Full Press Release Details
Assembly Biosciences Reports Third Quarter 2020 Financial Results and
SOUTH SAN FRANCISCO, CA, November 5, 2020 -- 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 a business update for the third quarter ended September 30, 2020.
"We continue to make progress to develop our pipeline of core inhibitor candidates for the treatment of patients with HBV," said John McHutchison, AO, MD, Chief Executive Officer and President of Assembly Biosciences. "We have made great strides toward initiating the vebicorvir Phase 3 registrational program, as well as advancing ABI-H2158 and ABI-H3733, our more potent, next-generation core inhibitor compounds, in the clinic."
Corporate Highlights
Anticipated Milestones and Events
Third Quarter 2020 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 Bio's fully integrated platform, including a robust process for strain identification and selection, GMP manufacturing expertise 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 that are subject to certain risks and uncertainties that could cause actual results to materially
differ. These risks and uncertainties include: Assembly Bio's ability to initiate and complete clinical trials involving its HBV Cure and Microbiome therapeutic product candidates in the currently anticipated timeframes; safety and efficacy data from clinical studies may not warrant further development of Assembly Bio's product candidates; clinical and nonclinical data presented at conferences may not differentiate Assembly Bio's product candidates from other companies' candidates; Assembly Bio may not observe sustained virologic response in patients who stop therapy in Study 211; the timing and ability to implement strategic alternatives with respect to Assembly Bio's Microbiome program; Assembly Bio's ability to maintain financial resources necessary to continue its clinical trials and fund business operations; any impact that the spread of the coronavirus and resulting COVID-19 pandemic may have on Assembly Bio's business and operations, including initiation and continuation of its clinical trials or timing of discussions with regulatory authorities; and other risks identified from time to time in Assembly Bio's reports filed with the U.S. Securities and Exchange Commission (the SEC). You are urged to consider statements that include the words may, will, would, could, should, might, believes, hopes, estimates, projects, potential, expects, plans, anticipates, intends, continues, forecast, designed, goal or the negative of those words or other comparable words to be uncertain and forward-looking. Assembly Bio 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. More information about Assembly Bio's risks and uncertainties are more fully detailed under the heading "Risk Factors" in Assembly Bio's filings with the SEC, including its most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Except as required by law, Assembly Bio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor and Corporate:
Senior Vice President, Investor Relations and Corporate Affairs
ASSEMBLY BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands except for share amounts and par value)
| September 30, | December 31, | |||||||
| 2020 | 2019 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 58,311 | $ | 46,732 | ||||
| Marketable securities | 179,630 | 227,311 | ||||||
| Accounts receivable from collaboration | 3,590 | 3,374 | ||||||
| Prepaid expenses and other current assets | 4,856 | 5,363 | ||||||
| Total current assets | 246,387 | 282,780 | ||||||
| Property and equipment, net | 1,904 | 1,830 | ||||||
| Operating lease right-of-use (ROU) assets | 10,397 | 11,975 | ||||||
| Other assets | 5,980 | 1,684 | ||||||
| Indefinite-lived intangible asset | 29,000 | 29,000 | ||||||
| Goodwill | 12,638 | 12,638 | ||||||
| Total assets | $ | 306,306 | $ | 339,907 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 1,611 | $ | 1,731 | ||||
| Accrued clinical expenses | 4,451 | 4,826 | ||||||
| Other accrued expenses | 7,404 | 8,286 | ||||||
| Deferred revenue - short-term | - | 6,411 | ||||||
| Operating lease liabilities - short-term | 3,338 | 3,186 | ||||||
| Total current liabilities | 16,804 | 24,440 | ||||||
| Deferred tax liabilities | 2,531 | 2,531 | ||||||
| Deferred revenue - long-term | 8,987 | 30,637 | ||||||
| Operating lease liabilities - long-term | 7,435 | 9,082 | ||||||
| Total liabilities | 35,757 | 66,690 | ||||||
| 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, 2020 and December 31, 2019; 32,924,536 and 32,558,307 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively | 33 | 32 | ||||||
| Additional paid-in capital | 732,829 | 712,807 | ||||||
| Accumulated other comprehensive loss | (158 | ) | (201 | ) | ||||
| Accumulated deficit | (462,155 | ) | (439,421 | ) | ||||
| Total stockholders' equity | 270,549 | 273,217 | ||||||
| Total liabilities and stockholders' equity | $ | 306,306 | $ | 339,907 |
ASSEMBLY BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
(In thousands except for share and per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Collaboration revenue | $ | 34,611 | $ | 4,231 | $ | 78,068 | $ | 11,197 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 26,941 | 21,736 | 73,314 | 63,141 | ||||||||||||
| General and administrative | 11,689 | 8,488 | 29,888 | 22,085 | ||||||||||||
| Total operating expenses | 38,630 | 30,224 | 103,202 | 85,226 | ||||||||||||
| Loss from operations | (4,019 | ) | (25,993 | ) | (25,134 | ) | (74,029 | ) | ||||||||
| Other income | ||||||||||||||||
| Interest and other income, net | 670 | 983 | 2,400 | 3,446 | ||||||||||||
| Total other income | 670 | 983 | 2,400 | 3,446 | ||||||||||||
| Loss before income taxes | (3,349 | ) | (25,010 | ) | (22,734 | ) | (70,583 | ) | ||||||||
| Income tax benefit | - | 15 | - | 33 | ||||||||||||
| Net loss | $ | (3,349 | ) | $ | (24,995 | ) | $ | (22,734 | ) | $ | (70,550 | ) | ||||
| Other comprehensive (loss) income | ||||||||||||||||
| Unrealized (loss) gain on marketable securities, net of tax | (262 | ) | (18 | ) | 43 | 142 | ||||||||||
| Comprehensive loss | $ | (3,611 | ) | $ | (25,013 | ) | $ | (22,691 | ) | $ | (70,408 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.09 | ) | $ | (0.96 | ) | $ | (0.64 | ) | $ | (2.74 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 35,506,042 | 25,912,568 | 35,321,393 | 25,765,414 |