Full Press Release Details
Biotechnology Expects Recent $33 Million Capital Raise to Fully Fund Ongoing Pivotal Phase 3 Trial of Novel Telomere-Targeting Anticancer
participation in recent $33 million common stock offering highlights investor confidence in late-stage clinical momentum and commercial
assessments point to high probability of technical success in Phase 3 full approval trial
granted Fast Track designation for dual mechanism therapy as a treatment for non-small cell lung cancer (NSCLC)
- April 08, 2026 - MAIA Biotechnology, Inc. (NYSE American: MAIA) ("MAIA", the "Company"), a
clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that net proceeds
from its $33 million public offering of common stock in March 2026 are expected to fully fund the Company's ongoing pivotal Phase
3 clinical trial of its lead investigational therapy, ateganosine, as a treatment for non-small cell lung cancer (NSCLC). Ateganosine
is a dual mechanism therapy designed to break down telomere structure and function in cancer cells while inducing immune activation.
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the drug in third line (3L) NSCLC treatment.
are grateful for the support and confidence shown by the healthcare-dedicated investors and existing shareholders who participated in
our recent offering. The $33 million raise is expected to complete the necessary funding for our pivotal Phase 3 trial through completion,"
said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA
assessments point to a high probability of technical success in the third-line setting if Phase 3 data is consistent with our
Phase 2 trial results," Dr. Vitoc continued. "Interim data from the Phase 3 trial, expected next year, may support a discussion
with the FDA to present our case for early full commercial approval in third-line NSCLC."
pivotal Phase 3 trial, THIO-104, evaluates the efficacy of ateganosine administered in sequence with a checkpoint inhibitor (CPI) in
third-line NSCLC patients who are resistant to checkpoint inhibitors alone and chemotherapy. The global 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. Chemotherapy is
the standard utilized treatment for third-line NSCLC patients.
(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
induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric
fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential
treatment of ateganosine 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. Ateganosine 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.
THIO-104 Phase 3 Clinical Trial
is a multicenter, open-label, randomized Phase 3 clinical trial, designed to evaluate ateganosine's telomere-targeting anti-tumor
activity when followed by PD-(L)1 inhibition in patients with advanced third-line NSCLC who previously did not respond or developed resistance
to treatment regimens containing checkpoint inhibitor and/or chemotherapy and have progressed. The trial has two primary objectives:
(1) to assess the clinical efficacy of ateganosine compared to investigator's choice of chemotherapy, using median Overall Survival
(OS) as the primary clinical endpoint (2) to evaluate the safety and tolerability of ateganosine in sequential combination with a checkpoint
inhibitor. For more information on this Phase 3 trial, please visit ClinicalTrials.gov using the identifier NCT06908304.
MAIA Biotechnology, Inc.
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
ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients
with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements.
Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry's
actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements.
The use of words such as "may," "might," "will," "should," "could," "expect,"
"plan," "anticipate," "believe," "estimate," "project," "intend,"
"future," "potential," or "continue," and other similar expressions are intended to identify forward
looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements
we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and
development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing
or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates
and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth
potential of the markets for our product candidates and our ability to serve those markets, (vii) our expectations regarding our ability
to obtain and maintain intellectual property protection for our product candidates and (viii) the funding status for our Phase 3 trial
for ateganosine, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by
our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation
or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is
made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond
our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking
statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking
statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the
context requires otherwise, "MAIA," "Company," "we," "our," and "us" refers
to MAIA Biotechnology, Inc. and its subsidiaries.