Assembly Biosciences Reports Second Quarter 2025 Financial Results and Recent Updates
Assembly Biosciences (NASDAQ: ASMB) reported Q2 2025 financial results and clinical progress across its viral disease pipeline. The company ended Q2 with $75.0 million in cash, projecting operations funding into mid-2026. Revenue from Gilead collaboration increased to $9.6 million, while net loss improved to $10.2 million ($1.33 per share).
Key clinical developments include: positive Phase 1b results for ABI-4334 in chronic HBV patients, interim data from ABI-6250's Phase 1a study showing target engagement for HDV treatment, and advancement of ABI-5366 and ABI-1179 trials for genital herpes, with proof-of-concept data expected by fall 2025. The company initiated U.S. site expansion for ABI-1179's Phase 1b trial following IND clearance.
Assembly Biosciences (NASDAQ: ASMB) ha comunicato i risultati finanziari del secondo trimestre 2025 e i progressi clinici nel suo portafoglio di malattie virali. La societ脿 ha chiuso il secondo trimestre con 75,0 milioni di dollari in liquidit脿, prevedendo di finanziare le operazioni fino a met脿 2026. I ricavi dalla collaborazione con Gilead sono aumentati a 9,6 milioni di dollari, mentre la perdita netta si 猫 ridotta a 10,2 milioni di dollari (1,33 dollari per azione).
Gli sviluppi clinici principali includono: risultati positivi di Fase 1b per ABI-4334 in pazienti con HBV cronica, dati intermedi dallo studio di Fase 1a di ABI-6250 che mostrano un coinvolgimento del target per il trattamento dell'HDV, e l'avanzamento delle sperimentazioni di ABI-5366 e ABI-1179 per l'herpes genitale, con dati di prova di concetto attesi entro l'autunno 2025. La societ脿 ha avviato l'espansione dei siti negli Stati Uniti per la sperimentazione di Fase 1b di ABI-1179 dopo l'approvazione dell'IND.
Assembly Biosciences (NASDAQ: ASMB) inform贸 los resultados financieros del segundo trimestre de 2025 y los avances cl铆nicos en su cartera de enfermedades virales. La compa帽铆a cerr贸 el segundo trimestre con 75,0 millones de d贸lares en efectivo, proyectando financiar sus operaciones hasta mediados de 2026. Los ingresos por la colaboraci贸n con Gilead aumentaron a 9,6 millones de d贸lares, mientras que la p茅rdida neta mejor贸 a 10,2 millones de d贸lares (1,33 d贸lares por acci贸n).
Los desarrollos cl铆nicos clave incluyen: resultados positivos de la Fase 1b para ABI-4334 en pacientes con HBV cr贸nica, datos interinos del estudio de Fase 1a de ABI-6250 que muestran compromiso del objetivo para el tratamiento de HDV, y el avance de los ensayos de ABI-5366 y ABI-1179 para herpes genital, con datos de prueba de concepto esperados para el oto帽o de 2025. La compa帽铆a inici贸 la expansi贸n de sitios en EE.UU. para el ensayo de Fase 1b de ABI-1179 tras la aprobaci贸n del IND.
Assembly Biosciences (NASDAQ: ASMB)電� 2025雲� 2攵勱赴 鞛 鞁れ爜瓿� 氚旍澊霟姢 歆堩櫂 韺岇澊頂勲澕鞚胳潣 鞛勳儊 歆勴枆 靸來櫓鞚� 氚滍憸頄堨姷雼堧嫟. 須岇偓電� 2攵勱赴 毵愳棎 7,500毵� 雼煬鞚� 順勱笀鞚� 氤挫湢頄堨溂氅�, 2026雲� 欷戨皹旯岇 鞖挫榿 鞛愱笀鞚� 頇曤炒頃� 瓴冹溂搿� 鞓堨儊頃╇媹雼�. 旮鸽Μ鞏措摐鞕�鞚� 順戨牓鞐愳劀 氚滌儩頃� 靾橃澋鞚� 960毵� 雼煬搿� 歃濌皜頄堨溂氅�, 靾滌啇鞁れ潃 1,020毵� 雼煬(欤茧嫻 1.33雼煬)搿� 臧滌劆霅橃棃鞀惦媹雼�.
欤检殧 鞛勳儊 臧滊皽 靷暛鞙茧電� 毵岇劚 HBV 頇橃瀽毳� 雽�靸侅溂搿� 頃� ABI-4334鞚� 旮嶌爼鞝侅澑 1b靸� 瓴瓣臣, HDV 旃橂毳� 鞙勴暅 ABI-6250 1a靸� 欷戧皠 雿办澊韯�鞐愳劀 氇╉憸 韮�旯� 甏�鞐� 頇曥澑, 攴鸽Μ瓿� ABI-5366 氚� ABI-1179鞚� 靸濎嫕旮� 項るゴ韼橃姢 鞁滍棙 歆勴枆鞚� 韽暔霅橂┌, 臧滊厫 歃濍獏 雿办澊韯半姅 2025雲� 臧�鞚勳棎 鞓堨爼霅橃柎 鞛堨姷雼堧嫟. 須岇偓電� IND 鞀轨澑 頉� ABI-1179 1b靸� 鞁滍棙鞚� 鞙勴暅 氙戈淡 雮� 靷澊韸� 頇曥灔鞚� 鞁滌瀾頄堨姷雼堧嫟.
Assembly Biosciences (NASDAQ : ASMB) a publi茅 ses r茅sultats financiers du deuxi猫me trimestre 2025 ainsi que les avanc茅es cliniques de son portefeuille de maladies virales. La soci茅t茅 a termin茅 le deuxi猫me trimestre avec 75,0 millions de dollars en liquidit茅s, pr茅voyant de financer ses op茅rations jusqu'脿 la mi-2026. Les revenus issus de la collaboration avec Gilead ont augment茅 脿 9,6 millions de dollars, tandis que la perte nette s'est am茅lior茅e 脿 10,2 millions de dollars (1,33 dollar par action).
Les d茅veloppements cliniques cl茅s comprennent : des r茅sultats positifs de phase 1b pour ABI-4334 chez des patients atteints d'h茅patite B chronique, des donn茅es interm茅diaires de l'茅tude de phase 1a d'ABI-6250 montrant un engagement de la cible pour le traitement de l'HDV, ainsi que l'avancement des essais de ABI-5366 et ABI-1179 pour l'herp猫s g茅nital, avec des donn茅es de preuve de concept attendues pour l'automne 2025. La soci茅t茅 a lanc茅 l'expansion des sites aux 脡tats-Unis pour l'essai de phase 1b d'ABI-1179 apr猫s l'approbation de l'IND.
Assembly Biosciences (NASDAQ: ASMB) berichtete 眉ber die Finanzergebnisse des zweiten Quartals 2025 und den klinischen Fortschritt in seiner Pipeline f眉r Viruskrankheiten. Das Unternehmen schloss das zweite Quartal mit 75,0 Millionen US-Dollar in bar ab und plant, die Betriebsmittel bis Mitte 2026 zu finanzieren. Die Einnahmen aus der Zusammenarbeit mit Gilead stiegen auf 9,6 Millionen US-Dollar, w盲hrend der Nettoverlust sich auf 10,2 Millionen US-Dollar (1,33 US-Dollar pro Aktie) verbesserte.
Wichtige klinische Entwicklungen umfassen: positive Phase-1b-Ergebnisse f眉r ABI-4334 bei chronischen HBV-Patienten, Zwischenberichte aus der Phase-1a-Studie von ABI-6250, die eine Zielbindung f眉r die HDV-Behandlung zeigen, sowie den Fortschritt der Studien zu ABI-5366 und ABI-1179 bei Genitalherpes, mit Proof-of-Concept-Daten, die bis Herbst 2025 erwartet werden. Das Unternehmen hat nach IND-Freigabe mit der Erweiterung der US-Standorte f眉r die Phase-1b-Studie von ABI-1179 begonnen.
- Cash position of $75.0M sufficient to fund operations into mid-2026
- Revenue from Gilead collaboration increased to $9.6M from $8.5M YoY
- Net loss improved to $10.2M from $11.2M YoY
- Positive Phase 1b results for ABI-4334 in chronic HBV patients
- Successful interim data from ABI-6250 Phase 1a study showing target engagement
- Operating expenses remain high with R&D at $16.1M and G&A at $4.6M
- Continued cash burn with $16M reduction in cash position from Q1 2025
Insights
Assembly Bio reports positive clinical data across multiple candidates while maintaining sufficient cash runway into mid-2026 despite ongoing quarterly losses.
Assembly Biosciences is making substantial clinical progress across its viral disease pipeline, particularly with its HSV helicase-primase inhibitors (ABI-5366 and ABI-1179) for genital herpes, which are approaching crucial proof-of-concept data no later than fall 2025. This represents a significant potential catalyst, as recurrent genital herpes affects millions of patients who could benefit from long-acting treatment options.
The company has already delivered two positive datasets in 2025. First, its next-generation HBV capsid assembly modulator ABI-4334 showed promising antiviral activity in chronic hepatitis B patients. Second, the HDV entry inhibitor ABI-6250 demonstrated target engagement against NTCP (the viral entry receptor) with pharmacokinetics supporting once-daily dosing.
Financially, Assembly maintains a relatively stable position with
The Gilead collaboration remains strategically important, as it contributed the ABI-1179 candidate and provides significant research funding. R&D expenses have stabilized at
The upcoming fall data readout for both HSV candidates represents the most significant near-term value inflection point, potentially validating Assembly's pivot toward diversifying beyond its original HBV focus into multiple viral targets including HSV and HDV.
鈥� On track for proof-of-concept Phase 1b data no later than this fall in participants with recurrent genital herpes for long-acting herpes simplex virus (HSV) helicase-primase inhibitor candidates, ABI-5366 and ABI-1179 鈥�
鈥� Positive topline data reported for Phase 1b study of ABI-4334, a next-generation highly potent capsid assembly modulator candidate, in participants with chronic hepatitis B virus (HBV) 鈥�
鈥� Interim data, including a biomarker for target engagement, reported from Phase 1a study in healthy volunteers of ABI-6250, an orally bioavailable, small molecule viral entry inhibitor candidate in development for chronic hepatitis delta virus (HDV) 鈥�
SOUTH SAN FRANCISCO, Calif., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today reported financial results and recent updates for the second quarter ended June 30, 2025.
鈥淲e are advancing toward our goal of generating impactful clinical datasets for four development candidates in 2025,鈥� said Jason Okazaki, chief executive officer and president of Assembly Bio. 鈥淲e have delivered two important datasets already this year from our hepatitis programs, including positive topline data from our Phase 1b study of our most potent capsid assembly modulator, ABI-4334, in participants with chronic HBV, as well as interim data from a Phase 1a study of ABI-6250, including biomarker data supporting target engagement. Looking ahead, we remain on track to report key proof-of-concept Phase 1b data, including antiviral activity, no later than fall for ABI-5366 and ABI-1179 in participants with recurrent genital herpes, a chronic viral infection that significantly impacts the lives of millions of individuals.鈥澨�
Second Quarter 2025 and Recent Highlights
- Initiated dosing in the Phase 1b portion of the ongoing Phase 1a/b trial for ABI-1179 and received clearance for an Investigational New Drug application to support expansion of this study to sites in the United States
- Released positive topline Phase 1b results for ABI-4334 that met Assembly Bio鈥檚 target clinical profile for the study, including strong antiviral activity in participants with chronic HBV infection
- Shared interim data from a Phase 1a study of ABI-6250 in healthy volunteers, including pharmacokinetics (PK) supportive of a once-daily oral dosing profile and biomarker data indicating engagement of its target, sodium taurocholate cotransporting polypeptide (NTCP), the receptor used by HDV to infect hepatocytes
- Presented four posters, including one late-breaker, highlighting Phase 1a clinical data for ABI-5366 and ABI-1179, preclinical data for ABI-5366, and claims data estimating U.S. genital herpes prevalence and treatment patterns at the STI & HIV 2025 World Congress, July 26-30, 2025
- Presented one oral and one poster presentation describing the Phase 1a clinical and preclinical profiles for ABI-5366 and ABI-1179 at the 49th Annual International Herpesvirus Workshop, July 26-30, 2025
Anticipated Milestones and Events
- ABI-5366 and ABI-1179: No later than fall 2025, interim efficacy, safety and PK data from Phase 1b studies for ABI-5366 and ABI-1179
- Assembly Bio is running both studies concurrently and plans to evaluate weekly (and, for ABI-5366, monthly) oral dosing in participants with recurrent genital herpes over a 28-day dosing period
- ABI-6250: Abstract describing preclinical profiling of ABI-6250 accepted for oral presentation at the International HBV Meeting, September 8-12, 2025
ABI-1179 was contributed by Gilead Sciences, Inc. (Gilead) under the collaboration between Assembly Bio and Gilead. ABI-5366, ABI-1179, ABI-6250 and ABI-4334 are investigational product candidates that have not been approved anywhere globally, and their safety and efficacy have not been established.
Second Quarter 2025 Financial Results
- Cash, cash equivalents and marketable securities were
$75.0 million as of June 30, 2025, compared to$91.0 million as of March 31, 2025. Assembly Bio鈥檚 cash position is projected to fund operations into mid-2026. - Revenue from collaborative research with Gilead was
$9.6 million for the three months ended June 30, 2025, compared to$8.5 million in the same period in 2024. The change reflects the increase in research and development incurred under the collaboration as well as an increase in collaboration funding from amending the agreement in December 2024. - Research and development expenses were
$16.1 million for the three months ended June 30, 2025, compared to$16.3 million for the same period in 2024. The decrease is most largely due to a decrease in spending on ABI-6250, which we had incurred significant preclinical and start-up activities for the Phase 1a study in 2024. - General and administrative expenses were
$4.6 million for the three months ended June 30, 2025, compared to$4.5 million for the same period in 2024, remaining essentially flat. - Net loss attributable to common stockholders was
$10.2 million , or$1.33 per basic and diluted share, for the three months ended June 30, 2025, compared to$11.2 million , or$1.98 per basic and diluted share, for the same period in 2024.
About Assembly Biosciences
Assembly Biosciences is a biotechnology company dedicated to the development of innovative small-molecule therapeutics designed to change the path of serious viral diseases and improve the lives of patients worldwide. Led by an accomplished team of leaders in virologic drug development, Assembly Bio is committed to improving outcomes for patients struggling with the serious, chronic impacts of herpesvirus, hepatitis B virus (HBV) and hepatitis delta virus (HDV) infections. For more information, visit assemblybio.com.
Forward-Looking Statements
The information in this press release contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to materially differ. These risks and uncertainties include: Assembly Bio鈥檚 ability to maintain financial resources and secure additional funding necessary to continue its research activities, clinical studies, other business operations and continue as a going concern; Assembly Bio鈥檚 ability to realize the potential benefits of its collaboration with Gilead, including all financial aspects of the collaboration and equity investments; Assembly Bio鈥檚 ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio鈥檚 collaboration with Gilead, in the currently anticipated timeframes or at all; safety and efficacy data from clinical or nonclinical studies may not warrant further development of Assembly Bio鈥檚 product candidates; clinical and nonclinical data may not differentiate Assembly Bio鈥檚 product candidates from other companies鈥� candidates; potential effects of changes in government regulation, including as a result of the change in U.S. administration in 2025; results of nonclinical studies may not be representative of disease behavior in a clinical setting and may not be predictive of the outcomes of clinical studies; and other risks identified from time to time in Assembly Bio鈥檚 reports filed with the U.S. Securities and Exchange Commission (the SEC). You are urged to consider statements that include the words may, will, would, could, should, might, believes, hopes, estimates, projects, potential, expects, plans, anticipates, intends, continues, forecast, designed, goal or the negative of those words or other comparable words to be uncertain and forward-looking. Assembly Bio intends such forward-looking statements to be covered by the safe harbor provisions contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. More information about Assembly Bio鈥檚 risks and uncertainties are more fully detailed under the heading 鈥淩isk Factors鈥� in Assembly Bio鈥檚 filings with the SEC, including its most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Except as required by law, Assembly Bio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Contacts
Investor and Corporate:
Shannon Ryan
SVP, Investor Relations, Corporate Affairs and Alliance Management
(415) 738-2992
Media:
Sam Brown Healthcare Communications
Alyssa Kuciunas
(331) 481-3751
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| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
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| ASSETS | 听 | 听 | 听 | 听 | ||||
| Current assets | 听 | 听 | 听 | 听 | ||||
| Cash and cash equivalents | 听 | $ | 24,006 | 听 | 听 | $ | 38,344 | 听 |
| Marketable securities | 听 | 听 | 50,974 | 听 | 听 | 听 | 73,735 | 听 |
| Prepaid expenses and other current assets | 听 | 听 | 2,487 | 听 | 听 | 听 | 3,424 | 听 |
| Total current assets | 听 | 听 | 77,467 | 听 | 听 | 听 | 115,503 | 听 |
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| Property and equipment, net | 听 | 听 | 219 | 听 | 听 | 听 | 284 | 听 |
| Operating lease right-of-use assets | 听 | 听 | 2,782 | 听 | 听 | 听 | 3,069 | 听 |
| Other assets | 听 | 听 | 312 | 听 | 听 | 听 | 312 | 听 |
| Total assets | 听 | $ | 80,780 | 听 | 听 | $ | 119,168 | 听 |
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| LIABILITIES AND STOCKHOLDERS' EQUITY | 听 | 听 | 听 | 听 | ||||
| Current liabilities | 听 | 听 | 听 | 听 | ||||
| Accounts payable | 听 | $ | 743 | 听 | 听 | $ | 585 | 听 |
| Accrued research and development expenses | 听 | 听 | 1,691 | 听 | 听 | 听 | 2,273 | 听 |
| Other accrued expenses | 听 | 听 | 3,407 | 听 | 听 | 听 | 6,862 | 听 |
| Deferred revenue from a related party - short-term | 听 | 听 | 40,917 | 听 | 听 | 听 | 37,622 | 听 |
| Operating lease liabilities - short-term | 听 | 听 | 533 | 听 | 听 | 听 | 461 | 听 |
| Total current liabilities | 听 | 听 | 47,291 | 听 | 听 | 听 | 47,803 | 听 |
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| Deferred revenue from a related party - long-term | 听 | 听 | 13,038 | 听 | 听 | 听 | 35,378 | 听 |
| Operating lease liabilities - long-term | 听 | 听 | 2,351 | 听 | 听 | 听 | 2,628 | 听 |
| Total liabilities | 听 | 听 | 62,680 | 听 | 听 | 听 | 85,809 | 听 |
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| Preferred stock, | 听 | 听 | 鈥� | 听 | 听 | 听 | 鈥� | 听 |
| Common stock, | 听 | 听 | 8 | 听 | 听 | 听 | 7 | 听 |
| Additional paid-in capital | 听 | 听 | 863,312 | 听 | 听 | 听 | 859,488 | 听 |
| Accumulated other comprehensive loss | 听 | 听 | (279 | ) | 听 | 听 | (211 | ) |
| Accumulated deficit | 听 | 听 | (844,941 | ) | 听 | 听 | (825,925 | ) |
| Total stockholders' equity | 听 | 听 | 18,100 | 听 | 听 | 听 | 33,359 | 听 |
| Total liabilities and stockholders' equity | 听 | $ | 80,780 | 听 | 听 | $ | 119,168 | 听 |
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| 听 | ASSEMBLY BIOSCIENCES, INC. | ||||||||||||||||
| 听 | CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||||||||||
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| 听 | 听 | 听 | Three Months Ended June 30, | 听 | Six Months Ended June 30, | ||||||||||||
| 听 | 听 | 听 | 听 | 2025 | 听 | 听 | 听 | 2024 | 听 | 听 | 听 | 2025 | 听 | 听 | 听 | 2024 | 听 |
| 听 | Collaboration revenue from a related party | 听 | $ | 9,626 | 听 | 听 | $ | 8,533 | 听 | 听 | $ | 19,045 | 听 | 听 | $ | 14,318 | 听 |
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| 听 | Operating expenses | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | ||||||||
| 听 | Research and development | 听 | 听 | 16,125 | 听 | 听 | 听 | 16,259 | 听 | 听 | 听 | 30,976 | 听 | 听 | 听 | 28,138 | 听 |
| 听 | General and administrative | 听 | 听 | 4,594 | 听 | 听 | 听 | 4,477 | 听 | 听 | 听 | 9,103 | 听 | 听 | 听 | 9,112 | 听 |
| 听 | Total operating expenses | 听 | 听 | 20,719 | 听 | 听 | 听 | 20,736 | 听 | 听 | 听 | 40,079 | 听 | 听 | 听 | 37,250 | 听 |
| 听 | Loss from operations | 听 | 听 | (11,093 | ) | 听 | 听 | (12,203 | ) | 听 | 听 | (21,034 | ) | 听 | 听 | (22,932 | ) |
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| 听 | Other income | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | ||||||||
| 听 | Interest and other income, net | 听 | 听 | 895 | 听 | 听 | 听 | 1,457 | 听 | 听 | 听 | 2,018 | 听 | 听 | 听 | 3,109 | 听 |
| 听 | Total other income | 听 | 听 | 895 | 听 | 听 | 听 | 1,457 | 听 | 听 | 听 | 2,018 | 听 | 听 | 听 | 3,109 | 听 |
| 听 | Loss before income taxes | 听 | 听 | (10,198 | ) | 听 | 听 | (10,746 | ) | 听 | 听 | (19,016 | ) | 听 | 听 | (19,823 | ) |
| 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | ||||||||
| 听 | Income tax expense | 听 | 听 | 鈥� | 听 | 听 | 听 | 406 | 听 | 听 | 听 | 鈥� | 听 | 听 | 听 | 406 | 听 |
| 听 | Net loss | 听 | $ | (10,198 | ) | 听 | $ | (11,152 | ) | 听 | $ | (19,016 | ) | 听 | $ | (20,229 | ) |
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| 听 | Other comprehensive loss | 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | ||||||||
| 听 | Unrealized loss on marketable securities | 听 | 听 | 26 | 听 | 听 | 听 | 54 | 听 | 听 | 听 | 68 | 听 | 听 | 听 | 212 | 听 |
| 听 | Comprehensive loss | 听 | $ | (10,224 | ) | 听 | $ | (11,206 | ) | 听 | $ | (19,084 | ) | 听 | $ | (20,441 | ) |
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| 听 | Net loss per share, basic and diluted | 听 | $ | (1.33 | ) | 听 | $ | (1.98 | ) | 听 | $ | (2.51 | ) | 听 | $ | (3.64 | ) |
| 听 | Weighted average common shares outstanding, basic and diluted | 听 | 听 | 7,655,854 | 听 | 听 | 听 | 5,642,752 | 听 | 听 | 听 | 7,581,501 | 听 | 听 | 听 | 5,563,033 | 听 |
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FAQ
What were Assembly Biosciences' (ASMB) Q2 2025 financial results?
What are the key clinical trial milestones for ASMB in 2025?
How much revenue did ASMB generate from its Gilead collaboration in Q2 2025?
What is the cash runway for Assembly Biosciences as of Q2 2025?
What progress has ASMB made in its viral disease pipeline?
