Full Press Release Details
Assembly Biosciences Reports Third Quarter 2019 Financial Results and Recent Highlights
SOUTH SAN FRANCISCO, Calif., November 7, 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 third quarter ended September 30, 2019.
"I'm thrilled to have joined Assembly during the third quarter; this is an exciting time as our HBV and microbiome programs are building important momentum. We have also had the opportunity to attract industry-leading talent to our team with the recent additions of Tom Russo as CFO and Luisa Stamm as CMO," said John McHutchison, AO, MD, Chief Executive Officer and President. "We look forward to presenting data from our Phase 2a trials of ABI-H0731 in more detail on Monday, November 11 during the AASLD Annual Meeting in Boston. As our abstract indicated, the combination of 731 with nucleos(t)ide therapy not only showed superior antiviral activity to nucleos(t)ide therapy alone, but is also associated with declines in surrogate markers predictive of cccDNA pool depletion, suggesting our core inhibitor regimens may be on the path to HBV cure. We also continue to advance our second and third core inhibitor candidates, with interim data from the Phase 1b trial of 2158 scheduled for presentation at AASLD."
Third Quarter 2019 and Recent Highlights
Anticipated Milestones and Events
Upcoming Events and Conferences
Upcoming Conference Call and Webcast Information
Assembly will host a live conference call and audio webcast on Monday, November 11, 2019, at 8:30 am ET following the start of the late breaking poster session at the AASLD meeting. The live audio webcast can be accessed through the Events & Presentations page in the Investors section of the company's website at assemblybio.com. Alternatively, participants can dial (866) 438-0453 (domestic) or (409) 220-9366 (international) and refer to conference ID 4283686.
Third 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; whether our cash resources will be sufficient to fund continuing operations for the periods and/or trials; 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 September 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)
| September 30, | December 31, | |||||||
| 2019 | 2018 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 24,867 | $ | 41,471 | ||||
| Marketable securities | 132,070 | 176,609 | ||||||
| Accounts receivable from collaboration | 2,944 | 2,430 | ||||||
| Prepaid expenses and other current assets | 5,441 | 1,992 | ||||||
| Total current assets | 165,322 | 222,502 | ||||||
| Property and equipment, net | 1,931 | 557 | ||||||
| Operating lease right-of-use assets | 12,783 | - | ||||||
| Other assets | 1,671 | 3,348 | ||||||
| Indefinite-lived intangible asset | 29,000 | 29,000 | ||||||
| Goodwill | 12,638 | 12,638 | ||||||
| Total assets | $ | 223,345 | $ | 268,045 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 2,709 | $ | 3,693 | ||||
| Accrued expenses | 9,430 | 9,679 | ||||||
| Deferred revenue - short-term | 6,151 | 5,100 | ||||||
| Operating lease liabilities - short-term | 3,208 | - | ||||||
| Total current liabilities | 21,498 | 18,472 | ||||||
| Deferred rent | - | 108 | ||||||
| Deferred tax liabilities | 3,251 | 3,252 | ||||||
| Deferred revenue - long-term | 32,268 | 35,560 | ||||||
| Operating lease liabilities - long-term | 9,839 | - | ||||||
| Total liabilities | 66,856 | 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 September 30, 2019 and December 31, 2018; 25,872,723 and 25,495,425 shares issued and outstanding as of September 30, 2019 and December 31, 2018, respectively | 26 | 25 | ||||||
| Additional paid-in capital | 569,005 | 552,762 | ||||||
| Accumulated other comprehensive loss | (205 | ) | (347 | ) | ||||
| Accumulated deficit | (412,337 | ) | (341,787 | ) | ||||
| Total stockholders' equity | 156,489 | 210,653 | ||||||
| Total liabilities and stockholders' equity | $ | 223,345 | $ | 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 September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Collaboration revenue | $ | 4,231 | $ | 4,286 | $ | 11,197 | $ | 11,069 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 21,736 | 19,109 | 63,141 | 51,490 | ||||||||||||
| General and administrative | 8,488 | 7,752 | 22,085 | 25,992 | ||||||||||||
| Total operating expenses | 30,224 | 26,861 | 85,226 | 77,482 | ||||||||||||
| Loss from operations | (25,993 | ) | (22,575 | ) | (74,029 | ) | (66,413 | ) | ||||||||
| Other income (expenses) | ||||||||||||||||
| Interest and other income | 983 | 1,116 | 3,441 | 2,015 | ||||||||||||
| Other income (expense), net | - | (82 | ) | 5 | (232 | ) | ||||||||||
| Total other income | 983 | 1,034 | 3,446 | 1,783 | ||||||||||||
| Loss before income taxes | (25,010 | ) | (21,541 | ) | (70,583 | ) | (64,630 | ) | ||||||||
| Income tax benefit | 15 | 6 | 33 | 40 | ||||||||||||
| Net loss | $ | (24,995 | ) | $ | (21,535 | ) | $ | (70,550 | ) | $ | (64,590 | ) | ||||
| Other comprehensive (loss) income | ||||||||||||||||
| Unrealized gain (loss) on marketable securities, net of tax | (18 | ) | 17 | 142 | 37 | |||||||||||
| Comprehensive loss | $ | (25,013 | ) | $ | (21,518 | ) | $ | (70,408 | ) | $ | (64,553 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.96 | ) | $ | (0.87 | ) | $ | (2.74 | ) | $ | (2.95 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 25,912,568 | 24,878,413 | 25,765,414 | 21,900,943 |