Assembly Biosciences Reports Third Quarter 2021 Financial Results and Recent Highlights

November 04, 2021

SOUTH SAN FRANCISCO, Calif., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV), today reported financial results and recent highlights for the third quarter ended September 30, 2021.

John McHutchison, AO, MD, chief executive officer and president of Assembly Bio, said, “We are excited to advance our latest core inhibitor ABI-4334, with a potential best-in-class profile, and we are working quickly and diligently to move this candidate into clinical development as soon as possible next year. In parallel, we have expanded evaluation of triple combination regimens to treat HBV, which include the potential backbone therapy of our lead investigational core inhibitor candidate vebicorvir (VBR) plus standard-of-care nucleos(t)ide reverse transcriptase inhibitor (Nrtl) therapy together with an additional complementary mechanism. Our two ongoing Phase 2 studies include interferon (peg-IFNα) and Arbutus’ RNAi therapeutic candidate, and we look forward to initiating a third Phase 2, all-oral triple combination cohort with Antios’ ASPIN, ATI-2173. We anticipate initial data from all three of these studies during 2022. Meanwhile, we are pleased to feature our science and portfolio at scientific and clinical meetings, demonstrating our commitment to pursuing finite and curative therapies for the more than a quarter of a billion individuals living with chronic HBV infection worldwide.”

Recent Updates

Anticipated Milestones and Events

Upcoming Conferences

Third Quarter 2021 Financial Results

About Assembly Biosciences
Assembly Bio is a clinical-stage biotechnology company committed to bringing finite and curative therapies to the 270 million people living with hepatitis B virus (HBV) worldwide. A pioneer in the development of a new class of potent, oral core inhibitor drug candidates, Assembly Bio’s approach aims to break the complex viral replication cycle of HBV to free patients from a lifetime of therapy. Assembly Bio’s strategy toward cure includes a leading portfolio of more potent, next-generation core inhibitors, proof-of-concept combination studies and a research program focused on the discovery of novel HBV targets. 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 initiate and complete clinical studies involving its HBV therapeutic product candidates, including studies contemplated by Assembly Bio’s clinical 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 Assembly Bio’s HBV product candidates, if successful, in the China territory will be dependent on, and subject to, Assembly Bio’s collaboration agreement governing its 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 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:
Lauren Glaser
Senior Vice President, Investor Relations and Corporate Affairs
(415) 521-3828

Sam Brown Inc. 
Audra Friis 
(917) 519-9577

(In thousands except for share amounts and par value)
    September 30,   December 31,
      2021       2020  
Current assets        
Cash and cash equivalents   $ 70,760     $ 59,444  
Marketable securities - short-term     110,142       156,969  
Accounts receivable from collaborations     769       1,230  
Prepaid expenses and other current assets     6,548       6,850  
Total current assets     188,219       224,493  
Marketable securities - long-term     9,180        
Property and equipment, net     1,241       1,600  
Operating lease right-of-use (ROU) assets     6,773       9,131  
Other assets     1,922       6,392  
Indefinite-lived intangible asset     29,000       29,000  
Goodwill     12,638       12,638  
Total assets   $ 248,973     $ 283,254  
Current liabilities        
Accounts payable   $ 2,628     $ 4,598  
Accrued clinical expenses     3,744       4,444  
Other accrued expenses     5,457       11,987  
Operating lease liabilities - short-term     3,099       3,404  
Total current liabilities     14,928       24,433  
Deferred tax liabilities     2,531       2,531  
Deferred revenue     2,733       8,987  
Operating lease liabilities - long-term     4,136       6,725  
Total liabilities     24,328       42,676  
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; 100,000,000 shares authorized as of September 30, 2021 and December 31, 2020; 47,077,052 and 34,026,680 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively     47       34  
Additional paid-in capital     796,057       742,387  
Accumulated other comprehensive loss     (288 )     (270 )
Accumulated deficit     (571,171 )     (501,573 )
Total stockholders' equity     224,645       240,578  
Total liabilities and stockholders' equity   $ 248,973     $ 283,254  

(In thousands except for share and per share amounts)
    Three Months Ended
September 30,
  Nine Months Ended
September 30,
      2021       2020       2021       2020  
Collaboration revenue   $ 6,254     $ 34,611     $ 6,254     $ 78,068  
Operating expenses:                
Research and development     18,474       26,941       53,777       73,314  
General and administrative     6,655       11,689       22,276       29,888  
Total operating expenses     25,129       38,630       76,053       103,202  
Loss from operations     (18,875 )     (4,019 )     (69,799 )     (25,134 )
Other income:                
Interest and other income, net     72       670       201       2,400  
Total other income     72       670       201       2,400  
Net loss   $ (18,803 )   $ (3,349 )   $ (69,598 )   $ (22,734 )
Other comprehensive (loss) income                
Unrealized (loss) gain on marketable securities     (15 )     (262 )     (18 )     43  
Comprehensive loss   $ (18,818 )   $ (3,611 )   $ (69,616 )   $ (22,691 )
Net loss per share, basic and diluted   $ (0.41 )   $ (0.09 )   $ (1.63 )   $ (0.64 )
Weighted average common shares outstanding, basic and diluted     45,569,276       35,506,042       42,725,109       35,321,393  

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