Rein Therapeutics Reports $62.88 Million Net Loss for 2024, Plans for Additional Funding

Rein Therapeutics, Inc. (formerly Aileron Therapeutics, Inc.) reported a net loss of $62.88 million for the year ended December 31, 2024, compared to a net loss of $15.73 million in 2023. This significant increase in net loss is primarily attributable to a $37 million impairment loss on intangible assets related to the temporary delay of further clinical development of LTI-01, an increase in research and development expenses from $4.0 million to $14.2 million, and an increase in general and administrative expenses from $11.4 million to $13.9 million. The company attributed the increase in research and development expenses to the termination of ALRN-6924 in 2023 and new clinical programs acquired as part of the Lung Therapeutics, Inc. acquisition in October 2023. The increase in general and administrative expenses stemmed from increased employee-related expenses and facilities costs associated with the Lung acquisition.

The company's cash and cash equivalents totaled $12.9 million as of December 31, 2024, down from $17.3 million at the end of 2023. Rein anticipates that its existing cash will fund operations through August 2025, but additional funding will be required to initiate the planned Phase 2 clinical trial of LTI-03 and to sustain operations beyond August 2025. The company plans to secure this additional capital through equity or debt financings, collaborations, licensing arrangements, or other sources. In May 2024, Rein completed a follow-on public offering, raising net proceeds of $17.7 million. In January 2025, the company also issued and sold common stock for net proceeds of $0.7 million through an "at-the-market" offering.

Significant developments during the year included the acquisition of Lung Therapeutics, Inc. on October 31, 2023, which shifted the company's focus to orphan pulmonary and fibrosis indications. This acquisition resulted in the issuance of common stock and Series X Preferred Stock to Lung's stockholders, as well as the assumption of Lung's stock options and warrants. A subsequent private placement, the PIPE Financing, raised an additional $17.5 million. The company also entered into an exclusive option agreement with Advancium Health Network for the sale of ALRN-6924, a clinical-stage oncology agent. As of December 31, 2024, Rein had 11 full-time employees.

Rein's two lead product candidates are LTI-03, currently in Phase 1b clinical trials for Idiopathic Pulmonary Fibrosis (IPF), and LTI-01, which has completed Phase 2a trials for loculated pleural effusion (LPE). Positive data from the Phase 1b trial of LTI-03 were announced in May 2024, and positive topline data from the high-dose Cohort 2 were announced in November 2024. The company plans to initiate a Phase 2 clinical trial for LTI-03 in the first half of 2025, subject to securing additional funding. Further clinical development of LTI-01 has been temporarily delayed pending additional funding. The company also has preclinical programs targeting cystic fibrosis and systemic fibrosis.

Rein's financial statements include several critical audit matters, primarily concerning the high degree of subjective judgment involved in the impairment assessment of goodwill and indefinite-lived intangible assets. The company identified material weaknesses in its internal control over financial reporting as of December 31, 2024, and is implementing remediation plans to address these weaknesses. The company's outlook is contingent upon securing additional funding to support its clinical development programs and ongoing operations. The company does not anticipate paying dividends in the foreseeable future.