Item 1A. Risk Factors 51
Item 1B. Unresolved Staff Comments 101
Item 1C. Cybersecurity 101
Item 2. Properties 102
Item 3. Legal Proceedings 102
Item 4. Mine Safety Disclosures 102
PART II
Item 6. [Reserved] 103
Item 7A. Quantitative and Qualitative Disclosures About Market Risk 115
Item 8. Financial Statements and Supplementary Data 116
Item 9A. Controls and Procedures 116
Item 9B. Other Information 116
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 116
PART III
Item 10. Directors, Executive Officers and Corporate Governance 117
Item 11. Executive Compensation 117
Item 14. Principal Accountant Fees and Services 117
PART IV
Item 15. Exhibits and Financial Statement Schedules 117
i
Special
Note Regarding Forward-Looking Statements
This
Annual Report on Form 10-K contains forward-looking statements. All statements other than statements of historical facts contained in
this report, including statements regarding our future results of operations and financial position, business strategy, product candidates,
planned preclinical studies and clinical trials, research and development costs, regulatory approvals, timing and likelihood of success,
as well as plans and objectives of management for future operations, are forward-looking statements. In some cases, forward-looking statements
may be identified by words such as “believe,” “may,” “will,” “estimate,” “continue,”
“anticipate,” “intend,” “could,” “would,” “expect,” “objective,”
“plan,” “potential,” “seek,” “grow,” “target,” “if,” and similar
expressions intended to identify forward-looking statements.
We
have based these forward-looking statements largely on our current expectations and projections about future events and trends that we
believe may affect our financial condition, results of operations, business strategy short-term and long-term business operations and
objectives and financial needs. These forward-looking statements are subject to known and unknown risks, uncertainties and assumptions,
including risks described in the section titled “Risk Factors” set forth in Part I, Item 1A of this Annual Report on Form
10-K and in our other filings with the Securities and Exchange Commission (the “SEC”). It is not possible for our management
to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of
factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of
these risks, uncertainties and assumptions, the future events and trends discussed in this Annual Report on Form 10-K may not occur,
and actual results may differ materially and adversely from those anticipated or implied in the forward-looking statements. Forward-looking
statements contained in this Annual Report on Form 10-K include, but are not limited to, statements about:
● our financial performance;
● the ability to receive FDA clearance for clinical trials;
● our plans relating to commercializing our drug candidates, if approved;
● our ability to attract and retain key scientific and clinical personnel;
● our ability to establish our own manufacturing facilities domestically;
● the success of competing therapies that are or may become available;
● the beneficial characteristics, safety and efficacy of our drug candidates;
● regulatory developments in the United States and other jurisdictions;
● our plans and ability to obtain or protect intellectual property rights;
● potential claims relating to our intellectual property.
We
caution you that the foregoing list may not contain all of the forward-looking statements made in this Annual Report on Form 10-K. You
should not rely upon forward-looking statements as predictions of future events. The events and circumstances reflected in the forward-looking
statements may not be achieved or occur. Although we believe that the expectations reflected in the forward-looking statements are reasonable,
we cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, we do not intend to update
any of these forward-looking statements after the date of this Annual Report on Form 10-K or to conform these statements to actual results
or revised expectations.
Because
some of these risks and uncertainties cannot be predicted or quantified and may be beyond our control, you should read this Annual Report
on Form 10-K with the understanding that our actual future results, levels of activity, performance and events and circumstances may
be materially different from what we expect.
This
Annual Report on Form 10-K contains estimates, projections and other information concerning our industry, our business and the markets
for our product candidates. We obtained the industry, market and similar data set forth in this report from our own internal estimates
and research and from academic and industry research, publications, surveys and studies conducted by third parties, including governmental
agencies. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject
to uncertainties and actual events or circumstances may differ materially from events and circumstances that are assumed in this information.
While we believe that the data we use from third parties are reliable, we have not separately verified these data. Further, while we
believe our internal research is reliable, such research has not been verified by any third party. You are cautioned not to give undue
weight to any such information, projections and estimates.
PART
I
Item
1. Business.
Our
Company
MAIA Biotechnology, Inc. (MAIA, the Company, we, or us) is a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer. Ateganosine (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 ateganosine in our Phase 2 human trial (THIO-101) in Australia.
In December 2022, regulatory authorities in three European countries, Hungary, Poland, and Bulgaria, approved the implementation of THIO-101,
Phase 2 clinical trial evaluating ateganosine in patients with Non-Small Cell Lung Cancer (NSCLC). In the trial, patients with advanced
NSCLC are treated first with ateganosine followed a few days later by the immune checkpoint inhibitor Libtayo® (cemiplimab),
manufactured and commercialized by Regeneron. Cemiplimab is a fully human monoclonal antibody targeting the immune checkpoint receptor
PD-1 on T-cells. Cemiplimab has been approved in the United States and the rest of the world for multiple cancer indications, including
NSCLC. In February 2021, we signed a clinical supply agreement with Regeneron to receive cemiplimab at no cost, which represents a significant
cost-savings for the study. In return, we have granted Regeneron exclusive development rights in combination with PD-1 inhibitors for
NSCLC for the study period. In July 2025, we initiated an expansion of the THIO-101 trial focused on third-line NSCLC patients who are
resistant to checkpoint inhibitors and chemotherapy. The expansion will enroll up to 48 patients with two arms: Arm 1, continuing the
evaluation of ateganosine sequenced with Libtayo® (cemiplimab); and Arm 2, evaluating ateganosine as a monotherapy, to further gain
experience of ateganosine in the contribution of components. Based on the clinical data generated by our THIO-101 trial, we plan to seek
filing for an accelerated approval of ateganosine in the United States for the treatment of patients with advanced NSCLC in 2026, but
even if granted, accelerated approval status does not guarantee an accelerated review or marketing approval by the Food and Drug Administration
(FDA).We initiated a Phase 3 pivotal trial in 2025, named THIO-104, to evaluate the efficacy of ateganosine administered in sequence
with a checkpoint inhibitor (CPI) in third-line NSCLC patients who are resistant to checkpoint inhibitors and chemotherapy. 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 ateganosine administered in sequence with
BeOne Medicines’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.
Our
Lead Product Candidate
Ateganosine
is a telomere-targeting agent currently in clinical development to evaluate its activity in NSCLC. Telomeres, along with the enzyme telomerase,
play a fundamental role in the survival of cancer cells and their resistance to current therapies. Ateganosine is being developed as
a second- or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint
inhibitors.
In
2019, our research team discovered that ateganosine produced telomere modifications and disruption, which ultimately induced cancer-specific
innate and adaptive immune responses against immunologically “cold” or tumor types that were unresponsive to immune checkpoint
inhibitors. This hypothesis was tested and demonstrated in syngeneic and humanized mouse models. Ateganosine administered to mice in
low doses and followed by an immune-checkpoint inhibiting agent, such as an anti-PD-1 or anti-PD-L1 compound, induced complete tumor
regression with no tumor recurrence during the 14 weeks of observation. Further, no toxicities were reported in the tumor-free mice.
These new findings were published in the peer-reviewed research scientific journal, Cancer Cell in July 2020. Based on these recent discoveries,
a new therapeutic approach has been designed to advance ateganosine in patients with advanced
NSCLC.
Our
regulatory strategy includes a filing of an Investigational New Drug application (IND) with the United States Food and Drug Administration
(U.S. FDA or FDA). This was granted and will allow U.S. sites to participate in the THIO-101 NSCLC trial. 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 ateganosine in light of the fact
that the ateganosine 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 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. IND application. The U.S. IND was granted in 2023.
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. Based on the clinical data we aim to generate in
the THIO-101 study and assuming ateganosine achieves its intended clinical effect with a manageable safety profile at one of the doses
tested in the study, we expect to seek early FDA guidance on the possibility of utilizing one or more of FDA’s expedited programs
for serious conditions, such as fast track designation (FTD), breakthrough therapy designation, priority review and/or accelerated approval
designation. Accelerated approval status does not guarantee an accelerated review or marketing approval by the FDA. In July 2025, the
FDA granted fast track designation for ateganosine and we intend to utilize the incentives of the Fast Track Program to expedite the
development and review of ateganosine.
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 ateganosine, 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.
On
April 18, 2023, we published data in Hepatocellular Carcinoma (HCC) models: as monotherapy, ateganosine 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. Even upon rechallenge with two times more cancer cells and no
additional treatment, tumor growth was completely prevented. Administration of ateganosine alone and in combination with Libtayo®
generated anticancer immune memory.
On
April 20, 2023, we announced preliminary survival data from Part A of THIO-101. The first two patients enrolled in Part A of the study
continued 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 of therapy respectively after previously failing treatment with an
immune checkpoint inhibitor. They continue to be progression free following their last dose of ateganosine, 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
June 20, 2023, we announced updates in enrollment in THIO-101 in Europe. To that date, 29 patients have been dosed in THIO-101. With
the addition of sites in Hungary, Poland, and Bulgaria in March 2023, THIO-101 has rapidly increased the number of patients enrolled
and dosed with ateganosine. Thirteen sites were activated with another two new additional sites ready to open shortly afterward.
On
July 10, 2023, we announced updates on preliminary survival data in the Part A safety lead-in of THIO-101. The first 2 patients enrolled
in the study continued to be alive, approximately 12.2 and 11.5 months respectively, from treatment initiation. Both patients have advanced
Stage IV metastatic disease and failed 2 prior lines of therapy, including one line with an immune CPI, and platinum-based
chemotherapy. Following the conclusion of study treatment, they have remained free of disease progression for 10.2 and 8.5 months, respectively,
without requiring any additional therapy.
On
July 11, 2023, we announced updates on disease control data in the part A safety lead-in of THIO-101. Of the first 11 patients enrolled
in THIO-101 to complete at least 1 post baseline response assessment, 9 (82%) met the primary endpoint of disease control (defined as
a Complete Response, Partial Response, or Stable Disease per RECIST 1.1). All patients enrolled have previously failed 2 or more prior
lines of treatment including an immune CPI and platinum-based chemotherapy for advanced NSCLC.
On
October 24, 2023, we reported unprecedented interim disease control rate (DCR) of 100% in second-line treatment that far surpasses standard
of care (SoC) DCR of 53-64%, presented at ESMO 2023. DCR is far stronger than overall response rate (ORR) in predicting overall survival
benefit, as shown in a recent meta-analysis of 74 clinical trials worldwide in NSCLC.
On
December 19, 2023, we announced dose selection for THIO-101, a Phase 2 clinical trial evaluating its lead asset, ateganosine, in sequential
combination with Regeneron’s anti-PD-1 cemiplimab (Libtayo®) in patients with advanced NSCLC. During the dose-finding stage of THIO-101, patients were administered either 60mg, 180mg, or 360mg of ateganosine 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. Subsequently, all future trial participants will be treated with ateganosine
180mg/cycle.
On
January 17, 2024, we announced new interim data for our ongoing THIO-101 Phase 2 trial in NSCLC. In the
latest available data from THIO-101 (November 13, 2023), 60 patients had been dosed with ateganosine in sequential combination with Libtayo®.
The patients received either 60mg, 180mg, or 360mg of ateganosine 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 Treat (PCT) application titled “Dinucleotides and
Their Use in Treating Cancer.” The new dinucleotides disclosed in the patent application are telomere-targeting molecules, such
as ateganosine fragments or other ateganosine 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 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. As of the latest data available for the trial, 79 patients had received
either 60mg (24 patients), 180mg (41 patients) or 360mg (14 patients). The original trial design targeted up to 182 patients, including
all patients in the safety lead-in and 41 patients in each of the 3 tested doses (60mg, 180mg, and 360mg). 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, 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 ateganosine 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 ateganosine 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 ateganosine 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 ateganosine, 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
ateganosine 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 ateganosine in Phase 2 clinical trial, with 38% ORR in third-line (3L) setting (ateganosine 180mg) compared to ~6% for currently
available treatments in a similar population and 5.5 months median progression-free survival (PFS) (3L, ateganosine 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 ateganosine. 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 ateganosine 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 ateganosine sequenced with cemiplimab.
On
September 10, 2024, we announced updates from our lead clinical candidate ateganosine, 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) ateganosine’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 ateganosine in sequential administration with cemiplimab (Libtayo®). The new expansion
will further assess the efficacy of MAIA’s lead asset, ateganosine, 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 ateganosine 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 ateganosine, its small molecule telomere-targeting anticancer agent, in combination with BeiGene’s immune CPI tislelizumab in three cancer indications. The single arm pivotal Phase 2 trials will study the drug combination in HCC, SCLC and 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 ateganosine
and is free to develop the programs in combination with other agents and in other indications. Since May 2025, BeiGene has changed its
company name to BeOne Medicines.
On
February 4, 2025, we announced positive updated data from THIO-101 Phase 2 clinical trial evaluating its lead clinical candidate, ateganosine,
sequenced with Regeneron’s immune CPI cemiplimab (Libtayo®) in patients with advanced 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 ateganosine (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 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 ateganosine sequenced with Libtayo® (cemiplimab); and Arm
2, evaluating ateganosine as a monotherapy, to further gain experience of ateganosine in the contribution of components. Treatment cycles
for patients in both arms will administer ateganosine 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 ateganosine
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 a telomere-targeting anticancer agent in clinical development as a first-in-class treatment for
advanced non-small cell lung cancer (NSCLC). The company chose a name inspired by the mechanism of action of THIO: altering telomeric
guanosine of the cancer cells. The generic name ateganosine is a unique and consistent identity that aims to support clear communication
between healthcare providers, patients and researchers. MAIA will retain the name THIO in its clinical trial designations (THIO-101,
THIO-102, THIO-103, THIO-104).
On
March 20, 2025, we announced the publication of preclinical data for our lead proprietary telomere-targeting ateganosine dimer in
the peer-reviewed scientific journal Naunyn-Schmiedeberg’s Archives of Pharmacology. In a preclinical study, ateganosine and
its new described dimer form were found to be potent inhibitors of Glutathione S-transferase Pi (GSTP1), a key enzyme implicated in
cancer progression and chemoresistance and a highly important factor for the detoxification of cancer cells. The findings suggest
that the dimerized form of ateganosine could enhance chemotherapeutic efficacy by effectively targeting GSTP1 and reducing drug
resistance. The article, titled “Investigation of the inhibitory effects of the telomere-targeted compounds on glutathione
S-transferase P1,” was published on February 15, 2025.
On
June 5, 2025, we announced updated data from its THIO-101 pivotal Phase 2 clinical trial. As of May 15, 2025, third line (3L) data showed
median overall survival (OS) of 17.8 months for the 22 NSCLC patients who received at least one dose of ateganosine (the intent-to-treat
population) in parts A and B of the trial. The updated analysis continues to demonstrate a 95% confidence interval (CI) lower bound of
12.5 months and a 99% CI lower bound of 10.8 months. The Company also mentioned that treatment had been generally well-tolerated to date
in this heavily pre-treated population.
On
June 5, 2025, we announced that a new partial response (PR) was identified in a patient after 20 months of treatment in our Phase 2 THIO-101
clinical trial. A partial response is defined as a decrease in tumor size of at least 30%.
On
June 18, 2025, we announced its entry into a clinical master supply agreement with Roche for future studies investigating the combination
of MAIA’s telomere targeting agent ateganosine (THIO), sequenced with Roche’s checkpoint inhibitor (CPI), atezolizumab (Tecentriq®),
for the treatment of multiple hard-to-treat cancers.
On
June 24, 2025, we announced the appointment of two prominent oncologists to its Scientific Advisory Board (SAB), Claudia Fulgenzi, MD,
and David J. Pinato, MD, MRCP (UK), PhD. Both are specialists in hepatocellular carcinoma (HCC), a tumor type to be studied in future
clinical trials of MAIA’s lead candidate ateganosine (THIO) sequenced with a checkpoint inhibitor.
On
July 9, 2025, we announced the dosing of the first patient in Taiwan in the expansion phase of our THIO-101 Phase 2 trial for advanced
non-small cell lung cancer (NSCLC). The trial’s entry into another continent marks a key milestone for MAIA, opening a significantly
larger patient pool for its evaluations of ateganosine (THIO). MAIA also announced that screening for the trial is ongoing in Europe
and Asia.
On
July 17, 2025, we announced the publication of preclinical data from its second generation ateganosine prodrugs platform in Nucleic Acids
Research (NAR), a leading open-access peer-reviewed scientific journal. The study, titled “Novel Telomere-Targeting Dual-Pharmacophore
Dinucleotide Prodrugs for Anticancer Therapy,” details MAIA’s lead ateganosine (THIO)-derived second-generation prodrugs
as promising new molecules in its strategy for enhancing cancer treatment and overcoming drug resistance. The manuscript with the data
was published on June 26, 2025, in Volume 53, Issue 12 of the NAR journal.
On
July 28, 2025, we announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ateganosine (THIO,
6-thio-dG or 6-thio2’-deoxyguanosine) for the treatment of non-small cell lung cancer (NSCLC). Ateganosine is currently being evaluated
in a pivotal Phase 2 THIO-101 clinical trial evaluating its anti-tumor activity when followed by a checkpoint inhibitor.
On
August 13, 2025, we announced that the European Patent Office granted a patent broadly covering a portfolio of ateganosine-based analogues
for telomere targeting anticancer therapy and methods of using ateganosine (THIO) alone or before administration of checkpoint inhibitors
(CPIs). The patent, titled “Mercaptopurine Ribonucleoside Analogues for Altering Telomerase Mediated Telomere,” was invented
by MAIA’s Chief Scientific Officer Sergei M. Gryaznov, PhD and Scientific Advisory Board member Jerry W. Shay, PhD. MAIA’s
global patent and patent-pending estate covers several areas including telomerase mediated telomere altering compounds and treatment
of therapy-resistant cancers. Further, ateganosine’s immunogenic treatment strategy, which focuses on sequential combination with
checkpoint inhibitors, has been filed worldwide. MAIA’s IP portfolio for ateganosine currently comprises 10 issued patents worldwide
including Europe (validated in 19 countries) along with 24 pending patent applications.
On
August 27, 2025, we announced that a manuscript detailing developments in its Phase 2 THIO-101 clinical trial was accepted and published
in the international peer-reviewed open access scientific journal, Cells, in a special issue, “Cellular Mechanisms of Anti-Cancer
Therapies.” The manuscript, titled “Perioperative Management of Non-Small Cell Lung Cancer in the Era of Immunotherapy,”
was authored by a group of oncology researchers in Turkey and the U.S. including MAIA scientists Sergei Gryaznov, Ph.D., Chief Scientific
Officer and Ilgen Mender, Director of Biology Research, along with MAIA Scientific Advisory Board members Z. Gunnur Dikmen, M.D., Ph.D.
and Saadettin Kiliçkap, M.D., M.Sc.
On
September 11, 2025, we highlighted positive efficacy data from its Phase 2 clinical trial, THIO-101, including that as of June 30, 2025:
(i) estimated median progression free survival (PFS) in third-line treatment (180 mg dose) was 5.6 months; (ii) Estimated median overall
survival (OS) was 17.8 months, with a 95% confidence interval (CI) lower bound of 12.5 months and a 99% CI lower bound of 10.8 months,
consistent with the prior data readout (May 15, 2025); (iii) Across patients of all treatment lines, 2 patients have completed 33 cycles
of therapy, highlighting ateganosine’ potential for extended dosing, which usually translates into longer patient survival.
On
October 23, 2025, we announced that as of September 17, 2025, a patient that began therapy in March 2023 has shown survival of 30
months, or 912 days, an outstanding measure relative to many of the high-risk cancers. The patient with thirty month survival
received therapy every three weeks and concluded treatment upon reaching the maximum treatment duration of 2 years based on protocol
requirements.
On
October 27, 2025, we announced that we have enrolled five patients from Taiwan and Turkey in the expansion phase of its THIO-101 Phase
2 trial.
On
November 20, 2025, we announced Romania as an additional country to begin screening patients for the expansion phase of its THIO-101
Phase 2 clinical trial which evaluates ateganosine sequenced with an immune checkpoint inhibitor as a third-line treatment for non-small
cell lung cancer (NSCLC).
On
November 21, 2025, we announced that we have enrolled 12 patients from Taiwan, Turkey, Hungary and Poland in the expansion phase
of its THIO-101 Phase 2 trial.
On
December 11, 2025, we announced that the first patient has been dosed in THIO-104 Phase 3 pivotal trial evaluating the efficacy of ateganosine
administered in sequence with a checkpoint inhibitor (CPI) as a third-line treatment for advanced non-small cell lung cancer (NSCLC).
The multicenter, open-label trial is designed to assess overall survival for ateganosine sequenced with a CPI compared to investigator’s
choice of chemotherapy in a 1:1 randomization of up to 300 patients. MAIA has received regulatory approval to screen patients in Taiwan,
Turkey, select European Medicines Agency (EMA) countries, and Georgia. Screening and enrollment are now underway.
On
January 20, 2026, we provided a corporate update on 2025 achievements and highlighted key targeted milestones and growth catalysts for
2026. The targeted milestones include: (i) initial measures of efficacy from Phase 3 study, with interim disease control rates (DCR),
overall response rates (ORR) and progression free survival (PFS) analysis of ateganosine compared to the control arm will support regulatory
discussions; (ii) expected conclusion of Part C of Phase 2 study, which will provide additional clinical efficacy data to support regulatory
review for commercial approval; (iii) Plan to engage in regulatory interactions with the FDA to expand ongoing FDA dialogue under the
Fast Track designation, including discussions around trial enhancements and prospects for Accelerated Approval and Priority Review; (iv)
clinical development of second-generation molecules planned to start in Phase 1 trials, with additional small molecules fully developed
in-house with better expected efficacy compared to ateganosine.
In
addition to NSCLC, HCC, SCLC and CRC we plan to conduct clinical trials evaluating ateganosine (THIO) in sequential combination with
an immune checkpoint inhibitor in several other cancer indications, including solid tumors, such as breast, prostate, gastric, pancreatic
and ovarian cancers.
Our
Science—Driven Telomere Targeting Approach
Telomeres
are regions of repetitive DNA nucleotide sequences that are associated with specialized proteins at the ends of linear chromosomes in
cells. Ateganosine’s mechanism of action comprises telomere targeting and induction of anti-cancer immunogenicity. The enzyme telomerase
recognizes ateganosine’s metabolite formed in situ and incorporates it into the structure of the cancer cell’s telomeres,
creating a faulty structure, which breaks apart the telomere spatial structure. As a result, the ateganosine-modified telomeric structure
unwinds, recognized as DNA damage, and the cancer cells die. We believe ateganosine transforms “cold” tumors into “hot”
tumors rendering them responsive to immunotherapy (checkpoint inhibitors) and this process takes place promptly within 24 to 72 hours.
We also believe we can improve the immunotherapy efficacy and we can restore the immunotherapy efficacy in patients who have progressed
or developed resistance to prior immunotherapy.
Telomere
maintenance is a fundamental biologic process for cell proliferation and resilience in cancer cells and thus represents one of the key
therapeutic targets for cancer treatment. Telomerase is an enzyme that is present in a majority of human cancer cells (over 85% in the
aggregate), across various tumor types. In contrast, its activity is detected in less than 1% of normal cells. Ateganosine has only been
shown to be active in cancer cells that are telomerase positive (TERT+) and actively dividing. Cancer cells are constantly telomerase
positive due to an uncontrolled division process, while a relatively small number of normal cells are telomerase positive only transiently.
Therefore, ateganosine activity is expected to be highly specific to cancer cells versus normal cells. Cancer-specific disturbance of
telomeric structure, mediated by telomerase, is likely to lead to disruption in the cell cycle, followed by a very rapid and telomere-length
independent cell death. Ateganosine was observed in preliminary in vitro and in vivo studies to induce cancer-specific telomere disruption,
by using the enzyme telomerase which differentiates ateganosine from all other available cancer therapies currently in clinical use.
We are also currently developing potential next-generation small molecule telomere modifying agents with the goal of identifying additional
proprietary drug candidates, across multiple cancer types. We have generated eighty-two (82) new telomere-targeting compounds of which
sixty (60) compounds have been evaluated in vitro. Currently, seven (7) molecules have been selected for further evaluation in additional
in vitro and in vivo models.
Human
clinical trials prior to approval are typically conducted in three sequential Phases that may overlap or be combined. In Phase 1, the
drug or biologic is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism,
distribution and excretion. In Phase 2, the drug or biologic is evaluated in a limited patient population to identify possible adverse
effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage
tolerance, optimal dosage and dosing schedule for patients having the specific disease. In Phase 3, larger-scale clinical trials are
undertaken to evaluate clinical efficacy and safety and the overall risk/benefit ratio of the product. Post-approval studies, or Phase
4 clinical trials, may be conducted voluntarily, or as a condition of FDA’s approval of a drug. These studies may be used to confirm
preliminary efficacy results, gain additional experience from the treatment of certain patient populations, or to support additional
indications or labeling changes.
We
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 was approved on March 1, 2022, by the Australian Regulatory Agency—Bellberry Human Research Ethics Committee.
In July 2022, the first patient was administered with ateganosine in our Phase 2 human trial (THIO-101) in Australia. In December 2022,
regulatory authorities in three European countries, Hungary, Poland, and Bulgaria, approved the implementation of THIO-101, Phase 2 clinical
trial evaluating ateganosine in patients with NSCLC. In July 2025, we initiated an expansion of the THIO-101 trial focused on third-line
NSCLC patients who are resistant to checkpoint inhibitors and chemotherapy.
We
initiated a Phase 3 pivotal trial in 2025, named THIO-104, to evaluate the efficacy of ateganosine administered in sequence with a checkpoint
inhibitor (CPI) in third-line NSCLC patients who are resistant to checkpoint inhibitors and chemotherapy. 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
March 2022, the FDA granted Orphan Drug Designation (ODD) to ateganosine for the treatment of HCC, in May 2022, the FDA granted the second
ODD to ateganosine for the treatment of small cell lung cancer, and in late 2023, a third ODD for Malignant Gliomas Brain 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
December 2024, the FDA granted rare pediatric disease designation (RPDD) for ateganosine for the treatment of pediatric-type diffuse
high-grade gliomas (PDHGG). 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 or sold as an asset. Rare pediatric disease priority review vouchers (PRVs) can be redeemed by drug
developers for FDA priority review of a different product or transferred or sold to another sponsor. Since 2015, FDA priority review
vouchers have sold as assets at an average amount of $100 million.
In
July 2025, the FDA granted fast track designation (FTD) for the treatment of NSCLC. Ateganosine is currently being evaluated in a pivotal
Phase 2 THIO-101 clinical trial evaluating its anti-tumor activity when followed by a checkpoint inhibitor. The FDA Fast Track is a process
designed to facilitate development and expedite the review of drugs for treating serious conditions and filling an unmet medical need,
as in providing a therapy where none exists or which may be potentially better than available therapy. If relevant criteria are met during
the Fast Track process, a drug will be eligible for FDA Accelerated Approval and Priority Review.
Our
Second Generation Molecule Candidates
We
have initiated an early-stage research and discovery program aimed at identifying new compounds capable of acting through similar mechanisms
of activity as ateganosine, such as the targeting and modifying telomeric structures of cancer cells through cancer-cell intrinsic telomerase
activity. The main objective for this program is to discover new compounds with potentially improved specificity towards cancer cells
relative to normal cells and with potentially increased anticancer activity. This program may also allow us to strengthen our patent
portfolio. Although the program is in early stages and we may not be able to identify suitable compounds, we believe we will be able
to create a second generation of ateganosine-like compounds.
Our
current 2nd-generation pipeline of potential telomere-targeting agents includes seven compounds that have successfully undergone in vitro
inhibitory testing in five cancer models. The data from those studies showed a significantly lower 50% inhibitory concentration (IC50)
for those compounds compared to ateganosine. Based on those data, we have progressed those seven compounds to in vivo testing. In January
2023, we nominated one lead new molecular entity candidate (designated as MAIA-2021-20) and one back-up new molecular entity candidate
(MAIA-2022-12) for further advancement into preclinical GLP-toxicity and other studies and may advance one of these candidates into human
clinical trials upon completion of the required preclinical evaluations. A third candidate (MAIA-2021-029) was selected in June 2023.
MAIA has filed three different families of patent applications that cover
its 2nd-generation of compounds. One family (Dinucleotides and Their Use in Treating Cancer) is filed in the US, AU, BR, CA, CH, EPO,
KR, MX, JP and TW. The second family (Tumor Redox-Activated 6-thiopurine Containing Dimer Compounds) has been filed in the US, AU, BR,
CA, CN, EP, IL, JP, KR, MX, RU, and SG. The third patent application (Dinucleotides And Their Use In Treating Cancer) has been filed in
the US and under the PCT (Patent Cooperation Treaty) and will undergo national phase filings in March 2026.
OUR
PIPELINE
Our
robust pipeline includes several targeted immuno-oncology candidates for relapsed and refractory cancers.
Our
Therapeutic Strategy
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 clinical programs with ateganosine in sequential combination with a checkpoint
inhibitor for the treatment of NSCLC. Ultimately, our goal would be to position ateganosine as a patient anticancer immunity priming
treatment for all immune-activating agents used in the treatment of cancer. To date THIO-101 and THIO-104 are the only clinical trials
testing ateganosine in combination with a checkpoint inhibitor. The key elements of our strategy are to:
● Develop a franchise of telomere-targeting cancer treatments.
● Expand our existing intellectual property portfolio.
We
will face certain challenges in implementing our business strategy including, among others, the fact that earlier development of ateganosine
was not commercially pursued. Even if ateganosine successfully advances through clinical studies and towards approval for use, we may
face early competition from generic alternatives to ateganosine after expiration of any applicable regulatory exclusivities.
Ateganosine
Market Opportunity and Unmet Medical Need
Most
cancer cells are telomerase positive (TERT+), including 57% to 100% of primary human cancers dependent upon tumor type, indicating a
significant potential therapeutic utilization for ateganosine across most of the tumor types. We believe successful targeting of telomeres
in TERT+ cancers may represent a significant potential for broad therapeutic utilization.
Tumor Type TERT(+) Tumor Type TERT(+)
Non-Small Cell Lung Cancer (NSCLC) 78% Pancreatic Cancer 95%
Colorectal (CRC) 82-89% Small Cell Lung Cancer (SCLC) 100%
Hepatocellular Carcinoma (HCC) 79-86% Ovarian Cancer 91%
Breast Cancer 88% Renal Cell Carcinoma (RCC) 83%
Prostate Cancer 90% Glioblastoma Multiforme (GBM) 75%
Bladder Cancer 92% Neuroblastoma 94%
Head & Neck Squamous Cell Carcinoma (HNSCC) 86% Lymphoma (high grade) 100%
Gastric Cancer 85% Chronic Myeloid Leukemia (CML) 71%
Melanoma 83-86% Chronic Lymphocytic Leukemia (CLL) 57%
Cervical Cancer 100% Acute Myeloid Leukemia (AML) 73%
Sources:
A Survey of Telomerase Activity in Human Cancer – JW Shay, S Bacchetti – European Journal of Cancer, 33,5,787-791, 1997.
Telomerase Active in Human Liver Tissues; H Tahara, et al; Cancer Research 55, 2734-2736 1995; Highly /aggressive Metastatic Melanoma
Cell Unable to Maintain Telomere Length; N Viceconte et al; Cell Reports 2017; 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;
Shou et al; 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.
Each tumor type and area of unmet or undermet needs represent significant clinical and commercial opportunity. We believe that ateganosine
offers a desirable profile with significant commercial potential.
Sources:
Global incidence, prevalence, mortality (Global Cancer Observatory / WHO); Global sales (Global Data; BioSpace).
The
table below reflects the current market for checkpoint inhibitors because there is no current market for ateganosine-like molecules.
The years in the indication columns on the table below signify the timing of FDA approval in the US for the clinical indications of interest.
Because the key element of our strategy is to develop ateganosine to work in combination with check-point inhibitors, if ateganosine
is eventually approved by the FDA for use in conjunction with check-point inhibitors, this table provides a high-level understanding
of the potential market for ateganosine in that combination. There is no assurance, however, that any potential market for ateganosine
would follow the current landscape for checkpoint inhibitor franchises.
Current
Landscape of Checkpoint Inhibitor Franchises
2024 Sales Indications (tumor NSCLC SCLC CRC HCC
Drug Company ($B) types) Year of FDA Approval
LIBTAYO (cemiplimab) Regeneron 1.2 3 2021
TEVIMBRA (tislelizumab) BeOne Medicines 0.4 4 2024
TYVYT (sintilimab) Eli Lilly / Innovent 0.6 3
BAVENCIO (avelumab) Pfizer / Merck AG 0.6 3
JEMPERLI (dostarlimab) GSK 0.6 2
Source:
BioMed Tracker 2025
Intellectual
Property
Our global patent and patent-pending estate covers
several areas. Telomerase mediated telomere altering compounds and treatment of therapy-resistant cancers. Further, ateganosine’s
immunogenic treatment strategy, which focuses on sequential combination with checkpoint inhibitors has been filed worldwide. With respect
to ateganosine IP, we maintain three (3) issued US patents, nine (9) issued foreign patents and have four (4) pending US patent applications
and eleven (11) pending foreign 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. Our practice is to actively seek to obtain, where appropriate, intellectual property protection for our
current product candidates and any future product candidates, proprietary information, and proprietary technology through a combination
of patents, protection of proprietary know-how and trade secrets, and contractual arrangements, both in the United States and abroad.
However, full patent protection may not provide us with complete protection against competitors who may seek to circumvent our intellectual
property. Our success will depend on the skills, knowledge, experience and know-how of our management research and development personnel,
as well as that of our advisors, consultants, and other contractors. To help protect our proprietary know-how that is not patentable,
we seek to put in place appropriate internal policies for the management of confidential information requiring all our employees, consultants,
advisors, and other contractors to enter into confidentiality agreements that prohibit the disclosure of confidential information, and
which will require disclosure and assignment to us of the ideas, developments, discoveries, and inventions important to our business.
See “Risk Factors – Risks Related to our Intellectual Property” for additional information.
We
file for patents, both directly and in collaboration with our licensing partners, in the United States with counterparts in certain countries
in Europe and certain key market countries in the rest of the world, thereby covering the major pharmaceutical markets.
On
December 8, 2020, 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). Pursuant to
the amended and restated agreement, which we refer to as the UTSW1 Agreement, we obtained (1) an exclusive, worldwide license to develop
and commercialize the following patent families, which are generally directed to methods of using ateganosine and are owned and/or controlled
by UTSW:
THIO (ateganosine) Intellectual Property
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 US patent no. 12,070,472 (having an anticipated
expiration of March 23, 2037), and patent application No. 18/511,417 (having an earliest expiration of March 22, 2039, if a patent
is granted). All patents are method of use.
On
December 23, 2020, we entered into a second agreement with UTSW, which granted the Company option rights in the UTSW1 Agreement and obtaining
additional license rights. This second license with UTSW, which we refer to as the UTSW2 Agreement, we obtained (1) an exclusive, worldwide
license to develop and commercialize the following UTSW patent family:
Sequential Treatment of Cancers Using 6-Thio-dG and Checkpoint Inhibitors
and
(2) a non-exclusive worldwide license to develop and commercialize related technology rights. The UTSW2 Agreement includes an
exclusive license to issued US patent no. 12,097,213 (having an earliest expiration of July 28, 2041, which includes 138 days of
patent term adjustment). This patent is generally directed to methods of using ateganosine 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 in AU, BR, CA, CH, EPO, KR, MX, JP, US, and TW.
On