RNTX — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-15

• In the fourth quarter of 2025, we decided to pause development activities related to LTI-01 for an indefinite period.

• In October 2025, we received authorization from the European Medicines Agency, or the EMA, to initiate our Phase 2 RENEW trial of our lead candidate, LTI-03, at sites in Germany and Poland. We had previously received regulatory clearance from the U.K.’s Medicines and Healthcare products Regulatory A…

• As of the date of this Quarterly Report, we activated sites and are enrolling patients in the U.S. and are seeking to activate additional sites, enroll patients and initiate the RENEW trial throughout the U.S., UK, Europe and other jurisdictions. In March 2026, we dosed our first patient in the RENE…

• described below and $4.3 million in net proceeds from our securities purchase agreements with three institutional investors in January 2026 and February 2026 described below. As of March 31, 2026, we had $4.4 million in cash and cash equivalents, without giving effect to the May 2026 Offering.

• Since our inception, we have incurred significant losses on an aggregate basis. Our net losses were $5.8 million and $5.5 million for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $407.1 million. These losses have resulted primar…

Text removed vs the prior filing · source: 10-Q · 2025-11-14

• In June 2024, we decided to temporarily delay clinical development of LTI-01 in an effort to focus our resources on clinical development of LTI-03 and until additional funds are raised. In the fourth quarter of 2024, we determined that the temporary delay of further clinical development of LTI-01 ma…

• On June 10, 2025, the U.S. Food and Drug Administration, or the FDA, advised us that it had put the Phase 2 RENEW trial of LTI-03 on clinical hold and we paused enrollment and patient dosing at our clinical trial sites in the United States. On July 8, 2025, we received a formal Clinical Hold Letter …

• We are seeking to activate sites, enroll patients and initiate the RENEW trial in the United Kingdom and Europe and other jurisdictions. In October 2025, we received authorization from the European Medicines Agency, or the EMA, to initiate our Phase 2 RENEW trial, at sites in Germany and Poland, of …

• On October 29, 2025 we were notified by the FDA that it had lifted the full clinical hold on our Phase 2 RENEW trial evaluating in patients with IPF. The FDA’s decision follows a review of our submission, which addressed all of the agency’s concerns. In its correspondence, the FDA confirmed that Stu…

• Since our inception, we have incurred significant losses on an aggregate basis. Our net losses were $5.6 million and $5.8 million for the three months ended September 30, 2025 and 2024, respectively, and $17.9 million and $21.9 million for the nine months ended September 30, 2025 and 2024, respectiv…

Text added vs the prior filing · source: 10-Q · 2026-05-15

• We identified material weaknesses in our internal control over financial reporting. A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting such that there is a possibility that a material misstatement of our financial statements will not be …

• Continued to reassess staffing and add additional resources, as required, with the requisite technical accounting experience and training, to further allow for segregation of duties and to support our system of internal control.

• In addition to implementing and executing the aforementioned activities, the following activities are expected to be completed in fiscal year 2026:

• Continue to act upon the enhancements to our internal controls that we implemented in 2025.

Text removed vs the prior filing · source: 10-Q · 2025-11-14

• We identified material weaknesses in our internal control over financial reporting. A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting such that there is a possibility that a material misstatement of our financial statements will not be …

• We have implemented and are continuing to implement procedures to remediate these material weaknesses, including the hiring of a Controller with the requisite supervisory background and knowledge in financial reporting, integration into one accounting system, engaging third party accounting speciali…

• In addition to implementing and executing the aforementioned activities, the following activities are expected to be completed in fiscal year 2025:

• Continue to reassess staffing and add additional resources, as required, with the requisite technical accounting experience and training, to further allow for segregation of duties and to support our system of internal control.

• Define user roles within our ERP system to ensure proper segregation of duties within our accounting systems.

Text added vs the prior filing · source: 10-Q · 2026-05-15

• For a discussion of our risk factors, see “Part I, Item 1A-Risk Factors” in our Annual Report for the year ended December 31, 2025.

• You should carefully consider the risks included in our Annual Report, together with all of the other information in this Quarterly Report on Form 10-Q, including our unaudited condensed consolidated financial statements and the related notes included elsewhere in this Quarterly Report on Form 10-Q.…

Text removed vs the prior filing · source: 10-Q · 2025-11-14

• We require substantial additional capital to finance our operations. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our clinical and research and development programs, future commercialization efforts or o…

• As of September 30, 2025, we had cash and cash equivalents of $4.0 million. Based on our current operating plan, we believe that our existing cash and cash equivalents as of September 30, 2025, together with the proceeds received by us pursuant to the PPA in October 2025, will be sufficient to enabl…

• We believe that our working capital as of September 30, 2025, together with the proceeds received by us pursuant to the PPA in October 2025, lack of revenue and recurring net losses raise substantial doubt about our ability to continue as a going concern.

• For a discussion of our other risk factors, see “Part I, Item 1A-Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on April 7, 2025.

• You should carefully consider the risks included in our Annual Report on Form 10-K, together with all of the other information in this Quarterly Report on Form 10-Q, including our unaudited condensed consolidated financial statements and the related notes included elsewhere in this Quarterly Report …