Month: September 2026

Strong pace of patient enrollment supports continued advancement toward regulatory milestones

Most recent assessment of novel telomere targeting agent sequenced with a checkpoint inhibitor showed 90.5% disease control rate (DCR) in heavily pretreated NSCLC

CHICAGO, Sept. 22, 2026 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that enrollment has reached 65 patients in its ongoing pivotal Phase 3 trial, THIO-104, evaluating its novel telomere-targeting therapy as a third-line (3L) treatment for advanced non-small cell lung cancer (NSCLC). The THIO-104 trial currently has 38 trial sites activated in 6 foreign countries (Taiwan, Romania, Turkey, Georgia, Poland and Hungary).

“Reaching 65 randomized patients marks an important milestone in our Phase 3 trial. With additional clinical sites expected to begin enrolling patients, we remain on track to achieve our goal of more than 100 randomized patients by year-end,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “As we’ve stated previously, statistical assessments of the Phase 3 trial point to a very high probability of technical success for regulatory approval of ateganosine.¹ We believe third-line NSCLC is an excellent market entry segment due to the substantial unmet medical need in this large immunotherapy-resistant and chemotherapy-resistant population. No current standard of care exists in this NSCLC treatment setting and competition for clinical trial patients is limited.”

In its most recent assessment, ateganosine sequenced with a checkpoint inhibitor showed 90.5% interim disease control rate (DCR) in heavily pretreated 3L NSCLC in MAIA’s ongoing phase 2 THIO-101 clinical trial. This measure contrasts with reported 25%–35% DCRs for standard third-line chemotherapy regimens.

In July 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for ateganosine for the treatment of NSCLC. This designation allows for more frequent FDA communication, potential rolling review, and eligibility for Accelerated Approval and Priority Review. If approved, ateganosine will hold FDA New Chemical Entity (NCE) five-year marketing exclusivity. An NCE is a small molecule drug with a novel active ingredient that hasn’t been previously approved or marketed.

About Ateganosine

Ateganosine (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.

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 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.

About THIO-104 Phase 3 Clinical Trial

THIO-104 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.

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. 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, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, 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.

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

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¹ See latest MAIA investor presentation and 2026 shareholder letter at ir.maiabiotech.com/company-information/presentations.

TR-1: Standard form for notification of major holdings

NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible) i
1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attached ii:			Mothercare PLC
1b. Please indicate if the issuer is a non-UK issuer (please mark with an “X” if appropriate)
Non-UK issuer
2. Reason for the notification (please mark the appropriate box or boxes with an “X”)
An acquisition or disposal of voting rights							X
An acquisition or disposal of financial instruments
An event changing the breakdown of voting rights
Other (please specify) iii:
3. Details of person subject to the notification obligation iv
Name			Lombard Odier Asset Management (Europe) Limited
City and country of registered office (if applicable)			London, United Kingdom
4. Full name of shareholder(s) (if different from 3.) v
Name			Disclosure on behalf of accounts managed on a discretionary basis by Lombard Odier Investment Managers group.
City and country of registered office (if applicable)
5. Date on which the threshold was crossed or reached vi:			18.09.2026
6. Date on which issuer notified (DD/MM/YYYY):			22.09.2026
7. Total positions of person(s) subject to the notification obligation
	% of voting rights attached to shares (total of 8. A)	% of voting rights through financial instruments (total of 8.B 1 + 8.B 2)		Total of both in % (8.A + 8.B)	Total number of voting rights held in issuer (8.A + 8.B) vii
Resulting situation on the date on which threshold was crossed or reached	0.0%			0.0%		0
Position of previous notification (if applicable)	18.93%			18.93%

8. Notified details of the resulting situation on the date on which the threshold was crossed or reached viii
A: Voting rights attached to shares
Class/type of shares ISIN code (if possible)		Number of voting rights ix					% of voting rights
		Direct (DTR5.1)		Indirect (DTR5.2.1)			Direct (DTR5.1)		Indirect (DTR5.2.1)
GB0009067447				0					0.0%
SUBTOTAL 8. A		0					0.0%
B 1: Financial Instruments according to DTR5.3.1R (1) (a)
Type of financial instrument		Expiration date x	Exercise/ Conversion Period xi			Number of voting rights that may be acquired if the instrument is exercised/converted.			% of voting rights
			SUBTOTAL 8. B 1
B 2: Financial Instruments with similar economic effect according to DTR5.3.1R (1) (b)
Type of financial instrument	Expiration date x		Exercise/ Conversion Period xi		Physical or cash Settlement xii			Number of voting rights	% of voting rights
					SUBTOTAL 8.B.2

9. Information in relation to the person subject to the notification obligation (please mark the applicable box with an “X”)
Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuer xiii				X
Full chain of controlled undertakings through which the voting rights and/or the financial instruments are effectively held starting with the ultimate controlling natural person or legal entity (please add additional rows as necessary) xiv
Name xv	% of voting rights if it equals or is higher than the notifiable threshold	% of voting rights through financial instruments if it equals or is higher than the notifiable threshold	Total of both if it equals or is higher than the notifiable threshold
10. In case of proxy voting, please identify:
Name of the proxy holder
The number and % of voting rights held
The date until which the voting rights will be held
11. Additional information xvi

Place of completion	London, United Kingdom
Date of completion	22.09.2026

Collaboration builds on Itron’s proven security-first platform and integrates Crytica’s Rapid Detection, Alert and Isolation technology to help utilities prepare for emerging cyber and operational risks at the grid edge

LIBERTY LAKE, Wash., Sept. 22, 2026 (GLOBE NEWSWIRE) — Itron, Inc. (NASDAQ: ITRI), the intelligent infrastructure provider for modern energy and water management, and Crytica Security announced a strategic technology collaboration to advance rapid cyber threat detection and operational visibility across its intelligent grid-edge infrastructure.

Cybersecurity threats to critical infrastructure are ever-present and evolving rapidly. As utilities modernize their infrastructure, deploy more distributed intelligence at the grid edge, integrate distributed energy resources and prepare for new AI-enabled threat vectors, security must adapt. Utilities require solutions that build on proven protection while adapting faster to new risks emerging across distributed, connected and intelligent networks.

The collaboration is designed to integrate Crytica’s patented Rapid Detection, Alert and Isolation technology, RDAi™, into Itron’s Grid Edge Intelligence portfolio, adding continuous integrity monitoring and actionable alerts closer to where grid activity occurs. The combination of Itron’s secure, utility-grade platform with Crytica’s deterministic detection technology, provides utilities with an additional layer of cybersecurity visibility across IT and OT environments and intelligent grid edge devices, meter-hosted applications and edge workloads as the security landscape evolves.

Itron’s Grid Edge Intelligence portfolio is built on a strong security foundation that includes layered device, network, communications and data protection. The integration of Crytica’s RDAi technology is intended to extend that foundation with active, embedded monitoring that can detect unauthorized changes to devices without negatively affecting device performance. This added layer helps utilities identify potential compromise earlier, accelerate investigation and response, and strengthen resilience across critical field assets.

“Utilities are moving intelligence closer to the edge of the grid, and cybersecurity must move with it,” said Don Reeves, Itron’s senior vice president of Outcomes. “Itron has long helped utilities deploy secure, reliable and resilient infrastructure at scale. Our collaboration with Crytica builds on that foundation by adding rapid, embedded threat detection designed for the next generation of grid-edge applications. Together, we are helping utilities prepare for what is coming next while continuing to protect the essential services communities rely on every day.”

Unlike traditional cybersecurity approaches that focus primarily on centralized systems or enterprise endpoints, the Itron-Crytica collaboration is designed to bring monitoring directly into resource-constrained utility field devices and the applications running on them. Crytica’s lightweight probe continuously monitors and delivers high-fidelity alerts when unauthorized changes are detected. This approach is designed to complement existing cybersecurity platforms by extending visibility into operational technology environments where traditional endpoint tools may not operate.

This collaboration aims to advance embedded grid-edge threat detection by helping utilities monitor both the meter and meter-hosted applications through a common integrity monitoring framework, a capability not available to utilities today.

The collaboration also supports broader operational awareness. In addition to cybersecurity monitoring, the integration is expected to provide performance-related alerts that help utilities identify conditions that may affect device health, reliability and availability. These capabilities can help utilities improve situational awareness, prioritize investigation and support more resilient operations as AMI networks evolve into intelligent grid-edge platforms.

“Crytica’s RDAi technology was purpose-built for demanding, resource-constrained operational environments,” said C. Lloyd Mahaffey, Executive Chairman and Co-Founder, Crytica Security. “By working with Itron, we can extend rapid detection and actionable alerts into utility grid-edge infrastructure at scale, helping utilities see potential issues earlier and respond with greater confidence.”

The collaboration reinforces Itron’s strategy to help utilities transition from traditional AMI to Grid Edge Intelligence by combining distributed intelligence, intelligent connectivity, advanced analytics and security-centered innovation. As utilities prepare for more dynamic grid operations, the ability to detect, alert and respond closer to the edge will become increasingly important to maintaining reliability, resilience and trust.

Customer benefits

• Builds on a proven security foundation: Extends Itron’s secure, utility-grade platform with an additional layer of embedded threat detection.
• Strengthens grid-edge visibility: Helps utilities monitor intelligent devices, meter-hosted applications and edge workloads closer to where grid activity occurs.
• Enables faster detection and response: Uses Crytica’s RDAi technology to identify unauthorized instruction-set changes within seconds and generate actionable alerts.
• Supports operational resilience: Adds visibility into device health and performance conditions that may affect reliability, availability or service delivery.
• Prepares utilities for emerging threats: Helps utilities adapt to an evolving threat landscape, including risks associated with increasing connectivity, distributed intelligence and AI-enabled cyber activity.

About Itron
Itron is transforming how the world manages energy, water and city services. Our trusted intelligent infrastructure solutions help utilities and cities improve efficiency, build resilience and deliver safe, reliable and affordable service. With edge intelligence, we connect people, data insights and devices so communities can better manage the essential resources they rely on to live and thrive. Join us as we create a more resourceful world: www.itron.com

About Crytica Security
Crytica Security’s patented Rapid Detection, Alert (RDAi™), and Isolation technology embeds a lightweight, under 100 Kilobyte, Probe directly within operational technology, IoT, embedded systems and other cyber-physical environments to continuously monitor system integrity and detect unauthorized changes to instruction sets within seconds. Designed to complement existing cybersecurity platforms, RDAi extends visibility into devices where traditional tools may not operate, delivering deterministic detection and actionable alerts that enable faster security response for mission-critical operations. See how RDAi can help you “detect and protect” by visiting www.cryticasecurity.com.

Media Contacts:
Itron, Inc.
Alison Mallahan
Senior Manager, Corporate Communications
509-891-3802
PR@Itron.com

Paul Vincent
Vice President, Investor Relations
512-560-1172
Investors@itron.com

Crytica Security, Inc.
Jake Blanchard, VP, OEM Sales
Email: jake@cryticasecurity.com
Mobile: (208) 559-3399