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]

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]

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]

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.

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.

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]

PART I. FINANCIAL INFORMATION [Condensed Consolidated Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) The company reported a net loss of $23.9 million for Q1 2025, an increase from $22.4 million in Q1 2024, with total assets decreasing to $339.3 million, reflecting its clinical-stage status with no product revenue [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets decreased to $339.3 million from $363.9 million, driven by reduced cash and marketable securities, while total liabilities also decreased to $13.3 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $139,023 | $161,439 | | Marketable securities | $195,241 | $196,725 | | **Total Assets** | **$339,315** | **$363,929** | | **Liabilities & Equity** | | | | Total current liabilities | $10,935 | $15,650 | | **Total Liabilities** | **$13,272** | **$18,059** | | **Total Stockholders' Equity** | **$326,043** | **$345,870** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a net loss of $23.9 million for Q1 2025, an increase from $22.4 million in Q1 2024, primarily due to higher general and administrative expenses Statement of Operations Highlights (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Research and development | $18,720 | $18,587 | | General and administrative | $8,707 | $6,859 | | **Total operating expenses** | **$27,427** | **$25,446** | | Loss from operations | ($27,427) | ($25,446) | | Interest income | $3,643 | $3,182 | | **Net loss** | **($23,908)** | **($22,373)** | | Net loss per share, basic and diluted | ($0.26) | ($0.30) | [Condensed Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Total stockholders' equity decreased from $345.9 million to $326.0 million in Q1 2025, primarily due to the net loss, partially offset by stock-based compensation - Stockholders' equity decreased by **$19.9 million** during Q1 2025, from **$345.9 million** to **$326.0 million**[19](index=19&type=chunk) - The main drivers of the change in equity were the net loss of **$23.9 million** and stock-based compensation expense of **$3.7 million**[19](index=19&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to $24.4 million in Q1 2025, with cash and cash equivalents ending at $139.0 million, down from $161.4 million Cash Flow Summary (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($24,440) | ($22,798) | | Net cash provided by investing activities | $1,959 | $7,997 | | Net cash provided by financing activities | $68 | $0 | | **Net decrease in cash and cash equivalents** | **($22,416)** | **($14,827)** | | **Cash and cash equivalents at end of period** | **$139,023** | **$65,099** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail accounting policies and financial activities, including the company's focus on oncology and obesity treatments, financing activities, and breakdowns of stock-based compensation and lease obligations - The company is a clinical-stage biopharmaceutical company focused on developing small-molecule product candidates for oncology and obesity[25](index=25&type=chunk) - In September 2024, the company raised aggregate net proceeds of **$161.9 million** from a public offering of common stock and pre-funded warrants[34](index=34&type=chunk) - The company has an effective at-the-market (ATM) offering agreement for up to **$150.0 million**, with no sales made through March 31, 2025[33](index=33&type=chunk) - As of March 31, 2025, there was **$33.2 million** of unrecognized stock-based compensation expense related to unvested stock options, expected to be recognized over **3.12 years**[87](index=87&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the clinical-stage pipeline for oncology and obesity, highlighting positive early data and increased operating expenses, while affirming sufficient liquidity of $334.3 million to fund operations into 2028 - The company is a clinical-stage biopharmaceutical company developing small-molecule candidates for oncology and obesity[104](index=104&type=chunk) - TERN-701 (CML): Positive early data from Phase 1 dose escalation led to selecting **320 mg** and **500 mg** doses for the expansion portion, with additional data expected in Q4 2025[105](index=105&type=chunk) - TERN-601 (obesity): Positive Phase 1 results showed up to **5.5% weight loss** over **28 days**, with a Phase 2 trial beginning in March 2025 and top-line 12-week data expected in Q4 2025[106](index=106&type=chunk) - The company believes its existing cash and cash equivalents will be sufficient to fund planned operations and capital expenditures into **2028**[122](index=122&type=chunk)[127](index=127&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20operations) Total operating expenses increased slightly to $27.4 million in Q1 2025, driven by higher general and administrative costs, while research and development expenses remained relatively flat Comparison of Operating Results (in thousands) | Expense Category | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $18,720 | $18,587 | $133 | | General and administrative | $8,707 | $6,859 | $1,848 | | **Total operating expenses** | **$27,427** | **$25,446** | **$1,981** | | **Net loss** | **($23,908)** | **($22,373)** | **($1,535)** | - The increase in R&D expenses was due to a **$1.6 million** increase in clinical and preclinical program expenses, offset by a **$1.3 million** decrease in personnel-related costs[113](index=113&type=chunk) - The increase in G&A expenses was primarily due to a **$1.1 million** increase in personnel-related expenses and a **$0.7 million** increase in professional services consulting[116](index=116&type=chunk) [Liquidity and Capital Resources](index=30&type=section&id=Liquidity%20and%20capital%20resources) As of March 31, 2025, the company held $334.3 million in cash and marketable securities, deemed sufficient to fund operations into 2028, with past funding primarily from equity sales - The company believes its existing cash and cash equivalents of **$334.3 million** (as of March 31, 2025) will fund planned operating expenses into **2028**[122](index=122&type=chunk)[124](index=124&type=chunk)[127](index=127&type=chunk) - Primary sources of liquidity have been proceeds from sales of common stock, including a September 2024 public offering that yielded **$161.9 million** in net proceeds[123](index=123&type=chunk)[126](index=126&type=chunk) - The company expects to incur significant expenses and operating losses for the foreseeable future as it advances its product candidates, requiring substantial additional funding[128](index=128&type=chunk) [Cash Flows](index=33&type=section&id=Cash%20flows) Net cash used in operating activities was $24.4 million in Q1 2025, primarily due to the net loss, while investing activities provided $2.0 million from marketable securities - Net cash used in operating activities was **$24.4 million** in Q1 2025, compared to **$22.8 million** in Q1 2024[134](index=134&type=chunk)[135](index=135&type=chunk) - Net cash provided by investing activities was **$2.0 million** in Q1 2025, a decrease from **$8.0 million** in Q1 2024, due to lower net proceeds from marketable securities transactions[136](index=136&type=chunk)[137](index=137&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) There have been no material changes to the company's quantitative and qualitative disclosures about market risk since its Annual Report on Form 10-K - There have been no material changes to the company's market risk disclosures since the last Annual Report[143](index=143&type=chunk) [Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - Management concluded that as of March 31, 2025, the company's disclosure controls and procedures were effective at a reasonable assurance level[145](index=145&type=chunk) - No changes occurred during the quarter ended March 31, 2025, that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[146](index=146&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) As of March 31, 2025, the company was not involved in any litigation or legal proceedings deemed to have a material adverse effect on its business - The company is not currently involved in any material legal proceedings[149](index=149&type=chunk) [Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks from potential FDA disruptions due to funding cuts and personnel losses, changes in U.S. trade policies, and uncertainties in patent law and U.S.-China trade relations - Disruptions at the FDA from funding cuts, personnel losses, and government shutdowns could hinder the ability to secure timely approval for product candidates[152](index=152&type=chunk) - Specific risks include a Reduction in Force (RIF) at HHS affecting **3,500 FDA employees** and a proposed **$700 million** FDA budget cut for the 2026 fiscal year, which could delay PDUFA reviews[153](index=153&type=chunk)[154](index=154&type=chunk) - Changes in U.S. trade policy, including a **10% baseline reciprocal tariff** and specific tariffs on China, could negatively impact the company's research and manufacturing environment[163](index=163&type=chunk) - Changes in U.S. patent law, such as the America Invents Act (AIA), and recent Supreme Court rulings have created uncertainty regarding the value and enforceability of patents[160](index=160&type=chunk)[161](index=161&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=40&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or issuer purchases of equity securities during the period - There were no unregistered sales of equity securities or issuer purchases of equity securities in the quarter[167](index=167&type=chunk)[168](index=168&type=chunk) [Defaults Upon Senior Securities](index=40&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[169](index=169&type=chunk) [Mine Safety Disclosures](index=40&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - None[170](index=170&type=chunk) [Other Information](index=40&type=section&id=Item%205.%20Other%20Information) No directors or officers entered into, modified, or terminated a Rule 10b5-1 trading arrangement during the three months ended March 31, 2025 - No directors or officers entered into, modified, or terminated a Rule 10b5-1 trading plan during the quarter[171](index=171&type=chunk) [Exhibits](index=41&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including new consulting and employment agreements, and CEO and CFO certifications - Exhibits filed include a consulting agreement with Mark Vignola and an employment agreement with Andrew Gengos, both dated in February 2025[175](index=175&type=chunk) - Standard CEO and CFO certifications pursuant to Sarbanes-Oxley Sections 302 and 906 were also filed as exhibits[175](index=175&type=chunk)

[Terns Pharmaceuticals First Quarter 2025 Report](index=1&type=section&id=Terns%20Pharmaceuticals%20First%20Quarter%202025%20Report) [Corporate and Clinical Highlights](index=1&type=section&id=Corporate%20and%20Clinical%20Highlights) The company advanced its lead CML and obesity programs, anticipating key data in H2 2025 while maintaining a cash runway into 2028 - Initiated the dose expansion portion of the Phase 1 CARDINAL trial for TERN-701 in Chronic Myeloid Leukemia (CML)[1](index=1&type=chunk)[2](index=2&type=chunk) - The Phase 2 FALCON trial for TERN-601 in obesity is enrolling well, with **top-line 12-week weight loss data expected in Q4 2025**[1](index=1&type=chunk)[2](index=2&type=chunk) - TERN-701 demonstrated a **highly encouraging safety profile** with no dose-limiting toxicities up to the maximum 500 mg dose in the dose escalation phase[2](index=2&type=chunk) - The company confirms its **cash runway is sufficient to fund operations into 2028**[2](index=2&type=chunk) [Clinical Pipeline Developments](index=1&type=section&id=Recent%20Clinical%20Pipeline%20Developments%20and%20Anticipated%20Milestones) The company detailed progress for its CML and obesity programs and outlined discovery efforts for its TERN-800 series and TERN-501 [TERN-701 for CML](index=1&type=section&id=TERN-701%3A%20Oral%2C%20small-molecule%20next-generation%20allosteric%20BCR-ABL%20inhibitor%20for%20chronic%20myeloid%20leukemia%20(CML)) The Phase 1 CARDINAL study advanced to dose expansion, with key 6-month MMR efficacy data expected in Q4 2025 - The first patient was enrolled in the dose expansion portion of the Phase 1 CARDINAL study in April 2025[3](index=3&type=chunk) - Patients in the expansion phase will be randomized to either a 320 mg or 500 mg once-daily (QD) dose, with up to 40 patients per arm[3](index=3&type=chunk) - Additional safety and efficacy data, including **6-month MMR rates**, are planned for release in Q4 2025 to inform the path to a pivotal trial[3](index=3&type=chunk) - Interim data from December 2024 showed an **encouraging safety profile** with no dose-limiting toxicities or treatment discontinuations due to adverse events[3](index=3&type=chunk) [TERN-601 for Obesity](index=2&type=section&id=TERN-601%3A%20Oral%2C%20small-molecule%20glucagon-like%20peptide-1%20(GLP-1)%20receptor%20agonist%20for%20obesity) The Phase 2 FALCON trial is enrolling patients, with top-line 12-week weight loss data expected in Q4 2025 - The primary endpoint of the Phase 2 FALCON trial is the percent change from baseline in body weight compared to placebo over 12 weeks[6](index=6&type=chunk) - The trial is evaluating four active cohorts (250 mg, 500 mg, 500 mg slow titration, 750 mg) against a placebo, with 30 patients per cohort[6](index=6&type=chunk) - **Top-line 12-week data** from the FALCON trial is anticipated in Q4 2025[6](index=6&type=chunk) [Other Pipeline Programs](index=2&type=section&id=Pipeline%20and%20Partnering%20Programs) The company is advancing its TERN-800 GIPR antagonist program and positions TERN-501 as a complementary therapy to GLP-1 - TERN-800 Series: The company is prioritizing the nomination of a glucose-dependent insulinotropic polypeptide receptor (GIPR) antagonist for obesity treatment, potentially in combination with a GLP-1 agonist[6](index=6&type=chunk) - TERN-501: This oral thyroid hormone receptor-beta (THR-β) agonist is considered a complementary mechanism to GLP-1, potentially offering additional metabolic, liver, and weight loss benefits[6](index=6&type=chunk) [Corporate Updates](index=2&type=section&id=Corporate%20Updates) Senior leadership will participate in two key investor conferences in June 2025 - Management will participate in the Jefferies Global Healthcare Conference (June 3-5, 2025) and the Goldman Sachs 46th Annual Global Healthcare Conference (June 9-11, 2025)[6](index=6&type=chunk) [First Quarter 2025 Financial Results](index=3&type=section&id=First%20Quarter%202025%20Financial%20Results) The company reported a Q1 net loss of $23.9 million and ended the quarter with $334.3 million in cash, sufficient into 2028 - Cash, cash equivalents, and marketable securities were **$334.3 million** as of March 31, 2025, sufficient to fund planned operating expenses into 2028[7](index=7&type=chunk) [Key Financial Metrics](index=3&type=section&id=Key%20Financial%20Metrics) The company's Q1 2025 net loss increased to $23.9 million, driven by higher G&A expenses while R&D costs remained stable Q1 2025 vs Q1 2024 Financial Comparison | Metric | Q1 2025 ($M) | Q1 2024 ($M) | | :--- | :--- | :--- | | R&D Expenses | $18.7 | $18.6 | | G&A Expenses | $8.7 | $6.9 | | Net Loss | $23.9 | $22.4 | Cash Position Comparison | Metric | March 31, 2025 ($M) | December 31, 2024 ($M) | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $334.3 | $358.2 | [Condensed Consolidated Statements of Operations](index=3&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Total operating expenses of $27.4 million resulted in a net loss of $23.9 million, or ($0.26) per share, for Q1 2025 Terns Pharmaceuticals, Inc. Condensed Consolidated Statements of Operations (Unaudited; in thousands except share and per share amounts) | | Three Months Ended March 31, | | | :--- | :--- | :--- | | | **2025** | **2024** | | **Operating expenses:** | | | | Research and development | $18,720 | $18,587 | | General and administrative | $8,707 | $6,859 | | **Total operating expenses** | **$27,427** | **$25,446** | | Loss from operations | ($27,427) | ($25,446) | | Interest income | $3,643 | $3,182 | | Other expense, net | ($36) | ($12) | | Loss before income taxes | ($23,820) | ($22,276) | | Income tax expense | ($88) | ($97) | | **Net loss** | **($23,908)** | **($22,373)** | | Net loss per share, basic and diluted | ($0.26) | ($0.30) | | Weighted average common stock outstanding | 91,473,948 | 74,399,378 | [Selected Balance Sheet Data](index=3&type=section&id=Selected%20Balance%20Sheet%20Data) Total assets were $339.3 million and stockholders' equity was $326.0 million as of March 31, 2025 Terns Pharmaceuticals, Inc. Selected Balance Sheet Data (Unaudited; in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $334,264 | $358,164 | | Total assets | $339,315 | $363,929 | | Total liabilities | $13,272 | $18,059 | | Total stockholders' equity | $326,043 | $345,870 | [Company Information and Disclosures](index=4&type=section&id=Company%20Information%20and%20Disclosures) [About Terns Pharmaceuticals](index=4&type=section&id=About%20Terns%20Pharmaceuticals) The company is a clinical-stage biopharmaceutical firm developing small-molecule candidates for oncology and obesity - The company's pipeline includes an allosteric BCR-ABL inhibitor (TERN-701), a small-molecule GLP-1 receptor agonist (TERN-601), a THR-β agonist (TERN-501), and a preclinical GIPR modulator discovery program[11](index=11&type=chunk) [Cautionary Note Regarding Forward-Looking Statements](index=4&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) The report includes forward-looking statements regarding clinical trials, product potential, and financial runway that involve significant risks - Forward-looking statements relate to expectations for clinical trials (CARDINAL, FALCON), potential of product candidates (TERN-701, TERN-601, TERN-800 Series, TERN-501), and the company's cash runway[12](index=12&type=chunk) - Investors are cautioned not to place undue reliance on these statements as they are based on current expectations and are subject to risks detailed in the company's SEC filings[12](index=12&type=chunk)

Core Insights - Terns Pharmaceuticals has initiated the dose expansion phase of the Phase 1 CARDINAL trial for TERN-701, targeting chronic myeloid leukemia (CML) [1][2] - The Phase 2 FALCON trial for TERN-601, aimed at obesity treatment, is progressing well, with top-line data expected in the fourth quarter of 2025 [1][2] - The company reported a cash position of $334.3 million as of March 31, 2025, sufficient to support operations into 2028 [5][10] Clinical Developments - TERN-701 is an oral, small-molecule allosteric BCR-ABL inhibitor for CML, with the dose expansion phase enrolling patients at doses of 320 mg and 500 mg [3] - The Phase 2 FALCON trial for TERN-601 is designed to demonstrate competitive weight loss and a favorable safety profile, with data expected in 4Q 2025 [3][8] - Interim data from TERN-701's dose escalation showed no dose-limiting toxicities and encouraging molecular responses in heavily pre-treated CML patients [2][3] Financial Performance - Research and development expenses for Q1 2025 were $18.7 million, slightly up from $18.6 million in Q1 2024 [6][9] - General and administrative expenses increased to $8.7 million in Q1 2025 from $6.9 million in Q1 2024 [6][9] - The net loss for Q1 2025 was $23.9 million, compared to a net loss of $22.4 million in Q1 2024 [6][9] Corporate Updates - Terns' leadership will participate in upcoming investor conferences, with webcasts available on the company's website [5] - The company is prioritizing the development of a GIPR antagonist based on scientific rationale supporting GLP-1 agonist/GIPR antagonist combinations for obesity [8][11]

Summary of Terns Pharmaceuticals (TERN) Conference Call Company Overview - **Company**: Terns Pharmaceuticals (TERN) - **Date of Conference**: May 07, 2025 - **Key Speakers**: Scott Harris (Chief Development Officer), Andrew Gragos (Chief Financial Officer) Key Points on Oncology and CML - **Unmet Need in CML**: Chronic Myeloid Leukemia (CML) treatment has evolved since the introduction of Gleevec in 2001, but there remains a need for improved efficacy and safety in treatments [6][7] - **Introduction of TURN701**: TURN701 is positioned as a potential best-in-class allosteric TKI for CML, showing preclinical potency greater than Novartis' Osimhenib and improved pharmacokinetics [8][12] - **Safety and Tolerability**: TURN701 has demonstrated no dose-limiting toxicities in trials, lacks significant drug-drug interactions, and is not an inhibitor of CYP3A4, which is crucial for patient safety [10][11] - **Patient Convenience**: TURN701 is a once-daily medication with no clinically meaningful food effect, contrasting with Osimhenib, which requires fasting [11][12] - **Switching Rates**: Up to 50% of patients on active site TKIs switch treatments within the first year, primarily due to suboptimal response or tolerability issues [14][15] - **Early Clinical Data**: In a phase one study, a 50% cumulative Major Molecular Response (MMR) rate was observed at three months among evaluable patients, with no significant adverse effects reported [17][18][22] Key Points on TURN601 (Oral GLP-1) - **Overview of TURN601**: An orally available GLP-1 receptor agonist, with initial studies showing weight loss of up to 5.5% at the highest dose over 28 days [28][35] - **Tolerability Profile**: TURN601 is designed to have a favorable tolerability profile, with rapid absorption and less central nervous system liability [30][31] - **Comparison with Competitors**: The discontinuation of Pfizer's Donluplin does not pose a direct risk to TURN601, as it has distinct pharmaceutical properties [32][33] - **Ongoing Studies**: A twelve-week study is currently enrolling, with expectations for data release in Q4 2025 [28][44] - **Market Positioning**: The company aims to establish partnerships for TURN601, given the high costs associated with obesity drug development [47][48] Additional Insights - **Market Dynamics**: The presence of multiple players in the obesity market is seen as beneficial for patient access and treatment options [52][53] - **Patient Segmentation**: There is a shift in focus towards gradual weight loss and tolerability, appealing to a broader patient population [58][59] - **Future Directions**: The company is optimistic about the potential for TURN701 and TURN601 to establish themselves in their respective markets, with ongoing studies and data expected to support their claims [54][56]