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Assembly Biosciences Reports First Quarter 2024 Financial Results and Recent Highlights

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Assembly Biosciences, Inc. (Nasdaq: ASMB) reported financial results for Q1 2024, including regulatory clearances for Phase 1 trials for ABI-5366 targeting recurrent genital herpes and ABI-4334 in chronic HBV infection. The company highlighted upcoming clinical milestones, abstract acceptance for ABI-6250 at EASL CongressTM 2024, and financial results showing $113.0 million in cash as of March 31, 2024. Revenues from collaborative research were $5.8 million, with research and development expenses at $11.9 million and a net loss of $9.1 million for Q1 2024.

Positive
  • Regulatory clearances received for Phase 1 trials for ABI-5366 and ABI-4334, indicating progress in the development of innovative therapies targeting serious viral diseases.

  • Anticipated milestones for 2024 include initiation of studies for ABI-5366 and ABI-4334, with two additional candidates expected to enter the clinic by the end of the year.

  • Acceptance of abstract highlighting preclinical data for ABI-6250 at EASL CongressTM 2024, showcasing the company's commitment to scientific collaboration and research.

Negative
  • Cash, cash equivalents, and marketable securities decreased to $113.0 million as of March 31, 2024, compared to $130.2 million as of December 31, 2023, raising concerns about the company's financial position.

  • Despite a decrease in research and development expenses compared to the same period in 2023, Assembly Bio reported a net loss of $9.1 million for Q1 2024, signaling ongoing financial challenges.

The recent financial figures from Assembly Biosciences indicate a noteworthy decrease in net loss year-over-year, from $19.0 million to $9.1 million, which is a reflection of heightened operational efficiency, particularly stemming from the discontinuation of less promising drugs and general cost optimization. This is coupled with a cash and equivalents reserve sufficient to fund operations well into the second half of 2025, thus alleviating immediate liquidity concerns that are critical for investors monitoring burn rate and runway in biotech ventures.

Focusing on their pipeline, the initiation of clinical trials for ABI-5366 and ABI-4334 is indicative of progress towards potentially monetizable assets, albeit the inherent risk in drug development persists until later-stage trial results affirm efficacy and safety. Revenue from collaboration with Gilead, amounting to $5.8 million, introduces a strategic partnership dynamic that may result in shared risk and increased resources. However, as this is early-stage news, the immediate stock market influence may be muted, with investor sentiment likely to sway based on subsequent data readouts slated for later in the year.

The green light for clinical trials for ABI-5366 and ABI-4334 is a testament to Assembly Biosciences' dexterity in advancing their antiviral pipeline, targeting conditions with significant unmet medical needs like recurrent genital herpes and chronic HBV. The meticulous selection of their investigational therapies, particularly the novel mechanism of action of ABI-4334 as a capsid assembly modulator, could represent a disruptive technological advancement in the treatment landscape if successful.

Interim data, expected in Q3 and Q4 of 2024, will be important in validating the initial safety profiles and potential efficacy signals. For investors, such milestones are critical pivot points – positive data could serve as catalysts for value appreciation, while adverse results might trigger skepticism about the company's pipeline integrity. Nonetheless, the true impact of these developments will only be tangible post-phase 3 trials, which define regulatory approval prospects and commercial viability.

The clearance to proceed with Phase 1a/1b trials for ABI-5366 and a Phase 1b trial for ABI-4334 provides a preliminary validation of the preclinical work undertaken by Assembly Biosciences. It is pertinent to note that Phase 1 trials largely center on safety, tolerability and pharmacokinetics rather than efficacy, which is more thoroughly scrutinized in later-stage trials.

For investors, it's essential to understand that clinical trial clearances are an initial step in a protracted and uncertain journey towards potential commercialization. The positive reception of an abstract for a poster presentation at a reputable congress like EASL is a nod to the scientific community's interest; however, it bears minimal immediate commercial impact. As the results from these early trials become available, they will serve as a barometer for the compound's clinical promise, influencing investor sentiments accordingly.

  • Clinical trial application clearances received for a Phase 1a/1b trial for ABI-5366 targeting recurrent genital herpes, and a Phase 1b trial for ABI-4334 in chronic HBV infection; both studies on track to initiate by mid-2024
  • ABI-5366 interim Phase 1a first-in-human data expected in Q3 2024 and ABI-4334 interim Phase 1b data expected by end of year

SOUTH SAN FRANCISCO, Calif., May 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 highlights for the first quarter ended March 31, 2024.

“We are pleased that we now have regulatory clearance to initiate trials evaluating our promising investigational therapies ABI-5366 and ABI-4334 and look forward to sharing interim data from these studies later this year,” said Jason Okazaki, chief executive officer and president of Assembly Bio. “These clearances are a significant step toward our goal of reaching key clinical inflection points for multiple programs in our antiviral pipeline by year end. Our continued clinical progress reflects the strength and agility of our highly experienced team and our singular focus of improving treatment options for those living with serious viral diseases.”

First Quarter 2024 and Recent Highlights

  • Two clinical trial applications received clearance to proceed:
    • ABI-5366, a long-acting herpes simplex virus (HSV) helicase-primase inhibitor candidate, for initiation of Phase 1a/1b clinical studies in both healthy volunteers and in individuals with recurrent genital herpes
    • ABI-4334, a next-generation, highly potent capsid assembly modulator candidate, for initiation of a Phase 1b study in individuals with chronic hepatitis B virus (HBV) infection
  • An abstract highlighting preclinical data for ABI-6250, an oral, small molecule HBV/hepatitis delta virus (HDV) entry inhibitor candidate, has been accepted for poster presentation at the European Association for the Study of the Liver (EASL) CongressTM 2024, June 5-8, 2024

Anticipated 2024 Milestones

  • ABI-5366 and ABI-4334 studies expected to initiate by mid-2024:
    • ABI-5366 Phase 1a interim clinical data expected in Q3 2024 and interim Phase 1b data expected in the first half of 2025
    • ABI-4334 Phase 1b interim clinical data expected by the end of 2024
  • Two additional candidates are anticipated to enter the clinic by the end of 2024:
    • ABI-1179, a long-acting HSV helicase-primase inhibitor contributed by Gilead Sciences, Inc. (Gilead) under the collaboration between Assembly Bio and Gilead
    • ABI-6250, a small molecule orally-bioavailable HDV entry inhibitor

      First Quarter 2024 Financial Results

  • Cash, cash equivalents and marketable securities were $113.0 million as of March 31, 2024, compared to $130.2 million as of December 31, 2023. Assembly Bio’s cash position is projected to fund operations into the second half of 2025.
  • Revenues from collaborative research were $5.8 million for the three months ended March 31, 2024. There was no revenue recognized for the same period in 2023. Revenue for the three months ended March 31, 2024 consists of amounts recognized under the collaboration with Gilead.
  • Research and development expenses were $11.9 million for the three months ended March 31, 2024, compared to $14.5 million for the same period in 2023. Increased expenses related to the development of ABI-1179 and ABI-6250 were more than offset by savings from the discontinuation of ABI-H3733 and vebicorvir as well as reduced employee and contractor-related expenses.
  • General and administrative expenses were $4.6 million for the three months ended March 31, 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 $9.1 million, or $1.66 per basic and diluted share, for the three months ended March 31, 2024, compared to $19.0 million, or $4.46 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) 
      
  March 31, December 31, 
  2024 2023 
  (Unaudited)   
ASSETS     
Current assets     
Cash and cash equivalents $18,749  $19,841  
Marketable securities  94,227   110,406  
Accounts receivable from collaboration  43   43  
Prepaid expenses and other current assets  4,149   3,497  
Total current assets  117,168   133,787  
       
Property and equipment, net  367   385  
Operating lease right-of-use assets  2,036   2,339  
Other assets  312   312  
Total assets $                119,883   $              136,823   
      
LIABILITIES AND STOCKHOLDERS' EQUITY     
Current liabilities     
Accounts payable $727  $461  
Accrued research and development expenses  2,059   885  
Other accrued expenses  2,051   5,744  
Deferred revenue from a related party - short-term  32,771   30,915  
Operating lease liabilities - short-term  1,145   1,220  
Total current liabilities  38,753   39,225  
      
Deferred revenue from a related party - long-term  47,738   55,379  
Operating lease liabilities - long-term  791   1,122  
Total liabilities  87,282   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 March 31, 2024 and December 31, 2023; 5,482,752 shares issued and outstanding as of March 31, 2024 and December 31, 2023  5   5  
Additional paid-in capital  827,660   826,921  
Accumulated other comprehensive loss  (239)  (81) 
Accumulated deficit  (794,825)  (785,748) 
Total stockholders' equity  32,601   41,097  
Total liabilities and stockholders' equity $                119,883   $              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 March 31, 
  2024 2023 
Collaboration revenue from a related party $5,785  $  
      
Operating expenses     
Research and development  11,879   14,547  
General and administrative  4,635   5,012  
Total operating expenses  16,514   19,559  
Loss from operations  (10,729)  (19,559) 
      
Other income     
Interest and other income, net  1,652   609  
Total other income  1,652   609  
Net loss $                  (9,077) $                (18,950) 
      
Other comprehensive loss     
Unrealized (loss) gain on marketable securities  (158)  290  
Comprehensive loss $                  (9,235) $                (18,660) 
      
Net loss per share, basic and diluted $(1.66) $(4.46) 
Weighted average common shares outstanding, basic and diluted  5,483,313   4,251,037  

FAQ

What are the anticipated milestones for ABI-5366 and ABI-4334 in 2024?

ABI-5366 Phase 1a interim clinical data is expected in Q3 2024, with Phase 1b data projected for the first half of 2025. ABI-4334 Phase 1b interim clinical data is expected by the end of 2024.

What was Assembly Biosciences' cash position as of March 31, 2024?

Assembly Bio's cash, cash equivalents, and marketable securities totaled $113.0 million as of March 31, 2024, compared to $130.2 million as of December 31, 2023.

What were the revenues from collaborative research in Q1 2024?

Revenues from collaborative research were $5.8 million for the three months ended March 31, 2024, with no revenue recognized for the same period in 2023.

What were the research and development expenses for Q1 2024?

Research and development expenses were $11.9 million for the three months ended March 31, 2024, compared to $14.5 million for the same period in 2023.

What was the net loss attributable to common stockholders in Q1 2024?

The net loss attributable to common stockholders was $9.1 million, or $1.66 per basic and diluted share, for the three months ended March 31, 2024, compared to $19.0 million, or $4.46 per basic and diluted share, for the same period in 2023.

Assembly Biosciences, Inc.

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