Assembly Biosciences Reports Third Quarter 2022 Financial Results and Recent Highlights and Announces Upcoming Conference Participation

November 08, 2022

Phase 1a Trial of Next-Generation Core Inhibitor, ABI-4334, Now Underway Following Clinical Trial Application (CTA) Clearance

SOUTH SAN FRANCISCO, Calif., Nov. 08, 2022 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage biotechnology company developing innovative, investigational therapeutics targeting hepatitis B virus (HBV) and other viral diseases, today announced financial results and recent highlights for the third quarter ended September 30, 2022.

“During the third quarter, we have advanced clinical development of both of our next-generation, more potent core inhibitors with the Phase 1b study of 3733 on track to report initial data by the end of this year and the initiation of the first clinical study for 4334,” said John McHutchison, AO, MD, chief executive officer of Assembly Bio. “This quarter also marked the further expansion of our pipeline with the introduction of our first research programs outside of HBV and hepatitis delta virus. These programs, targeting high-recurrence genital herpes and transplant-associated herpesviruses, apply the deep expertise of our organization in small molecule antiviral drug development to develop differentiated approaches for viral diseases with significant unmet medical need. We are thrilled with the progress of our preclinical and clinical programs, and we remain encouraged about the potential for our next-generation core inhibitors with the recently presented data at AASLD and upcoming clinical data readout for 3733.”

Recent Updates

Anticipated Milestones and Events

Upcoming Conferences

Third Quarter 2022 Financial Results

About Assembly Biosciences

Assembly Bio is a clinical-stage biotechnology company pioneering the development of novel therapeutics for serious viral diseases. Assembly Bio is advancing a leading portfolio of more potent, next-generation core inhibitor drug candidates that aim to break the complex viral replication cycle of hepatitis B virus (HBV) to achieve finite and potentially curative therapies for the 296 million people living with HBV worldwide. The company’s research pipeline includes differentiated antiviral approaches against HBV/hepatitis delta virus and herpesviruses. For more information, visit

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 successfully execute its previously announced reprioritization and restructuring activities, including the CEO transition; potential adverse legal, reputational, operational and financial effects on Assembly Bio resulting from the reprioritization and restructuring activities; Assembly Bio’s ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio’s collaboration agreements, in the currently anticipated timeframes; safety and efficacy data from clinical 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; continued development and commercialization of ABI-H3733, if successful, in the China territory will be dependent on, and subject to, Assembly Bio’s collaboration agreement governing this activity in the China territory; Assembly Bio’s ability to maintain financial resources necessary to continue its clinical studies and fund business operations; any impact that the COVID-19 pandemic may have on Assembly Bio’s business and operations, including initiation, enrollment and continuation of its clinical studies or timing of discussions with regulatory authorities; 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.


Investor and Corporate:
Shannon Ryan
SVP, Investor Relations, Corporate Affairs and Alliance Management
(415) 738-2992   

Sam Brown Inc. 
Hannah Hurdle 
(805) 338-4752

(In thousands except for share amounts and par value)
  September 30,   December 31,
    2022       2021  
Current assets      
Cash and cash equivalents $ 54,673     $ 45,627  
Marketable securities - short-term   53,978       101,000  
Accounts receivable from collaborations   1,246       336  
Prepaid expenses and other current assets   5,181       7,241  
Total current assets   115,078       154,204  
Marketable securities - long-term         27,972  
Property and equipment, net   867       1,139  
Operating lease right-of-use (ROU) assets   3,958       6,042  
Other assets   1,613       1,703  
Total assets $ 121,516     $ 191,060  
Current liabilities      
Accounts payable $ 1,942     $ 2,659  
Accrued research and development expenses   4,462       3,400  
Other accrued expenses   5,686       6,863  
Operating lease liabilities - short-term   3,371       3,151  
Total current liabilities   15,461       16,073  
Deferred revenue   2,733       2,733  
Operating lease liabilities - long-term   918       3,325  
Total liabilities   19,112       22,131  
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 and 100,000,000 shares authorized as of September 30, 2022 and December 31, 2021, respectively; 48,481,194 and 48,120,437 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively   48       48  
Additional paid-in capital   805,480       800,728  
Accumulated other comprehensive loss   (999 )     (419 )
Accumulated deficit   (702,125 )     (631,428 )
Total stockholders' equity   102,404       168,929  
Total liabilities and stockholders' equity $ 121,516     $ 191,060  

(In thousands except for share and per share amounts)
  Three Months Ended September 30,   Nine Months Ended September 30,
    2022       2021       2022       2021  
Collaboration revenue $     $ 6,254     $     $ 6,254  
Operating expenses:              
Research and development   18,130       18,474       53,127       53,777  
General and administrative   5,271       6,655       18,009       22,276  
Total operating expenses   23,401       25,129       71,136       76,053  
Loss from operations   (23,401 )     (18,875 )     (71,136 )     (69,799 )
Other income:              
Interest and other income, net   256       72       439       201  
Total other income   256       72       439       201  
Net loss $ (23,145 )   $ (18,803 )   $ (70,697 )   $ (69,598 )
Other comprehensive loss              
Unrealized loss on marketable securities   (1 )     (15 )     (580 )     (18 )
Comprehensive loss $ (23,146 )   $ (18,818 )   $ (71,277 )   $ (69,616 )
Net loss per share, basic and diluted $ (0.48 )   $ (0.41 )   $ (1.46 )   $ (1.63 )
Weighted average common shares outstanding, basic and diluted   48,448,399       45,569,276       48,289,501       42,725,109  

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