Assembly Biosciences Announces Second Quarter 2018 Financial Results

August 8, 2018 at 4:05 PM EDT

-  ABI-H0731 Phase 2a Clinical Trials Actively Enrolling Patients; Initial Data Continues to be Anticipated in H1 2019

-  Strong Balance Sheet Provides Significant Runway

SAN FRANCISCO and INDIANAPOLIS, Aug. 08, 2018 (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 second quarter ended June 30, 2018.

“Based on the positive Phase 1b data for ABI-H0731 that we reported at EASL 2018 in April, we have initiated enrollment in our Phase 2a viral antigen and viral load trials in HBV patients and have raised approximately $155 million in an oversubscribed public stock offering. This gives us substantial resources to advance our pipeline, including completion of these Phase 2a trials and the introduction of ABI-H2158 into the clinic, which is planned for later this year,” said Derek Small, President and Chief Executive Officer. “We also were pleased that ABI-H0731 received Fast Track Designation from the FDA, which allows us to work closely with the agency to bring this new therapeutic candidate to HBV patients as quickly as possible.”

Recent Highlights

  • Assembly began enrolling patients in two Phase 2a proof of concept studies evaluating ABI-H0731, the Company’s lead core inhibitor targeting HBV. Initial data from both studies are expected in the first half of 2019. ABI-H0731 was also granted Fast Track Designation by the U.S. Food and Drug Administration (FDA).
     
  • On July 16, 2018, Assembly announced the closing of an underwritten public offering of 4,600,000 shares of common stock at a public offering price of $36.00 per share, which includes the full exercise of the underwriters’ option to purchase additional shares. Net proceeds to Assembly from this offering were approximately $155 million.
     
  • Assembly hosted its first Research and Development Day in New York on June 20, 2018.  Two key opinion leaders highlighted the need for new and curative treatments for the millions of patients living with HBV. Company management also presented the development plans for ABI-H0731 and the second generation core inhibitor candidate, ABI-H2158. The presentation and recorded replay of the event can be accessed in the Investors section of the Company’s website.

Anticipated Milestones and Events

  • ABI-H0731
    • Initial Phase 2a data expected in the first half of 2019
       
  • ABI-H2158
    • Phase 1a clinical trial initiation in healthy volunteers expected in the fourth quarter of 2018
       
  • Upcoming events
    • Baird Global Healthcare Conference in New York, September 5-6, 2018
    • Morgan Stanley Global Healthcare Conference in New York, September 12-14, 2018

Second Quarter Financial Results

  • Cash, cash equivalents and marketable securities were approximately $94.9 million as of June 30, 2018 compared to approximately $109.2 million as of March 31, 2018. As of July 16, 2018, Assembly’s pro forma cash balance is approximately $250 million which includes net proceeds from the offering of approximately $155.4 million.
     
  • Revenues consisting of revenue from collaborative research were approximately $3.2 million for the three months ended June 30, 2018, compared to approximately $2.4 million for the same period in 2017. The increase in revenue was due to an increase in Allergan-related activities and expense reimbursement.
     
  • Research and development expenses, excluding stock-based compensation expense, were approximately $14.2 million for the three months ended June 30, 2018, compared to approximately $10.9 million for the same period in 2017. This increase was primarily due to an increase of approximately $3.1 million in research and development expenses related to the HBV program. Stock-based compensation expense was approximately $3.7 million for the three months ended June 30, 2018, compared to approximately $1.2 million for the same period in 2017.
     
  • General and administrative expenses, excluding stock-based compensation expense, were approximately $4.6 million for the three months ended June 30, 2018, compared to approximately $3.0 million for the same period in 2017. This increase was primarily due to increased headcount across the organization.  Stock-based compensation expense was approximately $7.9 million for the three months ended June 30, 2018, as compared to $0.8 million for the same period in 2017. This increase was primarily due to a $4.3 million one-time non-cash expense related to the departure and transition to consultant of a former officer of Assembly and $3.5 million of expenses related to non-cash, stock-based compensation grants and employee incentive programs including the 2018 Employee Stock Purchase Plan.
     
  • Net loss attributable to common stockholders was approximately $26.7 million, or $1.30 per basic and diluted share, for the three months ended June 30, 2018, compared to approximately $13.5 million, or $0.78 per basic and diluted share for the same period in 2017. This increase was primarily due to an increase in research and development expenses related to the HBV program, and expenses related to non-cash, stock-based compensation, employee incentive programs and increased headcount across the organization.

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 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, including ABI-H0731 and ABI-H2158, Assembly’s development programs, the results of earlier nonclinical and clinical trials being predictive of future clinical trials, the initiation, progress and results of Assembly’s ongoing and planned clinical studies and the timing of these events, our estimates and projections regarding expenses, use of cash, cash equivalents and marketable securities, future revenue, capital requirements, adequacy of capital and financing requirements. Certain forward-looking statements may be identified by reference to a future period or by use of forward-looking terminology such as “anticipated”, “upcoming,” “look forward,” “will,” “expected,” 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. 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, 2018 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        
    June 30,   December 31,  
     2018     2017   
    (Unaudited)      
  ASSETS        
  Current assets        
  Cash and cash equivalents $   54,192,131     $   82,033,209    
  Marketable securities, at fair value     38,480,105         37,914,482    
  Accounts receivable from collaboration     2,125,597         2,273,421    
  Prepaid expenses and other current assets     2,731,385         897,400    
  Total current assets    97,529,218        123,118,512    
           
  Long-term assets        
  Marketable securities, at fair value     2,204,103         3,347,213    
  Property, plant and equipment, net     639,897         860,026    
  Security deposits     406,735         339,558    
  Intangible assets      29,000,000         29,000,000    
  Goodwill     12,638,136         12,638,136    
  Total long-term assets     44,888,871         46,184,933    
  Total assets $   142,418,089     $   169,303,445    
           
  LIABILITIES AND STOCKHOLDERS' EQUITY        
  Current liabilities        
  Accounts payable  $   2,538,976     $   2,123,939    
  Accrued expenses      5,079,780         6,139,000    
  Deferred revenue - short-term     5,512,109         5,229,227    
  Total current liabilities     13,130,865         13,492,166    
           
  Long-term liabilities        
  Deferred tax liabilities     2,108,367         2,135,802    
  Deferred revenue - long-term     38,078,292         40,555,708    
  Total long-term liabilities     40,186,659         42,691,510    
  Total liabilities     53,317,524         56,183,676    
           
  Commitments and contingencies        
           
  Stockholders' equity        
  Preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding     -         -    
  Common stock, $0.001 par value; 100,000,000 and 50,000,000 shares authorized as of June 30, 2018 and December 31, 2017, respectively; 20,614,498 and 20,137,974 shares issued and outstanding as of June 30, 2018 and December 31, 2017, respectively     20,614         20,138    
  Additional paid-in capital   383,543,035       364,528,037    
  Accumulated other comprehensive loss     (372,078 )       (392,391 )  
  Accumulated deficit   (294,091,006 )     (251,036,015 )  
  Total stockholders' equity     89,100,565       113,119,769    
  Total liabilities and stockholders' equity $   142,418,089     $  169,303,445    
           

 

  Assembly Biosciences, Inc.                  
  Condensed Consolidated Statements of Operations and Comprehensive Loss                  
  (Unaudited)                  
      Three Months Ended June 30,   Six Months Ended June 30,  
       2018    2017     2018     2017   
  Collaboration revenue   $   3,217,865     $   2,359,311     $   6,782,925     $   3,043,680    
                     
   Operating expenses:                   
   Research and development      17,840,128       12,125,021       32,381,302       22,698,760    
   General and administrative      12,543,658         3,801,541       18,239,693         7,842,000    
   Total operating expenses       30,383,786       15,926,562       50,620,995        30,540,760    
   Loss from operations       (27,165,921 )     (13,567,251 )     (43,838,070 )     (27,497,080 )  
                     
   Other income (expenses)                   
   Interest and other income        453,016         239,858         899,422         376,342    
   Realized loss from marketable securities        (127,234 )       (340,984 )       (150,250 )       (478,232 )  
   Total other income        325,782         (101,126 )       749,172         (101,890 )  
   Loss before income taxes        (26,840,139 )       (13,668,377 )       (43,088,898 )       (27,598,970 )  
                     
   Income tax benefit        33,907         69,513         33,907         69,513    
   Net loss    $  (26,806,232 )   $  (13,598,864 )   $  (43,054,991 )   $   (27,529,457 )  
                     
   Other comprehensive (loss) income                   
   Unrealized loss recognized in accumulated other comprehensive loss before reclassification, net of tax benefit of $29,835, $57,437, $29,835 and $57,437, respectively        (39,962 )       (31,203 )       (129,937 )       (92,359 )  
   Reclassification adjustment of unrealized loss included in net loss, net of tax expense of $36,307, $183,371, $36,307 and $183,371, respectively        127,234         157,613         150,250         294,861    
   Comprehensive loss    $  (26,718,960 )   $   (13,472,454 )   $   (43,034,678 )   $   (27,326,955 )  
                     
  Net loss per share, basic and diluted   $   (1.30 )   $   (0.78 )   $   (2.11 )   $   (1.59 )  
                     
  Weighted average common shares outstanding, basic and diluted       20,541,549         17,342,623         20,387,532         17,305,657    
                     

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Source: Assembly Biosciences