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Assembly Biosciences Reports Fourth Quarter and Year End 2023 Financial Results and Recent Highlights

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Assembly Biosciences, Inc. reported financial results for Q4 2023 and year-end 2023, showcasing progress in antiviral pipeline development. The company entered a partnership with Gilead Sciences, strengthened leadership, and filed a clinical trial application for ABI-5366. Anticipated milestones include interim data from Phase 1a studies by Q3 2024 and Phase 1b studies by end of 2024. Financially, the company's cash position improved significantly, with $130.2 million in cash, cash equivalents, and marketable securities as of December 31, 2023.
Positive
  • Assembly Biosciences, Inc. reported positive financial results for Q4 2023 and year-end 2023, reflecting progress in antiviral pipeline development.
  • The company entered a long-term partnership with Gilead Sciences to advance novel antiviral therapies.
  • The addition of Dr. Anuj Gaggar as Chief Medical Officer strengthens the leadership team.
  • ABI-5366, a herpes simplex virus inhibitor, is expected to enter Phase 1a/1b studies by mid-2024.
  • Interim data from Phase 1a studies for ABI-5366 is anticipated by Q3 2024, with Phase 1b data expected by end of 2024.
  • Financially, the company's cash position improved significantly, with $130.2 million in cash, cash equivalents, and marketable securities as of December 31, 2023.
Negative
  • None.

The acceleration of clinical development timelines for ABI-5366 by Assembly Biosciences, in partnership with Gilead Sciences, marks a significant stride in the antiviral therapeutic space. The focus on recurrent genital herpes and chronic hepatitis B virus infection addresses substantial unmet medical needs, potentially affecting global health outcomes. The initiation of Phase 1b studies and the expected interim data from these trials are key indicators of the compound's safety and efficacy, which, if positive, could lead to increased investor confidence and potentially elevate stock valuations for both companies involved.

Furthermore, the financial results indicating an increase in cash reserves from $46.2 million to $130.2 million quarter-over-quarter and the recognition of $7.2 million in collaborative research revenue reflect a robust financial position. This improved liquidity is important for sustaining operations and funding ongoing research, which could reassure investors of the company's stability and ability to manage its burn rate effectively. The anticipated funding into the second half of 2025 suggests a lower immediate risk of dilutive financing, which can be favorable for current shareholders.

From a research and development perspective, the decrease in expenses year-over-year, coupled with the discontinuation of less promising drug candidates, demonstrates a strategic reallocation of resources towards more promising therapies. This streamlining could potentially lead to a more efficient capital allocation, enhancing the company's long-term value generation capabilities.

Assembly Biosciences' strategic partnership with Gilead Sciences and the entrance of novel antiviral candidates into clinical development could signal a bullish outlook for investors. The shift in focus towards novel antiviral therapies, such as ABI-5366 and ABI-4334 and the discontinuation of other candidates like ABI-H3733, signifies a pivot towards potentially higher-impact projects. This realignment of the pipeline, underscored by the financial collaboration with a major industry player like Gilead, may provide a competitive edge and serve as a catalyst for future stock appreciation.

The reported net loss decrease from $93.1 million in 2022 to $61.2 million in 2023, alongside a reduced loss per share, is indicative of improved operational efficiency. This financial metric will likely be viewed positively by the market, as it suggests a trend towards reduced cash burn and a more sustainable path forward. The company's ability to extend its cash runway without additional financing rounds in the near term is a key consideration for risk-averse investors.

It's important to note that the investigational products' lack of approval and established safety and efficacy present inherent investment risks. However, the milestones set for 2024 and 2025, including the anticipated interim data, offer potential value inflection points that could drive investor interest and stock volatility around those timeframes.

The antiviral market is highly competitive and Assembly Biosciences' focused approach on HSV and HBV through its partnership with Gilead Sciences could disrupt the current market dynamics. The therapeutic potential of a long-acting herpes simplex virus helicase-primase inhibitor and a capsid assembly modulator for hepatitis B represents a significant advancement in treatment options. Positive interim data from these trials could position Assembly Biosciences as a leader in this niche, potentially capturing a significant market share.

The introduction of ABI-1179 and ABI-6250 into the clinical pipeline adds depth to the company's portfolio, which could diversify risk and enhance the company's attractiveness to investors who value a robust pipeline as an indicator of long-term growth potential. The partnership with Gilead not only provides financial backing but also leverages Gilead's extensive experience in antiviral drug development, potentially increasing the likelihood of clinical success.

However, the discontinuation of other drug candidates, while streamlining focus, does eliminate potential revenue streams. This strategy puts more pressure on the success of the remaining pipeline and any setbacks in clinical trials could have a disproportionate impact on investor sentiment and the company's market valuation.

  • Four candidates planned to be in clinical development in 2024 with interim data from two studies anticipated by year end
  • Clinical development timelines accelerated for ABI-5366; now anticipating interim data from Phase 1a available in 3Q2024, initiation of Phase 1b in individuals with recurrent genital herpes by end of 2024 and interim Phase 1b data available in 1H2025
  • Gilead Sciences, Inc. partnership supports advancement and strengthening of antiviral pipeline targeting serious viral diseases

SOUTH SAN FRANCISCO, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today reported financial results and recent highlights for the fourth quarter and year ended December 31, 2023.

“Our progress in 2023 demonstrated our capacity to drive our expanded antiviral pipeline forward and our commitment to individuals suffering from life-impacting viral diseases,” said Jason Okazaki, chief executive officer and president of Assembly Bio. “With our long-term partnership in place with Gilead and the addition of Dr. Anuj Gaggar to our management team as CMO, we are well-positioned to make critical progress clinically across multiple programs in 2024 and look forward to sharing preliminary data on 5366 and 4334 later this year.”

Fourth Quarter 2023 and Recent Highlights

  • Entered a long-term partnership with Gilead to advance discovery and development of novel antiviral therapies
  • Strengthened the leadership team with the naming of Anuj Gaggar, MD, PhD, as chief medical officer
  • Filed a clinical trial application for ABI-5366 to support initiation of Phase 1a/1b clinical studies

Anticipated Milestones and Events

By mid-year 2024:

  • ABI-5366, a long-acting herpes simplex virus (HSV) helicase-primase inhibitor targeting recurrent genital herpes, is expected to enter a Phase 1a/1b study
  • ABI-4334, a next-generation, highly potent capsid assembly modulator, is anticipated to enter a Phase 1b study in individuals with chronic hepatitis B virus infection

Q3 2024:

  • Interim clinical data from the ABI-5366 Phase 1a study portion expected to be available

By the end of 2024:

  • Interim clinical data from the ABI-4334 Phase 1b study expected to be available
  • The Phase 1b portion of the ABI-5366 study, in individuals with recurrent genital herpes, is anticipated to be underway
  • Two additional candidates are anticipated to enter the clinic:
    • ABI-1179, a long-acting HSV helicase-primase inhibitor contributed by Gilead under the collaboration between Assembly Bio and Gilead
    • ABI-6250, a small molecule orally-bioavailable hepatitis delta virus entry inhibitor

First half 2025:

  • Interim clinical data from the Phase 1b portion of the ABI-5366 study expected to be available

Fourth Quarter 2023 and Year End Financial Results

  • Cash, cash equivalents and marketable securities were $130.2 million as of December 31, 2023, compared to $46.2 million as of September 30, 2023, and $91.6 million as of the year ended December 31, 2022. The company’s cash position is projected to fund operations into the second half of 2025.
  • Revenues from collaborative research were $7.2 million for the year ended December 31, 2023. There was no revenue recognized for the same period in 2022. Revenue for the year ended December 31, 2023, consists of $4.4 million recognized under the collaboration with Gilead and the remaining deferred revenue balance of $2.7 million under the collaboration agreement with BeiGene following Assembly Bio’s decision to discontinue further development of ABI-H3733 in conjunction with entering into the Gilead collaboration, following the previous prioritization of ABI-4334 over ABI-H3733.
  • Research and development expenses were $48.9 million for the year ended December 31, 2023, compared to $70.0 million in 2022. The decrease is due to completion of the clinical trials for ABI-H3733 and ABI-4334, discontinued development of vebicorvir and ABI-H2158, and decreases in employee and contractor-related expenses.
  • General and administrative expenses were $22.9 million for the year ended December 31, 2023, compared to $24.1 million in 2022. The decrease is due to overall cost-saving initiatives.
  • Net loss attributable to common stockholders was $61.2 million, or $13.38 per basic and diluted share, for the year ended December 31, 2023, compared to $93.1 million, or $23.08 per basic and diluted share in 2022.

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.
CONSOLIDATED BALANCE SHEETS
(In thousands except for share amounts and par value)
     
  As of December 31,
   2023   2022 
     
ASSETS    
Current assets    
Cash and cash equivalents $19,841  $52,418 
Marketable securities  110,406   39,192 
Accounts receivable from collaboration  43   944 
Prepaid expenses and other current assets  3,497   4,413 
Total current assets  133,787   96,967 
     
Property and equipment, net  385   743 
Operating lease right-of-use assets  2,339   3,195 
Other assets  312   889 
Total assets $ 136,823  $ 101,794 
     
LIABILITIES AND STOCKHOLDERS' EQUITY    
Current liabilities    
Accounts payable $461  $2,493 
Accrued research and development expenses  885   3,122 
Other accrued expenses  5,744   7,317 
Deferred revenue - short-term ($30,915 and $− to a related party)  30,915    
Operating lease liabilities - short-term  1,220   3,364 
Total current liabilities  39,225   16,296 
     
Deferred revenue - long-term ($55,379 and $− to a related party)  55,379   2,733 
Operating lease liabilities - long-term  1,122   101 
Total liabilities  95,726   19,130 
     
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 December 31, 2023 and December 31, 2022; 5,482,752 and 4,074,552 shares issued and outstanding as of December 31, 2023 and December 31, 2022, respectively  5   4 
Additional paid-in capital  826,921   807,983 
Accumulated other comprehensive loss  (81)  (803)
Accumulated deficit  (785,748)  (724,520)
Total stockholders' equity  41,097   82,664 
Total liabilities and stockholders' equity $ 136,823  $ 101,794 
     


ASSEMBLY BIOSCIENCES, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands except for share and per share amounts)
 
     
  Year Ended December 31,
   2023   2022 
Collaboration revenue ($4,430 and $− from a related party) $7,163  $ 
     
Operating expenses    
Research and development  48,900   69,980 
General and administrative  22,909   24,134 
Total operating expenses  71,809   94,114 
Loss from operations  (64,646)  (94,114)
     
Other income    
Interest and other income, net  3,451   1,022 
Total other income  3,451   1,022 
Loss before income taxes  (61,195)  (93,092)
     
Income tax expense  (33)   
Net loss $ (61,228) $ (93,092)
     
Other comprehensive loss    
Unrealized gain (loss

FAQ

What were Assembly Biosciences, Inc.'s cash, cash equivalents, and marketable securities as of December 31, 2023?

Assembly Biosciences, Inc.'s cash, cash equivalents, and marketable securities were $130.2 million as of December 31, 2023.

What partnership did Assembly Biosciences, Inc. enter into recently?

Assembly Biosciences, Inc. entered a long-term partnership with Gilead Sciences to advance novel antiviral therapies.

Who was appointed as the Chief Medical Officer of Assembly Biosciences, Inc.?

Dr. Anuj Gaggar was appointed as the Chief Medical Officer of Assembly Biosciences, Inc.

What is the expected timeline for ABI-5366 in clinical development?

ABI-5366 is expected to enter Phase 1a/1b studies by mid-2024.

When is the interim data from Phase 1a studies for ABI-5366 anticipated?

Interim data from Phase 1a studies for ABI-5366 is anticipated by Q3 2024.

What was Assembly Biosciences, Inc.'s net loss attributable to common stockholders for the year ended December 31, 2023?

Assembly Biosciences, Inc.'s net loss attributable to common stockholders was $61.2 million, or $13.38 per basic and diluted share, for the year ended December 31, 2023.

Assembly Biosciences, Inc.

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