Full Press Release Details
Assembly Biosciences Announces Third
Quarter 2018 Financial Results and Provides HBV Program Update
- ABI-H0731 Phase 2a Clinical Trials Actively Enrolling Patients; Data Continues to be Anticipated in 1H 2019
- ABI-H2158 Phase 1a Study Initiated
- ABI-H3733 Nominated as Third Core Inhibitor Candidate
SAN FRANCISCO, November 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 third quarter ended September 30, 2018 and
provided an update on the progress in its HBV and microbiome pipelines.
"We are excited about the advancements we have made in
our HBV portfolio, with two core inhibitors now in clinical trials and the selection of a third potent, novel clinical candidate,"
said Derek Small, President and Chief Executive Officer. "With the nomination of ABI-H3733 as our third candidate, we
have a deep pipeline of HBV core inhibitors in development and continue our discovery efforts focused on identifying additional
chemical scaffolds. We are actively enrolling patients in our ongoing ABI-H0731 Phase 2a proof-of-concept studies, and our team
is committed to advancing potential curative therapy to HBV patients. Our microbiome platform has also made great strides over
the past quarter and pending the successful conclusion of IND-enabling studies, we hope to have our first candidate ABI-M201 for
ulcerative colitis in the clinic next year. Importantly, our strong balance sheet supports our development plans through multiple
Third Quarter and Recent Highlights
Anticipated Milestones and Events
Third 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, ABI-H2158 and ABI-H3733, Assembly's development
programs, the initiation, progress and results of Assembly's ongoing and planned clinical studies and the timing of these
events, and the sufficiency of capital through inflection points. Certain forward-looking statements may be identified by reference
to a future period or by use of forward-looking terminology such as "plan," "upcoming," "anticipated,"
"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 September 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.
Assembly Biosciences, Inc.
Condensed Consolidated Balance Sheets
| September 30, | December 31, | |||||||
| 2018 | 2017 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 119,752,339 | $ | 82,033,209 | ||||
| Marketable securities, at fair value | 114,187,793 | 37,914,482 | ||||||
| Accounts receivable from collaboration | 2,589,862 | 2,273,421 | ||||||
| Prepaid expenses and other current assets | 3,342,759 | 897,400 | ||||||
| Total current assets | 239,872,753 | 123,118,512 | ||||||
| Long-term assets | ||||||||
| Marketable securities, at fair value | - | 3,347,213 | ||||||
| Property, plant and equipment, net | 515,798 | 860,026 | ||||||
| Security deposits | 950,515 | 339,558 | ||||||
| Intangible assets | 29,000,000 | 29,000,000 | ||||||
| Goodwill | 12,638,136 | 12,638,136 | ||||||
| Total long-term assets | 43,104,449 | 46,184,933 | ||||||
| Total assets | $ | 282,977,202 | $ | 169,303,445 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 2,987,565 | $ | 2,123,939 | ||||
| Accrued expenses | 6,517,053 | 6,139,000 | ||||||
| Deferred revenue - short-term | 5,105,104 | 5,229,227 | ||||||
| Total current liabilities | 14,609,722 | 13,492,166 | ||||||
| Long-term liabilities | ||||||||
| Deferred rent | 7,903 | - | ||||||
| Deferred tax liabilities | 2,107,300 | 2,135,802 | ||||||
| Deferred revenue - long-term | 36,819,053 | 40,555,708 | ||||||
| Total long-term liabilities | 38,934,256 | 42,691,510 | ||||||
| Total liabilities | 53,543,978 | 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 September 30, 2018 and December 31, 2017; 25,460,122 and 20,137,974 shares issued and outstanding as of September 30, 2018 and December 31, 2017, respectively | 25,460 | 20,138 | ||||||
| Additional paid-in capital | 545,388,704 | 364,528,037 | ||||||
| Accumulated other comprehensive loss | (354,896 | ) | (392,391 | ) | ||||
| Accumulated deficit | (315,626,044 | ) | (251,036,015 | ) | ||||
| Total stockholders' equity | 229,433,224 | 113,119,769 | ||||||
| Total liabilities and stockholders' equity | $ | 282,977,202 | $ | 169,303,445 |
Assembly Biosciences, Inc.
Consolidated Statements of Operations and Comprehensive Loss
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Collaboration revenue | $ | 4,285,848 | $ | 2,659,613 | $ | 11,068,773 | $ | 5,703,293 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 19,108,918 | 10,929,436 | 51,490,220 | 33,628,196 | ||||||||||||
| General and adm inistrative | 7,752,493 | 4,180,357 | 25,992,186 | 12,022,357 | ||||||||||||
| Total operating expenses | 26,861,411 | 15,109,793 | 77,482,406 | 45,650,553 | ||||||||||||
| Loss from operations | (22,575,563 | ) | (12,450,180 | ) | (66,413,633 | ) | (39,947,260 | ) | ||||||||
| Other income (expenses) | ||||||||||||||||
| Interest and other income | 1,116,053 | 241,326 | 2,015,475 | 617,668 | ||||||||||||
| Realized loss from marketable securities | (82,070 | ) | (99,068 | ) | (232,320 | ) | (577,300 | ) | ||||||||
| Total other income | 1,033,983 | 142,258 | 1,783,155 | 40,368 | ||||||||||||
| Loss before income taxes | (21,541,580 | ) | (12,307,922 | ) | (64,630,478 | ) | (39,906,892 | ) | ||||||||
| Income tax benefit | 6,542 | 35,903 | 40,449 | 105,416 | ||||||||||||
| Net loss | $ | (21,535,038 | ) | $ | (12,272,019 | ) | $ | (64,590,029 | ) | $ | (39,801,476 | ) | ||||
| Other comprehensive (loss) income | ||||||||||||||||
| Unrealized loss recognized in accumulated other comprehensive loss before reclassification, net of tax benefit of $50,664, $31,844, $44,192 and $89,281, respectively | (8,749 | ) | (51,203 | ) | (138,686 | ) | (143,562 | ) | ||||||||
| Reclassification adjustment of unrealized loss included in net loss, net of tax expense of $56,139, $37,987, $56,139 and $221,358, respectively | 25,931 | 61,081 | 176,181 | 355,942 | ||||||||||||
| Comprehensive loss | $ | (21,517,856 | ) | $ | (12,262,141 | ) | $ | (64,552,534 | ) | $ | (39,589,096 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.87 | ) | $ | (0.71 | ) | $ | (2.95 | ) | $ | (2.30 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 24,878,413 | 17,367,523 | 21,900,943 | 17,326,506 |