Terns Pharmaceuticals(TERN)
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临床节点密集来袭,高盛看好生物科技股2025重估机会
Zhi Tong Cai Jing· 2025-08-12 08:31
Group 1: Core Insights - Goldman Sachs' latest report focuses on "2Q25 EPS updates," analyzing biotech companies such as Amylyx (AMLX.US), CG Oncology (CGON.US), GPCR (GPCR.US), and Ideaya Biosciences (IDYA.US), concluding that operational data largely meets expectations with minor adjustments to target prices due to cash flow or clinical milestones [1] Group 2: Amylyx (AMLX.US) - In Q2, Amylyx reported operating expenses of approximately $43 million, slightly above market consensus of $41 million and Goldman Sachs' estimate of $40 million, primarily due to higher R&D costs of $27 million compared to the expected range of $22 million to $25 million [2] - The management reiterated the timeline for the Phase III clinical trial for post-bariatric hypoglycemia (PBH), aiming for enrollment completion in 2025, data readout in the first half of 2026, and potential market entry in 2027, with an estimated patient population of around 160,000 [2] - Goldman Sachs maintains a "Buy" rating with a target price of $10 [2] Group 3: CG Oncology (CGON.US) - CG Oncology's BOND-003 Phase III trial data showed a complete response rate of 75.5% for its bladder cancer gene therapy, with 12-month and 24-month sustained response rates of 50.7% and 42.3%, respectively [3] - The company has $661 million in cash, sufficient to support operations until mid-2028, and Goldman Sachs maintains a "Buy" rating with minor model adjustments [3] Group 4: GPCR (GPCR.US) - GPCR's Q2 R&D expenses were approximately $54 million, significantly higher than market expectations of $36 million and Goldman Sachs' estimate of $44 million, attributed to workforce expansion and increased trial costs [4] - The company has $787 million in cash, expected to last until 2027, and plans to read out Phase 2b ACCESS data in 2025 [4] Group 5: Ideaya Biosciences (IDYA.US) - Ideaya reported Q2 R&D expenses of about $74 million, slightly above market expectations of $71 million and Goldman Sachs' estimate of $68 million, with cash reserves of $992 million projected to last until 2029 [5] - The core pipeline includes darovasertib in combination with crizotinib for HLA-A2 negative metastatic uveal melanoma, with Phase 2/3 results expected by year-end [5] Group 6: Terns Pharmaceuticals (TERN.US) and RNA (RNA.US) - Terns Pharmaceuticals plans to release preliminary data for its leukemia drug TERN-701 and obesity drug TERN-601 in Q4 2025, with cash reserves of $315 million sufficient until 2028 [6] - RNA has signed a manufacturing agreement with Lonza to ensure product supply stability from 2026 to 2028, with BLA submissions expected for its treatments by the end of 2025 and mid-2026 [6] Group 7: AI in Biotech - Goldman Sachs emphasizes the core role of biotechnology R&D, highlighting collaborations with institutions like OpenAI to drive innovation, while also focusing on the pricing potential of rare disease drugs and opportunities for indication expansion [7] Group 8: Overall Industry Outlook - The biotech sector is expected to see over 15 key clinical data readouts from late 2025 to early 2026, with a focus on companies like AMLX, CGON, and RNA for their potential breakthroughs [8] - Despite some companies facing increased short-term losses due to R&D spending, pipeline progress remains in line with expectations, and cash flow is generally secure [8]
Terns (TERN) Q2 Net Loss Narrows 16%
The Motley Fool· 2025-08-06 06:52
Core Insights - Terns Pharmaceuticals reported progress in its clinical programs for chronic myeloid leukemia (CML) and obesity, while maintaining a strong cash position [1][3][12] Financial Performance - GAAP net loss per share was $(0.26), better than the expected $(0.29) and improved from $(0.31) in Q2 2024, reflecting a 16.1% year-over-year improvement [2][7] - Total revenue remained at $0.0, consistent with Q2 2024 [2] - Research and development expenses increased by 10.9% to $20.4 million compared to $18.4 million in Q2 2024 [2][7] - General and administrative expenses decreased slightly to $7.0 million from $7.2 million in Q2 2024 [2][7] - The net loss for the quarter was $24.1 million, widening from $22.7 million in the prior year [2][7] Clinical Development - TERN-701, a kinase inhibitor for CML, is in the dose expansion phase of the Phase 1 CARDINAL trial, with positive interim results indicating meaningful molecular responses and a favorable safety profile [5][9] - TERN-601, an oral GLP-1 receptor agonist for obesity, completed enrollment for its Phase 2 FALCON trial, with results expected in early Q4 2025 [6][10] Strategic Focus - The company has shifted its strategy to prioritize oncology, particularly CML, while seeking external partnerships for its metabolic disease assets [4][10] - Terns plans to host an educational session in September 2025 to discuss CML unmet needs and TERN-701's positioning [9] Partnerships and Intellectual Property - Terns maintains an exclusive licensing agreement with Hansoh for TERN-701 development in China, which includes milestone payments and royalties [8] - TERN-701 has Orphan Drug status in the U.S., providing seven-year market exclusivity upon approval [8] Outlook - The company has $315.4 million in cash and equivalents, projected to fund operations into 2028, allowing for continued clinical development without immediate capital needs [12] - Key clinical readouts for TERN-701 and TERN-601 are anticipated by the end of 2025, which will be critical for future partnerships and commercialization [13]
Terns Pharmaceuticals(TERN) - 2025 Q2 - Quarterly Report
2025-08-05 20:31
PART I. FINANCIAL INFORMATION [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) This section presents Terns Pharmaceuticals' unaudited condensed consolidated financial statements for Q2 2025, detailing balance sheets, operations, equity, cash flows, and accounting policies [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides a snapshot of the company's financial position, detailing assets, liabilities, and stockholders' equity as of June 30, 2025, and December 31, 2024 | Metric (in thousands) | June 30, 2025 | December 31, 2024 | Change | Percentage Change | | :-------------------- | :------------ | :---------------- | :----- | :---------------- | | Cash and cash equivalents | $145,966 | $161,439 | $(15,473) | -9.58% | | Marketable securities | $169,479 | $196,725 | $(27,246) | -13.85% | | Total current assets | $318,952 | $362,109 | $(43,157) | -11.92% | | Total assets | $320,415 | $363,929 | $(43,514) | -11.96% | | Total current liabilities | $12,914 | $15,650 | $(2,736) | -17.48% | | Total liabilities | $15,186 | $18,059 | $(2,873) | -15.91% | | Total stockholders' equity | $305,229 | $345,870 | $(40,641) | -11.75% | | Accumulated deficit | $(469,482) | $(421,481) | $(47,999) | 11.39% | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section outlines the company's financial performance over the past three and six months, detailing revenues, expenses, and net loss | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change | | :-------------------- | :------------------------------- | :------------------------------- | :----- | :----------------------------- | :----------------------------- | :----- | | Research and development | $20,353 | $18,352 | $2,001 | $39,073 | $36,939 | $2,134 | | General and administrative | $7,030 | $7,185 | $(155) | $15,737 | $14,044 | $1,693 | | Total operating expenses | $27,383 | $25,537 | $1,846 | $54,810 | $50,983 | $3,827 | | Loss from operations | $(27,383) | $(25,537) | $(1,846) | $(54,810) | $(50,983) | $(3,827) | | Interest income | $3,350 | $2,876 | $474 | $6,993 | $6,058 | $935 | | Net loss | $(24,093) | $(22,736) | $(1,357) | $(48,001) | $(45,109) | $(2,892) | | Net loss per share, basic and diluted | $(0.26) | $(0.31) | $0.05 | $(0.52) | $(0.61) | $0.09 | [Condensed Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) This section details changes in the company's stockholders' equity, including common stock, additional paid-in capital, and accumulated deficit | Metric (in thousands) | Balances at December 31, 2024 | Balances at June 30, 2025 | Change | | :-------------------- | :---------------------------- | :------------------------ | :----- | | Common Stock (Amount) | $9 | $9 | $0 | | Additional Paid-in Capital | $767,621 | $774,724 | $7,103 | | Accumulated Other Comprehensive (Loss) Income | $(279) | $(22) | $257 | | Accumulated Deficit | $(421,481) | $(469,482) | $(48,001) | | Total Stockholders' Equity | $345,870 | $305,229 | $(40,641) | - The company issued **95,276 shares** under its employee stock purchase plan and **36,637 shares** from stock option exercises during the six months ended June 30, 2025[19](index=19&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section presents the company's cash inflows and outflows from operating, investing, and financing activities for the six months ended June 30, 2025 | Metric (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change | | :-------------------- | :----------------------------- | :----------------------------- | :----- | | Net cash used in operating activities | $(43,320) | $(38,977) | $(4,343) | | Net cash provided by investing activities | $27,459 | $50,188 | $(22,729) | | Net cash provided by financing activities | $392 | $399 | $(7) | | Net (decrease) increase in cash and cash equivalents | $(15,473) | $11,570 | $(27,043) | | Cash and cash equivalents at end of period | $145,966 | $91,496 | $54,470 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the unaudited condensed consolidated financial statements [1. Nature of the Business, Basis of Presentation and Summary of Significant Accounting Policies](index=8&type=section&id=1.%20Nature%20of%20the%20Business,%20Basis%20of%20Presentation%20and%20Summary%20of%20Significant%20Accounting%20Policies) This note describes Terns Pharmaceuticals' business, the basis for its financial statement presentation, and its key accounting policies - Terns Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing small-molecule product candidates for oncology and obesity[27](index=27&type=chunk) - In September 2024, the company completed an underwritten public offering, issuing **14,064,048 shares of common stock** and pre-funded warrants for **2,380,952 shares**, generating aggregate net proceeds of **$161.9 million**[36](index=36&type=chunk)[137](index=137&type=chunk) - The company manages its operations as a single segment for performance assessment and operating decisions[29](index=29&type=chunk)[102](index=102&type=chunk)[103](index=103&type=chunk) [2. Cash Equivalents and Marketable Securities](index=18&type=section&id=2.%20Cash%20Equivalents%20and%20Marketable%20Securities) This note details the composition and fair value of the company's cash equivalents and marketable securities, primarily money market funds and U.S. government securities | Asset Type (in thousands) | Amortized Cost (June 30, 2025) | Fair Value (June 30, 2025) | Amortized Cost (December 31, 2024) | Fair Value (December 31, 2024) | | :------------------------ | :----------------------------- | :------------------------- | :--------------------------------- | :------------------------------- | | Money market funds | $124,002 | $124,002 | $147,566 | $147,566 | | U.S. government securities | $169,272 | $169,479 | $196,803 | $196,725 | | Total | $293,274 | $293,481 | $344,369 | $344,291 | - As of June 30, 2025, the company had **5 available-for-sale marketable securities** in an unrealized loss position, but management does not intend to sell them and expects to hold them until maturity, believing an allowance for credit losses is unnecessary due to high credit quality and market-driven fair value declines[72](index=72&type=chunk) [3. Fair Value Measurements](index=19&type=section&id=3.%20Fair%20Value%2
Terns Pharmaceuticals(TERN) - 2025 Q2 - Quarterly Results
2025-08-05 20:17
[Overview and Strategic Focus](index=1&type=section&id=Overview%20and%20Strategic%20Focus) Terns Pharmaceuticals reported strong Q2 2025 clinical momentum, strategically focusing on oncology and projecting cash runway into 2028 - Key clinical data readouts are expected in the **fourth quarter of 2025** for two main programs: **TERN-701** in CML (including **6-month MMR rates**) and **TERN-601** for obesity (**12-week efficacy and safety data**)[1](index=1&type=chunk) - The company is strategically focusing its resources on the oncology program (**TERN-701**) with the goal of advancing it to a pivotal trial[2](index=2&type=chunk) - Terns plans to partner its portfolio of metabolic assets and will not invest in their clinical development beyond **year-end 2025**[2](index=2&type=chunk) - The company's cash runway is projected to be sufficient to fund planned operating expenses **into 2028**[1](index=1&type=chunk)[8](index=8&type=chunk) [Pipeline Developments and Anticipated Milestones](index=2&type=section&id=Recent%20Pipeline%20Developments%20and%20Anticipated%20Milestones) Terns' lead candidates, TERN-701 (CML) and TERN-601 (obesity), are advancing with Q4 2025 data readouts anticipated [TERN-701 (CML Program)](index=2&type=section&id=TERN-701%3A%20Oral%2C%20small-molecule%20next-generation%20allosteric%20BCR-ABL%20inhibitor%20for%20CML) TERN-701's Phase 1 CARDINAL trial for CML is progressing with dose expansion, expecting 6-month MMR data in Q4 2025 - The company plans to report efficacy and safety data from the Phase 1 CARDINAL trial in **Q4 2025**, including the **6-month MMR** achievement rate[5](index=5&type=chunk) - The dose expansion portion of the CARDINAL trial began in **April 2025**, with patients randomized to **320 mg** or **500 mg** once-daily (QD) cohorts[5](index=5&type=chunk) - Preclinical data presented at **EHA 2025** highlighted greater potency of TERN-701 compared to asciminib against several resistance mutations[2](index=2&type=chunk)[5](index=5&type=chunk) [TERN-601 (Obesity Program)](index=2&type=section&id=TERN-601%3A%20Oral%2C%20small-molecule%20glucagon-like%20peptide-1%20receptor%20agonist%20(GLP1-RA)%20for%20obesity) TERN-601's Phase 2 FALCON trial for obesity completed Q2 2025 enrollment, with 12-week data expected in early Q4 2025 - The Phase 2 FALCON trial completed enrollment in **Q2 2025**, with top-line **12-week data** expected in **early Q4 2025**[5](index=5&type=chunk) - The primary endpoint of the FALCON trial is the percent change from baseline in body weight compared to placebo over **12 weeks**[5](index=5&type=chunk) - Previous Phase 1 results demonstrated weight loss of up to **5.5%** over **28 days** with favorable safety and tolerability[5](index=5&type=chunk) [Pipeline and Partnering Programs](index=3&type=section&id=Pipeline%20and%20Partnering%20Programs) Terns seeks strategic partners for its metabolic programs, prioritizing GIPR antagonist and THR-β agonist candidates - Terns is prioritizing its discovery efforts on a GIPR antagonist development candidate (**TERN-800 Series**) for potential combination therapies in obesity[6](index=6&type=chunk) - The company is seeking a strategic partner to advance both the **TERN-800 series** (GIPR modulator) and **TERN-501** (THR-β agonist) programs[6](index=6&type=chunk)[7](index=7&type=chunk) [Second Quarter 2025 Financial Results](index=3&type=section&id=Second%20Quarter%202025%20Financial%20Results) Terns reported a net loss for Q2 2025, driven by increased R&D expenses, while maintaining a strong cash position into 2028 Key Financial Metrics (Millions USD) | Financial Metric | Q2 2025 (Millions USD) | Q2 2024 (Millions USD) | | :--- | :--- | :--- | | R&D Expenses | $20.4 | $18.4 | | G&A Expenses | $7.0 | $7.2 | | Net Loss | $(24.1) | $(22.7) | | Cash Position (as of June 30, 2025) | $315.4 | N/A | - Cash, cash equivalents, and marketable securities were **$315.4 million** as of **June 30, 2025**, which is expected to fund planned operating expenses **into 2028**[8](index=8&type=chunk) [Financial Tables](index=4&type=section&id=Financial%20Tables) This section presents Terns Pharmaceuticals' unaudited condensed consolidated statements of operations and selected balance sheet data as of June 30, 2025 [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Terns reported an increased net loss for Q2 2025 compared to the prior year, primarily driven by higher research and development expenses Condensed Consolidated Statements of Operations (Thousands USD, except per share data) | Metric | Three Months Ended June 30, 2025 (Thousands USD) | Three Months Ended June 30, 2024 (Thousands USD) | | :--- | :--- | :--- | | Total operating expenses | $27,383 | $25,537 | | Net loss | $(24,093) | $(22,736) | | Net loss per share, basic and diluted | $(0.26) | $(0.31) | [Selected Balance Sheet Data](index=4&type=section&id=Selected%20Balance%20Sheet%20Data) As of June 30, 2025, Terns reported its cash, cash equivalents, marketable securities, and total stockholders' equity balances Selected Balance Sheet Data (Thousands USD) | Metric | June 30, 2025 (Thousands USD) | December 31, 2024 (Thousands USD) | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $315,445 | $358,164 | | Total assets | $320,415 | $363,929 | | Total stockholders' equity | $305,229 | $345,870 |
Terns Pharmaceuticals Reports Second Quarter 2025 Financial Results and Provides Corporate Updates
Globenewswire· 2025-08-05 20:05
Core Insights - Terns Pharmaceuticals is advancing its clinical programs with a focus on oncology and obesity, expecting key clinical readouts by year-end 2025 [2][3] - The company has a strong cash position, with sufficient funds to support operations into 2028 [7][10] Clinical Trials and Pipeline Developments - The Phase 1 trial of TERN-701 for chronic myeloid leukemia (CML) is enrolling well, with efficacy and safety data, including 6-month major molecular response (MMR) rates, expected in Q4 2025 [1][3] - The Phase 2 trial of TERN-601 for obesity has completed enrollment, with 12-week efficacy, safety, and tolerability data anticipated in early Q4 2025 [1][8] - Terns plans to report data from the Phase 1 CARDINAL trial of TERN-701 in Q4 2025, which will allow for comparisons with other CML treatments [2][3] Financial Performance - As of June 30, 2025, Terns reported cash, cash equivalents, and marketable securities of $315.4 million, down from $358.2 million at the end of 2024 [7][10] - Research and development expenses for Q2 2025 were $20.4 million, compared to $18.4 million in Q2 2024 [7][9] - The net loss for Q2 2025 was $24.1 million, slightly higher than the $22.7 million loss in Q2 2024 [9] Corporate Updates - Terns will host an educational webinar focused on TERN-701 in September 2025 [1][3] - Members of Terns' senior leadership will participate in the Morgan Stanley 23 Annual Global Healthcare Conference in September 2025 [7]
Terns Pharmaceuticals (TERN) Earnings Call Presentation
2025-06-27 08:57
TERN-701 Opportunity - TERN-701 is a novel allosteric BCR-ABL TKI in Phase 1 studies, representing a new generation of therapies for CML with superior target coverage, improved kinase selectivity, and high potency against common mutations[16] - TERN-701 has the potential to transform the standard of care for CML by offering enhanced efficacy, minimal off-target activity, optimized dosing, and more rapid and deeper levels of response, potentially leading to treatment-free remission[16] - TERN-701 is expected to be the 2nd allosteric TKI to market, differentiating itself from asciminib[78] CML Market and Treatment Landscape - Approximately 10,000 new CML cases are diagnosed in the U S annually[10] - The U S CML prevalence is approximately 110,000 and is expected to triple by 2040[10] - Around 40% of CML patients switch therapy within 5 years due to intolerance or resistance[10] - About half of CML patients do not achieve deep molecular response (DMR) by 4 years after switching to a second treatment[10] - Allosteric inhibitors represent the latest evolution in CML treatment, with asciminib being the first approved allosteric BCR-ABL inhibitor[12] Clinical Development and Data Interpretation - Baseline BCR-ABL levels impact the speed and attainment of MMR in relapsed/refractory (R/R) CML patients; patients with baseline BCR-ABL of >10% had the lowest molecular response rates to asciminib in Phase 1[38, 42] - Terns' initial Phase 1 data for TERN-701 will comprise patients with shorter treatment duration compared to precedent initial Phase 1 data disclosures[64] - Interim dose escalation data for TERN-701, expected in December, will include an estimated 10-20 enrolled patients, with 5-10 patients having ≥3 months of treatment across at least 2 dose levels[66] Future Strategy - TERN-701 has broad anticipated opportunity across 1L and 2L, with the potential to split 1L allosteric share and capture 2G TKI intolerant/resistant patients[76, 77] - Subsequent readout in 2025 is anticipated to show 6-month data and inform potential registrational trial[79]
Terns Pharmaceuticals Presents Positive Data from Phase 1 Study of TERN-601 Once-daily Oral GLP-1R Agonist for Treatment of Obesity at 85th Annual American Diabetes Association Scientific Sessions
Globenewswire· 2025-06-23 20:07
Core Insights - Terns Pharmaceuticals announced positive results from the Phase 1 clinical study of TERN-601, a novel oral GLP-1 receptor agonist, which demonstrated a differentiated profile in weight loss and tolerability [1][2] - The Phase 2 FALCON trial has completed enrollment, with topline data expected in the fourth quarter of 2025, focusing on weight loss efficacy and safety [1][2] Efficacy - The Phase 1 study showed statistically significant and dose-dependent weight loss of up to 5.5% over 28 days with once-daily dosing, with 67% of patients losing 5% or more body weight at the highest dose [5] - Unique pharmacological properties of TERN-601 resulted in a flat pharmacokinetic curve, allowing for 24-hour target coverage with a half-life of 9-10 hours [5] Safety - TERN-601 was well-tolerated, with no treatment-related interruptions or discontinuations at any dose, and over 95% of gastrointestinal adverse events were mild [5] - There were no significant changes in liver enzymes, vital signs, or ECGs observed during the trial [5] Tolerability and Ease of Use - TERN-601 features the simplest dose titration among GLP-1 receptor agonist therapies, allowing for dosing with or without food and compatibility with PPIs, H2RA, and/or antacids [5] Trial Details - The Phase 1 trial was a randomized, double-blind, placebo-controlled study assessing safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy adults with obesity or overweight [7] - The ongoing FALCON Phase 2 trial is evaluating the efficacy and safety of TERN-601 in adults with obesity or overweight, with a primary endpoint of percent change in body weight compared to placebo over 12 weeks [8] Company Overview - Terns Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing small-molecule product candidates for serious diseases, including oncology and obesity [9] - The company's pipeline includes multiple clinical-stage programs, highlighting its commitment to addressing significant health challenges [9]
Terns Pharmaceuticals (TERN) FY Conference Transcript
2025-06-09 21:00
Summary of Terns Pharmaceuticals (TERN) FY Conference Call - June 09, 2025 Company Overview - Terns Pharmaceuticals is a small molecule company founded in 2017, focusing on developing innovative therapies for chronic diseases, particularly chronic myeloid leukemia (CML) and obesity [3][4] Key Value Drivers - The company anticipates significant data readouts in Q4 2025 for two best-in-class medicines: - A BCR ABL inhibitor for CML - An oral GLP-1 receptor agonist for obesity [4] Chronic Myeloid Leukemia (CML) Program - **Market Size**: The CML market includes approximately 100,000 patients in the G7, with 17,000 new diagnoses annually. The market is expected to triple by 2040 [9] - **Unmet Needs**: Current therapies have limitations in tolerability and safety. Terns aims to improve on these aspects with its allosteric inhibitor, TURN-701 [5][10] - **Target Product Profile**: TURN-701 aims for better efficacy, safety, and convenience compared to existing therapies, with a once-daily dosing regimen without food restrictions [10][11] - **Clinical Data**: Initial data shows a 50% cumulative major molecular response (MMR) rate, with no dose-limiting toxicities observed in trials [22][23] - **Upcoming Data**: A robust dataset with six-month MMR is expected in Q4 2025, with over 40 patients involved [31][32] Efficacy and Safety - TURN-701 is designed to have superior pharmacokinetics (PK) and target coverage compared to osiminib, the current standard [19][29] - The drug does not inhibit CYP3A4, reducing drug-drug interaction risks, which is crucial for the older patient population typically affected by CML [13][14] Obesity Program - The obesity market is seen as still developing, with limited competition for oral drugs. Terns believes its oral GLP-1 receptor agonist, TURN-601, can differentiate itself through improved tolerability and simpler titration [55][56] - **Tolerability**: TURN-601 aims to achieve competitive weight loss with a better tolerability profile, expecting to see potentially half the rate of nausea and vomiting compared to existing treatments [67] - **Partnership Strategy**: Terns plans to seek a partnership for TURN-601 post-trial, focusing on capital allocation and leveraging its resources for the CML program [72] Financial Outlook - The company has sufficient cash to fund operations into 2028, focusing on advancing the CML program and completing the Phase IIa study for TURN-601 [73] Discovery Efforts - Terns continues to work on its GPRA antagonist program, which is an area of interest for future development [74] Conclusion - Terns Pharmaceuticals is positioned to make significant advancements in the treatment of CML and obesity, with promising data expected in the near future. The company is strategically focused on partnerships and efficient capital allocation to maximize its development efforts.
Terns Pharmaceuticals (TERN) 2025 Conference Transcript
2025-06-05 16:07
Summary of Terns Pharmaceuticals Conference Call Company Overview - Terns Pharmaceuticals was founded in 2017 and focuses on small molecules with validated mechanisms of action [2][4] - The company is currently prioritizing its chronic myeloid leukemia (CML) program and an oral GLP-1 receptor agonist for obesity [2][3] Key Developments - Terns has two clinical data readouts in 2024 and two in 2025 for its CML program, specifically for its oral BCR ABL inhibitor [2] - The company believes it has a best-in-class molecule for CML that could be transformational for patients [2] - The oral GLP-1 receptor agonist is expected to show competitive efficacy with better tolerability and simpler titration [3] CML Program Insights - Terns is focusing on its CML asset, TURN-701, which has a high probability of reaching patients and a clear path to market [4][5] - The company plans to pursue CML aggressively while seeking partnerships for its metabolic assets [6] - The upcoming data cut in Q4 2025 will provide insights into the six-month major molecular response (MMR) rate, a key regulatory endpoint [11] Competitive Landscape - TURN-701 is being compared to Enliven and Asiminib, with Terns viewing Asiminib as the primary benchmark [9][10] - The company aims for a 25-30% MMR achievement rate in a post-disseminated failure population, which would indicate competitiveness [14][20] Safety and Efficacy - Terns has not observed dose-limiting toxicities (DLTs) at the highest tested dose of 500 mg, indicating a favorable safety profile [21][22] - The company believes that the allosteric mechanism of TURN-701 allows for a wider therapeutic index compared to active site inhibitors [35] Market Potential - There are approximately 17,000 new CML diagnoses annually in the G7, presenting a significant market opportunity [31] - Terns anticipates that its allosteric drug will capture a substantial market share as it offers a superior profile in terms of efficacy and safety [32] Oral GLP-1 Program Insights - TURN-601 is positioned favorably following the discontinuation of a competitor, with a differentiated profile demonstrated in early data [37] - The drug has shown a linear dose response with weight loss and excellent tolerability, with no discontinuations reported [38] - Terns emphasizes the importance of tolerability and simplicity in titration for primary care settings, which is crucial for market acceptance [39] Future Expectations - The company expects to release Phase II twelve-week data for TURN-601 in Q4 2025, which will further clarify its market position [40] - Terns is confident in its ability to manage safety and efficacy in longer trials, with no expected accumulation of adverse events [48][49] Conclusion - Terns Pharmaceuticals is strategically focused on its CML and obesity programs, with promising data expected in the near future. The company is well-positioned to capture market share through its innovative drug profiles and strong safety data.
Terns Pharmaceuticals Selected for Oral Presentation at European Hematology Association Congress For Preclinical Data on Novel Allosteric BCR-ABL Inhibitor TERN-701
Globenewswire· 2025-05-14 13:30
Core Insights - Terns Pharmaceuticals is presenting preclinical data on TERN-701, a next-generation allosteric BCR-ABL inhibitor, at the European Hematology Association Congress, highlighting its improved potency against various resistance mutations in chronic myeloid leukemia (CML) [1][2][3] Group 1: TERN-701 Overview - TERN-701 targets the ABL myristoyl pocket and shows potency against over 20 clinically relevant resistance mutations in BCR-ABL [2] - The drug is expected to provide meaningful clinical benefits over existing therapies, particularly in patients with difficult-to-treat resistance mutations [2][3] Group 2: Clinical Trial Details - The CARDINAL Phase 1 clinical trial is assessing the safety, tolerability, and efficacy of TERN-701 in previously treated CML patients, with the dose escalation portion completed in January 2025 [5][6] - No dose-limiting toxicities were observed up to the maximum dose of 500 mg QD, and the trial has moved into the dose expansion phase [5][6] Group 3: Presentation Details - The oral presentation titled "Characterization & Efficacy of TERN-701 in Pre-Clinical Models of Chronic Myeloid Leukemia" is scheduled for June 13, 2025, at EHA25 [4] Group 4: Safety and Efficacy Data - Interim data from the trial indicated compelling molecular responses in heavily pre-treated CML patients, with an encouraging safety profile and no adverse event-related treatment discontinuations [6] - Additional safety and efficacy data, including 6-month major molecular response rates, are expected in Q4 2025 [1][5]