The United States Patent and Trademark Office (USPTO) grant extends the ThyrOxy intellectual property estate to six issued global patents. The new claims protect a lung-delivered T3 composition paired with an inhibitor of deiodinase-3 (D3), the enzyme that inactivates thyroid hormone in the injured lung, and extend method claims to congestive heart failure.
MINNEAPOLIS, MN — Herald Therapeutics, Inc., a clinical-stage biopharmaceutical company developing the ThyrOxy thyroid hormone–based therapeutic platform for life-threatening lung and heart diseases, today announced that the U.S. Patent and Trademark Office (USPTO) has issued U.S. Patent No. 12,758,495, titled “Compositions and Methods for Treating Pulmonary Edema or Lung Inflammation,” further extending intellectual property protection around Herald’s ThyrOxy platform. The newly issued patent is the fourth U.S. patent covering ThyrOxy and was prosecuted by the University of Minnesota, Herald’s exclusive licensor. The patent issued on October 13, 2026, with a term extending to December 2039.
The newly granted patent claims a pharmaceutical composition of tri-iodothyronine (T3) combined with an inhibitor of deiodinase-3 (D3), buffered to a lung-compatible pH and dosed for delivery directly to the pulmonary tract. The claimed approach addresses a central finding of Herald’s founding science: in the lungs of patients with Acute Respiratory Distress Syndrome (ARDS), D3 activity is markedly elevated and local T3 is depleted. By pairing T3 with a D3 inhibitor, the composition is designed both to replenish thyroid hormone where it is therapeutically active and to slow its breakdown in the injured lung.
The patent further protects methods of treating lung inflammation and lung injury with the composition, delivered by intratracheal instillation, aerosolization, or nebulization, administered either prophylactically or after clinical signs appear. Covered conditions include ARDS, premature birth, lung transplant, pneumonia, chest trauma, and a range of other inflammatory and injurious lung conditions. Notably, the patent also includes method claims for treating congestive heart failure, directly supporting Herald’s Acute Heart Failure program and its aerosolized formulation.
The patent’s named inventors include Herald’s three scientific and clinical co-founders: David H. Ingbar, MD, Chief Scientific Officer; Timothy P. Rich, MD, Chief Medical Officer; and Robert J. Schumacher, PhD, Chief Research & Development Officer. They are joined by University of Minnesota collaborators Jianxun Lei, PhD and Maneesh Bhargava, MD, PhD, whose cellular and preclinical studies of T3 in alveolar epithelial repair underpin the patent. The work was supported in part by the National Institutes of Health (grant HL050152).
A Deliberate, Multi-Layered Patent Strategy
With this grant, Herald’s global patent estate now includes six issued patents covering the ThyrOxy platform across a layered framework of composition, formulation, combination, methods of treatment, and dose-titration claims, with additional U.S. and international applications pending. Together, these claims are designed to provide robust, multi-tiered commercial exclusivity across Herald’s lead indications — Acute Respiratory Distress Syndrome (ARDS), Infant Respiratory Distress Syndrome (IRDS), and Acute Heart Failure — and across both instilled and aerosolized delivery forms.
“Our fourth U.S. patent extends our protection beyond the lung into heart failure, directly supporting our Acute Heart Failure program,” said Wade A. Smith, Chief Executive Officer of Herald Therapeutics. “With claims spanning instilled, aerosolized, and nebulized delivery, it reinforces that Herald is a true platform company: one thyroid hormone–based approach, multiple indications, multiple presentations. We thank the University of Minnesota for its continued partnership in building this portfolio.”
“The goal of Herald’s approach is to restore thyroid hormone in the lung to normal levels, because tissue levels are low in ARDS and other lung diseases,” said David H. Ingbar, MD, Co-Founder and Chief Scientific Officer of Herald Therapeutics and lead inventor on the patent. “Thyroid hormone is important to lung repair: it clears edema fluid, reduces inflammation, and lessens fibrosis. This patent accomplishes that restoration in two complementary ways — by delivering thyroid hormone directly into the lung, and by inhibiting its inactivation by deiodinase-3.”
Addressing High-Mortality Conditions with No Approved Therapy
ARDS remains a high-mortality condition with no approved disease-modifying therapy and a long-standing area of significant unmet need in critical care medicine. Herald’s scientific co-founders previously reported the first-in-human instillation of thyroid hormone into the lungs of a patient with ARDS. The company is advancing ThyrOxy toward pivotal clinical development in ARDS, with platform extension into IRDS and acute heart failure under active scientific evaluation.
About ThyrOxy
ThyrOxy™ is Herald Therapeutics’ proprietary thyroid hormone–based therapeutic platform, designed to address the fundamental biology of acute lung injury. In addition to its lead indication in ARDS, ThyrOxy is being advanced in Infant Respiratory Distress Syndrome (IRDS) and Acute Heart Failure. ThyrOxy was originally developed at the University of Minnesota and is exclusively licensed to Herald Therapeutics.
About Herald Therapeutics
Herald Therapeutics, Inc. is a clinical-stage biopharmaceutical company headquartered in Minneapolis, Minnesota, developing ThyrOxy, a thyroid hormone–based therapeutic platform targeting life-threatening lung and cardiac diseases. The company’s lead programs are in Acute Respiratory Distress Syndrome (ARDS), Infant Respiratory Distress Syndrome (IRDS), and Acute Heart Failure. For more information, please visit heraldtx.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the scope, duration, and enforceability of Herald’s patent estate; the therapeutic potential of ThyrOxy in ARDS, IRDS, acute heart failure, and other indications; and the Company’s broader development plans. Forward-looking statements are subject to known and unknown risks and uncertainties, many of which are beyond the Company’s control, including the risk that clinical trials may not produce the expected results, that patent protections may be challenged or narrowed, and that regulatory approvals may not be obtained. Actual results may differ materially from those expressed or implied. Herald Therapeutics undertakes no obligation to update any forward-looking statements except as required by law.
Investor & Media Contact
Wade A. Smith, CEO
Herald Therapeutics, Inc.
wsmith@heraldtx.com | 412-216-9988