SMSbiotech Receives FDA "Study May Proceed" Notification for First U.S. IND-Cleared Inhaled Stem Cell Therapy in COPD

• IND effective following 30-day FDA review; Phase 1b trial expected to initiate in Q4 2026. SMS Cells are the only known inhaled, refrigerated, allogeneic stem cell product in active Chronic Obstructive Pulmonary Disease (COPD) development
• Ongoing Australian Phase 1b COPD trial has completed the first of three cohorts, with dose escalation underway; U.S. Phase 1b first patient dosing targeted for Q4 2026
• SMS Cells are a proprietary, blood-derived, allogeneic, off-the-shelf stem cell platform delivered directly to the lung via nebulized inhalation using an established nebulization device

CARLSBAD, Calif., Sept. 16, 2026 /PRNewswire/ -- SMSbiotech, Inc., a clinical-stage regenerative-medicine company advancing Small Mobile Stem (SMS) Cells as a first-in-class nebulized stem cell therapy for COPD and other diseases with high unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Company's Investigational New Drug (IND) application and issued a "Study May Proceed" notification. This action clears the way for the Company to initiate a U.S. Phase 1b clinical study of SMS Cells in patients with COPD and expands the clinical development of its non-invasive, off-the-shelf, allogeneic inhaled cell platform into the United States.

The Company is currently evaluating nebulized SMS Cells in ascending-dose cohorts in an ongoing Phase 1b clinical trial in Melbourne, Australia. The first cohort was dosed and completed the protocol-specified 28-day safety monitoring period with no therapy-related adverse events, and dose escalation to the second of three cohorts is underway. First patient dosing in a U.S. Phase 1b study is targeted for the fourth quarter of 2026. Subject to Phase 1b safety and tolerability data, SMSbiotech plans to initiate a Phase 2a study in the first half of 2027.

"To our knowledge, SMSbiotech has achieved the first effective IND for an inhaled stem cell therapy in COPD — a significant milestone for both the Company and the field of regenerative medicine," said Joe Kiani, Chairman of SMSbiotech. "COPD remains without an approved disease-modifying treatment. We are committed to changing that."

COPD is the third leading cause of death globally, claiming over 3.5 million lives annually, according to the World Health Organization. It is characterized by progressive, irreversible lung tissue destruction and leaves hundreds of millions of patients with severe shortness of breath and eventual respiratory failure.

"COPD remains one of the most devastating chronic diseases in medicine, and for decades our therapeutic toolkit has been limited to interventions that ease symptoms without altering the underlying course of the disease," said Naresh Punjabi, M.D., Ph.D., Professor of Medicine at the Miller School of Medicine, University of Miami. "A nebulized stem cell therapy that can be delivered directly to the site of disease using a standard, established device — and is supported by preclinical evidence of structural and functional lung recovery — represents a genuinely new therapeutic modality."

Discovered and patented by SMSbiotech, Small Mobile Stem (SMS) Cells are a proprietary population of native, allogeneic adult stem cells derived from human blood. In preclinical studies, SMS Cells have been shown to selectively bind to endogenous mesenchymal stem and progenitor cells in the lung. The resulting interaction stimulates multi-gene regenerative activity associated with alveolar tissue repair — a cellular interaction the Company terms Targeted Multi-Gene Activity Modulation (TMAM). Unlike traditional stem cell therapies that may require invasive delivery, complex genetic modification, or specialized surgical settings, the SMS platform is designed to offer:

• Simple nebulized administration — direct-to-lung delivery via a standard, established nebulization device.
• Preclinical evidence of alveolar repair — demonstrated structural and functional lung recovery in standard COPD animal models, consistent with TMAM-associated alveolar tissue regeneration.
• Off-the-shelf, allogeneic supply — naturally low immunogenicity with a scalable manufacturing process designed to ensure consistent availability.
• Broad platform applicability — proof-of-concept demonstrated across orthopedic and other human indications, as well as veterinary applications.

"FDA authorization to proceed represents an important milestone for the science, the platform, and the team that built it," said Abdulkader Rahmo, Ph.D., Founder, President, and Chief Scientific Officer of SMSbiotech. "SMS Cells appear to engage the lung's own regenerative machinery through the TMAM cellular interaction, supported by a reproducible biomanufacturing process that is independent of donor availability. We now look forward to advancing this program with U.S. patients."

About SMSbiotech

SMSbiotech is a clinical-stage regenerative-medicine company headquartered in Carlsbad, California. Founded in 2015, the Company is advancing a proprietary platform of adult Small Mobile Stem (SMS) Cells derived from human blood, designed to promote native tissue regeneration across chronic respiratory conditions, orthopedics, chronic wounds, vascular repair, and age-related diseases. The Company operates a fully integrated, GMP-compliant, ISO Class 7 manufacturing facility in San Diego, California. SMSbiotech has filed patent applications worldwide and has been granted multiple patents covering SMS Cell technology and uses of SMS Cells.

The Company is actively exploring strategic partnerships and collaborations to accelerate development and potential commercialization.

For more information, visit www.smsbiotech.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of applicable securities laws. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially, including uncertainty regarding clinical trial results and regulatory approvals; risks inherent in the development of novel cell therapies; the Company's ability to enroll patients and complete clinical studies on expected timelines; manufacturing and supply chain risks; the need for additional capital; competition; dependence on key personnel; and general economic and market conditions. There can be no assurance that the Company's plans, objectives, expectations, or anticipated results will be achieved. The statement regarding the company's belief that it has achieved the first effective IND for an inhaled stem cell therapy in COPD is based on publicly available information as of September 16, 2026, including ClinicalTrials.gov, FDA public regulatory filings, and public sponsor disclosures. Such statements are subject to the availability and completeness of public information at the time of this release. SMSbiotech undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.

Contacts

Media:
Hannah Thulin
(949) 259-6377 x 225
[email protected]

Investor Relations:
Michael Swartzburg, Chief Financial Officer
[email protected]
(760) 290-3406

SOURCE SMSbiotech