Terns Pharmaceuticals(US:TERN)2025-11-10 21:30Clinical Trials and Drug Development - TERN-701 achieved a major molecular response (MMR) rate of 75% (24/32) by 24 weeks in the CARDINAL trial, with 100% (10/10) of patients maintaining MMR[107] - TERN-601 showed a maximum placebo-adjusted weight loss of 4.6% in the Phase 2 FALCON trial, but 12% of participants discontinued treatment due to adverse events[108] - TERN-701 received Orphan Drug Designation from the FDA for the treatment of chronic myeloid leukemia (CML) in March 2024[107] - The dose escalation portion of the CARDINAL trial was completed in January 2025 with no dose limiting toxicities observed up to 500 mg once daily[107] - TERN-800 series of GIPR modulators is being developed for obesity, with TERN-801 nominated as the first development candidate[110] - The majority (74%) of treatment-emergent adverse events (TEAEs) in the CARDINAL trial were low grade, with the most common being diarrhea (22%) and headache (18%)[107] Financial Performance - Research and development expenses for Q3 2025 were $19,917,000, an increase of $4,748,000 (31.3%) compared to Q3 2024[113] - Total operating expenses for Q3 2025 were $27,716,000, up $2,777,000 (11.1%) from $24,939,000 in Q3 2024[113] - The net loss for Q3 2025 was $24,635,000, compared to a net loss of $21,945,000 in Q3 2024, reflecting an increase of $2,690,000 (12.3%)[113] - Research and development expenses for the three months ended September 30, 2025, increased to $19.9 million from $15.2 million in 2024, a change of 31.3%[117] - For the nine months ended September 30, 2025, research and development expenses rose to $59.0 million, up from $52.1 million in 2024, reflecting a 12.6% increase[118] - Interest income for the nine months ended September 30, 2025, was $10.1 million, compared to $9.1 million in 2024, marking a 10.9% increase[123] - The company reported a net loss of approximately $72.6 million for the nine months ended September 30, 2025, compared to a net loss of $67.1 million for the same period in 2024[131] - As of September 30, 2025, the company had an accumulated deficit of approximately $494.1 million and cash, cash equivalents, and marketable securities totaling $295.6 million[131] - Net cash used in operating activities during the nine months ended September 30, 2025, was $63.1 million, compared to $55.4 million in 2024[141][142] - Net cash provided by investing activities for the nine months ended September 30, 2025, was $52.0 million, down from $81.9 million in 2024[143][144] Future Outlook - The company expects to incur significant operating losses for at least the next several years as it continues its research and development activities[129] - The company has not generated any revenue from product sales since inception and relies on funding from equity offerings and other sources[130][138] - The company anticipates needing substantial additional funding to support ongoing operations and research activities[135][137]