(NYSE: MAIA) Profile

January 22, 2024

OUR NEW PROFILE IS: (NYSE AMERICAN: MAIA)

______________________

LEAD CANDIDATE THIO MAINTAINS UNPRECEDENTED DISEASE CONTROL RATES IN PHASE 2 NON-SMALL CELL LUNG CANCER (NSCLC) CLINICAL TRIAL

MULTIPLE CLINICAL MILESTONES AHEAD FOR THIO-101 PHASE 2 TRIAL

MAIA ENTERS 2024 WITH ROBUST CLINICAL PIPELINE IN MULTIPLE HARD-TO-TREAT CANCER INDICATIONS

FDA GRANTS ORPHAN DRUG DESIGNATION TO MAIA BIOTECHNOLOGY FOR THIO AS A TREATMENT FOR GLIOBLASTOMA.

-THIS IS THE THIRD ORPHAN DRUG DESIGNATION GRANTED TO THIO, FOLLOWING THE RECEIPT OF ORPHAN DRUG DESIGNATIONS FOR HEPATOCELLULAR CARCINOMA (HCC) AND SMALL-CELL LUNG CANCER (SCLC) IN 2022. RECEIVING THREE DESIGNATIONS HIGHLIGHTS THE FDA’S RECOGNITION OF THIO’S POTENTIAL TO TREAT MULTIPLE TYPES OF CANCERS, INCLUDING RARE ONES LIKE GLIOBLASTOMA

READ THE INVESTOR PRESENTATION HERE

_______________________________________________________________________________________________________________

Hello Everyone,

We have a new NYSE profile for Today’s session.

This is a company that we have profiled in the past at much lower levels.

The last time we looked at it back in late November it traded as low as .91 on the session.

It recently hit 1.60 and is still sitting significantly that Novembers profile price.

There could be significant room to run based on the chart if it were to see some interest and momentum.

Pull up MAIA and start your research on it immediately .

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a first-in-class cancer telomere targeting agent in clinical development for the treatment of Non-Small Cell Lung Cancer (NSCLC) patients with telomerase-positive cancer cells.

THIO is a Unique Direct Telomere Targeting Agent
• Potential to be used in combination with other anticancer and immune therapies
• Dual, novel mechanism of action: telomere targeting + immunogenic
• FDA awarded THIO 2 Orphan Drug Designations: HCC and SCLC!
• Excellent efficacy: achieved complete and durable responses in HCC in vivo models (peer-reviewed published study)

Partnership with Regeneron

• Clinical supply agreement: Regeneron provides Libtayo® for THIO-101

• Equivalent to $32M non-dilutive participation (largest financing move to date)

• Potentially expand existing relationship and target new companies

Strong and Growing IP Portfolio

• Potential for receiving NCE marketing exclusivity; 5 patents issued, 12 patent applications pending Next Generation Potential Telomere Targeting Therapeutics
• 84 new molecules engineered in last 12 months; Same mechanism of action as THIO

• MAIA-2021-020, MAIA-2022-012 and MAIA-2021-029 significantly more efficacious
• Follow THIO to commercial stage within 4-5 years

MAIA BIOTECHNOLOGY PROVIDES POSITIVE PHASE 2 CLINICAL UPDATES FOR LEAD ANTICANCER AGENT AND OUTLINES TARGETED MILESTONES FOR 2024

January 17, 2024 9:00am EST

Lead candidate THIO maintains unprecedented disease control rates in Phase 2 non-small cell lung cancer (NSCLC) clinical trial
Multiple clinical milestones ahead for THIO-101 Phase 2 trial
Company enters 2024 with robust clinical pipeline in multiple hard-to-treat cancer indications

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, announced new interim data for its ongoing THIO-101 Phase 2 trial in non-small cell lung cancer (NSCLC) and outlined key clinical milestones for 2024.

In the latest available data from THIO-101 (November 13, 2023), 60 patients had been dosed with THIO in sequential combination with Libtayo®. The patients received either 60mg, 180mg, or 360mg of THIO per dose, and 42 had at least one post baseline assessment completed. The observed disease control was well sustained compared to previous scans.

“We are entering 2024 with strong momentum and great excitement about our programs and pipeline,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “To date, preliminary Phase 2 data on THIO in NSCLC has demonstrated unprecedented rates of disease control and response — measures that vastly outperform the standard of care.”

“In addition to NSCLC, our pipeline of immuno-oncology therapies includes THIO orphan drug designations for multiple hard-to-treat cancers, and our research includes THIO-like second-generation telomere-targeting agents. The main objective for the second-generation program is to discover new compounds with potentially improved specificity towards cancer cells relative to normal cells and with potentially increased anticancer activity,” Dr. Vitoc continued.

“Multiple milestones are on target for 2024 as enrollment continues in THIO-101, including long-term efficacy as a major clinical inflection point.”

Key 2023 Achievements

Positive Preliminary Efficacy Data: Key findings from THIO-101 included:

100% preliminary disease control rate (DCR) in second-line and 88% in third-line, in highly difficult-to-treat patients who already progressed through previous lines of treatment.
DCR across all dose levels met pre-determined statistical requirements earlier than expected to proceed to next stage of the trial.

Third orphan drug designation (ODD) granted to THIO: MAIA’s portfolio of immuno-oncology therapies with ODDs now includes a third hard-to-treat cancer, glioblastoma, the most aggressive and most common type of brain cancer with only limited treatment options.

U.S. FDA Investigational New Drug (IND) Clearance: The FDA cleared U.S.-based evaluation for THIO as part of THIO-101. The trial drew a strong pace of enrollment in 2023 compared with previous NSCLC trials by other drug developers.

Dose Selection: A 180mg/cycle dose of THIO was selected for THIO-101 based on stronger efficacy compared to other doses. The selected dose showed unprecedented disease control and overall response rates for a NSCLC clinical trial.

Next Generation Telomere Targeting Agents: MAIA’s second-generation telomere-targeting program is engaged in research and development for new prodrugs derived from lipid-modified THIO molecules. Capable of acting through similar mechanisms of activity as THIO, the higher potency of these compounds at lower dose levels will be investigated further in 2024.

THIO is the only direct telomere targeting agent currently undergoing clinical development in the field of cancer drug discovery and treatment.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently 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.

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with cemiplimab (Libtayo®) followed by THIO has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

FDA GRANTS ORPHAN DRUG DESIGNATION TO MAIA BIOTECHNOLOGY FOR THIO AS A TREATMENT FOR GLIOBLASTOMA

Third orphan drug designation (ODD) granted to THIO by the FDA; drug also holds ODDs for hepatocellular carcinoma and small cell lung cancer
Benefits include 7 years of U.S. market exclusivity after drug approval and tax credits for qualified clinical testing
Expected glioblastoma market growth from $2.2 billion to $3.2 billion globally in the next three years

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA” or the “Company”), a clinical-stage biopharmaceutical company developing telomere-targeting immunotherapies for cancer, announced today that the U.S. Food and Drug Administration (“FDA”) has granted orphan drug designation to its lead asset THIO, a cancer telomere-targeting agent, for the treatment of glioblastoma. This is the third orphan drug designation granted to THIO, following the receipt of orphan drug designations for hepatocellular carcinoma (HCC) and small cell lung cancer (SCLC) in 2022.

“We are pleased to receive a third orphan drug designation for THIO, further highlighting FDA’s recognition of THIO’s potential in the treatment of multiple cancer indications, including rare ones such as glioblastoma,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “Each year, globally, more than 300,000 people are diagnosed with brain tumors, of which, 25,000 are in the United States. Glioblastoma represents the majority of these cases in the U.S., with 15,000 new patients diagnosed and more than 10,000 deaths yearly, making it an orphan indication. Given this prevalence there is significant room for growth in the $2.2 billion glioblastoma market, which is expected to reach $3.2 billion globally in the next three years.¹ We consider this ODD an important milestone for our development strategy and for glioblastoma patients who could benefit from a potentially revolutionary therapy.”

“In the data presented to the FDA, THIO successfully penetrated the blood brain barrier (BBB) in syngeneic and humanized mouse models of telomerase-expressing brain cancers. Treatment with THIO resulted in potent anticancer activity and significant expansion of the animal lifespan for several difficult to treat cell lines and xenograft mouse models,” added Sergei Gryaznov, Ph.D., MAIA’s Chief Scientific Officer. “These results stem from THIO’s remarkable mechanism of action and its BBB penetrating property that allows for direct targeting of brain tumors in vivo and potentially in glioblastoma patients.”

“Glioblastoma is the most aggressive and most common type of cancer that originates in the brain. With very limited treatment options available, glioblastoma patients have exceptionally short survival durations, and only 7% remain alive five years after being diagnosed with the condition,”² said Mihail Obrocea, MD, MAIA’s Chief Medical Officer. “We are optimistic about our telomere-targeting agent’s ability to provide clinical benefit in patients with glioblastoma, and we look forward to studying THIO for the treatment of this highly unmet medical indication in a future trial.”

Enrollment is ongoing in a Phase 2 trial of THIO, THIO-101, evaluating the drug candidate in patients with advanced non-small cell lung cancer (NSCLC). THIO is the only direct telomere targeting agent currently in clinical development.

About Orphan Drug Designation

The FDA’s Orphan Drug Act of 1983 was designed to incentivize the development of therapies that demonstrate promise for the treatment of rare (orphan) diseases or conditions. A disease is classified as “rare” if it affects fewer than 200,000 people total in the U.S., or if the cost of developing a drug and making it available in the U.S. for such diseases will exceed any potential profits from its sale due to the small target population size. The FDA’s ODD program provides multiple incentives to make orphan drug development more financially possible for companies to pursue, such as up to seven years of market exclusivity for the approved orphan drug, up to 20 years of 25% federal tax credit for expenses incurred in conducting clinical research within the U.S. and waiver of Prescription Drug User Fee Act (PDUFA) fees for orphan drugs, a value of approximately $2.9 million in 2021.

MAIA BIOTECHNOLOGY REPORTS THIRD QUARTER 2023 FINANCIAL RESULTS AND HIGHLIGHTS RECENT DEVELOPMENT PROGRESS FOR ANTICANCER ASSET THIO

Substantial THIO program progress including unprecedented disease control rate (DCR) of 100% in second-line non-small cell lung cancer (NSCLC)
Key THIO findings in gliomas, pediatric brain cancer, and second generation THIO-derived cancer therapies
Strong pace of enrollment in THIO-101 Phase 2 trial exceeds average enrollment pace in similar NSCLC trials

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA” or the “Company”), a clinical-stage biopharmaceutical company developing telomere-targeting immunotherapies for cancer, today reported financial results for the third quarter ended September 30, 2023 and key operational updates.

“Our successful and productive third quarter was punctuated by the outstanding data on our lead asset THIO that we recently revealed, and an accelerating pace of enrollment in our THIO-101 Phase 2 trial,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “We are expanding our trial in Europe, and with the FDA’s recent clearance for THIO studies in the U.S. as part of THIO-101, we have reached an essential milestone in the clinical development of THIO. Preliminary efficacy data from the trial is excellent and includes an unprecedented disease control rate (DCR) of 100% in second-line NSCLC treatment, far surpassing the standard of care DCR of 53-64%. We achieved the pre-determined statistical requirements to proceed to the next stage of the trial earlier than expected, and we look forward to sharing our continuing progress in the coming months and into 2024.”

Third Quarter Business Highlights and Recent Developments

THIO Program

Announced 100% Disease Control in Second-Line Non-Small Cell Lung Cancer Demonstrating Impressive Positive Preliminary Efficacy Data: 100% preliminary DCR was observed in second-line and 88% in third-line, in highly difficult-to-treat patients who already progressed through previous lines of treatment. DCRs across all dose levels met the pre-determined statistical requirements earlier than expected to proceed to next stage of the THIO-101 Phase 2 trial.

Highly Potent Anticancer Activity in Gliomas: MAIA’slead asset THIO showed highly potent anticancer activity in models of glioma, an aggressive type of brain tumor that originates from glial cells and is among the most difficult-to-treat cancers. As a monotherapy, THIO demonstrated efficacy in multiple glioma cell lines that had acquired resistance to the current state-of-the-art care temozolomide (TMZ).

THIO as Potential Therapy for Pediatric Brain Cancer: Study data showed THIO’s potent anticancer activity in diffuse intrinsic pontine glioma (DIPG), one of the most aggressive tumors affecting the central nervous system in children. The treatment resulted in noticeably increased tumor sensitivity to immune or ionizing radiation therapies.

Higher Anticancer Potency of Next Generation THIO Conjugates: Positive Investigational New Drug-enabling study data on telomere-targeting agents derived from lipid-modified THIO molecules warrant further in vivo in-depth investigation of THIO-like agents as second generation cancer therapies.

THIO-101 Phase 2 Clinical Trial

U.S. FDA Clearance of THIO IND Application: TheU.S. Food and Drug Administration (FDA) cleared an Investigational New Drug (IND) application enabling THIO to be evaluated in the U.S. as part of THIO-101, the Company’s ongoing global phase 2 clinical study in patients with advanced non-small cell lung cancer (NSCLC). THIO is being tested in sequential combination with a checkpoint inhibitor (CPI) to evaluate anti-tumor activity and immune response in NSCLC patients.

Strong Pace of Enrollment in THIO-101: 49 patients have been dosed to date at a pace of enrollment that is currently exceeding the average enrollment pace in similar NSCLC trials. Out of the 49 patients dosed, 37 have already completed at least one post baseline assessment.

Continuing Positive Preliminary Survival Data: The first 2 subjects dosed on trial (both receiving 3rd line of treatment) reported long term survival of 14.6 and 12.5 months, respectively, at the latest post baseline assessment with no new anti-cancer treatment initiated. Follow up was ongoing for the first subject at the time of data cut-off.

Third Quarter 2023 Financial Results

Cash Position: Cash totaled approximately $6.1 million as of September 30, 2023, compared to $10.9 million in cash as of December 31, 2022.

Research and Development (R&D) Expenses: R&D expenses were approximately $2.6 million for the quarter ended September 30, 2023, compared to approximately $2.3 million for quarter ended September 30, 2022. The increase was primarily related to an increase in scientific research expenses.

General and Administrative (G&A) Expenses: G&A expenses were approximately $2.4 million for the quarter ended September 30, 2023, compared to approximately $1.7 million for the quarter ended September 30, 2022. The increase for the quarter was primarily related to an increase in professional fees related to the write-off of deferred offering costs and an increase in investor relations costs.

Other Income, Net: Other income was approximately $0.08 million for the quarter ended September 30, 2023, compared to other income, net of $0.19 million for the quarter ended September 30, 2022, primarily related to a change in the fair value of warrant liability.

Net Loss: Net loss was approximately $4.9 million, or $0.36 per share, for the quarter ended September 30, 2023, as compared to net loss of approximately $4.9 million, or $0.48 per share, for the quarter ended September 30, 2022. Weighted average shares outstanding were 13,675,802 in the third quarter of 2023, compared to 10,165,622 in the third quarter of 2022.

For additional information on the Company’s financial results for the quarter ended September 30, 2023, please refer to the Form 10-Q filed with the SEC.

About THIO

About THIO-101, Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to an anti-PD-1 agent will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

MAIA BIOTECHNOLOGY REVEALS NEW DATA SHOWING THIO’S POTENT ANTICANCER ACTIVITY IN AGGRESSIVE PEDIATRIC BRAIN CANCER

OCT 12, 2023 9:20AM EDT

Treatment demonstrates decreased cancer cell proliferation and increased tumor sensitivity to ionizing radiation

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage company developing telomere-targeting immunotherapies for cancer, announced that study data shows THIO’s potent anticancer activity in Diffuse Intrinsic Pontine Glioma (DIPG), one of the most aggressive tumors affecting the central nervous system in children.

The data was recently presented at the Society for Neuro-Oncology’s 2023 Pediatric Neuro-Oncology Research Conference and published in the Neuro-Oncology journal (Volume 25, Issue Supplement_1, June 2023, Page i13). The study evaluated THIO as a potential treatment for DIPG based on inducing direct telomeric DNA damage mediated cancer cell death and activating antitumor immunity in DIPG through the intracellular cGAS/STING pathway, which resulted in noticeably increased tumor sensitivity to immune or ionizing radiation therapies.

Radiotherapy is the only standard of care treatment option for DIPG, yet it is rarely curative. In recent years, several immunotherapy strategies have emerged as potential treatments for DIPG. However, the low mutational burden and rare infiltration of T lymphocytes renders these tumors immunologically “cold” and, therefore, poses challenges for general immunotherapy.

“We have shown that THIO treatment sensitized DIPG cells to ionizing radiation (IR), leading to a significant decrease in DIPG cell proliferation in vitro and in vivo models,” said MAIA’s Chief Scientific Officer Sergei Gryaznov, Ph.D. “These encouraging preclinical studies may support further potential preclinical and clinical development of THIO to be used in combination with IR to treat children with high-risk pediatric brain tumors.”

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer(NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently 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.

MAIA BIOTECHNOLOGY ANNOUNCES SHARE REPURCHASE PROGRAM

September 28, 2023 8:01am EDT

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage company developing telomere-targeting immunotherapies for cancer, today announced that its Board of Directors has approved a share repurchase program with authorization to purchase up to $800,000 of its Class A common stock through September 2024.

“This share repurchase program demonstrates the confidence we have in our market opportunity and our strategy to invest for long-term growth, which we believe is not reflected in the current market valuation,” said Vlad Vitoc, MAIA’s Chief Executive Officer. “By establishing a repurchase plan, we add another tool to our arsenal that can assist with our future financing efforts, enable us to unlock more of the long-term opportunity we see ahead, and drive sustainable value for all stakeholders.”

With a share repurchase program, MAIA may repurchase shares from time to time through various methods, including in open market transactions, in privately negotiated transactions or otherwise, including through the use of trading plans intended to qualify under Rule 10b5-1 under the Securities Exchange Act of 1934, as amended, in compliance with applicable state and federal securities laws. The timing, as well as the number and value of shares repurchased under the program, will be determined by the Company at its discretion and will depend on a variety of factors, including our assessment of the intrinsic value of the Company’s common stock, the market price of the Company’s common stock, general market and economic conditions, available liquidity, compliance with the Company’s debt and other agreements, applicable legal requirements, the nature of other investment opportunities available to the Company, and other considerations. The Company is not obligated to purchase any shares under the repurchase program, and the program may be suspended, modified, or discontinued at any time without prior notice. The Company expects to fund the repurchases by using cash on hand and expected free cash flow to be generated in the future.

Significant Market Opportunity

Cancer is the most dominant of the age-related disease categories and has life altering impacts in the lives of patients and their close ones
The number oF people aged 80 years or older is expectedtotriplebetween 2020 and 2050 to reach 426 million

Approximately40%ofpeoplealivetodayareprojectedtobediagnosed with a cancer type in their lifetime, and 20% will die of it
NSCLC is the leading tumor type: Mortality 1.7M / Sales $32B (2022)
CRCissecond:Mortality1M/Sales$20B(2022)

Clinical Programs

THIO-101: Ph 2 trial THIO + LIBTAYO® (cemiplimab) – enrolling (35 patients dosed to date)

Go-to-market trial in second line NSCLC
Objectives: select most efficacious dose and expand into pivotal trial
Started in 2022 in Australia & Europe; to include US in 2023
Regeneron clinical supply agreement for Libtayo®
File for accelerated approval in 2025
Part A (Safety Lead-in) Complete: No dose-limiting toxicities (DLTs), No Serious Adverse Events (SAE) or Serious Unexpected Suspected Adverse Reactions (SUSAR); Safety profile substantially better than current Standard of Care (SoC)
Preliminary Survival: first 2 patients dosed in Part A continue to be alive, 12.2 and 11.5 months from treatment initiation; progression free after last dose, 10.2 and 8.5 months respectively, with no new treatment; in real-world clinical practice, observed survival in similar heavily pretreated patients is 3-4 months; weeks without therapy
Disease Control Rate: 82%; subjects with 1+ post-baseline response assessment (n=11, 06/23/23); DCR for SoC in third line: 25-35%
Part B (efficacy/dose selection) initiated THIO-102: Ph 2 trial THIO + CPIs

Go-to-market trial in late line of therapy in multiple tumor. types: Colorectal Cancer (CRC), Hepatocellular Carcinoma (HCC, 90% of primary type of liver cancers), and Solid Tumors of any type (ST)
3 umbrellas in each: THIO + Libtayo (REGN); Keytruda (MRK); Tecentriq (Genentech/Roche)
Objectives: select most efficacious combination by tumor type and expand into pivotal trials (9+ possible market entry indications)
Start in 2023, to include US, Europe, Asia, etc.
File for accelerated approvals in 2026 and beyond THIO-103: Ph 2/3 trial of THIO + CPIs

First line NSCLC and SCLC
Expand to Breast, Prostate, Pancreatic, Ovarian, Gastric Cancer, etc.

THIO is a Unique Direct Telomere Targeting Agent
• Potential to be used in combination with other anticancer and immune therapies
• Dual, novel mechanism of action: telomere

targeting + immunogenic
• FDA awarded THIO 2 Orphan Drug

Designations: HCC and SCLC!
• Excellent efficacy: achieved complete and durable responses in HCC in vivo models (peer-reviewed published study)

MAIA BIOTECHNOLOGY ANNOUNCES POTENT ANTICANCER ACTIVITY OF THIO IN GLIOMAS

October 10, 2023 8:01 am EDT CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage company developing telomere-targeting immunotherapies for cancer, today announced that its lead asset THIO showed highly potent anticancer activity in gliomas, an aggressive type of brain tumor that originates from glial cells. THIO’s novel dual mechanism of action – direct telomere targeting and immune system activation, has previously demonstrated similar efficacy in multiple types of telomerase-active tumors.

THIO was evaluated in various in vitro and in vivo models of gliomas. The results demonstrate the promising therapeutic role of THIO for the treatment of primary and temozolomide-resistant recurrent gliomas through specific telomerase-mediated induction of telomeric DNA damage in glioma cells

“High grade adult gliomas are among the most difficult-to-treat cancers, with less-than-desirable clinical outcomes. These encouraging results further highlight THIO’s excellent anti-cancer activity across several cancer indications,” said Vlad Vitoc, M.D., MAIA’s Chief Executive Officer. “We look forward to evaluate THIO as a treatment for brain cancer in clinical setting.”

“THIO was effective in the majority of human and mouse glioma cell lines with no apparent toxicity against normal astrocytes. As a monotherapy, THIO demonstrated efficacy in multiple glioma cell lines that had acquired resistance to the current state-of-the art care temozolomide (TMZ). THIO induced apoptosis in several human glioma cell lines that grow as three-dimensional tumor mass-mimicking neurospheres,” said MAIA’s Chief Scientific Officer Sergei Gryaznov, Ph.D. “Additionally, THIO produced telomeric DNA damage responses not only in glioma cell lines, but also in diverse human-derived tumor specimens (PDXs). In vivo, THIO significantly decreased tumor proliferation in glioblastoma xenografts and a PDX model of glioblastoma.”

The reviewed results were published in: Clin Cancer Res (2021) 27 (24): 6800–6814.

About THIO

Partnership with Regeneron

• Clinical supply agreement: Regeneron provides Libtayo® for THIO-101

• Equivalent to $32M non-dilutive participation (largest financing move to date)

• Potentially expand existing relationship and target new companies

Strong and Growing IP Portfolio

• Potential for receiving NCE marketing exclusivity; 5 patents issued, 12 patent applications pending

Next Generation Potential Telomere Targeting Therapeutics
• 84 new molecules engineered in last 12

months; Same mechanism of action as THIO • MAIA-2021-020, MAIA-2022-012 and

MAIA-2021-029 significantly moreCefficacious
• Follow THIO to commercial stage within 4-5 years

NEWS

Jan 17, 2024 9:00am EST

MAIA BIOTECHNOLOGY PROVIDES POSITIVE PHASE 2 CLINICAL UPDATES FOR LEAD ANTICANCER AGENT AND OUTLINES TARGETED MILESTONES FOR 2024

Jan 05, 2024 8:00am EST

MAIA BIOTECHNOLOGY TO PRESENT AT BIOTECH SHOWCASE 2024 ON JANUARY 9, 2024

Dec 19, 2023 7:00am EST

MAIA BIOTECHNOLOGY ANNOUNCES DOSE SELECTION IN THIO-101 PHASE 2 CLINICAL TRIAL FOR NON-SMALL CELL LUNG CANCER

PUBLISHED

NOV 17, 2023

MAIA BIOTECHNOLOGY (NYSE: MAIA) HAS RECEIVED FDA ORPHAN DRUG DESIGNATION FOR THIO AS A TREATMENT FOR MOST AGGRESSIVE BRAIN CANCER

PUBLISHED

NOV 15, 2023

MAIA BIOTECHNOLOGY ANNOUNCES $4 MILLION REGISTERED DIRECT OFFERING

Nov 10, 2023 7:01am EST

FDA GRANTS ORPHAN DRUG DESIGNATION TO MAIA BIOTECHNOLOGY FOR THIO AS A TREATMENT FOR GLIOBLASTOMA

Nov 07, 2023 8:15am EST

MAIA BIOTECHNOLOGY REPORTS THIRD QUARTER 2023 FINANCIAL RESULTS AND HIGHLIGHTS RECENT DEVELOPMENT PROGRESS FOR ANTICANCER ASSET THIO

Oct 30, 2023 8:41am EDT

MAIA BIOTECHNOLOGY REVEALS HIGHER ANTICANCER POTENCY OF TELOMERE-TARGETING COMPOUNDS DERIVED FROM THIO

Oct 24, 2023 8:00am EDT

MAIA BIOTECHNOLOGY ANNOUNCES 100% DISEASE CONTROL IN SECOND-LINE NON-SMALL CELL LUNG CANCER DEMONSTRATING IMPRESSIVE POSITIVE PRELIMINARY EFFICACY DATA FOR ONGOING THIO-101 PHASE 2 TRIAL

Oct 19, 2023 8:35am EDT

MAIA BIOTECHNOLOGY TO PRESENT PRELIMINARY SAFETY AND EFFICACY DATA FROM THIO-101 PHASE 2 CLINICAL TRIAL AT EUROPEAN SOCIETY FOR MEDICAL ONCOLOGY CONGRESS 2023

Oct 17, 2023 8:01am EDT

MAIA BIOTECHNOLOGY TO PRESENT LATEST FINDINGS FOR SECOND GENERATION THIO PROGRAM AT TURKISH BIOCHEMICAL SOCIETY’S INTERNATIONAL BIOCHEMISTRY CONGRESS 2023

Oct 12, 2023 9:20am EDT

MAIA BIOTECHNOLOGY REVEALS NEW DATA SHOWING THIO’S POTENT ANTICANCER ACTIVITY IN AGGRESSIVE PEDIATRIC BRAIN CANCER

Oct 10, 2023 11:15am EDT

MAIA BIOTECHNOLOGY ACCELERATES ENROLLMENT IN THIO-101 PHASE II CLINICAL TRIAL AS EFFICACY IS OBSERVED IN DOSED PATIENTS

Oct 10, 2023 8:01am EDT

MAIA BIOTECHNOLOGY ANNOUNCES POTENT ANTICANCER ACTIVITY OF THIO IN GLIOMAS

Oct 03, 2023 8:01am EDT

MAIA BIOTECHNOLOGY ANNOUNCES FDA CLEARANCE OF IND APPLICATION FOR THIO, A FIRST-IN-CLASS TELOMERE TARGETING AGENT FOR THE TREATMENT OF NON-SMALL CELL LUNG CANCER

Sep 28, 2023 8:01am EDT

MAIA BIOTECHNOLOGY ANNOUNCES SHARE REPURCHASE PROGRAM

Aug 08, 2023 8:00am EDT

MAIA BIOTECHNOLOGY REPORTS SECOND QUARTER 2023 FINANCIAL RESULTS AND PROVIDES UPDATES FOR THIO-101 PHASE 2 TRIAL FOR NON-SMALL CELL LUNG CANCER

Jul 11, 2023 8:00am EDT

MAIA BIOTECHNOLOGY REPORTS UPDATES ON DISEASE CONTROL RATES FOR THIO-101 PHASE 2 TRIAL FOR ADVANCED NON-SMALL CELL LUNG CANCER

Jul 10, 2023 8:00am EDT

MAIA BIOTECHNOLOGY REPORTS UPDATES ON PRELIMINARY SURVIVAL DATA FOR THIO-101 PHASE 2 TRIAL FOR ADVANCED NON-SMALL CELL LUNG CANCER

Jun 20, 2023 8:00am EDT

MAIA BIOTECHNOLOGY ANNOUNCES UPDATES IN ENROLLMENT IN PHASE II CLINICAL TRIAL: THIO-101 HAS ENROLLED 29 PATIENTS

Jun 07, 2023 8:00am EDT

MAIA BIOTECHNOLOGY FILES SECOND PATENT FOR NEW TELOMERE-TARGETING MOLECULES PROGRAM

May 08, 2023 8:00am EDT

MAIA BIOTECHNOLOGY REPORTS FIRST QUARTER 2023 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE

Apr 27, 2023 4:10pm EDT

MAIA BIOTECHNOLOGY, INC. ANNOUNCES CLOSING OF PUBLIC OFFERING

Apr 24, 2023 9:06pm EDT

MAIA BIOTECHNOLOGY, INC. ANNOUNCES PRICING OF PUBLIC OFFERING

Apr 20, 2023 8:00am EDT

MAIA BIOTECHNOLOGY REPORTS PRELIMINARY SURVIVAL DATA IN PART A OF THIO-101 PHASE 2 TRIAL FOR NON-SMALL CELL LUNG CANCER

MANAGEMENT TEAM

VLAD VITOC, MD, MBA

CHIEF EXECUTIVE OFFICER AND CHAIRMAN

Dr. Vitoc is our Chairman of Board, Chief Executive Officer, and President. Dr. Vitoc has a broad array of experience across commercial strategic analysis and planning and medical affairs, in which he has 20 years of experience. During that time, Dr. Vitoc has managed and supported over 20 early, launch, and mature stage compounds, which have included targeted therapies and immune therapies across more than 25 tumor types, including colorectal cancer, hepatocellular carcinoma, lung cancer, breast cancer, prostate cancer, and renal cell carcinoma. Vlad received an M.D. from the University of Medicine and Pharmacy “Iuliu Hatieganu”, Cluj-Napoca, Romania, and his M.B.A. from the University of South Carolina.

JOSEPH F. MCGUIRE

CHIEF FINANCIAL OFFICER

Mr. McGuire is our Chief Financial Officer, and he brings over 30 years of experience to MAIA, having served as Chief Financial Officer for several privately held and publicly traded companies in the healt

SERGEI M. GRYAZNOV, PHD

CHIEF SCIENTIFIC OFFICER

Dr. Gryaznov is our Chief Scientific Officer. Dr. Gryaznov is an internationally recognized scientist and expert in the areas of modern drug discovery and development, oncology, telomerase, immune-regulatory therapeutics, nucleosides, nucleotides, DNA and RNA analogues, lipid and other conjugates, small molecules, and nucleic acid based therapeutic agents. Dr. Gryaznov is the co-inventor of a novel telomere-by-telomerase-targeting therapeutic approach to potential cancer treatment and responsible for leading the research team that characterized THIO’s telomere targeting activity, our lead compound in development. Dr. Gryaznov obtained an M.S., with Honors, in Organic Chemistry and a Ph.D. in Chemistry of Natural Products from M.V. Lomonosov Moscow State University. Dr. Gryaznov also completed a post-doctoral fellowship program in Chemistry at Northwestern University in Evanston, IL.

MIHAIL OBROCEA, MD

CHIEF MEDICAL OFFICER

Mihail is a board-certified internist and hematologist/oncologist with over 25 years’ experience in drug development in both academia and pharmaceutical/biotechnology industry. His broad clinical drug development expertise in both hematology and oncology covers equally early and late-stage development of cell therapy, cancer vaccines, monoclonal antibodies, and small molecules. Mihail completed a residency program in internal medicine at Yale University followed by a fellowship program in hematology/oncology at Dartmouth with academic appointment as Instructor of Medicine in the division of Hematology & Oncology at Mary Hitchcock Medical Center and Geisel Medical School at Dartmouth.

He started his career in pharmaceutical industry at Pfizer Oncology leading the CD40 agonist and IGF-1R antibodies projects, which entered in early clinical trials. Subsequently he led the Medical Affairs Oncology group at MedImmune, Gaithersburg MD and later as VP, Clinical Development Oncology at MannKind Corp., Valencia, CA successfully brought into clinic two cancer vaccine programs. As a Global Project Lead for AbbVie Biotherapeutics in Redwood City, CA, he was responsible for the early clinical oncology monoclonal antibody programs and as Head, Medical Sciences at Pharmacyclics, Sunnyvale CA he took part in the commercial launch of ibrutinib (IMBRUVICA™) program in mantle cell lymphoma and chronic lymphocytic leukemia. As VP of Clinical and Medical Affairs at SFJ Pharmaceutical Group, a venture pharma company supported the medical and business operations of the Pfizer Oncology partnership on the Phase 3, pivotal trial which led to the FDA approval of Besponsa® (inotuzumab ozogamicin) in the R/R adult B-cell ALL.

Later as US Clinical Lead at Nanobiotix Corp, a biotechnology company based in Paris, France which develops nanotechnologies for use in radiation oncology, established the US clinical programs and was involved in the strategic business development, investor, and partner interaction. As a Program Lead at Juno Therapeutics Inc and later Celgene he had the US clinical oversight of 2 clinical trials including the registration Ph 3 trial in second line aggressive large B-cell lymphomas of BREYANZI® (lisocabtagene maralucel) an autologous CD19 targeted CAR T program approved in both US and EU in R/R large B-cell lymphoma. More recently, as Project and Clinical Lead at Atara Bio, a T-cell therapy company based in Thousand Oaks, CA he supported the pre-clinical and clinical development of the Atara’s allogeneic CAR T platform for both lymphoma and solid tumor indications.

Mihail published in oncology peer-reviewed literature and is co-author of a couple of books related to cancer vaccines and immunology as well as he holds several patents in the field of biotechnology.

SINCERELY,

DISCLAIMER

THIS WEBSITE/NEWSLETTER IS OWNED SUBSIDIARY BY DEDICATED INVESTORS, LLC.

OUR REPORTS/RELEASES ARE A COMMERCIAL ADVERTISEMENT AND ARE FOR GENERAL INFORMATION PURPOSES ONLY. WE ARE ENGAGED IN THE BUSINESS OF MARKETING AND ADVERTISING COMPANIES FOR MONETARY COMPENSATION. WE HAVE BEEN COMPENSATED A FEE OF TEN THOUSAND USD BY SICA MEDIA LLC FOR A ONE DAY MAIA AWARENESS CAMPAIGN. NEVER INVEST IN ANY STOCK FEATURED ON OUR SITE OR EMAILS UNLESS YOU CAN AFFORD TO LOSE YOUR ENTIRE INVESTMENT. THE DISCLAIMER IS TO BE READ AND FULLY UNDERSTOOD BEFORE USING OUR SERVICES, JOINING OUR SITE OR OUR EMAIL/BLOG LIST AS WELL AS ANY SOCIAL NETWORKING PLATFORMS WE MAY USE.PLEASE NOTE WELL: DEDICATED INVESTORS LLC AND ITS EMPLOYEES ARE NOT A REGISTERED INVESTMENT ADVISOR, BROKER DEALER OR A MEMBER OF ANY ASSOCIATION FOR OTHER RESEARCH PROVIDERS IN ANY JURISDICTION WHATSOEVER.RELEASE OF LIABILITY: THROUGH USE OF THIS WEBSITE VIEWING OR USING YOU AGREE TO HOLD DEDICATED INVESTORS LLC, ITS OPERATORS OWNERS AND EMPLOYEES HARMLESS AND TO COMPLETELY RELEASE THEM FROM ANY AND ALL LIABILITY DUE TO ANY AND ALL LOSS (MONETARY OR OTHERWISE), DAMAGE (MONETARY OR OTHERWISE), OR INJURY (MONETARY OR OTHERWISE) THAT YOU MAY INCUR. THE INFORMATION CONTAINED HEREIN IS BASED ON SOURCES WHICH WE BELIEVE TO BE RELIABLE BUT IS NOT GUARANTEED BY US AS BEING ACCURATE AND DOES NOT PURPORT TO BE A COMPLETE STATEMENT OR SUMMARY OF THE AVAILABLE DATA. DEDICATED INVESTORS LLC ENCOURAGES READERS AND INVESTORS TO SUPPLEMENT THE INFORMATION IN THESE REPORTS WITH INDEPENDENT RESEARCH AND OTHER PROFESSIONAL ADVICE. ALL INFORMATION ON FEATURED COMPANIES IS PROVIDED BY THE COMPANIES PROFILED, OR IS AVAILABLE FROM PUBLIC SOURCES AND DEDICATED INVESTORS LLC MAKES NO REPRESENTATIONS, WARRANTIES OR GUARANTEES AS TO THE ACCURACY OR COMPLETENESS OF THE DISCLOSURE BY THE PROFILED COMPANIES. NONE OF THE MATERIALS OR ADVERTISEMENTS HEREIN CONSTITUTE OFFERS OR SOLICITATIONS TO PURCHASE OR SELL SECURITIES OF THE COMPANIES PROFILED HEREIN AND ANY DECISION TO INVEST IN ANY SUCH COMPANY OR OTHER FINANCIAL DECISIONS SHOULD NOT BE MADE BASED UPON THE INFORMATION PROVIDED HEREIN. INSTEAD DEDICATED INVESTORS LLC STRONGLY URGES YOU CONDUCT A COMPLETE AND INDEPENDENT INVESTIGATION OF THE RESPECTIVE COMPANIES AND CONSIDERATION OF ALL PERTINENT RISKS. READERS ARE ADVISED TO REVIEW SEC PERIODIC REPORTS: FORMS 10-Q, 10K, FORM 8-K, INSIDER REPORTS, FORMS 3, 4, 5 SCHEDULE 13D.DEDICATED INVESTORS LLC IS COMPLIANT WITH THE CAN SPAM ACT OF 2003. DEDICATED INVESTORS LLC DOES NOT OFFER SUCH ADVICE OR ANALYSIS, AND DEDICATED INVESTORS LLC FURTHER URGES YOU TO CONSULT YOUR OWN INDEPENDENT TAX, BUSINESS, FINANCIAL AND INVESTMENT ADVISORS. INVESTING IN MICRO-CAP AND GROWTH SECURITIES IS HIGHLY SPECULATIVE AND CARRIES AND EXTREMELY HIGH DEGREE OF RISK. IT IS POSSIBLE THAT AN INVESTORS INVESTMENT MAY BE LOST OR IMPAIRED DUE TO THE SPECULATIVE NATURE OF THE COMPANIES PROFILED.THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 PROVIDES INVESTORS A SAFE HARBOR IN REGARD TO FORWARD-LOOKING STATEMENTS. ANY STATEMENTS THAT EXPRESS OR INVOLVE DISCUSSIONS WITH RESPECT TO PREDICTIONS, EXPECTATIONS, BELIEFS, PLANS, PROJECTIONS, OBJECTIVES, GOALS, ASSUMPTIONS OR FUTURE EVENTS OR PERFORMANCE ARE NOT STATEMENTS OF HISTORICAL FACT MAY BE FORWARD LOOKING STATEMENTS. FORWARD LOOKING STATEMENTS ARE BASED ON EXPECTATIONS, ESTIMATES, AND PROJECTIONS AT THE TIME THE STATEMENTS ARE MADE THAT INVOLVE A NUMBER OF RISKS AND UNCERTAINTIES WHICH COULD CAUSE ACTUAL RESULTS OR EVENTS TO DIFFER MATERIALLY FROM THOSE PRESENTLY ANTICIPATED. FORWARD LOOKING STATEMENTS IN THIS ACTION MAY BE IDENTIFIED THROUGH USE OF WORDS SUCH AS PROJECTS, FORESEE, EXPECTS, WILL, ANTICIPATES, ESTIMATES, BELIEVES, UNDERSTANDS, OR THAT BY STATEMENTS INDICATING CERTAIN ACTIONS & QUOTE; MAY, COULD, OR MIGHT OCCUR. UNDERSTAND THERE IS NO GUARANTEE PAST PERFORMANCE WILL BE INDICATIVE OF FUTURE RESULTS. IN PREPARING THIS PUBLICATION, DEDICATED INVESTORS LLC HAS RELIED UPON INFORMATION SUPPLIED BY ITS CUSTOMERS, PUBLICLY AVAILABLE INFORMATION AND PRESS RELEASES WHICH IT BELIEVES TO BE RELIABLE; HOWEVER, SUCH RELIABILITY CANNOT BE GUARANTEED. INVESTORS SHOULD NOT RELY ON THE INFORMATION CONTAINED IN THIS WEBSITE. RATHER, INVESTORS SHOULD USE THE INFORMATION CONTAINED IN THIS WEBSITE AS A STARTING POINT FOR DOING ADDITIONAL INDEPENDENT RESEARCH ON THE FEATURED COMPANIES. DEDICATED INVESTORS LLC HAS NOT BEEN COMPENSATED FOR THIS EMAIL. THE ADVERTISEMENTS IN THIS WEBSITE ARE BELIEVED TO BE RELIABLE, HOWEVER, DEDICATED INVESTORS LLC AND ITS OWNERS, AFFILIATES, SUBSIDIARIES, OFFICERS, DIRECTORS, REPRESENTATIVES AND AGENTS DISCLAIM ANY LIABILITY AS TO THE COMPLETENESS OR ACCURACY OF THE INFORMATION CONTAINED IN ANY ADVERTISEMENT AND FOR ANY OMISSIONS OF MATERIALS FACTS FROM SUCH ADVERTISEMENT. DEDICATED INVESTORS LLC IS NOT RESPONSIBLE FOR ANY CLAIMS MADE BY THE COMPANIES ADVERTISED HEREIN, NOR IS DEDICATED INVESTORS LLC RESPONSIBLE FOR ANY OTHER PROMOTIONAL FIRM, ITS PROGRAM OR ITS STRUCTURE. DEDICATED INVESTORS LLC IS NOT AFFILIATED WITH ANY EXCHANGE, ELECTRONIC QUOTATION SYSTEM, THE SECURITIES EXCHANGE COMMISSION OR FINRA.