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CST: 24/08/2019 02:31:52   

Assembly Biosciences Reports Second Quarter 2019 Financial Results and Recent Highlights

18 Days ago

SOUTH SAN FRANCISCO, Calif., Aug. 05, 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 and recent highlights for the second quarter ended June 30, 2019.

“The second quarter of 2019 has been a period of great progress as we continue our transition into later stage clinical development. Following a series of data presentations at EASL in Vienna and IASL in China, we have continued to progress our HBV clinical candidates, now on a global scale,” said Derek Small, President and Chief Executive Officer.  “We are also excited that the first oral microbiome biologic drug candidate from our proprietary platform is being evaluated in patients, with our Phase 1b clinical trial of ABI-M201 for mildly to moderately active ulcerative colitis underway.”
  
Second Quarter 2019 and Recent Highlights

  • Oral presentation, “New Therapies to More Effectively Eliminate Viral Replication and Increase Cure Rates in CHB Patients,” at the first International Association for the Study of the Liver (IASL) Congress on June 22, 2019 in Beijing, China by Richard Colonno, EVP and CSO of Virology Operations.
      •  Reviewed science and strategies for utilizing HBV core inhibitors as well as interim clinical data previously reported by the company in April 2019 at The International Liver Congress™(ILC), the Annual Meeting of the European Association for the Study of the Liver (EASL).   
  • Received Clinical Trial Application (CTA) approvals from China’s Center for Drug Evaluation (CDE), part of the National Medical Products Administration (NMPA) in China, enabling Assembly’s plans to initiate Phase 2 and Phase 1 clinical trials of both 731 and 2158, respectively, at leading HBV trial sites in China.
  • Dosed first patient with ABI-H2158 in Phase 1b dose escalation study in HBV patients.
  • Dosed first patient with ABI-M201 in a Phase 1b clinical trial for mildly to moderately active ulcerative colitis (UC).
      •  First oral microbiome biologic drug candidate from Assembly’s proprietary microbiome platform to enter clinical trials in patients.
  • Steve Knox, SVP, Clinical Development and David Houck, PhD, SVP Product Development & Portfolio Management joined Assembly’s leadership team as the company transitions to a later stage development organization.                 

Anticipated Milestones and Events

HBV Program

  • ABI-H0731
      •  Additional data from the ongoing long-term Phase 2a trial combining 731 with Nuc therapy, including 48-week interim results, expected in Q4 2019.
     
  • ABI-H2158
      •  Data from Phase 1b trial in HBV-infected subjects expected in Q1 2020.
     
  • ABI-H3733
      •  Phase 1a trial expected to initiate in Q1 2020.

Microbiome Program

  • ABI-M201
      •  Enrollment and dosing ongoing in Phase 1b trial in patients with mildly to moderately active UC.
     
  • Microbiome Platform
      •  Leveraging discovery and development capabilities and manufacturing expertise to advance new proprietary candidates for other disease indications. 

Upcoming Conferences

  • Baird’s 2019 Global Healthcare Conference, in New York on September 5, 2019 at 10:15am ET

Second Quarter 2019 Financial Results

  • Cash, cash equivalents and marketable securities were approximately $173.8 million as of June 30, 2019, compared to approximately $193.5 million as of March 31, 2019. This quarter-end cash position is projected to fund operations into 2021.
     
  • Revenues from collaborative research were approximately $3.1 million for the three months ended June 30, 2019 compared to $3.2 million for the same period in 2018.
     
  • Research and development expenses, excluding stock-based compensation expense, were approximately $15.6 million for the three months ended June 30, 2019, compared to approximately $14.2 million for the same period in 2018. Stock-based compensation expense was approximately $3.1 million for the three months ended June 30, 2019, compared to approximately $3.7 million for the same period in 2018.
     
  • General and administrative expenses, excluding stock-based compensation expense, were approximately $5.1 million for the three months ended June 30, 2019, compared to $4.6 million for the same period in 2018. Stock-based compensation expense was approximately $(1.1) million for the three months ended June 30, 2019, compared to approximately $7.9 million for the same period in 2018. This decrease was primarily due to the reversal of previously recognized expense of $3.6 million related to forfeited awards to a former officer who departed during the most recent period coupled with a $4.3 million one-time expense related to the departure and transition to consultant of a former officer in 2018.
     
  • Net loss attributable to common stockholders was approximately $18.5 million, or $0.72 per basic and diluted share, for the three months ended June 30, 2019, compared to approximately $26.8 million, or $1.30 per basic and diluted share, for the same period in 2018.

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’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 assemblybio.com.

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,” “plans,” “potential” and “projected.” 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 June 30, 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.

Contacts
Assembly Biosciences, Inc.
Investors:
Lauren Glaser
(415) 521-3828
lglaser@assemblybio.com 

  ASSEMBLY BIOSCIENCES, INC.  
  CONDENSED CONSOLIDATED BALANCE SHEETS  
  ($ in thousands except for share and per share amounts)  
           
    June 30,   December 31,  
      2019       2018    
    (Unaudited)      
  ASSETS        
  Current assets        
  Cash and cash equivalents $   34,258     $   41,471    
  Marketable securities    139,553        176,609    
  Accounts receivable from collaboration     2,903         2,430    
  Prepaid expenses and other current assets     6,746         1,992    
  Total current assets     183,460         222,502    
           
  Property and equipment, net     2,048         557    
  Operating lease right-of-use assets     12,672         -    
  Other assets     1,693         3,348    
  Indefinite-lived intangible asset     29,000         29,000    
  Goodwill     12,638         12,638    
  Total assets $     241,511     $     268,045    
           
  LIABILITIES AND STOCKHOLDERS' EQUITY        
  Current liabilities        
  Accounts payable  $   3,414     $   3,693    
  Accrued expenses      7,585         9,679    
  Deferred revenue - short-term     6,082         5,100    
  Operating lease liabilities - short-term     2,854         -    
  Total current liabilities     19,935         18,472    
           
  Deferred rent     -         108    
  Deferred tax liabilities     3,252         3,252    
  Deferred revenue - long-term     33,582         35,560    
  Operating lease liabilities - long-term     10,035         -    
  Total liabilities     66,804         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 June 30, 2019 and December 31, 2018; 25,646,783 and 25,495,425 shares issued and outstanding as of June 30, 2019 and December 31, 2018, respectively     26         25    
  Additional paid-in capital     562,210         552,762    
  Accumulated other comprehensive loss     (187 )       (347 )  
  Accumulated deficit     (387,342 )       (341,787 )  
  Total stockholders' equity     174,707         210,653    
  Total liabilities and stockholders' equity $     241,511     $     268,045    
           

 

  ASSEMBLY BIOSCIENCES, INC.  
  CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS  
  ($ in thousands except for share and per share amounts)  
  (Unaudited)  
                     
      Three Months Ended June 30,   Six Months Ended June 30,  
        2019       2018       2019       2018    
                     
  Collaboration revenue   $   3,080     $   3,218     $   6,966     $   6,783    
                     
    Operating expenses:                    
   Research and development        18,700         17,840         41,405         32,381    
   General and administrative        4,080         12,544         13,597         18,240    
   Total operating expenses        22,780         30,384         55,002         50,621    
    Loss from operations         (19,700 )       (27,166 )       (48,036 )       (43,838 )  
                     
   Other income (expenses)                   
   Interest and other income        1,182         453         2,458         899    
   Other income (expense), net        4         (127 )       5         (150 )  
   Total other income        1,186         326         2,463         749    
    Loss before income taxes         (18,514 )       (26,840 )       (45,573 )       (43,089 )  
                     
   Income tax benefit        11         34         18         34    
    Net loss     $     (18,503 )   $     (26,806 )   $     (45,555 )   $     (43,055 )  
                     
    Other comprehensive (loss) income                    
   Unrealized gain on marketable securities, net of tax        52         87         160         20    
    Comprehensive loss     $     (18,451 )   $     (26,719 )   $     (45,395 )   $     (43,035 )  
                     
  Net loss per share, basic and diluted   $   (0.72 )   $   (1.30 )   $   (1.77 )   $   (2.11 )  
                     
  Weighted average common shares outstanding, basic and diluted       25,740,500         20,541,549         25,690,617         20,387,532    
                     

 

 

 

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