What changed in this filing

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Item 1. Business

2025-03-21 compared with 2024-03-21 · 163 added, 74 removed, 1024 unchanged (19% of the section changed)

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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, in late 2024, we plan to seek an accelerated approval of THIO in the United States for the treatment of patients with advanced NSCLC, but even if granted, accelerated approval status does not guarantee an accelerated review or marketing approval by the Food and Drug Administration (FDA).

In addition, in 2025, we plan to initiate a Phase 2 clinical trial in multiple solid tumor indications of THIO administered in sequence with Anti-PD-1or Anti-PD-L1 agents.

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.

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.

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The human safety data generated in Australia and Europe constituted the basis of the IND application.

Although we plan to rely solely on the safety and efficacy data we generate in our own clinical trials in support of our planned New Drug Application (NDA) filing, and do not plan to rely on clinical data generated by unaffiliated third parties, we take added confidence in the potential tolerability of THIO in light of the fact that the THIO dose selected of 180 mg/cycle is 14 times lower than the maximum tolerated dose tested in the earlier clinical trials sponsored by the National Cancer Institute (NCI) in the 1970s.

THIO in light of the fact that the THIO dose selected of 180 mg/cycle is 14 times lower than the maximum tolerated dose tested in the earlier clinical trials sponsored by the National Cancer Institute (NCI) in the 1970s.

The THIO-101 Phase 2 trial is a proof-of-concept study that may be modified depending on interim results to include both primary and secondary endpoints and be consistent with previously approved cancer treatments.

In September 2022, we submitted a pre-IND meeting request to the FDA to discuss, among other elements, the existing non-clinical and clinical data to support the conduct of our planned THIO-101 Phase 2 trial under an IND to include patients from the U.S.

MAIA received feedback in-line with the proposed plans from the FDA regarding its

manufacturing, preclinical and clinical development plan.

MAIA received feedback in-line with the proposed plans from the FDA regarding its manufacturing, preclinical and clinical development plan.

MAIA also obtained guidance from the FDA on the assessment of its safety and efficacy in the THIO-101 Phase 2 trial that was incorporated in the U.S.

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Accelerated approval status does not guarantee an accelerated review or marketing approval by the FDA.

The TH10-101 study protocol may need to be amended to increase the number of patients enrolled, undergo modification of the statistical analysis, or change in the trial design and/or primary endpoints.

The THIO-101 study protocol was amended in December 2024 to increase the number of patients enrolled in an expansion arm to further evaluate efficacy of the treatment in third-line NSCLC patients resistant to checkpoint inhibitor and chemotherapy.

The study may undergo modification of the statistical analysis, a change in the trial design, and/or primary endpoints.

On April 11, 2023, we announced positive topline data related to the completion of Part A, safety lead-in portion of the THI0-101 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 ® was well tolerated with no dose limiting toxicities or significant treatment-related adverse events reported.

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During the dose-finding stage of THIO-101, patients were administered either 60mg, 180mg, or 360mg of THIO per cycle, followed by 350mg of cemiplimab (Libtayo ® ).

The selected dose, 180mg/cycle, presented better safety profile and outperformed the other doses in the key measures of efficacy for NSCLC trials.

The selected dose, 180mg/cycle, presented better safety profile and outperformed the

other doses in the key measures of efficacy for NSCLC trials.

Subsequently, all future trial participants will be treated with THIO 180mg/cycle.

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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 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 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 MAIA 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 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 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 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 18, 2025, we announced that the United States Adopted Names (USAN) Council had approved “ateganosine” as the nonproprietary (generic) name for its lead molecule THIO, a telomere-targeting anticancer agent in clinical development as a first-in-class treatment for advanced non-small cell lung cancer (NSCLC).

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

altering telomeric guanosine of the cancer cells.

The generic name ateganosine is a unique and consistent identity that aims to support clear communication between healthcare providers, patients and researchers.

MAIA will retain the name THIO in its clinical trial designations (THIO-101, THIO-102, THIO-103, THIO-104).

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.

Our Science--Driven Telomere Targeting Approach

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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 NSCLC.

In March 2022, the FDA granted Orphan Drug Designation (ODD) to THIO for the treatment of HCC, in May 2022, the FDA granted the second ODD to THIO for the treatment of small cell lung cancer, and in late 2023, a third ODD for Malignant Gliomas Brain

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.

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Our goal is to be the leader in the discovery, development and commercialization of cancer telomere targeting agents and other similar small molecules.

Our initial focus is to efficiently advance our Phase 2 clinical program with THIO in sequential combination with cemiplimab.

Our initial focus is to efficiently advance our Phase 2 clinical program with THIO in sequential combination with cemiplimab for the treatment of NSCLC.

Ultimately, our goal would be to position THIO as a patient anticancer immunity priming treatment for all immune-activating agents used in the treatment of cancer.

To date, THIO has never been tested in clinical trials in combination with any check-point inhibitor.

To date THIO-101 is the only clinical trial testing THIO in combination with a check-point inhibitor.

The key elements of our strategy are to:

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Cell Reports 2017;

and Clinical Relevance of Telomerase Status and Telomerase Activity in Colorectal Cancer;

Clinical Relevance of Telomerase Status and Telomerase Activity in Colorectal Cancer;

T Femandez et al;

PLOS one 2016;

and Telomeres, Telomerase, and Cancer:

Mechanisms, Biomarkers, and Therapeutics;

Experimental Hematology & Oncology 14:8 2025.

Our initial development program will focus on Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Hepatocellular Carcinoma (HCC) and Small Cell Lung Cancer (SCLC) in areas of clear unmet need and/or areas with deficient immunotherapy effect within each tumor type.

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We believe that THIO offers a desirable profile with significant commercial potential.

2028 ($B) (projected)

Non-Small Cell Lung Cancer

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IMFINZI (durvalumab)

LIBTAYO (cemiplimab)

TEVIMBRA (tislelizumab)

TYVYT (sintilimab)

Eli Lilly / Innovent

LIBTAYO (cemiplimab)

BAVENCIO (avelumab)

Pfizer / Merck AG

TEVIMBRA (tislelizumab)

JEMPERLI (dostarlimab)

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Telomerase mediated telomere altering compounds and treatment of therapy-resistant cancers are part of our portfolio.

Further, THIO’s immunogenic treatment strategy, which focuses on sequential combination with checkpoint inhibitors has been filed.

We maintain five (5) issued patents and have twenty-nine (29) pending applications.

Further, THIO’s immunogenic treatment strategy, which focuses on sequential combination with checkpoint inhibitors has been filed worldwide.

We maintain nine (9) issued patents and have twenty-two (22) pending patent applications.

Our goal is to obtain, maintain and enforce patent protection wherever appropriate for our product candidates, formulations, processes, methods and any other proprietary technologies, and operate without infringing on the proprietary rights of other parties, both in the United States and in other countries.

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Telomerase Mediated Telomere Altering Compounds / PCT/US2014/33330 (WO2014/168947), issued in the US (patent no.

10,463,685), CA, MX, NZ and RU (all method of use) pending in BR, CN, EPO, HK and SG.

10,463,685), CA, MX, NZ and RU (all method of use) pending in BR, EPO (received an Intent to Grant), HK, and SG.

6-Thio-2'-Deoxyguanosine (6-Thio-dG) Results in Telomerase Dependent Telomere Dysfunction and Cell Death in Various Models of Therapy-Resistant Cancer Cells /

PCT/US2017/34706 (WO2017/205756), pending in the US (method of use), AU, CA, and EPO.

PCT/US2017/34706 (WO2017/205756), pending in the US (method of use), CA, and EPO.

Use of 6-thio-dG to Treat Therapy-Resistant Telomerase positive Pediatric Brain Tumors /

PCT/US2019/023596 (WO2019/183482), pending in the US (method of use)

Treatment of Drug Resistant Proliferative Diseases with Telomerase Mediated Telomere Altering Compounds / PCT/US2017/023858 (WO/2017/165675), pending in the US (method of use)

Treatment of Drug Resistant Proliferative Diseases with Telomerase Mediated Telomere Altering Compounds / PCT/US2017/023858 (WO/2017/165675), issued in the US (patent no.

12,070,472) and one application pending in the US (18,781,413).

and (2) a non-exclusive worldwide license to develop and commercialize related technology rights.

The UTSW1 Agreement includes an exclusive license to US patent no.

10,463,685 (expires April 8, 2034), and pending US patent application nos.

16/450,430 (having an earliest expiration of March 23, 2037, if a patent is granted), 16/304,538 (having an earliest expiration of May 26, 2037, if a patent is granted), and 18/511,417 (having an earliest expiration of March 22, 2039, if a patent is granted).

10,463,685 (expires April 8, 2034), and US patent no.

12,070,472 (having an anticipated expiration of March 23, 2037), and 18/511,417 (having an earliest expiration of March 22, 2039, if a patent is granted).

All patents are method of use.

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Title / PCT Application Number

Sequential Treatment of Cancers Using 6-Thio-dG and Checkpoint Inhibitors / PCT/US2021/022090, pending in the US and PCT (method of use), AU, BR, CA, CN, EPO, IL,JP, KR, MX, RU, SG, US

Sequential Treatment of Cancers Using 6-Thio-dG and Checkpoint Inhibitors / PCT/US2021/022090, issued in the US, RU, EP (validated in AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HU, IE, IS, IT, LI, LT, LU, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR) (method of use), pending in AU, BR, CA, CN, IL, JP, KR, MX, SG, and US.

and (2) a non-exclusive worldwide license to develop and commercialize related technology rights.

The UTSW2 Agreement includes an exclusive license to pending US patent application no.

17/200,539 (having an earliest expiration of March 12, 2041, if a patent is granted).

The UTSW2 Agreement includes an exclusive license to issued US patent no.

12,097,213 (having an earliest expiration of March 12, 2041, not including any potential patent term adjustment).

This patent is generally directed to methods of using THIO in combination with immune checkpoint inhibitors.

On July 13, 2022, MAIA Biotechnology filed PCT/US23/70177, US 18/352,220, and TW 112126229, Dinucleotides and their use in treating cancer, for Dinucleotide compounds that target telomers in cancer cells and method for using the dinucleotide compounds in treating cancers alone and in combination with other anticancer-agents and therapies, such as in combination with checkpoint inhibitors and radiation therapy.

Pending PCT, US, and TW.

On May 30, 2023, MAIA Biotechnology filed US 63/469,782, Tumor Redox-Activated 6-Thiopurine containing dimer compounds, for 6-thiopurine containing compounds that target telomers in cancer cells and methods for using the compounds in treating cancers alone and in combination with other anticancer agents and therapies.

Pending in US.

On October 22, 2023, MAIA Biotechnology and Regeneron filed US ser no.

18/382,521, Treatment of Non-Small Cell Lung Cancer with 6-THIO-dG and Cemiplimab, that discloses the use of treating Non-Small Cell Lung Cancer with 6-THIO-dG followed by cemiplimab.

Pending in US.

This application is under petition to be converted to a provisional application.

On October 29, 2023, MAIA Biotechnology filed US ser.

63/546,242, Telomere-Targeting Phosphatidyl-THIO Conjugates, for Telomere-targeting phosphatidyl-THIO conjugates that target telomers in cancer cells and methods for using the telomere-targeting phosphatidyl-THIO conjugates compounds to treat cancers.

Pending in US.

Pending in AU, BR, CA, CH, EPO, KR, MX, JP, US, and TW.

On May 30, 2023, MAIA Biotechnology filed PCT/US2024/031754, Tumor Redox-Activated 6-Thiopurine containing dimer compounds, for 6-thiopurine containing compounds that target telomers in cancer cells and methods for using the compounds in treating cancers alone and in combination with other anticancer agents and therapies.

Pending in PCT.

On October 22, 2024, MAIA Biotechnology and Regeneron filed PCT/US2024/052463, Treatment of Non-Small Cell Lung Cancer with 6-THIO-dG and Cemiplimab, that discloses the use of treating Non-Small Cell Lung Cancer with 6-THIO-dG selected from three different doses followed by cemiplimab.

Pending in PCT.

On October 29, 2024, MAIA Biotechnology filed PCT/US2024/053473, Telomere-Targeting Phosphatidyl-THIO Conjugates, for Telomere-targeting phosphatidyl-THIO conjugates that target telomers in cancer cells and methods for using the telomere-targeting phosphatidyl-THIO conjugates compounds to treat cancers.

Pending in PCT.

We continually assess and refine our intellectual property strategy as we develop new technologies and therapeutic candidates.

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• On our SAB, will assist in development and strategy for approval of THIO in multiple tumor types

Saadettin Kiliçkap, M.D., M.Sc – Faculty member at İstinye University Faculty of Medicine, Department of Internal Medicine, Türkiye

• Graduated from Gazi University Faculty of Medicine, completed his Internal Medicine specialty training at Hacettepe University Faculty of Medicine.

Completed the education programme of Medical Oncology at Hacettepe University Oncology Institute and the Cancer Epidemiology Thesis Master's Program at Hacettepe University Oncology Institute Preventive Oncology Department, granting him the title of “Master of Science”

• Received more than 20 oral presentations or best work awards at national congresses, has more than 240 scientific articles published in international peer-reviewed journals and more than 50 papers presented at international congresses.

He took part as principle or sub-investigator in more than 50 national and international multicenter phase 2 and phase 3 clinical studies

• On our SAB, will assist in development and strategy for approval of THIO in multiple solid tumor types, including lung cancer, breast cancer, melanoma, and the gastrointestinal tract

Our SAB is primarily compensated by way of the grant of stock options as determined by the Company as appropriate in recognition of the specific services or areas of expertise of each member.

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In human cells, the telomerase holoenzyme consists of a high-molecular-weight complex with a template region-containing RNA subunit, hTR, and a protein component, the catalytic subunit human telomerase reverse transcriptase (hTERT).

In most normal

somatic cells, telomerase activity is absent and telomere repeats are lost with cell division and with aging.

In most normal somatic cells, telomerase activity is absent and telomere repeats are lost with cell division and with aging.

Telomerase is especially important in fetal tissues, reproductive cells and other tissues where extensive cell proliferation is necessary.

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In both in vitro and in vivo studies, THIO showed a very prompt effect, causing telomere uncapping and leading to cancer cell death , independent of the initial tumor telomere length.

The above graphic represents an established method of action from previously conducted research in rodents that forms the scientific rationale for further clinical studies, but has not yet been tested in humans.

The above graphic represents an established method of action from previously conducted research in rodents that forms the scientific rationale for further clinical studies.

In 2019, further non-clinical research in syngeneic and humanized mouse models of telomerase-expressing cancers uncovered previously unknown telomere targeting activity of THIO specifically resulting from its breakdown of cancer cells.

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(1) safety of THIO administered as a priming immune system agent prior to cemiplimab administration and (2) clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint.

The study is ongoing in Australia and Europe and we expect will be followed by the United States.

An expansion arm has been amended to the trial protocol on December 2024 to further assess the efficacy of THIO in combination with cemiplimab in third-line NSCLC patients who are resistant to chemotherapy and checkpoint inhibitors.

The following chart sets forth the design of the THIO-101 trial:

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As of February 2024, dose selection and enrollment had been completed, but monitoring and assessment of dosed subjects are ongoing as patients continue to with the postbaseline scans and data matures.

As of February 2025,

the expansion arm to further assess the efficacy of the treatment with THIO sequenced with cemiplimab is planned to start enrolling new patients in Q1 2025, in select countries in Asia, Europe and in the US.

In an effort to obtain FDA and/or EMEA approval of THIO in combination with other standard of care approved cancer immunotherapies, we will have to conduct head-to-head studies which will compare standard of care treatment alone to standard of care treatment combined with THIO.

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The agreement may be terminated in the event of unsafe use of cemiplimab, material breach, regulatory action or corruption.

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.

In December 2024, we entered into a Clinical Supply Agreement with BeiGene, Ltd (BeiGene) to supply tislelizumab for the upcoming THIO-102 studies in HCC, CRC and SCLC.

BeiGene will receive development exclusivity for HCC, CRC and SCLC indications during the study period, which means that MAIA cannot study THIO in HCC, CRC or SCLC with any other PD-1 antagonist (a product sub-class of immune checkpoint inhibitors).

All other tumor types remain open, and we are in discussions with other pharmaceutical companies to evaluate additional agreements that may be appropriate to support the expanded development of THIO.

The supply agreement will remain in force until all of the obligations of the parties’ related to the studies contemplated by the agreement are completed, or until terminated by either party.

The agreement may be terminated in the event of unsafe use of tislelizumab, material breach, regulatory action or corruption.

In addition, our management believes that strong partnership interest will develop from other pharmaceutical companies who have checkpoint inhibitor franchises or those with cancer immunotherapy interest.

6 unchanged sentences

Telomerase Mediated Telomere Altering Compounds / PCT/US2014/33330 (WO2014/168947), issued in the US (patent no.

10,463,685), CA, MX, NZ and RU (all method of use) pending in BR, CN, EPO, HK and SG.

10,463,685), CA, MX, NZ and RU (all method of use) pending in BR, EPO (received an Intent to Grant), HK and SG.

6-Thio-2'-Deoxyguanosine (6-Thio-dG) Results in Telomerase Dependent Telomere Dysfunction and Cell Death in Various Models of Therapy-Resistant Cancer Cells /

PCT/US2017/34706 (WO2017/205756), pending in the US (method of use), AU, CA, and EPO.

PCT/US2017/34706 (WO2017/205756), pending in the US (method of use), CA, and EPO.

Use of 6-thio-dG to Treat Therapy-Resistant Telomerase positive Pediatric Brain Tumors /

PCT/US2019/023596 (WO2019/183482), pending in the US (method of use)

Treatment of Drug Resistant Proliferative Diseases with Telomerase Mediated Telomere Altering Compounds / PCT/US2017/023858 (WO/2017/165675), pending in the US (method of use)

Treatment of Drug Resistant Proliferative Diseases with Telomerase Mediated Telomere Altering Compounds issued in the US patent no.

12,070,472 (method of use) and pending in the U.S.

(18,781,413).

Under the UTSW1 Agreement, we agreed to pay UTSW a minimal license fee, deferred license fees, milestone fees, and running royalties beginning on the first net sale (among others).

For additional details regarding our relationship with UTSW, see the section entitled “ Business — Intellectual Property —License Agreement 1 with The Board of Regents of The University of Texas System / The University of Texas Southwestern Medical Center .” The UTSW1 Agreement includes an exclusive license to US patent no.

10,463,685 (expires April 8, 2034), and pending US patent application nos.

16/450,430 (having an earliest expiration of March 23, 2037, if a patent is granted), 16/304,538 (having an earliest expiration of May 26, 2037, if a patent is granted), and 16/982,979 (having an earliest expiration of March 22, 2039, if a patent is granted).

” The UTSW1 Agreement includes an exclusive license to US patent no.

10,463,685 (expires April 8, 2034), and US patent no.

12,070,472 (having an earliest expiration of March 23, 2037), and 16,982,979 (having an earliest expiration of March 22, 2039, if a patent is granted).

The University of Texas Southwestern Medical Center License Agreement 2

2 unchanged sentences

Title / PCT Application Number

Sequential Treatment of Cancers Using 6-Thio-dG and Checkpoint Inhibitors / PCT/US2021/022090, pending in the US and PCT (method of use), AU, BR, CA, CN, EPO, IL,JP, KR, MX, RU, SG, US

Sequential Treatment of Cancers Using 6-Thio-dG and Checkpoint Inhibitors issued in the US, EP (validated in AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HU,

IE, IS, IT, LI, LT, LU, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), and RU (method of use), pending in AU, BR, CA, CN, IL, JP, KR, MX, SG, and US.

Under the UTSW2 Agreement, we agreed to pay UTSW a minimal license fee, deferred license fees, milestone fees, and running royalties beginning on the first net sale (among others).

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On December 8, 2020 (the “Effective Date”), we entered into an amended and restated agreement (of our prior November 29, 2018 agreement) with The Board of Regents of The University of Texas System on behalf of The University of Texas Southwestern Medical Center, (collectively, UTSW) to develop and commercialize certain UTSW owned and/or controlled patents and related technology directed to methods of using THIO (“the UTSW1 Agreement”).

The license is exclusive as to worldwide Patent Rights for all uses in the Field, which is defined as all therapeutic, prophylactic and diagnostic fields of use for all indications, including

discovery and development uses.

The license is exclusive as to worldwide Patent Rights for all uses in the Field, which is defined as all therapeutic, prophylactic and diagnostic fields of use for all indications, including discovery and development uses.

The license is sublicensable with prior UTSW written approval consistent with the terms of UTSW1 Agreement.

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Telomerase Mediated Telomere Altering Compounds / PCT/US2014/33330 (WO2014/168947), issued in the US (patent no.

10,463,685), CA, MX, NZ and RU (all method of use) pending in BR, CN, EPO, HK and SG.

10,463,685), CA, MX, NZ and RU (all method of use) pending in BR, EPO (received an Intent to Grant), HK and SG.

6-Thio-2'-Deoxyguanosine (6-Thio-dG) Results in Telomerase Dependent Telomere Dysfunction and Cell Death in Various Models of Therapy-Resistant Cancer Cells /

PCT/US2017/34706 (WO2017/205756), pending in the US (method of use), AU, CA, and EPO.

PCT/US2017/34706 (WO2017/205756), pending in the US (method of use), CA, and EPO.

Use of 6-thio-dG to Treat Therapy-Resistant Telomerase positive Pediatric Brain Tumors /PCT/US2019/023596 (WO2019/183482), pending in the US (method of use)

Treatment of Drug Resistant Proliferative Diseases with Telomerase Mediated Telomere Altering Compounds / PCT/US2017/023858 (WO/2017/165675), pending in the US (method of use)

Treatment of Drug Resistant Proliferative Diseases with Telomerase Mediated Telomere Altering Compounds / PCT/US2017/023858 (WO/2017/165675), issued in the US (patent no.

12,070,472) (method of use).

The UTSW1 Agreement also grants the Company a non-exclusive worldwide license under the Technology Rights to develop, manufacture, have manufactured, distribute, have distributed, use, offer for Sale, Sell, lease, loan and/or import Licensed Products in the Field, wherein Technology Rights means Licensor’s rights in technical information, know-how, processes, procedures, compositions, devices, methods, formulas, protocols, techniques, designs, drawings or data created before the Effective Date by Inventors at UTSW which are necessary or reasonably useful for practicing Patent Rights.

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(ii) first commercial sale in the U.S.

of licensed product for treating a non-oncology

of licensed product for treating a non-oncology indications;

(iii) first time aggregate Net Sales (as defined in the UTSW1 Agreement) of licensed product for treating an oncology indications exceeds low-nine figure sales in a contract year;

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The UTSW1 Agreement contains a representation that UTSW has the rights and authority to grant to Company the licensed rights and is to its knowledge unaware of any third-party infringer or any infringement of third-party intellectual property rights.

The UTSW1 Agreement also requires the Company to indemnify UTSW and other related parties against any liabilities, damages, causes of action, suits, judgments, liens, penalties, fines, losses, costs and expenses arising out of any product the Company produces under the UTSW1 Agreement, and requires the Company, beginning with the earlier of the first clinical trial or commercial sale or other commercialization, to obtain liability insurance.

Agreement also requires the Company to indemnify UTSW and other related parties against any liabilities, damages, causes of action, suits, judgments, liens, penalties, fines, losses, costs and expenses arising out of any product the Company produces under the UTSW1 Agreement, and requires the Company, beginning with the earlier of the first clinical trial or commercial sale or other commercialization, to obtain liability insurance.

The Company will have the first and sole right but not the obligation, at its own expense, to initiate an infringement suit or other appropriate actions against third party infringers and monetary recovery received therefrom, after the Company is reimbursed for expenses in enforcing the Patent Rights, is shared between the Company and UTSW pursuant to a good faith negotiation between the parties at that time.

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Title / PCT Application Number

Sequential Treatment of Cancers Using 6-Thio-dG and Checkpoint Inhibitors / PCT/US2021/022090, pending in the US and PCT (method of use), AU, BR, CA, CN, EPO, IL,JP, KR, MX, RU, SG, US

Sequential Treatment of Cancers Using 6-Thio-dG and Checkpoint Inhibitors / PCT/US2021/022090, issued in the US, EPO, and RU (method of use), pending in AU, BR, CA, CN, IL,JP, KR, MX, SG, and US.

The UTSW2 Agreement also grants the Company a non-exclusive worldwide license under the Technology Rights to develop, manufacture, have manufactured, distribute, have distributed, use, offer for Sale, Sell, lease, loan and/or import Licensed Products in the Field, wherein Technology Rights means UTSW’s rights in technical information, know-how, processes, procedures, compositions, devices, methods, formulas, protocols, techniques, designs, drawings or data created before the Effective Date by inventors at UTSW which are necessary or reasonably useful for practicing Patent Rights.

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In the event that the Company or its sublicensee challenges the Patent Rights, then the Company will be obligated to pay multiple times the applicable royalty rate of the Net Sales and, should the outcome of such challenge determine that any claim of the Patent Rights challenged is both valid and infringed then the Company will pay royalties at the rate of multiple times the applicable royalty rate of the Net Sales sold thereafter and reimburse UTSW for all fees and costs associated with defending such challenge, including attorney’s fees and expert fees.

have manufactured, distribute, have distributed, use, lease, loan, import, offer for sale and/or sell any licensed products and licensed services, the Company may reduce payments to UTSW by a certain percentage of the royalty, milestone or other payments paid to such third party.

The UTSW2 Agreement also contains an anti-stacking provision pursuant to which in the event the Company or its sublicensee pays royalties or other payments to a third party who owns or controls intellectual property deemed necessary to develop, manufacture, have manufactured, distribute, have distributed, use, lease, loan, import, offer for sale and/or sell any licensed products and licensed services, the Company may reduce payments to UTSW by a certain percentage of the royalty, milestone or other payments paid to such third party.

However, such adjustment in royalty payments to UTSW may not be reduced by more than a minimum percentage of the royalty obligation in any contract year.

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There are also many other large and small companies developing products for this indication.

Key product features that, if approved, would affect our ability to effectively compete with other therapeutics include the efficacy, safety and convenience of our therapeutics, the ease of use and effectiveness of any complementary diagnostics and/or companion diagnostics, and price and levels of reimbursement.

Key product features that, if approved, would affect our ability to effectively compete with other therapeutics include the efficacy, safety

and convenience of our therapeutics, the ease of use and effectiveness of any complementary diagnostics and/or companion diagnostics, and price and levels of reimbursement.

Our competitors also include large pharmaceutical and biotechnology companies, which may be developing therapeutic candidates with mechanisms similar to our compounds or targeting the same clinical indications as our therapeutic candidates.

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Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.

These early stage and more established competitors also compete with us in

recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.

These early stage and more established competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.

Government Regulation

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In this case, the IND sponsor and the FDA must resolve any outstanding concerns before clinical trials can begin.

clinical hold may occur at any time during the life of an IND and may affect one or more specific studies or all studies conducted under the IND.

A clinical hold may occur at any time during the life of an IND and may affect one or more specific studies or all studies conducted under the IND.

Clinical trials involve the administration of the drug or biological candidate to healthy volunteers or patients having the disease being studied under the supervision of qualified investigators, generally physicians not employed by or under the trial sponsor’s control.

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Concurrent with clinical trials, companies usually complete additional animal studies and develop additional information about the chemistry and physical characteristics of the drug or biologic as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements.

The manufacturing process must be capable of consistently producing quality batches of the drug or biological candidate and, among other things, must include methods for testing the identity, strength, quality and purity of the final drug or biologic.

The manufacturing process must be capable of consistently producing

quality batches of the drug or biological candidate and, among other things, must include methods for testing the identity, strength, quality and purity of the final drug or biologic.

Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the drug or biological candidate does not undergo unacceptable deterioration over its shelf life.

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Many drugs for cancer indications involving patient-specific genetic mutations or biomarkers are approved by FDA with limitations that the specific genetic mutation must be confirmed in each patient by use of an FDA-approved diagnostic test, commonly referred to as a “companion diagnostic.” The FDA issued a final guidance document in July 2014 addressing agency policy in relation to in vitro companion diagnostic tests.

The guidance explains that for some drugs and therapeutic biologics, the use of a companion diagnostic test is essential for the safe and effective use of the product, such as when the use of a product is limited to a specific patient subpopulation that can be identified by using the test.

The guidance explains that for some drugs and therapeutic biologics, the use of a companion diagnostic

test is essential for the safe and effective use of the product, such as when the use of a product is limited to a specific patient subpopulation that can be identified by using the test.

According to the guidance, the FDA generally will not approve such a product if the companion diagnostic is not also approved or cleared for the appropriate indication, and accordingly the therapeutic product and the companion diagnostic should be developed and approved or cleared contemporaneously.

The FDA has also issued a Guidance, Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product (2016), which is “is intended to be a practical guide to assist therapeutic product sponsors and IVD sponsors in developing a therapeutic product and an accompanying IVD companion diagnostic,” and a Guidance, Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products (2020), which “describes considerations for the development and labeling of in vitro companion diagnostic devices (referred to as “companion diagnostics” herein) to support the indicated uses of multiple drug or biological oncology products, when appropriate.”

unapproved or uncleared in vitro companion diagnostic device are so pronounced as to outweigh the risks from the lack of an approved or cleared in vitro companion diagnostic device.

As stated in its Guidance, the FDA may decide that it is appropriate to approve such a product without an approved or cleared in vitro companion diagnostic device when the drug or therapeutic biologic is intended to treat a serious or life-threatening condition for which no satisfactory alternative treatment exists and the FDA determines that the benefits from the use of a product with an unapproved or uncleared in vitro companion diagnostic device are so pronounced as to outweigh the risks from the lack of an approved or cleared in vitro companion diagnostic device.

The FDA encourages sponsors considering developing a therapeutic product that requires a companion diagnostic to request a meeting with both relevant device and therapeutic product review divisions to ensure that the product development plan will produce sufficient data to establish the safety and effectiveness of both the therapeutic product and the companion diagnostic.

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The patent term restoration period is generally one half of the time between the effective date of an IND and the submission date of a NDA, plus the time between the submission date of a NDA and the approval of that application, except that the review period is reduced by any time during which the applicant failed to exercise due diligence.

Only one patent applicable to an approved product or therapeutic candidate is eligible for the extension and the application for extension

must be made prior to expiration of the patent.

Only one patent applicable to an approved product or therapeutic candidate is eligible for the extension and the application for extension must be made prior to expiration of the patent.

The United States Patent and Trademark Office (USPTO), in consultation with the FDA, reviews and approves the application for any patent term extension or restoration.

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ANDA and 505(b)(2) NDA Patent Certification Requirements

Any applicant who files an ANDA seeking approval of a generic equivalent version of a drug listed in the Orange Book or a Section 505(b)(2) NDA referencing a drug listed in the Orange Book must certify to the FDA, as applicable, that (1) no patent information on the drug product that is the subject of the application has been submitted to the FDA;

the drug product that is the subject of the application has been submitted to the FDA;

(2) such patent has expired;

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As in the United States, we may apply for designation of a therapeutic candidate as an orphan drug for the treatment of a specific indication in the European Union before the application for marketing authorization is made.

Orphan drugs in the European Union enjoy economic and marketing benefits, including up to ten years of market exclusivity for the approved indication unless another applicant can show that its product is safer, more effective or otherwise clinically superior to the orphan-designated product, the marketing authorization holder is unable to supply sufficient quantity of the medicinal product, or the marketing authorization holder has given its consent.

orphan-designated product, the marketing authorization holder is unable to supply sufficient quantity of the medicinal product, or the marketing authorization holder has given its consent.

Coverage, Pricing and Reimbursement

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Payment rates may vary according to the use of the product and the clinical setting in which it is used, may be based on payments allowed for lower cost products that are already reimbursed and may be incorporated into existing payments for other services.

Net prices for products may

be reduced by mandatory discounts or rebates required by third-party payors and by any future relaxation of laws that presently restrict imports of products from countries where they may be sold at lower prices than in the United States.

Net prices for products may be reduced by mandatory discounts or rebates required by third-party payors and by any future relaxation of laws that presently restrict imports of products from countries where they may be sold at lower prices than in the United States.

In the U.S., third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies, but they also have their own methods and approval process apart from Medicare coverage and reimbursement determinations.

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• The federal civil and criminal false claims laws, including the civil False Claims Act, and civil monetary penalty laws, prohibit, among other things, knowingly presenting or causing the presentation of a false, fictitious or fraudulent claim for payment to the U.S.

government, knowingly making, using, or causing to be made or used a false record or statement

material to a false or fraudulent claim to the U.S.

government, knowingly making, using, or causing to be made or used a false record or statement material to a false or fraudulent claim to the U.S.

government, or from knowingly making a false statement to avoid, decrease or conceal an obligation to pay money to the U.S.

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It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations, agency guidance or case law involving applicable fraud and abuse or other healthcare laws and regulations.

If our operations are found to be in violation of any such requirements, we may be subject to significant civil, criminal and administrative penalties, including monetary damages, fines, disgorgement, imprisonment, loss of eligibility to obtain approvals from the FDA, exclusion from participation in government contracting, healthcare reimbursement or other government programs, including Medicare and Medicaid, reputational harm, diminished profits and future earnings, additional reporting requirements if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with any of these laws, and the curtailment or restructuring of our operations.

reputational harm, diminished profits and future earnings, additional reporting requirements if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with any of these laws, and the curtailment or restructuring of our operations.

Manufacturing

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Manufacturers of our products are required to comply with applicable FDA manufacturing requirements contained in the FDA’s current good manufacturing practices, or cGMP, regulations.

cGMP regulations require, among other things, quality control and

quality assurance as well as corresponding maintenance of records and documentation.

cGMP regulations require, among other things, quality control and quality assurance as well as corresponding maintenance of records and documentation.

Pharmaceutical product manufacturers and other entities involved in the manufacture and distribution of approved pharmaceutical products are required to register their establishments with the FDA and certain state agencies and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP and other laws.

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Our Corporate Information

We were incorporated in Delaware in August 2018, and we have operations in Chicago, Illinois, with some of our team members setup virtually and working remotely in California, Nevada, North Carolinia, New Jersey, and Florida, among others.

We were incorporated in Delaware in August 2018, and we have operations in Chicago, Illinois, with some of our team members setup virtually and working remotely in California, Oregon, Massachusetts, Iowa, Ohio, Texas, North Carolinia, and New Jersey.

Our principal executive office is located at 444 West Lake Street, Suite 1700, Chicago, IL 60606, and our phone number is (312) 416-8592.

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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 1. Business