Assembly Biosciences Reports Second Quarter 2024 Financial Results and Recent Updates

Rhea-AI Summary

Assembly Biosciences (ASMB) reported Q2 2024 financial results and updates. Key highlights include:

- Dosing initiated in Phase 1a/b trial for ABI-5366 (genital herpes treatment) and Phase 1b trial for ABI-4334 (chronic HBV treatment)

- Two additional pipeline candidates expected to enter clinic by year-end

- Q2 revenue: $8.5 million; R&D expenses: $16.3 million; Net loss: $11.2 million ($1.98 per share)

- Cash position: $109.2 million as of June 30, 2024, projected to fund operations into Q1 2026

- Upcoming milestones: ABI-5366 Phase 1a interim data in Q3 2024, ABI-4334 Phase 1b interim data by year-end

Positive

• Initiated dosing in Phase 1a/b trial for ABI-5366 and Phase 1b trial for ABI-4334
• Two additional pipeline candidates (ABI-1179 and ABI-6250) expected to enter clinic by year-end
• Revenue from collaborative research increased to $8.5 million in Q2 2024
• Cash position of $109.2 million projected to fund operations into Q1 2026
• Net loss decreased to $11.2 million in Q2 2024 compared to $16.9 million in Q2 2023

Negative

• R&D expenses increased to $16.3 million in Q2 2024 compared to $12.5 million in Q2 2023
• Cash position decreased from $113.0 million in Q1 2024 to $109.2 million in Q2 2024

Insights

Financial Analyst

Assembly Biosciences' Q2 2024 results show promising progress in their clinical pipeline, but financial metrics remain mixed. Revenue of $8.5 million from the Gilead collaboration is a positive sign, compared to no revenue in Q2 2023. However, net loss of $11.2 million, while improved from $16.9 million last year, indicates ongoing cash burn.

R&D expenses increased to $16.3 million, reflecting expanded clinical programs. The cash position of $109.2 million, projected to fund operations into Q1 2026, provides a decent runway but may require additional funding in the future. The $12.6 million raised through equity investments helps, but dilution is a concern for existing shareholders.

Overall, while progress is evident, ASMB remains in a cash-burning phase typical of early-stage biotech companies. Investors should closely monitor upcoming clinical milestones for potential value inflection points.

Medical Research Analyst

Assembly Bio's pipeline is advancing rapidly, with two clinical trials now dosing participants. The ABI-5366 Phase 1a/b trial for recurrent genital herpes and the ABI-4334 Phase 1b trial for chronic HBV are key programs to watch. Interim data expected in Q3 2024 and by year-end, respectively, could provide important insights into these candidates' potential.

The company's focus on long-acting antivirals, exemplified by ABI-5366's targeted once-weekly oral dosing, could be a significant differentiator in the market. The addition of ABI-6250, an HBV/HDV entry inhibitor, further diversifies their antiviral portfolio.

With four candidates potentially in clinical trials by year-end, Assembly Bio is building a robust pipeline. However, as these are early-stage trials, significant risks remain. The upcoming data readouts will be critical in assessing the company's long-term prospects in the competitive antiviral space.

• Dosing initiated in healthy participants in Phase 1a/b trial for ABI-5366 targeting recurrent genital herpes, with interim Phase 1a first-in-human data expected in Q3 2024 and interim Phase 1b data in participants with recurrent genital herpes expected in first half of 2025
• Dosing initiated in Phase 1b trial for ABI-4334 in participants with chronic HBV infection, with interim Phase 1b data expected by end of year
• Two additional pipeline candidates, ABI-1179 and ABI-6250, anticipated to enter clinic by end of year
  

SOUTH SAN FRANCISCO, Calif., Aug. 08, 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 second quarter ended June 30, 2024.

“Entering the second half of the year, I’m incredibly proud of our team’s accomplishments on our path to delivering novel therapeutics for individuals living with serious viral diseases,” said Jason Okazaki, chief executive officer and president of Assembly Bio. “We are rapidly progressing toward key inflection points for our clinical development programs and remain on track with the data sets we plan to deliver in 2024. Specifically, in the third quarter, we look forward to sharing interim Phase 1a data for ABI-5366 in healthy participants. The pharmacokinetic data in this study will enable us to assess ABI-5366's ability to reach the target concentrations we have established for antiviral efficacy and to support our once-weekly oral dosing profile, while also informing dose selection in the Phase 1b part of the study in participants with recurrent genital herpes.”

Second Quarter 2024 and Recent Highlights

• First participants were dosed in two clinical trials:
  • The Phase 1a portion of a Phase 1a/b clinical study of ABI-5366, a long-acting herpes simplex virus (HSV) helicase-primase inhibitor candidate; the Phase 1a portion in healthy participants and the Phase 1b portion to be conducted in participants with recurrent genital herpes
  • A Phase 1b study of ABI-4334, a next-generation, highly potent capsid assembly modulator candidate, in participants with chronic hepatitis B virus (HBV) infection
• Scientific conference presentations highlighted:
  • Preclinical data for ABI-5366 (poster presentation) and ABI-1179 (poster and oral presentation) featured at the International Herpesvirus Workshop held July 13-17, 2024. ABI-1179 is the long-acting HSV helicase-primase inhibitor candidate contributed by Gilead Sciences, Inc. (Gilead) under the collaboration between Assembly Bio and Gilead
  • Preclinical data for ABI-6250, an oral, small molecule HBV/hepatitis delta virus (HDV) entry inhibitor candidate, featured in a poster presentation at the European Association for the Study of the Liver (EASL) Congress™ 2024 held June 5-8, 2024
  • Preclinical data for ABI-6250 featured in an oral presentation at the Science of HBV Cure Meeting 2024 held July 26-27, 2024
• Strengthened balance sheet with equity investments that resulted in aggregate gross proceeds to Assembly Bio of approximately $12.6 million, supporting advancement of antiviral portfolio and extending cash runway into Q1 2026

Upcoming Anticipated Milestones

• ABI-5366 Phase 1a interim clinical data in healthy participants expected in Q3 2024 and interim Phase 1b data in participants with recurrent genital herpes expected in the first half of 2025
• ABI-4334 Phase 1b interim clinical data expected by the end of 2024
• Two additional candidates, ABI-1179 and ABI-6250, are anticipated to enter the clinic by the end of 2024
  

Upcoming Conferences

• Abstract highlighting preclinical data for ABI-6250 accepted for poster presentation at the International HBV Meeting taking place September 11-15, 2024, in Chicago
  

Second Quarter 2024 Financial Results

• Cash, cash equivalents and marketable securities were $109.2 million as of June 30, 2024, compared to $113.0 million as of March 31, 2024. Assembly Bio’s cash position is projected to fund operations into Q1 2026.
• Revenue from collaborative research was $8.5 million for the three months ended June 30, 2024. There was no revenue recognized for the same period in 2023. Revenue for the three months ended June 30, 2024, consists of amounts recognized under the collaboration with Gilead.
• Research and development expenses were $16.3 million for the three months ended June 30, 2024, compared to $12.5 million for the same period in 2023. The increase is attributable to having more candidates in development in 2024.
• General and administrative expenses were $4.5 million for the three months ended June 30, 2024, compared to $5.0 million for the same period in 2023. The decrease is primarily due to a decrease in non-cash stock-based compensation expense.
• Net loss attributable to common stockholders was $11.2 million, or $1.98 per basic and diluted share, for the three months ended June 30, 2024, compared to $16.9 million, or $3.88 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 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)
	June 30,				December 31,
	2024				2023
	(Unaudited)
ASSETS
Current assets
Cash and cash equivalents	$	19,208			$	19,841
Marketable securities	90,011				110,406
Accounts receivable from collaboration	—				43
Prepaid expenses and other current assets	3,712				3,497
Total current assets	112,931				133,787
Property and equipment, net	349				385
Operating lease right-of-use assets	1,731				2,339
Other assets	312				312
Total assets	$	115,323			$	136,823
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable	$	801			$	461
Accrued research and development expenses	2,531				885
Other accrued expenses	3,587				5,744
Deferred revenue from a related party - short-term	33,060				30,915
Operating lease liabilities - short-term	1,295				1,220
Total current liabilities	41,274				39,225
Deferred revenue from a related party - long-term	38,916				55,379
Operating lease liabilities - long-term	451				1,122
Total liabilities	80,641				95,726
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 June 30, 2024 and December 31, 2023; 6,345,561 and 5,482,752 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively	6				5
Additional paid-in capital	840,946				826,921
Accumulated other comprehensive loss	(293		)		(81		)
Accumulated deficit	(805,977		)		(785,748		)
Total stockholders' equity	34,682				41,097
Total liabilities and stockholders' equity	$	115,323			$	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 June 30,								Six Months Ended June 30,
	2024				2023				2024				2023
Collaboration revenue from a related party	$	8,533			$	—			$	14,318			$	—
Operating expenses
Research and development	16,259				12,523				28,138				27,070
General and administrative	4,477				4,965				9,112				9,977
Total operating expenses	20,736				17,488				37,250				37,047
Loss from operations	(12,203		)		(17,488		)		(22,932		)		(37,047		)
Other income
Interest and other income, net	1,457				592				3,109				1,201
Total other income	1,457				592				3,109				1,201
Loss before income taxes	(10,746		)		(16,896		)		(19,823		)		(35,846		)
Income tax expense	406				—				406				—
Net loss	$	(11,152	)		$	(16,896	)		$	(20,229	)		$	(35,846	)
Other comprehensive loss
Unrealized (loss) gain on marketable securities	(54		)		188				(212		)		478
Comprehensive loss	$	(11,206	)		$	(16,708	)		$	(20,441	)		$	(35,368	)
Net loss per share, basic and diluted	$	(1.98	)		$	(3.88	)		$	(3.64	)		$	(8.33	)
Weighted average common shares outstanding, basic and diluted	5,642,752				4,355,007				5,563,033				4,303,244

FAQ

What were Assembly Biosciences' (ASMB) Q2 2024 financial results?

Assembly Biosciences reported Q2 2024 revenue of $8.5 million, R&D expenses of $16.3 million, and a net loss of $11.2 million ($1.98 per share). The company's cash position was $109.2 million as of June 30, 2024.

What are the upcoming milestones for Assembly Biosciences' (ASMB) clinical trials in 2024?

Assembly Biosciences expects to report interim Phase 1a data for ABI-5366 in Q3 2024 and interim Phase 1b data for ABI-4334 by the end of 2024. Additionally, two pipeline candidates, ABI-1179 and ABI-6250, are anticipated to enter clinical trials by year-end.

How long is Assembly Biosciences' (ASMB) current cash position expected to fund operations?

Assembly Biosciences' cash position of $109.2 million as of June 30, 2024, is projected to fund operations into Q1 2026.

What are the main drug candidates in Assembly Biosciences' (ASMB) pipeline?

Assembly Biosciences' main drug candidates include ABI-5366 for genital herpes, ABI-4334 for chronic HBV infection, ABI-1179 for HSV, and ABI-6250 for HBV/HDV entry inhibition.