OUR NEW PROFILE IS:   

(NYSE AMERICAN: MAIA)

THE COMPANY HAD CASH TOTALING APPROXIMATELY $9.1 MILLION AS OF JUNE 30, 2023

MAIA BIOTECHNOLOGY ANNOUNCES SHARE REPURCHASE PROGRAM JUST LAST WEEK!!

MAIA HAS CLOSED GREEN 4 SESSIONS IN A ROW AFTER BOUNCING OFF OF THE 52 WEEK LOW, TRIGGERING A MAJOR REVERSAL

READ THE INVESTOR PRESENTATION HERE

Hello Everyone,

We have a brand new NYSE profile for tomorrow’s session.

This is a company that we have never featured on this newsletter before.  In fact, I have never seen anyone profile this one in the past.

This could be a hidden gem with a major catalyst driving an intense reversal off of the 52 week low that it just recently hit.

It has been on a tear since then with above average interest starting to come into the company.

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.

Last weeks news announcement regarding a share repurchase program certainly got the attention of investors and this one has been on fire as of late.

It has closed green 4 sessions in a row now and needs to be on your radar heading into tomorrow.

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)

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

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

August 08, 2023 8:00am EDT

• Filed second provisional new composition of matter patent application for MAIA’s third entirely home-grown telomere-targeting molecule
• Reported 35 patients enrolled as of July 2023 in THIO-101 Phase 2 Trial
• First 2 patients dosed with THIO continue to be without documented disease progression for 12.2 and 11.5 months, and remarkably without any new anti-cancer treatment 10.2 and 8.5 months after concluding treatment with THIO, most patients only live for 3-4 months in similar heavily pretreated conditions
• Announced preliminary disease control rate (DCR) of 82%, with 9 of the first 11 patients with post-baseline scans meeting the disease control primary endpoint at first response assessment, typical DCRs are in the 25-35% range for chemotherapy
• Celebrated its 5^th anniversary since being founded on August 3^rd, 2018

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today reported financial results for the second quarter ended June 30, 2023, and provided a corporate update.

“We recently reached an important milestone in the THIO-101 phase 2 trial, with our first patients dosed in the trial crossing the 1 year mark since starting therapy with THIO followed by an immune checkpoint inhibitor, without any additional cancer treatment. These positive preliminary results align well with our preclinical data and supported a faster pace of enrollment in the last quarter in Europe as we continue to activate more sites,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “In addition to THIO, we have 3 proprietary home-grown telomere-targeting molecules patented which further expands our options to treat several cancer indications. For the second half of the year, we look forward to continue evolving in the Part B randomized efficacy/dose selection of THIO-101.”

Corporate Highlights

Reported second broad provisional patent application, nominating MAIA-2021-029 as the third new molecular candidate in MAIA’s Telomere-Targeting Molecule Program: MAIA is creating and evaluating multiple telomere-targeting compounds designed to modify the telomeric structure through the cancer cell intrinsic telomerase activity and cause the death of these cells. The studies, conducted in vitro in multiple cancer cell lines and in vivo in several pre-clinical cancer models, demonstrated the intended mechanism of action and high-level anti-cancer activity for these new molecules.

Announced updates in enrollment in THIO-101 Phase 2 clinical trial: As of July 2023, announced that 35 patients have been dosed in MAIA’s Phase 2 clinical trial, THIO-101, evaluating THIO in patients with advanced Non-Small Cell Lung Cancer (NSCLC). 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 THIO.

Reported positive updates on preliminary survival data for THIO-101: As of July 2023, the first 2 patients dosed with THIO continue to be alive for approximately 12.2 and 11.5 months respectively, from treatment initiation. They have remained free of disease progression for 10.2 and 8.5 months, respectively, without requiring any additional therapy.

Reported updates on disease control rates for THIO-101 Phase 2 trial for advanced Non-Small Cell Lung Cancer: As of July 2023, out of the first 11 patients with post-baseline scans, 82% (9 patients) met the disease control primary endpoint (defined as a complete response, partial response, or stable disease per RECIST 1.1) at first response assessment. In similar heavily treated NSCLC patients, typical disease control rates (DCR) are in the 25-35% range. All patients enrolled had previously failed 2 or more prior lines of treatment including an immune checkpoint inhibitor (CPI) and platinum-based chemotherapy for advanced NSCLC. No new safety analysis was conducted at the time.

Second Quarter 2023 Financial Results

Cash Position: The Company had cash totaling approximately $9.1 million as of June 30, 2023, compared to $8.2 million in cash as of June 30, 2022.

Research and Development (R&D) Expenses: R&D expenses were approximately $2.6 million for the quarter ended June 30, 2023, compared to approximately $2.1 million for quarter ended June 30, 2022. The increase was primarily related to an increase in scientific research expenses of approximately $0.44 million, an increase in payroll and bonus expenses of approximately $0.20 million related to the increased headcount of additional research and development employees, an increase in stock-based compensation costs of approximately $0.06 million and an increase of approximately $0.03 million in other expenses offset by a decrease in Clinical and Scientific research expenses of approximately $0.21 million due to less THIO-101 trial start-up fees, and a decrease in consulting of approximately $0.04 million.

General and Administrative (G&A) Expenses: G&A expenses were approximately $2.0 million for the quarter ended June 30, 2023, compared to approximately $1.3 million for the quarter ended June 30, 2022. The increase for the quarter was primarily due to an increase in other expenses of approximately $0.73 million related to the costs of operating as a public company, and an increase in payroll expense of approximately $0.13 million, offset by a decrease in stock-based compensation of approximately $0.02 million and professional fees of approximately $0.09 million.

Other Income (Expense): Other income was approximately $0.14 million for the quarter ended June 30, 2023, and other income for the quarter ended June 30, 2022 was approximately $0.14 million. The quarterly activity included a gain from the change in the fair value of the warrant liability of approximately $0.10 million offset by a reduction in the Australia research and development incentives of approximately $0.10 million and an increase in interest expense of approximately $0.002 million.

Net Income (Loss): Net loss was approximately $4.5 million for the quarter ended June 30, 2023, as compared to net loss of approximately $3.3 million for the quarter ended June 30, 2022.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is an 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. THIO 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.

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 potential immune system activation effects in NSCLC patients by administering THIO in sequential combination an anti-PD1 therapy, allowing for immune activation and PD-1 sensitivity to take effect. The trial will test the hypothesis that low doses of THIO administered prior to a checkpoint inhibitor 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 agent and a priming immune system agent (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.

NEWS

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,

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