreased headcount of research and development employees and the reversal of the accrued bonus, decrease in stock-based compensation costs of approximately $290,000, and a decrease in other expenses of approximately $34,000, offset by an increase in scientific research and clinical research of approximately $851,000.

Current wording

Research and development expenses decreased by approximately $355,000 (or approximately 5%) from approximately $7,395,000 for the nine months ended September 30, 2023, to approximately $7,040,000 for the nine months ended September 30, 2024. The decrease was primarily related to a decrease in payroll expense of approximately $1,120,000 related to the decreased headcount of research and development employees and the reversal of the accrued bonus, decrease in stock-based compensation costs of approximately $345,000, and a decrease in other expenses of approximately $37,000, offset by an increase in scientific research and clinical research of approximately $1,147,000.

Previous wording

General and administrative expenses decreased by approximately $662,000 (or approximately 16%) from approximately $4,053,000 for the six months ended June 30, 2023 compared to approximately $3,391,000 for the six months ended June 30, 2024. The decrease was primarily related to a decrease in payroll expense of approximately $525,000 relating to the reversal of the accrued bonus, a decrease in other expenses of approximately $123,000 related to lower insurance expenses, and a decrease in stock-based compensation of approximately $97,000, offset by an increase in professional fees of approximately $83,000 relating to higher usage of consultants.

Current wording

General and administrative expenses decreased by approximately $1,497,000 (or approximately 23%) from approximately $6,409,000 for the nine months ended September 30, 2023, to approximately $4,912,000 for the nine months ended September 30, 2024. The decrease was primarily related to a decrease in payroll expense of approximately $535,000 relating to the reversal of the accrued bonus, a decrease in professional fees of approximately $418,000, a decrease in other expenses of approximately $381,000 related to lower insurance expenses, and a decrease in stock-based compensation of approximately $163,000.

Previous wording

Other expense, net increased by approximately $9,391,000 (or approximately 4506%) from other income of approximately $208,000 for the six months ended June 30, 2023 compared to other expense of approximately $9,183,000 for the six months ended June 30, 2024. The increase was primarily related to the change in the fair value of the warrant liability of approximately $9,462,000, a loss on fair value of warrants over proceeds of approximately $13,000, a reduction in the Australia research and development incentives of approximately $54,000 and a net increase of interest income of approximately $138,000.

Current wording

Other expense, net increased by approximately $8,018,000 (or approximately 2781%) from other income, net of approximately $288,000 for the nine months ended September 30, 2023, to other expense, net of approximately $7,730,000 for the nine months ended September 30, 2024. The increase was primarily related to the change in the fair value of the warrant liability of approximately $8,149,000, a loss on fair value of warrants over proceeds of approximately $13,000, a reduction in the Australia research and development incentives of approximately $98,000 and a net increase of interest income of approximately $242,000.

Previous wording

As of June 30, 2024, our cash totaled approximately $11,579,000 which represented an increase of approximately $4,428,000 compared to December 31, 2023. As of June 30, 2024, we had working capital of approximately $8,506,000 which represents an increase of approximately $5,879,000 compared to December 31, 2023. We have generated no revenues as of June 30, 2024. Our current operating plan indicates that it will continue to incur losses from operations and generate negative cash flows from operating activities given ongoing expenditures related to the completion of its ongoing clinical trials and our lack of revenue generating activities. Based on our cash reserves as of June 30, 2024 of $11,579,000 and current financial condition as of the date of this Quarterly Report, the accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Current wording

As of September 30, 2024, our cash totaled approximately $8,691,000 which represented an increase of approximately $1,540,000 compared to December 31, 2023. As of September 30, 2024, we had working capital of approximately $5,631,000 which represents an increase of approximately $3,004,000 compared to December 31, 2023. We have generated no revenues as of September 30, 2024. Our current operating plan indicates that we will continue to incur losses from operations and generate negative cash flows from operating activities given ongoing expenditures related to the completion of its ongoing clinical trials and our lack of revenue generating activities. Based on our cash reserves as of September 30, 2024 of $8,691,000 and current financial condition as of the date of this Quarterly Report, the accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Previous wording

Between February 14, 2024, we have sold 507,754 shares of Common Stock at an average price of approximately $1.47 per share, resulting in aggregate gross proceeds of approximately $745,228 under the ATM Agreement dated February 14, 2024, for which we paid Wainwright approximately $22,357 in commissions. Between April 1, 2024 and June 30, 2024, we have sold 2,015,122 shares of our Common Stock at an average price of $3.53 per share, resulting in aggregate gross proceeds of approximately $7,117,000 under the ATM Agreement dated February 14, 2024 with Wainwright, for which we paid Wainwright $213,509 in commissions. During the six months ended June 30, 2024, we have sold 2,522,876 shares of Common Stock at an average price of approximately $3.12 per share, resulting in aggregate gross proceeds of approximately $7,862,228 under the ATM Agreement dated February 14, 2024, for which we paid Wainwright approximately $235,867 in commissions.

Current wording

Between February 14, 2024 and March 31, 2024, we sold 507,754 shares of Common Stock at an average price of approximately $1.47 per share, resulting in aggregate gross proceeds of approximately $745,251 under the ATM Agreement dated February 14, 2024, for which we paid Wainwright approximately $22,357 in commissions resulting in net proceeds to us of approximately $722,894. Between April 1, 2024 and June 30, 2024, we sold 2,015,122 shares of our Common Stock at an average price of $3.53 per share, resulting in aggregate gross proceeds of approximately $7,116,978 under the ATM Agreement dated February 14, 2024 with Wainwright, for which we paid Wainwright $213,509 in commissions, resulting in net proceeds of approximately $6,903,469. Between July 1, 2024 and September 30, 2024, we sold 177,606 shares of Common Stock at an average price of approximately $3.72 per share, resulting in aggregate gross proceeds of approximately $660,437 under the ATM Agreement dated May 15, 2024, for which we paid Wainwright approximately $19,813 in commissions, resulting in net proceeds to us of approximately $640,624.

Previous wording

Cash Flows for the Six Months ended June 30, 2024 and 2023

Current wording

Cash Flows for the Nine Months ended September 30, 2024 and 2023

Previous wording

For the six months ended June 30, 2024, net cash used in operating activities was approximately $8,272,000, which consisted of a consolidated net loss of approximately $16,947,000 offset by non-cash charges of approximately $764,000 in stock-based compensation, approximately $12,000 of non-cash expense to issue stock to consultants, the remeasurement of the warrant liability of approximately $9,339,000, and the loss on fair value of warrants over proceeds of approximately $13,000. Total changes in operating assets and liabilities of approximately $1,452,000 were driven by an approximate $1,423,000 net decrease in accounts payable and accrued expenses, an approximate $37,000 decrease in the Australia research and development incentives receivable, an approximate $73,000 decrease in other receivables, and an approximate $81,000 increase in prepaid expense and other assets.

Current wording

For the nine months ended September 30, 2024, net cash used in operating activities was approximately $11,796,000, which consisted of a consolidated net loss of approximately $19,683,000 offset by non-cash charges of approximately $1,219,000 in stock-based compensation, approximately $112,000 of non-cash expense to issue stock to consultants, the remeasurement of the warrant liability of approximately $8,008,000, and the loss on fair value of warrants over proceeds of approximately $13,000. Total changes in operating assets and liabilities of approximately $1,465,000 were driven by an approximate $1,330,000 net decrease in accounts payable and accrued expenses, an approximate $93,000 increase in the Australia research and development incentives receivable, and an approximate $227,000 decrease in prepaid expense and other assets.

Previous wording

For the six months ended June 30, 2023, net cash used in operating activities was approximately $5,921,000, which consisted of a net loss of approximately $8,641,000 offset by non-cash charges of approximately $1,156,000 in stock-based compensation, approximately $488,000 of non-cash expense to issue stock to consultants, and the remeasurement of the warrant liability of approximately $124,000. Total changes in operating assets and liabilities of approximately $1,198,000 were driven by an approximate $980,000 increase in accounts payable and accrued liabilities, an approximate increase of $309,000 in prepaid expenses and other assets and an approximate decrease of $91,000 in Australia research and development incentives receivables.

Current wording

For the nine months ended September 30, 2023, net cash used in operating activities was approximately $9,079,000, which consisted of a net loss of approximately $13,516,000 offset by non-cash charges of approximately $1,727,000 in stock-based compensation, approximately $683,000 of non-cash expense to issue stock to consultants, and the remeasurement of the warrant liability of approximately $142,000. Total changes in operating assets and liabilities of approximately $2,169,000 were driven by an approximate $1,861,000 increase in accounts payable and accrued liabilities, an approximate increase of $134,000 in prepaid expenses and other assets and an approximate increase of $134,000 in Australia research and development incentives receivables.

Previous wording

For the six months ended June 30, 2024 the effect of foreign currency exchange rate changes on cash decreased the cash balance as of June 30, 2024 by approximately $4,000 versus approximately $3,000 for the six months ended June 30, 2023.

Current wording

For the nine months ended September 30, 2024 the effect of foreign currency exchange rate changes on cash increased the cash balance as of September 30, 2024 by approximately $5,000 versus a decrease of approximately $13,000 for the nine months ended September 30, 2023.

Previous wording

Net cash provided by financing activities was approximately $12,704,000 and $4,120,000 for the six months ended June 30, 2024 and 2023, respectively. Total net cash provided by financing activities for the six months ended June 30, 2024 consisted primarily of approximately $5,254,000 gross proceeds from private placement offerings, proceeds from the at-the-market offering of approximately $7,862,000, proceeds from the exercise of stock options of $185,000, and offset by approximately $597,000 of offering costs.

Current wording

Net cash provided by financing activities was approximately $13,331,000 and $4,245,000 for the nine months ended September 30, 2024 and 2023, respectively. Total net cash provided by financing activities for the nine months ended September 30, 2024 consisted primarily of approximately $5,254,000 gross proceeds from private placement offerings, proceeds from the at-the-market offering of approximately $8,523,000, proceeds from the exercise of stock options of $216,000, and were offset by approximately $661,000 of offering costs.

Previous wording

Net cash provided by financing activities for the six months ended June 30, 2023 consisted primarily of approximately $5,750,000 of gross proceeds from the sales of Common Stock in a follow-on offering, offset by approximately $1,352,000 of offering costs and approximately $278,000 of deferred offering costs.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2023 consisted primarily of approximately $5,750,000 of gross proceeds from the sales of Common Stock in a follow-on offering, offset by approximately $1,352,000 of offering costs and approximately $154,000 of deferred offering costs.