Assembly Biosciences Reports First Quarter 2019 Financial Results and Recent Highlights

May 09, 2019

SAN FRANCISCO, May 09, 2019 (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 for the first quarter ended March 31, 2019 and provided a business update.

“We are dedicated to increasing cure rates for individuals with chronic HBV and were honored to have data highlighting our deep pipeline of novel core inhibitor candidates featured at The International Liver Congress™ (ILC) last month, including our ABI-H0731 presentation as a ‘Best of ILC’ selection,” said Derek Small, President and Chief Executive Officer. “We showed interim data from the ongoing Phase 2a trials of ‘731 demonstrating the potential of core inhibitors in combination with Nuc therapy to be the backbone of HBV cure regimens going forward, along with updates on our next generation core inhibitor programs. Additionally, we initiated a Phase 1b trial for our first microbiome clinical program in collaboration with Allergan, with ABI-M201 now being evaluated in ulcerative colitis patients.”

Mr. Small continued, “Our progress this year has helped us to attract development veterans to our leadership team to support both of our programs: Steven J. Knox as Senior Vice President Clinical Development and David R. Houck, Ph.D., as Senior Vice President Product Development and Portfolio Management. These additions reflect our continued evolution into a clinical-stage organization across both our HBV and microbiome programs, allowing us to focus our resources on key pipeline priorities and improving our cash runway.”

First Quarter 2019 and Recent Highlights

Anticipated Milestones and Events

HBV Program

Microbiome Program

Upcoming Conferences

First Quarter 2019 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 synthetic biotherapeutic candidates with Assembly’s fully integrated platform, including a robust process for strain identification and selection, GMP banking and production, 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 regarding future events, including statements about the clinical and therapeutic potential of core inhibitors, the timing of the initiation of and the availability of data from our ongoing and planned clinical trials and cash projections. Certain forward-looking statements may be identified by reference to a future period or by use of forward-looking terminology such as “expected,” “may,” “will,” “projected” and “potential.” Assembly 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. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. These risks and uncertainties include, among others: the components, timing, cost and results of clinical trials and other development activities involving our product candidates (including those licensed by Allergan Pharmaceuticals International Limited); the unpredictability of the preclinical and clinical development of our product candidates and of the duration and results of regulatory review of those candidates by the FDA and foreign regulatory authorities; our anticipated capital expenditures and our estimates regarding our capital requirements; and the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties.  More information about the risks and uncertainties faced by Assembly are more fully detailed under the heading “Risk Factors” in Assembly's Quarterly Report on Form 10-Q for the quarter ended March 31, 2019 filed with the Securities and Exchange Commission. Except as required by law, Assembly assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

1Sovaldi®, Harvoni® and Vemlidy® are registered trademarks of Gilead Sciences, Inc., or its related companies.

Assembly Biosciences, Inc.
Lauren Glaser
(415) 521-3828 

($ in thousands except for share and per share amounts)
  March 31,   December 31,
    2019       2018  
Current assets      
Cash and cash equivalents $ 29,107     $ 41,471  
Marketable securities   164,429       176,609  
Accounts receivable from collaboration   2,987       2,430  
Prepaid expenses and other current assets   4,283       1,992  
Total current assets   200,806       222,502  
Property and equipment, net   2,079       557  
Operating lease right-of-use assets   13,063       -  
Other assets   1,661       3,348  
Indefinite-lived intangible asset   29,000       29,000  
Goodwill   12,638       12,638  
Total assets $ 259,247     $ 268,045  
Current liabilities      
Accounts payable $ 2,427     $ 3,693  
Accrued expenses   10,141       9,679  
Deferred revenue - short-term   9,933       5,100  
Operating lease liabilities - short-term   2,704       -  
Total current liabilities   25,205       18,472  
Deferred rent   -       108  
Deferred tax liabilities   3,252       3,252  
Deferred revenue - long-term   29,868       35,560  
Operating lease liabilities - long-term   10,521       -  
Total liabilities   68,846       57,392  
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 March 31, 2019 and December 31, 2018; 25,549,757 and 25,495,425 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively   26       25  
Additional paid-in capital   559,453       552,762  
Accumulated other comprehensive loss   (239 )     (347 )
Accumulated deficit   (368,839 )     (341,787 )
Total stockholders' equity   190,401       210,653  
Total liabilities and stockholders' equity $ 259,247     $ 268,045  

($ in thousands except for share and per share amounts)
    Three Months Ended March 31,
      2019       2018  
Collaboration revenue   $ 3,885     $ 3,565  
 Operating expenses:        
Research and development     22,704       14,541  
General and administrative     9,517       5,696  
Total operating expenses     32,221       20,237  
 Loss from operations     (28,336 )     (16,672 )
Other income (expenses)        
Interest and other income     1,276       446  
Other income (expense), net     1       (23 )
Total other income     1,277       423  
 Loss before income taxes     (27,059 )     (16,249 )
Income tax benefit     7       -  
 Net loss    $ (27,052 )   $ (16,249 )
 Other comprehensive (loss) income        
Unrealized gain (loss) on marketable securities, net of tax     108       (67 )
 Comprehensive loss   $ (26,944 )   $ (16,316 )
Net loss per share, basic and diluted   $ (1.05 )   $ (0.80 )
Weighted average common shares outstanding, basic and diluted     25,668,798       20,231,804  



Source: Assembly Biosciences, Inc.

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