Full Press Release Details
Assembly Biosciences Announces Second
Quarter 2018 Financial Results
- 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, August 8, 2018 -
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
"Based on the positive Phase 1b data for ABI-H0731 that
we reported at EASL 2018 in April, we have initated 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-2158 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."
Anticipated Milestones and Events
Second Quarter 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 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.
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
| 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 |
Assembly Biosciences, Inc.