Rein Therapeutics (RNTX) investor relations material

Executive summary

• Focused on developing therapies for orphan pulmonary and fibrosis indications, with LTI-03 and LTI-01 as lead clinical candidates and several preclinical programs in fibrosis.

• LTI-03 Phase 2 RENEW trial for IPF was placed on FDA clinical hold in June 2025, but the hold was lifted in October 2025 after addressing regulatory concerns; global trial sites in the US, UK, Germany, Poland, and Australia are being activated.

• LTI-01 development remains on hold to prioritize LTI-03 and due to funding constraints.

• No revenue from product sales; operations funded by equity, warrants, and financing agreements.

Financial highlights

• Net loss for Q3 2025 was $5.6 million, down from $5.8 million in Q3 2024; net loss for the nine months ended September 30, 2025 was $17.9 million, down from $21.9 million year-over-year.

• Research and development expenses for the nine months ended September 30, 2025 were $9.0 million, down from $10.9 million in the prior year, mainly due to the clinical hold on LTI-03.

• General and administrative expenses for the nine months ended September 30, 2025 were $8.9 million, down from $11.4 million year-over-year.

• Cash and cash equivalents as of September 30, 2025 were $4.0 million.

• Accumulated deficit as of September 30, 2025 was $369.3 million.

Outlook and guidance

• Existing cash and recent financing expected to fund operations into December 2025, but not sufficient to complete the Phase 2 RENEW trial or maintain current operations beyond that point.

• Additional capital will be required to continue operations and complete clinical trials; management is actively seeking further funding through equity, debt, or strategic transactions.

• Substantial doubt exists about the ability to continue as a going concern beyond December 2025 without new funding.