1. -  TERN-201 is a highly selective VAP-1 inhibitor intended to address chronic liver inflammation and fibrosis in NASH

    -  Top-line TERN-201 NASH clinical data expected in 1Q 2022

    FOSTER CITY, Calif., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (NASDAQ:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, today announced the completion of patient enrollment of Part 1 of the AVIATION Trial, a Phase 1b clinical trial evaluating TERN-201, an orally-administered, highly selective inhibitor of vascular adhesion protein-1 (VAP-1…

    -  TERN-201 is a highly selective VAP-1 inhibitor intended to address chronic liver inflammation and fibrosis in NASH

    -  Top-line TERN-201 NASH clinical data expected in 1Q 2022

    FOSTER CITY, Calif., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (NASDAQ:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, today announced the completion of patient enrollment of Part 1 of the AVIATION Trial, a Phase 1b clinical trial evaluating TERN-201, an orally-administered, highly selective inhibitor of vascular adhesion protein-1 (VAP-1), in patients with NASH. Preliminary top-line 12-week data from Part 1 of the AVIATION Trial are expected in 1Q 2022.

    The AVIATION Trial (NCT04897594) is a multi-center, randomized, double-blind, dose-ranging, placebo-controlled, proof of concept, adaptive, Phase 1b clinical trial. The trial will evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of TERN-201 in patients with presumed non-cirrhotic NASH and a cT1 value of greater than 800ms. Corrected T1, or cT1, is a magnetic resonance-based imaging test measuring liver inflammation and fibrosis that has been associated with clinical outcomes and liver histology.

    "Completing enrollment of Part 1 of the AVIATION Trial is an important step towards our goal to bring a safe and effective medicine to NASH patients," said Diana Chung, Senior Vice President of Clinical Development & Operations at Terns. "We are grateful for the enthusiasm to participate in this trial from study investigators and patients which allowed us to achieve rapid enrollment, especially in light of the challenges of the ongoing COVID-19 pandemic."

    The primary objective of the AVIATION Trial is to evaluate the safety and tolerability of TERN-201 versus placebo when administered for 12 weeks in patients with NASH. The clinical trial will be conducted in two parts: Part 1 of the trial is evaluating a dose of 10 mg as compared to placebo while Part 2 is expected to enroll additional dose cohorts of TERN-201 based on an interim assessment of the 10 mg cohort. Each part of the AVIATION Trial is planned to include approximately 20 patients receiving each of the designated doses of TERN-201 and approximately 10 patients receiving placebo. The clinical trial will also explore the effects of TERN-201 on NASH imaging biomarkers (such as cT1) and NASH blood biomarkers.

    About TERN-201

    TERN-201 is a highly selective, irreversible, covalent inhibitor of vascular adhesion protein-1 (VAP-1). VAP-1 is a transmembrane protein highly expressed in hepatic vascular endothelial cells that binds to proteins on the surface of white blood cells to facilitate their deceleration, binding and transmigration from the blood stream into the liver. VAP-1 has been shown to be over-expressed in the livers of patients with NASH and fibrosis. In Terns' Phase 1 first-in-human (SAD/MAD) clinical trial across 61 healthy subjects, TERN-201 was shown to be well-tolerated and fully suppress the enzymatic activity of VAP-1 at all evaluated doses with suppression persisting up to seven days after a single dose. In preclinical studies, TERN-201 showed significant dose-dependent reductions in liver inflammation and fibrosis in a model of liver injury. TERN-201 exhibits high selectivity for VAP-1, enhanced liver distribution and minimal potential for off-target inhibition of monoamine oxidases (MAOs). The sustained activity of TERN-201, with its VAP-1 selectivity and anticipated low therapeutic dose, may make it suitable for co-administration with therapies directed at steatosis and other metabolic processes involved in NASH. Terns received Fast Track Designation from the FDA for TERN-201 for the treatment of NASH in August 2020.

    About Terns Pharmaceuticals

    Terns Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis, or NASH, and other chronic liver diseases. Terns' pipeline includes three clinical stage development programs including an FXR agonist, a VAP-1 inhibitor and a THR-β agonist, and a preclinical GLP-1 receptor agonist program. Terns is focused on developing combination therapies based on clinically validated and complementary mechanisms of action to address the multiple hepatic disease processes of NASH in order to drive meaningful clinical benefits for patients. For more information, please visit: www.ternspharma.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements about Terns Pharmaceuticals, Inc. (the "Company," "we," "us," or "our") within the meaning of the federal securities laws, including those related to the Company's expectations of timing and potential results of the Company's clinical trials and other development activities, including in relation to the Phase 1b AVIATION Trial of TERN-201; the therapeutic potential of TERN-201; the potential for vascular adhesion protein-1 (VAP-1) to be a therapeutic target for NASH; the potential utility and progress of the Company's product candidates in NASH, including the clinical utility of the data from and the endpoints used in the AVIATION Trial; the Company's clinical development plans and activities, including the development plans for TERN-201 in combination with therapies directed at steatosis and other metabolic processes involved in NASH; the Company's expectations regarding the profile of its product candidates, including tolerability, safety, metabolic stability and pharmacokinetic profile; and the Company's ability to continue to execute on its clinical strategy and plans. All statements other than statements of historical facts contained in this press release, including statements regarding the Company's strategy, future financial condition, future operations, future trial results, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "design," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "positioned," "potential," "predict," "seek," "should," "target," "will," "would" and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results and the implementation of the Company's plans to vary materially, including the risks associated with the initiation, cost, timing, progress and results of the Company's current and future research and development activities and preclinical studies and clinical trials. In particular, the impact of the COVID-19 pandemic on the Company's ability to progress with its research, development, manufacturing and regulatory efforts, including the Company's clinical trials for its product candidates, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the United States and in other countries, and the effectiveness of actions taken globally to contain and treat the disease. These risks are not exhaustive. For a detailed discussion of the risk factors that could affect the Company's actual results, please refer to the risk factors identified in the Company's SEC reports, including but not limited to its Annual Report on Form 10-K for the year ended December 31, 2020 and its Quarterly Reports on Form 10-Q for the periods ended March 31, 2021 and June 30, 2021. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.

    Contacts for Terns

    Investors

    Justin Ng

    investors@ternspharma.com

    Media

    Jenna Urban

    Berry & Company Public Relations

    media@ternspharma.com



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  2. FOSTER CITY, Calif., Sept. 02, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (NASDAQ:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, today announced that the Company's management team will present at the following upcoming investor conferences in September:

    2021 Virtual Wells Fargo Healthcare Conference

    • Date: September 9, 2021
    • Time: 1:20-1:50 p.m. ET

    H.C. Wainwright 23rd Annual Global Investment Conference

    • Date: September 13, 2021
    • Time: 7:00 a.m. ET

    Oppenheimer & Co. Inc.'s Fall Healthcare Life Sciences & MedTech Summit

    • Date…

    FOSTER CITY, Calif., Sept. 02, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (NASDAQ:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, today announced that the Company's management team will present at the following upcoming investor conferences in September:

    2021 Virtual Wells Fargo Healthcare Conference

    • Date: September 9, 2021
    • Time: 1:20-1:50 p.m. ET

    H.C. Wainwright 23rd Annual Global Investment Conference

    • Date: September 13, 2021
    • Time: 7:00 a.m. ET

    Oppenheimer & Co. Inc.'s Fall Healthcare Life Sciences & MedTech Summit

    • Date: September 20, 2021
    • Time: 2:55-3:35 p.m. ET

    A live webcast of the events will be available on the investor relations page of the Terns Pharmaceuticals website at http://ir.ternspharma.com. A replay of the webcasts will be archived on Terns' website for 30 days following the presentations.

    About Terns Pharmaceuticals

    Terns Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis, or NASH, and other chronic liver diseases. Terns' pipeline includes three clinical stage development programs including an FXR agonist, a VAP-1 inhibitor and a THR-β agonist, and a preclinical GLP-1 receptor agonist program. Terns is focused on developing combination therapies based on clinically validated and complementary mechanisms of action to address the multiple hepatic disease processes of NASH in order to drive meaningful clinical benefits for patients. For more information, please visit: www.ternspharma.com.

    Contacts for Terns

    Investors

    Justin Ng

    investors@ternspharma.com

    Media

    Jenna Urban

    Berry & Company Public Relations

    media@ternspharma.com



    Primary Logo

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    • Top-line data from ongoing Phase 1 proof of concept clinical trial of TERN-501 expected in 4Q 2021
    • Top-line data readout from Part 1 of ongoing AVIATION Trial of TERN-201 expected in 1H 2022
    • Cash and equivalents of $185.1 million provides runway into 2024

    FOSTER CITY, Calif., Aug. 16, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (NASDAQ:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, today reported financial results for the second quarter ended June 30, 2021 and corporate highlights.
            
    "We are pleased to report significant…

    • Top-line data from ongoing Phase 1 proof of concept clinical trial of TERN-501 expected in 4Q 2021
    • Top-line data readout from Part 1 of ongoing AVIATION Trial of TERN-201 expected in 1H 2022
    • Cash and equivalents of $185.1 million provides runway into 2024

    FOSTER CITY, Calif., Aug. 16, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (NASDAQ:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, today reported financial results for the second quarter ended June 30, 2021 and corporate highlights.

            

    "We are pleased to report significant progress across our clinical programs this quarter marked by several important achievements, including initiations of our Phase 1b AVIATION Trial of TERN-201 and the multiple ascending dose (MAD) cohort of our TERN-501 Phase 1 trial, as well as positive top-line data from our Phase 2a LIFT Study of TERN-101," said Senthil Sundaram, Chief Executive Officer at Terns. "These milestones highlight our commitment to rapidly advance our broad NASH pipeline. We look forward to proof of concept data for TERN-501 later this year and for TERN-201 in 2022."

    Recent Developments and Anticipated Upcoming Milestones

    TERN-501: Thyroid hormone receptor-beta (THR-β) agonist

    • Initiated 14-day multiple ascending dose (MAD) portion of Phase 1 trial in June 2021
    • Top-line, proof of concept data readout expected in 4Q 2021, including:
      • Pharmacodynamic markers of THR-β engagement in the liver linked to NASH efficacy, including sex hormone binding globulin (SHBG) and low-density lipoprotein (LDL) cholesterol
      • Indicators of pharmacokinetic stability
      • Safety and tolerability



    • Received Fast Track Designation (FTD) from the U.S. FDA in June 2021



      • Provides eligibility for more frequent FDA interactions, accelerated approval and priority review
      • TERN-501 is Terns' third development-stage compound with FTD for the treatment of NASH

    TERN-201: Vascular adhesion protein-1 (VAP-1) inhibitor

    • Initiated 12-week Phase 1b AVIATION Trial in NASH in June 2021
    • Top-line results from Part 1 of AVIATION Trial expected in 1H 2022, including:
      • Key efficacy readout in corrected T1 (cT1), an imaging marker of liver inflammation and fibrosis linked to clinical outcomes
      • Safety, tolerability and plasma VAP-1 activity

    TERN-101: Liver-distributed farnesoid X receptor (FXR) agonist

    • Reported positive top-line data from 12-week Phase 2a LIFT clinical trial in NASH in June 2021, demonstrating three firsts:
      • First FXR agonist trial to demonstrate no discontinuations due to adverse events, including pruritus
      • First 12-week placebo-controlled trial of an FXR agonist in NASH to show significant improvements in cT1, an imaging marker of liver inflammation and fibrosis linked to clinical outcomes
      • First FXR agonist planned to be studied in combination with a THR-β agonist (TERN-501)
    • Phase 1 data accepted for publication in Clinical Pharmacology in Drug Development

    GLP1-R: Oral, small-molecule glucagon-like peptide-1 (GLP1) receptor agonist

    • Nomination of final candidate expected in 2H 2021

    Second Quarter Financial Results

    • Cash Position: As of June 30, 2021, cash, cash equivalents and marketable securities were $185.1 million as compared with $74.9 million as of December 31, 2020. Based on its current operating plan, Terns expects these funds will be sufficient to support its planned operating expenses into 2024
    • Research and Development (R&D) Expenses: R&D expenses were $6.0 million for the quarter ended June 30, 2021, as compared with $7.6 million for the quarter ended June 30, 2020
    • General and Administrative (G&A) Expenses: G&A expenses were $4.9 million for the quarter ended June 30, 2021, as compared with $2.5 million for the quarter ended June 30, 2020
    • Net Loss: Net loss was $10.7 million for the quarter ended June 30, 2021, as compared with $9.7 million for the quarter ended June 30, 2020
    Terns Pharmaceuticals, Inc.        
    Condensed Consolidated Statements of Operations 
    (Unaudited; in thousands except share and per share amounts) 
             
      Three Months Ended

    June 30,
     Six Months Ended

    June 30,
       2021   2020   2021   2020 
    Operating expenses:        
    Research and development $5,961  $7,611  $14,696  $14,855 
    General and administrative  4,857   2,486   9,418   4,665 
    Total operating expenses  10,818   10,097   24,114   19,520 
    Loss from operations  (10,818)  (10,097)  (24,114)  (19,520)
    Interest income  55   2   66   52 
    Other income, net  39   250   26   417 
    Loss before income tax expense  (10,724)  (9,845)  (24,022)  (19,051)
    Income tax expense  (14)  -   (53)  - 
    Net loss  (10,738)  (9,845)  (24,075)  (19,051)
    Net loss attributable to noncontrolling interest  -   (157)  -   (362)
    Net loss attributable to common stockholders - basic and diluted $(10,738) $(9,688) $(24,075) $(18,689)
             
    Net loss per share attributable to common stockholders, basic and diluted $   (0.43) $(33.09) $   (1.19) $(73.48)
    Weighted average common stock outstanding, basic and diluted  25,109,973   292,813   20,162,496   254,351 



    Terns Pharmaceuticals, Inc.    
    Selected Balance Sheet Data    
    (Unaudited; in thousands)    
         
      June 30, 2021 December 31, 2020
    Cash, cash equivalents and marketable securities $185,084 $74,854 
    Total assets  188,007  92,290 
    Total liabilities  6,675  23,698 
    Preferred stock  -  186,033 
    Total stockholders' equity (deficit)  181,332  (117,441)
            

    About Terns Pharmaceuticals

    Terns Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis, or NASH, and other chronic liver diseases. Terns' pipeline includes three clinical stage development programs including an FXR agonist, a VAP-1 inhibitor and a THR-β agonist, and a preclinical GLP-1 receptor agonist program. Terns is focused on developing combination therapies based on clinically validated and complementary mechanisms of action to address the multiple hepatic disease processes of NASH in order to drive meaningful clinical benefits for patients. For more information, please visit: www.ternspharma.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements about Terns Pharmaceuticals, Inc. (the "Company," "we," "us," or "our") within the meaning of the federal securities laws, including those related to the Company's expectations of timing and potential results of the Company's clinical trials and other development activities; the therapeutic potential of the Company's single-agent and combination therapy candidates; the potential utility and progress of the Company's product candidates in NASH, including the clinical utility of the data from and the endpoints used in the clinical trials and nonclinical studies conducted by the Company; the Company's clinical development plans and activities for its single-agent and combination therapy candidates; the Company's expectations regarding the profile of its product candidates, including tolerability, safety, metabolic stability and pharmacokinetic profile; the Company's ability to continue to execute on its clinical strategy and plans; and the sufficiency of the Company's cash on hand to fund its operating expenses and capital expenditures. All statements other than statements of historical facts contained in this press release, including statements regarding the Company's strategy, future financial condition, future operations, future trial results, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "design," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "positioned," "potential," "predict," "seek," "should," "target," "will," "would" and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results and the implementation of the Company's plans to vary materially, including the risks associated with the initiation, cost, timing, progress and results of the Company's current and future research and development activities and preclinical studies and clinical trials. In particular, the impact of the COVID-19 pandemic on the Company's ability to progress with its research, development, manufacturing and regulatory efforts, including the Company's clinical trials for its product candidates, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the United States and in other countries, and the effectiveness of actions taken globally to contain and treat the disease. These risks are not exhaustive. For a detailed discussion of the risk factors that could affect the Company's actual results, please refer to the risk factors identified in the Company's SEC reports, including but not limited to its Annual Report on Form 10-K for the year ended December 31, 2020 and its Quarterly Report on form 10-Q for the three months ended March 31, 2021. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.



    Contacts for Terns
    
    Investors
    Justin Ng
    investors@ternspharma.com
    
    Media
    Jenna Urban
    Berry & Company Public Relations
    media@ternspharma.com

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  3. FOSTER CITY, Calif., Aug. 03, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (NASDAQ:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, today announced that management will be participating in a liver disease panel at the 2021 Wedbush PacGrow Healthcare Conference on Tuesday, August 10 at 2:20pm ET. Terns management will also present at the Canaccord Genuity 41st Annual Growth Conference on Wednesday, August 11 at 1:00pm ET.

    A live webcast of the events will be available on the investor relations page of the Terns Pharmaceuticals…

    FOSTER CITY, Calif., Aug. 03, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (NASDAQ:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, today announced that management will be participating in a liver disease panel at the 2021 Wedbush PacGrow Healthcare Conference on Tuesday, August 10 at 2:20pm ET. Terns management will also present at the Canaccord Genuity 41st Annual Growth Conference on Wednesday, August 11 at 1:00pm ET.

    A live webcast of the events will be available on the investor relations page of the Terns Pharmaceuticals website at http://ir.ternspharma.com. A replay of the webcasts will be archived on Terns' website for 30 days following the presentations.

    About Terns Pharmaceuticals

    Terns Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis, or NASH, and other chronic liver diseases. Terns' pipeline includes three clinical stage development programs including an FXR agonist, a VAP-1 inhibitor and a THR-β agonist, and a preclinical GLP-1 receptor agonist program. Terns is focused on developing combination therapies based on clinically validated and complementary mechanisms of action to address the multiple hepatic disease processes of NASH in order to drive meaningful clinical benefits for patients. For more information, please visit: www.ternspharma.com.



    Contacts for Terns
    
    Investors
    Justin Ng
    investors@ternspharma.com
    
    Media
    Jenna Urban
    Berry & Company Public Relations
    media@ternspharma.com

    Primary Logo

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    • TERN-201 is a highly selective VAP-1 inhibitor intended to address chronic liver inflammation and fibrosis in NASH
    • Sustained VAP-1 inhibition with TERN-201 may make it suitable for co-administration with other Terns therapies

    • Topline TERN-201 NASH clinical data expected in first half of 2022

    FOSTER CITY, Calif., June 24, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (NASDAQ:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, today announced the initiation of patient dosing in the AVIATION Trial, a Phase 1b clinical trial evaluating TERN-201…

    • TERN-201 is a highly selective VAP-1 inhibitor intended to address chronic liver inflammation and fibrosis in NASH
    • Sustained VAP-1 inhibition with TERN-201 may make it suitable for co-administration with other Terns therapies



    • Topline TERN-201 NASH clinical data expected in first half of 2022

    FOSTER CITY, Calif., June 24, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (NASDAQ:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, today announced the initiation of patient dosing in the AVIATION Trial, a Phase 1b clinical trial evaluating TERN-201, an orally-administered, highly selective inhibitor of vascular adhesion protein-1 (VAP-1) in patients with NASH.

    The AVIATION Trial (NCT04897594) is a multi-center, randomized, double-blind, dose-ranging, placebo-controlled, proof of concept, adaptive, Phase 1b clinical trial to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of TERN-201 in patients with presumed non-cirrhotic NASH and a cT1 value of greater than 800ms. Corrected T1, or cT1, is a magnetic resonance-based imaging test measuring liver inflammation and fibrosis that has been associated with clinical outcomes and liver histology. The primary objective of the AVIATION Trial is to evaluate the safety and tolerability of TERN-201 versus placebo when given for 12 weeks in patients with NASH. The clinical trial will be conducted in two parts: Part 1 of the trial has begun with a dose of 10 mg as compared to placebo while Part 2 is expected to enroll additional dose cohorts of TERN-201 based on an interim assessment of the 10 mg cohort. Each part of the AVIATION Trial is planned to include approximately 20 patients receiving each of the designated doses of TERN-201 and approximately 10 patients receiving placebo. The clinical trial will also explore the effects of TERN-201 on NASH imaging biomarkers (such as cT1) and NASH blood biomarkers (such as CK-18). Preliminary topline 12-week data from Part 1 and Part 2 of the AVIATION Trial are expected in 1H 2022 and 2H 2022, respectively.

    "Increasing evidence points to the role of VAP-1 in recruiting white blood cells to the liver as a key factor driving liver inflammation and fibrosis in people living with NASH," said Erin Quirk, M.D., President, Chief Medical Officer and Head of R&D at Terns, "We are excited by TERN-201's selective VAP-1 inhibition and its potential anti-inflammatory and anti-fibrotic effects which may complement the anti-steatotic activity seen with our other product candidates. Initiation of the AVIATION Trial is an important step towards a single once-daily pill as an effective NASH treatment."

    About TERN-201

    TERN-201 is a highly selective, irreversible, covalent inhibitor of vascular adhesion protein-1 (VAP-1). VAP-1 is a transmembrane protein highly expressed in hepatic vascular endothelial cells that binds to proteins on the surface of white blood cells to facilitate their deceleration, binding and transmigration from the blood stream into the liver. VAP-1 has been shown to be over-expressed in the livers of patients with NASH and fibrosis. In Terns' Phase 1 first-in-human (SAD/MAD) clinical trial across 61 healthy subjects, TERN-201 was shown to be well-tolerated and fully suppress the enzymatic activity of VAP-1 at all evaluated doses with suppression persisting up to 7 days after a single dose. In preclinical studies, TERN-201 showed significant dose-dependent reductions in liver inflammation and fibrosis in a model of liver injury. TERN-201 exhibits high selectivity for VAP-1, enhanced liver distribution and minimal potential for off-target inhibition of monoamine oxidases (MAO). The sustained activity of TERN-201, with its VAP-1 selectivity and anticipated low therapeutic dose, may make it suitable for co-administration with therapies directed at steatosis and other metabolic processes involved in NASH. Terns received Fast Track Designation from the FDA for TERN-201 for the treatment of NASH in August 2020.

    About Terns Pharmaceuticals

    Terns Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis, or NASH, and other chronic liver diseases. Terns' pipeline includes three clinical stage development programs including an FXR agonist, a VAP-1 inhibitor and a THR-β agonist, and a preclinical GLP-1 receptor agonist program. Terns is focused on developing combination therapies based on clinically validated and complementary mechanisms of action to address the multiple hepatic disease processes of NASH in order to drive meaningful clinical benefits for patients. For more information, please visit: www.ternspharma.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements about Terns Pharmaceuticals, Inc. (the "Company," "we," "us," or "our") within the meaning of the federal securities laws, including those related to the Company's expectations of timing and potential results of the Company's clinical trials and other development activities; the therapeutic potential of TERN-201; the potential for vascular adhesion protein-1 (VAP-1) to be a therapeutic target for NASH; the potential utility and progress of the Company's product candidates in NASH, including the clinical utility of the data from and the endpoints used in the Phase 1b AVIATION Trial of TERN-201; the Company's clinical development plans and activities, including the development plans for TERN-201 in combination with therapies directed at steatosis and other metabolic processes involved in NASH; the Company's expectations regarding the profile of its product candidates, including tolerability, safety, metabolic stability and pharmacokinetic profile; and the Company's ability to continue to execute on its clinical strategy and plans. All statements other than statements of historical facts contained in this press release, including statements regarding the Company's strategy, future financial condition, future operations, future trial results, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "design," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "positioned," "potential," "predict," "seek," "should," "target," "will," "would" and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results and the implementation of the Company's plans to vary materially, including the risks associated with the initiation, cost, timing, progress and results of the Company's current and future research and development activities and preclinical studies and clinical trials. In particular, the impact of the COVID-19 pandemic on the Company's ability to progress with its research, development, manufacturing and regulatory efforts, including the Company's clinical trials for its product candidates, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the United States and in other countries, and the effectiveness of actions taken globally to contain and treat the disease. These risks are not exhaustive. For a detailed discussion of the risk factors that could affect the Company's actual results, please refer to the risk factors identified in the Company's SEC reports, including but not limited to its Annual Report on Form 10-K for the year ended December 31, 2020 and its Quarterly Report on form 10-Q for the three months ended March 31, 2021. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.

    Contacts for Terns

    Investors

    Justin Ng

    investors@ternspharma.com

    Media

    Jenna Urban

    Berry & Company Public Relations

    media@ternspharma.com



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  4. First FXR agonist trial to demonstrate no discontinuations due to AEs, including pruritus, and both a differentiated pruritus and lipid profile in patients with NASH

    First 12-week controlled trial in patients with NASH to show significant improvements in corrected T1 (cT1), an imaging marker of liver inflammation and fibrosis linked to clinical outcomes

    Terns plans to initiate first NASH trial of an FXR agonist (TERN-101) in combination with a THR-β agonist (TERN-501) in 1H22

    Company to host conference call and webcast at 8:30 a.m. ET today

    FOSTER CITY, Calif., June 14, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (NASDAQ:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule…

    First FXR agonist trial to demonstrate no discontinuations due to AEs, including pruritus, and both a differentiated pruritus and lipid profile in patients with NASH

    First 12-week controlled trial in patients with NASH to show significant improvements in corrected T1 (cT1), an imaging marker of liver inflammation and fibrosis linked to clinical outcomes

    Terns plans to initiate first NASH trial of an FXR agonist (TERN-101) in combination with a THR-β agonist (TERN-501) in 1H22

    Company to host conference call and webcast at 8:30 a.m. ET today

    FOSTER CITY, Calif., June 14, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (NASDAQ:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, today reported positive top-line results from the Phase 2a LIFT clinical trial of TERN-101, a liver-distributed farnesoid X receptor (FXR) agonist for the treatment of patients with NASH.

    The LIFT study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 2a clinical trial to evaluate the safety, tolerability, efficacy, and pharmacokinetics of orally-administered TERN-101 tablets at doses of 5 mg, 10 mg and 15 mg in 100 adult patients with presumed non-cirrhotic non-alcoholic steatohepatitis (NASH). The primary objective of the clinical trial was to evaluate the safety and tolerability of TERN-101 over 12 weeks of treatment plus a four-week post-treatment follow-up period. Secondary endpoints included percent change from baseline in ALT levels and plasma pharmacokinetics of TERN-101. Exploratory efficacy endpoints included changes in liver fibro-inflammation measured by MRI corrected T1 (cT1), liver fat content by MRI proton density fat fraction (MRI-PDFF), pharmacodynamic parameters, and serum NASH biomarkers.

    In the LIFT trial, TERN-101 was generally well tolerated with a similar incidence of adverse events (AEs) across treatment groups. All treatment-related adverse events were mild/moderate with no apparent dose relationship. There were no treatment-related serious adverse events, and no patient discontinued TERN-101 due to any adverse event including pruritus. The most frequent treatment-emergent adverse events included pruritus, headache, constipation, diarrhea, decreased appetite and dizziness. Pruritus was reported in four patients (16%) in the 5 mg TERN-101 arm, three patients (11.5%) in the 10 mg TERN-101 arm, four patients (17.4%) in the 15 mg TERN-101 arm and no patients in the placebo group. Three pruritus cases were Grade 2 (widespread and intermittent); the rest were Grade 1 (mild or localized). Notably, there were no Grade 3 (widespread and constant) pruritus events and no discontinuations due to pruritus. Most pruritus cases resolved during continued TERN-101 treatment.

    No change in LDL cholesterol was observed in patients in the 5 mg and 10 mg TERN-101 arms as compared to placebo (Week 12 mean change: 4.8% for placebo, 6.7% for 5 mg TERN-101, 3.2% for 10 mg TERN-101, not significant). Statistically significant LDL changes were observed only in the 15 mg arm (Week 12 mean change: 15.9%, p<0.05). Significant decreases in HDL cholesterol were observed in all TERN-101 dose groups at Week 4 and Week 8 but returned toward baseline in the 5 mg and 10 mg dose groups without differences from placebo at Week 12. Decreases in HDL were significantly different from placebo for the 15 mg group at all observed timepoints through Week 12.

    Multiple efficacy biomarkers of NASH, including corrected T1 (cT1), MRI-PDFF and ALT, were evaluated in the LIFT Study:

    • Mean changes in cT1 at Week 12 were -0.8 msec for placebo, -38.0 msec (p=0.033) for the 5 mg arm, -57.7 msec (p=0.002) for the 10 mg arm, and -74.0 msec (p<0.001) for the 15 mg arm. Improvements of at least 80 msec in cT1 were observed in a significant proportion of patients in the 5 mg and 10 mg groups at Week 12 (as compared to placebo). Significant decreases in cT1 were also observed at Week 6 for all dose groups. cT1 is a magnetic resonance-based imaging test measuring free-water content in liver tissue, which has shown a strong correlation with inflammation and fibrosis histology and clinical outcomes in patients with liver disease.
    • Mean relative changes in MRI-PDFF were -8.4% (placebo), -15.1% (5 mg), -19.7% (10 mg), and -12.9% (15 mg) at Week 12. Mean relative changes in MRI-PDFF were significant at Week 6 for the 10 mg and 15 mg dose groups compared to placebo, although these changes were not statistically significant at Week 12. MRI-PDFF is an imaging marker that measures liver fat content.
    • Mean percent changes in ALT at Week 12 were -5.3% (placebo), -2.6% (5 mg), -18% (10 mg), and -13.2% (15 mg).
    • No discernable trends were observed in initial analyses of the enhanced liver fibrosis (ELF) score, CK-18 and Pro-C3.

    "NASH is a complex multifaceted condition, making it difficult to use just one target to treat the disease. The LIFT data are exciting because we see improvement in key non-invasive tests associated with disease severity along with an attractive safety profile with no discontinuations due to side effects," said Rohit Loomba, MD, MHSc, director of the UC San Diego NAFLD Research Center and director of Hepatology at UC San Diego School of Medicine. "The results add to the growing body of evidence showing the promise of TERN-101 as a multi-modal therapy to treat the multiple facets of this disease."

    Summary of Week 12 Analysis

      TERN-101 tablet formulation

    (once-daily)


    Mean change (baseline to week 12)





    Placebo

    N=26



    5 mg

    N=25



    10 mg

    N=26



    15 mg

    N=23



    LDL-c (%)4.8%6.7%3.2%15.9%*
    HDL-c (%)2.4%-2.6%-0.5%-8.2%*
    ALT (%)-5.3%-2.6%-18.0%-13.2%
    AST (%)0.3%1.4%-12.9%-4.2%
    GGT (%)8.1%-15.6%*-34.2% ***-17.6%*
    ALP (%)0.2%2.5%9.4%24.4%***
    cT1 (msec)+-0.8-38.0*-57.7**-74.0***
    MRI-PDFF relative change (%) -8.4%-15.1%-19.7%-12.9%

    *p<0.05, **p<0.01, ***p<0.001 versus placebo

    + cT1 was conducted only at available sites (n=22, 24, 20 and 18 for placebo, 5 mg, 10 mg and 15 mg groups, respectively).

    "We are encouraged by the positive effects of well tolerated doses of TERN-101 on cT1 relaxation time, a biomarker correlated with improved clinical outcomes. LIFT is the first controlled NASH trial to show significant cT1 improvement as early as Week 6. TERN-101 has the potential to be an effective component of a NASH treatment regimen. We look forward to advancing this program in our planned combination therapy trial," said Erin Quirk, MD, president, chief medical officer and head of research and development at Terns. "I would like to thank all those who have helped us rapidly advance the LIFT Study, including our outstanding team of investigators and clinical sites, the members of the Terns team, and the patients who participated in the study." 

    Terns plans to submit data from the LIFT Study to an upcoming scientific conference. Based on these positive results, Terns continues to plan a combination trial of TERN-101 together with TERN-501, the Company's thyroid hormone receptor beta agonist (THR-β) also in development for the treatment of NASH. The multiple ascending dose portion of the TERN-501 Phase 1 trial started in June 2021, and top-line data from the trial is expected in the second half of 2021. The combination trial of TERN-101 and TERN-501 is expected to start in the first half of 2022.

    Investor Conference Call

    Terns will host an update call for investors today, June 14, 2021, beginning at 8:30 a.m. ET. The webcast of the conference call will be made available at https://edge.media-server.com/mmc/p/2gsxxmta. To access the call via dial-in, please dial 1-833-665-0612 (U.S./Canada toll-free) or 1-929-517-0403 (international) using the conference code 7587739. A replay of the call will also be available on the investor page of the Terns website for 30 days.

    About TERN-101

    TERN-101 is a liver-distributed, non-bile acid FXR agonist that has demonstrated a differentiated tolerability profile and improved target engagement, likely due to its sustained FXR activation in the liver but only transient FXR activation in the intestine. FXR is a nuclear receptor primarily expressed in the liver, intestine and kidneys. FXR regulates hepatic expression of various genes involved in lipid metabolism, inflammation and fibrosis. Clinical studies of other FXR agonists have demonstrated significant histological NASH improvements but have also resulted in pruritus, adverse lipid changes and discontinuations.

    About Terns Pharmaceuticals

    Terns Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis, or NASH, and other chronic liver diseases. Terns' programs are based on clinically validated and complementary mechanisms of action to address the multiple hepatic disease processes of NASH in order to drive meaningful clinical benefits for patients. For more information, please visit www.ternspharma.com.

    Cautionary Note Regarding Forward-Looking Statements 

    This press release contains forward-looking statements about Terns Pharmaceuticals, Inc. (the "Company," "we," "us," or "our") within the meaning of the federal securities laws, including those related to the Company's therapeutic potential of TERN-101; the potential utility and progress of the Company's product candidates in NASH, including the clinical utility of the data from and the endpoints used in the Phase 2a LIFT Study of TERN-101; expectations of timing and potential results of the Company's clinical trials; the Company's clinical development plans and activities, including the development plans for TERN-101 in combination with TERN-501 and potentially other product candidates; the Company's expectations regarding the profile of its product candidates, including tolerability, safety, metabolic stability and pharmacokinetic profile; the Company's ability to continue to execute on its clinical strategy and plans; and the sufficiency of our cash on hand to fund our operating expenses and capital expenditures. All statements other than statements of historical facts contained in this press release, including statements regarding the Company's strategy, future financial condition, future operations, future trial results, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "design," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "positioned," "potential," "predict," "seek," "should," "target," "will," "would" and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results and the implementation of the Company's plans to vary materially, including the risks associated with the initiation, cost, timing, progress and results of the Company's current and future research and development activities and preclinical studies and clinical trials. In particular, the impact of the COVID-19 pandemic on the Company's ability to progress with its research, development, manufacturing and regulatory efforts, including the Company's clinical trials for its product candidates, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the United States and in other countries, and the effectiveness of actions taken globally to contain and treat the disease. These risks are not exhaustive. For a detailed discussion of the risk factors that could affect the Company's actual results, please refer to the risk factors identified in the Company's SEC reports, including but not limited to its Annual Report on Form 10-K for the year ended December 31, 2020 and Quarterly Report on form 10-Q for the three months ended March 31, 2021. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason. 

    Contacts for Terns 

    Investors 

    Justin Ng 

    investors@ternspharma.com

    Media 

    Jenna Urban

    Berry & Company Public Relations

    media@ternspharma.com



    Primary Logo

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  5. FOSTER CITY, Calif., June 13, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (NASDAQ:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, announced that the Company will host a conference call and live webcast on Monday, June 14, 2021 at 8:30 a.m. ET (5:30 a.m. PT) to discuss new top-line data from the Phase 2a LIFT study evaluating TERN-101 in patients with NASH. Webcast and conference call details are as follows:

    Webcast link: https://edge.media-server.com/mmc/p/2gsxxmta

    Live Conference Call
    Domestic Callers (U.S./Canada toll-free…

    FOSTER CITY, Calif., June 13, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (NASDAQ:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, announced that the Company will host a conference call and live webcast on Monday, June 14, 2021 at 8:30 a.m. ET (5:30 a.m. PT) to discuss new top-line data from the Phase 2a LIFT study evaluating TERN-101 in patients with NASH. Webcast and conference call details are as follows:

    Webcast link: https://edge.media-server.com/mmc/p/2gsxxmta

    Live Conference Call

    Domestic Callers (U.S./Canada toll-free): (833) 665-0612

    International Callers: (929) 517-0403

    Conference ID: 7587739

    Following the live audio webcast, a replay will be available on the investors page of the Terns Pharmaceuticals website at http://ir.ternspharma.com for 30 days.

    About Terns Pharmaceuticals

    Terns Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis, or NASH, and other chronic liver diseases. Terns' programs are based on clinically validated and complementary mechanisms of action to address the multiple hepatic disease processes of NASH in order to drive meaningful clinical benefits for patients. For more information, please visit www.ternspharma.com.

    Contacts for Terns:

    Investors

    Justin Ng

    investors@ternspharma.com

    Media

    Jenna Urban

    Berry & Company Public Relations

    media@ternspharma.com



    Primary Logo

    View Full Article Hide Full Article
  6. FOSTER CITY, Calif., May 19, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (NASDAQ:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, today announced that management will be presenting at the UBS Global Healthcare Virtual Conference on Monday, May 24 at 12:00 p.m. ET, and participating in the J.P. Morgan Biotech 2021 CEO Conference Call Series on Tuesday, May 25 at 1:00 p.m. ET.

    A live audio webcast of the events will be available on the investors page of the Terns Pharmaceuticals website at http://ir.ternspharma.com. A replay of…

    FOSTER CITY, Calif., May 19, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (NASDAQ:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, today announced that management will be presenting at the UBS Global Healthcare Virtual Conference on Monday, May 24 at 12:00 p.m. ET, and participating in the J.P. Morgan Biotech 2021 CEO Conference Call Series on Tuesday, May 25 at 1:00 p.m. ET.

    A live audio webcast of the events will be available on the investors page of the Terns Pharmaceuticals website at http://ir.ternspharma.com. A replay of the webcasts will be archived on Terns' website for 30 days following the presentation. J.P. Morgan Biotech 2021 CEO Conference Call Series webcasts require registration.

    About Terns Pharmaceuticals

    Terns Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis, or NASH, and other chronic liver diseases. Terns' programs are based on clinically validated and complementary mechanisms of action to address the multiple hepatic disease processes of NASH in order to drive meaningful clinical benefits for patients. For more information, please visit www.ternspharma.com.

    Contacts for Terns

    Investors

    Justin Ng

    investors@ternspharma.com

    Media

    media@ternspharma.com



    Primary Logo

    View Full Article Hide Full Article
  7. FOSTER CITY, Calif., May 13, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (NASDAQ:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, today reported financial results for the first quarter ended March 31, 2021 and provided a corporate update.

    "Our development team has continued to rapidly advance our NASH clinical programs, with top-line data for the Phase 2a LIFT study of FXR agonist TERN-101 in NASH now accelerated into June 2021. In the LIFT study, in addition to safety and tolerability, we are assessing multiple non-invasive…

    FOSTER CITY, Calif., May 13, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (NASDAQ:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, today reported financial results for the first quarter ended March 31, 2021 and provided a corporate update.

    "Our development team has continued to rapidly advance our NASH clinical programs, with top-line data for the Phase 2a LIFT study of FXR agonist TERN-101 in NASH now accelerated into June 2021. In the LIFT study, in addition to safety and tolerability, we are assessing multiple non-invasive endpoints, including MRI-PDFF (proton density fat fraction), a marker of steatosis, as well as ELF (enhanced liver fibrosis) and cT1 (MRI corrected T1) which are markers of fibrosis and/or inflammation linked to clinical outcomes and histological improvements in chronic liver diseases," said Senthil Sundaram, CEO at Terns. "In March, we initiated our first clinical trial of TERN-501 and look forward to announcing top-line data in the second half of 2021 that we hope will provide clinical confirmation of its high metabolic stability and differentiated pharmacokinetic profile."

    Recent Developments and Anticipated 2021 Milestones

    TERN-101: Liver-distributed farnesoid X receptor (FXR) agonist

    • Completed patient enrollment in the Phase 2a LIFT study in NASH patients in January 2021
    • Expecting top-line data from the Phase 2a LIFT study in June 2021

    TERN-501: Thyroid hormone receptor-beta (THR-β) agonist

    • Initiated dosing in a first-in-human Phase 1 SAD/MAD clinical trial in March 2021
    • Expecting top-line data from the ongoing Phase 1 trial in 2H21
    • Composition of matter claims allowed by USPTO

    TERN-201: Vascular adhesion protein-1 (VAP-1) inhibitor

    • Expecting to initiate dosing in 12-week Phase 1b clinical trial in NASH patients in 1H21 with expected top-line data in 1H22

    GLP1-R: Oral, small-molecule receptor agonist

    • Expecting to nominate a final candidate in 2H21 for further development

    Strengthened balance sheet

    • Completed an oversubscribed and upsized $147 million initial public offering in February 2021
    • Cash and equivalents support operations into 2024

    Terns also announced today that Erin Quirk, M.D., will assume the position of Head of Research & Development, in addition to President and Chief Medical Officer, effective immediately. Weidong Zhong, Ph.D. will be leaving his position as Chief Scientific Officer and board member, effective as of July 2, 2021. In the interim, Dr. Zhong will continue to support Dr. Quirk to ensure a smooth transition.

    Mr. Sundaram continued, "On behalf of our board and our entire team, I would like to thank Weidong for all of the contributions he made in founding Terns but also in successfully building and advancing our diverse NASH pipeline. At the same time, we are pleased to expand Erin's title in recognition of her ongoing role in leading our research, development and manufacturing teams, which she has done since 2020. With Erin's leadership, I am confident that we are well positioned to continue to advance our current and future pipeline candidates through all stages of research and development."

    First Quarter Financial Results

    • Cash Position: As of March 31, 2021, cash, cash equivalents and marketable securities were $195.6 million as compared with $74.9 million as of December 31, 2020. Based on its current operating plan, Terns expects these will be sufficient to fund its planned operating expenses into 2024.
    • Research and Development (R&D) Expenses: R&D expenses were $8.7 million for the quarter ended March 31, 2021, as compared with $7.2 million for the quarter ended March 31, 2020.
    • General and Administrative (G&A) Expenses: G&A expenses were $4.6 million for the quarter ended March 31, 2021, as compared with $2.2 million for the quarter ended March 31, 2020.
    • Net Loss: Net loss was $13.3 million for the quarter ended March 31, 2021, as compared with $9.2 million for the quarter ended March 31, 2020.



    Terns Pharmaceuticals, Inc.     
    Condensed Consolidated Statements of Operations     
    (Unaudited; in thousands except share and per share amounts)     
          
      Three Months Ended March 31, 
       2021   2020  
    Operating expenses:     
    Research and development $8,735  $7,244  
    General and administrative  4,561   2,179  
    Total operating expenses  13,296   9,423  
    Loss from operations  (13,296)  (9,423) 
    Interest income  11   50  
    Other (expense) income, net  (13)  167  
    Loss before income tax expense  (13,298)  (9,206) 
    Income tax expense  (39)  -  
    Net loss  (13,337)  (9,206) 
    Net loss attributable to noncontrolling interest  -   (205) 
    Net loss attributable to common stockholders - basic and diluted $(13,337) $(9,001) 
          
    Net loss per share attributable to common stockholders, basic and diluted $(0.88) $(41.69) 
    Weighted average common stock outstanding, basic and diluted  15,160,046   215,890  
          

     



    Terns Pharmaceuticals, Inc.     
    Selected Balance Sheet Data     
    (Unaudited; in thousands)     
          
      March 31, 2021 December 31, 2020

     
    Cash, cash equivalents and marketable securities $195,581 $74,854  
    Total assets  199,241  92,290  
    Total liabilities  9,239  23,698  
    Preferred stock  -  186,033  
    Total stockholders' equity (deficit)  190,002  (117,441) 
          

    About Terns Pharmaceuticals

    Terns Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis, or NASH, and other chronic liver diseases. Terns' programs are based on clinically validated and complementary mechanisms of action to address the multiple hepatic disease processes of NASH in order to drive meaningful clinical benefits for patients. For more information, please visit www.ternspharma.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements about Terns Pharmaceuticals, Inc. (the "Company," "we," "us," or "our") within the meaning of the federal securities laws, including those related to the Company's expectations of timing and potential results of the Company's clinical trials and other development activities; the Company's expectations regarding the profile of its product candidates, including tolerability, safety, metabolic stability and pharmacokinetic profile; the Company's ability to continue to execute on its clinical strategy and plans; the potential utility and progress of the Company's product candidates in NASH; and the sufficiency of our cash on hand to fund our operating expenses and capital expenditures. All statements other than statements of historical facts contained in this press release, including statements regarding the Company's strategy, future financial condition, future operations, future trial results, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "design," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "positioned," "potential," "predict," "seek," "should," "target," "will," "would" and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results and the implementation of the Company's plans to vary materially, including the risks associated with the initiation, cost, timing, progress and results of the Company's current and future research and development activities and preclinical studies and clinical trials. In particular, the impact of the COVID-19 pandemic on the Company's ability to progress with its research, development, manufacturing and regulatory efforts, including the Company's clinical trials for its product candidates, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the United States and in other countries, and the effectiveness of actions taken globally to contain and treat the disease. These risks are not exhaustive. For a detailed discussion of the risk factors that could affect the Company's actual results, please refer to the risk factors identified in the Company's SEC reports, including but not limited to its Annual Report on Form 10-K for the year ended December 31, 2020. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.

    Contacts for Terns

    Investors

    Justin Ng

    investors@ternspharma.com

    Media

    Cory Tromblee

    media@ternspharma.com



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  8. FOSTER CITY, Calif., April 07, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (NASDAQ:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, today announced that management will be presenting at the 19th Annual Virtual Needham Healthcare Conference on Wednesday, April 14 at 11:40 a.m. ET.

    A live audio webcast of the presentation will be available on the conference website and on Terns' website. A replay of the webcast will be archived on Terns' website for 30 days following the presentation.

    About Terns Pharmaceuticals
    Terns Pharmaceuticals…

    FOSTER CITY, Calif., April 07, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (NASDAQ:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, today announced that management will be presenting at the 19th Annual Virtual Needham Healthcare Conference on Wednesday, April 14 at 11:40 a.m. ET.

    A live audio webcast of the presentation will be available on the conference website and on Terns' website. A replay of the webcast will be archived on Terns' website for 30 days following the presentation.

    About Terns Pharmaceuticals

    Terns Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis, or NASH, and other chronic liver diseases. Terns' programs are based on clinically validated and complementary mechanisms of action to address the multiple hepatic disease processes of NASH in order to drive meaningful clinical benefits for patients. For more information, please visit www.ternspharma.com.

    Contacts for Terns

    Investors

    Mark Vignola

    investors@ternspharma.com

    Media

    Cory Tromblee

    media@ternspharma.com



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  9. -Terns ended 4Q 2020 with $75 million in cash and cash equivalents and completed an upsized initial public offering in February 2021, raising approximately $147 million in gross proceeds to support operations into 2024-

    -Top-line data from the ongoing Phase 2a LIFT study of TERN-101 expected in July 2021; data from the recently initiated Phase 1 trial of TERN-501 expected in 2H 2021-

    FOSTER CITY, Calif., March 30, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (NASDAQ:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, today reported…

    -Terns ended 4Q 2020 with $75 million in cash and cash equivalents and completed an upsized initial public offering in February 2021, raising approximately $147 million in gross proceeds to support operations into 2024-

    -Top-line data from the ongoing Phase 2a LIFT study of TERN-101 expected in July 2021; data from the recently initiated Phase 1 trial of TERN-501 expected in 2H 2021-

    FOSTER CITY, Calif., March 30, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (NASDAQ:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, today reported financial results for the fourth quarter and full year ended December 31, 2020 and provided a corporate update.

    2020 Business Highlights and Recent Developments

    TERN-101 - Liver-distributed farnesoid X receptor (FXR) agonist

    • Completed patient enrollment in the Phase 2a LIFT study in January 2021; reported final results from a Phase 1 clinical trial, which confirmed sustained liver FXR activation and a favorable tolerability profile

    TERN-201 - Vascular adhesion protein-1 (VAP-1) inhibitor

    • Reported positive results from the completed Phase 1 SAD/MAD clinical trial that demonstrated robust and sustained target engagement and tolerability

    TERN-501 - Thyroid hormone receptor-beta (THR-β) agonist

    • Initiated dosing in a first-in-human Phase 1 SAD/MAD clinical trial

    Expanded board of directors

    • Appointed three industry leaders to the board of directors: David Fellows, most recently Chief Executive Officer (CEO) of Nightstar Therapeutics, Jeff Kindler, CEO of Centrexion Therapeutics and former CEO of Pfizer, and Jill M. Quigley Chief Operating Officer at Passage Bio

    Key management team appointments

    • Added Senthil Sundaram, formerly Chief Financial Officer (CFO) of Nightstar Therapeutics, as CEO and Board Director, Mark Vignola, Ph.D., formerly CFO of Applied Therapeutics, as CFO, and Bryan Yoon, formerly Chief Administrative Officer, General Counsel and Secretary of LogicBio Therapeutics, as Chief Operating Officer and General Counsel, and promoted Erin Quirk, M.D., to President

    Strengthened balance sheet

    • Closed an $87 million Series C financing led by Deerfield Management Company alongside a strategic equity investment from Eli Lilly and Company in December 2020 and completed an upsized $147 million initial public offering in February 2021

    Anticipated 2021 Milestones

    TERN-101

    • Report top-line data from the ongoing Phase 2a LIFT study in NASH patients in July 2021

    TERN-201

    • Initiate 12-week Phase 1b clinical trial in NASH patients in 1H21 with expected top-line data in 1H22

    TERN-501

    • Report top-line data from the ongoing Phase 1 trial in 2H21

    GLP1-R agonist (oral):

    • Nominate a final candidate for further development in NASH in 2H21

    "2020 was a year of significant growth and momentum at Terns, during which the team made tremendous progress advancing our pipeline of single-agent and combination NASH therapies which in turn allowed us to significantly strengthen our financial position," said Senthil Sundaram, CEO at Terns. "With the recent initiation of our Phase 1 clinical trial of TERN-501, we now have three clinical-stage NASH programs focused on clinically validated targets. As we look ahead to 2021 and 2022, we anticipate data readouts for all three of our ongoing clinical programs and look forward to initiating our first combination clinical trial of TERN-101 and TERN-501 – all with the goal of developing best-in-class therapies we hope can change the lives of people with NASH."

    Full Year and Fourth Quarter Financial Results

    • Cash, Cash Equivalents and Investments Position: As of December 31, 2020, cash, cash equivalents and investments were $74.9 million as compared with $19.7 million as of December 31, 2019. Based on its current operating plan, Terns expects its cash and cash equivalents will be sufficient to fund its planned operating expenses into 2024.
    • Research and Development (R&D) Expenses: R&D expenses were $7.8 million and $28.0 million for the quarter and year ended December 31, 2020, respectively, as compared with $7.6 million and $61.5 million for the quarter and year ended December 31, 2019, respectively.
    • General and Administrative (G&A) Expenses: G&A expenses were $1.0 million and $9.0 million for the quarter and year ended December 31, 2020, respectively, as compared with $2.4 million and $8.7 million for the quarter and year ended December 31, 2019, respectively.
    • Net Loss: Net loss was $9.9 million and $40.6 million for the quarter and year ended December 31, 2020, respectively, as compared with $10.0 million and $68.8 million for the quarter and year ended December 31, 2019, respectively.
              
              
     Terns Pharmaceuticals, Inc. 
     Consolidated Statements of Operations 
     (Unaudited; in thousands except share and per share amounts) 
              
      Quarter Ended December 31,  Year Ended December 31,  
        2020     2019     2020     2019   
     Operating expenses:        
     Research and development$7,770  $7,556  $28,029  $61,534  
     General and administrative 998   2,388   8,996   8,663  
     Total operating expenses 8,768   9,944   37,025   70,197  
     Loss from operations (8,768)  (9,944)  (37,025)  (70,197) 
     Interest income 2   107   55   1,204  
     Change in fair value of loans payable (521)  -   (2,887)  -  
     Other income (expense), net 69   (207)  99   154  
     Loss before income tax (expense) benefit (9,218)  (10,044)  (39,758)  (68,839) 
     Income tax (expense) benefit (711)  (2)  (813)  20  
     Net loss (9,929)  (10,046)  (40,571)  (68,819) 
     Extinguishment of Series B convertible preferred stock 10,701   -   10,701   -  
     Net loss attributable to noncontrolling interest -   (271)  (518)  (208) 
     Series A and C participating preferred stock (772)  -   -   -  
     Net loss attributable to common stockholders - basic$-  $(9,775) $(29,352) $(68,611) 
                      
     Effect of dilutive securities:                
     Extinguishment of Series B convertible preferred stock (10,701)  -   -   -  
     Net loss attributable to common stockholders - diluted$(10,701) $(9,775) $(29,352) $(68,611) 
                      
     Net loss per share attributable to common stockholders, basic$-  $(45.28) $(102.93) $(374.39) 
     Weighted average common stock outstanding, basic 328,941   215,890   285,162   183,262  
                      
     Net loss per share attributable to common stockholders, diluted$(3.65) $(45.28) $(102.93) $(374.39) 
     Weighted average common stock outstanding, diluted 2,929,586   215,890   285,162   183,262  
              
              



           
     Terns Pharmaceuticals, Inc. 
     Selected Balance Sheet Data 
     (Unaudited; in thousands) 
           
       December 31, 
        2020   2019  
     Cash, cash equivalents and investments $74,854  $19,650  
     Total assets  92,290   23,904  
     Total liabilities  23,698   5,580  
     Preferred stock and noncontrolling interest  186,033   109,084  
     Stockholders' deficit  (117,441)  (90,760) 
           

    About Terns Pharmaceuticals

    Terns Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis, or NASH, and other chronic liver diseases. Terns' programs are based on clinically validated and complementary mechanisms of action to address the multiple hepatic disease processes of NASH in order to drive meaningful clinical benefits for patients. For more information, please visit www.ternspharma.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements about Terns Pharmaceuticals, Inc. (the "Company," "we," "us," or "our") within the meaning of the federal securities laws, including those related to the Company's expectations of timing and potential results of the Company's clinical trials and other development activities; the potential utility and progress of the Company's product candidates in NASH; and the sufficiency of our cash on hand to fund our operating expenses and capital expenditures. All statements other than statements of historical facts contained in this press release, including statements regarding the Company's strategy, future financial condition, future operations, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "design," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "positioned," "potential," "predict," "seek," "should," "target," "will," "would" and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results and the implementation of the Company's plans to vary materially, including the risks associated with the initiation, cost, timing, progress and results of the Company's current and future research and development activities and preclinical studies and clinical trials. In particular, the impact of the COVID-19 pandemic on the Company's ability to progress with its research, development, manufacturing and regulatory efforts, including the Company's clinical trials for its product candidates, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the United States and in other countries, and the effectiveness of actions taken globally to contain and treat the disease. These risks are not exhaustive. For a detailed discussion of the risk factors that could affect the Company's actual results, please refer to the risk factors identified in the Company's SEC reports, including but not limited to its prospectus dated February 4, 2021. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.

    Contacts for Terns

    Investors

    Mark Vignola

    investors@ternspharma.com

    Media

    Cory Tromblee

    media@ternspharma.com 



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  10. -TERN-501 is designed to have high metabolic stability, enhanced liver distribution and high selectivity for THR-β-

    -Top-line data expected in the second half of 2021-

    FOSTER CITY, Calif., March 22, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (NASDAQ:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, today announced the initiation of dosing in a Phase 1 clinical trial evaluating TERN-501, a selective thyroid hormone receptor beta (THR-β) agonist with high metabolic stability, enhanced liver distribution and greater selectivity…

    -TERN-501 is designed to have high metabolic stability, enhanced liver distribution and high selectivity for THR-β-

    -Top-line data expected in the second half of 2021-

    FOSTER CITY, Calif., March 22, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (NASDAQ:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, today announced the initiation of dosing in a Phase 1 clinical trial evaluating TERN-501, a selective thyroid hormone receptor beta (THR-β) agonist with high metabolic stability, enhanced liver distribution and greater selectivity for THR-β when compared with other THR-β agonists in development. Terns expects to report initial top-line data from the trial in the second half of 2021.

    "We are excited to initiate the first-in-human study of TERN-501 and are proud of the hard work our team has done to advance three NASH programs of different therapeutic classes into clinical development. We believe each of our single-agent programs has improved upon a validated mechanism of action for the treatment of NASH," said Erin Quirk, M.D., President and Chief Medical Officer of Terns. "It has always been our goal to rapidly advance monotherapy candidates with high potential to be used in combination regimens. Furthermore, initiating first-in-human dosing of TERN-501 advances Terns closer to our goal of starting a Phase 2a clinical proof-of-concept trial evaluating a combination of TERN-101, our liver-distributed farnesoid X receptor agonist currently in Phase 2a development, and TERN-501 in the first half of 2022."

    This Phase 1 clinical trial is being conducted in the United States and is expected to enroll approximately 90 healthy participants. The trial is designed to incorporate both single ascending dose and multiple ascending dose cohorts in which the safety, tolerability and pharmacokinetics of TERN-501 will be assessed, as well as pharmacodynamic biomarkers such as sex hormone binding globulin and serum lipid levels that could serve as an early marker of THR-β target engagement.

    About TERN-501

    TERN-501 is a thyroid hormone receptor beta (THR-β) agonist with high metabolic stability, enhanced liver distribution and greater selectivity for THR-β compared to other THR-β agonists in development. Agonism of THR-β increases fatty acid metabolism via mitochondrial oxidation and affects cholesterol synthesis and metabolism. As a result, THR-β stimulation has the ability to reduce hepatic steatosis and improve serum lipid parameters including LDL cholesterol and triglycerides. In vivo NASH studies in a rodent model have demonstrated that low-doses of TERN-501 achieved complete resolution of steatosis and reductions in serum lipids, hepatic inflammation and fibrosis. TERN-501 has high liver distribution and is 23-fold more selective for THR-β than for THR-α activation in a cell free assay, thereby minimizing the risk of cardiotoxicity and other off-target effects associated with non-selective THR stimulation. Finally, TERN-501 has been designed to be metabolically stable and is therefore expected to have little pharmacokinetic variability and a low clinical dose, making it an attractive candidate for use in fixed-dose combinations for NASH treatment.

    About TERN-101 

    TERN-101 is a liver-distributed, non-bile acid FXR agonist that has demonstrated a differentiated tolerability profile and improved target engagement, likely due to its sustained FXR activation in the liver but only transient FXR activation in the intestine. FXR is a nuclear receptor primarily expressed in the liver, intestine and kidneys. FXR regulates hepatic expression of various genes involved in lipid metabolism, inflammation and fibrosis. Studies have demonstrated that there is minimal overlap between liver and intestine FXR binding sites, indicating potentially a high degree of tissue-specific FXR function. Clinical studies of other FXR agonists have demonstrated significant histological NASH improvements but have also resulted in pruritus and adverse lipid changes. These tolerability issues have generally been observed in Phase 1 clinical trials of other FXR agonists in development and have been regarded as dose-limiting toxicities, which are suboptimal for patients and can lead to treatment discontinuation. However, in all four Phase 1 clinical trials of TERN-101, none of the 119 subjects who received TERN-101 reported pruritus, and the serum lipid profiles among TERN-101 recipients were similar to placebo recipients even at high doses.

    About Terns Pharmaceuticals

    Terns Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis, or NASH, and other chronic liver diseases. Terns' programs are based on clinically validated and complementary mechanisms of action to address the multiple hepatic disease processes of NASH in order to drive meaningful clinical benefits for patients. For more information, please visit www.ternspharma.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements about Terns Pharmaceuticals, Inc. (the "Company," "we," "us," or "our") within the meaning of the federal securities laws, including those related to the Company's expectations of timing and potential results of the Company's clinical trials and other development activities and the potential utility and progress of the Company's product candidates in NASH. All statements other than statements of historical facts contained in this press release, including statements regarding the Company's strategy, future financial condition, future operations, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "design," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "positioned," "potential," "predict," "seek," "should," "target," "will," "would" and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results and the implementation of the Company's plans to vary materially, including the risks associated with the initiation, cost, timing, progress and results of the Company's current and future research and development activities and preclinical studies and clinical trials. In particular, the impact of the COVID-19 pandemic on the Company's ability to progress with its research, development, manufacturing and regulatory efforts, including the Company's clinical trials for its product candidates, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the United States and in other countries, and the effectiveness of actions taken globally to contain and treat the disease. These risks are not exhaustive. For a detailed discussion of the risk factors that could affect the Company's actual results, please refer to the risk factors identified in the Company's SEC reports, including but not limited to its prospectus dated February 4, 2021. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.

    US Media Contact:

    Investor Relations Contact:

    Mark Vignola

    investors@ternspharma.com

    Media Contact:

    Cory Tromblee 

    media@ternspharma.com  



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  11. FOSTER CITY, Calif., March 08, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (NASDAQ:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, today announced it will present data from two of its clinical development programs for NASH at the NASH-TAG Conference 2021, taking place March 11-13, 2021.

    "We are pleased to be invited by the NASH-TAG conference organizers to give an oral presentation on the potential benefits of targeting vascular adhesion protein-1 (VAP-1) inhibition for the treatment of NASH, ahead of the initiation of our…

    FOSTER CITY, Calif., March 08, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (NASDAQ:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, today announced it will present data from two of its clinical development programs for NASH at the NASH-TAG Conference 2021, taking place March 11-13, 2021.

    "We are pleased to be invited by the NASH-TAG conference organizers to give an oral presentation on the potential benefits of targeting vascular adhesion protein-1 (VAP-1) inhibition for the treatment of NASH, ahead of the initiation of our NASH clinical trial for TERN-201, our highly selective VAP-1 inhibitor," said Erin Quirk, M.D., President and Chief Medical Officer of Terns. "In 2020, we presented data demonstrating that TERN-201 may have advantages over other VAP-1 inhibitor candidates and we look forward to showcasing the program with the hepatology community as we continue to advance our clinical studies. We will also be presenting data for our FXR agonist, TERN-101, demonstrating increased histological resolution of liver steatosis, inflammation and fibrosis in a preclinical NASH model. We expect to report 12-week clinical data from our Phase 2a LIFT Study of TERN-101 in NASH patients in the third quarter of 2021."

    The details of Terns' presentations are as follows:

    Oral Presentation

    Targeting VAP-1 Inhibition in NASH

    March 13, 2021

    6:45 PM, MST

    Poster

    Liver-distributed Farnesoid X Receptor agonist TERN-101 is more efficacious in a mouse model of non-alcoholic steatohepatitis than Obeticholic Acid

    Abstract # 13

    March 11-13

    A copy of the presentations will be accessible in the Scientific Publications section of the Terns website at www.TernsPharma.com.

    The NASH-TAG Conference is designed to bring together clinicians and researchers in academia and the pharmaceutical industry for a focused interactive educational update highlighting the most relevant advances and challenges in the diagnosis and therapy of NASH and liver fibrosis.

    About TERN-201

    TERN-201 is a highly-selective inhibitor of vascular adhesion protein-1 (VAP-1) that has demonstrated sustained target engagement in clinical trials without off-target liabilities associated with other VAP-1 inhibitors in development. VAP-1 has been shown to be over-expressed in the livers of NASH patients in response to local lipotoxicity and liver injury. TERN-201 may have advantages over other development candidates because it is highly specific for VAP-1 inhibition and has minimal potential for off-target effects. Terns plans to start its Phase 1b clinical trial of TERN-201 in NASH patients in the first half of 2021 and expects data in the first half of 2022. Terns received Fast Track designation from the FDA for TERN-201 for the treatment of NASH in August 2020.

    About TERN-101

    TERN-101 is a liver-distributed, non-bile acid FXR agonist that has demonstrated a differentiated tolerability profile and improved target engagement, likely due to its sustained FXR activation in the liver but only transient FXR activation in the intestine. FXR is a nuclear receptor primarily expressed in the liver, intestine and kidneys. FXR regulates hepatic expression of various genes involved in lipid metabolism, inflammation and fibrosis. Studies have demonstrated that there is minimal overlap between liver and intestine FXR binding sites, indicating potentially a high degree of tissue-specific FXR function. Clinical studies of other FXR agonists have demonstrated significant histological NASH improvements but have also resulted in pruritus and adverse lipid changes. These tolerability issues have generally been observed in Phase 1 clinical trials of other FXR agonists in development and have been regarded as dose-limiting toxicities, which are suboptimal for patients and can lead to treatment discontinuation. However, in all four Phase 1 clinical trials of TERN-101, none of the 119 subjects who received TERN-101 reported pruritus, and the serum lipid profiles among TERN-101 recipients were similar to placebo recipients even at high doses.

    About Terns Pharmaceuticals

    Terns Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis, or NASH, and other chronic liver diseases. Terns' programs are based on clinically validated and complementary mechanisms of action to address the multiple hepatic disease processes of NASH in order to drive meaningful clinical benefits for patients. For more information, please visit www.ternspharma.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements about Terns Pharmaceuticals, Inc. (the "Company," "we," "us," or "our") within the meaning of the federal securities laws, including those related to the Company's expectations of timing and potential results of the Company's clinical trials and other development activities and the potential utility and progress of the Company's product candidates in NASH. All statements other than statements of historical facts contained in this press release, including statements regarding the Company's strategy, future financial condition, future operations, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "design," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "positioned," "potential," "predict," "seek," "should," "target," "will," "would" and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results and the implementation of the Company's plans to vary materially, including the risks associated with the initiation, cost, timing, progress and results of the Company's current and future research and development activities and preclinical studies and clinical trials. In particular, the impact of the COVID-19 pandemic on the Company's ability to progress with its research, development, manufacturing and regulatory efforts, including the Company's clinical trials for its product candidates, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the United States and in other countries, and the effectiveness of actions taken globally to contain and treat the disease. These risks are not exhaustive. For a detailed discussion of the risk factors that could affect the Company's actual results, please refer to the risk factors identified in the Company's SEC reports, including but not limited to its prospectus dated February 4, 2021. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.

    US Media Contact:

    Investor Relations Contact:

    Mark Vignola

    investors@ternspharma.com

    Media Contact:

    Cory Tromblee

    media@ternspharma.com 



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  12. FOSTER CITY, Calif., Feb. 23, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (NASDAQ:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, today announced that management will be presenting at the Cowen 41st Annual Health Care Conference on Thursday, March 4 at 9:50 a.m. ET.

    A live audio webcast of the presentation will be available here and on Terns' website at http://ir.ternspharma.com/. A replay of the webcast will be archived on Terns' website for 30 days following the presentation.

    Terns will also participate in a NASH panel at…

    FOSTER CITY, Calif., Feb. 23, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (NASDAQ:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, today announced that management will be presenting at the Cowen 41st Annual Health Care Conference on Thursday, March 4 at 9:50 a.m. ET.

    A live audio webcast of the presentation will be available here and on Terns' website at http://ir.ternspharma.com/. A replay of the webcast will be archived on Terns' website for 30 days following the presentation.

    Terns will also participate in a NASH panel at the conference on Tuesday, March 2 from 12:50-1:50 p.m. ET.

    About Terns Pharmaceuticals

    Terns Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis, or NASH, and other chronic liver diseases. Terns' programs are based on clinically validated and complementary mechanisms of action to address the multiple hepatic disease processes of NASH in order to drive meaningful clinical benefits for patients. For more information, please visit www.ternspharma.com.

    US Media Contact:

    Investor Relations Contact:

    Mark Vignola

    investors@ternspharma.com

    Media Contact:

    Cory Tromblee

    media@ternspharma.com



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  13. FOSTER CITY, Calif., Feb. 10, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (NASDAQ:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis, or NASH, and other chronic liver diseases, today announced the closing of the Company's initial public offering of 7,500,000 shares of common stock at a public offering price of $17.00 per share, along with   the exercise in full by the underwriters of their option to purchase an additional 1,125,000 shares of common stock. The exercise of the underwriters' option to purchase additional shares is expected to close on February 12, 2021…

    FOSTER CITY, Calif., Feb. 10, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (NASDAQ:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis, or NASH, and other chronic liver diseases, today announced the closing of the Company's initial public offering of 7,500,000 shares of common stock at a public offering price of $17.00 per share, along with   the exercise in full by the underwriters of their option to purchase an additional 1,125,000 shares of common stock. The exercise of the underwriters' option to purchase additional shares is expected to close on February 12, 2021, subject to customary closing conditions. After giving effect to the full exercise by the underwriters of their option to purchase additional shares, aggregate gross proceeds to the Company are expected to be approximately $146.6 million, before underwriting discounts, commissions and estimated offering expenses. All of the shares in the offering were offered by Terns. Terns' common stock is listed on the Nasdaq Global Select Market under the ticker symbol "TERN."

    J.P. Morgan, Goldman Sachs & Co. LLC and Cowen are acting as joint book-running managers for the offering.

    Registration statements relating to the shares being sold in this offering were declared effective by the Securities and Exchange Commission on February 4, 2021. The offering of these securities is being made only by means of a prospectus, copies of which may be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at +1-866-803-9204 or by e-mail: prospectus-eq_fi@jpmchase.com, Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, by telephone at +1-212-902-1171 or by e-mail: prospectus-ny@ny.email.gs.com or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at +1-833-297-2926 or by e-mail: PostSaleManualRequests@broadridge.com.

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    Contact:

    Investor Relations Contact:

    Mark Vignola

    investors@ternspharma.com

    Media Contact:

    Cory Tromblee

    media@ternspharma.com



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  14. FOSTER CITY, Calif., Feb. 04, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (NASDAQ:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis, or NASH, and other chronic liver diseases, today announced the pricing of its upsized initial public offering of 7,500,000 shares of common stock at a public offering price of $17.00 per share, for gross proceeds of $127.5 million, before the underwriting discounts and commissions. All of the shares of common stock are being offered by Terns. The Company has also granted the underwriters a 30-day option to purchase from the Company an additional…

    FOSTER CITY, Calif., Feb. 04, 2021 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (NASDAQ:TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis, or NASH, and other chronic liver diseases, today announced the pricing of its upsized initial public offering of 7,500,000 shares of common stock at a public offering price of $17.00 per share, for gross proceeds of $127.5 million, before the underwriting discounts and commissions. All of the shares of common stock are being offered by Terns. The Company has also granted the underwriters a 30-day option to purchase from the Company an additional 1,125,000 shares of common stock at the initial public offering price, less the underwriting discounts and commissions. Terns' common stock has been approved for listing on the Nasdaq Global Select Market and is expected to begin trading under the ticker symbol "TERN" on February 5, 2021. The offering is expected to close on February 9, 2021, subject to customary closing conditions.

    J.P. Morgan, Goldman Sachs & Co. LLC and Cowen are acting as joint book-running managers for the offering.

    Registration statements relating to the shares being sold in this offering were declared effective by the Securities and Exchange Commission on February 4, 2021. The offering of these securities is being made only by means of a prospectus, copies of which may be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at +1-866-803-9204 or by e-mail: prospectus-eq_fi@jpmchase.com, Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, by telephone at +1-212-902-1171 or by e-mail: prospectus-ny@ny.email.gs.com or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at +1-833-297-2926 or by e-mail: PostSaleManualRequests@broadridge.com.

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    Contact:

    Investor Relations Contact:

    Mark Vignola

    investors@ternspharma.com

    Media Contact:

    Cory Tromblee

    media@ternspharma.com



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