Assembly Biosciences Reports Third Quarter 2024 Financial Results and Recent Updates
Assembly Biosciences (ASMB) reported Q3 2024 financial results and updates. The company announced positive Phase 1a interim data for ABI-5366, their genital herpes treatment candidate, supporting once-weekly and monthly oral dosing. Cash position was $95.0 million as of September 30, 2024, with funding projected into Q1 2026. Q3 revenue was $6.8 million from Gilead collaboration. R&D expenses increased to $13.5 million, while G&A expenses remained stable at $4.3 million. Net loss was $9.6 million ($1.51 per share), improved from $14.4 million loss in Q3 2023.
Assembly Biosciences (ASMB) ha riportato i risultati finanziari del terzo trimestre 2024 e aggiornamenti. L'azienda ha annunciato dati intermedi positivi della Fase 1a per ABI-5366, il loro candidato per il trattamento dell'herpes genitale, supportando dosi orali settimanali e mensili. La posizione di cassa era di $95,0 milioni al 30 settembre 2024, con finanziamenti previsti fino al primo trimestre del 2026. Le entrate del terzo trimestre sono state di $6,8 milioni dalla collaborazione con Gilead. Le spese di R&D sono aumentate a $13,5 milioni, mentre le spese generali e amministrative sono rimaste stabili a $4,3 milioni. La perdita netta è stata di $9,6 milioni ($1,51 per azione), in miglioramento rispetto alla perdita di $14,4 milioni nel terzo trimestre del 2023.
Assembly Biosciences (ASMB) informó sobre los resultados financieros del tercer trimestre de 2024 y actualizaciones. La compañía anunció d deliciosos datos intermedios positivos de la Fase 1a para ABI-5366, su candidato para el tratamiento del herpes genital, respaldando la dosificación oral semanal y mensual. La posición de efectivo era de $95.0 millones al 30 de septiembre de 2024, con financiamiento proyectado hasta el primer trimestre de 2026. Los ingresos del tercer trimestre fueron de $6.8 millones de la colaboración con Gilead. Los gastos de I+D aumentaron a $13.5 millones, mientras que los gastos generales y administrativos se mantuvieron estables en $4.3 millones. La pérdida neta fue de $9.6 millones ($1.51 por acción), mejorando desde una pérdida de $14.4 millones en el tercer trimestre de 2023.
어셈블리 바이오사이언스(ASMB)는 2024년 3분기 재무 결과 및 업데이트를 보고했습니다. 이 회사는 ABI-5366에 대한 긍정적인 1상 중간 데이터를 발표하여 성기 헤르페스 치료 후보로서 주 1회 및 월간 경구 투여를 지원하고 있습니다. 2024년 9월 30일 기준 현금 잔고는 9,500만 달러였으며, 2026년 1분기까지 자금 조달이 예상됩니다. 3분기 수익은 680만 달러로, Gilead와의 협업에서 발생했습니다. 연구 개발 비용은 1,350만 달러로 증가했고, 관리 및 일반 비용은 430만 달러로 안정적이었습니다. 순손실은 960만 달러($1.51 주당)로, 2023년 3분기 $1,440만 달러의 손실보다 개선되었습니다.
Assembly Biosciences (ASMB) a rapporté les résultats financiers du troisième trimestre 2024 et des mises à jour. La société a annoncé des données intermédiaires positives de la Phase 1a pour ABI-5366, leur candidat au traitement de l'herpès génital, soutenant une posologie orale hebdomadaire et mensuelle. La situation de trésorerie était de 95,0 millions de dollars au 30 septembre 2024, avec un financement prévu jusqu'au premier trimestre 2026. Les revenus du troisième trimestre se sont élevés à 6,8 millions de dollars provenant de la collaboration avec Gilead. Les dépenses de R&D ont augmenté à 13,5 millions de dollars, tandis que les dépenses génératives et administratives sont restées stables à 4,3 millions de dollars. La perte nette s'élevait à 9,6 millions de dollars (1,51 $ par action), en amélioration par rapport à une perte de 14,4 millions de dollars au troisième trimestre 2023.
Assembly Biosciences (ASMB) berichtete über die finanziellen Ergebnisse des dritten Quartals 2024 und Aktualisierungen. Das Unternehmen gab positive Zwischenberichte der Phase 1a für ABI-5366, ihrem Kandidaten für die Behandlung von Genitalherpes, bekannt und unterstützt die wöchentliche und monatliche orale Einnahme. Die Liquiditätsposition betrug zum 30. September 2024 95,0 Millionen USD, mit einer Prognose für die Finanzierung bis ins erste Quartal 2026. Die Einnahmen im dritten Quartal beliefen sich auf 6,8 Millionen USD aus der Zusammenarbeit mit Gilead. Die F&E-Ausgaben erhöhten sich auf 13,5 Millionen USD, während die allgemeinen und administrativen Ausgaben stabil bei 4,3 Millionen USD blieben. Der Nettoverlust betrug 9,6 Millionen USD (1,51 USD pro Aktie), was eine Verbesserung im Vergleich zum Verlust von 14,4 Millionen USD im dritten Quartal 2023 darstellt.
- Positive Phase 1a interim data for ABI-5366 showing favorable safety profile
- Revenue increased to $6.8 million from zero in previous year
- Net loss improved to $9.6 million from $14.4 million YoY
- Strong cash position of $95.0 million funding operations into Q1 2026
- R&D expenses increased 25% YoY to $13.5 million
- Cash decreased from $109.2 million in Q2 2024 to $95.0 million
Insights
Assembly Bio's Q3 results show mixed financial performance with notable developments.
The company's clinical progress, particularly with ABI-5366 and planned trials for ABI-1179 and ABI-6250, suggests strategic pipeline expansion. However, increased R&D spending and cash burn warrant monitoring. The Gilead collaboration provides valuable revenue stream and validates technology platform.
The interim Phase 1a data for ABI-5366 shows promising potential in the recurrent genital herpes market. Key highlights include a favorable safety profile with extended exposure (70 days) and approximately 20-day half-life, supporting once-weekly or monthly dosing regimens. This could represent a significant advancement over current daily treatment options.
The diversified pipeline targeting multiple viral diseases (HSV, HBV, HDV) demonstrates strategic positioning in the antiviral market. The advancement of four clinical candidates by year-end, including ABI-4334 for chronic HBV and ABI-6250 for HBV/HDV, indicates robust R&D execution. Near-term catalysts with multiple data readouts in 2024-2025 could provide significant value inflection points.
- Positive Phase 1a interim data released for ABI-5366, a long-acting HSV helicase-primase inhibitor candidate for recurrent genital herpes, supporting potential for once-weekly and once-monthly oral dosing
- First participants dosed in Phase 1b trial evaluating ABI-5366 in individuals with recurrent genital herpes with interim data expected in first half of 2025
- Phase 1b trial for ABI-4334, a next-generation highly potent capsid assembly modulator candidate, ongoing in participants with chronic HBV with interim data expected by end of year
- ABI-1179 and ABI-6250 candidates on track to enter clinic by end of year
SOUTH SAN FRANCISCO, Calif., Nov. 07, 2024 (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 third quarter ended September 30, 2024.
“I’m thrilled with the continued execution against our ambitious goal of advancing four candidates targeting serious viral diseases in the clinic and releasing two interim data sets by year end,” said Jason Okazaki, chief executive officer and president of Assembly Bio. “We recently reported positive interim Phase 1a data for ABI-5366 that exceeded our expectations and supported the initiation of dosing in participants with recurrent genital herpes for the Phase 1b portion of the study. We look forward to adding two candidates to our clinical pipeline in the fourth quarter with the initiation of Phase 1 studies for ABI-1179 and ABI-6250."
Third Quarter 2024 and Recent Highlights
- Positive Phase 1a interim data were released for ABI-5366 and dosing was initiated in the Phase 1b portion of the ongoing Phase 1a/b trial
- In Phase 1a interim data, ABI-5366 was well-tolerated with a favorable safety profile observed with exposures of up to 70 days and a half-life of approximately 20 days when dosed orally
- The Phase 1b study portion in participants with recurrent genital herpes is expected to explore both once-weekly and once-monthly oral dosing; interim data are expected in the first half of 2025
- Regulatory clearance was received for a Phase 1a/b study for ABI-1179, a long-acting herpes simplex virus (HSV) helicase-primase inhibitor contributed by Gilead Sciences, Inc. (Gilead) under the collaboration between Assembly Bio and Gilead
- Anuj Gaggar, MD, PhD, chief medical officer, and William Delaney, PhD, chief scientific officer, presented during the H.C. Wainwright 5th Annual Viral Hepatitis Virtual Conference held October 8, 2024
- Preclinical data for ABI-6250, an oral, small molecule hepatitis B virus (HBV)/hepatitis delta virus (HDV) entry inhibitor candidate, were highlighted in a poster presentation at the International HBV Meeting held September 11-15, 2024
Upcoming Anticipated Milestones
- ABI-5366 Phase 1b interim clinical data in participants with recurrent genital herpes expected in the first half of 2025
- ABI-4334 Phase 1b interim clinical data in participants with chronic HBV expected by the end of 2024
- ABI-1179 and ABI-6250 both on track to enter the clinic by the end of 2024
Third Quarter 2024 Financial Results
- Cash, cash equivalents and marketable securities were
$95.0 million as of September 30, 2024, compared to$109.2 million as of June 30, 2024. Assembly Bio’s cash position is projected to fund operations into Q1 2026. - Revenue from collaborative research was
$6.8 million for the three months ended September 30, 2024. There was no revenue recognized for the same period in 2023. Revenue for the three months ended September 30, 2024 consists of amounts recognized under the collaboration with Gilead. - Research and development expenses were
$13.5 million for the three months ended September 30, 2024, compared to$10.8 million for the same period in 2023. The increase is attributable to having more candidates in development in 2024. - General and administrative expenses remained essentially flat year over year, totaling
$4.3 million for the three months ended September 30, 2024, compared to$4.2 million for the same period in 2023. - Net loss attributable to common stockholders was
$9.6 million , or$1.51 per basic and diluted share, for the three months ended September 30, 2024, compared to$14.4 million , or$3.29 per basic and diluted share, for the same period in 2023.
The investigational products and investigational product candidates referenced here have not been approved anywhere globally, and their safety and efficacy have not been established.
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. | |||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||||
| (In thousands except for share amounts and par value) | |||||||||
| September 30, | December 31, | ||||||||
| 2024 | 2023 | ||||||||
| (Unaudited) | |||||||||
| ASSETS | |||||||||
| Current assets | |||||||||
| Cash and cash equivalents | $ | 28,452 | $ | 19,841 | |||||
| Marketable securities | 66,502 | 110,406 | |||||||
| Accounts receivable from collaboration | — | 43 | |||||||
| Prepaid expenses and other current assets | 3,259 | 3,497 | |||||||
| Total current assets | 98,213 | 133,787 | |||||||
| Property and equipment, net | 316 | 385 | |||||||
| Operating lease right-of-use assets | 1,421 | 2,339 | |||||||
| Other assets | 312 | 312 | |||||||
| Total assets | $ | 100,262 | $ | 136,823 | |||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||||
| Current liabilities | |||||||||
| Accounts payable | $ | 1,335 | $ | 461 | |||||
| Accrued research and development expenses | 1,586 | 885 | |||||||
| Other accrued expenses | 4,765 | 5,744 | |||||||
| Deferred revenue from a related party - short-term | 32,620 | 30,915 | |||||||
| Operating lease liabilities - short-term | 1,329 | 1,220 | |||||||
| Total current liabilities | 41,635 | 39,225 | |||||||
| Deferred revenue from a related party - long-term | 32,511 | 55,379 | |||||||
| Operating lease liabilities - long-term | 113 | 1,122 | |||||||
| Total liabilities | 74,259 | 95,726 | |||||||
| Commitments and contingencies | |||||||||
| Stockholders' equity | |||||||||
| Preferred stock, | — | — | |||||||
| Common stock, | 6 | 5 | |||||||
| Additional paid-in capital | 841,743 | 826,921 | |||||||
| Accumulated other comprehensive loss | (156 | ) | (81 | ) | |||||
| Accumulated deficit | (815,590 | ) | (785,748 | ) | |||||
| Total stockholders' equity | 26,003 | 41,097 | |||||||
| Total liabilities and stockholders' equity | $ | 100,262 | $ | 136,823 | |||||
| ASSEMBLY BIOSCIENCES, INC. | |||||||||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||||||||||||||||
| (In thousands except for share and per share amounts) | |||||||||||||||||
| (Unaudited) | |||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||||
| Collaboration revenue from a related party | $ | 6,845 | $ | — | $ | 21,163 | $ | — | |||||||||
| Operating expenses | |||||||||||||||||
| Research and development | 13,515 | 10,824 | 41,653 | 37,894 | |||||||||||||
| General and administrative | 4,286 | 4,224 | 13,398 | 14,201 | |||||||||||||
| Total operating expenses | 17,801 | 15,048 | 55,051 | 52,095 | |||||||||||||
| Loss from operations | (10,956 | ) | (15,048 | ) | (33,888 | ) | (52,095 | ) | |||||||||
| Other income | |||||||||||||||||
| Interest and other income, net | 1,343 | 628 | 4,452 | 1,829 | |||||||||||||
| Total other income | 1,343 | 628 | 4,452 | 1,829 | |||||||||||||
| Loss before income taxes | (9,613 | ) | (14,420 | ) | (29,436 | ) | (50,266 | ) | |||||||||
| Income tax expense | — | — | 406 | — | |||||||||||||
| Net loss | $ | (9,613 | ) | $ | (14,420 | ) | $ | (29,842 | ) | $ | (50,266 | ) | |||||
| Other comprehensive loss | |||||||||||||||||
| Unrealized gain (loss) on marketable securities | 137 | 50 | (75 | ) | 528 | ||||||||||||
| Comprehensive loss | $ | (9,476 | ) | $ | (14,370 | ) | $ | (29,917 | ) | $ | (49,738 | ) | |||||
| Net loss per share, basic and diluted | $ | (1.51 | ) | $ | (3.29 | ) | $ | (5.12 | ) | $ | (11.61 | ) | |||||
| Weighted average common shares outstanding, basic and diluted | 6,351,431 | 4,380,444 | 5,827,750 | 4,329,260 | |||||||||||||
FAQ
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