Item 2. Management’s Discussion and Analysis
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You
should read the following discussion together with our financial statements and the related notes included elsewhere in this Quarterly
Report on Form 10-Q. This discussion contains forward-looking statements that are based on our current expectations, estimates and projections
about our business and operations. Our actual results may differ materially from those currently anticipated and expressed in such forward-looking
statements as a result of a number of factors, including those which we discuss under “Risk Factors” and elsewhere in this
Quarterly Report on Form 10-Q.
Overview
We
are a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer. Ateganosine (also known as THIO, 6-thio-dG
or 6-thio-2 ‘-deoxyguanosine), our lead asset, is an investigational dual mechanism of action drug candidate incorporating telomere
targeting and immunogenicity. Our initial disease target is lung cancer, a serious medical condition with an incidence of over 235,000
new cases in the US in 2024, representing 12% of all cancers, and over 125,000 deaths, or 20% of all cancers. Worldwide, lung cancer
incidence is over 2,200,000 per year (ranking second only after breast cancer), and mortality over 1,800,000 (ranking first). Specifically,
we are targeting Non-Small Cell Lung Cancer (“NSCLC”), which represents 85% of all lung cancers. In July 2022, the first
patient was administered with ateganosine in our Phase 2 human trial (THIO-101) in Australia. In December 2022, regulatory authorities
in three European countries, Hungary, Poland, and Bulgaria, approved the implementation of THIO-101, Phase 2 clinical trial evaluating
ateganosine in patients with NSCLC. Patients with advanced NSCLC will be treated first with ateganosine followed a few days later by
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®),
for the treatment of multiple cancers indications. Clinical trials with other solid tumors (ST), such as breast, prostate, gastric, pancreatic
and ovarian, may still be considered for potential future trials.
We
were incorporated in Delaware in August 2018, and have operations in Chicago, Illinois, with some of our team members setup virtually
and working remotely in California, North Carolina, and New Jersey, among others. Our principal executive office is located at 444 West
Lake Street, Suite 1700, Chicago, IL 60606, and our phone number is (312) 416-8592. In July 2021, we established a wholly-owned Australian
subsidiary, MAIA Biotechnology Australia Pty Ltd., to conduct various preclinical and clinical activities for the development of our
product candidates. ln April 2022, we established a wholly owned Romanian subsidiary, MAIA Biotechnology Romania S.R.L. to conduct various
preclinical and clinical activities for the development of our product candidates. Our website address is www.MAIABiotech.com. The information
contained on our website is not incorporated by reference into this prospectus supplement, and you should not consider any information
contained on, or that can be accessed through, our website as part of this prospectus supplement or in deciding whether to purchase our
securities.
25
We
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
name THIO in the Company’s clinical trial designations (THIO-101, THIO-102, THIO-103, THIO-104).
●
On
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
inhibitor (CPI) tislelizumab in three cancer indications. The single arm pivotal Phase 2 trials will study the drug combination in
hepatocellular carcinoma (HCC), small cell lung cancer (SCLC) and colorectal cancer (CRC). Under the terms of the collaboration,
MAIA will sponsor and fund the planned clinical trials and BeiGene will provide tislelizumab. MAIA maintains global development and
commercial rights to THIO and is free to develop the programs in combination with other agents and in other indications.
●
On
February 4, 2025, we announced positive updated data from THIO-101 Phase 2 clinical trial evaluating its lead clinical candidate,
THIO, sequenced with Regeneron’s immune checkpoint inhibitor (CPI) cemiplimab (Libtayo ® ) in patients with advanced
non-small cell lung cancer (NSCLC) who failed two or more standard-of-care therapy regimens. As of January 15, 2025, third line (3L)
data updates showed that: (i) median overall survival (OS) of 16.9 months for the 22 NSCLC patients who received at least one dose
of THIO (the intent-to-treat population) in parts A and B of the trial. (ii) The analysis demonstrated a 95% confidence interval
(CI) lower bound of 12.5 months and a 99% CI lower bound of 10.8 months. (iii) The treatment has been generally well-tolerated to
date in this heavily pre-treated population.
●
On
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 in a private placement to certain accredited investors and Company directors pursuant to securities purchase agreements dated
February 18, 2025 at a price per share of $1.50 for which we received gross proceeds of approximately $2.72 million. The warrants
issued in the private placement have an exercise price of $1.87, are exercisable one year after issuance and expire 5-years after
the initial exercise date. The securities sold to our directors participating in the private placement were issued pursuant to our
2021 Equity Incentive Plan.
●
On
February 26, 2025, we announced the trial design for the expansion of its THIO-101 pivotal Phase 2 trial in non-small cell lung cancer
(NSCLC). The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L)
therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. The THIO-101 study in 3L will enroll
up to 48 patients with two arms: Arm 1, continuing the evaluation of THIO sequenced with Libtayo ® (cemiplimab); and
Arm 2, evaluating THIO as a monotherapy, to further gain experience of THIO in the contribution of components. Treatment cycles for
patients in both arms will administer THIO on 3 consecutive days, followed by immune activation on day 4. Arm 1 will administer Libtayo
on day 5. The Company plans to enroll an additional 100 patients for the registration phase of the trial. MAIA expects to conduct
the trials in the U.S. and select countries in Europe and Asia.
●
On
February 27, 2025, we announced plans to initiate a Phase 3 pivotal trial in 2025, named THIO-104, to evaluate the efficacy of THIO
administered in sequence with a checkpoint inhibitor (CPI) in third-line non-small cell lung cancer (NSCLC) patients who are resistant
to checkpoint inhibitors and chemotherapy. 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.
●
On
March 3, 2025, we issued and sold 952,633 shares of our common stock and warrants to purchase 952,633 shares of our common stock
in a non-brokered private placement to accredited investors and certain Company directors pursuant to securities purchase agreements
dated February 24, 2025 at a price per share of $1.50 for which we received gross proceeds of approximately $1.43 million, prior
to offering expenses payable by the Company. The warrants issued in the private placement have an exercise price of $1.85, are exercisable
one year after issuance and expire 5-years after the initial exercise date. The securities sold to our directors participating in
the private placement were issued pursuant to our 2021 Equity Incentive Plan.
26
●
On
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). 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).
●
On
March 20, 2025, we announced the publication of preclinical data for our lead proprietary telomere-targeting THIO dimer in the peer-reviewed
scientific journal Naunyn-Schmiedeberg’s Archives of Pharmacology. In a preclinical study, ateganosine (THIO) and its new described
dimer form were found to be potent inhibitors of Glutathione S-transferase Pi (GSTP1), a key enzyme implicated in cancer progression
and chemoresistance and a highly important factor for the detoxification of cancer cells. The findings suggest that the dimerized
form of ateganosine could enhance chemotherapeutic efficacy by effectively targeting GSTP1 and reducing drug resistance. The article,
titled “Investigation of the inhibitory effects of the telomere-targeted compounds on glutathione S-transferase P1,”
was published on February 15, 2025.
●
Effective
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”)
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 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,
resulting in net proceeds to the Company of approximately $1,419,762. 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
$5,101,253.
●
On
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 non-brokered private placement to accredited investors and certain Company directors pursuant to securities purchase agreements
dated May 5, 2025 at a price per share of $1.50 for which we received gross proceeds of approximately $1.08 million, prior to offering
expenses payable by the Company. The warrants issued in the private placement have an exercise price of $2.05, are exercisable one
year after issuance and expire 5-years after the initial exercise date. The securities sold to our directors participating in the
private placement were issued pursuant to our 2021 Equity Incentive Plan.
●
On
June 3, 2025, we issued and sold 463,332 shares of our common stock and warrants to purchase 463,332 shares of our common stock in
a non-brokered private placement to accredited investors and certain Company directors pursuant to securities purchase agreements
dated May 27, 2025 at a price per share of $1.50 for which we received gross proceeds of approximately $0.7 million, prior to offering
expenses payable by the Company. The warrants issued in the private placement have an exercise price of $1.71, are exercisable six
months after issuance and expire 5-years after the issued date. The securities sold to our directors participating in the private
placement were issued pursuant to our 2021 Equity Incentive Plan.
●
On
June 5, 2025, MAIA announced updated data from its THIO-101 pivotal Phase 2 clinical trial. As of May 15, 2025, third line (3L) data
showed median overall survival (OS) of 17.8 months for the 22 NSCLC patients who received at least one dose of ateganosine (the intent-to-treat
population) in parts A and B of the trial. The updated analysis continues to demonstrate a 95% confidence interval (CI) lower bound
of 12.5 months and a 99% CI lower bound of 10.8 months. The Company also mentioned that treatment had been generally well-tolerated
to date in this heavily pre-treated population.
27
●
On
June 5, 2025, we announced that a new partial response (PR) was identified in a patient after 20 months of treatment in our Phase
2 THIO-101 clinical trial. A partial response is defined as a decrease in tumor size of at least 30%.
●
On
June 18, 2025, MAIA 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
(Tecentriq®), for the treatment of multiple hard-to-treat cancers.
●
On
June 24, 2025, we announced the appointment of two prominent oncologists to its Scientific Advisory Board (SAB), Claudia Fulgenzi,
MD, and David J. Pinato, MD, MRCP (UK), PhD. Both are specialists in hepatocellular carcinoma (HCC), a tumor type to be studied in
future clinical trials of MAIA’s lead candidate ateganosine (THIO) sequenced with a checkpoint inhibitor.
●
On
July 9, 2025, we announced the dosing of the first patient in Taiwan in the expansion phase of our THIO-101 Phase 2 trial for advanced
non-small cell lung cancer (NSCLC). The trial’s entry into another continent marks a key milestone for MAIA, opening a significantly
larger patient pool for its evaluations of ateganosine (THIO). MAIA also announced that screening for the trial is ongoing in Europe
and Asia.
●
On
July 17, 2025, MAIA 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. The study, titled “Novel Telomere-Targeting Dual-Pharmacophore
Dinucleotide Prodrugs for Anticancer Therapy,” details MAIA’s lead ateganosine (THIO)-derived second-generation prodrugs
as promising new molecules in its strategy for enhancing cancer treatment and overcoming drug resistance. The manuscript with the
data was published on June 26, 2025, in Volume 53, Issue 12 of the NAR journal.
●
On
July 28, 2025, we announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ateganosine (THIO,
6-thio-dG or 6-thio-2’-deoxyguanosine) for the treatment of non-small cell lung cancer (NSCLC). Ateganosine is currently being
evaluated in a pivotal Phase 2 THIO-101 clinical trial evaluating its anti-tumor activity when followed by a checkpoint inhibitor.
●
In
addition to NSCLC, HCC, SCLC and CRC we plan to conduct clinical trials evaluating ateganosine (THIO) in sequential combination with
an immune checkpoint inhibitor in several other cancer indications, including solid tumors, such as breast, prostate, gastric, pancreatic
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.
Impact
of the War in Ukraine and War in Israel on Our Operations
The
short and long-term implications of war in Ukraine and war in Israel are difficult to predict at this time. The imposition of sanctions
and counter sanctions may have an adverse effect on the economic markets generally and could impact our business, financial condition,
and results of operations. Because of the highly uncertain and dynamic nature of these events, the Company terminated any planned research
activities in the impacted areas.
28
Results
of Operations for the Three and Six Months Ended June 30, 2025 and 2024
Comparison
of Three Months ended June 30, 2025 and 2024
Three Months Ended
June 30,
Change
2025
2024
Dollars
Percentage
Operating expenses:
Research and development expenses
$ 3,110,867
$ 2,052,233
$ 1,058,634
52 %
General and administrative expenses
2,055,191
1,763,029
292,162
17 %
Total operating costs and expenses
5,166,058
3,815,262
1,350,796
35 %
Loss from operations
(5,166,058
(3,815,262 )
(1,350,796 )
35 %
Other (expense) income:
Interest income
79,697
88,383
(8,686 )
(10 )%
Australian research and development incentives
—
18,048
(18,048 )
(100 )%
Change in fair value of warrant liability
(260,602 )
(5,157,493 )
4,896,891
(95 )%
Loss on fair value of warrants over proceeds
—
(12,952 )
12,952
(100 )%
Other expense, net
(180,905 )
(5,064,014 )
4,883,109
(96 )%
Net loss
(5,346,963 )
(8,879,276 )
3,532,313
(40 )%
Net loss attributable to MAIA Biotechnology, Inc. shareholders
$ (5,346,963 )
$ (8,879,276 )
$ 3,532,313
(40 )%
Operating
Costs and Expenses
Research
and development expenses
Research
and development expenses increased by approximately $1,059,000 (or approximately 52%), from approximately $2,052,000 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.
General
and administrative expenses
General
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.
Other
income (expense), net
Other
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,
2025. 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.
29
Comparison
of Six Months Ended June 30, 2025 and 2024
Six Months Ended
June 30,
Change
2025
2024
Dollars
Percentage
Operating expenses:
Research and development expenses
$ 6,308,399
$ 4,372,975
$ 1,935,424
44 %
General and administrative expenses
4,283,090
3,391,163
891,927
26 %
Total operating costs and expenses
10,591,489
7,764,138
2,827,351
36 %
Loss from operations
(10,591,489 )
(7,764,138 )
(2,827,351 )
36 %
Other income (expense):
Interest income
161,880
132,501
29,379
22 %
Australian research and development incentives
—
36,649
(36,649 )
(100 )%
Loss on fair value of warrants over proceeds
—
(12,952 )
12,952
(100 )%
Change in fair value of warrant liability
565,387
(9,338,791 )
9,904,178
(106 )%
Other income (expense) net:
727,267
(9,182,593 )
9,909,860
(108 )%
Net loss
$ (9,864,222 )
$ (16,946,731 )
$ 7,082,509
(42 )%
Operating
Costs and Expenses
Research
and development expenses
Research
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.
General
and administrative expenses
General
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.
Other
income (expense), net
Other
income (expense), net increased by approximately $9,910,000 (or approximately 108%) from other (expense), net of approximately $ 9,183,000
for the six months ended June 30, 2024, to other income, net of approximately $727,000 for the six months ended June 30, 2025. The increase
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.
30
Liquidity
and Capital Resources
Our
Ability to Continue as a Going Concern
As
of June 30, 2025, our cash totaled approximately $10,145,000 which represented an increase of approximately $543,000 compared to December
31, 2024. As of June 30, 2025, we had working capital of approximately $5,999,000 which represents a decrease of approximately $323,000
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.
To
meet the Company’s future working capital needs, we will need to raise additional equity or enter into debt financing. While we
have historically been able to raise additional capital through issuance of equity and/or debt financing, and we have implemented a plan
to control its expenses in order to satisfy its obligations due within one year from the date of issuance of these financial statements,
we cannot guarantee that it will be able to raise additional equity, raise debt, or contain expenses. Accordingly, there is substantial
doubt about our ability to continue as a going concern within one year after these financial statements are issued.
Sales
of Common Stock
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 to our participating directors pursuant to securities purchase agreements
dated March 11, 2024 at a price $1.17 per share, 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.
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 of $2.295
per share, for which we received gross proceeds of approximately $1.33 million.
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.
On
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
in a private placement to certain accredited investors and to our participating directors pursuant to securities purchase agreements
dated February 18,2025 at a price of $1.50 per share, for which we received gross proceeds of approximately $2.7 million. The securities
sold to our directors participating in the February 24, 2025, private placement were issued pursuant to the MAIA 2021 Plan.
On
March 3, 2025, we issued and sold 952,633 shares of our Common Stock and warrants to purchase 952,633 shares of our Common Stock in a
private placement to certain accredited investors and to our participating directors pursuant to securities purchase agreements dated
February 25, 2025 at a price of $1.50 per share, for which we received gross proceeds of approximately $1.4 million. The securities sold
to our directors participating in the March 3, 2025, private placement were issued pursuant to the MAIA 2021 Plan.
31
From
January 1, 2025 through March 31, 2025, we sold 666,323 shares of Common Stock through Wainwright under the ATM Agreement at an average
price of approximately $2.28 per share, resulting in aggregate gross proceeds of approximately $1,521,091, for which we paid Wainwright
approximately $45,633 in commissions and other issuance costs of $84,587, resulting in net proceeds to us of approximately $1,390,871.
From
April 1, 2025 through June 30, 2025, we 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 we paid Wainwright
approximately $44,427 in commissions and other issuance costs of $16,705, resulting in net proceeds to us of approximately $1,419,762.
On
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
placement to certain accredited investors and to our participating directors pursuant to securities purchase agreements dated May 5,
2025, at a price of $1.50 per share, for which we received gross proceeds of approximately $1.08 million. The securities sold to our
directors participating in the May 8, 2025 private placement were issued pursuant to the MAIA 2021 Plan.
On
June 3, 2025, we issued and sold 463,332 shares of our Common Stock and warrants to purchase 463,332 shares of our Common Stock in a
private placement to certain accredited investors and to our participating directors pursuant to securities purchase agreements dated
May 27, 2025, at a price of $1.50 per share, for which we received gross proceeds of approximately $0.7 million. The securities sold
to our directors participating in the June 3, 2025 private placement were issued pursuant to the MAIA 2021 Plan.
We
will need to raise additional capital to fund our operations, to develop and commercialize ateganosine, and to develop, acquire or in-license
other products. We may seek to fund our operations through public equity, private equity, or debt financing, as well as other sources.
We cannot make any assurances that additional financing will be available to us and, if available, on acceptable terms or at all. This
could negatively impact our business and operations and could also lead to the reduction of our operations.
Cash
Flows
Cash
Flows for the Six Months ended June 30, 2025 and 2024
Six Months Ended June 30,
2025
2024
Net cash flows used in operating activities
$ (8,337,611 )
$ (8,271,571 )
Net cash flows provided by financing activities
8,869,406
12,704,327
Effect of foreign currency exchange rate changes on cash
11,429
(4,060 )
Net increase in cash
$ 543,224
$ 4,428,696
Operating
Activities
For
the six months ended June 30, 2025, net cash used in operating activities was approximately $8,338,000, which consisted of a consolidated
net loss of approximately $9,864.000 offset by non-cash charges of approximately $1,173,000 in stock-based compensation, approximately
$62,000 of non-cash expense to issue stock to consultants and vendors, and the decrease in the remeasurement of the warrant liability
of approximately $565,000. Total changes in operating assets and liabilities of approximately $856,000 were driven by an approximate
$1,208,000 net increase in accounts payable and accrued expenses, and an approximate $352,000 decrease in prepaid expense and other assets.
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.
32
For
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.
Investing
Activities
For
the six months ended June 30, 2025 and 2024, we did not have any cash provided by or used in investing activities.
Financing
Activities
Net
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
of offering costs.
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.
Off-Balance
Sheet Arrangements
None.
Critical
Accounting Policies and Significant Judgments and Estimates
Our
condensed consolidated financial statements are prepared in accordance with GAAP. These accounting principles require us to make certain
estimates, judgments and assumptions that affect the reported amounts of assets and liabilities as of the date of the financial statements.
We believe that the estimates, judgments and assumptions are reasonable based upon information available to us at the time that these
estimates, judgments and assumptions are made. To the extent there are material differences between these estimates, judgments or assumptions
and actual results, our financial statements will be affected. For a discussion of our critical accounting estimates, please read Part
II, Item 7 — Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on
Form 10-K for the year ended December 31, 2024 filed with the SEC on March 21, 2025. There have been no material changes to the critical
accounting estimates previously disclosed in such report.
Recently
Issued Accounting Standards Not Yet Effective or Adopted
Management
does not believe that any recently issued, but not yet effective accounting pronouncements, if adopted, would have a material impact
on the accompanying unaudited condensed consolidated financial statements.
Item
3. Quantitative and Qualitative Disclosures About Market Risk.
We
are a smaller reporting company and are not required to provide the information otherwise required under this item.
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