Full Press Release Details
Assembly Biosciences Reports Second Quarter
2019 Financial Results and Recent Highlights
SOUTH SAN FRANCISCO, August 5, 2019 - 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
Anticipated Milestones and Events
Upcoming Conferences
Second 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 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.
Assembly Biosciences, Inc.
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)
| 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 |