Assembly Biosciences Reports First Quarter 2025 Financial Results and Recent Updates

Rhea-AI Summary

Assembly Biosciences (NASDAQ: ASMB) reported Q1 2025 financial results and updates on its antiviral portfolio. The company ended Q1 with $91.0 million in cash, projecting operations funding into mid-2026. Revenue from Gilead collaboration increased to $9.4 million, up from $5.8 million in Q1 2024. Net loss was $8.8 million ($1.17 per share), improved from $9.1 million in Q1 2024. Key clinical developments include: - Interim Phase 1b data expected in fall 2025 for ABI-5366 and ABI-1179 in recurrent genital herpes - Phase 1a data for HDV candidate ABI-6250 expected in Q3 2025 - Phase 1b data for HBV candidate ABI-4334 expected in H1 2025 The company presented new data at multiple conferences (ICAR, ESCMID, EASL 2025) and has upcoming presentations at the Jefferies Healthcare Conference and STI & HIV World Congress.

Positive

• Revenue from Gilead collaboration increased 62% YoY to $9.4 million
• Strong cash position of $91.0 million funding operations into mid-2026
• Net loss per share improved to $1.17 from $1.66 YoY
• Multiple clinical data readouts expected throughout 2025

Negative

• Cash position decreased from $112.1M in December 2024 to $91.0M in March 2025
• R&D expenses increased 25% YoY to $14.9 million

Insights

Biotech/Pharmaceutical Analyst

Assembly Bio advancing early-stage antiviral pipeline with multiple 2025 readouts; financial runway into mid-2026 supports development timeline.

Assembly Biosciences is making steady progress across its antiviral pipeline with four clinical-stage candidates targeting significant viral diseases. The company's development timeline remains intact with multiple data readouts expected throughout 2025.

Their most advanced programs target recurrent genital herpes with two long-acting helicase-primase inhibitors (ABI-5366 and ABI-1179). The anticipated Phase 1b interim efficacy data in fall 2025 will provide crucial proof-of-concept for both candidates. Notably, these programs are evaluating weekly and monthly dosing regimens, which could represent a substantial improvement over current standard-of-care treatments that typically require daily administration for herpes suppression.

For their hepatitis D virus (HDV) program, ABI-6250 continues advancing with Phase 1a data expected in Q3 2025. This oral HDV entry inhibitor addresses a disease with extremely limited treatment options. Similarly, their hepatitis B virus (HBV) candidate ABI-4334, a next-generation capsid assembly modulator, will generate Phase 1b data in the first half of 2025.

The company's scientific approach has gained external validation through their collaboration with Gilead Sciences, which contributed the ABI-1179 asset. Their active presence at major scientific conferences (ICAR, ESCMID, EASL) demonstrates transparent communication of preclinical and early clinical data to the scientific community.

While all programs remain in early clinical development with corresponding risks, the company's focus on viral diseases with significant unmet needs positions them in therapeutic areas where demonstrated efficacy could generate substantial interest from potential partners and investors.

Financial Analyst

Assembly Biosciences ended Q1 2025 with $91.0 million in cash and marketable securities, down from $112.1 million at year-end 2024. Management projects this runway extends into mid-2026, providing approximately 14 months of operational funding from current date.

The $21.1M quarterly cash burn merits attention, as it suggests an annualized burn rate of approximately $84 million. This is partially offset by collaboration revenue from Gilead, which increased 62% year-over-year to $9.4 million in Q1. This revenue growth stems from both increased R&D activities and enhanced funding from their December 2024 collaboration amendment.

R&D expenses increased 25% to $14.9 million versus Q1 2024, reflecting intensified investment in development programs, particularly ABI-6250 and ABI-5366. G&A expenses remained efficiently managed at $4.5 million, slightly down from the prior year.

The bottom line shows modest improvement, with net loss for Q1 at $8.8 million ($1.17 per share) compared to $9.1 million ($1.66 per share) in Q1 2024. The improvement in loss per share despite similar total net loss suggests changes in outstanding share count.

The company's financial position appears strategically aligned with their clinical development timeline, with multiple data readouts expected before their projected cash runway ends. However, should they advance multiple candidates to later-stage trials beyond 2026, additional funding would likely be required. The Gilead collaboration provides valuable non-dilutive funding, but investors should monitor quarterly burn rate and potential need for future capital raises.

– Ongoing clinical studies for four candidates on track with data expected in 2025, including interim Phase 1b data for long-acting helicase-primase inhibitors ABI-5366 and ABI-1179 anticipated in fall 2025 –

– New data from multiple programs highlighted at ICAR, ESCMID and EASL 2025 –

SOUTH SAN FRANCISCO, Calif., May 08, 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 first quarter ended March 31, 2025.

“We continue the strong progress across our antiviral portfolio and remain on track for the multiple key clinical data sets we plan to deliver in 2025,” said Jason Okazaki, chief executive officer and president of Assembly Bio. “This includes proof-of-concept Phase 1b data we expect in the fall for ABI-5366 and ABI-1179 that will provide an initial look at antiviral activity for both candidates in participants with recurrent genital herpes. I’m proud of the accomplishments of our team as we focus on improving therapeutic options for those living with viral diseases where the need for treatment innovation is significant.”

First Quarter 2025 and Recent Highlights

• ICAR 2025: Presented three posters and one oral presentation describing the preclinical potency and pharmacokinetic (PK) profiles of ABI-5366 (poster), ABI-1179 (poster) and ABI-6250, an oral hepatitis D virus (HDV) entry inhibitor candidate (a poster and an oral presentation), at the International Conference on Antiviral Research (ICAR), March 17-21, 2025
• ESCMID 2025: Presented three posters highlighting new Phase 1a clinical data and preclinical data for therapeutic candidate ABI-5366 and claims data estimating U.S. genital herpes prevalence and treatment patterns at the 2025 Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID), April 11-15, 2025
• EASL 2025: Presented two posters, including one late-breaker, highlighting new preclinical profile data for ABI-6250 (late-breaker) and results from in vitro studies of ABI-4334, a next-generation hepatitis B virus (HBV) capsid assembly modulator (poster), at the 2025 European Association for the Study of the Liver (EASL) Congress, May 7-10, 2025
  
  

Anticipated Milestones and Events

• Recurrent genital herpes (ABI-5366 and ABI-1179)
  • In fall 2025, interim efficacy, safety and PK data from Phase 1b studies 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 in participants with chronic HBV infection for ABI-4334

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.

Upcoming Conferences

• Presentation by Mr. Okazaki and Anuj Gaggar, MD, PhD, chief medical officer of Assembly Bio, during the Jefferies Healthcare Conference, June 3-5, 2025
• Multiple abstracts accepted for presentation from Assembly Bio’s herpes simplex virus (HSV) program at the STI & HIV World Congress, being held in Montreal, Canada, from July 26-30, 2025

First Quarter 2025 Financial Results

• Cash, cash equivalents and marketable securities were $91.0 million as of March 31, 2025, compared to $112.1 million as of December 31, 2024. Assembly Bio’s cash position is projected to fund operations into mid-2026.
• Revenue from collaborative research with Gilead was $9.4 million for the three months ended March 31, 2025, compared to $5.8 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 $14.9 million for the three months ended March 31, 2025, compared to $11.9 million for the same period in 2024. The increase is most largely due to increases in spending on ABI-6250 and ABI-5366.
• General and administrative expenses were $4.5 million for the three months ended March 31, 2025, compared to $4.6 million for the same period in 2024. The decrease is primarily due to a reduction in rent under Assembly Bio’s amended corporate headquarters sublease.
• Net loss attributable to common stockholders was $8.8 million, or $1.17 per basic and diluted share, for the three months ended March 31, 2025, compared to $9.1 million, or $1.66 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’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 may not differentiate Assembly Bio’s product candidates from other companies’ 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’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)
		March 31,				December 31,
			2025				2024
		(Unaudited)
ASSETS
Current assets
Cash and cash equivalents		$	23,413			$	38,344
Marketable securities			67,615				73,735
Prepaid expenses and other current assets			4,499				3,424
Total current assets			95,527				115,503
Property and equipment, net			251				284
Operating lease right-of-use assets			2,927				3,069
Other assets			312				312
Total assets		$	99,017			$	119,168
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable		$	875			$	585
Accrued research and development expenses			2,106				2,273
Other accrued expenses			2,302				6,862
Deferred revenue from a related party - short-term			40,819				37,622
Operating lease liabilities - short-term			529				461
Total current liabilities			46,631				47,803
Deferred revenue from a related party - long-term			22,762				35,378
Operating lease liabilities - long-term			2,491				2,628
Total liabilities			71,884				85,809
Commitments and contingencies
Stockholders' equity
Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued or outstanding			—				—
Common stock, $0.001 par value; 150,000,000 shares authorized as of March 31, 2025 and December 31, 2024; 7,618,885 and 7,457,240 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively			8				7
Additional paid-in capital			862,121				859,488
Accumulated other comprehensive loss			(253	)			(211	)
Accumulated deficit			(834,743	)			(825,925	)
Total stockholders' equity			27,133				33,359
Total liabilities and stockholders' equity		$	99,017			$	119,168

ASSEMBLY BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands except for share and per share amounts)
(Unaudited)
		Three Months Ended March 31,
			2025				2024
Collaboration revenue from a related party		$	9,419			$	5,785
Operating expenses
Research and development			14,851				11,879
General and administrative			4,509				4,635
Total operating expenses			19,360				16,514
Loss from operations			(9,941	)			(10,729	)
Other income
Interest and other income, net			1,123				1,652
Total other income			1,123				1,652
Net loss		$	(8,818	)		$	(9,077	)
Other comprehensive loss
Unrealized loss on marketable securities			42				158
Comprehensive loss		$	(8,860	)		$	(9,235	)
Net loss per share, basic and diluted		$	(1.17	)		$	(1.66	)
Weighted average common shares outstanding, basic and diluted			7,506,321				5,483,313

FAQ

What were Assembly Biosciences (ASMB) key financial results for Q1 2025?

ASMB reported Q1 2025 revenue of $9.4M, net loss of $8.8M ($1.17 per share), and ended with $91.0M in cash. R&D expenses were $14.9M and G&A expenses were $4.5M.

What are the major clinical milestones expected for ASMB in 2025?

ASMB expects Phase 1b data for ABI-5366 and ABI-1179 in fall 2025, Phase 1a data for ABI-6250 in Q3 2025, and Phase 1b data for ABI-4334 in H1 2025.

How long can ASMB fund its operations with current cash position?

Assembly Biosciences' current cash position of $91.0 million is projected to fund operations into mid-2026.

What is the status of ASMB's collaboration with Gilead Sciences?

The collaboration is active with revenue increasing to $9.4M in Q1 2025 from $5.8M in Q1 2024, reflecting increased R&D activity and enhanced funding from a December 2024 agreement amendment.