What changed in this filing

/stocks — the workspaceLOADING

Item 7. Management’s Discussion and Analysis

2025-03-21 compared with 2024-03-21 · 184 added, 134 removed, 112 unchanged (74% of the section changed)

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 Annual Report on Form 10-K.

You should read the following discussion together with our consolidated financial statements and the related notes included elsewhere in this Annual Report on Form 10-K.

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 Annual Report on Form 10-K.

See “Cautionary Note Regarding Forward-Looking Statements.”

We are a clinical stage biotechnology company engaged in the discovery, development and commercialization of therapies targeting cancer.

2 unchanged sentences

Specifically, we are targeting Non-Small Cell Lung Cancer (“NSCLC”), which represents 85% of all lung cancers.

We accomplished the following key milestones:

• In November 2018, the Company in-licensed THIO from University of Texas Southwestern, in Dallas.

The patent license is global and exclusive for the duration of the patients’ lives.

• In 2019, the Company generated the first data for THIO demonstrating complete regression with no recurrence when administered in advance of atezolizumab (TecentriQ®;

Genentech), in colorectal and lung cancer preclinical models.

• In the First Quarter 2020, the Company filed a provisional patent application for THIO in sequential combination with checkpoint inhibitors, covering all tumor types.

The patent was allowed in the US in the First Quarter 2021 and expires in 2041, excluding any patent term adjustment or patent extension.

• In the first quarter 2021, the Company entered into a Drug Supply Agreement with Regeneron Pharmaceuticals, Inc.

Under this 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.

This 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.

• In the First Quarter 2021, the Company initiated our clinical supply manufacturing under Good Manufacturing Practices conditions to provide clinical supply for THIO-101 and other development needs.

• In the first half of 2022, the Company 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 $2.4 million.

• In the first quarter 2022, THIO received approval by the Bellberry Human Research Ethics Committee in Australia to initiate the THIO-101 Phase 2 clinical study.

• In March 2022, the U.S.

Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to THIO for the treatment of hepatocellular carcinoma, 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.

• In May 2022, the Company entered into a research and collaboration agreement with the Nationwide Children’s Hospital to evaluate the potential of THIO in combination with current standard-of-care therapies for brain cancer.

The organizations are conducting preclinical studies to assess the efficacy and safety of THIO in combination with radiotherapy and immune checkpoint inhibitors in vitro and in vivo models.

• In July 2022, the Company completed our selection process for the clinical sites for our Phase 2 study in Australia and Europe and our application to start the Phase 2 study in Australia has been approved.

In July 2022, the first patient was administered with THIO-101 in Australia.

We have also submitted a similar application to conduct the same Phase 2 study in Europe.

• On July 28, 2022, the Company’s shares of common stock began trading on the NYSE American under the symbol MAIA.

On August 1, 2022, the Company sold 2,000,000 shares of common stock at $5.00 per share for gross proceeds of $10,000,000 in an initial public offering prior to deducting underwriting discounts, commissions, and other offering expenses.

On August 3, 2022, the Company sold an additional 300,000 shares of common stock at $5.00 per share when the underwriter exercised the overallotment for net proceeds of $1,500,000 prior to deducting underwriting discounts, commissions, and other offering expenses.

• In November 2022, the Company completed a pre-Investigational New Drug meeting with the FDA for the planned U.S.

expansion of the THIO-101 Phase 2 trial evaluating THIO, an investigational telomere-targeting agent, in patients with advanced NSCLC.

• In December 2022, regulatory authorities in three European countries, Hungary, Poland, and Bulgaria, approved the implementation of THIO-101, MAIA’s Phase 2 clinical trial.

THIO-101 is a critical component of THIO’s clinical development process and it is of the utmost importance that we collaborate with leading cancer institutes in Australia and now in Europe, for a target total of 30 clinical trial sites in six countries.

• In the first week of March 2023, the first two patients were dosed in Europe in MAIA’s Phase 2 clinical trial, THIO-101 evaluating THIO in patients with advanced NSCLC.

Following regulatory clearances in Hungary, Poland, and Bulgaria, nine clinical sites have been activated in these three European countries.

• On April 11, 2023, we announced positive topline data related to the completion of Part A, safety lead-in portion of the THIO-101 trial which showed that administration of THIO, at the highest dose of 360 mg/cycle in sequential combination with Regeneron’s anti-PD-1 therapy, Libtayo Ò was well tolerated with no dose-limiting toxicities or significant treatment-related adverse events reported.

• On April 18, 2023, the Company published data in Hepatocellular Carcinoma (HCC) (liver cancer) models:

as monotherapy, THIO achieved complete and durable responses in HCC, the dominant histology in primary liver cancer (90%), in in vivo models.

When combined with Libtayo®, duration of response was further potentiated.

Upon rechallenge with two times more cancer cells and no additional treatment, tumor growth was completely prevented.

Administration of THIO alone and in combination with Libtayo® generated anti-cancer immune memory.

• On April 20, 2023, the Company announced preliminary survival data from Part A of THIO-101.

The first two patients enrolled in Part A of the study continue to be alive, approximately 10 and 9 months respectively, from treatment initiation.

Both patients have advanced Stage IV metastatic disease and are heavily pretreated, receiving third and fourth line therapy respectively after previously failing treatment with an immune checkpoint inhibitor.

They continue to be progression free following their last dose of THIO, 7 and 6 months respectively, with no new treatment.

The current treatment options in patients with advanced relapsed or refractory NSCLC who failed two or more therapy regimens are limited and show minimal benefit.

Furthermore, discontinuation of treatment is rapidly followed by physical decline and death, therefore seeing patients with such survival and no disease progression in this clinical setting, is noteworthy.

In real-world clinical practice, observed survival in such heavily pretreated patients is 3-4 months.

• On April 27, 2023, the Company closed a follow-on offering and sold 2,555,500 shares of common stock at a public offering price of $2.25 per share, for gross proceeds of approximately $5.75 million, before deducting underwriting discounts and offering expenses.

The shares sold in the offering include the exercise in full by the underwriter of its option to purchase an additional 333,300 shares of common stock, in addition to the 2,222,200 shares of common stock which the underwriters initially agreed to purchase.

• In July 2023, MAIA announced that the first 2 patients dosed with THIO continue to be alive for approximately 12.2 and 11.5 months respectively, from treatment initiation.

They have remained free of disease progression for 10.2 and 8.5 months, respectively, without requiring any additional therapy.

We also highlighted that out of the first 11 patients with post-baseline

scans, 82% (9 patients) met the disease control primary endpoint at first response assessment.

For contrast, in similar heavily treated NSCLC patients, typical disease control rates are in the 25-35% range.

• On August 23, 2023, our universal shelf registration statement on Form S-3 (File No.

333-273984) (the “Form S-3”) for possible future offerings was declared effective by the SEC.

• On September 1, 2023, the Company entered into an “at-the-market” Sales Agreement (the “Sales Agreement”) with ThinkEquity LLC (the “Sales Agent”), pursuant to which the Company may offer and sell, from time to time, through the Sales Agent, shares of the Company’s common stock having an aggregate offering price of up to $7,000,000, subject to the terms and conditions of the Sales Agreement.

The shares will be offered and sold pursuant to the Company’s prospectus supplement (the “Prospectus Supplement”), filed September 1, 2023 with the SEC to the prospectus forming a part of the Form S-3.

We terminated the Sales Agreement on November 15, 2023.

We sold 758,388 shares of our common stock through the Sales Agent for which the Company received net proceeds of approximately $1,238,688.

• On September 28, 2023, the Company announced that its board of directors approved a share repurchase program pursuant to which the Company may repurchase up to $800,000 of the Company’s issued and outstanding shares of common stock through September 2024.

The Company expects to fund repurchases by using cash on hand and expected cash flow to be generated in the future.

As of December 31, 2023, no repurchases have been executed.

• On October 3, 2023, the Company announced that the FDA has cleared its IND application for THIO to be evaluated in the U.S.

as part of THIO-101, the Company’s ongoing global Phase 2 clinical study in patients with advanced NSCLC.

THIO is being tested in sequential combination with Regeneron’s anti PD-1 monoclonal antibody cemiplimab (Libtayo®) to evaluate anti-tumor activity and immune response in NSCLC patients.

• On October 10, 2023, the Company announced that 49 patients have been dosed in MAIA’s Phase 2 clinical trial, THIO-101, evaluating THIO in sequential combination with an immune checkpoint inhibitor in patients with advanced NSCLC.

• On November 10, 2023, the Company announced that the FDA granted orphan drug designation as a treatment for glioblastoma.

This is the third orphan drug designation granted following the receipt of orphan drug designations for hepatocellular carcinoma and small cell lung cancer in 2022.

• On November 17, 2023, the Company announces the closing of a $4 million registered direct offering for the issuance and sale of an aggregate of 2,424,243 of its shares of common stock at a purchase price of $1.65 per share.

In a concurrent private place, MAIA also issued and sold unregistered warrants to purchase up to an aggregate of 2,424,243 share of its common stock.

• On February 14, 2024, the Company entered into an “at-the-market" Offering Agreement (the “ATM Agreement”) with H.C.

Wainwright & Co., LLC (“Wainwright”), to sell shares of common stock, par value $0.0001 per share (the “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 H.C.

Wainwright will act as sales agent.

As of the date of this Annual Report, the Company has sold 507,754 shares of common stock at an average price of $1.47 per share, resulting in aggregate gross proceeds of approximately $745,250 .

• On February 22, 2024, the Company announced completion of enrollment in Phase 2 THIO-101 go-to-market clinical trial.

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.

We are a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer.

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.

In July 2022, the first patient was administered with THIO 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 THIO in patients with Non-Small Cell Lung Cancer (NSCLC).

Patients with advanced NSCLC will be treated first with THIO 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 THIO 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 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 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).

Phase 2 clinical trials in HCC, CRC and SCLC are planned to be initiated in 2026, evaluating treatment with THIO administered in sequence with BeiGene's immune checkpoint inhibitor, tislelizumab.

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.

We accomplished the following key milestones in the fiscal year ended December 31, 2024 and the first quarter of 2025:

• On January 17, 2024, we announced new interim data for our ongoing THIO-101 Phase 2 trial in non-small cell lung cancer (NSCLC).

In the latest available data from THIO-101 (November 13, 2023), 60 patients had been dosed with THIO in sequential combination with Libtayo®.

The patients received either 60mg, 180mg, or 360mg of THIO per dose, and 42 had at least one post baseline assessment completed.

The observed disease control was well sustained compared to previous scans.

• 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.

• 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.

Effective December 23, 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 $30,000,000 from time to time.

As of the date of this Annual Report, we have sold 3,940,683 shares of our Common Stock under the ATM Agreement at an average price of $2.95 per share, resulting in aggregate gross proceeds of approximately $11,633,086, for which we paid Wainwright $348,993 in commissions resulting in net proceeds to us of approximately $11,284,093.

• On February 22, 2024, we announced completion of enrollment in Phase 2 THIO-101 go-to-market clinical trial.

The trial reached the enrollment target of 41 patients for the 180mg/dose on February 19, 2024.

2 unchanged sentences

Following the selection of 180 mg/cycle as the optimal dose in December 2023, all patients were subsequently enrolled at the 180mg/cycle dose and trial enrollment was completed ahead of schedule.

• On March 6, 2024, Company announced interim efficacy data for THIO-101 Phase 2 trial in NSCLC.

• On March 6, 2024, we announced interim efficacy data for THIO-101 Phase 2 trial in NSCLC.

In the latest data available (January 8, 2024), the overall response rate (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.

• On March 11, 2024, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain accredited investors (the “Investors”) for the issuance and sale in a private placement (the “Private Placement”) of (i) 2,043,587 shares (the “Investor Shares”) of the Company’s common stock, par value $0.0001 per share (“Common Stock”), and (ii) warrants (the “Investor Warrants”) to purchase up to 2,043,587 shares of the Company’s Common Stock, at a price per share of $1.17 for an aggregate purchase price of approximately $2.4 million.

The Shares and the Warrants (and the

shares of common stock underlying the Warrants) sold in the Private Placement are being issued as restricted securities as defined in Rule 144 of the Securities Act of 1933, as amended and do not contain any registration rights.

The Common Warrants are exercisable at a price per Share of $1.30, which price represents the greater of the book or market value of the stock on the date the Purchase Agreement was executed (subject to customary adjustments as set forth in the Investor Warrants, which do not include any provisions relating to price protection), are exercisable commencing six months following issuance and have a term of five years from the initial exercise date.

In addition, in recognition of the past and continued future services provided by members of the Company’s board of directors (the “Board”) and to further align the interests of directors with those of the Company’s stockholders, the Board has determined it advisable and in the best interests of the Company and its stockholders to allow members of the Board to participate in the Private Placement and directors of the Company executed the Purchase Agreement to subscribe for (i) 452,731 shares of Common Stock (the “Director Shares,” together with the Investor Shares, the “Shares”) and (ii) common stock purchase warrants to purchase up to 452,731 shares of the Company’s Common Stock (the “Director Warrants,” together with the Investor Warrants, the “Warrants”) at a price per share of $1.17 for an aggregate purchase price of approximately $529,695 The Director Warrants are exercisable at a price of $1.30 per share, which price represents the greater of the book or market value of the stock on the date the Purchase Agreement was executed (subject to customary adjustments as set forth in the Director Warrants), are exercisable commencing six months following issuance and will have a term of five years from the initial exercise date.

The Director Shares and Director Warrants (and any shares of Common Stock issuable upon exercise thereof) are being issued under the Company’s 2021 Equity Incentive Plan (the “Plan”) as an Unrestricted Stock Award (as defined in the Plan) and an Award of Options (as such terms are defined in the Plan), respectively.

The Private Placement closed on March 14, 2024, and the combined gross proceeds from the Private Placement was approximately $2.92 million, prior to deducting offering expenses payable by the Company.

• 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”).

• 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.

• On March 27, 2024, we evaluated additional clinical data from its Phase 2 clinical trial, THIO-101.

At such time, a total of 68 patients have been dosed and had a post-baseline scan in MAIA’s Phase 2 clinical trial, THIO-101, evaluating THIO in sequential combination with an immune checkpoint inhibitor in patients with advanced NSCLC.

Preliminary efficacy across all lines of therapy in this March 2024 data cut were consistent with previous reports including:

(i) 75% of patients receiving THIO 180mg as third-line therapy for NSCLC have surpassed the overall survival (“OS”) threshold of 5.8 months;

(ii) 88% of patients in the same setting (3L, 180mg) also crossed the 2.5 months progression free survival (“PFS”) threshold and have shown ORR of 38%, greatly improving on current chemo treatment that have ORRs of around 6-10%;

and (iii) across all third-line patients, DCR of 85% remained superior to current chemotherapy options, which ranges from 25-35% DCR.

• 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.

• 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.

• On June 6, 2024, we announced highlights and key achievements year-to-date, including:

(i) exceptional measures of efficacy by lead drug THIO in Phase 2 clinical trial, with 38% ORR in third-line (3L) setting (THIO 180mg) compared to ~6% for currently available treatments in a similar population and 5.5 months median progression-free survival (PFS) (3L, THIO 180mg);

and (ii) secured continued insider investment through independent board members’ participation in private placement equity financings, with funding of more than $12M year-to-date.

• 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.

• 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.

• On September 10, 2024, we announced updates from our lead clinical candidate THIO, in our Phase 2 clinical trial, THIO-101.

The updates included:

(i) As of August 1, 2024, 16 patients had survival follow-up surpassing 12 months, including 9 in third line treatment (3L);

(ii) Interim median survival follow-up in 3L was 10.6 months.;

and (iii) THIO's substantial survival benefit in third line surpasses comparable standard-of-care overall survival of 5.8 months.

• On November 1, 2024, we issued and sold 1,079,784 shares of our common stock and warrants to purchase 1,079,784 shares of our common stock in a private placement to certain accredited investors and Company directors pursuant to securities purchase agreements dated October 28, 2024 at a price per share of $2.259 for which we received gross proceeds of approximately $2.44 million.

The warrants issued in the private placement have an exercise price of $2.51, are exercisable six months 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 December 3, 2024, we announced the amendment of the 2021 clinical supply agreement with Regeneron for the expansion portion of THIO-101, its Phase 2 clinical trial evaluating THIO in sequential administration with cemiplimab (Libtayo ® ).

The new expansion will further assess the efficacy of MAIA’s lead asset, THIO, sequenced with immune checkpoint inhibitor (CPI) Libtayo ® (cemiplimab) for advanced non-small cell lung cancer (NSCLC) patients receiving third-line therapy who were resistant to previous checkpoint inhibitor treatments and chemotherapy.

The original 2021 agreement between MAIA and Regeneron was designed to supply the original THIO-101 trial through the dose selection and safety evaluation process.

• On December 13, 2024, we issued and sold 507,364 shares of our common stock and warrants to purchase 507,364 shares of our common stock in a private placement to certain accredited investors and Company directors pursuant to securities purchase agreements dated December 9, 2024 at a price per share of $1.872 for which we received gross proceeds of approximately $950,000.

The warrants issued in the private placement have an exercise price of $2.08, are exercisable six months 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 December 16, 2024, we announced that the FDA has designated THIO for the treatment of pediatric-type diffuse high-grade gliomas (PDHGG) as a drug for a “rare pediatric disease” (RPDD).

Upon FDA approval of a future new drug application in PDHGG, MAIA would be eligible to receive a priority review voucher that can be redeemed by drug developers for FDA priority review of a different product or transferred or sold to another sponsor.

• 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 952,300 shares of our common stock and warrants to purchase 952,300 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.

• 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 its lead proprietary telomere-targeting THIO dimer in the peer-reviewed scientific journal Naunyn-Schmiedeberg's Archives of Pharmacology.

In a preclinical study, 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 THIO 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.

• In addition to NSCLC, HCC, SCLC and CRC we plan to conduct clinical trials evaluating 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 THIO in first-line patients for both NSCLC and SCLC.

Impact of the War in Ukraine on Our Operations

8 unchanged sentences

General and administrative

Ratchet share expense

Total operating costs and expenses

6 unchanged sentences

Change in fair value of warrant

Loss on fair value of warrants over proceeds

Other income (expense), net

Deemed dividend on warrant

modifications

Net loss attributable to MAIA

Biotechnology, Inc.

Operating Expenses

Research and development expenses

Research and development expenses increased by approximately $2,179,000 or 24%, from approximately $8,933,000 for the year ended December 31, 2022 to approximately $11,112,000 for the year ended December 31, 2023.

The increase was primarily related to an increase in payroll expense of approximately $658,000 related to accrued severance booked for an Officer terminated in 2023, the increase in clinical expenses related to the clinical trial startup of THIO of approximately $331,000, an increase in Scientific pre-clinical research of approximately $529,000, and an increase in stock based compensation of approximately $696,000 related to accelerated vesting of stock options for a terminated Officer, offset by a decrease of other expenses related to research and development of approximately $35,000.

Research and development expenses decreased by approximately $1,103,000 (or approximately 10%) from approximately $11,112,000 for the year ended December 31, 2023 to approximately $10,009,000 for the year ended December 31, 2024.

The decrease was primarily related to a decrease in payroll expense of approximately $1,610,000 related to the decrease in the headcount of research and development employees and the reversal of the accrued bonus that was not paid, a decrease in stock based compensation of approximately $954,000 as no bonuses were paid in stock compensation in 2024, a decrease in Scientific pre-clinical research of approximately $630,000, a decrease of other expenses related to research and development of approximately $34,000, offset by the increase in clinical expenses related to the clinical trial of THIO of approximately $2,054,000, and the increase in professional fees of $71,000.

General and administrative expenses

General and administrative expenses increased by approximately $2,927,000 or 48% from approximately $6,144,000 for the year ended December 31, 2022 to approximately $9,070,000 for the year ended December 31, 2023.

The increase was primarily attributable to an increases in payroll expense of approximately $562,000 related to accrued severance booked for an Officer terminated in 2023, the net increase in stock based compensation of approximately $74,000 related to accelerated vesting of stock options for a terminated Officer offset by the reduction of stock based compensation for the Board of Directors, a net increase in professional fees of approximately $74,000 related to an increase in legal fees offset by a reduction in audit fees, and an increase in other expenses of $2,217,000 related to an increase in Investor Relations expense incurred and Directors & Officers Insurance.

Ratchet Expense

Ratchet expense decreased by approximately $1,099,000 or 100% for the year ended December 31, 2023 due to the fact that the ratchet shares issuance was a one-time event in 2022 and thus no ratchet share issuance occurred in 2023.

General and administrative expenses decreased by approximately $2,122,000 (or approximately 23%) from approximately $9,070,000 for the year ended December 31, 2023 to approximately $6,948,000 for the year ended December 31, 2024.

The decrease was primarily related to a decrease in other expenses of approximately $951,000 related to lower investor relations and insurance expenses, a decrease in payroll expense of approximately $795,000 relating to the decreased headcount of general and administrative employees and the reversal of the accrued bonus, a decrease in stock-based compensation of approximately $222,000, and a decrease in professional fees of approximately $154,000,

Other income (expense), net

Other income (expense), net increased by approximately $3,000 from other income of approximately $407,000 for the year ended December 31, 2022 to other income of approximately $410,000 for the year ended December 31, 2023.

The increase in other income (expense), net was primarily the result of approximately $107,000 of income for the change in fair value of the warrant liability, a decrease by approximately $137,000 of expense related to the Australian research and development incentives for the year ended December 31, 2023 offset by approximately $33,000 of net interest income for the year ended December 31, 2023.

Other income (expense), net increased by approximately $6,707,000 (or approximately 1638%) from other income, net of approximately $410,000 for the year ended December 31, 2023 to other expense, net of approximately $6,297,000 for the year ended December 31, 2024.

The increase was primarily related to the change in the fair value of the warrant liability of approximately

$6,888,000, a loss on fair value of warrants over proceeds of approximately $13,000, a reduction in the Australia research and development incentives of approximately $97,000 and an increase of interest income, net of approximately $291,000.

Liquidity and Capital Resources

5 unchanged sentences

Accrued bonus

Deferred compensation

Total stockholders' equity

2 unchanged sentences

Our Ability to Continue as a Going Concern

As of December 31, 2023, our available cash totaled approximately $7,151,000 which represented a decrease of approximately $3,800,000 compared to December 31, 2022.

As of December 31, 2023, we had working capital of approximately $2,627,000 which represents a decrease of approximately $5,912,000 compared to December 31, 2022.

We have generated no revenues as of

December 31, 2023.

As of December 31, 2024, our available cash totaled approximately $9,601,000 which represented an increase of approximately $2,451,000 compared to December 31, 2023.

As of December 31, 2024, we had working capital of approximately $6,322,000 which represents an increase of approximately $3,696,000 compared to December 31, 2023.

We have generated no revenues as of December 31, 2024.

The Company’s 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 the Company’s lack of revenue generating activities.

Based on the Company’s cash reserves as December 31, 2023 of $7,150,695 million and current financial condition as of the date of the Annual Report on Form 10-K, the accompanying 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.

Based on the Company’s cash reserves as December 31, 2024 of $9,601,298 and current financial condition as of the date of the Annual Report on Form 10-K, the accompanying 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 consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

3 unchanged sentences

Sale of Common Stock

On April 27, 2023, the Company sold 2,555,500 shares of the Company’s common stock at a price of $2.25 per share in an underwritten public offering.

On April 27, 2023, we sold 2,555,500 shares of the Company’s common stock at a price of $2.25 per share in an underwritten public offering.

ThinkEquity served as the underwriter of the offering.

1 unchanged sentence

The shares of common stock were offered, issued and sold to the public pursuant to the Registration Statement on Form S-1, as amended from time to time (File No.

In October and November 2023, the Company issued and sold an aggregate of 758,388 shares of common stock through ThinkEquity LLC (“ThinkEquity”), pursuant to the terms of an “at-the-market" Sales Agreement, dated September 1, 2023 (the “Sales Agreement”), by and between the Company and ThinkEquity, the Company’s sale agent thereunder, for which the Company received aggregate gross proceeds of approximately $1.7 million.

On November 17, 2023, the Company issued and sold an aggregate of 2,424,243 shares of common stock in a registered direct offering pursuant to securities purchase agreements, for which the Company received aggregate gross proceeds of $4 million.

In October and November 2023, we issued and sold an aggregate of 758,388 shares of common stock through ThinkEquity LLC (“ThinkEquity”), pursuant to the terms of an “at-the-market" Sales Agreement, dated September 1, 2023 (the “Sales Agreement”), by and between the Company and ThinkEquity, the Company’s sale agent thereunder, for which the Company received aggregate gross proceeds of approximately $1.7 million.

On November 17, 2023, we issued and sold an aggregate of 2,424,243 shares of common stock in a registered direct offering pursuant to securities purchase agreements, for which the Company received aggregate gross proceeds of $4 million.

Wainwright was the placement agent for the registered direct offering.

On February 14, 2024, the Company entered into an “at-the-market" Offering Agreement with H.C.

Wainwright will act as sales agent.

As of the date of this filing, the Company has sold 507,754 shares of common stock at an average price of $1.47 per share, resulting in aggregate gross proceeds of approximately $745,250.

On March 11, 2024, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain accredited investors (the “Investors”) for the issuance and sale in a private placement (the “Private Placement”) of (i) 2,043,587 shares (the “Investor Shares”) of the Company’s common stock, par value $0.0001 per share (“Common Stock”), and (ii) warrants (the “Investor Warrants”) to purchase up to 2,043,587 shares of the Company’s Common Stock, at a price per share of $1.17 for an aggregate purchase price of approximately $2.4 million.

The Shares and the Warrants (and the shares of common stock underlying the Warrants) sold in the Private Placement are being issued as restricted securities as defined in Rule 144 of the Securities Act of 1933, as amended and do not contain any registration rights.

In addition, in recognition of the past and continued future services provided by members of the Company’s board of directors (the “Board”) and to further align the interests of directors with those of the Company’s stockholders, the Board has determined it advisable and in the best interests of the Company and its stockholders to allow members of the Board to participate in the Private Placement and directors of the Company executed the Purchase Agreement to subscribe for (i) 452,731 shares of Common Stock (the “Director Shares,” together with the Investor Shares, the “Shares”) and (ii) common stock purchase warrants to purchase up to 452,731 shares of the Company’s Common Stock (the “Director Warrants,” together with the Investor Warrants, the “Warrants”) at a price per share of $1.17 for an aggregate purchase price of approximately $0.53 million The Director Warrants are exercisable at a price of $1.30 per share, which price represents the greater of the book or market value of the stock on the date the Purchase Agreement was executed (subject to customary adjustments as set forth in the Director Warrants), are exercisable commencing six months following issuance and will have a term of five years from the initial exercise date.

The Private Placement closed on March 14, 2024 and the combined gross proceeds from the Private Placement was

approximately $2.92 million, prior to deducting offering expenses payable by the Company.

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.

Between October 1, 2024 and December 31, 2024, we sold 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.

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 warrants are exercisable at a price per Share of $1.30, which price represents the greater of the book or market value of the stock on the date the purchase agreement was executed, are exercisable commencing six-months following issuance and have a term of five and a half years from the initial issuance date.

The securities sold to our directors participating in the March 14, 2024 private placement were issued pursuant to the MAIA 2021 Plan.

The following Company directors participated in the aforementioned private placement as follows:

(i) Stan Smith purchased 170,940 Director Shares and 170,940 Director Warrants for an aggregate purchase price of $200,0000;

(ii) Louie Ngar Yee purchased 170,940 Director Shares and 170,940 Director Warrants for an aggregate purchase price of $200,000;

(iii) Cristian Luput purchased 69,282 Director Shares and 69,282 Director Warrants for an aggregate purchase price of $81,060 (iv) Steven Chaouki purchased 34,641 Director Shares of common stock and 34,461 Director Warrants for an aggregate purchase price of $40,530 and (v) Ramiro Guerrero purchased 6,928 Director Shares and 6,928 Director Warrants for an aggregate purchase price of $8,106.

(i) Stan Smith purchased 170,940 shares and 170,940 warrants for an aggregate purchase price of $200,0000;

(ii) Louie Ngar Yee purchased 170,940 shares and 170,940 warrants for an aggregate purchase price of $200,000;

(iii) Cristian Luput purchased 69,282 shares and 69,282 warrants for an aggregate purchase price of $81,060 (iv) Steven Chaouki purchased 34,641 shares of common stock and 34,461 warrants for an aggregate purchase price of $40,530 and (v) Ramiro Guerrero purchased 6,928 shares and 6,928 warrants for an aggregate purchase price of $8,106.

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.

The warrants are exercisable at a price per Share of $2.55, which price represents the greater of the book or market value of the stock on the date the purchase agreement was executed, are exercisable commencing six-months following issuance and have a term of five and a half years from the initial issuance date.

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 to our participating directors pursuant to securities purchase agreements dated April 22, 2024 at a price of $2.034 per share, for which we received gross proceeds of approximately $1.0 million.

The warrants are exercisable at a price per Share of $2.26, which price represents the greater of the book or market value of the stock on the date the purchase agreement was executed, are exercisable commencing six-months following issuance and have a term of five and a half years from the initial issuance date.

The securities sold to our directors participating in the April 25, 2024 private placement were issued pursuant to the MAIA 2021 Plan.

Company director Stan Smith purchased 147,492 shares and 147,492 warrants for an aggregate purchase price of approximately $300,000 and Company director Louie Ngar Yee purchased 19,665 shares and 19,665 warrants for an aggregate purchase price of approximately $40,000.

On November 1, 2024, we issued and sold 1,079,784 shares of our Common Stock and warrants to purchase 1,079,784 shares of our Common Stock in a private placement to certain accredited investors and to our participating directors pursuant to securities purchase agreements dated October 28, 2024 at a price of $2.259 per share, for which we received gross proceeds of approximately $2.44 million.

The warrants are exercisable at a price per Share of $2.51, which price represents the greater of the book or market value of the stock on the date the purchase agreement was executed, are exercisable commencing six-months following issuance and have a term of five and a half years from the initial issuance date.

The securities sold to our directors participating in the November 1, 2024 private placement were issued pursuant to the MAIA 2021 Plan.

Company director Stan Smith purchased 100,000 shares and 100,000 warrants for an aggregate purchase price of approximately $225,900;

Company director Ramiro Guerrero purchased 88,534 shares and 88,534 warrants for an aggregate purchase price of approximately $200,000;

Company director Steven Chaouki purchased 22,133 shares and 22,133 warrants for an aggregate purchase price of approximately $50,000;

and Company director Cristian Luput purchased 22,133 shares and 22,133 warrants for an aggregate purchase price of approximately $50,000.

In addition, the son of Company director Stan Smith purchased 40,000 shares and 40,000 warrants for an aggregate purchase price of approximately $90,360 and related party 5% stockholder FGMK Business Holdings, LLC purchased 243,470 shares and 243,670 warrants for a purchase price of approximately $550,000.

On December 13, 2024, we issued and sold 507,364 shares of our Common Stock and warrants to purchase 507,364 shares of our Common Stock in a private placement to certain accredited investors and to our participating directors pursuant to securities purchase agreements dated December 9, 2024 at a price of $1.872 per share, for which we received gross proceeds of approximately $950,000.

The warrants are exercisable at a price per Share of $2.08, which price represents the greater of the book or market value of the stock on the date the purchase agreement was executed, are exercisable commencing six-months following issuance and have a term of five

and a half years from the initial issuance date.

The securities sold to our directors participating in the December 13, 2024 private placement were issued pursuant to the MAIA 2021 Plan.

Company director Stan Smith purchased 25,000 shares and 25,000 warrants for an aggregate purchase price of approximately $46,800 and Company director Ramiro Guerrero purchased 53,418 shares and 53,418 warrants for an aggregate purchase price of approximately $100,000.

In addition, Sylvia Guerrero, the sister of one of the Company directors purchased 5,341 shares and 5,341 warrants for an aggregate purchase price of approximately $10,000.

We will need to raise additional capital to fund our operations, to develop and commercialize THIO, and to develop, acquire or in-license other products.

7 unchanged sentences

Effect of foreign currency exchange rate changes on cash

Net increase in cash and cash equivalents

Net increase (decrease) in cash

Operating Activities

For the year ended December 31, 2024, net cash used in operating activities was approximately $15,704,000, which consisted of a consolidated net loss of approximately $23,255,000 offset by non-cash charges of approximately $7,550,000 which primarily includes approximately $1,913,000 in stock-based compensation, approximately $179,000 of expense related restricted shares issued for consulting services, and a loss of approximately $6,683,000 related to the changes in fair value of the warrant liability, and the loss on fair value of warrants over proceeds of approximately $13,000.

Total changes in operating assets and liabilities of approximately $1,238,000 were primarily driven by an approximate $119,000 decrease in accounts payable, an approximate $980,000 decrease in an accrued expenses, an approximate decrease of $57,000 in Australian research and development incentives receivable, and an approximate $196,000 increase in prepaid expenses and other current assets.

For the year ended December 31, 2023, net cash used in operating activities was approximately $13,071,000, which consisted of a consolidated net loss of approximately $19,773,000 offset by non-cash charges of approximately $6,702,000 which primarily includes approximately $3,089,000 in stock-based compensation, approximately $732,000 of expense related restricted shares issued for consulting services, and a gain of approximately $205,000 related to the changes in fair value of the warrant liability.

Total changes in operating assets and liabilities of approximately $3,086,000 were primarily driven by an approximate $472,000 increase in accounts payable, an approximate $2,170,000 increase in an accrued expenses an approximate decrease of $158,000 in Australian research and development incentives receivable and an approximate $285,000 decrease in prepaid expenses and other current assets.

For the year ended December 31, 2022, net cash used in operating activities was approximately $12,096,000, which consisted of a consolidated net loss of approximately $15,769,000 offset by non-cash charges of approximately $3,320,000 which primarily includes approximately $2,319,000 in stock-based compensation, approximately $1,099,000 of expense related to the ratchet share issuance, offset by a gain of approximately $98,000 related to the changes in fair value of the warrant liability.

Total changes in operating assets and liabilities of approximately $353,000 were primarily driven by an approximate $211,000 increase in accounts payable, and an approximate $916,000 increase in accrued expenses, offset by an approximate increase of $269,000 in Australian research and development incentives receivable and an approximate $505,000 increase in prepaid expenses and other current assets.

Total changes in operating assets and liabilities of approximately $3,086,000 were primarily driven by an approximate $472,000 increase in accounts payable, an approximate $2,170,000 increase in accrued expenses, an approximate decrease of $158,000 in Australian research and development incentives receivable, and an approximate $285,000 decrease in prepaid expenses and other current assets.

Financing Activities

Net cash provided by financing activities for the year ended December 31, 2023 was approximately $9,271,000 consisted primarily of gross proceeds from the sale of common stock of approximately $5,750,000 in a public offering, proceeds from issuance of common stock of approximately $4,000,000 in a registered direct offering, gross proceeds of approximately of $1,667,000 in an at-the-market offering facility through our sales agent for such facility, and approximately $1,000 from the proceeds from exercising of stock options, offset by approximately $2,147,000 of offering costs paid.

Net cash provided by financing activities for the year ended December 31, 2022 was approximately $12,477,000 consisted primarily of gross proceeds from the sale of common stock in the initial public offering of approximately $11,500,000, net proceeds from issuance of common stock of approximately of $2,474,000 in a crossover round, proceeds from issuance of common stock upon exercise of warrants of approximately $385,000, and approximate $440,000 decrease in deferred offering costs, and stock options of approximately $84,000, offset by approximately $2,406,000 of initial public offering costs paid.

Net cash provided by financing activities for the year ended December 31, 2024 was approximately $18,177,000 and consisted primarily of approximately $8,643,000 in gross proceeds from private placement offerings, proceeds from the at-the-market offering of approximately $10,112,000, proceeds from the exercise of stock options of $217,000, and were offset by approximately $795,000 of offering costs.

Net cash provided by financing activities for the year ended December 31, 2023 was approximately $9,271,000 and consisted primarily of gross proceeds from the sale of common stock of approximately $5,750,000 in a public offering, proceeds from issuance of common stock of approximately $4,000,000 in a registered direct offering, gross proceeds of approximately of $1,667,000 in an at-the-market offering facility through our sales agent for such facility, and approximately $1,000 from the proceeds from exercising of stock options, offset by approximately $2,147,000 of offering costs paid.

Critical Accounting Policies and Significant Judgments and Estimates

1 unchanged sentence

The preparation of these financial statements requires us to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes.

The most significant estimates in the Company’s financial statements relate to the valuation of stock options and warrants and accruals for

outsourced research and development activities.

These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources.

The most significant estimates in the Company’s financial statements relate to the valuation of stock options and warrants and accruals for outsourced research and development activities.

about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources.

Actual results may differ materially and adversely from these estimates.

9 unchanged sentences

Developing this assumption requires the use of judgment.

The Company lacks company-specific historical and implied volatility information.

Therefore, we estimate our expected stock volatility based on the historical volatility of a publicly traded set of peer companies.

The Company lacks sufficient company-specific historical and implied volatility information.

Therefore, we estimate our expected stock volatility based on the historical volatility of a publicly traded set of peer companies, while corroborating these volatilities with our actual limited historical volatility information.

Two of the assumptions used in the Black-Scholes-Merton valuation model are historical volatility and fair value of common stock.

28 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis