Durham, NC – [February 02, 2026] –MAA Laboratories, Inc. today announced that it has completed early regulatory engagement with the Therapeutic Goods Administration (TGA) of Australia for its Dasatinib Nanoparticle Tablets, developed using the Company’s proprietary NanoCont™ platform technology.

The engagement provides procedural clarity on the applicable regulatory pathway for the program in Australia. The product is being developed under a Category 1, Type F regulatory framework, consistent with global regulatory precedents for differentiated, suprabioavailable formulations of approved drug substances.

MAA’s Dasatinib Nanoparticle Tablets are designed to achieve equivalent systemic exposure at lower doses through enhanced bioavailability, enabling a development strategy centered on bioavailability and bioequivalence (BA/BE) studies. Under this pathway, regulatory evaluation is conducted at the time of submission.

Importantly, this approach is aligned with scientific advice previously received in Europe and Canada, as well as IND clearance by the U.S. Food and Drug Administration, where a BA/BE-based development strategy without additional clinical efficacy, safety, or toxicology studies was considered appropriate for this differentiated formulation.

“We view Australia as an important market for innovative, patient-focused therapies,” said Dr. Anjani Jha, Founder and CEO of MAA Laboratories. “Our engagement with the TGA provides clarity on the appropriate regulatory framework and is consistent with the global development strategy we are executing across the U.S., Europe, and Canada.”

MAA Laboratories’ NanoCont™ platform enables the development of differentiated, branded products that retain the regulatory efficiencies of established molecules while offering the potential benefits of improved bioavailability, optimized dosing, and enhanced tolerability. The Company continues to advance its dasatinib program and broader oncology pipeline toward global registration and commercialization.

For press and other inquiries, please contact:

Corporate Office
MAA Laboratories, Inc.
400 Park Offices Drive
Suite #214
Durham, NC 27709
United States of America
Email: info@maalaboratories.com
Phone: 919.271.7868

Durham, NC – August 13, 2025 — MAA Laboratories Inc., a specialty pharmaceutical company focused on developing clinically differentiated, value-added drug products, today announced that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for its Dasatinib Nanoparticle Tablets. This novel oral formulation was developed using MAA’s proprietary NanoCont™ technology platform, which was accepted into the FDA’s Emerging Technology Program in August 2024.

This regulatory milestone paves the way for MAA Laboratories to initiate its Phase I clinical study in healthy volunteers under the 505(b)(2) regulatory pathway.

“We are extremely pleased to receive IND clearance from the FDA for our third consecutive clinical-stage asset, following Methotrexate and Nintedanib,” said Anjani Jha, Founder and CEO of MAA Laboratories. “This achievement is a testament to the versatility and potential of our NanoCont™ platform to deliver advanced oral drug formulations with meaningful clinical, regulatory, and development advantages.”

Key Highlights

• IND clearance granted for Dasatinib Nanoparticle Tablets
• 505(b)(2) regulatory pathway confirmed for a Phase I BA/BE study in healthy volunteers
• Developed using NanoCont™, an FDA-recognized Emerging Technology
• Designed to optimize systemic exposure and patient experience across both oral and subcutaneous reference formulations
• Marks MAA’s third consecutive IND approval utilizing NanoCont™ technology

About Dasatinib Nanoparticle Tablets

MAA’s next-generation Dasatinib Nanoparticle Tablets are designed to address pharmacokinetic and patient-experience limitations associated with conventional Dasatinib formulations. By leveraging the NanoCont™ platform, the product aims to enhance absorption, achieve consistent dose proportionality across multiple strengths, and improve systemic exposure—supporting a modernized, patient-friendly approach to oral oncology formulation development.

Durham, NC – July 23, 2025 — MAA Laboratories Inc., a specialty pharmaceutical company focused on developing clinically differentiated, value‑added drug products, today announced that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for its Nintedanib Esylate Nanoparticle Tablets. This novel oral formulation was developed using MAA’s proprietary NanoCont™ technology platform, which was accepted into the FDA’s Emerging Technology Program in August 2024.

This regulatory milestone paves the way for MAA Laboratories to initiate its Phase I clinical study in healthy volunteers under the 505(b)(2) regulatory pathway.

“We are pleased to receive IND clearance from the FDA for our second clinical‑stage asset,” said Anjani Jha, Founder and CEO of MAA Laboratories. “This achievement further validates the potential of our NanoCont™ platform to enable enhanced oral drug formulations that deliver meaningful clinical and development advantages.”

Key Highlights

• IND clearance granted for Nintedanib Esylate Nanoparticle Tablets
• 505(b)(2) regulatory pathway confirmed for a Phase I BA/BE study in healthy volunteers
• Developed using NanoCont™, an FDA‑recognized Emerging Technology
• Designed to optimize pharmacokinetics, patient experience, and systemic exposure
• Supports a modernized approach to oral formulation development

About Nintedanib Esylate Nanoparticle Tablets

MAA’s next‑generation formulation of Nintedanib Esylate is designed to address limitations associated with conventional oral formulations. By leveraging the NanoCont™ platform, the tablet aims to improve absorption, enhance pharmacokinetic consistency, and support better patient adherence across its targeted indications.

For Media Inquiries or Partnership Opportunities, Please Contact:

Corporate Office
MAA Laboratories, Inc.
400 Park Offices Drive
Suite# 214
Durham, NC 27709
United States of America
? Email: info@maalaboratories.com
? Phone: 919.271.7868

Durham, NC – July 16, 2025 – MAA Laboratories is pleased to announce that it has received formal written scientific advice from the Federal Institute for Drugs and Medical Devices (BfArM) in Germany for its Dasatinib Nanoparticle Tablets.

The advice supports MAA’s ongoing development efforts and provides regulatory clarity for advancing the program in the European Union. Importantly, the feedback from BfArM is consistent with guidance previously received from the U.S. Food and Drug Administration (FDA), further validating the Company’s development strategy and the scientific strength of its NanoCont™ platform.

“We are grateful for BfArM’s constructive guidance,” said Dr. Anjani Jha, CEO of MAA Laboratories. “The alignment between U.S. and EU regulators provides strong validation for our regulatory and clinical approach and reinforces our confidence in the potential of our nanoparticle-based therapies.”

MAA Laboratories remains committed to delivering differentiated therapies that improve patient outcomes through enhanced drug delivery, tolerability, and systemic performance. The Company looks forward to initiating clinical studies and advancing its broader pipeline across global markets.

For press and other inquiries, please contact:

Corporate Office
MAA Laboratories, Inc.
400 Park Offices Drive
Suite# 214
Durham, NC 27709
United States of America
Email: info@maalaboratories.com
Phone: 919.271.7868

Durham, NC – July 2, 2025 — MAA Laboratories Inc., a specialty pharmaceutical company focused on developing clinically differentiated, value‑added drug products, today announced that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for its Methotrexate Nanoparticle Tablets. This novel oral formulation was developed using MAA’s proprietary NanoCont™ technology platform, which was accepted into the FDA’s Emerging Technology Program in August 2024.

This regulatory milestone paves the way for MAA Laboratories to initiate its Phase I clinical study in healthy volunteers under the 505(b)(2) regulatory pathway.

“We are thrilled to receive IND clearance from the FDA for our lead asset,” said Anjani Jha, Founder and CEO of MAA Laboratories. “This milestone validates not only the scientific integrity of our Methotrexate Nanoparticle Tablets but also the broader potential of our NanoCont™ platform. We believe this formulation could significantly improve methotrexate’s safety and tolerability profile—a longstanding unmet need for patients with autoimmune diseases and certain cancers.”

Key Highlights

• IND clearance granted for Methotrexate Nanoparticle Tablets
• 505(b)(2) regulatory pathway confirmed for BA/BE studies in healthy volunteers
• Developed using NanoCont™, an FDA‑recognized Emerging Technology
• Designed to improve safety, tolerability, and systemic exposure
• Potential for label differentiation post‑approval

About Methotrexate Nanoparticle Tablets

This next‑generation formulation is designed to reduce dose‑dependent toxicity and gastrointestinal side effects commonly associated with conventional methotrexate while maintaining therapeutic efficacy. By enhancing absorption and minimizing variability, the nanoformulation aims to improve patient adherence across both autoimmune and oncology indications.

For Media Inquiries or Partnership Opportunities, Please Contact:

Corporate Office
MAA Laboratories, Inc.
400 Park Offices Drive
Suite# 214
Durham, NC 27709
United States of America
Email: info@maalaboratories.com
Phone: 919.271.7868