What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2025-11-07 compared with 2025-08-11 · 204 added, 125 removed, 288 unchanged (53% of the section changed)

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the immune checkpoint inhibitor Libtayo ® (cemiplimab), manufactured and commercialized by Regeneron.

Cemiplimab is a fully human

monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells.

Cemiplimab has been approved in the United States and the

rest of the world for multiple cancer indications, including NSCLC.

In February 2021, we signed a clinical supply agreement with Regeneron

to receive cemiplimab at no cost, which represents a significant cost-savings for the study.

In return, we have granted Regeneron exclusive

development rights in combination with PD-1 inhibitors for NSCLC for the study period.

Based on the clinical data generated by our THIO-101

trial, we plan to seek filing for an accelerated approval of ateganosine in the United States for the treatment of patients with advanced

NSCLC in 2026, but even if granted, accelerated approval status does not guarantee an accelerated review or marketing approval by the

Food and Drug Administration (FDA).

We plan to initiate a Phase 3 pivotal trial in 2025, named THIO-104, to evaluate the efficacy of

ateganosine administered in sequence with a checkpoint inhibitor (CPI) in third-line NSCLC patients who are resistant to checkpoint inhibitors

and chemotherapy which could lead filing for early full commercial approval in 2026 and final analysis could lead to filing for full

commercial approval in 2027.

The multicenter, open-label, pivotal Phase 3 trial is designed to provide a direct comparison to chemotherapy

in a 1:1 randomization of up to 300 patients.

In addition, the originally planned Phase 2 clinical trial in multiple tumor indications

(THIO-102) is now divided into different trials for one tumor indication each:

hepatocellular carcinoma (HCC), colorectal cancer (CRC)

and small cell lung cancer (SCLC).

In January 2025, we entered into a clinical supply agreement with global oncology company BeOne Medicines

to assess the efficacy of ateganosine in combination with BeOne’s immune checkpoint inhibitor (CPI) tislelizumab in three cancer

indications across different trials to study the drug combination in HCC, SCLC and CRC.

Phase 2 clinical trials in HCC, CRC and SCLC

are planned to be initiated in 2026, evaluating treatment with ateganosine administered in sequence with BeOne’s immune checkpoint

inhibitor, tislelizumab.

In June, 2025, MAIA announced its entry into a clinical master supply agreement with Roche for future studies

investigating the combination of ateganosine sequenced with Roche’s checkpoint inhibitor (CPI), atezolizumab (Tecentriq®),

Cemiplimab is a fully

human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells.

Cemiplimab has been approved in the United States

and the rest of the world for multiple cancer indications, including NSCLC.

In February 2021, we signed a clinical supply agreement with

Regeneron to receive cemiplimab at no cost, which represents a significant cost-savings for the study.

In return, we have granted Regeneron

exclusive development rights in combination with PD-1 inhibitors for NSCLC for the study period.

Based on the clinical data generated

by our THIO-101 trial, we plan to seek filing for an accelerated approval of ateganosine in the United States for the treatment of patients

with advanced NSCLC in 2026, but even if granted, accelerated approval status does not guarantee an accelerated review or marketing approval

by the Food and Drug Administration (FDA).

We plan to initiate a Phase 3 pivotal trial in 2025, named THIO-104, to evaluate the efficacy

of ateganosine administered in sequence with a checkpoint inhibitor (CPI) in third-line NSCLC patients who are resistant to checkpoint

inhibitors and chemotherapy which could lead filing for early full commercial approval in 2027 and final analysis could lead to filing

for full commercial approval in 2028.

The multicenter, open-label, pivotal Phase 3 trial is designed to provide a direct comparison to

chemotherapy in a 1:1 randomization of up to 300 patients.

In addition, the originally planned Phase 2 clinical trial in multiple tumor

indications (THIO-102) is now divided into different trials for one tumor indication each:

hepatocellular carcinoma (HCC), colorectal

cancer (CRC) and small cell lung cancer (SCLC).

In January 2025, we entered into a clinical supply agreement with global oncology company

BeOne Medicines to assess the efficacy of ateganosine in combination with BeOne’s immune checkpoint inhibitor (CPI) tislelizumab

in three cancer indications across different trials to study the drug combination in HCC, SCLC and CRC.

Phase 2 clinical trials in HCC,

CRC and SCLC are planned to be initiated in 2026, evaluating treatment with ateganosine administered in sequence with BeOne’s immune

checkpoint inhibitor, tislelizumab.

In June 2025, MAIA announced its entry into a clinical master supply agreement with Roche for future

studies investigating the combination of ateganosine sequenced with Roche’s checkpoint inhibitor (CPI), atezolizumab (Tecentriq ® ),

for the treatment of multiple cancers indications.

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contained on, or that can be accessed through, our website as part of this prospectus supplement or in deciding whether to purchase our

accomplished the key milestones set forth below in the six months ended June 30, 2025 and the second quarter of 2025:

Please note that

for consistency of the announcements at the time of their releases, the milestones from January 1, 2025 to March 17, 2025, refer to the

molecule “ateganosine” as “THIO” only.

On March 18, 2025, the company announced “ateganosine” as

the nonproprietary (generic) name for THIO, and its intent to use the generic name to support clear communication, while keeping the

accomplished the key milestones set forth below in the nine months ended September 30, 2025 and the third quarter of 2025:

that for consistency of the announcements at the time of their releases, the milestones from January 1, 2025 to March 17, 2025, refer

to the molecule “ateganosine” as “THIO” only.

On March 18, 2025, the company announced “ateganosine”

as the nonproprietary (generic) name for THIO, and its intent to use the generic name to support clear communication, while keeping the

name THIO in the Company’s clinical trial designations (THIO-101, THIO-102, THIO-103, THIO-104).

January 7, 2025, we announced that we had entered into a clinical supply agreement with global oncology company BeiGene to assess

the efficacy of THIO, its small molecule telomere-targeting anticancer agent, in combination with BeiGene’s immune checkpoint

January 7, 2025, we announced that we had entered into a clinical supply agreement with global oncology company BeOne to assess

the efficacy of THIO, its small molecule telomere-targeting anticancer agent, in combination with BeOne’s immune checkpoint

inhibitor (CPI) tislelizumab in three cancer indications.

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Under the terms of the collaboration,

MAIA will sponsor and fund the planned clinical trials and BeiGene will provide tislelizumab.

MAIA will sponsor and fund the planned clinical trials and BeOne will provide tislelizumab.

MAIA maintains global development and

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the private placement were issued pursuant to our 2021 Equity Incentive Plan.

March 18, 2025, MAIA announced that the United States Adopted Names (USAN) Council had approved “ateganosine” as the

nonproprietary (generic) name for its lead molecule THIO, a telomere-targeting anticancer agent in clinical development as a first-in-class

treatment for advanced non-small cell lung cancer (NSCLC).

March 18, 2025, we announced that the United States Adopted Names (USAN) Council had approved “ateganosine” as the nonproprietary

(generic) name for its lead molecule THIO, a telomere-targeting anticancer agent in clinical development as a first-in-class treatment

for advanced non-small cell lung cancer (NSCLC).

The company chose a name inspired by the mechanism of action of THIO:

altering telomeric guanosine of the cancer cells.

The generic name ateganosine is a unique and consistent identity that aims to support

clear communication between healthcare providers, patients and researchers.

MAIA will retain the name THIO in its clinical trial

designations (THIO-101, THIO-102, THIO-103, THIO-104).

altering telomeric

guanosine of the cancer cells.

The generic name ateganosine is a unique and consistent identity that aims to support clear communication

between healthcare providers, patients and researchers.

MAIA will retain the name THIO in its clinical trial designations (THIO-101,

THIO-102, THIO-103, THIO-104).

March 20, 2025, we announced the publication of preclinical data for our lead proprietary telomere-targeting THIO dimer in the peer-reviewed

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was published on February 15, 2025.

March 26, 2025, the Company filed a prospectus supplement to amend, supplement and supersede certain information contained in the

earlier prospectus and prospectus supplement, which decreased the number of shares of the Company’s common stock, par value

$0.0001 per share that the Company may offer and sell under the At The Market Offering Agreement (the “ATM Agreement”)

Wainwright & Co., LLC (“Wainwright”), through an “at-the-market offering” program under which

Wainwright will act as sales agent the ATM.

During the quarter ended June 30, 2025, the Company sold 793,429 shares of Common Stock

through Wainwright under the ATM Agreement at an average price of approximately $1.87 per share, resulting in aggregate gross proceeds

of approximately $1,480,894, for which it paid Wainwright approximately $44,427 in commissions and other issuance costs of $16,705,

March 26, 2025, we filed a prospectus supplement to amend, supplement and supersede certain information contained in the earlier

prospectus and prospectus supplement, which decreased the number of shares of the Company’s common stock, par value $0.0001

per share that the Company may offer and sell under the At The Market Offering Agreement (the “ATM Agreement”) with H.C.

Wainwright & Co., LLC (“Wainwright”), through an “at-the-market offering” program under which Wainwright

will act as sales agent the ATM.

During the quarter ended September 30, 2025, the Company sold 2,086,312 shares of Common Stock

through Wainwright under the ATM Agreement at an average price of approximately $1.81 per share, resulting in aggregate gross

proceeds of approximately $3,779,251, for which it paid Wainwright approximately $113,378 in commissions and other issuance costs of

$3,758, resulting in net proceeds to the Company of approximately $3,662,115.

As of the date of this Quarterly Report, the Company has sold

2,634,492 shares of our Common Stock through Wainwright under the ATM Agreement at an average price of $2.00 per share, resulting in aggregate

gross proceeds of approximately $5,259,024, for which we paid Wainwright $157,771 in commissions resulting in net proceeds to us of approximately

As of the date of this Quarterly Report, the Company

has sold 3,782,335 shares of our Common Stock through Wainwright under the ATM Agreement at an average price of $1.90 per share,

resulting in aggregate gross proceeds of approximately $7,202,015, for which we paid Wainwright $216,060 in commissions and other

issuance fees of approximately $20,139 resulting in net proceeds to us of approximately $6,965,816.

May 8, 2025, we issued and sold 719,999 shares of our common stock and warrants to purchase 719,999 shares of our common stock in

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placement were issued pursuant to our 2021 Equity Incentive Plan.

June 5, 2025, MAIA announced updated data from its THIO-101 pivotal Phase 2 clinical trial.

June 5, 2025, we announced updated data from its THIO-101 pivotal Phase 2 clinical trial.

As of May 15, 2025, third line (3L) data

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A partial response is defined as a decrease in tumor size of at least 30%.

June 18, 2025, MAIA announced its entry into a clinical master supply agreement with Roche for future studies investigating the combination

June 18, 2025, we announced its entry into a clinical master supply agreement with Roche for future studies investigating the combination

of MAIA’s telomere-targeting agent ateganosine (THIO), sequenced with Roche’s checkpoint inhibitor (CPI), atezolizumab

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MAIA also announced that screening for the trial is ongoing in Europe

July 17, 2025, MAIA announced the publication of preclinical data from its second generation ateganosine prodrugs platform in Nucleic

July 17, 2025, we announced the publication of preclinical data from its second generation ateganosine prodrugs platform in Nucleic

Acids Research (NAR), a leading open-access peer-reviewed scientific journal.

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evaluated in a pivotal Phase 2 THIO-101 clinical trial evaluating its anti-tumor activity when followed by a checkpoint inhibitor.

August 13, 2025, we announced that the European Patent Office granted a patent broadly covering a portfolio of ateganosine-based

analogues for telomere-targeting anticancer therapy and methods of using ateganosine (THIO) alone or before administration of checkpoint

inhibitors (CPIs).

The patent, titled “Mercaptopurine Ribonucleoside Analogues for Altering Telomerase Mediated Telomere,”

was invented by MAIA’s Chief Scientific Officer Sergei M.

Gryaznov, PhD and Scientific Advisory Board member Jerry W.

MAIA’s global patent and patent-pending estate covers several areas including telomerase mediated telomere altering compounds

and treatment of therapy-resistant cancers.

Further, ateganosine’s immunogenic treatment strategy, which focuses on sequential

combination with checkpoint inhibitors, has been filed worldwide.

MAIA’s IP portfolio for ateganosine currently comprises 10

issued patents worldwide including Europe (validated in 19 countries) along with 24 pending patent applications.

August 27, 2025, we announced that a manuscript detailing developments in its Phase 2 THIO-101 clinical trial was accepted and published

in the international peer-reviewed open access scientific journal, Cells, in a special issue, “Cellular Mechanisms of Anti-Cancer

The manuscript, titled “Perioperative Management of Non-Small Cell Lung Cancer in the Era of Immunotherapy,”

was authored by a group of oncology researchers in Turkey and the U.S.

including MAIA scientists Sergei Gryaznov, Ph.D., Chief Scientific

Officer and Ilgen Mender, Director of Biology Research, along with MAIA Scientific Advisory Board members Z.

Gunnur Dikmen, M.D.,

and Saadettin Kiliçkap, M.D., M.Sc.

September 11, 2025, we highlighted positive efficacy data from its Phase 2 clinical trial, THIO-101, including that as of June 30,

(i) estimated median progression free survival (PFS) in third-line treatment (180 mg dose) was 5.6 months;

(ii) Estimated median

overall survival (OS) was 17.8 months, with a 95% confidence interval (CI) lower bound of 12.5 months and a 99% CI lower bound of

10.8 months, consistent with the prior data readout (May 15, 2025);

(iii) Across patients of all treatment lines, 2 patients have

completed 33 cycles of therapy, highlighting ateganosine’ potential for extended dosing, which usually translates into longer

patient survival.

October 1, 2025, we issued and sold 1,733,766 shares of our common stock and warrants to purchase 1,733,766 shares of our common

stock in a non-brokered private placement to accredited investors and a Company director pursuant to securities purchase agreements

dated September 29, 2025 at a price per share of $1.30 for which we received gross proceeds of approximately $2.25 million, prior

to offering expenses payable by the Company.

The warrants issued in the private placement have an exercise price of $1.57, are exercisable

six months after issuance and expire 3-years after the issued date.

The securities sold to our director participating in the private

placement were issued pursuant to our 2021 Equity Incentive Plan.

October 7, 2025, we announced MAIA’s launch of a new digital asset treasury strategy focused on top-tier cryptocurrency

On October 6, 2025, MAIA’s Board of Directors authorized holdings of up to 90% of the Company’s liquid assets in

various cryptocurrencies.

Corporate officers are authorized to purchase and sell Bitcoin (BTC), Ethereum (ETH), and USD Coin (USDC)

Management will regularly consult with the Board on cryptocurrency transactions and holdings, cybersecurity procedures,

accounting policies, risks, and material developments.

October 16, 2025, we issued and sold 603,769 shares of our common stock and warrants to purchase 603,769 shares of our common stock

in a non-brokered private placement to accredited investors pursuant to securities purchase agreements dated October 13, 2025 at

a price per share of $1.22 for which we received gross proceeds of approximately $736,600, prior to offering expenses payable by

The warrants issued in the private placement have an exercise price of $1.52, are exercisable six months after issuance

and expire 3-years after the issued date.

October 23, 2025, we announced that as of September 17, 2025, a patient that began therapy in March 2023 has shown survival of 30

months, or 912 days, an outstanding measure relative to many of the high-risk cancers.

The patient with 30-month survival received

therapy every three weeks, and concluded treatment upon reaching the maximum treatment duration of 2 years based on protocol requirements.

October 28, 2025, we announced that we have enrolled five patients from Taiwan and Turkey in the expansion phase of its THIO-101

Phase 2 trial.

addition to NSCLC, HCC, SCLC and CRC we plan to conduct clinical trials evaluating ateganosine (THIO) in sequential combination with

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and ovarian cancers.

THIO-103 is a Phase 2 clinical trial planned to evaluate treatment with ateganosine in first-line patients for

both NSCLC and SCLC.

of the War in Ukraine and War in Israel on Our Operations

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activities in the impacted areas.

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

of Three Months ended June 30, 2025 and 2024

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

of Three Months ended September 30, 2025 and 2024

Three Months Ended

September 30,

Operating expenses:

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Other (expense) income:

Interest expense

Interest income

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Change in fair value of warrant liability

Loss on fair value of warrants over proceeds

Other expense, net

Other income (expense) net

Net loss attributable to MAIA Biotechnology, Inc.

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$ (2,735,987 )

$ (6,167,202 )

Costs and Expenses

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and development expenses increased by approximately $3,690,000 (or approximately 138%), from approximately $2,667,000 for the three months

ended June 30, 2024, compared to approximately $3,111,000 for the three months ended June 30, 2025.

The increase was primarily related

to an increase in scientific research and clinical research of approximately $850,000, an increase in stock-based compensation cost of

approximately $76,000, an increase in payroll expense of approximately $120,000, and an increase in other expenses of $13,000.

ended September 30, 2024, compared to approximately $6,357,000 for the three months ended September 30, 2025.

The increase was primarily

related to an increase in scientific research and clinical research of approximately $3,369,000, an increase in stock-based compensation

cost of approximately $32,000, an increase in payroll expense of approximately $158,000, and increase in professional fees of approximately

$136,000, offset by a decrease in other expenses of $5,000.

and administrative expenses

and administrative expenses increased by approximately $292,000 (or approximately 17%) from approximately $1,763,000 for the three months

ended June 30, 2024, compared to approximately $2,055,000 for the three months ended June 30, 2025.

The increase was primarily related

to an increase in professional fees of approximately $220,000, an increase in stock-based compensation of approximately $313,000, and

an increase of approximately $44,000 payroll expense, offset by a decrease in investor relations of approximately $285,000.

and administrative expenses increased by approximately $1,482,000 (or approximately 97%) from approximately $1,521,000 for the three

months ended September 30, 2024, compared to approximately $3,003,000 for the three months ended September 30, 2025.

The increase was

primarily related to an increase in professional fees of approximately $89,000, an increase in stock-based compensation of approximately

$159,000, increase in investor relations of approximately $1,026,000, an increase in other expenses of approximately $67,000 and an increase

in payroll expense of approximately $141,000.

income (expense), net

income (expense), net increased by approximately $4,883,000 (or approximately 96%) from other expense, net of approximately $5,064,000

for the three months ended June 30, 2024, compared to other expense, net of approximately $181,000 for the three months ended June 30,

The increase was primarily related to the change in the fair value of the warrant liability of approximately $4,910,000, offset

by a reduction in the Australian research and development incentives of approximately $18,000 and a net decrease of interest income of

approximately $9,000.

of Six Months Ended June 30, 2025 and 2024

Six Months Ended

income (expense), net decreased by approximately $995,000 (or approximately 68%) from other income, net of approximately $1,452,000 for

the three months ended September 30, 2024, compared to other income, net of approximately $457,000 for the three months ended September

The decrease was primarily related to the change in the fair value of the warrant liability of approximately $952,000, a decrease

in the Australian research and development incentives of approximately $15,000, and a net decrease of interest income of approximately

of Nine Months Ended September 30, 2025 and 2024

Nine Months Ended

September 30,

Operating expenses:

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(19,952,414 )

(11,952,606 )

Other income (expense):

Interest expense

Interest income

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Other income (expense) net

Net loss attributable to MAIA Biotechnology, Inc.

$ (18,767,410 )

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and development expenses

and development expenses increased by approximately $1,935,000 (or approximately 44%), from approximately $4,373,000 for the six months

ended June 30, 2024, to approximately $6,308,000 for the six months ended June 30, 2025.

The increase was primarily related to an increase

in scientific research and clinical research of approximately $1,728,000, an increase in stock-based compensation cost of approximately

$129,000, an increase in payroll expense of approximately $83,000, offset by decrease in other expense of $5,000.

and development expenses increased by approximately $5,625,000 (or approximately 80%), from approximately $7,040,000 for the nine months

ended September 30, 2024, to approximately $12,665,000 for the nine months ended September 30, 2025.

The increase was primarily related

to an increase in scientific research and clinical research of approximately $5,096,000, an increase in stock-based compensation cost

of approximately $161,000, an increase in payroll expense of approximately $241,000, and an increase in professional fees of approximately

$137,000, offset by decrease in other expense of $10,000.

and administrative expenses

and administrative expenses increased by approximately $892,000 (or approximately 26%) from approximately $3,391,000 for the six months

ended June 30, 2024, to approximately $4,283,000 for the six months ended June 30, 2025.

The increase was primarily related to an increase

in professional fees of approximately $285,000, an increase of investor relations of approximately $306,000, an increase in stock-based

compensation of approximately $275,000, and an increase of approximately $26,000 payroll expense.

and administrative expenses increased by approximately $2,374,000 (or approximately 48%) from approximately $4,912,000 for the nine months

ended September 30, 2024, to approximately $7,286,000 for the nine months ended September 30, 2025.

The increase was primarily related

to an increase in professional fees of approximately $368,000, an increase of investor relations of approximately $1,025,000, an increase

in stock-based compensation of approximately $440,000, an increase of approximately $167,000 payroll expense, and an increase in other

expense of approximately $374,000.

income (expense), net

income (expense), net increased by approximately $8,915,000 (or approximately 115%) from other (expense), net of approximately $7,730,000

for the six months ended June 30, 2024, to other income, net of approximately $727,000 for the six months ended June 30, 2025.

was primarily related to the change in the fair value of the warrant liability of approximately $9,918,000, a net increase in interest

income of approximately $29,000, and a reduction in the Australian research and development incentives of approximately $37,000.

for the nine months ended September 30, 2024, to other income, net of approximately $1,185,000 for the nine months ended September 30,

The increase was primarily related to the change in the fair value of the warrant liability of approximately $8,965,000, a net

increase in interest income of approximately $2,000, and a reduction in the Australian research and development incentives of approximately

and Capital Resources

Ability to Continue as a Going Concern

of June 30, 2025, our cash totaled approximately $10,145,000 which represented an increase of approximately $543,000 compared to December

As of June 30, 2025, we had working capital of approximately $5,999,000 which represents a decrease of approximately $323,000

of September 30, 2025, our cash totaled approximately $10,892,000 which represented an increase of approximately $1,290,000 compared

to December 31, 2024.

As of September 30, 2025, we had working capital of approximately $1,761,000 which represents a decrease of approximately

$4,561,000 compared to December 31, 2024.

We have generated no revenue as of June 30, 2025.

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 June 30, 2025,

of $10,144,522 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.

We have generated no revenue as of September 30, 2025.

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, 2025, of $10,891,736 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.

meet the Company’s future working capital needs, we will need to raise additional equity or enter into debt financing.

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doubt about our ability to continue as a going concern within one year after these financial statements are issued.

Asset Treasury Plan (DATP)

October 6, 2025, our Board of Directors formally adopted a Digital Asset Treasury Plan.

This plan permits the Company to allocate up

to 90% of its corporate treasury reserves to acquire and hold Bitcoin, Ether, and USD Coin as a long-term store of value.

As of the date

of this Quarterly Report on Form 10-Q, the Company has not yet executed any purchases of Digital Assets under this plan.

The timing and

amount of any future purchases will depend on various factors, including our ongoing liquidity needs, the market price of the Digital

Asset, and general market and economic conditions.

Future utilization of the DATP could subject our capital resources and liquidity to

the significant market risks associated with Digital Assets.

of Common Stock

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$22,357 in commissions resulting in net proceeds to us of approximately $722,894.

Between October 1, 2024 and December 31, 2024, we sold 573,878 shares of Common Stock at an average price of approximately $2.77 per share,

resulting in aggregate gross proceeds of approximately $1,589,330 under the ATM Agreement dated May 15, 2024, for which we paid Wainwright

approximately $47,680 in commissions resulting in net proceeds to us of approximately $1,541,650.

February 24, 2025, we issued and sold 1,810,000 shares of our Common Stock and warrants to purchase 1,810,000 shares of our Common Stock

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approximately $44,427 in commissions and other issuance costs of $16,705, resulting in net proceeds to us of approximately $1,419,762.

July 1, 2025 through September 30, 2025, we sold 2,086,312 shares of Common Stock through Wainwright under the ATM Agreement at an average

price of approximately $1.81 per share, resulting in aggregate gross proceeds of approximately $3,779,251, for which we paid Wainwright

approximately $113,378 in commissions and other issuance costs of $3,758, resulting in net proceeds to us of approximately $3,662,115.

May 8, 2025, we issued and sold 719,999 shares of our Common Stock and warrants to purchase 719,999 shares of our Common Stock in a private

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could negatively impact our business and operations and could also lead to the reduction of our operations.

Flows for the Six Months ended June 30, 2025 and 2024

Six Months Ended June 30,

Flows for the Nine Months ended September 30, 2025 and 2024

Nine Months Ended September 30,

Net cash flows used in operating activities

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Net increase in cash

the six months ended June 30, 2025, net cash used in operating activities was approximately $8,338,000, which consisted of a consolidated

the nine months ended September 30, 2025, net cash used in operating activities was approximately $11,824,000, which consisted of a consolidated

net loss of approximately $18,767,000 offset by non-cash charges of approximately $1,821,000 in stock-based compensation, approximately

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$6,158,000 net increase in accounts payable and accrued expenses, and an approximate $341,000 decrease in prepaid expense and other assets.

the six months ended June 30, 2024, net cash used in operating activities was approximately $8,272,000, which consisted of a consolidated

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

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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.

the six months ended June 30, 2025, the effect of foreign currency exchange rate changes on cash increased the cash balance as of June

30, 2025 by approximately $11,000 versus a decrease of approximately $4,000 for the six months ended June 30, 2024.

the six months ended June 30, 2025 and 2024, we did not have any cash provided by or used in investing activities.

cash provided by financing activities was approximately $8,869,000 and $12,704,000 for the six months ended June 30, 2025 and 2024, respectively.

Total net cash provided by financing activities for the six months ended June 30, 2025 consisted primarily of approximately $5,919,000

gross proceeds from private placement offerings, proceeds from the at-the-market offering of approximately $3,002,000, proceeds from

the exercise of stock options of $1,000, proceeds from the exercise of warrants of $328,000 and were offset by an approximate $381,000

$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.

the nine months ended September 30, 2025, the effect of foreign currency exchange rate changes on cash increased the cash balance as

of September 30, 2025 by approximately $10,000 versus an increase of approximately $5,000 for the nine months ended September 30, 2024.

the nine months ended September 30, 2025 and 2024, we did not have any cash provided by or used in investing activities.

cash provided by financing activities was approximately 13,104,000 and $13,331,000 for the nine months ended September 30, 2025 and 2024,

respectively.

Total net cash provided by financing activities for the nine months ended September 30, 2025 consisted primarily of approximately

$5,919,000 gross proceeds from private placement offerings, proceeds from the at-the-market offering of approximately $6,781,000, proceeds

from the exercise of stock options of $1,000, and proceeds from the exercise of warrants of $901,000 and were offset by an approximate

$498,000 of offering costs.

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.

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 offset by approximately $661,000 of offering costs.

Sheet Arrangements

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What changed 10-Q

Item 2. Management’s Discussion and Analysis