(NYSE: MAIA) Profile

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MAIA BOASTS A 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

MAIA Just Made Another 52 Week High Earlier in This Session

READ THE INVESTOR PRESENTATION HERE

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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.

Pull up MAIA and start your research on it immediately.

MAIA Just made another 52 week high today.

This one could be on the verge of a breakout here as it enters mid-$4 territory.

MAIA has been on a Bull Run since before the New Year and with a strong partnership with Regeneron on the books there is no telling what the limit on MAIA could be.

• 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

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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)

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

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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.

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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.

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COMPARABLE COMPANIES

MAIA BIOTECHNOLOGY ANNOUNCES STRONG EFFICACY OF THIO AS THIRD-LINE TREATMENT FOR NON-SMALL CELL LUNG CANCER PATIENTS

March 06, 2024 8:48am EST Download as PDF

Combination THIO 180mg + cemiplimab achieved 38% overall response rate (ORR) in difficult-to-treat, third-line non-small cell lung cancer (NSCLC)
ORR of 38% significantly exceeds standard of care ORR in NSCLC third-line in patients without a targetable mutation who progressed on checkpoint inhibitors and chemotherapy

CHICAGO--(BUSINESS WIRE)-- MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced positive efficacy data for third-line treatment in its Phase 2 THIO-101 clinical trial evaluating THIO sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in advanced non-small cell lung cancer (NSCLC).

As of January 8, 2024, overall response rate (ORR), characterized as partial or complete response to therapy, was 38% (3 out of 8 patients) in the efficacy evaluable population for combination THIO 180mg + cemiplimab in third-line treatment for NSCLC patients who failed treatment with immune checkpoint inhibitors in prior lines of therapy, with or without chemotherapy.

“As an impressive measure of efficacy, the strong response rate of 38% in third-line treatment supports our premise that THIO administration prior to cemiplimab can improve tumor responses to immunotherapy in advanced NSCLC patients resistant to CPIs and other standard treatments,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “Around 60-70% of NSCLC patients do not have a targetable mutation and cannot benefit from a biomarker-targeted therapy, making it the greatest unmet medical need population in lung cancer. In currently available treatments for these patients in third-line, response rates range around 6%.¹ We are encouraged by the excellent efficacy findings in THIO-101 to date, adding impressive ORR to unprecented disease control rates (DCR), and further demonstrating the potential of our first-in-class treatment to redefine the standard of care for NSCLC patients.”

The efficacy evaluable population defined in the THIO-101 protocol considers all subjects who received at least one dose of THIO treatment and have at least one postbaseline tumor assessment (scans). Two third-line patients in the 180mg dose cohort did not have recorded scans at the data cutoff. Safety remained consistent with previous reports.

The Company recently announced early completion of enrollment in the THIO-101 trial. THIO-101 is expected to be the first completed clinical study of a telomere-targeting agent in the field of cancer drug discovery and treatment.

About THIO

NEWS

May 17, 2024 8:37am EDT

MAIA Biotechnology to Present at the BIO International Convention 2024

May 16, 2024 8:37am EDT

MAIA Biotechnology Abstract Accepted for Poster Presentation at American Society of Clinical Oncology (ASCO) 2024 Annual Meeting

Apr 30, 2024 8:08am EDT

MAIA Biotechnology Announces Share Purchase by Director Adelina Louie in Private Placement

Apr 29, 2024 8:08am EDT

MAIA Biotechnology Announces Share Purchase by Director Stan Smith, Ph.D. in Private Placement

Apr 23, 2024 8:51am EDT

MAIA Biotechnology Announces $1.00 Million Private Placement

Apr 05, 2024 8:01am EDT

MAIA Biotechnology to Present at Two Investor Conferences in April 2024

Mar 28, 2024 3:00pm EDT

MAIA Biotechnology Announces Share Purchases by Directors Cristian Luput and Ramiro Guerrero

Mar 26, 2024 3:00pm EDT

MAIA Biotechnology Announces Share Purchase by Director Adelina Louie in Private Placement

Mar 26, 2024 8:01am EDT

MAIA Biotechnology Announces $1.33 Million Private Placement

Mar 22, 2024 3:00pm EDT

MAIA Biotechnology Announces Share Purchase by Director Stan Smith, PhD in a $2.9 Million Private Placement

Mar 21, 2024 3:00pm EDT

MAIA Biotechnology Welcomes Prominent Medical Oncology Scientist Dr. Saadettin Kilickap to its Scientific Advisory Board

Mar 07, 2024 9:45am EST

MAIA Biotechnology to Participate in the 36th Annual ROTH Conference

Mar 06, 2024 11:04am EST

MAIA Biotechnology and Nationwide Children’s Hospital Announce Presentation of THIO’s Potency in Pediatric Brain Tumors at American Association of Cancer Research Annual Meeting

Mar 06, 2024 8:48am EST

MAIA Biotechnology Announces Strong Efficacy of THIO as Third-Line Treatment for Non-Small Cell Lung Cancer Patients

Mar 05, 2024 8:45am EST

MAIA Biotechnology CEO Details Immuno-Oncology Cancer Treatment Candidates and Development Pipeline in Letter to Shareholders

Feb 27, 2024 10:30am EST

MAIA Biotechnology Appoints Leading Immuno-Oncology Scientist Dr. Remus Vezan as Scientific Advisor

Feb 22, 2024 10:30am EST

MAIA Biotechnology Completes Enrollment in THIO-101 Phase 2 Clinical Trial for Non-Small Cell Lung Cancer

Feb 07, 2024 8:01am EST

MAIA Biotechnology Announces Publication in Nature Communications on Positive Effects of THIO for Potential Treatment of Small Cell Lung Cancer

Jan 24, 2024 7:15am EST

MAIA Biotechnology Announces Publication of International PCT Patent Application Covering Anticancer Telomere-Targeting Compounds

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

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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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