Core Points - Terns Pharmaceuticals, Inc. is a clinical-stage oncology company that will present at the Jefferies Global Healthcare Conference in London on November 17, 2025 [1] - The presentation will be available via a live webcast on the company's investor relations page, with a replay archived for at least 30 days [2] - Terns' lead program, TERN-701, is a selective allosteric BCR-ABL inhibitor aimed at improving treatment for chronic myeloid leukemia (CML) [3]

Clinical 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]

Financial Performance - Terns Pharmaceuticals reported a net loss of $24.6 million for Q3 2025, compared to a net loss of $21.9 million in Q3 2024, reflecting an increase of approximately 12.3% year-over-year[8]. - General and Administrative (G&A) expenses decreased to $7.8 million in Q3 2025 from $9.8 million in Q3 2024, a reduction of approximately 20.4%[7]. - The company reported total operating expenses of $27.7 million for Q3 2025, compared to $24.9 million in Q3 2024, representing an increase of about 11.2%[11]. Research and Development - Research and Development (R&D) expenses for Q3 2025 were $19.9 million, up from $15.2 million in Q3 2024, indicating a year-over-year increase of about 31.1%[7]. - Terns announced the discontinuation of internal clinical development of metabolic programs to focus on oncology, seeking external partnerships for these assets[5]. - Terns is seeking strategic partners to advance the development of TERN-801, an oral small-molecule GIPR antagonist[10]. Clinical Trials - The overall major molecular response (MMR) rate for TERN-701 in the CARDINAL trial was reported at 75% by 24 weeks, with 64% achieving MMR and 100% maintaining MMR[3]. - In difficult-to-treat patient subgroups, MMR rates were 69% for those with lack of efficacy to the last TKI, 60% for prior asciminib patients, and 67% for those with prior asciminib/ponatinib/investigational TKI[3]. - The company plans to present expanded data from the CARDINAL trial at the ASH Annual Meeting on December 8, 2025[3]. Financial Position - Cash, cash equivalents, and marketable securities totaled $295.6 million as of September 30, 2025, down from $358.2 million at the end of 2024, providing a runway into 2028[6].

Core Insights - Terns Pharmaceuticals reported unprecedented Phase 1 efficacy data for TERN-701, indicating a potential best-in-disease profile for chronic myeloid leukemia (CML) treatment [1][2] - The company has a cash position of $295 million, expected to sustain operations into 2028 [1][5] Pipeline Developments - TERN-701 is an investigational allosteric BCR::ABL1 inhibitor for CML, with a major molecular response (MMR) rate of 75% by 24 weeks in the ongoing CARDINAL trial [3][4] - TERN-601, an oral GLP-1 receptor agonist for obesity, showed a maximum placebo-adjusted weight loss of 4.6% but will not proceed further due to adverse events [3][4] Upcoming Milestones - An updated dataset from the CARDINAL trial will be presented at the 67th ASH Annual Meeting on December 8, 2025, with a conference call scheduled for the same day [4][5] Financial Performance - R&D expenses for Q3 2025 were $19.9 million, up from $15.2 million in Q3 2024, while G&A expenses decreased to $7.8 million from $9.8 million [6] - The net loss for Q3 2025 was $24.6 million, compared to $21.9 million in Q3 2024 [7][8] Balance Sheet Highlights - As of September 30, 2025, total assets were $301.7 million, with total liabilities of $17.6 million and stockholders' equity of $284.1 million [10]

Core Insights - Terns Pharmaceuticals experienced a significant stock price surge of 69.85% on November 3, 2025, due to promising clinical data for its chronic myeloid leukemia (CML) therapy, TERN-701, which is set to be presented at the upcoming ASH annual meeting [1][29]. Group 1: Clinical Data and Efficacy - TERN-701 is a highly selective BCR-ABL allosteric inhibitor, demonstrating over 10,000 times selectivity for ABL1 and ABL2 compared to other active site TKIs, which is 450 times higher than other inhibitors [3]. - The clinical trial for TERN-701 included 80 patients, with data from 55 patients presented at ASH, showing a remarkable 75% overall major molecular response (MMR) rate at 24 weeks, which is at least double the historical data of other products [15][20][29]. - Among patients who had previously failed other treatments, TERN-701 achieved a 69% MMR rate, and 60% in those who had prior asciminib treatment, indicating its effectiveness in heavily pre-treated populations [20][30]. Group 2: Market Context and Competitive Landscape - The current standard treatment for CML includes active site TKIs and allosteric TKIs like Asciminib, which has a peak sales forecast exceeding $3 billion, yet there remains a significant unmet clinical need as many patients do not achieve MMR [5][9]. - TERN-701's clinical data suggests it could potentially shift the treatment paradigm for CML, especially for patients with T315I mutations, who currently have limited options [30][34]. - The ability of TERN-701 to achieve high MMR rates in difficult-to-treat patients positions it as a potential best-in-class therapy in the CML market, which is characterized by a high unmet need [31][34]. Group 3: Company Strategy and Future Prospects - Terns Pharmaceuticals has shifted its focus from metabolic diseases to cancer therapies, particularly TERN-701 for CML, as it seeks to capitalize on the significant market opportunity in this area [32][34]. - The company plans to advance TERN-701 rapidly through clinical phases, with the potential to move directly from Phase 1 to Phase 3 trials due to the compelling clinical data [23][35]. - Despite the promising data, the company acknowledges the inherent risks in biotechnology investments, as TERN-701 is still in clinical development and faces several regulatory hurdles before potential approval [32].

Core Viewpoint - Terns Pharmaceuticals Inc. is experiencing a significant increase in stock price following positive data from the ongoing CARDINAL trial of TERN-701 for chronic myeloid leukemia (CML), suggesting the potential for TERN-701 to be a transformative therapy in the CML treatment landscape [1][2][3]. Group 1: Trial Data and Efficacy - The CARDINAL trial is currently in the dose-escalation and dose-expansion phases, with 55 patients enrolled as of June 30 [2]. - Among 32 efficacy-evaluable patients, the major molecular response (MMR) achievement rate at 24 weeks is reported at 64%, which is significantly higher than rates in other Phase 1 studies of CML therapies [2][3]. - The overall cumulative MMR rate is 75% (24 out of 32 patients), with 100% (10 out of 10) maintaining MMR [6]. Group 2: Market Reaction and Analyst Sentiment - TERN stock has surged by 88.67%, reaching $15.58 [4]. - William Blair has upgraded Terns to Outperform from Market Perform, highlighting the promising outcomes of the TERN-701 readout [3]. - Analyst Andy Hsieh believes that TERN-701 has the potential to significantly disrupt the current CML treatment market, which is dominated by Novartis AG's Scemblix [3].

Core Insights - Terns Pharmaceuticals announced unprecedented efficacy data from the CARDINAL trial of TERN-701, showing a 64% major molecular response (MMR) achievement by 24 weeks in a refractory chronic myeloid leukemia (CML) patient population [1][3] - The company will present these findings at the 67th American Society of Hematology (ASH) Annual Meeting on December 8, 2025, and will host an investor update call following the presentation [1][7] Efficacy Data - The CARDINAL trial reported a cumulative MMR rate of 75% (24 out of 32 patients) by 24 weeks, with 64% (14 out of 22) achieving MMR and 100% (10 out of 10) maintaining MMR [5] - In difficult-to-treat patient subgroups, MMR rates were 69% (11 out of 16) for those with lack of efficacy to the last tyrosine kinase inhibitor (TKI), 60% (6 out of 10) for patients who had prior asciminib, and 67% (8 out of 12) for those with prior asciminib/ponatinib/investigational TKI [5] Patient Population - The enrolled patients had heavily pretreated, refractory disease, with a median of 3 prior TKIs; 35% had 4 or more prior TKIs [5] - 64% of patients discontinued their last TKI due to lack of efficacy, and 13% had BCR::ABL1 mutations [5] Safety Profile - TERN-701 demonstrated an encouraging safety profile, with no dose-limiting toxicities observed during the dose escalation phase [10] - The majority (74%) of treatment-emergent adverse events (TEAEs) were low grade, with the most common TEAEs being diarrhea (22%), headache (18%), and nausea (16%) [10] Upcoming Events - The oral presentation at ASH will be led by Dr. Elias Jabbour and is scheduled for December 8, 2025, from 2:45 to 3:00 PM ET [6] - Following the presentation, Terns will host a conference call and webcast for investors at 4:30 PM ET to discuss the data and next steps in the development of TERN-701 [7]

Core Insights - The biotech sector presents high-risk, high-reward investment opportunities, with potential breakthroughs expected from lesser-known companies [1] Company Summaries Inovio Pharma (INO) - Inovio Pharma is valued at $123.8 billion and focuses on DNA-based medicines to combat diseases such as HPV, cancer, and infectious diseases [2] - The company plans to submit its Biologics License Application (BLA) for its lead candidate INO-3107 in the second half of 2025, anticipating FDA approval and commercial launch by 2026 [3] - The consensus rating for INO stock is a "Moderate Buy," with a potential upside of 200% based on a mean target price of $7.47, and a high price estimate of $13 suggesting a possible gain of 425% in the next 12 months [4] Terns Pharmaceuticals (TERN) - Terns Pharmaceuticals is valued at $679.9 billion and is advancing small-molecule therapies for serious diseases, focusing on oncology and obesity [5] - Its lead candidate, TERN-701, is in a Phase 1 clinical trial for chronic myeloid leukemia (CML) and has shown promising early results, while the development of TERN-601 for obesity has been discontinued due to low efficacy [6] - The consensus rating for TERN stock is a "Strong Buy," with a potential upside of 101% based on a mean target price of $15.83, and a high price estimate of $28 indicating a possible gain of 257% in the next 12 months [7]

Core Insights - Terns Pharmaceuticals, Inc. has announced the topline results of its Phase 2 clinical trial for TERN-601, an oral GLP-1 receptor agonist aimed at treating obesity [2][6] Group 1: Key Trial Results - Participants using doses above 500 mg experienced a maximum placebo-adjusted weight loss of 4.6%, with statistically significant weight loss observed at higher doses [3] - Weight loss results by dosage: - TERN-601 250 mg: -1.8% placebo-adjusted - TERN-601 500 mg (slow titration): -3.6% placebo-adjusted - TERN-601 500 mg: -4.6% placebo-adjusted - TERN-601 750 mg: -3.0% placebo-adjusted - Placebo: No significant weight loss observed - p-values for 500 mg and 750 mg doses were below 0.01, indicating statistical significance [3] Group 2: Safety Profile - 12% of participants discontinued treatment due to adverse events (AEs), primarily gastrointestinal issues, with nausea being the most common [4] - Gastrointestinal AEs were generally mild to moderate, including nausea (56%), vomiting (26.9%), constipation (11.9%), and diarrhea (9.7%), and were dose-related but did not result in severe cases [4] - Three participants experienced grade 3 liver enzyme elevations post-treatment, with two possibly related to the drug, consistent with drug-induced liver injury (DILI) [4] Group 3: Strategic Shift - Despite some treatment groups showing weight loss effects, the trial results did not meet the high standards for safety, efficacy, and tolerability required for a differentiated oral GLP-1RA treatment [6] - Consequently, Terns Pharmaceuticals has decided to discontinue the development of TERN-601 and will not pursue further investments in metabolic diseases [6] - The company will refocus on TERN-701, an allosteric BCR-ABL inhibitor for chronic myeloid leukemia (CML), with confidence in the ongoing Phase 1 CARDINAL trial and expects to release related data this quarter [6]

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