TLPH — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-13

• The Niyad NEPHRO CRRT registrational trial is ongoing with completion expected in 2026.

• Our net loss for each of the three-month periods ended March 31, 2026 and 2025, was $2.6 million. As of March 31, 2026, we had an accumulated deficit of $474.1 million compared to $471.5 million at December 31, 2025. As of March 31, 2026, we had cash and cash equivalents and short-term investments t…

• Critical Accounting Policies and Significant Accounting Estimates

• Research and development expenses increased for the three months ended March 31, 2026, as compared to 2025, primarily due to higher Niyad development expenses, reflecting increased enrollment.

• Selling, general and administrative expenses increased for the three months ended March 31, 2026, as compared to 2025, primarily due to a $0.3 million increase in compensation and related expenses largely due to an increase in estimated bonuses, a $0.1 million increase in consulting fees primarily r…

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• In March 2025, we announced our agreement with the U.S. Food and Drug Administration, or FDA, to reduce the size of the Niyad registrational study, known as NEPHRO CRRT, to 70 patients from the 166 previously included in the study protocol.

• In January 2025, the FDA also agreed to two other changes to broaden the clinical study inclusion criteria which allow us to enroll patients already on continuous renal replacement therapy, or CRRT, beyond 48 hours, as well as heparin-tolerant patients at certain institutions.

• Our net loss for the three and nine months ended September 30, 2025, was $4.4 million and $10.5 million, respectively, compared to $3.4 million and $11.1 million for the three and nine months ended September 30, 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $467.7 mi…

• In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires companies to disclose, on an annual basis, specific categories in the effective tax rate reconciliation and provide additional information for reconciling items that meet a…

• Research and development expenses decreased $0.3 million for the three months ended September 30, 2025, as compared to 2024, primarily due to a $0.1 million reduction in employee compensation and related expenses due to a reduction in headcount, and a $0.2 million net reduction in other Niyad-relate…

Text added vs the prior filing · source: 10-Q · 2026-05-13

• Our ability to maintain listing of our securities trading on the Nasdaq exchange;

• Macroeconomic uncertainties, including inflationary pressures, supply chain disruptions, labor shortages, significant volatility in global markets and recession risks have in the past and may continue to adversely affect our business, future results of operations, and financial condition, the effect…

• In October 2024, Alora notified us that they had discontinued their DSUVIA sales efforts to non-DoD customers.

• We were also notified in 2025 that Alora submitted a letter to the FDA to request the withdrawal of the DSUVIA NDA. While we have continued our efforts to facilitate sales of the remaining DSUVIA inventory held by Alora to the DoD, we have not obtained any orders from the DoD to purchase the remaini…

• There have been executive, judicial and Congressional challenges to certain aspects of the Affordable Care Act. For example, on July 4, 2025, the One Big Beautiful Bill Act, or the OBBBA, was signed into law, which narrowed access to Affordable Care Act marketplace exchange enrollment and declined t…

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• We face potential product liability claims and, if such claims are successful, we may incur substantial liability.

• Our involvement in securities-related class action and related derivative litigation could divert our resources and management's attention and harm our business.

• Macroeconomic uncertainties, including tariffs, inflationary pressures, supply chain disruptions, labor shortages, significant volatility in global markets and recession risks have in the past and may continue to adversely affect our business, future results of operations, and financial condition, t…

• We previously identified a material weakness in our internal control over financial reporting. In the future, we may identify additional material weaknesses or otherwise fail to maintain an effective system of internal control over financial reporting or adequate disclosure controls and procedures, …

• In October 2024, Alora notified us that they are discontinuing their DSUVIA sales efforts to non-DoD customers. At this time, we are uncertain as to the impact of this decision on sales of DSUVIA to the DoD, but we expect to be able to continue to market DSUVIA to the DoD until all inventory is sold…