- 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
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’s lead
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: The U.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
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, 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.
About MAIA Biotechnology, Inc.
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 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.
Forward Looking Statements
MAIA 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. 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.
These forward-looking statements are only predictions and may
differ materially from actual results due to a variety of factors
including: (i) lower than anticipated rate of patient enrollment,
(ii) the initiation, timing, cost, progress and results of our
preclinical and clinical studies and our research and development
programs, (iii) our ability to advance product candidates into, and
successfully complete, clinical studies, (iv) the timing or
likelihood of regulatory filings and approvals, (v) our ability to
develop, manufacture and commercialize our product candidates and
to improve the manufacturing process, (vi) the rate and degree of
market acceptance of our product candidates, (vii) the size and
growth potential of the markets for our product candidates and our
ability to serve those markets, (viii) our ability to obtain and
maintain intellectual property protection for our product
candidates and (ix) other risks and uncertainties detailed from
time to time in our filings with the Securities and Exchange
Commission, including without limitation our periodic reports on
Form 10-K and 10-Q, each as amended and supplemented from time to
time. 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.
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Investor Inquiries MAIA Biotechnology Joseph McGuire
Chief Financial Officer jmcguire@maiabiotech.com 904-228-2603
Investor Relations ir@maiabiotech.com
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