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Terns Pharmaceuticals Reports Third Quarter 2024 Financial Results and Corporate Updates

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Terns Pharmaceuticals reported Q3 2024 financial results and pipeline updates. Key highlights include expected interim data from Phase 1 CARDINAL trial of TERN-701 in CML in December 2024, and plans to initiate Phase 2 trial for TERN-601 in obesity in early Q2 2025. The company's cash position stands at $372.8 million, including a $172.7 million equity raise, providing runway into 2028. Q3 financial results show R&D expenses of $15.2 million, G&A expenses of $9.8 million, and a net loss of $21.9 million. TERN-601's Phase 1 trial demonstrated promising results with up to 5.5% weight loss over 28 days.

Terns Pharmaceuticals ha riportato i risultati finanziari del terzo trimestre 2024 e aggiornamenti sul pipeline. I punti salienti includono i dati provvisori attesi dalla fase 1 dello studio CARDINAL di TERN-701 nella CML a dicembre 2024, e i piani per avviare un trial di fase 2 per TERN-601 nell'obesità all'inizio del secondo trimestre 2025. La posizione di liquidità dell'azienda è di $372.8 milioni, inclusa una raccolta di capitale di $172.7 milioni, che garantirà le operazioni fino al 2028. I risultati finanziari del terzo trimestre mostrano spese per R&S di $15.2 milioni, spese generali e amministrative di $9.8 milioni e una perdita netta di $21.9 milioni. Il trial di fase 1 di TERN-601 ha dimostrato risultati promettenti con una perdita di peso fino al 5.5% in 28 giorni.

Terns Pharmaceuticals reportó los resultados financieros del tercer trimestre de 2024 y actualizaciones sobre su pipeline. Los puntos clave incluyen datos intermedios esperados del ensayo CARDINAL de Fase 1 de TERN-701 en LMC para diciembre de 2024, y planes para iniciar un ensayo de Fase 2 para TERN-601 en obesidad a principios del segundo trimestre de 2025. La posición de efectivo de la compañía es de $372.8 millones, que incluye una recaudación de capital de $172.7 millones, proporcionando financiamiento hasta 2028. Los resultados financieros del tercer trimestre muestran gastos en I+D de $15.2 millones, gastos generales y administrativos de $9.8 millones y una pérdida neta de $21.9 millones. El ensayo de Fase 1 de TERN-601 demostró resultados prometedores con una pérdida de peso de hasta 5.5% en 28 días.

Terns Pharmaceuticals는 2024년 3분기 재무 결과 및 파이프라인 업데이트를 보고했습니다. 주요 내용으로는 2024년 12월 CML에서 진행 중인 TERN-701의 1상 CARDINAL 시험 중간 데이터 예상과 2025년 2분기 초 TERN-601의 비만에 대한 2상 시험 개시 계획이 포함됩니다. 회사의 현금 포지션은 $372.8백만으로, $172.7백만의 자본 조달을 포함하여 2028년까지 운영 자금을 제공합니다. 3분기 재무 결과는 R&D 비용이 $15.2백만, 일반 관리 비용이 $9.8백만, 그리고 순손실이 $21.9백만으로 나타났습니다. TERN-601의 1상 시험은 28일간 최대 5.5%의 체중 감소라는 유망한 결과를 보여주었습니다.

Terns Pharmaceuticals a publié les résultats financiers du troisième trimestre 2024 et des mises à jour sur son pipeline. Les points clés incluent des données intermédiaires attendues de l'essai CARDINAL de Phase 1 pour TERN-701 dans la LMC en décembre 2024, ainsi que des plans pour initier un essai de Phase 2 pour TERN-601 dans l'obésité début du deuxième trimestre 2025. La position de trésorerie de l'entreprise s'élève à $372.8 millions, y compris une levée de fonds de $172.7 millions, assurant des fonds jusqu'en 2028. Les résultats financiers du troisième trimestre montrent des dépenses de R&D de $15.2 millions, des dépenses générales et administratives de $9.8 millions, et une perte nette de $21.9 millions. L'essai de Phase 1 de TERN-601 a démontré des résultats prometteurs avec une perte de poids allant jusqu'à 5.5% en 28 jours.

Terns Pharmaceuticals berichtete über die finanziellen Ergebnisse des dritten Quartals 2024 und Aktualisierungen zur Pipeline. Zu den wichtigsten Punkten gehören die erwarteten Zwischenresultate aus der Phase-1-Studie CARDINAL zu TERN-701 bei CML im Dezember 2024 sowie die Pläne zur Initiierung einer Phase-2-Studie für TERN-601 bei Fettleibigkeit zu Beginn des zweiten Quartals 2025. Die Liquiditätsposition des Unternehmens beträgt $372.8 Millionen, einschließlich einer Kapitalerhöhung von $172.7 Millionen, die eine Finanzierung bis 2028 gewährleistet. Die finanziellen Ergebnisse des dritten Quartals zeigen F&E-Ausgaben von $15.2 Millionen, allgemeine und Verwaltungskosten von $9.8 Millionen sowie einen Nettoverlust von $21.9 Millionen. Die Phase-1-Studie zu TERN-601 zeigte vielversprechende Ergebnisse mit einem Gewichtsverlust von bis zu 5.5% über 28 Tage.

Positive
  • Strong cash position of $372.8 million extending runway into 2028
  • Successful equity raise of $172.7 million in September 2024
  • TERN-601 showed significant weight loss results of up to 5.5% in 28 days
  • Reduced G&A expenses from $18.4M to $9.8M year-over-year
  • Decreased net loss from $29.8M to $21.9M compared to Q3 2023
Negative
  • R&D expenses increased to $15.2M from $14.8M year-over-year
  • Operating loss of $24.9M in Q3 2024

Insights

The Q3 results reveal significant financial strength with $372.8M in cash, bolstered by a successful $172.7M equity raise, extending runway into 2028. The quarterly net loss decreased to $21.9M from $29.8M year-over-year, showing improved cost management. G&A expenses notably decreased to $9.8M from $18.4M, while R&D expenses remained stable at $15.2M.

The company's robust cash position and extended runway provide substantial operational flexibility for advancing their pipeline, particularly the promising TERN-601 obesity drug and TERN-701 for CML. With multiple catalysts expected in 2025, including Phase 2 obesity trial data, the company appears well-positioned financially to execute its development strategy.

The clinical pipeline shows promising advancement, particularly with TERN-601's compelling Phase 1 results in obesity treatment, demonstrating 5.5% weight loss over 28 days. The upcoming Phase 2 trial in Q2 2025 could position TERN-601 as a significant competitor in the rapidly growing GLP-1 market. The drug's unique properties, including sustained target coverage and favorable tolerability profile, suggest potential advantages over existing oral GLP-1 agonists.

The imminent TERN-701 interim data in CML and the strategic development of GIPR antagonists for combination therapy indicate a well-thought-out pipeline strategy. The positive preclinical data for TERN-501 in combination with GLP-1 agonists further strengthens the company's position in metabolic disease treatment.

Interim data from initial dose escalation cohorts of Phase 1 CARDINAL trial evaluating TERN-701 (allosteric BCR-ABL tyrosine kinase inhibitor) in chronic myeloid leukemia (CML) expected in early December 2024

Plans to initiate Phase 2 clinical trial for TERN-601 in obesity in early 2Q25 with initial 12-week data expected in 2H25

Cash, cash equivalents and marketable securities of $372.8 million, including $172.7 million equity raise in September, expected to provide runway into 2028

FOSTER CITY, Calif., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity, today reported financial results for the third quarter ended September 30, 2024, and provided corporate updates.

“Our progress in the third quarter was highlighted by the compelling topline results from our Phase 1 study of TERN-601, which demonstrated class-leading potential as a differentiated, once-daily, oral GLP-1R agonist for the treatment of obesity and supports its rapid advancement into Phase 2 studies,” stated Amy Burroughs, chief executive officer of Terns. “We are looking forward to sharing interim dose escalation data from the Phase 1 CARDINAL trial of TERN-701 as a treatment for chronic myeloid leukemia (CML) and expect this early look at safety, tolerability and signals of efficacy to reinforce its potential as a best-in-class allosteric for the treatment of CML. Importantly, our successful equity raise underscores the strong support for our promising pipeline of differentiated small molecules, funds Terns through multiple catalysts across our clinical development programs and extends our cash runway into 2028.”

Recent Pipeline Developments and Anticipated Milestones

TERN-701: Oral, allosteric BCR-ABL tyrosine kinase inhibitor (TKI) for chronic myeloid leukemia (CML)

  • Interim data from initial dose escalation cohorts in Terns’ ongoing Phase 1 CARDINAL study of TERN-701 in CML expected in early December 2024
    • CARDINAL is a global, multicenter, open-label, two-part Phase 1 clinical trial to evaluate the safety, pharmacokinetics (PK) and efficacy of TERN-701 in patients with previously treated CML
    • The Company expects to share interim dose escalation data from the CARDINAL study, including safety, tolerability and early signals of efficacy
  • In August, Terns hosted a TERN-701 webinar event focused on interpreting early datasets in CML

TERN-601: Oral, small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist for obesity

  • Terns plans to initiate a Phase 2 clinical trial in early second quarter of 2025 with initial 12-week data expected in the second half of 2025
    • The trial will begin with a 12-week portion to optimize dose titration and inform subsequent cohorts
  • In September, Terns announced positive safety and 28-day weight loss data from the Phase 1 first-in-human clinical trial of TERN-601 in obese and overweight participants
    • The results showed TERN-601 was well tolerated and demonstrated dose-dependent, statistically significant mean weight loss up to 5.5% (4.9% placebo adjusted) over 28 days
    • 67% of study participants lost 5% or more of their baseline body weight at the highest dose of 740 mg once-daily (QD)
    • TERN-601 exhibited distinct properties for an oral GLP-1R agonist
      • Low solubility and high gut permeability allowed for prolonged absorption and sustained target coverage and a flat PK curve, while high drug levels in the gut wall may lead to robust GLP-1R activation in the gut triggering satiety centers in the brain
      • Low free fraction in circulation, combined with the flat PK curve, may contribute to TERN-601's tolerability profile at higher target doses than other oral GLP-1R agonists
    • TERN-601 was well-tolerated with no treatment-related dose interruptions, reductions, or discontinuations even with rapid dose titration

TERN-501: Oral, thyroid hormone receptor-beta (THR-β) agonist

  • In June, Terns presented new preclinical data at the American Diabetes Association (ADA) 84th Scientific Sessions supporting TERN-501 in combination with a GLP-1 receptor agonist for obesity
    • Preclinical findings demonstrated TERN-501 in combination with semaglutide significantly enhanced weight loss and showed proportionally greater loss of fat mass relative to lean mass compared to semaglutide alone
    • Supports the potential for TERN-501 as a combination partner for injectable and oral GLP-1 agonists for use in obesity and other metabolic disorders
    • The full poster is available on Terns’ scientific publications website
  • Terns continues to evaluate opportunities for TERN-501 in metabolic diseases

TERN-800 Series: Oral, small-molecule glucose-dependent insulinotropic polypeptide receptor (GIPR) agonist

  • Discovery efforts are ongoing for small molecule GIPR modulators for obesity, which have the potential for combination with GLP-1 receptor agonists, such as TERN-601
  • Terns is prioritizing its discovery efforts on nominating a GIPR antagonist development candidate based on in-house discoveries and growing scientific rationale supporting the potential of GLP-1 agonist/GIPR antagonist combinations for obesity

Corporate Updates

  • In September, Terns completed an upsized public offering of 14,064,048 shares of its common stock and 2,380,952 pre-funded warrants, generating gross proceeds of approximately $172.7 million before deducting underwriting discounts and commissions and other offering expenses, which extends the Company’s cash runway into 2028
  • In July, Terns appointed Elona Kogan as Chief Legal Officer

Third Quarter 2024 Financial Results

Cash Position: As of September 30, 2024, cash, cash equivalents and marketable securities were $372.8 million, as compared with $263.4 million as of December 31, 2023. Based on its current operating plan, Terns expects these funds will be sufficient to support its planned operating expenses into 2028.

Research and Development (R&D) Expenses: R&D expenses were $15.2 million for the quarter ended September 30, 2024, as compared with $14.8 million for the quarter ended September 30, 2023.

General and Administrative (G&A) Expenses: G&A expenses were $9.8 million for the quarter ended September 30, 2024, as compared with $18.4 million for the quarter ended September 30, 2023.

Net Loss: Net loss was $21.9 million for the quarter ended September 30, 2024, as compared with $29.8 million for the quarter ended September 30, 2023.

Financial Tables

         
Terns Pharmaceuticals, Inc.        
Condensed Consolidated Statements of Operations        
(Unaudited; in thousands except share and per share amounts)      
         
  Three Months Ended
September 30,
 Nine Months Ended
September 30,
   2024   2023   2024   2023 
Operating expenses:        
Research and development $15,169  $14,831  $52,108  $46,038 
General and administrative  9,770   18,353   23,814   32,462 
Total operating expenses  24,939   33,184   75,922   78,500 
Loss from operations  (24,939)  (33,184)  (75,922)  (78,500)
Interest income  3,088   3,480   9,146   9,568 
Other expense, net  (32)  (5)  (58)  (69)
Loss before income taxes  (21,883)  (29,709)  (66,834)  (69,001)
Income tax expense  (62)  (58)  (220)  (190)
Net loss $(21,945) $(29,767) $(67,054) $(69,191)
         
Net loss per share, basic and diluted $(0.28) $(0.42) $(0.89) $(0.98)
Weighted average common stock outstanding, basic and diluted 77,819,658   71,530,180   75,567,851   70,897,320 


Terns Pharmaceuticals, Inc.    
Selected Balance Sheet Data    
(Unaudited; in thousands)    
     
  September 30, 2024 December 31, 2023
Cash, cash equivalents and marketable securities $372,777  $263,440 
Total assets  378,233   268,517 
Total liabilities  13,763   13,150 
Total stockholders’ equity  364,470   255,367 
         


About Terns Pharmaceuticals

Terns Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity. Terns’ pipeline contains three clinical stage development programs including an allosteric BCR-ABL inhibitor, a small-molecule GLP-1 receptor agonist, a THR-β agonist, and a preclinical GIPR modulator discovery effort, prioritizing a GIPR antagonist nomination candidate. For more information, please visit: www.ternspharma.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements about the Company within the meaning of the federal securities laws, including those related to expectations, timing and potential results of the clinical trials and other development activities of the Company and its partners; the potential indications to be targeted by the Company with its small-molecule product candidates; the therapeutic potential of the Company’s small-molecule product candidates; the potential for the mechanisms of action of the Company’s product candidates to be therapeutic targets for their targeted indications; the potential utility and progress of the Company’s product candidates in their targeted indications, including the clinical utility of the data from and the endpoints used in the Company’s clinical trials; the Company’s clinical development plans and activities, including the results of any interactions with regulatory authorities on its programs; the Company’s expectations regarding the profile of its product candidates, including efficacy, tolerability, safety, metabolic stability and pharmacokinetic profile and potential differentiation as compared to other products or product candidates; the Company’s plans for and ability to continue to execute on its current development strategy, including potential combinations involving multiple product candidates; the Company’s plans and expectations around the addition of key personnel; and the Company’s expectations with regard to its cash runway and sufficiency of its cash resources. 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, results and utility of the Company’s current and future research and development activities and preclinical studies and clinical trials. 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, 2023. 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


FAQ

What were Terns Pharmaceuticals (TERN) Q3 2024 financial results?

In Q3 2024, TERN reported R&D expenses of $15.2M, G&A expenses of $9.8M, and a net loss of $21.9M. The company had $372.8M in cash, cash equivalents and marketable securities.

What were the Phase 1 trial results for TERN-601 in obesity?

TERN-601 demonstrated dose-dependent weight loss up to 5.5% over 28 days, with 67% of participants losing 5% or more body weight at the highest dose (740 mg once-daily). The drug was well-tolerated with no treatment-related discontinuations.

When will Terns Pharmaceuticals (TERN) release TERN-701 Phase 1 trial data?

Terns expects to release interim data from initial dose escalation cohorts of the Phase 1 CARDINAL trial for TERN-701 in CML in early December 2024.

Terns Pharmaceuticals, Inc.

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Biotechnology
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