Assembly Biosciences Reports Third Quarter 2020 Financial Results and Business Update

November 05, 2020

SOUTH SAN FRANCISCO, Calif., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome, today reported financial results and a business update for the third quarter ended September 30, 2020.

“We continue to make progress to develop our pipeline of core inhibitor candidates for the treatment of patients with HBV,” said John McHutchison, AO, MD, Chief Executive Officer and President of Assembly Biosciences. “We have made great strides toward initiating the vebicorvir Phase 3 registrational program, as well as advancing ABI-H2158 and ABI-H3733, our more potent, next-generation core inhibitor compounds, in the clinic.”

Recent Updates

HBV Portfolio

Corporate Highlights

Anticipated Milestones and Events

HBV Portfolio

Upcoming Conference

Third Quarter 2020 Financial Results

About Assembly Biosciences
Assembly Biosciences, Inc. is a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome. The HBV program is focused on advancing a new class of potent, oral core inhibitors that have the potential to increase cure rates for chronically infected patients. The microbiome program is developing novel oral live microbial biotherapeutic candidates with Assembly Bio’s fully integrated platform, including a robust process for strain identification and selection, GMP manufacturing expertise and targeted delivery to the lower gastrointestinal tract with the GEMICEL® technology. 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 trials involving its HBV Cure and Microbiome therapeutic product candidates 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; Assembly Bio may not observe sustained virologic response in patients who stop therapy in Study 211; the timing and ability to implement strategic alternatives with respect to Assembly Bio’s Microbiome program; Assembly Bio’s ability to maintain financial resources necessary to continue its clinical trials and fund business operations; any impact that the spread of the coronavirus and resulting COVID-19 pandemic may have on Assembly Bio’s business and operations, including initiation and continuation of its clinical trials 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,
  2020   2019
Current assets      
Cash and cash equivalents $ 58,311     $ 46,732  
Marketable securities   179,630       227,311  
Accounts receivable from collaboration   3,590       3,374  
Prepaid expenses and other current assets   4,856       5,363  
Total current assets   246,387       282,780  
Property and equipment, net   1,904       1,830  
Operating lease right-of-use (ROU) assets   10,397       11,975  
Other assets   5,980       1,684  
Indefinite-lived intangible asset   29,000       29,000  
Goodwill   12,638       12,638  
Total assets $ 306,306     $ 339,907  
Current liabilities      
Accounts payable $ 1,611     $ 1,731  
Accrued clinical expenses   4,451       4,826  
Other accrued expenses   7,404       8,286  
Deferred revenue - short-term         6,411  
Operating lease liabilities - short-term   3,338       3,186  
Total current liabilities   16,804       24,440  
Deferred tax liabilities   2,531       2,531  
Deferred revenue - long-term   8,987       30,637  
Operating lease liabilities - long-term   7,435       9,082  
Total liabilities   35,757       66,690  
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, 2020 and December 31, 2019; 32,924,536 and 32,558,307 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively   33       32  
Additional paid-in capital   732,829       712,807  
Accumulated other comprehensive loss   (158 )     (201 )
Accumulated deficit   (462,155 )     (439,421 )
Total stockholders' equity   270,549       273,217  
Total liabilities and stockholders' equity $ 306,306     $ 339,907  

(In thousands except for share and per share amounts)
  Three Months Ended September 30,   Nine Months Ended September 30,
  2020   2019   2020   2019
Collaboration revenue $ 34,611     $ 4,231     $ 78,068     $ 11,197  
Operating expenses:              
Research and development   26,941       21,736       73,314       63,141  
General and administrative   11,689       8,488       29,888       22,085  
Total operating expenses   38,630       30,224       103,202       85,226  
Loss from operations   (4,019 )     (25,993 )     (25,134 )     (74,029 )
Other income              
Interest and other income, net   670       983       2,400       3,446  
Total other income   670       983       2,400       3,446  
Loss before income taxes   (3,349 )     (25,010 )     (22,734 )     (70,583 )
Income tax benefit         15             33  
Net loss $ (3,349 )   $ (24,995 )   $ (22,734 )   $ (70,550 )
Other comprehensive (loss) income              
Unrealized (loss) gain on marketable securities, net of tax   (262 )     (18 )     43       142  
Comprehensive loss $ (3,611 )   $ (25,013 )   $ (22,691 )   $ (70,408 )
Net loss per share, basic and diluted $ (0.09 )   $ (0.96 )   $ (0.64 )   $ (2.74 )
Weighted average common shares outstanding, basic and diluted   35,506,042       25,912,568       35,321,393       25,765,414  

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