0001193125-26-126385
SEC filingRein Therapeutics Inc. reported a net loss of $49.9 million for fiscal year 2025, with no revenue generated. The company's operating loss was $50.6 million, primarily driven by research and development expenses of $11.0 million, general and administrative expenses of $10.9 million, and a significant impairment loss on intangible assets of $28.7 million. The company ended the year with $3.2 million in cash and cash equivalents, total assets of $24.2 million, and an accumulated deficit of $401.3 million. As a clinical-stage biopharmaceutical company, Rein Therapeutics is focused on developing novel therapies for orphan pulmonary and fibrosis indications, with its lead candidate LTI-03 currently in Phase 2 clinical trials for Idiopathic Pulmonary Fibrosis.
Rein Therapeutics Inc. reported a net loss of $49.9 million for fiscal year 2025, with no revenue generated during the period. The company's operating loss was $50.6 million, driven by research and development expenses of $11.0 million, general and administrative expenses of $10.9 million, and a significant impairment loss on intangible assets of $28.7 million. Other income contributed $48,000, while income tax benefit was $712,000. The company reported a net loss per share of $2.00 for both basic and diluted calculations, based on weighted average common shares outstanding of 25.4 million. Total comprehensive loss for the year was $49.9 million, which included other comprehensive loss of $44,000.
The company generated no revenue during fiscal year 2025, consistent with its status as a clinical-stage biopharmaceutical company. Rein Therapeutics is focused on developing novel therapies for orphan pulmonary and fibrosis indications, with its lead candidate LTI-03 currently in Phase 2 clinical trials for Idiopathic Pulmonary Fibrosis. The company's pipeline also includes LTI-01 for loculated pleural effusion, though development has been paused due to insufficient funding. The company has an out-license agreement with Taiho Pharmaceutical Co. Ltd. for LTI-01 in Japan, which provided an upfront payment of $5.0 million in 2020 and includes potential future milestone payments and royalties.
With no revenue generated, the company reported negative operating and net income margins. The total operating expenses of $50.6 million included $11.0 million for research and development and $10.9 million for general and administrative expenses. A significant portion of the operating loss was attributable to a $28.7 million impairment loss on intangible assets. The company also recorded stock-based compensation expense of $2.2 million during the year. The net loss of $49.9 million represents a substantial financial burden for the company, which has an accumulated deficit of $401.3 million as of December 31, 2025.
Net cash used in operating activities was $19.4 million for fiscal year 2025. Cash flows from financing activities provided $9.8 million, primarily from proceeds from issuance of common stock ($1.8 million), Pre-Paid Advances ($2.9 million), warrant exercises ($1.6 million), and warrant exchanges ($3.0 million). The company ended the year with $3.2 million in cash and cash equivalents, down from $12.9 million at the beginning of the year. Total assets were $24.2 million, including $6.3 million in goodwill and $13.5 million in intangible assets. Total liabilities were $7.2 million, with current liabilities of $6.2 million. The company had convertible preferred stock of $45.0 million and stockholders' equity components including common stock of $113,000, additional paid-in capital of $373.1 million, accumulated other comprehensive loss of $62,000, and accumulated deficit of $401.3 million.
The company faces significant challenges due to its limited cash resources and ongoing operating losses. Management has indicated that development of LTI-01 and preclinical programs has been paused indefinitely to focus limited resources on LTI-03 development. The company expects to report initial interim topline data from its Phase 2 RENEW clinical trial of LTI-03 in the fourth quarter of 2026. Key risk factors include the company's dependence on third-party manufacturers, need for additional financing to continue operations, regulatory uncertainties, and intense competition in the biopharmaceutical industry. The company's ability to continue as a going concern is dependent on its ability to raise additional capital through equity or debt financing, strategic collaborations, or other sources.