Assembly Biosciences Reports Year End 2024 Financial Results and Recent Highlights
Assembly Biosciences (ASMB) reported its financial results for 2024, highlighting progress across its antiviral pipeline. The company ended 2024 with $112.1 million in cash, projecting operations funding into mid-2026. Revenues increased to $28.5 million from $7.2 million in 2023, while net loss decreased to $40.2 million ($6.69 per share) from $61.2 million in 2023.
Key clinical developments include positive Phase 1a interim data for ABI-1179 for recurrent genital herpes, supporting once-weekly oral dosing. The company's ABI-4334 for chronic HBV infection showed promising results with a 2.9 log10 IU/mL mean decline in HBV DNA. ASMB initiated Phase 1a study for ABI-6250 for hepatitis delta virus and advanced ABI-7423 into IND/CTA-enabling studies.
The company received a $20.1 million equity investment and $10 million in accelerated funding from Gilead Sciences to advance clinical development programs.
Assembly Biosciences (ASMB) ha riportato i risultati finanziari per il 2024, evidenziando progressi nel suo pipeline antivirale. L'azienda ha concluso il 2024 con 112,1 milioni di dollari in contante, prevedendo finanziamenti operativi fino a metà 2026. I ricavi sono aumentati a 28,5 milioni di dollari rispetto ai 7,2 milioni di dollari del 2023, mentre la perdita netta è diminuita a 40,2 milioni di dollari (6,69 dollari per azione) rispetto ai 61,2 milioni di dollari del 2023.
Sviluppi clinici chiave includono dati positivi provvisori della Fase 1a per ABI-1179 per l'herpes genitale ricorrente, supportando dosaggi orali settimanali. Il ABI-4334 dell'azienda per l'infezione cronica da HBV ha mostrato risultati promettenti con una diminuzione media di 2,9 log10 IU/mL dell'HBV DNA. ASMB ha avviato uno studio di Fase 1a per ABI-6250 per il virus dell'epatite delta e ha avanzato ABI-7423 in studi abilitanti IND/CTA.
L'azienda ha ricevuto un investimento in equity di 20,1 milioni di dollari e 10 milioni di dollari in finanziamenti accelerati da Gilead Sciences per far progredire i programmi di sviluppo clinico.
Assembly Biosciences (ASMB) informó sus resultados financieros para 2024, destacando los avances en su pipeline antiviral. La compañía terminó 2024 con 112,1 millones de dólares en efectivo, proyectando financiamiento para operaciones hasta mediados de 2026. Los ingresos aumentaron a 28,5 millones de dólares desde 7,2 millones de dólares en 2023, mientras que la pérdida neta disminuyó a 40,2 millones de dólares (6,69 dólares por acción) desde 61,2 millones de dólares en 2023.
Los desarrollos clínicos clave incluyen datos interinos positivos de la Fase 1a para ABI-1179 para el herpes genital recurrente, apoyando la dosificación oral una vez a la semana. El ABI-4334 de la compañía para la infección crónica por HBV mostró resultados prometedores con una disminución media de 2,9 log10 IU/mL en el ADN del HBV. ASMB inició un estudio de Fase 1a para ABI-6250 para el virus de la hepatitis delta y avanzó ABI-7423 a estudios habilitantes de IND/CTA.
La compañía recibió una inversión de capital de 20,1 millones de dólares y 10 millones de dólares en financiamiento acelerado de Gilead Sciences para avanzar en los programas de desarrollo clínico.
Assembly Biosciences (ASMB)는 2024년 재무 결과를 보고하며 항바이러스 파이프라인의 진전을 강조했습니다. 이 회사는 2024년을 1억 1,210만 달러의 현금으로 마감하며 2026년 중반까지 운영 자금을 예측하고 있습니다. 수익은 2023년 720만 달러에서 2,850만 달러로 증가했으며, 순손실은 2023년 6,120만 달러에서 4,020만 달러 (주당 6.69달러)로 감소했습니다.
주요 임상 개발 사항으로는 ABI-1179의 재발성 생식기 헤르페스에 대한 긍정적인 1a상 중간 데이터가 포함되어 있으며, 주 1회 경구 투여를 지원합니다. 회사의 ABI-4334는 만성 HBV 감염에 대해 HBV DNA의 평균 2.9 log10 IU/mL 감소로 유망한 결과를 보여주었습니다. ASMB는 델타 간염 바이러스에 대한 ABI-6250의 1a상 연구를 시작했으며 ABI-7423를 IND/CTA 승인 연구로 진행했습니다.
회사는 임상 개발 프로그램을 진행하기 위해 Gilead Sciences로부터 2,010만 달러의 자본 투자와 1,000만 달러의 가속화 자금을 받았습니다.
Assembly Biosciences (ASMB) a annoncé ses résultats financiers pour 2024, mettant en avant les progrès de son pipeline antiviral. L'entreprise a terminé 2024 avec 112,1 millions de dollars en liquidités, prévoyant un financement des opérations jusqu'à mi-2026. Les revenus ont augmenté à 28,5 millions de dollars contre 7,2 millions de dollars en 2023, tandis que la perte nette a diminué à 40,2 millions de dollars (6,69 dollars par action) contre 61,2 millions de dollars en 2023.
Les développements cliniques clés incluent des données intermédiaires positives de la Phase 1a pour ABI-1179 pour l'herpès génital récurrent, soutenant un dosage oral une fois par semaine. Le ABI-4334 de l'entreprise pour l'infection chronique par le HBV a montré des résultats prometteurs avec une diminution moyenne de 2,9 log10 IU/mL de l'ADN du HBV. ASMB a lancé une étude de Phase 1a pour ABI-6250 pour le virus de l'hépatite delta et a avancé ABI-7423 vers des études permettant l'IND/CTA.
L'entreprise a reçu un investissement en capital de 20,1 millions de dollars et 10 millions de dollars de financement accéléré de Gilead Sciences pour faire progresser les programmes de développement clinique.
Assembly Biosciences (ASMB) berichtete über seine finanziellen Ergebnisse für 2024 und hob die Fortschritte in seiner antiviralen Pipeline hervor. Das Unternehmen schloss das Jahr 2024 mit 112,1 Millionen Dollar in bar ab und plant, die Betriebsfinanzierung bis Mitte 2026 sicherzustellen. Die Einnahmen stiegen auf 28,5 Millionen Dollar von 7,2 Millionen Dollar im Jahr 2023, während der Nettoverlust auf 40,2 Millionen Dollar (6,69 Dollar pro Aktie) von 61,2 Millionen Dollar im Jahr 2023 sank.
Wichtige klinische Entwicklungen umfassen positive vorläufige Daten der Phase 1a für ABI-1179 bei wiederkehrendem genitalem Herpes, die eine wöchentliche orale Dosierung unterstützen. Der ABI-4334 des Unternehmens für chronische HBV-Infektionen zeigte vielversprechende Ergebnisse mit einem durchschnittlichen Rückgang von 2,9 log10 IU/mL der HBV-DNA. ASMB begann eine Phase-1a-Studie für ABI-6250 für das Delta-Hepatitis-Virus und brachte ABI-7423 in IND/CTA-fähige Studien voran.
Das Unternehmen erhielt eine Eigenkapitalinvestition von 20,1 Millionen Dollar und 10 Millionen Dollar an beschleunigter Finanzierung von Gilead Sciences, um die klinischen Entwicklungsprogramme voranzutreiben.
- Revenue increased significantly to $28.5M from $7.2M in 2023
- Net loss reduced to $40.2M from $61.2M in 2023
- Secured $30.1M in funding from Gilead Sciences
- Strong cash position of $112.1M funding operations into mid-2026
- Positive Phase 1b data for ABI-4334 showing 2.9 log10 HBV DNA reduction
- R&D expenses increased by 14.3% to $55.9M
- Continued net loss of $40.2M despite revenue growth
Insights
Assembly Bio's financial performance shows a narrowing loss trajectory with net loss improving to
While R&D expenses increased to
The company's forward-looking catalysts are well-sequenced throughout 2025, potentially enabling continuous news flow with clinical readouts for ABI-4334 (1H 2025), ABI-6250 (Q3 2025), and proof-of-concept efficacy data for both herpes candidates in fall 2025. The financial foundation appears sufficient to reach these value-inflection points without immediate financing pressure.
Assembly Bio's antiviral pipeline demonstrates methodical clinical progression with encouraging early signals. For their recurrent genital herpes program, both helicase-primase inhibitor candidates (ABI-5366 and ABI-1179) have progressed to Phase 1b, with ABI-1179 showing a PK profile supporting weekly administration—a potential convenience advantage over existing daily therapies.
The HBV program's ABI-4334 data reveals a compelling 2.9 log10 IU/mL reduction in viral DNA, which is noteworthy for a capsid assembly modulator. This potency in predominately HBeAg-negative patients is particularly relevant as this population represents a significant portion of the global chronic HBV market.
The company's expansion into HDV with ABI-6250 addresses an underserved market with few treatment options. The planned assessment of target engagement biomarkers in the Phase 1a study demonstrates a translational approach to early clinical development. Advancing ABI-7423 for transplant-associated herpesviruses further diversifies their antiviral portfolio.
Most impressive is the pipeline's broad mechanism-of-action diversity: capsid assembly modulators (HBV), entry inhibitors (HDV), helicase-primase inhibitors (herpes), and polymerase inhibitors (herpesviruses). This strategy reduces program-specific risk while maintaining focus on antiviral discovery expertise. With multiple readouts in 2025, the sequential data flow creates multiple shots on goal across different viral targets.
– Four development candidates in clinical studies with data anticipated this year, continuing rapid progress of antiviral pipeline –
– Interim Phase 1b proof-of-concept data, including initial efficacy measures, anticipated in fall 2025 for ABI-5366 and ABI-1179, long-acting helicase-primase inhibitor candidates for recurrent genital herpes –
SOUTH SAN FRANCISCO, Calif., March 20, 2025 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today reported financial results for the year ended December 31, 2024, and recent highlights.
“We are well-positioned to deliver important clinical data on four of our novel antiviral candidates in 2025, including proof-of-concept efficacy data expected this fall from the Phase 1b studies of ABI-5366 and ABI-1179 for recurrent genital herpes,” said Jason Okazaki, chief executive officer and president of Assembly Bio. “We anticipate that the rapid progress across our clinical pipeline we saw in 2024 will continue this year, reinforcing the exceptional execution of our R&D organization and our commitment to changing the treatment paradigm for individuals living with serious viral diseases.”
Fourth Quarter 2024 and Recent Highlights
- Recurrent genital herpes
- Positive Phase 1a interim data released for ABI-1179
- ABI-1179 was well-tolerated, with observed half-life and exposure supporting the potential for once-weekly oral dosing at a low dose
- Positive Phase 1a interim data released for ABI-1179
- Hepatitis delta virus (HDV)
- Initiated dosing in the Phase 1a study for ABI-6250, an oral, small molecule entry inhibitor candidate for chronic HDV infection
- Hepatitis B virus (HBV)
- Positive Phase 1b interim data released for ABI-4334, a next-generation highly potent capsid assembly modulator candidate for chronic HBV (cHBV) infection
- ABI-4334 was well-tolerated, with an observed half-life supporting once-daily oral dosing
- In the initial 150 mg dose cohort, a mean decline in HBV DNA of 2.9 log10 IU/mL was observed in a population of predominately hepatitis B e antigen (HBeAg) negative participants
- Positive Phase 1b interim data released for ABI-4334, a next-generation highly potent capsid assembly modulator candidate for chronic HBV (cHBV) infection
- Transplant-associated herpesviruses
- Advanced ABI-7423, an oral broad-spectrum non-nucleoside polymerase inhibitor candidate targeting transplant-associated herpesviruses, into IND/CTA-enabling studies
- Partnership with Gilead Sciences, Inc. (Gilead)
- Received approximately
$20.1 million equity investment and$10 million in accelerated funding from Gilead to advance clinical development programs
- Received approximately
Anticipated Milestones and Events
- Recurrent genital herpes (ABI-5366 and ABI-1179)
- In fall 2025, interim efficacy, safety and pharmacokinetic (PK) Phase 1b data for ABI-5366 and ABI-1179
- Assembly Bio plans to run both studies concurrently and to evaluate weekly (and, for ABI-5366, monthly) oral dosing in participants with recurrent genital herpes over a 28-day dosing period
- HDV (ABI-6250)
- In Q3 2025, data from a Phase 1a study in healthy participants for ABI-6250
- Biomarker of ABI-6250 target engagement will be assessed in addition to safety and PK measures
- HBV (ABI-4334)
- In the first half of 2025, efficacy, safety and PK data from the remaining 400 mg once-daily oral dosing cohort in a Phase 1b study for ABI-4334 in participants with cHBV infection
ABI-1179 was contributed by Gilead under the collaboration between Assembly Bio and Gilead. ABI-5366, ABI-1179, ABI-6250, ABI-4334 and ABI-7423 are investigational product candidates that have not been approved anywhere globally, and their safety and efficacy have not been established.
Year End 2024 Financial Results
- Cash, cash equivalents and marketable securities were
$112.1 million as of December 31, 2024, compared to$95.0 million as of September 30, 2024, and$130.2 million as of the year ended December 31, 2023. The company’s cash position is projected to fund operations into mid-2026. - Revenues from collaborative research were
$28.5 million for the year ended December 31, 2024, compared to$7.2 million in 2023. The increase is primarily due to recognizing a full year of revenue in 2024 under the collaboration with Gilead. - Research and development expenses were
$55.9 million for the year ended December 31, 2024, compared to$48.9 million in 2023. The increase is attributable to having more candidates in development in 2024. - General and administrative expenses were
$18.0 million for the year ended December 31, 2024, compared to$22.9 million in 2023. The decrease is primarily due to decreases in legal and non-cash stock-based compensation expense. - Net loss attributable to common stockholders was
$40.2 million , or$6.69 per basic and diluted share, for the year ended December 31, 2024, compared to$61.2 million , or$13.38 per basic and diluted share, in 2023.
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’s ability to maintain financial resources necessary to continue its research activities, clinical studies and other business operations; Assembly Bio’s ability to realize the potential benefits of its collaboration with Gilead Sciences, Inc., including all financial aspects of the collaboration and equity investments; Assembly Bio’s ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio’s 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’s product candidates; clinical and nonclinical data presented at conferences may not differentiate Assembly Bio’s product candidates from other companies’ candidates; 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’s 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’s risks and uncertainties are more fully detailed under the heading “Risk Factors” in Assembly Bio’s 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
investor_relations@assemblybio.com
Media:
Sam Brown Inc.
Hannah Hurdle
(805) 338-4752
ASMBMedia@sambrown.com
| ASSEMBLY BIOSCIENCES, INC. | ||||||||
| CONSOLIDATED BALANCE SHEETS | ||||||||
| (In thousands except for share amounts and par value) | ||||||||
| As of December 31, | ||||||||
| 2024 | 2023 | |||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 38,344 | $ | 19,841 | ||||
| Marketable securities | 73,735 | 110,406 | ||||||
| Accounts receivable from collaboration | — | 43 | ||||||
| Prepaid expenses and other current assets | 3,424 | 3,497 | ||||||
| Total current assets | 115,503 | 133,787 | ||||||
| Property and equipment, net | 284 | 385 | ||||||
| Operating lease right-of-use assets | 3,069 | 2,339 | ||||||
| Other assets | 312 | 312 | ||||||
| Total assets | $ | 119,168 | $ | 136,823 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 585 | $ | 461 | ||||
| Accrued research and development expenses | 2,273 | 885 | ||||||
| Other accrued expenses | 6,862 | 5,744 | ||||||
| Deferred revenue from a related party - short-term | 37,622 | 30,915 | ||||||
| Operating lease liabilities - short-term | 461 | 1,220 | ||||||
| Total current liabilities | 47,803 | 39,225 | ||||||
| Deferred revenue from a related party - long-term | 35,378 | 55,379 | ||||||
| Operating lease liabilities - long-term | 2,628 | 1,122 | ||||||
| Total liabilities | 85,809 | 95,726 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity | ||||||||
| Preferred stock, | — | — | ||||||
| Common stock, | 7 | 5 | ||||||
| Additional paid-in capital | 859,488 | 826,921 | ||||||
| Accumulated other comprehensive loss | (211 | ) | (81 | ) | ||||
| Accumulated deficit | (825,925 | ) | (785,748 | ) | ||||
| Total stockholders' equity | 33,359 | 41,097 | ||||||
| Total liabilities and stockholders' equity | $ | 119,168 | $ | 136,823 | ||||
| ASSEMBLY BIOSCIENCES, INC. | ||||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||
| (In thousands except for share and per share amounts) | ||||||||
| Year Ended December 31, | ||||||||
| 2024 | 2023 | |||||||
| Collaboration revenue ( | $ | 28,520 | $ | 7,163 | ||||
| Operating expenses | ||||||||
| Research and development | 55,933 | 48,900 | ||||||
| General and administrative | 18,007 | 22,909 | ||||||
| Total operating expenses | 73,940 | 71,809 | ||||||
| Loss from operations | (45,420 | ) | (64,646 | ) | ||||
| Other income | ||||||||
| Interest and other income, net | 5,573 | 3,451 | ||||||
| Total other income | 5,573 | 3,451 | ||||||
| Loss before income taxes | (39,847 | ) | (61,195 | ) | ||||
| Income tax expense | 330 | 33 | ||||||
| Net loss | $ | (40,177 | ) | $ | (61,228 | ) | ||
| Other comprehensive loss | ||||||||
| Unrealized (loss) gain on marketable securities | (130 | ) | 722 | |||||
| Comprehensive loss | $ | (40,307 | ) | $ | (60,506 | ) | ||
| Net loss per share, basic and diluted | $ | (6.69 | ) | $ | (13.38 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 6,004,560 | 4,577,371 | ||||||
FAQ
What were Assembly Biosciences (ASMB) key financial results for 2024?
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